Device Access - HES Application 2025

Device Access UK Limited (DAUK) is a commercial organisation, working with Department for International Trade (DIT), the Office of Life Sciences (OLS) and the National Institute for Health Research (NIHR), National Institute for Health & Care Excellence (NICE), and working directly with Device Access’ medical technology and NHS clients. DAUK will carry out bespoke analysis of the data and provide that analysis to DAUK clients. The medical technology companies are, or wish to become, service providers to the NHS, or UK Government & NHS bodies.

DAUK charges for their services. DAUK’s clients are 90% MedTech companies, none are marketing agencies, the remaining 10% being NHS organisations within England. These companies wish to gain NICE recommendations in order to accelerate the adoption of their technologies into the NHS. The process for this involves collating various evidence of the benefit of the device including analysis of current patient pathways which is produced by DAUK via bespoke aggregated analysis

DAUK requires access to NHS England data for the purpose of a programme of work which identifies where medical and diagnostic technologies can best be used by healthcare providers worldwide, including NHS providers in NHS patient care pathways to improve patient outcomes, reduce lengths of stay, elective and diagnostic waiting times.

This programme of work is split into five distinct project areas as detailed below.

1. NICE applications on behalf of medical technological device companies (Approximately 70% of analysis and income stream produced by DAUK):

DAUK act as a bridge between medical technological device companies and the NHS by providing these companies with expertise and bespoke analysis in order to complete the NICE (National Institute of Clinical Excellence) process required before new innovations can be recommended and then adopted into the NHS for the benefit of patients. The commercial benefit to the MedTech companies arises when they fully go through NHS adoption via NICE approval using pre-existing evidence alongside HES data analysis carried out by DAUK as recommended by NICE in their recent methods guide (https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation#diagnostics-assessment-programme) which states that “The Medical Technologies Evaluation Programme uses a cost-minimisation approach to assess products. This approach considers the costs and resource consequences resulting from, or associated with, the technology under evaluation and comparator technologies. It considers clinical benefits (for example, effectiveness outcomes) alongside the cost analysis.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented. The device companies have no influence or decision on the research that is carried out or over the way in which the analysis is processed or the results. DAUK have a Data Reuse Agreement with each device company, which, alongside the Non-Disclosure Agreement, prevents the company from disseminating the bespoke aggregated and suppressed outputs produced by DAUK.

NICE programmes relating to the review of new or existing medical and diagnostic technologies require a submission based on a detailed understanding of and real evidence around, current NHS patient pathways.

NICE submissions offer relatively speedy assessments of selected innovations, with the aim of making relevant information available quickly to clinicians and NHS hospital decision makers, to support rapid adoption where this are appropriate.

Submissions to NICE require the following which DAUK extract from HES datasets;

• Understanding of the effect of disease; and how the current NHS patient population is diagnosed and / or treated. Bespoke analysis is carried out for each company on very specific patient cohorts. Since 2017, DAUK have carried out data analysis for approximately 100 MedTech companies and NHS organisations on various conditions, symptoms, diseases and treatments covering all clinical contexts, examples of which have been evaluated by NICE and have influenced the decision making are listed below in the Agreement.

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Detailed understanding of cost-effectiveness improvements compared to current NHS pathways

Before accepting a request for submission to Device Access Data Access Review Group (DADARG) and prior to any analysis or extraction of data, DAUK ensures that the technology meets the criteria of a potentially successful NICE submission by conducting internal research around the following formula (PICO);

I. Population - Who would the technology treat

II. Indication - how the technology works

III. Comparator - How care is currently delivered to the population

IV. Outcome - Are the benefits in line with the Health and Social Care Act 2012

Only once DAUK are satisfied that the technology meets these criteria and following approval from DADARG (that it will be of benefit to patients and/or the health care system) will they then conduct the bespoke analysis required for NICE submissions.

As an example of this work, DAUK provided bespoke analysis for a medical device company who have developed a medical technology which measures and records the EEG of patients with suspected epilepsy seizures.

DAUK’s analysis of NHS England data showed that over 400,000 episodes had patients with a diagnosis of epilepsy of which approximately 60,000 episodes were for frequent flyer patients, those that had 4 or more episodes in a 12 month period. These admissions resulted in significant use of NHS resources, including the use of over 130,000 bed days which when reduced allows NHS hospitals to treat additional patients with the increased spare beds, increasing efficiency as a result of changing the pathway.

2. NIHR research applications on behalf of medical technological device companies (Approximately 10% of analysis and income stream produced by DAUK):

Medical technological device companies can submit applications for research studies through the NIHR (National Institute for Health Research). NIHR research is often required to provide clinical evidence for NICE applications.

This activity is funded by the Medical Technology Company but can be funded directly to the Medical Technology Company though NIHR grants.

The bespoke analysis provided by DAUK includes;

• Clinical need analysis, evidence gap analysis and clinical endpoints

• Understanding of the effects of disease; and how the current NHS patient population is diagnosed and or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Understanding of potential cost-effectiveness improvements compared to current NHS pathways

DAUK provided bespoke analysis which has secured collaborative research for the manufacturer of the technology with the NIHR. DAUK have also identified the areas of the country where there is most need thus enabling faster patient enrolment into this study.

3. NHS adoption support on behalf of medical technological device companies (Approximately 10% of analysis and income stream produced by DAUK):

DAUK provide expertise and bespoke analysis to medical technological device companies and the NHS in order to assist with adoption and diffusion of NICE recommended technologies so new innovations can be adopted into the NHS for the benefit of patients, and the healthcare system. There is no split in the type of analysis carried out for MedTech companies and for the NHS. There is no device level coding within HES, the analysis is carried out on procedure and diagnostic codes. The commercial benefit to the MedTech companies arises when they fully go through NHS adoption via NICE approval using pre-existing evidence alongside bespoke aggregated analysis carried out by DAUK. The commercial gain is a fraction of the benefit to the NHS created from the adoption of new medical devices.

This analysis is used to support local NHS adoption by providing information relating to benefits for patients in a local area. This information is sent by DAUK to both the medical device company and also the NHS hospital stake holders to demonstrate the benefit to comply with NICE guidance. This activity is paid for by the Medical Technology Company. Although the Medical Technology Company pays for this activity, the actual data processing conducted is not influenced by any input from the Medical Technology Company. DAUK control the raw HES data supplied by NHS England Following approval via DADARG, DAUK produces bespoke aggregated and suppressed analysis on specific patient cohorts relevant to the device and its comparators.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be used. The device companies have no influence over the way in which the analysis is processed or the results.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases (Approximately 5% of analysis and income stream produced by DAUK):

DAUK provide expertise and bespoke analysis to the NHS in order to assist with identifying new medical technology and diagnostics in support of relevant disease states with a view that these will be adopted into the NHS for the benefit of patients, and NHS hospitals.

This activity is commissioned by the NHS, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented.

This work does not include broad based economic consultancy services such as benchmarking but is limited to the purposes described in this Agreement. The basis of DAUK’s consultancy service has remained unchanged since first receiving HES data in 2014. The consultancy service provided in relationship to data analysis are on named medical devices and analysing current care pathways in the NHS, therefore this is not broad consultancy but instead is a narrow evidence base. It is solely focused on adoption of named medical devices into the NHS via NICE approval. DAUK would submit an amendment application to NHS England if DAUK were to consider a consultancy service which fell outside this agreed purpose. To confirm, DAUK make the decisions on the purpose and means of the processing the data. On review of DADARG, MedTech companies agree via the Data Sharing Agreement to the terms and purposes of the bespoke aggregated and supressed analysis produced by DAUK.

5. Department for International Trade (DIT) and Office for Life Sciences (OLS) (Approximately 5% of analysis and income stream produced by DAUK):

Since 2010, DAUK has supported the Department of International Trade, formerly known as the UK Trade and Investment (UKTI) who are part of the Government’s Office for Life Sciences.

Part of the DIT and OLS objectives are to attract inward investment into the UK from companies across the world, to develop their business here in the life science sectors and DAUK has worked to support the strategy of the OLS and DIT. DAUK can draw upon the multinational team of experts from IGES, however this is not in relation to the HES data. DAUK continues to support the objectives of the OLS and DIT independently to IGES.

OLS and DIT commission DAUK with requests for market information, and DAUK provides free expertise on disease state, procedure volume and reimbursement. DAUK are the sole data controller for the HES data supplied. DIT and OLS are UK government bodies that DAUK supply expertise on disease state, procedure volume and NHS funding following standard processes of providing the above outside of DAUK. Neither OLS or DIT have any influence on the purpose for processing the NHS England data supplied under this Agreement, nor have any access to the data.

DAUK decide the manner and the process by which the analysis is carried out. DIT and OLS have no influence over the way in which the analysis is processed or the results.

The following NHS England data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care

o Accident & Emergency

o Critical Care

o Outpatients

• Emergency Care Data Set (ECDS)

Device Access produces analysis on multiple groups of patients and areas of medical fields. This involves understanding the flow of patients through NHS hospitals including those in admitted patient care or outpatients and those in critical care or admitted via emergency care. Therefore, all of the above four data sets are necessary to be able to comprehend the full story of these patients and their pathway.

The level of the data will be:

• Pseudonymised

The data will be minimised as follows:

•Limited to the latest 4 years of data that is available. When new annual data becomes available, the oldest year is destroyed to ensure a rolling 4 years at any one time.

DAUK is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party.

DAUK’s legitimate interest is in conducting scientific and statistical research in order to enable medical device providers to achieve NICE approvals and accreditation and subsequent NHS Adoption, and thus positively impact patients Hospitals and the NHS.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

As described in this Data Sharing Agreement, the processing carried out by Device Access, allows patients and hospitals to access new medical devices more rapidly by carrying out the research required by NICE to understand the impact and benefits of these new medical devices being used with NHS hospitals. This increases the efficiency of these hospitals and provides better care for the patients, for example via shorter lengths of stay and less readmissions.

DAUK charge their clients for services. In some instances of projects, these monies have been awarded to medical device companies via grants for medical technologies.

DAUK has a Data Access Review Group (DADARG) which is formed of five members; three of which are external to Device Access and employed by NHS England in a clinical or research role. Their roles within the NHS are a vascular surgeon, General manager Trauma and orthopaedics and Programme Lead, ICS Development in NHS England

It is the role of DADARG to review, approve or deny individual requests made from commercial Medical Device companies and NHS organisations (Requestors) to DAUK (Supplier). The group has a clear methodology for approving new requests and is covered by the terms of reference which govern the group. DADARG reviews the companies’ literature and information to determine if the medical device shows evidence for being beneficial to patients and the health and social care system in England and Wales. If there is evidence of this, DADARG approve DAUK to carry out HES analysis and supply the MedTech company with bespoke aggregated and supressed analysis which further supports the adoption of the medical device into the NHS.

DAUK is a dedicated medical technology reimbursement consultancy brought together under the IGES MedTech Group (https://medtech.iges.com/) which combines the expertise and excellent scientific work of three companies: AiM, Device Access UK and Meditech Access.

IGES MedTech is a multinational team of experts for all aspects of market access and reimbursement of medical devices in Europe.

DAUK work under the umbrella of IGES Group and remain an independent registered UK Limited company to them. IGES have no influence on the DADARG, have no access to the HES data controlled and managed by DAUK, and have no influence in the purposes for processing the data.

Data is accessed and processed by substantive employees of DAUK.

Commercial companies specifically agree not to use the analysis provided by DAUK within general marketing, or within collateral material used by sales and marketing teams, via their Data Reuse Agreement with DAUK. This is a contractual Agreement between DAUK and the MedTech company that is signed before any bespoke aggregated and supressed analysis is shared. Companies' websites are periodically reviewed to ensure this analysis is not included within their marketing outputs. These include sales brochures, emails, direct or mass mailing and advertising of medical technologies. DAUK do not allow portal access to the data by clients.

Description of outputs have been provided below;

1. NICE applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions to NICE for evaluation. These bespoke outputs are in the form of reports and graphical charts and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NICE applications.

Below are examples of DAUK analysis which has been used in NICE applications and have resulted in positive NICE guidance in 2022-2023:

• HTE10 - KardiaMobile 6L for measuring cardiac QT interval in adults having antipsychotic medication

• MTG64 - KardiaMobile for detecting atrial fibrillation

• MTG76 - AposHealth for knee osteoarthritis

• MTG39 - iFuse for treating chronic sacroiliac joint pain

• MTG74 - GreenLight XPS for treating benign prostatic hyperplasia

• IPG770 - Procept Biorobotics - Transurethral water-jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• IPG773 - Limflow - Percutaneous deep venous arterialisation for chronic limb-threatening ischaemia

• IPG758 - Merit medical - Radiofrequency ablation for palliation of painful spinal metastases

• IPG750 - iStar medical - Trabeculectomy with a biodegradable collagen matrix implant for glaucoma

• IPG749 - TORAX MEDICAL - Laparoscopic insertion of a magnetic ring for gastro-oesophageal reflux disease

• IPG745 - Glaukos - Ab interno canaloplasty for open-angle glaucoma

• IPG743 - Theraclion - Percutaneous ultrasound-guided microwave ablation for symptomatic benign thyroid nodules

• IPG737 - Butterfly medical - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

• IPG736 - Limflow - Superficial venous arterialisation for chronic limb threatening ischaemia

• IPG695 - Transmedics - Ex-situ machine perfusion for extracorporeal preservation of lungs (ex-vivo lung perfusion) for transplant

• IPG690 - OrganOx - Extracorporeal whole liver perfusion for acute liver failure

• IPG683 - Capnomed - Balloon cryoablation for squamous dysplasia of the oesophagus

• DG48 - Fibroscan Echosens - FibroScan for assessing liver fibrosis and cirrhosis outside secondary and specialist care

New NICE program for regulatory approval - IDAP program – Initiative device access pathway

The Innovative Devices Access Pathway (IDAP) pilot is an initiative to bring new technologies and solutions to the National Health Service (NHS) to help with medical needs that are not currently being met. The aim of IDAP is to enable and improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers. The aim of the pilot is to test the main elements of the pathway and to provide informative learning and feedback that helps to build the future IDAP. The IDAP is open to UK and international commercial and non-commercial developers with new health technology solutions. Successful applicants will receive support at key stages of their product design and development process from the IDAP partners. The following are examples of medical technological device companies who have received support from Device Access on IDAP applications:

• Histosonics - Liver tumour ablation

• Francis Medical - Malignanat prostate cancer

Prior to 2023, DAUK supported 59 additional NICE Medical Technology approvals leading to guidance;

• MIB316 - Ambu aScope 4 RhinoLaryngo for visualising upper airways during rhinolaryngoscopy

• MIB314 - Ambu aScope 4 Broncho for routine diagnostic and therapeutic bronchoscopy

• MIB299 - RespiraSense for continuously monitoring respiratory rate

• MIB286 - The Insides System for managing intestinal failure

• GID-DG10065 - Artificial intelligence-derived software to analyse chest X-rays for suspected lung cancer in primary care referrals: early value assessment

• MIB277 – UNEEG Medical - 24/7 EEG SubQ for epilepsy

• MIB275 – OrganOx - OrganOx metra for liver transplant

• MTG60 – DyeVert - DyeVert Systems for reducing the risk of acute kidney injury in coronary and peripheral angiography

• MTG62 – ClearGuardHD - ClearGuard HD antimicrobial barrier caps for preventing haemodialysis catheter-related bloodstream infections

• MTG20 – Parafricta - Parafricta Bootees and Undergarments to reduce skin breakdown in people with or at risk of pressure ulcers

• GID-MT533 – SEM scanner - SEM Scanner 200 for pressure ulcer prevention

• IPG681 - Pressurised intraperitoneal aerosol chemotherapy for peritoneal carcinomatosis

• MTG55 - Leukomed Sorbact for preventing surgical site infection

• IPG682 - Balloon cryoablation for Barrett’s oesophagus

• IPG683 - Balloon cryoablation for squamous dysplasia of the oesophagus

• MIB233 - Dexcom G6 for real-time continuous glucose monitoring

• MIB234 - ClearGuard HD Antimicrobial Barrier Cap for preventing haemodialysis catheter-related bloodstream infections

• MIB232 - KardiaMobile for the ambulatory detection of atrial fibrillation

• MTG49 – NxThera - Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

• MTG43 - PICO negative pressure wound dressings for closed surgical incisions

• MIB196 - DyeVert for reducing contrast media in coronary and peripheral angiography

NICE MIB158 – NxThera - Rezum for treating benign prostatic hyperplasia

• NICE MIB 159 – Hill-Rom – The Vest for delivering high-frequency chest wall oscillation in people with complex neurological needs

• NICE IPG629 – Procept Biorobotics - Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB165 – Cerebrotech - Cerebrotech Visor for detecting large vessel occlusion stroke

• NICE IPG625 - NxThera - Transurethral water vapour ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB173 – Acelity Prevena - Prevena incision management system for closed surgical incisions

• NICE MIB168 – Limax Humedics - LiMAx system for assessing the functional capacity of the liver

• NICE MTG45 – Endocuff - Endocuff Vision for assisting visualisation during colonoscopy

• NICE MIB182 – Bruin - SEM Scanner for pressure ulcer prevention

• NICE IPG641 – Medi-Tate - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB86 Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis

• NICE MIB 47 - TearLab - TearLab osmolarity system for diagnosing dry eye disease

• NICE TA628 - Zeiss - Intraoperative Radiotherapy for Breast Cancer

• NICE IPG 479 - Sequana Medical - Device to manage ascites

• NICE MTG19 - FirstKind Medical - Device to stimulate peripheral blood flow for DVT Prevention

• NICE IP475 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE MT241 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE DG12 - Aerocrine Ltd - Diagnostic Test to Manage Asthma

• NICE MIB8 - Airsonett Ltd - Airsonett temperature-controlled laminar airflow device for persistent allergic asthma

• NICE IPG396 - Glaukos - Trabecular stent bypass microsurgery for open angle glaucoma

• NICE IPG431 - Torax Medical - Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease

• NICE IPG549 - Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG29 - Boston - GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 - Entellus - XprESS multi sinus dilation system for treating chronic sinusitis

• NICE IPG578 - Si Bone - Spinal Fusion Technology for lumbar sacral pain

• NICE MTG19 - Geko First Kind - The geko device for reducing the risk of venous thromboembolism

• NICE IPG 1555 - NxThera - Water vapour for treating benign prostate hyperplasic

• NICE IPG 1520 - Thoraclion - Hi Intensity focussed ultrasound for breast lumps

• NICE MIB47 - Tearlab - Diagnosis of dry eye disorders

• NICE MTG32 - Heartflow – Diagnostic platform for the optimal placement of cardiac stents

• NICE MIB110 - Abbott - Diabetic Monitoring

• NICE MIB116 - Urethrotech - Urinary Catheterisation device for men with enlarged prostates

DAUK also uses the HES analysis to support publications for health economic studies to support NICE submissions, examples of publications are shown below:

• Continuous Monitoring of Respiratory Rate with Wearable Sensor in Patients Admitted to Hospital with Pneumonia Compared with Intermittent Nurse-Led Monitoring in the United Kingdom: A Cost-Utility Analysis (https://pubmed.ncbi.nlm.nih.gov/34387850/)

• Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1776298?scroll=top&needAccess=true)

• Cost-utility analysis of normothermic liver perfusion with the OrganOx metra compared to static cold storage in the United Kingdom (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1804391?scroll=top&needAccess=true)

• Cost utility analysis of continuous and intermittent versus intermittent vital signs monitoring in patients admitted to surgical wards (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1747474?scroll=top&needAccess=true&)

• A Corticosteroid-Eluting Sinus Implant Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: A UK-Based Cost-Effectiveness Analysis (https://link.springer.com/article/10.1007/s41669-020-00198-8)

• Ticagrelor Removal by CytoSorb® in Patients Requiring Emergent or Urgent Cardiac Surgery: A UK-Based Cost-Utility Analysis (https://link.springer.com/article/10.1007%2Fs41669-019-00183-w)

• DyeVert™ PLUS EZ System for Preventing Contrast-Induced Acute Kidney Injury in Patients Undergoing Diagnostic Coronary Angiography and/or Percutaneous Coronary Intervention: A UK-Based Cost–Utility Analysis (https://link.springer.com/article/10.1007/s41669-020-00195-x)

2. NIHR research applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions for NIHR funding. All bespoke outputs come in the form of reports and graphical charts and are aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NIHR applications. DAUK additionally have partnered with NIHR Medtech Collaborative from April 2024 for 5 years.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with adoption of NICE approved technologies into the NHS.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used as evidence to support discussions in NHS Hospitals with key NHS stakeholders including finance directors, clinical managers, clinicians and CCG͛s.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

DAUK uses the HES analysis to support their NHS clients with the development of new medical technology and diagnostics in support of relevant disease states.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide.

This analysis is used as evidence to support medical technology developments in NHS Hospitals with key NHS stakeholders including commissioners, clinicians and researchers.

5. Department for International Trade DIT and Office for Life Sciences (OLS):

A basic summary of National HES extracts of disease state, procedure volume and reimbursement analysis are supplied free of charge by DAUK to the DIT and OLS for use in direct and combined discussions with potential overseas companies considering UK market entry. DAUK only provides DIT and OLS with National information, not by hospital or provider. Outputs are therefore aggregated, with small numbers suppressed in line with the HES Analysis Guide.

DADARG Reviews and Approval numbers:

For all outputs produced by DAUK, these must be approved by the Device Access UK Limited (DAUK) Data Access Review Group (DADARG). The following is the review and approval numbers of DADARG for the previous 4 years:

*2023 – 30 Reviewed, 27 Approved

Areas of work: Obesity, Type II Diabetes, Heart attacks in hospital, Lung cancer, Gonarthrosis, Hospital and ventilator acquired pneumonia, Heart failure, Cardiomyopathy, Myocardial infarction, Neurostimulator for spinal cords, C-sections, Vascular procedures, Bowel resections, Sleep apnoea, Heart valve replacement, Staphylococcus infections, Bladder cancer, Kidney Injury, Macular degeneration, Coronary artery bypass graft, Otits Media, Breast cancer, Pancreatic cancer, Bile duct cancer, Cardiac procedures, Radiotherapy, Chemotherapy

*2022 – 24 Reviewed, 22 Approved

Areas of work: Obesity, Radiotherapy, low birth weight and hypothermic newborn patients, Hospital and ventilator acquired pneumonia, Age-related Macular Degeneration, C-sections, Vascular procedures, Pancreatic cancer, Bile duct cancer, Kidney Transplants, Skin cancer, Skin grafts, Breast cancer, Lung cancer, Stroke rehabilitation, Prostate cancer, Endometriosis, Brain cancer, Cardiac procedures, Colorectal procedures, Hip and Knee and Shoulder replacements, Lung Nodules, Ascities

*2021 – 31 Reviewed, 28 Approved

Areas of work: Obesity, Cardiac endovascular treatments, Angioplasty, Hospital and ventilator acquired pneumonia, Functional Endoscopic Sinus Surgery, Functional Endoscopic Nasal Surgery, Chronic Ischemic Heart Disease, Myocardial infarction, AMD, C-sections, Vascular procedures, Peripheral vascular disease, Oral Mucositis, Head and Neck cancer, Artery procedures, Electrocardiography, Replacement of mitral valve, Paralysis of vocal cords, Varicose Veins, Gall Bladder, Gastric Bypass, Breast procedures, Bladder Disorders, Lung cancer, Endoscopy, Epilepsy, Spine fractures, Chronic rhinitis

*2020 – 30 Reviewed, 26 Approved

Areas of work: Hospital and ventilator acquired pneumonia, Meningitis, Neurostimulator for spinal cords, Injury to nerves, Peripheral Nerve Operations, C-sections, Vascular procedures, Polyp of colon, Colon cancer, Epilepsy, Cardiac Arrest, Gastro-oesophageal reflux disease, Atrial fibrillation, Palpitations, Kidney transplants, Fistula of Intestine, Enterostomy, Myocardial infarction, Angioplasty, Glaucoma, Glucose monitoring, Cranioplasty, Pressure ulcers, Delirium, Sepsis, Surgical complications, Breast cancer

1. Histosonics – IDAP Program

Histotripsy uses pulsed sound waves to induce “bubble clouds” from gases naturally present in targeted tissue. These bubble clouds form and collapse in microseconds, creating mechanical forces strong enough to destroy tissue at cellular and sub-cellular levels in a non-invasive and non-thermal method. Edison® is a sophisticated platform that delivers pulsed sound energy into the body, without any incisions or needles, and has the ability to destroy tumours at the sub-cellular level, all while the treating physician continuously monitors the “bubble cloud” and treatment effect in real-time.

HistoSonics ®, the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today that the company’s Edison System has been selected to participate in the UK’s newly created Innovative Devices Access Pathway (IDAP) Pilot Program designed to accelerate the development of cost- effective medical devices and their integration into the UK market. Applications to compete for one of the 8 available places in the highly sought after UK program began in 2023 and was open to UK and international commercial and non-commercial developers with new health technology solutions.

The IDAP Pilot Program was designed and developed by a partnership of the Department of Health and Social Care, The Medicines and Healthcare products Regulatory Agency (MHRA), The National Institute for Health and Care Excellence (NICE), NHS England, Health Technology Wales, and Scottish Health Technology Group to test the IDAP pathway and to expedite the incorporation of novel medical technologies that have demonstrated the potential to meaningful address the UK’s top healthcare concerns of today, as well as in the future. The Edison Histotripsy System was measured against four distinct eligibility criteria that were required of applicants for consideration in the IDAP program. Applicants must have met the following in order to be considered for the IDAP Pilot Program; 1) the technology addresses a life-threatening or seriously debilitating condition and there is a significant patient need, 2) the technology is innovative and transformative, 3) the technology will provide system wide benefit, and 4) the technology clearly helps to address one of the following Life Sciences Vision’s Healthcare Missions. In addition to meeting the eligibility criterion set, the IDAP program enlisted patient experts in the shortlisting and selection of the eight innovative and transformative medical devices that were eventually chosen to participate.

Device Access analysed HES data on patients showing diagnostic codes for both liver cell carcinoma and secondary malignant neoplasms of liver to understand the population size within NHS England. The primary treatments of these patients including chemotherapy, radiotherapy and surgical treatments to see how the patient pathway currently looks within the system. This showed long lengths of stay and high readmission rates for large populations of patients where an earlier and novel treatment of cancer would reduce burdens to NHS hospitals.

2. Stryker Sage – Oral care to reduce the risk of pneumonia

Every hospitalised patient is at risk of contracting pneumonia during a stay in hospital. This is increased for ventilated, elderly or ICU patients but all patients are at risk throughout their stay. Stryker Sage sets out to improve patient oral hygiene which can significantly impact the risk factors of pneumonia.

Device Access carried out in depth analysis nationally and at an individual trust level to understand the risks associated with patients developing pneumonia in two separate cases – Hospital acquired pneumonia (HAP) and ventilator required pneumonia (VAP). Patient cohorts showing diagnostic codes for these conditions were compared to similar patient cohorts without these specific complications. Various factors of patients were studied, showing average length of stay increases for HAP of 4.9 days to 13.6 days and 9.7 days to 14.8 days for VAP. Additionally, mortality, sepsis and readmission rates were analysed showing increases in all factors across both types of pneumonia.

3. Sierra Medical

Sierra Medical is producing a promising test for early detection of lung cancer which is carried out by analysing cells from a simple cheek swab. Using cloud based analytical methods, diagnostic labs can process the data from these swabs automatically. AI algorithms automatically process and analyse sample data in the cloud to generate a tailored diagnostic report where no specialist operators are not required.

Data analysis was carried out on two main cohorts of patients, those diagnosed with lung cancer and those who underwent diagnostic testing for lung cancer without a positive diagnosis. The former allowed understanding of the patient pathway of lung cancer detection and gave insight into how earlier detection and therefore earlier treatment would be beneficial to the NHS and to patients, for example via reduced secondary cancers developing. The latter cohort was studied to understand the impact of ruling out lung cancer earlier in the process of testing. This reduces the impact on patients and the NHS trusts by requiring less diagnostic imagining as well as reducing more invasive surgical procedures such as biopsies.

4. MTG64 AliveCor – KardiaMobile

https://www.nice.org.uk/advice/mtg64

The AliveCor KardiaMobile ECG is a single-channel cardiac event recorder. It consists of a device and app that enables you to record and review electrocardiograms (ECG's) anywhere, anytime. The device attaches to the back of most iOS and Android devices, and communicates wirelessly with the free Kardia app, providing powerful display, analysis and communication capabilities.

Device Access carried out data analysis on patients diagnosed with atrial fibrillation and palpitations. Comorbidities of these patients, including breathlessness, dyspnoea, syncope, chest pain, heart failure and chronic ischaemic heart disease were identified as subset of cohorts of patients of interest, showing high lengths of stay, readmission rates and emergency admissions. By allowing earlier detection of heart issues, NHS trusts would be able to treat these patients before they develop further medical problems. This helps reduce readmissions to hospital as well as length of stay for patients who receive this earlier treatment, saving bed days and allowing trusts to treat additional patients.

5. MIB286 - The Insides System for managing intestinal failure

https://www.nice.org.uk/advice/mib286

The Insides System (The Insides Company) is a chyme reinfusion system designed to help people with high-output fistulas or stomas after bowel surgery. The system aims to infuse the effluent of the fistula or stoma into the distal gut.

The system works by chyme and intestinal fluid being pumped back into the distal intestines using an Insides Driver. The driver is a handheld battery‑powered device that connects magnetically to the Insides Pump found in the stoma bag. The driver powers the pump to refeed the content of the stoma bag back into the distal intestine. An Insides Tube is inserted into the distal intestine and connected to the Insides Pump as a tube to transport chyme. Five driver speed options are available to allow the person to control the rate of infusion manually, depending on tolerability and viscosity.

Patients undergoing enterostomy, ileostomy or showing the diagnostic code for fistula of intestine were identified to understand differences in length of stay, readmissions, comorbidities and complications within these groups and across subsets of patients with parenteral nutrition.

returning to hospital at least three times withing twelve months. This showed the operation gain available to NHS England and NHS trusts, by allowing patients earlier mobility, comorbidities that arise from immobile patients would not occur, reducing the treatment patients required and their subsequent length of stay. Additionally, patients could be discharged earlier, since patients would be able to rehabilitate at home, further decreasing length of stay and freeing up beds for additional patients to be treated.

7. Liquid Biopsies for Faster Diagnosis in Pancreatic and Bile Duct Cancer; DAUK worked with clinicians at Royal Marsden NHS Foundation Trust to understand how the implementation of liquid biopsies could affect patients undergoing diagnosis with pancreatic or bile duct cancer. DAUK analysis has contributed to technology that decreases time for diagnosis of pancreatic or bile duct cancer therefore allowing patients to be treated faster leading to fewer complications, shorter lengths of stay and reduced waiting lists.

8. DAUK has worked with over 10 NHS Hospitals in England, including Manchester Royal Infirmary, Charing Cross Hospital and Southampton General Hospital, in helping them decide if they should adopt a new mechanism of reducing admissions and length of stay through a technology that replaces treats patients with chronic rhinosinusitis following ethmoid, frontal or maxillary sinus surgery.

DAUK identified the numbers of treatments performed and the number of repeat episodes that patients returned for in specific hospitals. This was then entered into a costing model which was provided to the NHS Hospital as part of an adoption business case that summarised the patient and hospital benefits of adopting the new technology. The benefits for the patients are they may have improved sinus surgery outcomes from reduced inflammation, removing the need for readmissions for further treatment.

Device Access UK Limited (DAUK) is a commercial organisation, working with Department for International Trade (DIT), the Office of Life Sciences (OLS) and the National Institute for Health Research (NIHR), National Institute for Health & Care Excellence (NICE), and working directly with Device Access’ medical technology and NHS clients. DAUK will carry out bespoke analysis of the data and provide that analysis to DAUK clients. The medical technology companies are, or wish to become, service providers to the NHS, or UK Government & NHS bodies.

DAUK charges for their services. DAUK’s clients are 90% MedTech companies, none are marketing agencies, the remaining 10% being NHS organisations within England. These companies wish to gain NICE recommendations in order to accelerate the adoption of their technologies into the NHS. The process for this involves collating various evidence of the benefit of the device including analysis of current patient pathways which is produced by DAUK via bespoke aggregated analysis

DAUK requires access to NHS England data for the purpose of a programme of work which identifies where medical and diagnostic technologies can best be used by healthcare providers worldwide, including NHS providers in NHS patient care pathways to improve patient outcomes, reduce lengths of stay, elective and diagnostic waiting times.

This programme of work is split into five distinct project areas as detailed below.

1. NICE applications on behalf of medical technological device companies (Approximately 70% of analysis and income stream produced by DAUK):

DAUK act as a bridge between medical technological device companies and the NHS by providing these companies with expertise and bespoke analysis in order to complete the NICE (National Institute of Clinical Excellence) process required before new innovations can be recommended and then adopted into the NHS for the benefit of patients. The commercial benefit to the MedTech companies arises when they fully go through NHS adoption via NICE approval using pre-existing evidence alongside HES data analysis carried out by DAUK as recommended by NICE in their recent methods guide (https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation#diagnostics-assessment-programme) which states that “The Medical Technologies Evaluation Programme uses a cost-minimisation approach to assess products. This approach considers the costs and resource consequences resulting from, or associated with, the technology under evaluation and comparator technologies. It considers clinical benefits (for example, effectiveness outcomes) alongside the cost analysis.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented. The device companies have no influence or decision on the research that is carried out or over the way in which the analysis is processed or the results. DAUK have a Data Reuse Agreement with each device company, which, alongside the Non-Disclosure Agreement, prevents the company from disseminating the bespoke aggregated and suppressed outputs produced by DAUK.

NICE programmes relating to the review of new or existing medical and diagnostic technologies require a submission based on a detailed understanding of and real evidence around, current NHS patient pathways.

NICE submissions offer relatively speedy assessments of selected innovations, with the aim of making relevant information available quickly to clinicians and NHS hospital decision makers, to support rapid adoption where this are appropriate.

Submissions to NICE require the following which DAUK extract from HES datasets;

• Understanding of the effect of disease; and how the current NHS patient population is diagnosed and / or treated. Bespoke analysis is carried out for each company on very specific patient cohorts. Since 2017, DAUK have carried out data analysis for approximately 100 MedTech companies and NHS organisations on various conditions, symptoms, diseases and treatments covering all clinical contexts, examples of which have been evaluated by NICE and have influenced the decision making are listed below in the Agreement.

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Detailed understanding of cost-effectiveness improvements compared to current NHS pathways

Before accepting a request for submission to Device Access Data Access Review Group (DADARG) and prior to any analysis or extraction of data, DAUK ensures that the technology meets the criteria of a potentially successful NICE submission by conducting internal research around the following formula (PICO);

I. Population - Who would the technology treat

II. Indication - how the technology works

III. Comparator - How care is currently delivered to the population

IV. Outcome - Are the benefits in line with the Health and Social Care Act 2012

Only once DAUK are satisfied that the technology meets these criteria and following approval from DADARG (that it will be of benefit to patients and/or the health care system) will they then conduct the bespoke analysis required for NICE submissions.

As an example of this work, DAUK provided bespoke analysis for a medical device company who have developed a medical technology which measures and records the EEG of patients with suspected epilepsy seizures.

DAUK’s analysis of NHS England data showed that over 400,000 episodes had patients with a diagnosis of epilepsy of which approximately 60,000 episodes were for frequent flyer patients, those that had 4 or more episodes in a 12 month period. These admissions resulted in significant use of NHS resources, including the use of over 130,000 bed days which when reduced allows NHS hospitals to treat additional patients with the increased spare beds, increasing efficiency as a result of changing the pathway.

2. NIHR research applications on behalf of medical technological device companies (Approximately 10% of analysis and income stream produced by DAUK):

Medical technological device companies can submit applications for research studies through the NIHR (National Institute for Health Research). NIHR research is often required to provide clinical evidence for NICE applications.

This activity is funded by the Medical Technology Company but can be funded directly to the Medical Technology Company though NIHR grants.

The bespoke analysis provided by DAUK includes;

• Clinical need analysis, evidence gap analysis and clinical endpoints

• Understanding of the effects of disease; and how the current NHS patient population is diagnosed and or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Understanding of potential cost-effectiveness improvements compared to current NHS pathways

DAUK provided bespoke analysis which has secured collaborative research for the manufacturer of the technology with the NIHR. DAUK have also identified the areas of the country where there is most need thus enabling faster patient enrolment into this study.

3. NHS adoption support on behalf of medical technological device companies (Approximately 10% of analysis and income stream produced by DAUK):

DAUK provide expertise and bespoke analysis to medical technological device companies and the NHS in order to assist with adoption and diffusion of NICE recommended technologies so new innovations can be adopted into the NHS for the benefit of patients, and the healthcare system. There is no split in the type of analysis carried out for MedTech companies and for the NHS. There is no device level coding within HES, the analysis is carried out on procedure and diagnostic codes. The commercial benefit to the MedTech companies arises when they fully go through NHS adoption via NICE approval using pre-existing evidence alongside bespoke aggregated analysis carried out by DAUK. The commercial gain is a fraction of the benefit to the NHS created from the adoption of new medical devices.

This analysis is used to support local NHS adoption by providing information relating to benefits for patients in a local area. This information is sent by DAUK to both the medical device company and also the NHS hospital stake holders to demonstrate the benefit to comply with NICE guidance. This activity is paid for by the Medical Technology Company. Although the Medical Technology Company pays for this activity, the actual data processing conducted is not influenced by any input from the Medical Technology Company. DAUK control the raw HES data supplied by NHS England Following approval via DADARG, DAUK produces bespoke aggregated and suppressed analysis on specific patient cohorts relevant to the device and its comparators.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be used. The device companies have no influence over the way in which the analysis is processed or the results.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases (Approximately 5% of analysis and income stream produced by DAUK):

DAUK provide expertise and bespoke analysis to the NHS in order to assist with identifying new medical technology and diagnostics in support of relevant disease states with a view that these will be adopted into the NHS for the benefit of patients, and NHS hospitals.

This activity is commissioned by the NHS, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented.

This work does not include broad based economic consultancy services such as benchmarking but is limited to the purposes described in this Agreement. The basis of DAUK’s consultancy service has remained unchanged since first receiving HES data in 2014. The consultancy service provided in relationship to data analysis are on named medical devices and analysing current care pathways in the NHS, therefore this is not broad consultancy but instead is a narrow evidence base. It is solely focused on adoption of named medical devices into the NHS via NICE approval. DAUK would submit an amendment application to NHS England if DAUK were to consider a consultancy service which fell outside this agreed purpose. To confirm, DAUK make the decisions on the purpose and means of the processing the data. On review of DADARG, MedTech companies agree via the Data Sharing Agreement to the terms and purposes of the bespoke aggregated and supressed analysis produced by DAUK.

5. Department for International Trade (DIT) and Office for Life Sciences (OLS) (Approximately 5% of analysis and income stream produced by DAUK):

Since 2010, DAUK has supported the Department of International Trade, formerly known as the UK Trade and Investment (UKTI) who are part of the Government’s Office for Life Sciences.

Part of the DIT and OLS objectives are to attract inward investment into the UK from companies across the world, to develop their business here in the life science sectors and DAUK has worked to support the strategy of the OLS and DIT. DAUK can draw upon the multinational team of experts from IGES, however this is not in relation to the HES data. DAUK continues to support the objectives of the OLS and DIT independently to IGES.

OLS and DIT commission DAUK with requests for market information, and DAUK provides free expertise on disease state, procedure volume and reimbursement. DAUK are the sole data controller for the HES data supplied. DIT and OLS are UK government bodies that DAUK supply expertise on disease state, procedure volume and NHS funding following standard processes of providing the above outside of DAUK. Neither OLS or DIT have any influence on the purpose for processing the NHS England data supplied under this Agreement, nor have any access to the data.

DAUK decide the manner and the process by which the analysis is carried out. DIT and OLS have no influence over the way in which the analysis is processed or the results.

The following NHS England data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care

o Accident & Emergency

o Critical Care

o Outpatients

• Emergency Care Data Set (ECDS)

Device Access produces analysis on multiple groups of patients and areas of medical fields. This involves understanding the flow of patients through NHS hospitals including those in admitted patient care or outpatients and those in critical care or admitted via emergency care. Therefore, all of the above four data sets are necessary to be able to comprehend the full story of these patients and their pathway.

The level of the data will be:

• Pseudonymised

The data will be minimised as follows:

•Limited to the latest 4 years of data that is available. When new annual data becomes available, the oldest year is destroyed to ensure a rolling 4 years at any one time.

DAUK is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party.

DAUK’s legitimate interest is in conducting scientific and statistical research in order to enable medical device providers to achieve NICE approvals and accreditation and subsequent NHS Adoption, and thus positively impact patients Hospitals and the NHS.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

As described in this Data Sharing Agreement, the processing carried out by Device Access, allows patients and hospitals to access new medical devices more rapidly by carrying out the research required by NICE to understand the impact and benefits of these new medical devices being used with NHS hospitals. This increases the efficiency of these hospitals and provides better care for the patients, for example via shorter lengths of stay and less readmissions.

DAUK charge their clients for services. In some instances of projects, these monies have been awarded to medical device companies via grants for medical technologies.

DAUK has a Data Access Review Group (DADARG) which is formed of five members; three of which are external to Device Access and employed by NHS England in a clinical or research role. Their roles within the NHS are a vascular surgeon, General manager Trauma and orthopaedics and Programme Lead, ICS Development in NHS England

It is the role of DADARG to review, approve or deny individual requests made from commercial Medical Device companies and NHS organisations (Requestors) to DAUK (Supplier). The group has a clear methodology for approving new requests and is covered by the terms of reference which govern the group. DADARG reviews the companies’ literature and information to determine if the medical device shows evidence for being beneficial to patients and the health and social care system in England and Wales. If there is evidence of this, DADARG approve DAUK to carry out HES analysis and supply the MedTech company with bespoke aggregated and supressed analysis which further supports the adoption of the medical device into the NHS.

DAUK is a dedicated medical technology reimbursement consultancy brought together under the IGES MedTech Group (https://medtech.iges.com/) which combines the expertise and excellent scientific work of three companies: AiM, Device Access UK and Meditech Access.

IGES MedTech is a multinational team of experts for all aspects of market access and reimbursement of medical devices in Europe.

DAUK work under the umbrella of IGES Group and remain an independent registered UK Limited company to them. IGES have no influence on the DADARG, have no access to the HES data controlled and managed by DAUK, and have no influence in the purposes for processing the data.

Data is accessed and processed by substantive employees of DAUK.

Commercial companies specifically agree not to use the analysis provided by DAUK within general marketing, or within collateral material used by sales and marketing teams, via their Data Reuse Agreement with DAUK. This is a contractual Agreement between DAUK and the MedTech company that is signed before any bespoke aggregated and supressed analysis is shared. Companies' websites are periodically reviewed to ensure this analysis is not included within their marketing outputs. These include sales brochures, emails, direct or mass mailing and advertising of medical technologies. DAUK do not allow portal access to the data by clients.

Description of outputs have been provided below;

1. NICE applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions to NICE for evaluation. These bespoke outputs are in the form of reports and graphical charts and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NICE applications.

Below are examples of DAUK analysis which has been used in NICE applications and have resulted in positive NICE guidance in 2022-2023:

• HTE10 - KardiaMobile 6L for measuring cardiac QT interval in adults having antipsychotic medication

• MTG64 - KardiaMobile for detecting atrial fibrillation

• MTG76 - AposHealth for knee osteoarthritis

• MTG39 - iFuse for treating chronic sacroiliac joint pain

• MTG74 - GreenLight XPS for treating benign prostatic hyperplasia

• IPG770 - Procept Biorobotics - Transurethral water-jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• IPG773 - Limflow - Percutaneous deep venous arterialisation for chronic limb-threatening ischaemia

• IPG758 - Merit medical - Radiofrequency ablation for palliation of painful spinal metastases

• IPG750 - iStar medical - Trabeculectomy with a biodegradable collagen matrix implant for glaucoma

• IPG749 - TORAX MEDICAL - Laparoscopic insertion of a magnetic ring for gastro-oesophageal reflux disease

• IPG745 - Glaukos - Ab interno canaloplasty for open-angle glaucoma

• IPG743 - Theraclion - Percutaneous ultrasound-guided microwave ablation for symptomatic benign thyroid nodules

• IPG737 - Butterfly medical - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

• IPG736 - Limflow - Superficial venous arterialisation for chronic limb threatening ischaemia

• IPG695 - Transmedics - Ex-situ machine perfusion for extracorporeal preservation of lungs (ex-vivo lung perfusion) for transplant

• IPG690 - OrganOx - Extracorporeal whole liver perfusion for acute liver failure

• IPG683 - Capnomed - Balloon cryoablation for squamous dysplasia of the oesophagus

• DG48 - Fibroscan Echosens - FibroScan for assessing liver fibrosis and cirrhosis outside secondary and specialist care

New NICE program for regulatory approval - IDAP program – Initiative device access pathway

The Innovative Devices Access Pathway (IDAP) pilot is an initiative to bring new technologies and solutions to the National Health Service (NHS) to help with medical needs that are not currently being met. The aim of IDAP is to enable and improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers. The aim of the pilot is to test the main elements of the pathway and to provide informative learning and feedback that helps to build the future IDAP. The IDAP is open to UK and international commercial and non-commercial developers with new health technology solutions. Successful applicants will receive support at key stages of their product design and development process from the IDAP partners. The following are examples of medical technological device companies who have received support from Device Access on IDAP applications:

• Histosonics - Liver tumour ablation

• Francis Medical - Malignanat prostate cancer

Prior to 2023, DAUK supported 59 additional NICE Medical Technology approvals leading to guidance;

• MIB316 - Ambu aScope 4 RhinoLaryngo for visualising upper airways during rhinolaryngoscopy

• MIB314 - Ambu aScope 4 Broncho for routine diagnostic and therapeutic bronchoscopy

• MIB299 - RespiraSense for continuously monitoring respiratory rate

• MIB286 - The Insides System for managing intestinal failure

• GID-DG10065 - Artificial intelligence-derived software to analyse chest X-rays for suspected lung cancer in primary care referrals: early value assessment

• MIB277 – UNEEG Medical - 24/7 EEG SubQ for epilepsy

• MIB275 – OrganOx - OrganOx metra for liver transplant

• MTG60 – DyeVert - DyeVert Systems for reducing the risk of acute kidney injury in coronary and peripheral angiography

• MTG62 – ClearGuardHD - ClearGuard HD antimicrobial barrier caps for preventing haemodialysis catheter-related bloodstream infections

• MTG20 – Parafricta - Parafricta Bootees and Undergarments to reduce skin breakdown in people with or at risk of pressure ulcers

• GID-MT533 – SEM scanner - SEM Scanner 200 for pressure ulcer prevention

• IPG681 - Pressurised intraperitoneal aerosol chemotherapy for peritoneal carcinomatosis

• MTG55 - Leukomed Sorbact for preventing surgical site infection

• IPG682 - Balloon cryoablation for Barrett’s oesophagus

• IPG683 - Balloon cryoablation for squamous dysplasia of the oesophagus

• MIB233 - Dexcom G6 for real-time continuous glucose monitoring

• MIB234 - ClearGuard HD Antimicrobial Barrier Cap for preventing haemodialysis catheter-related bloodstream infections

• MIB232 - KardiaMobile for the ambulatory detection of atrial fibrillation

• MTG49 – NxThera - Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

• MTG43 - PICO negative pressure wound dressings for closed surgical incisions

• MIB196 - DyeVert for reducing contrast media in coronary and peripheral angiography

NICE MIB158 – NxThera - Rezum for treating benign prostatic hyperplasia

• NICE MIB 159 – Hill-Rom – The Vest for delivering high-frequency chest wall oscillation in people with complex neurological needs

• NICE IPG629 – Procept Biorobotics - Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB165 – Cerebrotech - Cerebrotech Visor for detecting large vessel occlusion stroke

• NICE IPG625 - NxThera - Transurethral water vapour ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB173 – Acelity Prevena - Prevena incision management system for closed surgical incisions

• NICE MIB168 – Limax Humedics - LiMAx system for assessing the functional capacity of the liver

• NICE MTG45 – Endocuff - Endocuff Vision for assisting visualisation during colonoscopy

• NICE MIB182 – Bruin - SEM Scanner for pressure ulcer prevention

• NICE IPG641 – Medi-Tate - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB86 Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis

• NICE MIB 47 - TearLab - TearLab osmolarity system for diagnosing dry eye disease

• NICE TA628 - Zeiss - Intraoperative Radiotherapy for Breast Cancer

• NICE IPG 479 - Sequana Medical - Device to manage ascites

• NICE MTG19 - FirstKind Medical - Device to stimulate peripheral blood flow for DVT Prevention

• NICE IP475 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE MT241 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE DG12 - Aerocrine Ltd - Diagnostic Test to Manage Asthma

• NICE MIB8 - Airsonett Ltd - Airsonett temperature-controlled laminar airflow device for persistent allergic asthma

• NICE IPG396 - Glaukos - Trabecular stent bypass microsurgery for open angle glaucoma

• NICE IPG431 - Torax Medical - Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease

• NICE IPG549 - Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG29 - Boston - GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 - Entellus - XprESS multi sinus dilation system for treating chronic sinusitis

• NICE IPG578 - Si Bone - Spinal Fusion Technology for lumbar sacral pain

• NICE MTG19 - Geko First Kind - The geko device for reducing the risk of venous thromboembolism

• NICE IPG 1555 - NxThera - Water vapour for treating benign prostate hyperplasic

• NICE IPG 1520 - Thoraclion - Hi Intensity focussed ultrasound for breast lumps

• NICE MIB47 - Tearlab - Diagnosis of dry eye disorders

• NICE MTG32 - Heartflow – Diagnostic platform for the optimal placement of cardiac stents

• NICE MIB110 - Abbott - Diabetic Monitoring

• NICE MIB116 - Urethrotech - Urinary Catheterisation device for men with enlarged prostates

DAUK also uses the HES analysis to support publications for health economic studies to support NICE submissions, examples of publications are shown below:

• Continuous Monitoring of Respiratory Rate with Wearable Sensor in Patients Admitted to Hospital with Pneumonia Compared with Intermittent Nurse-Led Monitoring in the United Kingdom: A Cost-Utility Analysis (https://pubmed.ncbi.nlm.nih.gov/34387850/)

• Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1776298?scroll=top&needAccess=true)

• Cost-utility analysis of normothermic liver perfusion with the OrganOx metra compared to static cold storage in the United Kingdom (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1804391?scroll=top&needAccess=true)

• Cost utility analysis of continuous and intermittent versus intermittent vital signs monitoring in patients admitted to surgical wards (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1747474?scroll=top&needAccess=true&)

• A Corticosteroid-Eluting Sinus Implant Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: A UK-Based Cost-Effectiveness Analysis (https://link.springer.com/article/10.1007/s41669-020-00198-8)

• Ticagrelor Removal by CytoSorb® in Patients Requiring Emergent or Urgent Cardiac Surgery: A UK-Based Cost-Utility Analysis (https://link.springer.com/article/10.1007%2Fs41669-019-00183-w)

• DyeVert™ PLUS EZ System for Preventing Contrast-Induced Acute Kidney Injury in Patients Undergoing Diagnostic Coronary Angiography and/or Percutaneous Coronary Intervention: A UK-Based Cost–Utility Analysis (https://link.springer.com/article/10.1007/s41669-020-00195-x)

2. NIHR research applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions for NIHR funding. All bespoke outputs come in the form of reports and graphical charts and are aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NIHR applications. DAUK additionally have partnered with NIHR Medtech Collaborative from April 2024 for 5 years.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with adoption of NICE approved technologies into the NHS.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used as evidence to support discussions in NHS Hospitals with key NHS stakeholders including finance directors, clinical managers, clinicians and CCG͛s.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

DAUK uses the HES analysis to support their NHS clients with the development of new medical technology and diagnostics in support of relevant disease states.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide.

This analysis is used as evidence to support medical technology developments in NHS Hospitals with key NHS stakeholders including commissioners, clinicians and researchers.

5. Department for International Trade DIT and Office for Life Sciences (OLS):

A basic summary of National HES extracts of disease state, procedure volume and reimbursement analysis are supplied free of charge by DAUK to the DIT and OLS for use in direct and combined discussions with potential overseas companies considering UK market entry. DAUK only provides DIT and OLS with National information, not by hospital or provider. Outputs are therefore aggregated, with small numbers suppressed in line with the HES Analysis Guide.

1. MTG64 AliveCor – KardiaMobile

https://www.nice.org.uk/advice/mtg64

The AliveCor KardiaMobile ECG is a single-channel cardiac event recorder. It consists of a device and app that enables you to record and review electrocardiograms (ECG's) anywhere, anytime. The device attaches to the back of most iOS and Android devices, and communicates wirelessly with the free Kardia app, providing powerful display, analysis and communication capabilities.

Device Access carried out data analysis on patients diagnosed with atrial fibrillation and palpitations. Comorbidities of these patients, including breathlessness, dyspnoea, syncope, chest pain, heart failure and chronic ischaemic heart disease were identified as subset of cohorts of patients of interest, showing high lengths of stay, readmission rates and emergency admissions.

2. AventaMed – Solo+ TTD

Otitis media with effusion (OME), also known as glue ear, is a common condition of early childhood in which an accumulation of fluid within the middle ear space causes hearing impairment. The hearing loss is usually transient and self-limiting over several weeks, but may be more persistent and lead to educational, language and behavioural problems.

OME may be overlooked because of the insidious nature of the condition, and suspicion of hearing loss in children must be acted upon effectively. In most instances of uncomplicated OME, no intervention is required because the fluid clears spontaneously and the hearing recovers. The Solo+ Tympanostomy Tube Device (Solo+ TTD) is an all-in-one ear tube placement device using as little as topical anaesthesia for the treatment of chronic ear infections (Otitis Media) in young children.

DAUK analysed HES data to understand the cohorts of patients showing the diagnosis of otitis media. This then showed the operational gains available to NHS trusts and NHS England, by reducing the length of stay of patients and the time within theatre, NHS trusts would be able to treat additional patients, reducing their waiting lists and providing access to elective recovery funding by showing the ability to increase these treatments carried out in recent years to pre-pandemic levels.

3. Sierra Medical

Sierra Medical is producing a promising test for early detection of lung cancer which is carried out by analysing cells from a simple cheek swab. Using cloud based analytical methods, diagnostic labs can process the data from these swabs automatically. AI algorithms automatically process and analyse sample data in the cloud to generate a tailored diagnostic report where no specialist operators are not required.

Data analysis was carried out on two main cohorts of patients, those diagnosed with lung cancer and those who underwent diagnostic testing for lung cancer without a positive diagnosis. The former allowed understanding of the patient pathway of lung cancer detection and gave insight into how earlier detection and therefore earlier treatment would be beneficial to the NHS and to patients, for example via reduced secondary cancers developing. The latter cohort was studied to understand the impact of ruling out lung cancer earlier in the process of testing. This reduces the impact on patients and the NHS trusts by requiring less diagnostic imagining as well as reducing more invasive surgical procedures such as biopsies.

4. Histosonics - Liver Tumour ablation

Histotripsy uses pulsed sound waves to induce “bubble clouds” from gases naturally present in targeted tissue. These bubble clouds form and collapse in microseconds, creating mechanical forces strong enough to destroy tissue at cellular and sub-cellular levels in a non-invasive and non-thermal method. Edison® is a sophisticated platform that delivers pulsed sound energy into the body, without any incisions or needles, and has the ability to destroy tumours at the sub-cellular level, all while the treating physician continuously monitors the “bubble cloud” and treatment effect in real-time.

Device Access carried out data analysis on patients showing the primary diagnosis of liver cancer in order to understand the treatments these patients undertake. This showed the effect of these patients to the hospitals of multiple admissions or outpatient appointments involving chemotherapy or radiotherapy with long waiting for each. Additionally, patients undergoing surgical treatment, for example resection, had long lengths of stay in hospital, with multiple long lengths of stay required in critical care for a significant percentage. The majority of these surgical patients were not minimal access, causing higher rates of readmissions due to complications following a procedure.

5. MIB286 - The Insides System for managing intestinal failure

https://www.nice.org.uk/advice/mib286

The Insides System (The Insides Company) is a chyme reinfusion system designed to help people with high-output fistulas or stomas after bowel surgery. The system aims to infuse the effluent of the fistula or stoma into the distal gut.

The system works by chyme and intestinal fluid being pumped back into the distal intestines using an Insides Driver. The driver is a handheld battery‑powered device that connects magnetically to the Insides Pump found in the stoma bag. The driver powers the pump to refeed the content of the stoma bag back into the distal intestine. An Insides Tube is inserted into the distal intestine and connected to the Insides Pump as a tube to transport chyme. Five driver speed options are available to allow the person to control the rate of infusion manually, depending on tolerability and viscosity.

Patients undergoing enterostomy, ileostomy or showing the diagnostic code for fistula of intestine were identified to understand differences in length of stay, readmissions, comorbidities and complications within these groups and across subsets of patients with parenteral nutrition.

6. Limflow

LimFlow is a minimally-invasive technology designed to divert blood around diseased arteries in the leg and into the tibial veins that feed the foot, bringing blood and oxygen to starved tissues in the foot. An abundance of oxygen in the tissue can immediately relieve pain and promote healing of chronic wounds for many patients, improving their quality of life and getting them back to the things they love.

Device access carried out data analysis on patients undergoing amputation to understand the impact on patients and hospitals. These patients had long lengths of stay, averaging 18.0 days, and high readmission rates within six months. Further analysis was carried out on the diagnosis of Chronic limb-threatening ischemia and Peripheral vascular disease, both of which showed patients returning to hospital at least three times withing twelve months.

7. Francis medical – Malignant prostate treatment

Francis Medical is a dynamic medical device company committed to developing urological cancer treatments that are tough on cancer, yet gentle on patients. Their work is fuelled by a compassionate belief that cancer can be stopped with minimally invasive treatments.

Initially, Francis Medical is focusing its efforts on prostate cancer, the second most common cancer in American men that often includes treatments with undesired side effects like urinary incontinence and erectile dysfunction. Francis Medical is named after Francis Hoey, the father of inventor and Francis Medical founder, Michael Hoey. In 1991, after undergoing prostate cancer treatments with debilitating effects on his daily living, Francis died from prostate cancer.

Water vapor technology, a new platform being explored for treating a variety of endourological cancers, uses the energy stored in a few drops of water to ablate cancerous tissue. This new therapy is designed to not only ablate cancer cells but also protect surrounding structures, lessening the likelihood of the life-altering side effects common with other cancer treatments.

DAUK used data analysis to see the trends of patients over four years with malignant prostate cancer and understand the treatments that these patients underwent. Surgical treatments, such as open excisions or endoscopic resections showed long lengths of stay, increasing the pressure on hospitals and increasing the likelihood of complications arising.

8. Liquid Biopsies for Faster Diagnosis in Pancreatic and Bile Duct Cancer; DAUK worked with clinicians at Royal Marsden NHS Foundation Trust to understand how the implementation of liquid biopsies could affect patients undergoing diagnosis with pancreatic or bile duct cancer. DAUK analysis has contributed to technology that decreases time for diagnosis of pancreatic or bile duct cancer therefore allowing patients to be treated faster leading to fewer complications, shorter lengths of stay and reduced waiting lists.

9. DAUK has worked with over 10 NHS Hospitals in England, including Manchester Royal Infirmary, Charing Cross Hospital and Southampton General Hospital, in helping them decide if they should adopt a new mechanism of reducing admissions and length of stay through a technology that replaces treats patients with chronic rhinosinusitis following ethmoid, frontal or maxillary sinus surgery.

DAUK identified the numbers of treatments performed and the number of repeat episodes that patients returned for in specific hospitals. This was then entered into a costing model which was provided to the NHS Hospital as part of an adoption business case that summarised the patient and hospital benefits of adopting the new technology. The benefits for the patients are they may have improved sinus surgery outcomes from reduced inflammation, removing the need for readmissions for further treatment.

Device Access UK Limited (DAUK) requires access to NHS England data for the purpose of a programme of work which identifies where medical and diagnostic technologies can best be used by NHS providers in NHS patient care pathways to improve patient outcomes, reduce lengths of stay, elective and diagnostic waiting times.

DAUK is a commercial organisation, working with Department for International Trade (DIT), the Office of Life Sciences (OLS) and the National Institute for Health Research (NIHR), National Institute for Health & Care Excellence (NICE), and working directly with Device Access’ medical technology and NHS clients. DAUK will carry out bespoke analysis of the data and provide that analysis to DAUK clients. The medical technology companies are or wish to become service providers to the NHS, or UK Government & NHS bodies.

DAUK charges for their services. DAUK’s clients are 90% MedTech companies, none are marketing agencies, the remaining being NHS organisations within England. These companies wish to gain NICE recommendations in order to accelerate the adoption of their technologies into the NHS. The process for this involves collating various evidence of the benefit of the device including analysis of current patient pathways which is produced by DAUK via bespoke aggregated analysis

This programme of work is split into five distinct project areas as detailed below.

1. NICE applications on behalf of medical technological device companies (Approximately 70% of analysis produced by DAUK):

DAUK act as a bridge between medical technological device companies and the NHS by providing these companies with expertise and bespoke analysis in order to complete the NICE (National Institute of Clinical Excellence) process required before new innovations can be recommended and then adopted into the NHS for the benefit of patients. The commercial benefit to the MedTech companies arises when they fully go through NHS adoption via NICE approval using pre-existing evidence alongside HES data analysis carried out by DAUK as recommended by NICE in their recent methods guide (https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation#diagnostics-assessment-programme) which states that “The Medical Technologies Evaluation Programme uses a cost-minimisation approach to assess products. This approach considers the costs and resource consequences resulting from, or associated with, the technology under evaluation and comparator technologies. It considers clinical benefits (for example, effectiveness outcomes) alongside the cost analysis.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented. The device companies have no influence or decision on the research that is carried out or over the way in which the analysis is processed or the results. DAUK have a Data Reuse Agreement with each device company, which, alongside the Non-Disclosure Agreement, prevents the company from disseminating the bespoke aggregated and suppressed outputs produced by DAUK.

NICE programmes relating to the review of new or existing medical and diagnostic technologies require a submission based on a detailed understanding of and real evidence around, current NHS patient pathways.

NICE submissions offer relatively speedy assessments of selected innovations, with the aim of making relevant information available quickly to clinicians and NHS hospital decision makers, to support rapid adoption where this are appropriate.

Submissions to NICE require the following which DAUK extract from HES datasets;

• Understanding of the effect of disease; and how the current NHS patient population is diagnosed and / or treated. Bespoke analysis is carried out for each company on very specific patient cohorts. Since 2017, DAUK have carried out data analysis for approximately 100 MedTech companies and NHS organisations on various conditions, symptoms, diseases and treatments covering all clinical contexts, examples of which have been evaluated by NICE and have influenced the decision making are listed below in the Agreement.

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Detailed understanding of cost-effectiveness improvements compared to current NHS pathways

Before accepting a request for submission to Device Access Data Access Review Group (DADARG) and prior to any analysis or extraction of data, DAUK ensures that the technology meets the criteria of a potentially successful NICE submission by conducting internal research around the following formula (PICO);

I. Population - Who would the technology treat

II. Indication - how the technology works

III. Comparator - How care is currently delivered to the population

IV. Outcome - Are the benefits in line with the Health and Social Care Act 2012

Only once DAUK are satisfied that the technology meets these criteria and following approval from DADARG (that it will be of benefit to patients and/or the health care system) will they then conduct the bespoke analysis required for NICE submissions.

As an example of this work, DAUK provided bespoke analysis for a medical device company who have developed a medical technology which measures and records the EEG of patients with suspected epilepsy seizures.

DAUK’s analysis of NHS England data showed that over 400,000 episodes had patients with a diagnosis of epilepsy of which approximately 60,000 episodes were for frequent flyer patients, those that had 4 or more episodes in a 12 month period. These admissions resulted in significant use of NHS resources, including the use of over 130,000 bed days which when reduced allows NHS hospitals to treat additional patients with the increased spare beds, increasing efficiency as a result of changing the pathway.

2. NIHR research applications on behalf of medical technological device companies (Approximately 10% of analysis produced by DAUK):

Medical technological device companies can submit applications for research studies through the NIHR (National Institute for Health Research). NIHR research is often required to provide clinical evidence for NICE applications.

This activity is funded by the Medical Technology Company but can be funded directly to the Medical Technology Company though NIHR grants.

The bespoke analysis provided by DAUK includes;

• Clinical need analysis, evidence gap analysis and clinical endpoints

• Understanding of the effects of disease; and how the current NHS patient population is diagnosed and or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Understanding of potential cost-effectiveness improvements compared to current NHS pathways

DAUK provided bespoke analysis which has secured collaborative research for the manufacturer of the technology with the NIHR. DAUK have also identified the areas of the country where there is most need thus enabling faster patient enrolment into this study.

3. NHS adoption support on behalf of medical technological device companies (Approximately 10% of analysis produced by DAUK):

DAUK provide expertise and bespoke analysis to medical technological device companies and the NHS in order to assist with adoption and diffusion of NICE recommended technologies so new innovations can be adopted into the NHS for the benefit of patients, and the healthcare system. There is no split in the type of analysis carried out for MedTech companies and for the NHS. There is no device level coding within HES, the analysis is carried out on procedure and diagnostic codes. The commercial benefit to the MedTech companies arises when they fully go through NHS adoption via NICE approval using pre-existing evidence alongside bespoke aggregated analysis carried out by DAUK. The commercial gain is a fraction of the benefit to the NHS created from the adoption of new medical devices.

This analysis is used to support local NHS adoption by providing information relating to benefits for patients in a local area. This information is sent by DAUK to both the medical device company and also the NHS hospital stake holders to demonstrate the benefit to comply with NICE guidance. This activity is paid for by the Medical Technology Company. Although the Medical Technology Company pays for this activity, the actual data processing conducted is not influenced by any input from the Medical Technology Company. DAUK control the raw HES data supplied by NHS England Following approval via DADARG, DAUK produces bespoke aggregated and suppressed analysis on specific patient cohorts relevant to the device and its comparators.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be used. The device companies have no influence over the way in which the analysis is processed or the results.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases (Approximately 5% of analysis produced by DAUK):

DAUK provide expertise and bespoke analysis to the NHS in order to assist with identifying new medical technology and diagnostics in support of relevant disease states with a view that these will be adopted into the NHS for the benefit of patients, and NHS hospitals.

This activity is commissioned by the NHS, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented.

This work does not include broad based economic consultancy services such as benchmarking but is limited to the purposes described in this Agreement. The basis of DAUK’s consultancy service has remained unchanged since first receiving HES data in 2014. The consultancy service provided in relationship to data analysis are on named medical devices and analysing current care pathways in the NHS, therefore this is not broad consultancy but instead is a narrow evidence base. It is solely focused on adoption of named medical devices into the NHS via NICE approval. DAUK would submit an amendment application to NHS England if DAUK were to consider a consultancy service which fell outside this agreed purpose. To confirm, DAUK make the decisions on the purpose and means of the processing the data. On review of DADARG, MedTech companies agree via the Data Sharing Agreement to the terms and purposes of the bespoke aggregated and supressed analysis produced by DAUK.

5. Department for International Trade (DIT) and Office for Life Sciences (OLS) (Approximately 5% of analysis produced by DAUK):

Since 2010, DAUK has supported the Department of International Trade, formerly known as the UK Trade and Investment (UKTI) who are part of the Government’s Office for Life Sciences.

Part of the DIT and OLS objectives are to attract inward investment into the UK from companies across the world, to develop their business here in the life science sectors and DAUK has worked to support the strategy of the OLS and DIT. DAUK can draw upon the multinational team of experts from IGES, however this is not in relation to the HES data. DAUK continues to support the objectives of the OLS and DIT independently to IGES.

OLS and DIT commission DAUK with requests for market information, and DAUK provides free expertise on disease state, procedure volume and reimbursement. DAUK are the sole data controller for the HES data supplied. DIT and OLS are UK government bodies that DAUK supply expertise on disease state, procedure volume and NHS funding following standard processes of providing the above outside of DAUK. Neither OLS or DIT have any influence on the purpose for processing the NHS England data supplied under this Agreement, nor have any access to the data.

DAUK decide the manner and the process by which the analysis is carried out. DIT and OLS have no influence over the way in which the analysis is processed or the results.

The following NHS England data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care

o Accident & Emergency

o Critical Care

o Outpatients

• Emergency Care Data Set (ECDS)

Device Access produces analysis on multiple groups of patients and areas of medical fields. This involves understanding the flow of patients through NHS hospitals including those in admitted patient care or outpatients and those in critical care or admitted via emergency care. Therefore, all of the above four data sets are necessary to be able to comprehend the full story of these patients and their pathway.

The level of the data will be:

• Pseudonymised

The data will be minimised as follows:

•Limited to the latest 4 years of data that is available. When new annual data becomes available, the oldest year is destroyed to ensure a rolling 4 years at any one time.

DAUK is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party.

DAUK’s legitimate interest is in conducting scientific and statistical research in order to enable medical device providers to achieve NICE approvals and accreditation and subsequent NHS Adoption, and thus positively impact patients Hospitals and the NHS.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

As described in this Data Sharing Agreement, the processing carried out by Device Access, allows patients and hospitals to access new medical devices more rapidly by carrying out the research required by NICE to understand the impact and benefits of these new medical devices being used with NHS hospitals. This increases the efficiency of these hospitals and provides better care for the patients, for example via shorter lengths of stay and less readmissions.

DAUK charge their clients for services. In some instances of projects, these monies have been awarded to medical device companies via grants for medical technologies.

DAUK has a Data Access Review Group (DADARG) which is formed of five members; three of which are external to Device Access and employed by NHS England in a clinical or research role. Their roles within the NHS are a vascular surgeon, General manager Trauma and orthopaedics and Programme Lead, ICS Development in NHS England

It is the role of DADARG to review, approve or deny individual requests made from commercial Medical Device companies and NHS organisations (Requestors) to DAUK (Supplier). The group has a clear methodology for approving new requests and is covered by the terms of reference which govern the group. DADARG reviews the companies’ literature and information to determine if the medical device shows evidence for being beneficial to patients and the health and social care system in England and Wales. If there is evidence of this, DADARG approve DAUK to carry out HES analysis and supply the MedTech company with bespoke aggregated and supressed analysis which further supports the adoption of the medical device into the NHS.

DAUK is a dedicated medical technology reimbursement consultancy brought together under the IGES MedTech Group (https://medtech.iges.com/) which combines the expertise and excellent scientific work of three companies: AiM, Device Access UK and Meditech Access.

IGES MedTech is a multinational team of experts for all aspects of market access and reimbursement of medical devices in Europe.

DAUK work under the umbrella of IGES Group and remain an independent registered UK Limited company to them. IGES have no influence on the DADARG, have no access to the HES data controlled and managed by DAUK, and have no influence in the purposes for processing the data.

Data is accessed and processed by substantive employees of DAUK.

Commercial companies specifically agree not to use the analysis provided by DAUK within general marketing, or within collateral material used by sales and marketing teams, via their Data Reuse Agreement with DAUK. This is a contractual Agreement between DAUK and the MedTech company that is signed before any bespoke aggregated and supressed analysis is shared. Companies' websites are periodically reviewed to ensure this analysis is not included within their marketing outputs. These include sales brochures, emails, direct or mass mailing and advertising of medical technologies. DAUK do not allow portal access to the data by clients.

Description of outputs have been provided below;

1. NICE applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions to NICE for evaluation. These bespoke outputs are in the form of reports and graphical charts and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NICE applications.

Below are examples of DAUK analysis which has been used in NICE applications and have resulted in positive NICE guidance in 2022-2023:

• MIB316 - Ambu aScope 4 RhinoLaryngo for visualising upper airways during rhinolaryngoscopy

• MIB314 - Ambu aScope 4 Broncho for routine diagnostic and therapeutic bronchoscopy

• MIB299 - RespiraSense for continuously monitoring respiratory rate

• MIB286 - The Insides System for managing intestinal failure

• GID-DG10065 - Artificial intelligence-derived software to analyse chest X-rays for suspected lung cancer in primary care referrals: early value assessment

Prior to 2022, DAUK supported 51 additional NICE Medical Technology approvals leading to guidance;

• MIB277 – UNEEG Medical - 24/7 EEG SubQ for epilepsy

• MIB275 – OrganOx - OrganOx metra for liver transplant

• MTG60 – DyeVert - DyeVert Systems for reducing the risk of acute kidney injury in coronary and peripheral angiography

• MTG62 – ClearGuardHD - ClearGuard HD antimicrobial barrier caps for preventing haemodialysis catheter-related bloodstream infections

• MTG64 – KardiaMobile - KardiaMobile for detecting atrial fibrillation

• MTG20 – Parafricta - Parafricta Bootees and Undergarments to reduce skin breakdown in people with or at risk of pressure ulcers

• GID-MT533 – SEM scanner - SEM Scanner 200 for pressure ulcer prevention

• IPG681 - Pressurised intraperitoneal aerosol chemotherapy for peritoneal carcinomatosis

• MTG55 - Leukomed Sorbact for preventing surgical site infection

• IPG682 - Balloon cryoablation for Barrett’s oesophagus

• IPG683 - Balloon cryoablation for squamous dysplasia of the oesophagus

• MIB233 - Dexcom G6 for real-time continuous glucose monitoring

• MIB234 - ClearGuard HD Antimicrobial Barrier Cap for preventing haemodialysis catheter-related bloodstream infections

• MIB232 - KardiaMobile for the ambulatory detection of atrial fibrillation

• MTG49 – NxThera - Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

• MTG43 - PICO negative pressure wound dressings for closed surgical incisions

• MIB196 - DyeVert for reducing contrast media in coronary and peripheral angiography

NICE MIB158 – NxThera - Rezum for treating benign prostatic hyperplasia

• NICE MIB 159 – Hill-Rom – The Vest for delivering high-frequency chest wall oscillation in people with complex neurological needs

• NICE IPG629 – Procept Biorobotics - Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB165 – Cerebrotech - Cerebrotech Visor for detecting large vessel occlusion stroke

• NICE IPG625 - NxThera - Transurethral water vapour ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB173 – Acelity Prevena - Prevena incision management system for closed surgical incisions

• NICE MIB168 – Limax Humedics - LiMAx system for assessing the functional capacity of the liver

• NICE MTG45 – Endocuff - Endocuff Vision for assisting visualisation during colonoscopy

• NICE MIB182 – Bruin - SEM Scanner for pressure ulcer prevention

• NICE IPG641 – Medi-Tate - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB86 Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis

• NICE MIB 47 - TearLab - TearLab osmolarity system for diagnosing dry eye disease

• NICE TA628 - Zeiss - Intraoperative Radiotherapy for Breast Cancer

• NICE IPG 479 - Sequana Medical - Device to manage ascites

• NICE MTG19 - FirstKind Medical - Device to stimulate peripheral blood flow for DVT Prevention

• NICE IP475 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE MT241 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE DG12 - Aerocrine Ltd - Diagnostic Test to Manage Asthma

• NICE MIB8 - Airsonett Ltd - Airsonett temperature-controlled laminar airflow device for persistent allergic asthma

• NICE IPG396 - Glaukos - Trabecular stent bypass microsurgery for open angle glaucoma

• NICE IPG431 - Torax Medical - Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease

• NICE IPG549 - Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG29 - Boston - GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 - Entellus - XprESS multi sinus dilation system for treating chronic sinusitis

• NICE IPG578 - Si Bone - Spinal Fusion Technology for lumbar sacral pain

• NICE MTG19 - Geko First Kind - The geko device for reducing the risk of venous thromboembolism

• NICE IPG 1555 - NxThera - Water vapour for treating benign prostate hyperplasic

• NICE IPG 1520 - Thoraclion - Hi Intensity focussed ultrasound for breast lumps

• NICE MIB47 - Tearlab - Diagnosis of dry eye disorders

• NICE MTG32 - Heartflow – Diagnostic platform for the optimal placement of cardiac stents

• NICE MIB110 - Abbott - Diabetic Monitoring

• NICE MIB116 - Urethrotech - Urinary Catheterisation device for men with enlarged prostates

DAUK also uses the HES analysis to support publications for health economic studies to support NICE submissions, examples of publications are shown below:

• Continuous Monitoring of Respiratory Rate with Wearable Sensor in Patients Admitted to Hospital with Pneumonia Compared with Intermittent Nurse-Led Monitoring in the United Kingdom: A Cost-Utility Analysis (https://pubmed.ncbi.nlm.nih.gov/34387850/)

• Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1776298?scroll=top&needAccess=true)

• Cost-utility analysis of normothermic liver perfusion with the OrganOx metra compared to static cold storage in the United Kingdom (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1804391?scroll=top&needAccess=true)

• Cost utility analysis of continuous and intermittent versus intermittent vital signs monitoring in patients admitted to surgical wards (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1747474?scroll=top&needAccess=true&)

• A Corticosteroid-Eluting Sinus Implant Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: A UK-Based Cost-Effectiveness Analysis (https://link.springer.com/article/10.1007/s41669-020-00198-8)

• Ticagrelor Removal by CytoSorb® in Patients Requiring Emergent or Urgent Cardiac Surgery: A UK-Based Cost-Utility Analysis (https://link.springer.com/article/10.1007%2Fs41669-019-00183-w)

• DyeVert™ PLUS EZ System for Preventing Contrast-Induced Acute Kidney Injury in Patients Undergoing Diagnostic Coronary Angiography and/or Percutaneous Coronary Intervention: A UK-Based Cost–Utility Analysis (https://link.springer.com/article/10.1007/s41669-020-00195-x)

2. NIHR research applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions for NIHR funding. All bespoke outputs come in the form of reports and graphical charts and are aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NIHR applications.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with adoption of NICE approved technologies into the NHS.These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used as evidence to support discussions in NHS Hospitals with key NHS stakeholders including finance directors, clinical managers, clinicians and CCG͛s.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

DAUK uses the HES analysis to support their NHS clients with the development of new medical technology and diagnostics in support of relevant disease states. These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is used as evidence to support medical technology developments in NHS Hospitals with key NHS stakeholders including commissioners, clinicians and researchers.

5. Department for International Trade DIT and Office for Life Sciences (OLS):

A basic summary of National HES extracts of disease state, procedure volume and reimbursement analysis are supplied free of charge by DAUK to the DIT and OLS for use in direct and combined discussions with potential overseas companies considering UK market entry. DAUK only provides DIT and OLS with National information, not by hospital or provider. Outputs are therefore aggregated, with small numbers suppressed in line with the HES Analysis Guide.

1. MIB299 - RespiraSense for continuously monitoring respiratory rate

https://www.nice.org.uk/advice/mib299

RespiraSense (PMD Solutions) is a motion-tolerant digital technology for continuously monitoring respiratory rate. It is intended to be used by people admitted to hospital who are at risk of respiratory compromise and are having over 4 litres per minute of oxygen or are on high flow or non-invasive ventilation treatment. It can be used across multiple indications, such as pneumonia, sepsis, chronic obstructive pulmonary disease, heart failure and COVID-19.

RespiraSense is a wearable sensor that is made up of 2 parts: a single-use adhesive sensor and a rechargeable plastic lobe, which are joined together and attached to the chest. It continuously records respiratory data when a person is moving or walking. People can wear the device continuously from admission to discharge from hospital. RespiraSense measures the repetitive mechanical movement of breathing by analysing the movements of the chest and abdomen using piezoelectric film sensors. The device processes the breathing signals and uses an algorithm to remove background noise not associated with breathing.

Data collected by the device is transmitted by a Bluetooth connection to a smart device, such as an iPad or smartphone, where it can be viewed by healthcare professionals using the RespiraSense app. The app also allows healthcare professionals to monitor multiple RespiraSense devices at once. Both the device and the smart device will alarm if the respiratory rate changes and is outside of preset limits. RespiraSense can integrate with any electronic health record system or can be used as a stand-alone respiratory monitor.

Data analysis was carried out by Device Access on patients undergoing ventilation based on patients with recorded procedure codes, comparing mortality rates of different patient cohorts with specific wards and within an intensive care unit setting.

2. MIB286 - The Insides System for managing intestinal failure

https://www.nice.org.uk/advice/mib286

The Insides System (The Insides Company) is a chyme reinfusion system designed to help people with high-output fistulas or stomas after bowel surgery. The system aims to infuse the effluent of the fistula or stoma into the distal gut.

The system works by chyme and intestinal fluid being pumped back into the distal intestines using an Insides Driver. The driver is a handheld battery‑powered device that connects magnetically to the Insides Pump found in the stoma bag. The driver powers the pump to refeed the content of the stoma bag back into the distal intestine. An Insides Tube is inserted into the distal intestine and connected to the Insides Pump as a tube to transport chyme. Five driver speed options are available to allow the person to control the rate of infusion manually, depending on tolerability and viscosity.

Patients undergoing enterostomy, ileostomy or showing the diagnostic code for fistula of intestine were identified to understand differences in length of stay, readmissions, comorbidities and complications within these groups and across subsets of patients with parenteral nutrition.

3. Samsara Vision – Implantable Telescope Technology

Samsara Vision's expertise in ultra-precision micro-optics and machining allows us to make miniaturized telescopes that can be placed safely in the eye by an ophthalmic surgeon. Based on the principles of the seventeenth-century Italian physicist Galileo Galilei, the telescope technology platform employs first-of-kind bi-convex and bi-concave convergent and divergent micro-lenses, coupled with air lenses, to create a magnified image onto healthy retinal tissue surrounding the degenerated macula. The telescopic device and the cornea enlarge images in front of the eye approximately 2.2 or 2.7 times their normal size (depending on the model used).

The magnification helps these more peripheral parts of the retina 'see' the image viewed in straight-ahead vision by reducing the apparent impact of the blind spot. (The blind spot does not go away, but it appears smaller to the patient due to magnification.) Clinical research trials have demonstrated that the majority of suitable patients with late-stage AMD enjoy clinically significant improvements in visual acuity and visual function with Samsara Vision's micro-sized, 3.6mm diameter telescope implant. Our research will continue to push the technology envelope on high-performance micro-optical design and manufacturing to help even more people with severe vision disorders.

Data analysis was carried out on patients with age related macular degeneration and cataracts. This led to further studies into patients showing diagnostic codes for depression, tendency to fall and fractures, all of which appeared as effects of age related macular degeneration within the first data search. Of our side effect cohorts, tendency to fall had the highest rate of 14% of all secondary age related macular degeneration episodes. This was followed by depression at 6% and closely behind fractures at 5%. Those with tendency to fall and fractures showed higher average age, length of stay and emergency admission rate compared to our overall secondary age related macular degeneration cohort, increasing by 6 years, 4 days and 40% respectively. The size of these cohorts and various factors of these patients remained relatively constant over the 4 years.

4. mOm incubators – mOm Essential Incubator

The mOm Essential Incubator is a compact and portable neonatal incubator developed by mOm Incubators and the engineering team at EG Technology. There are more than one million premature infant deaths each year, three quarters of which could be prevented through thermoregulation. The mOm incubator is intended to save the lives of premature infants in complicated, low or middle-income environments, as well as expand routine neonatal care alternatives in the UK and other developed nations.

The incubator helps maintain babies’ core temperature during intradepartmental transfer by offering them a safe thermoregulated environment. It can be operated across various settings, from remote and rural births, intrahospital transport and transitional care to neonatal units of diverse capabilities, and can be used on multiple power sources.

Various cohorts of patients were studied to understand the size of the population of premature infant deaths. These patients were split into multiple categories based on location of birth, comparisons between in hospital and out of hospital births, and different diagnoses and treatments, for example those with low birth weight, hypothermia or undergoing ventilation support. The readmissions within 28 days of birth for further treatment of these patients, of which there were 72,386, were studied to understand the full story of these patients and how they were treated by the healthcare system.

5. AliveCor – KardiaMobile

The AliveCor KardiaMobile ECG is a single-channel cardiac event recorder. It consists of a device and app that enables you to record and review electrocardiograms (ECG's) anywhere, anytime. The device attaches to the back of most iOS and Android devices, and communicates wirelessly with the free Kardia app, providing powerful display, analysis and communication capabilities.

Device Access carried out data analysis on patients diagnosed with atrial fibrillation and palpitations. Comorbidities of these patients, including breathlessness, dyspnoea, syncope, chest pain, heart failure and chronic ischaemic heart disease were identified as subset of cohorts of patients of interest, showing high lengths of stay, readmission rates and emergency admissions.

6. Liquid Biopsies for Faster Diagnosis in Pancreatic and Bile Duct Cancer; DAUK worked with clinicians at Royal Marsden NHS Foundation Trust to understand how the implementation of liquid biopsies could affect patients undergoing diagnosis with pancreatic or bile duct cancer. DAUK analysis has contributed to technology that decreases time for diagnosis of pancreatic or bile duct cancer therefore allowing patients to be treated faster leading to fewer complications, shorter lengths of stay and reduced waiting lists.

7. DAUK has worked with over 10 NHS Hospitals in England, including Manchester Royal Infirmary, Charing Cross Hospital and Southampton General Hospital, in helping them decide if they should adopt a new mechanism of reducing admissions and length of stay through a technology that replaces treats patients with chronic rhinosinusitis following ethmoid, frontal or maxillary sinus surgery.

DAUK identified the numbers of treatments performed and the number of repeat episodes that patients returned for in specific hospitals. This was then entered into a costing model which was provided to the NHS Hospital as part of an adoption business case that summarised the patient and hospital benefits of adopting the new technology. The benefits for the patients are they may have improved sinus surgery outcomes from reduced inflammation, removing the need for readmissions for further treatment.

Overview of objective for processing:

Device Access UK Limited (known as Device Access or DAUK throughout this document) conduct bespoke analyses on behalf of commercial companies, the NHS, academics and charities. In the last 12 months, approximately 90% of DAUK’s clients were MedTech companies, the remaining being NHS organisations within England such as Royal Marsden hospitals with regards to early diagnosis of pancreatic cancer. This is a programme of work which identifies where medical and diagnostic technological devices can best be used by NHS providers in NHS patient care pathways to improve patient outcomes reduce lengths of stay, elective and diagnostic waiting times.

DAUK are not in receipt of any state funding and are a private limited UK company.

DAUK has a Data Access Review Group (DADARG) which is formed of five members; three of which are external to Device Access and employed by NHS England in a clinical or research role. Their roles within the NHS are a vascular surgeon, General manager Trauma and orthopaedics and Programme Lead, ICS Development in NHS England

It is the role of DADARG to review, approve or deny individual requests made from commercial Medical Device companies (Requestors) to DAUK Supplier). The group has a clear methodology for approving new requests and is covered by the terms of reference which govern the group. DADARG reviews the companies’ literature and information to determine if the medical device shows evidence for being beneficial to patients and the health and social care system in England and Wales. If there is evidence of this, DADARG approve DAUK to carry out HES analysis and supply the MedTech company with bespoke aggregated and supressed analysis which further supports the adoption of the medical device into the NHS.

The analysis carried out by DAUK is on current patient pathways for specific cohorts of patients for each named medical device. The effects to NHS hospitals on increased length of stay, additional complications and further readmissions are studied to determine the benefits of introducing a new technology.

DAUK is the sole Data Controller who also process the data for the purposes described in this Agreement. Device Access UK is a dedicated medical technology reimbursement consultancy brought together under the IGES MedTech Group which combines the expertise and excellent scientific work of three companies: AiM, Device Access UK and Meditech Access. DAUK work under the umbrella of IGES Group and remain an independent registered UK Limited company to them. IGES have no influence on the DADARG, have no access to the HES data controlled and managed by DAUK, and have no influence in the purposes for processing the data.

DAUK's purpose is to provide Europe-wide support for MedTech companies navigating the complex reimbursement landscapes in healthcare markets. However, the IGES Group have no influence on the decision making and do not have any access to NHS Digital data.

DAUK outputs are all aggregate with small numbers suppressed in line with the HES Analysis Guide.

The legal basis for Device Access to process the data falls under General Data Protection Regulation Article 6 (1) (f) and General Data Protection Regulation Article 9 (2) (j). In relation to article 6(1)(f), processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.

DAUK’s legitimate interest is in conducting scientific and statistical research in order to enable medical device providers to achieve NICE approvals and accreditation and subsequent NHS Adoption, and thus positively impact patients Hospitals and the NHS. Device Access UK goals are to help get great technologies to patients faster. Since 2010, it has helped 100’s of MedTech clients gain product adoption faster within NHS Hospitals, as well as help them gain recommendations and approvals though the National Institute for Health and Care Excellence (NICE).

The commercial gain is a fraction of the NHS benefits created from the adoption of new medical devices. The benefits to health and social care include reduced length of stay, removing the need for readmissions and a reduction in complications for patients receiving treatments. This allows further patients to access treatment and reduce strain on healthcare providers by lowering waiting lists. These benefits have been further outlined and quantified in the yielded benefits of this application, showing how the benefits to health and social care far outweigh the benefits to the medical technology companies. As an example, for MTG30, XprESS multi-sinus dilation system for treating chronic sinusitis, the NICE website states that "by adopting this technology, the NHS in England may save around £7.4 million a year”. This means that the NHS gains productivity by transferring this funding to treat additional patients, reducing waiting lists and improving productivity.

NHS Digital have assessed DAUK’s Legitimate Interests Assessment against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that all requirements are met. An annual assessment is carried out by DAUK with a purpose test, necessity test and balancing test to ensure that correct assessment criteria is met for legitimate interest. The benefit expected from processing the data with legitimate interests is to help understand the current treatment trends, outcomes, costs and impacts required for Medical Device Manufacturers when formally submitting to NICE and engagement with NHS England Hospitals and providers.

In relation to article 9(2)(j) – needed because health data is included in the definition of special categories of personal data and therefore requires an additional condition for processing – the processing is necessary for scientific and research purposes, subject to appropriate safeguards. Article 9(2)(j) states that “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”. Since scientific research purposes and statistical purposes are met though the analysis carried out, DAUK meets schedule 1 of the DPA 2018. The preparation and delivery of the bespoke anonymised, aggregated dataset to any medical device manufacturer is only processed following a formal approval process to ensure it meets the purpose, necessity and balancing test criteria.

This programme of work can be split into five distinct project areas as detailed below;

1. NICE applications on behalf of medical technological device companies (Approximately 70% of analysis produced by DAUK):

Device Access UK Ltd (DAUK) act as a bridge between medical technological device companies and the NHS by providing these companies with expertise and bespoke analysis in order to complete the NICE (National Institute of Clinical Excellence) process required before new innovations can be recommended and then adopted into the NHS for the benefit of patients. The commercial benefit to the MedTech companies arises when they fully go through NHS adoption via NICE approval using pre-existing evidence alongside HES data analysis carried out by DAUK as recommended by NICE in their recent methods guide (I https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation#diagnostics-assessment-programme) which states that “The Medical Technologies Evaluation Programme uses a cost-minimisation approach to assess products. This approach considers the costs and resource consequences resulting from, or associated with, the technology under evaluation and comparator technologies. It considers clinical benefits (for example, effectiveness outcomes) alongside the cost analysis.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented. The device companies have no influence or decision on the research that is carried out or over the way in which the analysis is processed or the results. DAUK have a Data Reuse Agreement with each device company, which, alongside the Non-Disclosure Agreement, prevents the company from disseminating the bespoke aggregated and suppressed outputs produced by DAUK.

NICE programmes relating to the review of new or existing medical and diagnostic technologies require a submission based on a detailed understanding of and real evidence around, current NHS patient pathways.

NICE submissions offer relatively speedy assessments of selected innovations, with the aim of making relevant information available quickly to clinicians and NHS hospital decision makers, to support rapid adoption where this are appropriate.

Submissions to NICE require the following which DAUK extract from HES datasets;

• Understanding of the effect of disease; and how the current NHS patient population is diagnosed and / or treated. Bespoke analysis is carried out for each company on very specific patient cohorts. Since 2017, DAUK have carried out data analysis for approximately 100 MedTech companies and NHS organisations on various conditions, symptoms, diseases and treatments covering all clinical contexts, examples of which have been evaluated by NICE and have influenced the decision making are listed below in the Agreement.

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Detailed understanding of cost-effectiveness improvements compared to current NHS pathways

Before accepting a request for submission to DADARG and prior to any analysis or extraction of data, DAUK ensures that the technology meets the criteria of a potentially successful NICE submission by conducting internal research around the following formula (PICO);

I. Population - Who would the technology treat

II. Indication - how the technology works

III. Comparator - How care is currently delivered to the population

IV. Outcome - Are the benefits in line with the Health and Social Care Act 2012

Only once DAUK are satisfied that the technology meets these criteria and following approval from DADARG (that it will be of benefit to patients and/or the health care system) will they then conduct the bespoke analysis required for NICE submissions. In the last 12 months, 3 data requests have been refused at the DADARG level.

As an example of this work, DAUK provided bespoke analysis for a medical device company who have developed a medical technology which measures and records the EEG of patients with suspected epilepsy seizures.

DAUK’s analysis of NHS Digital data showed that over 400,000 episodes had patients with a diagnosis of epilepsy of which approximately 60,000 episodes were for frequent flyer patients, those that had 4 or more episodes in a 12 month period. These admissions resulted in significant use of NHS resources, including the use of over 130,000 bed days which when reduced allows NHS hospitals to treat additional patients with the increased spare beds, increasing efficiency as a result of changing the pathway.

2. NIHR research applications on behalf of medical technological device companies companies (Approximately 10% of analysis produced by DAUK):

The objectives for processing the HES data are to provide bespoke analysis to medical technological device companies for their applications for research studies through the NIHR (National Institute for Health Research). NIHR research is often required to provide clinical evidence for NICE applications.

This activity is funded by the Medical Technology Company but can be funded directly to the Medical Technology Company though NIHR grants.

The bespoke analysis provided by DAUK includes;

• Clinical need analysis, evidence gap analysis and clinical endpoints

• Understanding of the effects of disease; and how the current NHS patient population is diagnosed and or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Understanding of potential cost-effectiveness improvements compared to current NHS pathways

As an example, DAUK are currently working with another medical device company on a monitoring device for transplants. The decision to transplant or discard is one of the hardest a surgeon can make, particularly with the growing number of organs from older donors and those with comorbidities. Discard rates average 15-20% and rise with Kidney Donor Profile Index (36% 80-90, 63% 91-100). However, over-caution may be preventing thousands of dialysis-dependent patients from returning to a normal life.

DAUK provided bespoke analysis which has secured collaborative research for the manufacturer of the technology with the NIHR. DAUK have also identified the areas of the country where there is most need thus enabling faster patient enrolment into this study.

3. NHS adoption support on behalf of medical technological device companies (Approximately 10% of analysis produced by DAUK):

DAUK provide expertise and bespoke analysis to medical technological device companies and the NHS in order to assist with adoption and diffusion of NICE recommended technologies so new innovations can be adopted into the NHS for the benefit of patients, and the healthcare system. There is no split in the type of analysis carried out for MedTech companies and for the NHS. There is no device level coding within HES, the analysis is carried out on procedure and diagnostic codes. The commercial benefit to the MedTech companies arises when they fully go through NHS adoption via NICE approval using pre-existing evidence alongside bespoke aggregated analysis carried out by DAUK. The commercial gain is a fraction of the benefit to the NHS created from the adoption of new medical devices.

This analysis is used to support local NHS adoption by providing information relating to benefits for patients in a local area. This information is sent by DAUK to both the medical device company and also the NHS hospital stake holders to demonstrate the benefit to comply with NICE guidance. This activity is paid for by the Medical Technology Company. Although the Medical Technology Company pays for this activity, the actual data processing conducted is not influenced by any input from the Medical Technology Company. DAUK control the raw HES data supplied by NHS Digital. Following approval via DADARG, DAUK produces bespoke aggregated and suppressed analysis on specific patient cohorts relevant to the device and its comparators.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be used. The device companies have no influence over the way in which the analysis is processed or the results.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases (Approximately 5% of analysis produced by DAUK):

DAUK provide expertise and bespoke analysis to the NHS in order to assist with identifying new medical technology and diagnostics in support of relevant disease states with a view that these will be adopted into the NHS for the benefit of patients, and NHS hospitals.

This activity is commissioned by the NHS, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented.

This work does not include broad based economic consultancy services such as benchmarking but is limited to the purposes described in this Agreement. The basis of DAUK’s consultancy service has remained unchanged since first receiving HES data in 2014. The consultancy service provided in relationship to data analysis are on named medical devices and analysing current care pathways in the NHS, therefore this is not broad consultancy but instead is a narrow evidence base. It is solely focused on adoption of named medical devices into the NHS via NICE approval. DAUK would submit an amendment application to NHS Digital if DAUK were to consider a consultancy service which fell outside this agreed purpose. To confirm, DAUK make the decisions on the purpose and means of the processing the data. On review of DADARG, MedTech companies agree via the Data Sharing Agreement to the terms and purposes of the bespoke aggregated and supressed analysis produced by DAUK.

5. Department for International Trade (DIT) and Office for Life Sciences (OLS) (Approximately 5% of analysis produced by DAUK):

Since 2010, DAUK has supported the Department of International Trade, formerly known as the UK Trade and Investment (UKTI) who are part of the Government’s Office for Life Sciences.

Part of the DIT and OLS objectives are to attract inward investment into the UK from companies across the world, to develop their business here in the life science sectors and DAUK has worked to support the strategy of the OLS and DIT. DAUK can draw upon the multinational team of experts from IGES, however this is not in relation to the HES data. DAUK continues to support the objectives of the OLS and DIT independently to IGES.

OLS and DIT commission DAUK with requests for market information, and DAUK provides free expertise on disease state, procedure volume and reimbursement. DAUK are the sole data controller for the HES data supplied. DIT and OLS are UK government bodies that DAUK supply expertise on disease state, procedure volume and NHS funding following standard processes of providing the above outside of DAUK. Neither OLS or DIT have any influence on the purpose for processing the NHS Digital data supplied under this Agreement, nor have any access to the data.

DAUK decide the manner and the process by which the analysis is carried out. DIT and OLS have no influence over the way in which the analysis is processed or the results.

Commercial companies specifically agree not to use the analysis provided by DAUK within general marketing, or within collateral material used by sales and marketing teams, via their Data Reuse Agreement with DAUK. This is a contractual Agreement between DAUK and the MedTech company that is signed before any bespoke aggregated and supressed analysis is shared. Companies' websites are periodically reviewed to ensure this analysis is not included within their marketing outputs. These include sales brochures, emails, direct or mass mailing and advertising of medical technologies. DAUK do not allow portal access to the data by clients.

Description of outputs have been provided below;

1. NICE applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions to NICE for evaluation. These bespoke outputs are in the form of reports and graphical charts and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NICE applications.

Below are examples of DAUK analysis which has been used in NICE applications and have resulted in positive NICE guidance in 2021-2022:

• MIB277 – UNEEG Medical - 24/7 EEG SubQ for epilepsy

• MIB275 – OrganOx - OrganOx metra for liver transplant

• MTG60 – DyeVert - DyeVert Systems for reducing the risk of acute kidney injury in coronary and peripheral angiography

• MTG62 – ClearGuardHD - ClearGuard HD antimicrobial barrier caps for preventing haemodialysis catheter-related bloodstream infections

• MTG64 – KardiaMobile - KardiaMobile for detecting atrial fibrillation

• MTG20 – Parafricta - Parafricta Bootees and Undergarments to reduce skin breakdown in people with or at risk of pressure ulcers

Prior to 2021, DAUK supported 45 additional NICE Medical Technology approvals leading to guidance;

• GID-MT533 – SEM scanner - SEM Scanner 200 for pressure ulcer prevention

• IPG681 - Pressurised intraperitoneal aerosol chemotherapy for peritoneal carcinomatosis

• MTG55 - Leukomed Sorbact for preventing surgical site infection

• IPG682 - Balloon cryoablation for Barrett’s oesophagus

• IPG683 - Balloon cryoablation for squamous dysplasia of the oesophagus

• MIB233 - Dexcom G6 for real-time continuous glucose monitoring

• MIB234 - ClearGuard HD Antimicrobial Barrier Cap for preventing haemodialysis catheter-related bloodstream infections

• MIB232 - KardiaMobile for the ambulatory detection of atrial fibrillation

• MTG49 – NxThera - Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

• MTG43 - PICO negative pressure wound dressings for closed surgical incisions

• MIB196 - DyeVert for reducing contrast media in coronary and peripheral angiography

NICE MIB158 – NxThera - Rezum for treating benign prostatic hyperplasia

• NICE MIB 159 – Hill-Rom – The Vest for delivering high-frequency chest wall oscillation in people with complex neurological needs

• NICE IPG629 – Procept Biorobotics - Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB165 – Cerebrotech - Cerebrotech Visor for detecting large vessel occlusion stroke

• NICE IPG625 - NxThera - Transurethral water vapour ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB173 – Acelity Prevena - Prevena incision management system for closed surgical incisions

• NICE MIB168 – Limax Humedics - LiMAx system for assessing the functional capacity of the liver

• NICE MTG45 – Endocuff - Endocuff Vision for assisting visualisation during colonoscopy

• NICE MIB182 – Bruin - SEM Scanner for pressure ulcer prevention

• NICE IPG641 – Medi-Tate - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB86 Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis

• NICE MIB 47 - TearLab - TearLab osmolarity system for diagnosing dry eye disease

• NICE TA628 - Zeiss - Intraoperative Radiotherapy for Breast Cancer

• NICE IPG 479 - Sequana Medical - Device to manage ascites

• NICE MTG19 - FirstKind Medical - Device to stimulate peripheral blood flow for DVT Prevention

• NICE IP475 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE MT241 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE DG12 - Aerocrine Ltd - Diagnostic Test to Manage Asthma

• NICE MIB8 - Airsonett Ltd - Airsonett temperature-controlled laminar airflow device for persistent allergic asthma

• NICE IPG396 - Glaukos - Trabecular stent bypass microsurgery for open angle glaucoma

• NICE IPG431 - Torax Medical - Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease

• NICE IPG549 - Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG29 - Boston - GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 - Entellus - XprESS multi sinus dilation system for treating chronic sinusitis

• NICE IPG578 - Si Bone - Spinal Fusion Technology for lumbar sacral pain

• NICE MTG19 - Geko First Kind - The geko device for reducing the risk of venous thromboembolism

• NICE IPG 1555 - NxThera - Water vapour for treating benign prostate hyperplasic

• NICE IPG 1520 - Thoraclion - Hi Intensity focussed ultrasound for breast lumps

• NICE MIB47 - Tearlab - Diagnosis of dry eye disorders

• NICE MTG32 - Heartflow – Diagnostic platform for the optimal placement of cardiac stents

• NICE MIB110 - Abbott - Diabetic Monitoring

• NICE MIB116 - Urethrotech - Urinary Catheterisation device for men with enlarged prostates

DAUK also uses the HES analysis to support publications for health economic studies to support NICE submissions, examples of publications are shown below:

• Continuous Monitoring of Respiratory Rate with Wearable Sensor in Patients Admitted to Hospital with Pneumonia Compared with Intermittent Nurse-Led Monitoring in the United Kingdom: A Cost-Utility Analysis (https://pubmed.ncbi.nlm.nih.gov/34387850/)

• Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1776298?scroll=top&needAccess=true)

• Cost-utility analysis of normothermic liver perfusion with the OrganOx metra compared to static cold storage in the United Kingdom (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1804391?scroll=top&needAccess=true)

• Cost utility analysis of continuous and intermittent versus intermittent vital signs monitoring in patients admitted to surgical wards (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1747474?scroll=top&needAccess=true&)

• A Corticosteroid-Eluting Sinus Implant Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: A UK-Based Cost-Effectiveness Analysis (https://link.springer.com/article/10.1007/s41669-020-00198-8)

• Ticagrelor Removal by CytoSorb® in Patients Requiring Emergent or Urgent Cardiac Surgery: A UK-Based Cost-Utility Analysis (https://link.springer.com/article/10.1007%2Fs41669-019-00183-w)

• DyeVert™ PLUS EZ System for Preventing Contrast-Induced Acute Kidney Injury in Patients Undergoing Diagnostic Coronary Angiography and/or Percutaneous Coronary Intervention: A UK-Based Cost–Utility Analysis (https://link.springer.com/article/10.1007/s41669-020-00195-x)

2. NIHR research applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions for NIHR funding. All bespoke outputs come in the form of reports and graphical charts and are aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NIHR applications.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with adoption of NICE approved technologies into the NHS.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used as evidence to support discussions in NHS Hospitals with key NHS stakeholders including finance directors, clinical managers, clinicians and CCG͛s.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

DAUK uses the HES analysis to support their NHS clients with the development of new medical technology and diagnostics in support of relevant disease states.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide.

This analysis is used as evidence to support medical technology developments in NHS Hospitals with key NHS stakeholders including commissioners, clinicians and researchers.

5. Department for International Trade DIT and Office for Life Sciences (OLS):

A basic summary of National HES extracts of disease state, procedure volume and reimbursement analysis are supplied free of charge by DAUK to the DIT and OLS for use in direct and combined discussions with potential overseas companies considering UK market entry. DAUK only provides DIT and OLS with National information, not by hospital or provider. Outputs are therefore aggregated, with small numbers suppressed in line with the HES Analysis Guide.

1. MIB277 – UNEEG Medical - 24/7 EEG SubQ for epilepsy https://www.nice.org.uk/advice/mib277

The 24/7 EEG SubQ device (UNEEG Medical) is an electroencephalogram (EEG) recording device for people with epilepsy. The system is intended to monitor seizures for adults with uncontrolled epilepsy, when treatment has been adjusted and seizures remain uncontrolled or when there is a doubt about the true seizure being experienced. As a monitoring tool, it is intended to capture an objective count of frequency, type and circadian distribution of seizures. The implant can stay in place for up to 15 months to help identify seizures happening during daily life over a long time period.

Data analysis was carried out by DAUK on cohorts of patients with epilepsy diagnoses. Cohorts of patients with 4 or more episodes outpatient appointments involving epilepsy were identified to analyse the effect to NHS Hospitals of these patients. These pateints were found to have an increased rate of emergency admission into admitted patient care with an increase of approximately 17% emergency hospital admissions compared to standard epilepsy patients. Comorbidities of these cohorts were further studied, finding increases in overall complexity of those patients with more than 4 episodes of outpatient appointments involving epilepsy and identifying subsets of those more likely to meet this criteria – for example patients with specific developmental disorders of scholastic skills or mental and behavioural disorders due to use of alcohol showed increased likelihood of repeat outpatient attendances of 4.5% and 4.0% respectively. Published evidence suggests that the 24/7 EEG SubQ can identify additional seizure counts and seizure pattern information compared with standard care, to inform individual management plans. This allows the patients to be transferred to a more complete patient pathway before creating the effect of increased comorbidities and emergency admissions. These benefits of reducing the admissions and complications have been seen with the introduction of SubQ.

2. MIB275 – OrganOx - OrganOx metra for liver transplant https://www.nice.org.uk/guidance/mib275

The OrganOx metra (OrganOx Limited) is a fully automated transportable normothermic organ perfusion device. It is used for normothermic machine perfusion of livers awaiting transplant to improve organ preservation and reduce the rate of organ discard. The device works by placing the liver in a sterile environment and continuously perfusing the organ with oxygenated blood, medicines and nutrients at normal body temperature to mimic normal physiology. This can be done for up to 24 hours before transplant and aims to minimise liver injury, reducing the number of donor livers discarded. This also means the liver is functional, enabling assessment and evidence-based decisions about whether to transplant.

Patient cohorts for those with liver transplants or liver failure were studied to understand the effect of failed and successful transplantations. The diagnostic code for liver transplant failure and rejection was identified, showing 492 patients having a total of 1,185 failed liver transplants over a 12 month extract period. This cohort was compared to those with successful transplantations showing an increase of future readmissions with a total of 3,292 admissions and a further average length of stay of 39 days per patient in the 12 months following. All clinical studies carried out for OrganOx metra suggested that the device may help increase the number of donor livers that can be successfully transplanted therefore removing these additional stays and helping to free beds for hospitals, allowing additional treatment for other patients, and reducing the treatment required for patients undergoing transplants.

3. MTG20 – Parafricta - Parafricta Bootees and Undergarments to reduce skin breakdown in people with or at risk of pressure ulcers

https://www.nice.org.uk/advice/mtg20

Parafricta Bootees and Undergarments (APA Parafricta) are intended to reduce the potential for both the development and the progression of skin damage caused by friction and shear in people who have, or are at risk of developing, pressure ulcers, and in people with frail skin or those who have medical conditions in which skin frailty is a primary factor. Bootees provide protection for the heel and ankle, and Undergarments provide protection for the sacrum, buttocks and hips. The items are made from proprietary Parafricta fabric which is designed to reduce the shear stress and friction associated with movement. Parafricta fabric has no stiction, which is the additional force needed to overcome skin sticking to a surface before sliding. Because of this, it reduces the 'jerk' effect on skin when movement occurs. The lower the friction and stiction, the less likely it is that shear forces will develop and break the skin down, thereby reducing the risk of pressure ulcers. This mechanism of action is different from current methods of pressure ulcer management or prevention, which aim to manage or prevent pressure ulcers by reducing or redistributing pressure. The reduction in pressure ulcers ensures that the patients do not have these extended stays, additionally freeing up beds for hospitals

Data on patients with category II, III and IV pressure ulcers was analysed at a national level to study the effect of patients developing ulcers in hospital. Similar cohorts of patients who did not develop pressure ulcers (based on most common primary diagnoses) were compared to showing length of stay reductions of 7.1, 7.4 and 8.4 days for each of the respective categories. For example, one of the main primary diagnoses for patients developing category II ulcers was pneumonia. There were 12,569 episodes of pneumonia patients developing category II ulcers with an average length of stay of 6.4 days and 352,180 episodes of pneumonia patients who did not develop ulcers with an average length of stay of 3.9 days. This national data was then compared to similar data from a hospital where Parafricta Bootees had already been implemented showing reductions in pressure ulcer incidence of approximately 7%. The reduction in pressure ulcers ensures that the patients do not have these extended stays, additionally freeing up beds for hospitals to treat further patients.

4. MTG62 - ClearGuard HD Antimicrobial Barrier Cap for preventing haemodialysis catheter-related bloodstream infections

https://www.nice.org.uk/advice/ mtg62

ClearGuard HD Antimicrobial Barrier Cap (ICU Medical) is a central venous catheter (CVC) cap for haemodialysis catheters. Cohorts of patients on dialysis (renal, peritoneal, haemodialysis, automated peritoneal and continuous ambulatory peritoneal) were analysed.

Alongside studies from randomised controlled trials this data produced by DAUK showed the benefits of ClearGuard with a decrease in hospitalisation for bloodstream infections reducing the total bed days of 375,758 for the above cohorts. Specialist centres with the largest need from these patients were identified from the data analysis with 47% of all episodes taking place in 5 trusts across England. As a result, NICE have developed formal Medical Technologies Guidance on this technology and the ClearGuard HD Antimicrobial Barrier Cap has been implemented in healthcare to achieve these benefits for patients

5. MTG60 - DyeVert for reducing contrast media in coronary and peripheral angiography. DyeVert is a non-invasive system designed to reduce the amount of contrast media given during coronary and peripheral angiographies, when a manual or power injection of contrast media is needed. After the analysis, the main cohort of interest was patients with the diagnostic codes of acute kidney failure immediately followed by the ICD10 code for x-ray contrast media, the combination of which described patients whose AKI was induced by the contrast media. These patients took up an additional 10.0 bed days (12.2 days compared to 2.2) on average in a 12 month extract period, compared to similar patients who did not develop AKIs. and moreover, the 94 patients within this cohort were readmitted for a further 150 readmissions hospital stays in the 12 months following their contrast induced AKI causing greater strain to the hospitals.

Due to the benefits of reduced length of stay and readmissions, NICE have now developed a formal Medical Technologies Guidance on this technology which reduces the likelihood of developing post contrast AKIs.

6. Prevention of surgical swabs left behind after surgery; DAUK worked with clinicians at University Hospitals of North Midlands NHS Trust to understand how complications caused by surgical swabs left behind after surgery affected affect patients, hospitals, and NHS England. DAUK analysis has contributed to technology that reduces surgical swabs being left behind after surgery which benefits patients and hospitals by reducing complications, removing the need for additional length of stay or readmission, saving bed days and reducing waiting lists.

7. DAUK has worked with over 10 NHS Hospitals in England, including Manchester Royal Infirmary, Charing Cross Hospital and Southampton General Hospital, in helping them decide if they should adopt a new mechanism of reducing admissions and length of stay through a technology that replaces treats patients with chronic rhinosinusitis following ethmoid, frontal or maxillary sinus surgery.

DAUK identified the numbers of treatments performed and the number of repeat episodes that patients returned for in specific hospitals. This was then entered into a costing model which was provided to the NHS Hospital as part of an adoption business case that summarised the patient and hospital benefits of adopting the new technology. The benefits for the patients are they may have improved sinus surgery outcomes from reduced inflammation, removing the need for readmissions for further treatment.

Overview of objective for processing:

Device Access UK Limited (known as Device Access or DAUK throughout this document) conduct bespoke analyses on behalf of commercial companies, the NHS, academics and charities. This is a programme of work which identifies where medical and diagnostic technological devices can best be used by NHS providers in NHS patient care pathways to improve patient outcomes reduce lengths of stay, elective and diagnostic waiting times.

DAUK has a transparent Data Access Review Group (DADARG) which is formed of five members; three of which are external to Device Access and employed by NHS England in a clinical or research role.

It is the role of DADARG to review, approve or deny individual requests made from commercial Medical Device companies (Requestors) to DAUK Supplier). The group has a clear methodology for approving new requests and is covered by the terms of reference which govern the group. The key focus is that there are clear benefits to patient’s health outcomes and/or the healthcare system.

DAUK is the sole Data Controller who also process the data for the purposes described in this Agreement. Device Access UK is a dedicated medical technology reimbursement consultancy brought together under the IGES MedTech Group which combines the expertise and excellent scientific work of three companies: AiM, Device Access UK and Meditech Access.

DAUK's purpose is to provide Europe-wide support for MedTech companies navigating the complex reimbursement landscapes in healthcare markets. However, the IGES Group have no influence on the decision making and do not have any access to NHS Digital data.

DAUK outputs are all aggregate with small numbers suppressed in line with the HES Analysis Guide.

The legal basis for Device Access to process the data falls under General Data Protection Regulation Article 6 (1) (f) and General Data Protection Regulation Article 9 (2) (j). In relation to article 6(1)(f), processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.

DAUK’s legitimate interest is in conducting scientific and statistical research in order to enable medical device providers to achieve NICE approvals and accreditation and subsequent NHS Adoption, and thus positively impact patients Hospitals and the NHS.

NHS Digital have assessed DAUK’s Legitimate Interests Assessment against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that all requirements are met. In relation to article 9(2)(j) – needed because health data is included in the definition of special categories of personal data and therefore requires an additional condition for processing – the processing is necessary for scientific and research purposes, subject to appropriate safeguards.

This programme of work can be split into five distinct project areas as detailed below;

1. NICE applications on behalf of medical technological device companies:

Device Access UK Ltd (DAUK) act as a bridge between medical technological device companies and the NHS by providing these companies with expertise and bespoke analysis in order to complete the NICE (National Institute of Clinical Excellence) process required before new innovations can be recommended and then adopted into the NHS for the benefit of patients.

This activity is commissioned by the Medical Technology Companies, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented. The device companies have no influence over the way in which the analysis is processed or the results.

NICE programmes relating to the review of new or existing medical and diagnostic technologies require a submission based on a detailed understanding of and real evidence around, current NHS patient pathways.

NICE submissions offer relatively speedy assessments of selected innovations, with the aim of making relevant information available quickly to clinicians and NHS hospital decision makers, to support rapid adoption where this are appropriate.

Submissions to NICE require the following which DAUK extract from HES datasets;

• Understanding of the burden of disease; and how the current NHS patient population is diagnosed and / or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Detailed understanding of cost-effectiveness improvements compared to current NHS pathways

Before accepting a request for submission to DADARG and prior to any analysis or extraction of data, DAUK ensures that the technology meets the criteria of a potentially successful NICE submission by conducting internal research around the following formula (PICO);

I. Population - Who would the technology treat

II. Indication - how the technology works

III. Comparator - How care is currently delivered to the population

IV. Outcome - Are the benefits in line with the health and social care act 2014

Only once DAUK are satisfied that the technology meets these criteria and following approval from DADARG (that it will be of benefit to patients and/or the health care system) will they then conduct the bespoke analysis required for NICE submissions.

As an example of this work, DAUK provided bespoke analysis for a medical device company who have developed a medical technology which measures and records the EEG of patients with suspected epilepsy seizures.

DAUK’s analysis of NHS Digital data showed that over 400,000 episodes had patients with a diagnosis of epilepsy of which approximately 60,000 episodes were for frequent flyer patients, those that had 4 or more episodes in a 12 month period. These admissions resulted in significant use of NHS resources, including the use of over 130,000 bed days and estimated £55 million costs.

2. NIHR research applications on behalf of medical technological device companies:

The objectives for processing the HES data are to provide bespoke analysis to medical technological device companies for their applications for research studies through the NIHR (National Institute for Health Research). NIHR research is often required to provide clinical evidence for NICE applications.

This activity is commissioned and funded by the Medical Technology Company but can be funded directly to the Medical Technology Company though NIHR grants.

The bespoke analysis provided by DAUK includes;

• Clinical need analysis, evidence gap analysis and clinical endpoints

• Understanding of the burden of disease; and how the current NHS patient population is diagnosed and or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Understanding of potential cost-effectiveness improvements compared to current NHS pathways

As an example, DAUK are currently working with another medical device company on a monitoring device for transplants. The decision to transplant or discard is one of the hardest a surgeon can make, particularly with the growing number of organs from older donors and those with comorbidities. Discard rates average 15-20% and rise with Kidney Donor Profile Index (36% 80-90, 63% 91-100). However, over-caution may be preventing thousands of dialysis-dependent patients from returning to a normal life.

DAUK provided bespoke analysis which has secured collaborative research for the manufacturer of the technology with the NIHR. DAUK have also identified the areas of the country where there is most need thus enabling faster patient enrolment into this study.

3. NHS adoption support on behalf of medical technological device companies:

DAUK provide expertise and bespoke analysis to medical technological device companies and the NHS in order to assist with adoption and diffusion of NICE recommended technologies so new innovations can be adopted into the NHS for the benefit of patients, and the healthcare system.

This analysis is used to support local NHS adoption by providing information relating to benefits for patients in a local area. This information is sent by DAUK to both the commissioning medical device company and also the NHS hospital stake holders to demonstrate the benefit to comply with NICE guidance. This activity is commissioned and paid for by the Medical Technology Company.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be used. The device companies have no influence over the way in which the analysis is processed or the results.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

DAUK provide expertise and bespoke analysis to the NHS in order to assist with identifying new medical technology and diagnostics in support of relevant disease states with a view that these will be adopted into the NHS for the benefit of patients, and NHS hospitals.

This activity is commissioned by the NHS, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented.

This work does not include broad based economic consultancy services such as benchmarking but is limited to the purposes described in this document. DAUK would submit an amendment application to NHS Digital if DAUK were to consider a consultancy service which fell outside this agreed purpose.

5. Department for International Trade DIT and Office for Life Sciences:

Since 2010, DAUK has supported the Department of International Trade or DIT, formerly known as the UK Trade and Investment (UKTI) who are part of the Government’s Office for Life Sciences (OLS).

Part of the DIT and OLS objectives are to attract inward investment into the UK from companies across the world, to develop their business here in the life science sectors and DAUK has worked to support the strategy of the OLS and DIT.

OLS and DIT commission DAUK with requests for market information, and DAUK provides free expertise on disease state, procedure volume and reimbursement.

DAUK decide the manner and the process by which the analysis is carried out. DIT and OLS have no influence over the way in which the analysis is processed or the results.

Commercial companies specifically agree not to use the analysis provided by DAUK within general marketing, or within collateral material used by sales and marketing teams. These include sales brochures, emails, direct or mass mailing and advertising of medical technologies. DAUK do not allow portal access to the data by clients.

Description of outputs have been provided below;

1. NICE applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions to NICE for evaluation. These bespoke outputs are in the form of reports and graphical charts and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NICE applications.

Below are examples of DAUK analysis which has been used in NICE applications and have resulted in positive NICE guidance in 2020-2021:

• GID-MT533 – SEM scanner - SEM Scanner 200 for pressure ulcer prevention

• IPG681 - Pressurised intraperitoneal aerosol chemotherapy for peritoneal carcinomatosis

• MTG55 - Leukomed Sorbact for preventing surgical site infection

• IPG682 - Balloon cryoablation for Barrett’s oesophagus

• IPG683 - Balloon cryoablation for squamous dysplasia of the oesophagus

• MIB233 - Dexcom G6 for real-time continuous glucose monitoring

• MIB234 - ClearGuard HD Antimicrobial Barrier Cap for preventing haemodialysis catheter-related bloodstream infections

• MIB232 - KardiaMobile for the ambulatory detection of atrial fibrillation

• MTG49 – NxThera - Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

• MTG43 - PICO negative pressure wound dressings for closed surgical incisions

• MIB196 - DyeVert for reducing contrast media in coronary and peripheral angiography

Prior to 2020, DAUK supported 34 additional NICE Medical Technology approvals leading to guidance;

• NICE MIB158 – NxThera - Rezum for treating benign prostatic hyperplasia

• NICE MIB 159 – Hill-Rom – The Vest for delivering high-frequency chest wall oscillation in people with complex neurological needs

• NICE IPG629 – Procept Biorobotics - Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB165 – Cerebrotech - Cerebrotech Visor for detecting large vessel occlusion stroke

• NICE IPG625 - NxThera - Transurethral water vapour ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB173 – Acelity Prevena - Prevena incision management system for closed surgical incisions

• NICE MIB168 – Limax Humedics - LiMAx system for assessing the functional capacity of the liver

• NICE MTG45 – Endocuff - Endocuff Vision for assisting visualisation during colonoscopy

• NICE MIB182 – Bruin - SEM Scanner for pressure ulcer prevention

• NICE IPG641 – Medi-Tate - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB86 Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis

• NICE MIB 47 - TearLab - TearLab osmolarity system for diagnosing dry eye disease

• NICE TA628 - Zeiss - Intraoperative Radiotherapy for Breast Cancer

• NICE IPG 479 - Sequana Medical - Device to manage ascites

• NICE MTG19 - FirstKind Medical - Device to stimulate peripheral blood flow for DVT Prevention

• NICE IP475 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE MT241 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE DG12 - Aerocrine Ltd - Diagnostic Test to Manage Asthma

• NICE MIB8 - Airsonett Ltd - Airsonett temperature-controlled laminar airflow device for persistent allergic asthma

• NICE IPG396 - Glaukos - Trabecular stent bypass microsurgery for open angle glaucoma

• NICE IPG431 - Torax Medical - Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease

• NICE IPG549 - Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG29 - Boston - GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 - Entellus - XprESS multi sinus dilation system for treating chronic sinusitis

• NICE IPG578 - Si Bone - Spinal Fusion Technology for lumbar sacral pain

• NICE MTG19 - Geko First Kind - The geko device for reducing the risk of venous thromboembolism

• NICE IPG 1555 - NxThera - Water vapour for treating benign prostate hyperplasic

• NICE IPG 1520 - Thoraclion - Hi Intensity focussed ultrasound for breast lumps

• NICE MIB47 - Tearlab - Diagnosis of dry eye disorders

• NICE MTG32 - Heartflow – Diagnostic platform for the optimal placement of cardiac stents

• NICE MIB110 - Abbott - Diabetic Monitoring

• NICE MIB116 - Urethrotech - Urinary Catheterisation device for men with enlarged prostates

DAUK also uses the HES analysis to support publications for health economic studies to support NICE submissions, examples of publications are shown below:

• Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1776298?scroll=top&needAccess=true)

• Cost-utility analysis of normothermic liver perfusion with the OrganOx metra compared to static cold storage in the United Kingdom (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1804391?scroll=top&needAccess=true)

• Cost utility analysis of continuous and intermittent versus intermittent vital signs monitoring in patients admitted to surgical wards (https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1747474?scroll=top&needAccess=true&)

• A Corticosteroid-Eluting Sinus Implant Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: A UK-Based Cost-Effectiveness Analysis (https://link.springer.com/article/10.1007/s41669-020-00198-8)

• Ticagrelor Removal by CytoSorb® in Patients Requiring Emergent or Urgent Cardiac Surgery: A UK-Based Cost-Utility Analysis (https://link.springer.com/article/10.1007%2Fs41669-019-00183-w)

• DyeVert™ PLUS EZ System for Preventing Contrast-Induced Acute Kidney Injury in Patients Undergoing Diagnostic Coronary Angiography and/or Percutaneous Coronary Intervention: A UK-Based Cost–Utility Analysis (https://link.springer.com/article/10.1007/s41669-020-00195-x)

2. NIHR research applications on behalf of medical technological device companies:

DAUK uses the HES analysis to support their Medical Technology clients with their submissions for NIHR funding. All bespoke outputs come in the form of reports and graphical charts and are aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NIHR applications.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with adoption of NICE approved technologies into the NHS.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used as evidence to support discussions in NHS Hospitals with key NHS stakeholders including finance directors, clinical managers, clinicians and CCG͛s.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

DAUK uses the HES analysis to support their NHS clients with the development of new medical technology and diagnostics in support of relevant disease states.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide.

This analysis is used as evidence to support medical technology developments in NHS Hospitals with key NHS stakeholders including commissioners, clinicians and researchers.

5. Department for International Trade DIT and Office for Life Sciences (OLS):

A basic summary of National HES extracts of disease state, procedure volume and reimbursement analysis are supplied free of charge by DAUK to the DIT and OLS for use in direct and combined discussions with potential overseas companies considering UK market entry. DAUK only provides DIT and OLS with National information, not by hospital or provider. Outputs are therefore aggregated, with small numbers suppressed in line with the HES Analysis Guide.

In 2020/2021 DAUK have a number of new technologies going through NICE approvals;

These can be viewed on the NICE website, links and titles below:

https://www.nice.org.uk/guidance/mtg49

https://www.nice.org.uk/advice/mib196

https://www.nice.org.uk/advice/mib253

https://www.nice.org.uk/advice/mib234

https://www.nice.org.uk/guidance/ipg681

https://www.nice.org.uk/guidance/ipg682

https://www.nice.org.uk/guidance/ipg683

In addition to the following:

• MTG49 – NxThera - Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

• IPG681 - Pressurised intraperitoneal aerosol chemotherapy for peritoneal carcinomatosis

• IPG682 - Balloon cryoablation for Barrett’s oesophagus

• IPG683 - Balloon cryoablation for squamous dysplasia of the oesophagus

• MIB233 - Dexcom G6 for real-time continuous glucose monitoring

• MIB232 - KardiaMobile for the ambulatory detection of atrial fibrillation

The following benefits have also been achieved:

MIB232 - KardiaMobile for the ambulatory detection of atrial fibrillation

https://www.nice.org.uk/advice/mib232

The KardiaMobile heart monitor developed by AliveCor is a device used for identifying atrial fibrillation (AF), two fingers from each hand are placed on the KardiaMobile heart monitor to record an electrocardiogram (ECG). This is then transmitted to the Kardia app which analyses and displays the ECG trace.

Device Access identified and analysed various cohorts of patients with both atrial fibrillation and palpitations to fully understand the burden of the problem to NHS England.

These cohorts were split into subsets based on the patients’ additional comorbidities, seeing a total of approximately 110,000 patients across these subsets with 240,000 beddays used across a 12-month period. KardiaMobile can treat multiple different populations, in different settings and in different clinical scenarios so a full understand of these subsets helped the medtech innovation briefing be developed by NICE, who are now evaluating the product through medical technology guidance program to show the cost effectiveness.

MIB233 - Dexcom G6 for real-time continuous glucose monitoring

https://www.nice.org.uk/advice/mib233

The Dexcom G6 is a real-time continuous glucose monitoring system which measures interstitial fluid glucose levels in people with type 1 or type 2 diabetes.

Data analysis was carried out by DAUK on cohorts of patients with either type 1 or type 2 diabetes. Survival probabilities (the probability that a patient would stay longer than a certain number of nights in hospital for a given episode) were calculated for the overall cohorts and breakdowns of these cohorts by the most common primary diagnosis. This allowed the identification of key comorbidities of diabetic patients that would cause the largest burden on hospitals during stays. Lengths of stays increased by around 44% for type 1 diabetes and 71% for type 2 for all primary diagnoses.

Of these primary diagnoses, certain ICD10 codes were identified having the highest incidence of type 1 or type 2 diabetes which helped find cohorts of patients who were most at risk of becoming high burden patients, to support the NICE evaluation of G6.

MTG55 - Leukomed Sorbact for preventing surgical site infection

https://www.nice.org.uk/guidance/mtg55

Leukomed Sorbact is a sterile, single-use, bacteria-binding, adhesive-bordered wound dressing used to prevent surgical site infection (SSI) from caesarean section or vascular surgery.

Readmission data of patients with caesarean section or vascular surgery was analysed to understand the burden to NHS trusts of patients who developed infection after these surgeries. For caesarean section 3.2%, 1.0% and 0.6% of patients where readmitted into hospital in the following 2 weeks, 2-4 weeks and 4+ weeks respectively for treatment of infections. This created a total of 9,955 additional readmissions resulting in an additional 13,355 bed days taken up by these patients. For vascular surgeries, these figures totaled 10,121 readmissions and 74,383 bed days with 1.3%, 1.2% and 2.8% of patients being readmitted over the same time periods.

This analysis alongside data from further studies showed a cost saving of up to £5.3 million per year for caesarean section and up to £1.2 million per year for vascular surgery for reduced readmissions.

MIB253 - PROPEL sinus implants for maintaining sinus patency after surgery

https://www.nice.org.uk/advice/mib253

For another example, PROPEL sinus implants are designed to keep the sinus open and deliver steroids directly to the sinus mucosa after sinus surgery. The target population is for patients with chronic rhinosinusitis (CRS), with or without nasal polyps, for whom all medical therapy has failed. These patients are attending for CRS surgery, where multiple sinuses are treated with one episode of care. Five cohorts of patients were extracted and analysed to understand the possible benefits to these patients.

The largest group of these patients were those with functional endoscopic sinus surgery recorded as secondary procedures. They produced an estimated cost of £3.8 million in a 12-month period based on 9,450 days in care.

Understanding NHS Heart Transplant outcomes and patient pathway activity helped Device Access UK Ltd in 2014 to produce a paper to support NICE Approval with a company called Transmedics Inc who supply a new organ transplant system for the Heart. This was shown on a BBC2 documentary recently which highlighted the benefits of reducing the current 71% disposal of donated human hearts for transplantation. Link https://www.bbc.co.uk/programmes/b0b3gfth. Device Access are now embarking on helping introduce the same platform for Lung & Liver transplantation.

MIB234 - ClearGuard HD Antimicrobial Barrier Cap for preventing haemodialysis catheter-related bloodstream infections

https://www.nice.org.uk/advice/mib234

ClearGuard HD Antimicrobial Barrier Cap (ICU Medical) is a central venous catheter (CVC) cap for haemodialysis catheters. Cohorts of patients on dialysis (renal, peritoneal, haemodialysis, automated peritoneal and continuous ambulatory peritoneal) were analysed.

Alongside studies from randomised controlled trials this data produced by

Device Access showed the benefits of ClearGuard with a decrease in hospitalisation for bloodstream infections reducing the total bed days of 375,758 for the above cohorts. Specialist centres with the largest burden from these patients were identified from the data analysis with 47% of all episodes taking place in 5 trusts across England. Because of these benefits, NICE are currently developing formal Medical Technologies Guidance on this technology.

MIB196 - DyeVert for reducing contrast media in coronary and peripheral angiography

https://www.nice.org.uk/advice/mib196

DyeVert is a non-invasive system designed to reduce the amount of contrast media given during coronary and peripheral angiographies, when a manual or power injection of contrast media is needed. Nine different cohorts of patients were studied in HES data for patients with acute kidney failure and further comorbidities and procedures relating to AKI.

After the analysis, the main cohort of interest was patients with the diagnostic codes of acute kidney failure immediately followed by the ICD10 code for x-ray contrast media, the combination of which described patients whose AKI was induced by the contrast media. These patients took up 10.0 bed days on average in a 12 month extract period and had a further 150 readmissions in the 12 months following their contrast induced AKI.

Because of these benefits, NICE are currently developing formal Medical Technologies Guidance on this technology.

GID-IPG10149 - Ex-situ machine perfusion for extracorporeal preservation of lungs (ex - vivo lung perfusion) for transplantation

https://www.nice.org.uk/guidance/indevelopment/gid-ipg10149

Understanding NHS Heart Transplant outcomes and patient pathway activity helped DAUK in 2014 to produce a paper to support NICE Approval with a company called Transmedics Inc who supply a new organ transplant system for the Heart. This was shown on a BBC2 documentary recently which highlighted the benefits of reducing the current 71% disposal of donated human hearts for transplantation. Link https://www.bbc.co.uk/programmes/b0b3gfth. DAUK are now embarking on helping introduce the same platform for Lung & Liver transplantation.

NICE are currently developing the IPG-guidance for the transplant system (https://www.nice.org.uk/guidance/indevelopment/gid-ipg10149) titled ex-situ machine perfusion for extracorporeal preservation of lungs (ex - vivo lung perfusion) for transplantation with an expected publication date of 26th May 2021.

Overview of objective for processing:

Device Access UK Limited (known as Device Access or DAUK throughout this document) conduct bespoke analyses on behalf of commercial companies, the NHS, academics and charities. This is a programme of work which identifies where medical and diagnostic technological devices can best be used by NHS providers in NHS patient care pathways to improve patient outcomes reduce lengths of stay, elective and diagnostic waiting times.

Device Access has a transparent Data Access Review Group (DADARG) which is formed of five members; three of which are external to Device Access and employed by NHS England in a clinical or research role.

It is the role of DADARG to review, approve or deny individual requests made from commercial Medical Device companies (Requestors) to Device Access UK (Data Supplier). The group has a clear methodology for approving new requests and is covered by the terms of reference which govern the group. The key focus is that there are clear benefits to patient’s health outcomes and/or the healthcare system.

DAUK outputs are all aggregate with small numbers suppressed in line with the HES Analysis Guide.

The legal basis for Device Access to process the data falls under General Data Protection Regulation Article 6 (1) (f) and General Data Protection Regulation Article 9 (2) (j). In relation to article 6(1)(f), processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. NHS Digital have assessed DAUK’s Legitimate Interests Assessment against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that all requirements are met. In relation to article 9(2)(j) – needed because health data is included in the definition of special categories of personal data and therefore requires an additional condition for processing – the processing is necessary for scientific and research purposes, subject to appropriate safeguards.

This programme of work can be split into five distinct project areas as detailed below;

1. NICE applications on behalf of medical technological device companies:

Device Access UK Ltd (DAUK) act as a bridge between medical technological device companies and the NHS by providing these companies with expertise and bespoke analysis in order to complete the NICE (National Institute of Clinical Excellence) process required before new innovations can be recommended and then adopted into the NHS for the benefit of patients.

This activity is commissioned by the Medical Technology Companies, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented. The device companies have no influence over the way in which the analysis is processed or the results.

NICE programmes relating to the review of new or existing medical and diagnostic technologies require a submission based on a detailed understanding of and real evidence around, current NHS patient pathways.

NICE submissions offer relatively speedy assessments of selected innovations, with the aim of making relevant information available quickly to clinicians and NHS hospital decision makers, to support rapid adoption where this are appropriate.

Submissions to NICE require the following which DAUK extract from HES datasets;

• Understanding of the burden of disease; and how the current NHS patient population is diagnosed and / or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Detailed understanding of cost-effectiveness improvements compared to current NHS pathways

Before accepting a request for submission to DADARG and prior to any analysis or extraction of data, DAUK ensures that the technology meets the criteria of a potentially successful NICE submission by conducting internal research around the following formula (PICO);

I. Population - Who would the technology treat

II. Indication - how the technology works

III. Comparator - How care is currently delivered to the population

IV. Outcome - Are the benefits in line with the health and social care act 2014

Only once DAUK are satisfied that the technology meets these criteria and following approval from DADARG (that it will be of benefit to patients and/or the health care system) will they then conduct the bespoke analysis required for NICE submissions.

As an example of this work, DAUK provided bespoke analysis for a medical device company who have developed a medical technology which monitors vital signs of patients outside of high acuity areas.

Patient deterioration is a significant and growing problem but there is a mounting body of published evidence that supports early identification of the changes in physiology as the most critical factor in avoiding these dangerous and costly episodes. Deterioration in patient condition can happen at any point throughout the care pathway but is more likely following emergency admission, post-surgery or during recovery from a major illness. Such cases and incidents, as well as their reasons for occurring, are well documented in published literature and there is an acceptance that some degree of patient deterioration in these circumstances is likely. There is consensus that the absolute key to reducing the number, severity and economic impact of these largely avoidable deterioration episodes is early clinical intervention at the first sign of potential patient decline. Studies suggest that the greatest area for improvement is not treating the deteriorated patient but more importantly early identification of the deteriorating patient. Delayed recognition of the signs of patient decline is the strongest predictor of patient mortality.

Device Access’s analysis of NHS Digital data showed that over 300,000 spells had patients with a diagnosis of sepsis of which almost 50,000 spells were for patients who had acquired sepsis in a hospital setting. These admissions resulted in significant use of NHS resources, including the use of over 1.2 million bed days and estimated £491 million costs.

2. NIHR research applications on behalf of medical technological device companies:

The objectives for processing the HES data are to provide bespoke analysis to medical technological device companies for their applications for research studies through the NIHR (National Institute for Health Research). NIHR research is often required to provide clinical evidence for NICE applications.

This activity is commissioned and funded by the Medical Technology Company but can be funded directly to the Medical Technology Company though NIHR grants.

The bespoke analysis provided by DAUK includes;

• Clinical need analysis, evidence gap analysis and clinical endpoints

• Understanding of the burden of disease; and how the current NHS patient population is diagnosed and or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Understanding of potential cost-effectiveness improvements compared to current NHS pathways

As a new example, Device Access are currently working with another medical device company on a monitoring device for transplants. The decision to transplant or discard is one of the hardest a surgeon can make, particularly with the growing number of organs from older donors and those with comorbidities. Discard rates average 15-20% and rise with Kidney Donor Profile Index (36% 80-90, 63% 91-100). However, over-caution may be preventing thousands of dialysis-dependent patients from returning to a normal life.

DAUK provided bespoke analysis which has secured collaborative research for the manufacturer of the technology with the NIHR. DAUK have also identified the areas of the country where there is most need thus enabling faster patient enrolment into this study.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd provide expertise and bespoke analysis to medical technological device companies and the NHS in order to assist with adoption and diffusion of NICE recommended technologies so new innovations can be adopted into the NHS for the benefit of patients, and the healthcare system.

This analysis is used to support local NHS adoption by providing information relating to benefits for patients in a local area. This information is sent by Device Access to both the commissioning medical device company and also the NHS hospital stake holders to demonstrate the benefit to comply with NICE guidance. This activity is commissioned and paid for by the Medical Technology Company.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be used. The device companies have no influence over the way in which the analysis is processed or the results.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

Device Access UK Ltd provide expertise and bespoke analysis to the NHS in order to assist with identifying new medical technology and diagnostics in support of relevant disease states with a view that these will be adopted into the NHS for the benefit of patients, and NHS hospitals.

This activity is commissioned by the NHS, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented.

This work does not include broad based economic consultancy services such as benchmarking but is limited to the purposes described in this document. DAUK would submit an amendment application to NHS Digital if DAUK were to consider a consultancy service which fell outside this agreed purpose.

5. Department for International Trade DIT and Office for Life Sciences:

Since 2010, Device Access UK Ltd has supported the Department of International Trade or DIT, formerly known as the UK Trade and Investment (UKTI) who are part of the Government’s Office for Life Sciences (OLS).

Part of the DIT and OLS objectives are to attract inward investment into the UK from companies across the world, to develop their business here in the life science sectors and DAUK has worked to support the strategy of the OLS and DIT.

OLS and DIT commission DAUK with requests for market information, and DAUK provides free expertise on disease state, procedure volume and reimbursement.

DAUK decide the manner and the process by which the analysis is carried out. DIT and OLS have no influence over the way in which the analysis is processed or the results.

Commercial companies specifically agree not to use the analysis provided by DAUK within general marketing, or within collateral material used by sales and marketing teams. These include sales brochures, emails, direct or mass mailing and advertising of medical technologies. Device Access Ltd do not allow portal access to the data by clients.

Description of outputs have been provided below;

1. NICE applications on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with their submissions to NICE for evaluation. These bespoke outputs are in the form of reports and graphical charts and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NICE applications.

Below are examples of DAUK analysis which has been used in NICE applications and have resulted in positive NICE guidance in 2019-2020:

• GID-MT533 – SEM scanner - SEM Scanner 200 for pressure ulcer prevention

• MTG49 – NxThera - Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

• MTG43 - PICO negative pressure wound dressings for closed surgical incisions

• IPG673 – Shockwave Medical - Intravascular lithotripsy for calcified coronary arteries during percutaneous coronary intervention

• IPG670 – Medtronic - Cyanoacrylate glue occlusion for varicose veins

• MIB196 - DyeVert for reducing contrast media in coronary and peripheral angiography

Prior to 2019, Device Access UK Ltd supported 34 additional NICE Medical Technology approvals leading to guidance;

• NICE MIB158 – NxThera - Rezum for treating benign prostatic hyperplasia

• NICE MIB 159 – Hill-Rom – The Vest for delivering high-frequency chest wall oscillation in people with complex neurological needs

• NICE IPG629 – Procept Biorobotics - Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB165 – Cerebrotech - Cerebrotech Visor for detecting large vessel occlusion stroke

• NICE IPG625 - NxThera - Transurethral water vapour ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB173 – Acelity Prevena - Prevena incision management system for closed surgical incisions

• NICE MIB168 – Limax Humedics - LiMAx system for assessing the functional capacity of the liver

• NICE MTG45 – Endocuff - Endocuff Vision for assisting visualisation during colonoscopy

• NICE MIB182 – Bruin - SEM Scanner for pressure ulcer prevention

• NICE IPG641 – Medi-Tate - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB86 Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis

• NICE MIB 47 - TearLab - TearLab osmolarity system for diagnosing dry eye disease

• NICE TA628 - Zeiss - Intraoperative Radiotherapy for Breast Cancer

• NICE IPG 479 - Sequana Medical - Device to manage ascites

• NICE MTG19 - FirstKind Medical - Device to stimulate peripheral blood flow for DVT Prevention

• NICE IP475 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE MT241 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE DG12 - Aerocrine Ltd - Diagnostic Test to Manage Asthma

• NICE MIB8 - Airsonett Ltd - Airsonett temperature-controlled laminar airflow device for persistent allergic asthma

• NICE IPG396 - Glaukos - Trabecular stent bypass microsurgery for open angle glaucoma

• NICE IPG431 - Torax Medical - Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease

• NICE IPG549 - Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG29 - Boston - GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 - Entellus - XprESS multi sinus dilation system for treating chronic sinusitis

• NICE IPG578 - Si Bone - Spinal Fusion Technology for lumbar sacral pain

• NICE MTG19 - Geko First Kind - The geko device for reducing the risk of venous thromboembolism

• NICE IPG 1555 - NxThera - Water vapour for treating benign prostate hyperplasic

• NICE IPG 1520 - Thoraclion - Hi Intensity focussed ultrasound for breast lumps

• NICE MIB47 - Tearlab - Diagnosis of dry eye disorders

• NICE MTG32 - Heartflow – Diagnostic platform for the optimal placement of cardiac stents

• NICE MIB110 - Abbott - Diabetic Monitoring

• NICE MIB116 - Urethrotech - Urinary Catheterisation device for men with enlarged prostates

2. NIHR research applications on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with their submissions for NIHR funding. All bespoke outputs come in the form of reports and graphical charts and are aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NIHR applications.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with adoption of NICE approved technologies into the NHS.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used as evidence to support discussions in NHS Hospitals with key NHS stakeholders including finance directors, clinical managers, clinicians and CCG͛s.

For example, Device Access has worked with over 10 NHS Hospitals in England, including Manchester Royal Infirmary, Charing Cross Hospital and Southampton General Hospital, in helping them decide if they should adopt a new mechanism of reducing admissions and length of stay through a technology that replaces treats patients with chronic rhinosinusitis following ethmoid, frontal or maxillary sinus surgery.

Device Access identified the numbers of treatments performed and the number of repeat episodes that patients returned for in specific hospitals.

This was then entered into a costing model which was provided to the NHS Hospital as part of an adoption business case that summarised the patient and hospital benefits of adopting the new technology.

The benefits for the patients are they may have improved sinus surgery outcomes from reduced inflammation.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

Device Access UK Ltd uses the HES analysis to support their NHS clients with the development of new medical technology and diagnostics in support of relevant disease states.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide.

This analysis is used as evidence to support medical technology developments in NHS Hospitals with key NHS stakeholders including commissioners, clinicians and researchers.

5. Department for International Trade DIT and Office for Life Sciences (OLS):

A basic summary of National HES extracts of disease state, procedure volume and reimbursement analysis are supplied free of charge by DAUK to the DIT and OLS for use in direct and combined discussions with potential overseas companies considering UK market entry. DAUK only provides DIT and OLS with National information, not by hospital or provider. Outputs are therefore aggregated, with small numbers suppressed in line with the HES Analysis Guide.

In 2020 Device Access have a number of new technologies going through NICE approvals;

These can be viewed on the NICE website, links and titles below:

https://www.nice.org.uk/guidance/mtg43

https://www.nice.org.uk/guidance/mtg49

https://www.nice.org.uk/guidance/ipg670

https://www.nice.org.uk/guidance/ipg673

https://www.nice.org.uk/advice/mib196

• MTG43 - PICO negative pressure wound dressings for closed surgical incisions

• MTG49 – NxThera - Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia

• IPG670 – Medtronic - Cyanoacrylate glue occlusion for varicose veins

• IPG673 – Shockwave Medical - Intravascular lithotripsy for calcified coronary arteries during percutaneous coronary intervention

• MIB196 - DyeVert for reducing contrast media in coronary and peripheral angiography

Understanding NHS Heart Transplant outcomes and patient pathway activity helped Device Access UK Ltd in 2014 to produce a paper to support NICE Approval with a company called Transmedics Inc who supply a new organ transplant system for the Heart. This was shown on a BBC2 documentary recently which highlighted the benefits of reducing the current 71% disposal of donated human hearts for transplantation. Link https://www.bbc.co.uk/programmes/b0b3gfth. Device Access are now embarking on helping introduce the same platform for Lung & Liver transplantation

Overview of objective for processing:

Device Access UK Limited (known as Device Access or DAUK throughout this document) conduct bespoke analyses on behalf of commercial companies, the NHS, academics and charities. This is a programme of work which identifies where medical and diagnostic technological devices can best be used by NHS providers in NHS patient care pathways to improve patient outcomes reduce lengths of stay, elective and diagnostic waiting times.

Device Access has a transparent Data Access Review Group (DADARG) which is formed of five members; three of which are external to Device Access and employed by NHS England in a clinical or research role.

It is the role of DADARG to review, approve or deny individual requests made from commercial Medical Device companies (Requestors) to Device Access UK (Data Supplier). The group has a clear methodology for approving new requests and is covered by the terms of reference which govern the group. The key focus is that there are clear benefits to patient’s health outcomes and/or the healthcare system.

DAUK outputs are all aggregate with small numbers suppressed in line with the HES Analysis Guide.

The legal basis for Device Access to process the data falls under General Data Protection Regulation Article 6 (1) (f) and General Data Protection Regulation Article 9 (2) (j). In relation to article 6(1)(f), processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. NHS Digital have assessed DAUK’s Legitimate Interests Assessment against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that all requirements are met. In relation to article 9(2)(j) – needed because health data is included in the definition of special categories of personal data and therefore requires an additional condition for processing – the processing is necessary for scientific and research purposes, subject to appropriate safeguards.

This programme of work can be split into five distinct project areas as detailed below;

1. NICE applications on behalf of medical technological device companies:

Device Access UK Ltd (DAUK) act as a bridge between medical technological device companies and the NHS by providing these companies with expertise and bespoke analysis in order to complete the NICE (National Institute of Clinical Excellence) process required before new innovations can be recommended and then adopted into the NHS for the benefit of patients.

This activity is commissioned by the Medical Technology Companies, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented. The device companies have no influence over the way in which the analysis is processed or the results.

NICE programmes relating to the review of new or existing medical and diagnostic technologies require a submission based on a detailed understanding of and real evidence around, current NHS patient pathways.

NICE submissions offer relatively speedy assessments of selected innovations, with the aim of making relevant information available quickly to clinicians and NHS hospital decision makers, to support rapid adoption where this are appropriate.

Submissions to NICE require the following which DAUK extract from HES datasets;

• Understanding of the burden of disease; and how the current NHS patient population is diagnosed and / or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Detailed understanding of cost-effectiveness improvements compared to current NHS pathways

Before accepting a request for submission to DADARG and prior to any analysis or extraction of data, DAUK ensures that the technology meets the criteria of a potentially successful NICE submission by conducting internal research around the following formula (PICO);

I. Population - Who would the technology treat

II. Indication - how the technology works

III. Comparator - How care is currently delivered to the population

IV. Outcome - Are the benefits in line with the health and social care act 2014

Only once DAUK are satisfied that the technology meets these criteria and following approval from DADARG (that it will be of benefit to patients and/or the health care system) will they then conduct the bespoke analysis required for NICE submissions.

As an example of this work, DAUK are currently providing bespoke analysis for a medical device company who have developed a medical technology which assists with effective airway clearance in more than 500 diseases and conditions in adults and children including cerebral palsy, cystic fibrosis and bronchiectasis.

Manual Chest Wall Physiotherapy (MCWP) is the standard treatment for managing airway clearance; MCWP involves techniques aimed at clearing the lungs by percussion, vibration, deep breathing, and huffing or coughing. The positioning of the patient during chest wall physiotherapy is important as posture can assist with secretion drainage. Community respiratory physiotherapy teams train carers in these techniques. A typical session takes about 30 minutes but can range from 10 to 60 minutes. Patients typically require 2 to 4 sessions a day but may need up to 6 sessions daily if they have a respiratory infection. As children grow older and into adulthood, maintaining the best position to support drainage can be very difficult for a carer providing the therapy on their own. This places a high burden on patients and carers who find it difficult to complete MCWP as frequently and effectively as recommended. This can result in insufficient airway clearance, recurrent respiratory infections, and increased health resource use.

Device Access’s analysis of NHS Digital data showed that nearly 19,000 non- elective emergency admissions for patients with neuromuscular disease were related to a respiratory condition. There were also 4,400 non-elective emergency respiratory-related admissions for patients with cerebral palsy. These admissions resulted in significant use of NHS resources, including the use of over 120,000 bed days and estimated £60 million costs.

The results of DAUK’s analysis show that adoption of the new pathway with the Vest™ may result in approximately £6 million cost savings per 1,000 patients with complex neurological disorders in 5 years. Per 1,000 patients, 2,442 hospital admissions and 49,868 bed days could be averted with the use of the Vest™ in NHS England.

2. NIHR research applications on behalf of medical technological device companies:

The objectives for processing the HES data are to provide bespoke analysis to medical technological device companies for their applications for research studies through the NIHR (National Institute for Health Research). NIHR research is often required to provide clinical evidence for NICE applications.

This activity is commissioned and funded by the Medical Technology Company but can be funded directly to the Medical Technology Company though NIHR grants.

The bespoke analysis provided by DAUK includes;

• Clinical need analysis, evidence gap analysis and clinical endpoints

• Understanding of the burden of disease; and how the current NHS patient population is diagnosed and or treated

• The way the potential new technology works differently for this specific population in NHS England

• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology

• Understanding of potential cost-effectiveness improvements compared to current NHS pathways

As a new example, working with another medical device company on a diagnostic device to identify delirium. Delirium is an abrupt change in the brain that causes mental confusion and emotional disruption. It makes it difficult to think, remember, sleep & pay attention. This common condition has a significant effect for specific patient cohorts in terms of length of stay in NHS Hospitals.

DAUK provided bespoke analysis which has secured collaborative research for the manufacturer of the technology with the NIHR. DAUK have also identified the areas of the country where there is most need thus enabling faster patient enrolment into this study.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd provide expertise and bespoke analysis to medical technological device companies and the NHS in order to assist with adoption and diffusion of NICE recommended technologies so new innovations can be adopted into the NHS for the benefit of patients, and the healthcare system.

This analysis is used to support local NHS adoption by providing information relating to benefits for patients in a local area. This information is sent by Device Access to both the commissioning medical device company and also the NHS hospital stake holders to demonstrate the benefit to comply with NICE guidance. This activity is commissioned and paid for by the Medical Technology Company.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be used. The device companies have no influence over the way in which the analysis is processed or the results.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

Device Access UK Ltd provide expertise and bespoke analysis to the NHS in order to assist with identifying new medical technology and diagnostics in support of relevant disease states with a view that these will be adopted into the NHS for the benefit of patients, and NHS hospitals.

This activity is commissioned by the NHS, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented.

This work does not include broad based economic consultancy services such as benchmarking but is limited to the purposes described in this document. DAUK would submit an amendment application to NHS Digital if DAUK were to consider a consultancy service which fell outside this agreed purpose.

5. Department for International Trade DIT and Office for Life Sciences:

Since 2010, Device Access UK Ltd has supported the Department of International Trade or DIT, formerly known as the UK Trade and Investment (UKTI) who are part of the Government’s Office for Life Sciences (OLS).

Part of the DIT and OLS objectives are to attract inward investment into the UK from companies across the world, to develop their business here in the life science sectors and DAUK has worked to support the strategy of the OLS and DIT.

OLS and DIT commission DAUK with requests for market information, and DAUK provides free expertise on disease state, procedure volume and reimbursement.

DAUK decide the manner and the process by which the analysis is carried out. DIT and OLS have no influence over the way in which the analysis is processed or the results.

Commercial companies specifically agree not to use the analysis provided by DAUK within general marketing, or within collateral material used by sales and marketing teams. These include sales brochures, emails, direct or mass mailing and advertising of medical technologies. Device Access Ltd do not allow portal access to the data by clients.

Description of outputs have been provided below;

1. NICE applications on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with their submissions to NICE for evaluation. These bespoke outputs are in the form of reports and graphical charts and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NICE applications.

Below are examples of DAUK analysis which has been used in NICE applications and have resulted in positive NICE guidance in 2018-2019

• NICE MIB158 – NxThera - Rezum for treating benign prostatic hyperplasia

• NICE MIB 159 – Hill-Rom – The Vest for delivering high-frequency chest wall oscillation in people with complex neurological needs

• NICE IPG629 – Procept Biorobotics - Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB165 – Cerebrotech - Cerebrotech Visor for detecting large vessel occlusion stroke

• NICE IPG625 - NxThera - Transurethral water vapour ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia

• NICE MIB173 – Acelity Prevena - Prevena incision management system for closed surgical incisions

• NICE MIB168 – Limax Humedics - LiMAx system for assessing the functional capacity of the liver

• NICE MTG45 – Endocuff - Endocuff Vision for assisting visualisation during colonoscopy

• NICE MIB182 – Bruin - SEM Scanner for pressure ulcer prevention

• NICE IPG641 – Medi-Tate - Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

Prior to 2018, Device Access UK Ltd supported 24 additional NICE Medical Technology approvals leading to guidance;

• NICE MIB86 Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis

• NICE MIB 47 - TearLab - TearLab osmolarity system for diagnosing dry eye disease

• NICE TA628 - Zeiss - Intraoperative Radiotherapy for Breast Cancer

• NICE IPG 479 - Sequana Medical - Device to manage ascities

• NICE MTG19 - FirstKind Medical - Device to stimulate peripheral blood flow for DVT Prevention

• NICE IP475 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE MT241 - Neotract Inc - Device for relief of benign prostate hyperplasia

• NICE DG12 - Aerocrine Ltd - Diagnostic Test To Manage Asthma

• NICE MIB8 - Airsonett Ltd - Airsonett temperature-controlled laminar airflow device for persistent allergic asthma

• NICE IPG396 - Glaukos - Trabecular stent bypass microsurgery for open angle glaucoma

• NICE IPG431 - Torax Medical - Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease

• NICE IPG549 - Transmedics - Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

• NICE MTG29 - Boston - GreenLight XPS for treating benign prostatic hyperplasia

• NICE MTG30 - Entellus - XprESS multi sinus dilation system for treating chronic sinusitis

• NICE IPG578 - Si Bone - Spinal Fusion Techology for lumbar sacral pain

• NICE MTG19 - Geko First Kind - The geko device for reducing the risk of venous thromboembolism

• NICE IPG 1555 - NxThera - Water vapour for treating benign prostate hyperplasic

• NICE IPG 1520 - Thoraclion - Hi Intensity focussed ultrasound for breast lumps

• NICE MIB47 - Tearlab - Diagnosis of dry eye disorders

• NICE MTG32 - Heartflow – Diagnostic platform for the optimal placement of cardiac stents

• NICE MIB110 - Abbott - Diabetic Monitoring

• NICE MIB116 - Urethrotech - Urinary Catheterisation device for men with enlarged prostates

2. NIHR research applications on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with their submissions for NIHR funding. All bespoke outputs come in the form of reports and graphical charts and are aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NIHR applications.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with adoption of NICE approved technologies into the NHS.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used as evidence to support discussions in NHS Hospitals with key NHS stakeholders including finance directors, clinical managers, clinicians and CCG͛s.

For example, Device Access has worked with over 20 NHS Hospitals in England in helping them decide if they should adopt a new mechanism of reducing emergency admissions and length of stay through a technology that replaces traditional paracentesis procedures for patients with liver cancer. This technology moves ascites fluid from the abdomen into the bladder using an implantable rechargeable pump called the AlfaPump.

The NHS Hospitals contacted Device Access, and requested their specific length of stay information based on their individual annual activity.

Device Access identified the numbers of treatments performed and the number of repeat episodes that patients returned for.

This was then entered into a costing model which was provided to the NHS Hospital as part of an adoption business case that summarised the patient and hospital benefits of adopting the new technology.

The benefits for the patients are they now do not need to return to the hospital for repeat paracentesis and are able to live independently.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

Device Access UK Ltd uses the HES analysis to support their NHS clients with the development of new medical technology and diagnostics in support of relevant disease states.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide.

This analysis is used as evidence to support medical technology developments in NHS Hospitals with key NHS stakeholders including commissioners, clinicians and researchers.

5. Department for International Trade DIT and Office for Life Sciences (OLS):

A basic summary of National HES extracts of disease state, procedure volume and reimbursement analysis is supplied free of charge by DAUK to the DIT and OLS for use in direct and combined discussions with potential overseas companies considering UK market entry. DAUK only provides DIT and OLS with National information, not by hospital or provider. Outputs are therefore aggregated, with small numbers suppressed in line with the HES Analysis Guide.

In the past year, Device Access have a number of new technologies that have gone through NICE review and approvals;

These can be viewed on the NICE website, links and titles below:

https://www.nice.org.uk/advice/mib158

https://www.nice.org.uk/advice/mib159

https://www.nice.org.uk/advice/mib165

https://www.nice.org.uk/advice/mib168

https://www.nice.org.uk/advice/mib173

https://www.nice.org.uk/advice/mib182

• NICE MIB158 – NxThera - Rezum for treating benign prostatic hyperplasia

• NICE MIB 159 – Hill-Rom – The Vest for delivering high-frequency chest wall oscillation in people with complex neurological needs

• NICE MIB165 – Cerebrotech - Cerebrotech Visor for detecting stroke

• NICE MIB168 – Limax Humedics - LiMAx system for assessing the functional capacity of the liver

• NICE MIB173 – Acelity Prevena - Prevena incision management system for closed surgical incisions

• NICE MIB182 – Bruin - SEM Scanner for pressure ulcer prevention

Understanding NHS Heart Transplant outcomes and patient pathway activity helped Device Access UK in 2014 to produce a paper to support NICE Approval with a company called Transmedics Inc who supply a new organ transplant system for the Heart. This was shown on a BBC2 documentary which highlighted the benefits of reducing the current 71% disposal of donated human hearts for transplantation. Link https://www.bbc.co.uk/programmes/b0b3gfth. Device Access UK are now embarking on helping introduce the same platform for Lung & Liver transplantation.