The future of expedited access to innovative medical devices - IDAP clearing the path for eight lucky applicants
How do medical devices get on the market quickly? There are lots of (usually long) answers to this question, but one significant new route will be via the Innovative Devices Access Pathway (IDAP).
The Government's idea is that IDAP will enable innovators to get funded support (to be clear, not including funding) from multiple partners and enjoy an end-to-end regulatory and access pathway. This was an ambition of the UK Med Tech Strategy.
IDAP is in its pilot phase at the moment and it is still accepting expressions of interest from prospective participants, however only eight applicants will be chosen to take part. The MHRA has published guidance on the IDAP pilot. IDAP is designed to get innovative technology quickly to the patients and clinicians who need it, with a particular focus on unmet clinical needs.
If you think you or your product fit this description, then you have until 29 October to apply. The announcement says it closes on 29 October - so best to get your application in by 28 October.
Applicant and product eligibility criteria
Applicants might be big, small, alone, leading a group, UK, non-UK (excluding sanctioned jurisdictions), commercial or non-commercial organisations.
Each applicant must be a legal entity and it must have the rights to market its product in the UK (this means owning or being a licensee of relevant rights in or to the product). The applicant must also intend to market the product in the UK and obtain regulatory authorisation and commit to working with partners to develop a 'Target Development Profile' (TDP).
The product must be a 'medical device'. The definition for that is in regulation 2 of the Medical Devices Regulation 2002 (SI 2002/618). Combination products incorporating medicines and medical devices are not eligible. The MHRA has also stated that eligible devices are those that have not been CE or UKCA marked or otherwise received regulatory approval.
If the product is what the guidance calls "early-stage health technology", then applicants must submit data generated from studies on a near-final prototype which demonstrates "proof of concept".
In addition, the applicant must:
- have planned a clinical investigation in the UK, with sites lined up (presumably, some basic evidence of this will be required - possibly a signed contract)
- provide evidence of compliance with ISO13485 (the main medical device quality standard) or an equivalent standard
The IDAP pilot criteria
For businesses that can get past the eligibility criteria, there are four further criteria set out in the guidance. They are summarised in this section.
There must be a significant patient need with respect to a life-threatening or seriously debilitating condition. To support this, applicant's will need a letter of support (or similar document) from a relevant individual. The individual could be from an healthcare organisation or charity.
The product must be innovative, which may include modifications of existing technology, and have the potential to be transformative in the NHS. A product would not be considered innovative/transformative if an authorised product exists for the same indication and clinical need.
The product must provide system wide benefit through cost-effective, wide and sustainable adoption.
Applicants must also show that their technology is clearly linked to one of the healthcare missions in the Life Sciences Vision.
IDAP Partners
Successful applicants will receive support at key stages of their product design and development process from the following IDAP partners:
- 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)
TDP roadmaps
The main output of IDAP will be TDP roadmaps for the participants, which will have been developed in partnership with the main organisations that device businesses meet along the path to market. The guidance suggests that the roadmaps might include sections with advice on:
- Quality management systems.
- System navigation.
- Clinical investigations.
- Scientific principles.
- Health Technology Assessments (HTA).
- NHS adoption.
- Exceptional use authorisation and related safety standards (this is particularly relevant for Northern Ireland patients).
Even if a business is not accepted into IDAP, this is a useful checklist that can help guide regulatory and access strategy.
Submissions
The MHRA has also published guidance on the application requirements, which makes clear at the start that the IDAP pilot is for established products or solutions. Submissions must be made using a strict process set out in the guidance.
There are many elements to the eligibility and pilot criteria, some of which will require significant effort to meet and then support with actual evidence. Some of that evidence may be commercially sensitive, and applicants should consider the potential impact of disclosure.
For businesses that have concerns about the contents of their application, it is made clear that the submitted information may be shared within and between partners for evaluation purposes. Also, although stated in the context of data privacy compliance, the expectation is that information is held by the MHRA for 15 years and, in addition to sharing between partners, it may be shared with patient and public representatives on the 'IDAP Delivery Group' and external clinical experts.