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) is a breakthrough multi-partner collaboration between NHS stakeholders in England, Scotland and Wales. The partners will fast-track innovative solutions by providing free-of-charge regulatory and market access support to eligible Medtech developers.
- When will the IDAP pilot open?
- Who can apply for IDAP?
- The IDAP application process
- What does IDAP require of applicants?
- What support will successful applicants receive?
- How can Mtech Access support applicants?
When will the IDAP pilot open?
The pilot just opened! Device manufacturers can apply to be part of the IDAP pilot from Monday 25th September, with the application portal closing on Sunday 29th October.
Only 8 applications will be selected for inclusion in the pilot phase. The decision will be made by a panel of experts and patient representatives, with the successful applicants announced in December 2023.
As the project is in its pilot stage, the final criteria, structure and process have not yet been fully established, although this is what we know about the pilot stage so far:
Who can apply for IDAP?
All commercial and non-commercial, UK and international, developers (except those in sanctioned countries) can apply, more than once if they have multiple products. Developers must be a legal entity in the UK. They will have to prove their product:
- Is an innovation in a life threatening and/or severely debilitating disease area
- Is the only available solution to fulfil that clinical need (no licensed competitors)
- Can be widely adopted (sustainable and cost-effective)
- Helps address one or more of the Life Sciences Vision missions
The last criterion relates to unmet clinical need in selected areas such as:
- Cardiovascular disease and its risk factors (e.g. obesity)
- Respiratory diseases
- Mental health
What is the IDAP application process?
The portal links to a YouGov submission form with 7 parts.
Applications must be completed and submitted in one go; however, a pdf template is provided and it is advisable to complete this and then copy across your responses to the submission form.
What does the IDAP require of applicants?
The onus is on Medtech companies to prove their product complies with the IDAP pilot eligibility requirements (see above).
Additionally, applicants will have to provide proof of ISO 13485 (quality management system) or equivalent, as well as letter(s) of support from clinicians or patient organisations.
If the product is in an early developmental stage, proof-of-concept evidence from a prototype is also required.
The application asks Medtech developers to specify their support needs and provides several examples of what these could be. Regulatory approval, navigation of the market access landscape, and scientific advice are all listed as options, along with a number of activities.
What support will successful applicants receive?
Successful developers will work in collaboration with IDAP partners to develop a Target Development Profile (TDP) roadmap. (This is similar to the approach in the Innovative Licensing and Access Pathway (ILAP) initiative for medicines.)
IDAP partners will then offer support in key areas of the roadmap. Activities listed on the latest UK Government press release 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 could be deeply helpful for any Medtech developer looking to launch in the UK market.
How can Mtech Access support applicants?
At Mtech Access, we have a team of experts who are highly experienced in medical devices and with health technology assessments. Our team are ready to help Medtech companies exploring and preparing their IDAP applications.
We can help you prepare or review your IDAP template application to ensure your eligibility is evidenced and clearly communicated. We can help you prove your eligibility by:
- Reviewing your evidence package to ensure it is robust and effectively demonstrates the clinical efficacy of your innovation in a life threatening and/or severely debilitating disease area
- 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 / uptake figures to demonstrate that your product is economically sustainable in the UK market and can be widely adopted
- Writing a clear and compelling value proposition that outlines how your product addresses one or more of the Life Sciences Vision missions
Following your application we can also offer advice on how to commercialise your product, including how to use the evidence from your IDAP application in other materials to support your product launch.
If you are considering applying for the IDAP, get in touch via firstname.lastname@example.org to arrange a no-obligation consultation call to explore how we can best support your application.