The Innovative Devices Access Pathway (IDAP) pilot was launched
today by the Department of Health and Social Care (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).
The IDAP, supported by £10 million of Government funding, 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 National Health Service (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 pathway 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 2023 and delivers on the ambitions set
out in the Government’s Life Sciences Vision.
Following announcement of the IDAP
on 25 May 2023, today the government launched the pilot phase
and innovators are invited to submit Expressions of Interest for
access into the pathway.
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
Department of Health and Social Care, 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 Susan Myles, Director of Health Technology Wales,
said:
We are proud to be a part of this ground-breaking project which
aims to speed up access to innovative technologies for patients
across the country.
We would urge innovators to consider applying for this exciting
opportunity. And we look forward to supporting the successful
applicants on their journey through the pathway.
Dr Marc Bailey, MHRA Chief Science and Innovation
Officer, said:
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.
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.
Jeanette Kusel, Director of NICE Scientific Advice,
said:
At NICE we’re committed to focussing on what matters most to
patients and healthcare providers. This pathway will offer
companies the direction they need to properly demonstrate the
value of innovations that have the potential to address unmet
need in the system. The opportunity for developers of game
changing health technologies to access expertise from both
regulators and health technology appraisers is a unique aspect of
IDAP.
Ed Clifton, Unit Head of the Scottish Health Technologies
Group (SHTG) which is part of Healthcare Improvement Scotland,
said:
IDAP offers a fantastic opportunity to transform access to
medical technologies across the UK – for the benefit of our
patients, the delivery of our health and care services, and our
life sciences sector. The collaboration between MHRA and HTA
partners (like SHTG) means that IDAP is uniquely placed to
deliver the right regulatory and evidence support, at the right
time, for all successful applicants on the pathway.
Submissions for the pilot phase open 19 September 2023
and close 29 October 2023.
To be eligible for the programme, applicants must submit devices
that do not have a CE mark, UK CA mark or regulatory approval.
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.
Further information about the IDAP and how to apply:
The Innovative Devices
Access Pathway (IDAP)
This follows a previous announcement from the Partners in May 2023encouraging
innovators of medical technology to register their interest in
the pathway ahead of the pilot launch.
Find out more
The Innovative Devices
Access Pathway (IDAP)
