On 19 September 2023, the UK Government announced the launch of the Innovative Devices Access Pathway (“IDAP”) pilot scheme. The UK already has in place an Innovative Licensing and Access Pathway (“ILAP”) for medicines. IDAP is the equivalent for medical devices, and is groundbreaking in the UK devices space.
The IDAP scheme aims to improve access to innovative and transformative medical devices, and meet unmet patient needs. Currently, it is in a pilot phase. This pilot phase is open to applications from manufacturers seeking to develop and commercialize an innovative device in the UK. Successful applicants will receive regulatory and market access advice and support at key stages of the development process from “IDAP partners.” IDAP partners include regulatory and market access bodies such as the Medicines and Healthcare products Regulatory Agency (“MHRA”), National Institute for Health and Care Excellence (“NICE”) and the Department of Health and Social Care (“DHSC”). The pilot is limited to up to eight innovative devices. Applications for the pilot phase open on 25 September 2023 and close on 29 October 2023.
Why apply for the IDAP?
The core aim of IDAP is to provide developers of medical devices with joined-up support that complies with regulatory requirements and accelerates market access to the UK State healthcare system. In other words, IDAP aims to co-ordinate and accelerate the process by which developers of medical devices can place innovative devices on the UK market and gain reimbursement.
Successful applicants will receive non-financial support from IDAP partners to develop a Target Development Profile (“TDP”) roadmap.
In addition to MHRA, NICE and DHSC, IDAP partners include the Health Technology Wales (“HTW”), National Health Service England (“NHSE”), Office of Life Sciences (“OLS”) and Scottish Health Technologies Group (“SHTG”).
The TDP roadmap will address specific targets in the regulatory and market access processes for the selected device, including:
- quality management system support;
- system navigation advice;
- a fast-tracked clinical investigation;
- joint scientific advice with partners;
- support with Health Technology Assessments (“HTA”) for product realization and adoption;
- safe-harbour meetings to discuss NHS adoption; and
- exceptional use authorization granted by the MHRA, provided necessary safety standards are met.
Who is eligible to apply?
Applicants for the pilot scheme must meet (1) general eligibility criteria and (2) pilot criteria.
The eligibility criteria include the following:
- the product must be a medical device (hardware or software);
- lead applicants must have a right to market their product in the UK and intend to obtain authorization and market the device in the UK;
- early-stage products must show proof-of-concept;
- the applicant must have UK clinical investigation sites lined up and commit to working with IDAP partners to create a TDP roadmap; and
- the applicant must provide evidence of ISO 13485 compliance (or equivalent).
Importantly, the product cannot be a drug-device combination product, and applicants cannot be headquartered or operating in jurisdictions subject to UK Government Sanctions.
There are also four IDAP Pilot criteria:
- Criterion 1: the intended purpose of the device should be for a condition that is life-threatening or seriously debilitating and where there is a significant patient need;
- Criterion 2: the product must innovative and transformative;
- Criterion 3: the product will provide system wide benefit; and
- Criterion 4: the technology clearly helps to address one of the “Life Sciences Vision’s Healthcare Missions.” These Missions cover a number of priority areas such as neurodegeneration/dementia, early diagnosis/treatment, cardiovascular diseases, respiratory diseases, the underlying biology of ageing and increased understanding of mental health conditions.
There is some overlap between the IDAP pilot criteria and the ILAP criteria. However, IDAP appears to have more of a focus on sustainability and cost-effectiveness of the devices. Additionally, the pathways focus on different health issues/missions.
How can applicants apply?
Prospective applicants must submit an application form, which encompasses the following areas: Eligibility, Company Information, Product Details, Regulation and Compliance, the IDAP Pilot Criteria, IDAP Support and Declaration & Submission.
Applications can be submitted from 25 September 2023 until the deadline of29 October 2023.
A panel will select up to eight medical devices (which must all be at the development and prototyping stage) that it considers most likely to receive the most benefit from the expertise and tools offered in the pilot. The panel will be made up of representatives from IDAP partners, healthcare professionals and patient representatives. It will notify applicants of its decisions from December 2023.
What is the potential impact of the IDAP?
The IDAP follows a similar pattern to the ILAP for medicines, which accelerates the time to market for certain medicines such as those with new chemical entities, biological medicines, and medicines with new indications or which have been repurposed. The Government claims the IDAP will provide developers with “an integrated and enhanced regulatory and access pathway”, and the pilot aims to “test the main elements of the pathway” to assist development of the future IDAP structure.
The launch of the IDAP follows a growing trend by the UK Government to streamline the market approval and market access processes for medical devices. This has been traditionally more difficult to address for devices than medicines due to a number of factors, such as inclusion of a broad range of products and the fact that regulators do not authorize the pre-market approval of devices. The UK may become a more attractive place to develop and launch innovative devices as this pathway should help to reduce the time to market and help secure reimbursement for the most promising medical devices, particularly those purporting to meet significant patient need.