A version of this article was originally published in September 2023 as the IDAP pilot launched. The article was updated in September 2024 to reflect progress with the IDAP pilot.
The UK government recently launched its latest initiative to encourage innovation in the Medtech space and expedite access of medical devices to patients and healthcare professionals. The Innovative Devices Access Pathway (IDAP) pilot, launched in September 2023, is a breakthrough multi-partner collaboration between National Health Service (NHS) stakeholders in England, Scotland, and Wales.
The aim of the IDAP pilot is to reduce uncertainty in the route to market for technology developers by providing regulatory and market access support to eligible Medtech developers. The pilot is scheduled to run until March 2025, with the aim to establish IDAP as an ongoing programme beyond 2025.
The IDAP pilot stems from the Life Sciences Vision, published in July 2021, which set out the government’s intention to create an outstanding environment for life sciences businesses to start, grow, and invest, as well as strengthen access and uptake of innovation.
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Which technologies were selected for the IDAP pilot?
The IDAP pilot received ten times more applications than available spots. Applications covered a wide array of health and wellness areas, such as cardiac health, oncology, ageing and geriatrics, long-term condition management, mental health, early diagnostics innovations, and remote monitoring technologies.
On 14th February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA), and its partners, announced the selection of the first eight novel technologies to test the IDAP pathway. Products were picked based on their potential to meet unmet medical needs and fulfil the UK Life Sciences Vision. One device aims to destroy liver cancer tumours using ultrasonic waves, offering a safer alternative to radiotherapy. Another selected technology supports earlier diagnosis of Alzheimer’s disease and stroke through novel blood tests. Another was a software medical device that uses artificial intelligence to predict patients at risk of hospitalisation for chronic obstructive pulmonary disease, helping to prioritise patients for treatment optimisation.
What benefits does the IDAP pilot offer Medtech developers?
The IDAP pilot is the first example of system partners working together to provide Medtech developers with tailored, joined-up support that complies with regulatory requirements and accelerates market access along a single pathway. This includes advice on regulation, assessment, and access considerations to develop and commercialise an innovative device in the UK.
The IDAP scheme builds on the UK’s intention to develop an end-to-end pathway for innovation. The Innovative Licensing and Access Pathway (ILAP) for medicines is already in place for those operating in medicinal development. IDAP seeks an equivalent for medical devices.
Medtech developers will receive non-financial support from IDAP partners, such as the National Institute for Health and Care Excellence (NICE), MHRA, Department of Health and Social Care (DHSC), Health Technology Wales (HTW), National Health Service England (NHSE), Office for Life Sciences (OLS), and Scottish Health Technologies Group (SHTG), to develop a Target Development Profile (TDP) roadmap. The TDP roadmap will define regulatory and access touchpoints across the product development, and ensure touchpoints are specific to the maturity of the technology. The touchpoints could include:
- System navigation advice
- A priority clinical investigation
- Joint scientific advice
- Support with health technology assessment (HTA)
- Safe-harbour meetings to discuss NHS adoption
- Exceptional use authorisation, granted by the MHRA (provided necessary standards are met)
This support will accelerate the process by which Medtech developers can launch innovative products in the UK market.
The IDAP pilot identifies and supports the need for safe, timely, and efficient generation of evidence to underpin both regulatory approval and HTA of innovative medical devices.
How can Mtech Access provide support in bringing Medtech innovations to market?
At Mtech Access, we are on a mission to ensure that medical technologies are available to the patients who need them, while meeting the needs of the healthcare environment.
We hope this route will become available to other medical device developers following the IDAP pilot and look forward to supporting future clients with their applications. In the meantime, we can advise on other reimbursement and market access routes.
Our team of experts, highly experienced in medical devices and HTAs, are ready to support Medtech companies throughout the product lifecycle, addressing all evidence and access hurdles.
Our experts can support with:
- Generating a robust evidence base to effectively demonstrates the clinical efficacy of your innovation
- Conducting a competitive landscape assessment to demonstrate that your innovation is the only available solution to fulfil that clinical need
- Conducting a cost-effectiveness analysis and determining epidemiology to demonstrate that your product is economically sustainable in the UK market and can be widely adopted
- The full HTA journey from strategy to implementation
If you are looking for support in bringing your Medtech innovation to market, reach out to us at info@mtechaccess.co.uk to arrange a no-obligation consultation call to explore how we can best support your needs.
