The UK government has launched the pilot phase of the long-awaited Innovative Devices Access Pathway (IDAP). Applications for participation in the pilot phase opened on 19 September 2023 and the application deadline is 29 October 2023, so would-be participants need to get a move on!
A successful IDAP applicant will receive various non-financial support from partner organisations such as the MHRA, NICE and NHS England to develop and bring an innovative medical device to market in the UK. Crucially, such support will include an Exceptional Use Authorisation from the MHRA. This has the potential to enable innovative devices to be deployed in the UK years before ‘approval’ from a Notified Body.
Supported by £10 million of government funding, the pathway aims to ‘accelerate the development of cost-effective medical devices and their integration into the UK market.’ The IDAP is a key way in which the UK is seeking to differentiate itself from the EU and remain a hub for research and development in the life sciences following Brexit.
The eligibility criteria for participation in the IDAP pilot phase are relatively broad.
(1) The device must not already have a regulatory approval (such as a CE mark).
(2) The applicant:
- can be a commercial or non-commercial innovator;
- need not be in the UK, but must have rights to commercialise the device in the UK;
- must intend to obtain regulatory approval (such as a CE Mark or UKCA Mark) and to market the device in the UK;
- must possess an ISO 13485 Quality Management System (QMS) certification or equivalent;
- must have lined up a clinical investigation site in the UK;
- must have sought clinical input from at least one UK health organisation or medical charity;
- must have a proof of concept evidenced by data in a near-final prototype; and
- must commit to working with the IDAP partner organisations to create a Target Development Profile for the device (essentially a roadmap to regulatory approval and deployment in the NHS).
Four additional substantive criterion must also be satisfied:
- The device must address an unmet clinical need and condition that is potentially life-threatening or seriously debilitating. The application must be supported by at least one individual in a relevant health and/or care organisation.
- The device must be innovative (in that there are no approved alternative solutions) and the use of the device must have the potential to be transformative in the healthcare system.
- The device should provide system wide benefit in that it could be widely adopted and sustainable. The device should also have the potential to be cost effective.
- The technology should address one of the Life Sciences Vision’s Healthcare Missions:
- Improve translational capabilities in neurodegeneration and dementia.
- Enable early diagnosis and treatments, including immune therapies such as cancer vaccines.
- Treat and/or prevent cardiovascular diseases and its major risk factors, including obesity.
- Reduce mortality and morbidity from respiratory disease.
- Address the underlying biology of ageing.
- Increase the understanding of mental health conditions, including work to redefine diseases and develop translational tools to address them.
In addition to the golden ticket of an Exceptional Use Authorisation, successful applicants may receive support such as:
- Quality management system support;
- System navigation advice;
- A ‘fast-tracked clinical investigation’ – presumably this means a fast-tracked review of a clinical investigation notification by the MHRA;
- Joint scientific advice with partners;
- Support with Health Technology Assessments; and
- ‘Safe-harbour meetings’ to discuss NHS adoption.
The IDAP will be run by the following partner organisations:
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Department of Health and Social Care (DHSC)
- National Health Service England (NHSE)
- Health Technology Wales (HTW)
- National Institute for Health and Care Excellence (NICE)
- Scottish Health Technologies Group (SHTG)
- Office of Life Sciences (OLS)
First, the IDAP is a genuinely exciting innovation which has the potential to make the UK an even better place to do life sciences research and development. In particular, given the laborious and unpredictable nature of Notified Body conformity assessments, the availability of an Exceptional Use Authorisation to allow innovative devices onto the market early under the direct supervision of the MHRA will be a highly appealing prospect for innovators.
Second, it is encouraging to see that the UK government has dropped some of the IDAP eligibility criteria which it previously mooted. In particular, it is reassuring that the IDAP is not reserved for SME device developers. This would have deprived the IDAP of a wide range of promising applicant devices, and severely limited the IDAP’s impact on the UK as an appealing place to develop medical devices.
There are some aspects of the IDAP pilot which give pause for thought:
- An applicant will need to already have an ISO 13485-certified QMS and will need to have lined up clinical investigation sites. This means an applicant will need to have already undertaken quite a lot of legwork. This will limit the impact of the quality management system support and clinical investigation support which may be available from the IDAP partner organisations.
- The Health Research Authority (HRA) is not among the IDAP partner organisations. While the MHRA may provide an expedited clinical investigation review, this raises the question whether an expedited research ethics committee review will also be available.
- The IDAP offers an Exceptional Use Authorisation prior to full regulatory approval, but there is no guarantee of similarly fast-tracked reimbursement. The most the IDAP can offer is ‘support’ with completing a Health Technology Assessment and ‘safe-harbour meetings’ to discuss NHS adoption. Will a successful applicant be able to reap any commercial benefit from its Exceptional Use Authorisation?
An applicant ‘must commit to working with the IDAP partner organisations to create a Target Development Profile.’ There is a risk here that a successful applicant could lose control of the development strategy for its device if the IDAP partner organisations seek to dictate the contents of the Target Development Profile for their own objectives. While the MHRA has publicly committed to being a facilitative and helpful regulator, the priority for NHSE, NICE, HTW and SHTG will always be getting the best value for money for the NHS. A successful applicant should go into the process prepared to work with the partner organisations, but also to defend its own interests – and to pull out if the benefits of the scheme no longer add up.
We sincerely hope that the IDAP will prove to be a positive and cooperative way to bring innovative medical devices onto the UK market quickly. We are excited to see how the IDAP pilot plays out in practice.