The Department of Health and Social Care (DHSC) has announced the launch of a pilot scheme aimed at bringing innovative medical technologies to patients faster.
The Innovative Devices Access Pathway (IDAP) is a collaboration between the DHSC, Health Technology Wales (HTW), the Medicines and Healthcare products Regulatory Agency (MHRA), the National Health Service England (NHSE), the National Institute for Health and Care Excellence (NICE), the Office for Life Sciences (OLS), and the Scottish Health Technologies Group (SHTG).
Supported by £10m of Government funding, the IDAP has the potential to expedite UK patient access to innovative technologies by providing innovators and manufacturers with multi-partner support and targeted scientific advice.
The ambition of this new pathway is to support the rapid development of innovative technologies that can be introduced into the NHS to address unmet clinical needs for patients and healthcare professionals at the earliest opportunity, without compromising on standards of safety, quality, and effectiveness.
The IDAP launch marks an exciting step in accelerating the delivery of cutting-edge medical technologies safely to patients across the UK
And it builds on the Government’s intention to develop an end-to-end pathway for innovation as set out in the Medical Technology Strategy published on 3 February and delivers on the ambitions set out in the Government’s Life Sciences Vision.
Following announcement of the IDAP in May, the Government launched the pilot phase and innovators are being invited to submit Expressions of Interest for access into the scheme.
Throughout the pathway the partners will offer targeted support to successful applicants which may include:
- The development of a targeted product roadmap
- System navigation advice
- A priority clinical investigation
- Joint scientific advice with partners
- Support with Health Technology Assessments (HTA) for product realisation and adoption
- Safe-harbour meetings to discuss NHS adoption
- Exceptional use authorisation granted by the MHRA, provided necessary safety standards are met
David Lawson, director of medical technology at the DHSC, said: !Today’s launch marks an important step forward in the implementation of the Medical Technology Strategy published in February this year.
“It signals our commitment to move towards a rules-based pathway which will ensure the adoption of specialty innovative medical technology into the NHS, helping to benefit patient outcomes.
“The IDAP showcases our internationally-respected regulatory and guidance bodies and the tailored support on offer for technologies that meet the specific needs of the NHS.”
Dr Marc Bailey, MHRA chief science and innovation officer, added: “The IDAP launch marks an exciting step in accelerating the delivery of cutting-edge medical technologies safely to patients across the UK.
“The insights gained during the pilot phase will be crucial in shaping the future direction of this new pathway.
The IDAP showcases our internationally-respected regulatory and guidance bodies and the tailored support on offer for technologies that meet the specific needs of the NHS
“We encourage medical technology innovators in the UK and abroad to submit their applications and benefit from this combined support service.
“By working together, we can fast-track access to the most-advanced technologies for those in urgent need.”
Submissions for the pilot phase opened of 19 September and will close 29 October.
To be eligible for the programme, applicants must submit devices that do not have a CE mark, UK CA mark, or regulatory approval.
And products must meet criteria – addressing a significant unmet clinical need as defined in the programme.
Applicants will need to demonstrate a proof of concept evidenced by data to a near-final prototype and have already sought clinical input from at least one UK health organisation or medical charity.
Entry to the IDAP is open to both commercial and non-commercial innovators of medical technology in the UK and abroad.