Guidance

The Innovative Devices Access Pathway (IDAP) - pilot phase

Updated 29 February 2024

The pilot phase of the development of a new pathway supporting innovative technologies to address unmet clinical needs in the UK has entered the next phase. The IDAP Partners have selected eight technologies that will receive tailored regulatory and access support.

Overview

The Innovative Devices Access Pathway (IDAP) pilot is an initiative to bring new medical technologies to the National Health Service (NHS) to help with medical needs that are currently unmet.

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. It stems from the Life Sciences Vision, published in July 2021, which set out the government’s intention to strengthen access and uptake of innovation, and create an outstanding environment for life sciences businesses to start, grow and invest.

The pilot will:

• Test the main elements of the pathway,
• Provide informative learning and feedback to help build the future IDAP
• Inform the wider development of an end-to-end innovation pathway, as per the Medical Technology Strategy published in February 2023.

The IDAP pilot was open to applications from commercial and non-commercial developers from the UK and international markets who have developed new medical devices. The successful applicants will receive support from IDAP partners at key stages of their product development journey.

Partners

The IDAP partners comprise of the following organisations:

• Department of Health and Social Care (DHSC)
• Health Technology Wales (HTW)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• National Health Service England (NHSE)
• National Institute for Health and Care Excellence (NICE)
• Office of Life Sciences (OLS)
• Scottish Health Technologies Group (SHTG), part of Healthcare Improvement Scotland

The benefits the IDAP delivers

The successful applicants will receive non-financial support from a team of experts to develop a product specific Target Development Profile (TDP) roadmap. The TDP roadmap will define Regulatory and Access touchpoints across the product development, which could include;

• system navigation advice
• quality management system support
• a fast-tracked clinical investigation review
• joint scientific advice with partners
• safe-harbour meetings with HTAs, NHS and other key system stakeholders to discuss product realisation, NHS adoption and commercial challenges
• dialogue to discuss potential reimbursement options
• exceptional use authorisation granted by the MHRA, provided necessary safety standards are met.

The eight selected innovative medical devices

Blood-based biomarker test for Alzheimer’s Disease: Developed by Roche Diagnostics Ltd.

Alzheimer’s Disease is characterised by the build-up of abnormal proteins in and around brain cells which have been shown to occur many years before symptoms begin. Potentially, people with Alzheimer’s Disease could be treated earlier if they could be identified when they have Mild Cognitive Impairment (MCI) which is thought to be an early sign of dementia and Alzheimer’s Disease.

Current guidelines recommend testing cerebrospinal fluid (CSF) and PET-CT imaging for patients who are suspected to have Alzheimer’s Disease. With the expectation that disease modifying medication may soon be available, there will be a need for the CSF and PET-CT tests to access these treatments. The Amyloid Plasma Panel is a blood-test based in vitro diagnostic device that has the potential to help clinicians decide if patients with mild cognitive impairment should undergo the more invasive CSF test or expensive PET-CT imaging to confirm Alzheimer’s Disease.

Algorithm-based infection predictor: Developed by Presymptom Health Ltd.

Patients with suspected infection or sepsis often present with non-specific inflammatory symptoms including rapid heart rate, elevated/reduced body temperature and/or rapid respiration rate. Such symptoms may arise from many non-infectious causes, including injury, surgery, auto-immune disease or malignancy. Identifying patients who don’t have infection enables clinicians to avoid unnecessary use of antibiotics in such patients. This in vitro diagnostic device uses a molecular test and a cloud-based algorithm to accurately predict infection status up to three days before conventional clinical diagnosis is possible. It has the potential to reduce unnecessary antibiotic use and delays in appropriate treatment.

Liver cancer treatment using focused ultrasound: Developed by HistoSonics Inc.

Thousands of people each year are diagnosed with primary liver cancer and many more have tumours appear in their liver from cancers in other organs. This medical device is designed to target and destroy cancer in the liver without incisions or needles through the use of a technique called histotripsy. This is a non-invasive, non-ionizing and non-thermal method of treatment which uses focused ultrasound waves for the mechanical breakdown of the tumour without damaging non-target tissue. It offers a more accessible and safer alternative to the conventional treatments of surgery, radiotherapy and thermal ablation. It has the potential to improve quality of life for patients, with a reduction in hospital resources , costly post-procedure complications and pain management including opioids.

Oxygen measuring technology irrespective of skin pigmentation: Developed by Earswitch Ltd.

Pulse oximetry measures the amount of oxygen carried by red blood cells in the body.  It typically involves an oximeter device clipped over the end of a fingertip and is used widely in healthcare settings and at home to assess how well the lungs and heart are working. However, there is evidence to suggest that this technology may not accurately detect reducing oxygen levels in people with darker skin tones. This device has been developed to detect oxygen levels from the inner ear-canal, which is not pigmented irrespective of the person’s skin colour. This has the potential to provide an innovative and equitable approach to oxygen level monitoring, with better quality readings and uses a location where the device is better tolerated and less prone to being dislodged than conventional finger clip devices.

Multiple Sclerosis fatigue app: Developed by King’s College London and Avegen Ltd

People living with Multiple Sclerosis (MS) often suffer from a particularly debilitating form of fatigue; an extreme feeling of weakness and exhaustion that is not cured by rest. Whilst many people receive medication, evidence suggests that balance exercises, cognitive behaviour therapy and targeted physical activity programmes are more likely to help with MS-fatigue. Unfortunately, these options are currently only offered to a small proportion of patients due to NHS capacity limitations. This software medical device is a smartphone app that delivers each of these options in a personally customisable format with expert guidance from health psychologists, physiotherapists and occupational therapists. The app is intended to improve accessibility to NICE-recommended MS-fatigue symptom management programmes that aim to reduce fatigue severity and its impact on overall quality of life.

The programme is funded by a grant awarded by the National Institute for Health and Care Research and co-funded by the Multiple Sclerosis Society. The Chief Investigator is Professor Rona Moss-Morris based at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London, her team are leading the development of the app with Avegen Ltd as their technology partner.

Portable diagnostic device for stroke identification: Developed by Upfront  Diagnostics Ltd

Stroke caused by a blockage of a large blood vessel in the brain can cause death, severe disability and long-term on-going care costs. The chance of recovery is much improved following urgent treatment to remove the blockage (thrombectomy) which is only available at dedicated stroke centres. Currently, ambulance staff cannot recognise people with large artery blockage to take them directly to a stroke centre instead of the local hospital. The longer the delay, the less effective the treatment is in reducing long-term disability. This portable in vitro diagnostic blood test has been developed to rapidly identify people with large artery blockage stroke and aids the ambulance paramedics in triaging patients requiring thrombectomy. Potentially this could reduce the impact of long-term disability, care costs and improve quality of life.

Self-test diagnostic device for neutropenia: Developed by 52 North Health

Neutropenic sepsis is a life-threatening condition which occurs in patients whose immune system is suppressed (e.g., cancer patients undergoing chemotherapy or people with autoimmune diseases), which means that their bodies lack sufficient white blood cells to fight infections. Currently, chemotherapy patients who feel unwell must attend A&E for blood tests to check for neutropenia and receive precautionary intravenous antibiotics.  This is an in vitro diagnostic test which enables patients to self-test using a finger-prick blood test to measure two key biomarkers. The related app supports the patient to report the results through a telephone conversation with the hospital and be triaged at home reducing unnecessary visits to A&E and unnecessary antibiotic treatment for patients not at-risk, while also identifying at-risk patients earlier on, enabling them to be treated more quickly.

Artificial intelligence  to predict at risk COPD patients: Developed by Lenus Health Ltd

Chronic Obstructive Pulmonary Disease (COPD) is a lung disease in which airways become narrow and damaged, leading to breathing difficulties. COPD tends to worsen over time including periods of acute events known as exacerbations leading to a significant increase in unscheduled care and hospital admissions. Accurate assessment of disease severity has important implications for both treatment and prognosis. This software medical device uses machine learning models to generate risk prediction scores for patients with COPD. Identifying those at increased risk of hospital admission to help prioritise patients for treatment optimisation. The device has the potential to reorientate care provision from what is currently a largely reactive and expensive model to one focused on proactive intervention and delivery of preventative and personalised care.

Eligibility

The following eligibility and innovation criteria needed to be met for successful entry to the IDAP pilot. The IDAP partners and patient and public representatives selected eight products that best meet those criteria and are most likely to benefit from the expertise and tools available in the pilot. Those that did not meet the criteria or were not successful at the selection stage will not progress through the pathway. Companies of all sizes were invited to apply and the lead applicant may work with other companies or organisations.

Eligibility criteria used in the IDAP pilot

• The product must be a medical device.
• The lead applicant must be a legal entity with the rights to market their health product in the UK.
• For early-stage health technologies, organisations must demonstrate a proof of concept evidenced by data from a near final prototype.
• The applicant must be intending to market the health product in the UK and intend to obtain regulatory authorisation.
• Applicants are expected to have identified clinical investigation sites and ideally have signed agreements in place.
• The applicant must commit to working with the IDAP partners to create a Target Development Profile.
• Organisations must have a recognised quality management system in place. Whilst certification is not mandatory, the system must satisfy the requirements of ISO 13485 or equivalent.

Out of scope/companies that could not apply:

• Drug medical device combination products
• Legal entities headquartered or operating out of jurisdictions that are the subject of UK Government sanctions. View the sanctions list.

IDAP Pilot criteria

These criteria will be reviewed and updated once the IDAP pilot is complete.

Criterion one: The condition is life-threatening or seriously debilitating and there is a significant patient need.

• The product must address a potentially life-threatening or seriously debilitating condition.
• The product must address an unmet clinical need.
• Applications must be supported by at least one individual in a relevant health and/or care organisation or network.

Criterion two: The product is innovative and transformative.

• The product is either new or a novel modification of existing technologies.
• There are no solutions that fulfil the same clinical need that have regulatory approval in the UK.
• The use of the device in the healthcare system has the potential to be transformative.

Criterion three: The product will provide system wide benefit.

• The product will be widely adopted and is sustainable.
• The product has potential to be cost effective.

Criterion four: the technology clearly helps to address one of the following Life Sciences Vision’s Healthcare Missions:

• Improving translational capabilities in neurodegeneration and dementia.
• Enabling early diagnosis and treatments, including immune therapies such as cancer vaccines.
• Treatment and prevention of cardiovascular diseases and its major risk factors, including obesity.
• Reducing mortality and morbidity from respiratory disease in the UK and globally.
• Addressing the underlying biology of ageing.
• Increasing the understanding of mental health conditions, including work to redefine diseases and develop translational tools to address them.

IDAP governance and patient and public involvement

It is important that the activities and decisions of the IDAP partners are managed and coordinated effectively. To ensure effective governance and that patient involvement remains integral to how the pathway operates, a delivery group has been set up. 

All members are required to adhere to NDA/ Conflict of interest procedures. This includes invited patient and public representatives.

Delivery group

IDAP activities are overseen by a cross-partner delivery group. The group is mandated to make decisions on which technologies were accepted onto the pilot scheme. The delivery group is also responsible for the strategic development and implementation of the IDAP.

Patient and public representatives

IDAP will seek the lived experience of patients and the public to support development of innovative devices that better meet the needs of patients. We aim to include this lived experience where it will be most meaningful and impactful across the pathway.

Selection of the eight innovative medical devices

We have involved patient experts in the shortlisting and selection the eight innovative and transformative medical devices that will enter the pilot. Patient experts have joined the delivery group for this activity.

Next steps for the successful medical device products: Target Development Profile meetings

Target Development Profile (TDP) meetings between the product developers and IDAP partners will take place early in the pilot. Patient and public involvement at these meetings will be determined on a case-by-case basis.

The TDP defines a pathway for the selected manufacturers that enables direct interaction with partners in an innovative approach to support the safe, timely and efficient generation of evidence to underpin both regulatory approval and Health Technology Assessment (HTA) of innovative medical devices.

Further information

If you would like help with your application or to find our more, please email IDAPenquiries@mhra.gov.uk.

IDAP data protection and privacy information