On 19 September 2023, the UK Government launched the pilot phase of the Innovative Devices Access Pathway (IDAP), an initiative to help bring innovative technologies to the NHS where there is an unmet medical need. As discussed in a previous post, IDAP has been designed to accelerate the development of innovative medical devices, with the aim of taking delays and uncertainty out of the route to market. IDAP will provide an integrated support service for medical device developers that will include enhanced opportunities for engagement with the regulatory authorities and a streamlined adoption process.
Companies of all sizes are being invited to apply, both internationally and in the UK, where they intend to launch a device for the UK market. 8 products will be selected during the pilot phase, which is designed to test the main elements of the pathway to inform how best to build the future IDAP.
Support provided through IDAP
Successful applicants to the pilot will receive non-financial support from the IDAP partners at key stages of their medical device product design to expedite the development and integration of their new device into the UK market. The partners include the Department of Health and Social Care (DHSC), the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE), as well as NHS organisations in England, Wales and Scotland.
A team of experts from these partners will help successful applicants develop a Target Development Profile (TDP) roadmap. This will define regulatory and market access touchpoints during the product development, which may include quality management system support, fast-tracked clinical investigation or support with Health Technology Assessments (HTA) for the product. The MHRA will offer support with testing and regulation of the products, while NICE will conduct a feasibility study of the product and facilitate its integration into the UK public health system. The aim is to offer more coordinated support through the product development and therefore streamline the data collection and regulatory submissions for the product, and ultimately speed up the time taken for the product to reach patients.
To be eligible for the pathway, applicants must meet the following criteria:
- The product is a medical device; drug-device combination products are excluded.
- The applicant must be a legal entity with the rights to market the product in the UK. Legal entities headquartered or operating in jurisdictions that are the subject of UK Government sanctions are excluded.
- Organisations must demonstrate a proof of concept evidenced by data from a near final prototype.
- The applicant must be intending to market the product in the UK and to obtain regulatory authorisation.
- The applicant must have UK clinical investigation sites in place.
- The applicant must commit to working with the IDAP partners to create a TDP.
- Technologies must be able to demonstrate evidence of ISO 13485 certification (Quality Management System) or equivalent.
These criteria will likely require substantial work for companies before selection, particularly where the technology is at an early stage, as clinical investigations must be already set up and ISO certification in place. Further, the TDP touchpoints include support with the quality management system and with clinical investigations, and it will be interesting to see how much is expected to be in place at the beginning of the process compared to support provided as part of IDAP.
There are also four additional criteria for successful entry to the IDAP pilot:
- The condition is life-threatening or seriously debilitating and there is a significant patient need.
- The product is innovative and transformative, and there must be no solutions with regulatory approval that fulfil the same clinical need.
- The product will provide system wide benefit and have the potential to be cost effective.
- The technology helps to address one of the Life Sciences Vision’s Healthcare Missions, which include a number of therapy and policy areas such as neurodegeneration and dementia, cardiovascular diseases, early diagnosis and treatments, and mental health conditions.
Applications will be evaluated through a panel of experts, who will assess which products are likely to receive the most benefit from the expertise and tools offered in the pilot. Application outcomes will be communicated in December 2023, and TDP engagements should begin from January 2024.
What does this mean for medical device companies?
The IDAP is a long awaited initiative that has the potential to transform health outcomes and to increase the adoption of innovative technologies in the UK. The Innovative Licensing and Access Pathway (ILAP), which is an equivalent pathway for medicinal products, was launched in March 2021, and the medical devices industry has been hoping for a similar framework for innovative devices. The route to market for devices is more piecemeal compared to medicines and the focus on innovative technologies is welcomed.
The scheme includes the possibility of MHRA granting an exceptional use authorisation, which is likely to be a key benefit of the pathway and a significant incentive for medical device companies to apply. Further, given the number of different agencies involved, streamlining advice and support for companies will be seen as a benefit for both companies and patients. Given this is a pilot scheme, it is hoped a range of products will be included to fully assess how the IDAP works and how it can be rolled out more widely.
The MHRA has announced that the IDAP Pilot application window has been extended to Wednesday 1st November 2023 – 5pm GMT.