UK's Medical Device through IDAP
AF Pharma Facilitates Access to UK's Innovative Medical Device Regulations through IDAP as UKRP
In an exciting development for the healthcare industry, the UK has introduced the Innovative Devices Access Pathway (IDAP) pilot program. This initiative, launched jointly 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), holds the promise of revolutionizing patient access to innovative medical technologies. AF Pharma, with its expertise in medical device regulations, is poised to play a crucial role in assisting innovators and manufacturers to navigate this groundbreaking pathway. Also, by acting as UKRP.
IDAP: A Game-Changer for UK Patients:
The IDAP pilot program is backed by £10 million of government funding and aims to expedite the introduction of innovative medical technologies into the National Health Service (NHS). The primary objective is to address unmet clinical needs for patients and healthcare professionals while maintaining stringent standards of safety, quality, and effectiveness. This initiative aligns with the government's broader goal of establishing an end-to-end innovation pathway, as outlined in the Medical Technology Strategy published earlier in 2023.
Key Features of IDAP:
The IDAP program offers a range of support services to successful applicants, including:
Targeted Product Roadmap: Providing guidance for product development.
System Navigation Advice: Assisting with navigating the healthcare system.
Priority Clinical Investigations: Facilitating vital research.
Joint Scientific Advice: Collaborating with partners.
Health Technology Assessments (HTA): Supporting product realization and adoption.
Safe-Harbour Meetings: Engaging with NHS stakeholders.
Exceptional Use Authorization: Granting by the MHRA, contingent on safety standards.
What the Experts Say:
Leading figures in the healthcare industry have expressed their enthusiasm for IDAP:
- David Lawson, Director of Medical Technology at the DHSC: Emphasized the significance of this pathway in ensuring the adoption of specialty medical technology into the NHS, ultimately benefiting patient outcomes.
- Dr. Susan Myles, Director of Health Technology Wales: Encouraged innovators to consider applying for this opportunity and pledged support for successful applicants.
- Dr. Marc Bailey, MHRA Chief Science and Innovation Officer: Highlighted the importance of accelerating the delivery of cutting-edge medical technologies safely to patients and encouraged innovators to seize this opportunity.
- Jeanette Kusel, Director of NICE Scientific Advice: Emphasized the unique aspect of IDAP, which allows developers to access expertise from both regulators and health technology appraisers.
- Ed Clifton, Unit Head of the Scottish Health Technologies Group (SHTG): Described IDAP as a fantastic opportunity to transform access to medical technologies across the UK.
Submissions for the IDAP pilot phase are open from 19th September 2023 to 29th October 2023. To be eligible, applicants must submit devices lacking a CE mark, UK CA mark, or regulatory approval. Products must address a significant unmet clinical need, demonstrate a proof of concept, and have received clinical input from at least one UK health organization or medical charity. Commercial and non-commercial innovators from both the UK and abroad are welcome to apply.
AF Pharma: Your Partner in Navigating IDAP:
Navigating the IDAP pathway can be complex, but AF Pharma stands ready to assist innovators and manufacturers in this exciting journey. With our deep understanding of medical device regulations and our commitment to advancing healthcare, we are well-equipped to facilitate access to this groundbreaking initiative. Contact us today to learn how we can support your innovative medical technology's journey through IDAP.
The launch of the IDAP pilot program marks a pivotal moment in the UK's commitment to innovation in healthcare. AF Pharma, with its expertise and dedication, is poised to play a vital role in helping innovators realize their vision and contribute to improved patient outcomes, as UKRP. As this pathway unfolds, it holds the potential to revolutionize the landscape of medical technology in the UK, ultimately benefiting patients, healthcare professionals, and the entire healthcare industry.