MHRA selects eight technologies to help it test its new innovative devices pathway

Quick background on the future U.K. device regulations and the pilot for innovative products.

• In late 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) launched the pilot of its Innovative Devices Access Pathway (IDAP). Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs.
• The pilot planned to choose eight technologies as a testing ground to determine how IDAP would ultimately function once the pilot is completed. To qualify for the pilot, products were supposed to be at the end of the prototyping phase and developers were asked to have their clinical sites lined up and be close to ISO 13495 quality management certification.
• Devices would be eligible if they 1) addressed a life-threatening or debilitating disease; 2) would be transformative with no equivalent solutions in the U.K.; 3) provide a system-wide benefit; and 4) target the Life Sciences Vision Healthcare Missions (e.g., cancer vaccines, cardiovascular disease). [Read AgencyIQ’s complete analysis of the IDAP pilot here.]
• MHRA also offered guidance on the pathway, the pilot phase, how to apply and how the public would be engaged. In addition to the press release on the new program, there was guidance on the new pathway, guidance on the pilot phase, a pilot application guidance, and information on how the regulator intended to engage the public. MHRA also offered an online webinar to learn more about the pathway and public involvement. [ Read AgencyIQ’s complete analysis of the program here.]

This week, MHRA announced the eight technologies chosen for the pilot

• All eight devices had to meet the pilot criteria in order to be chosen, according to the revised IDAP pilot phase guidance – they would address life-threatening disease with no equivalent solutions, they would provide a system-wide benefit and they target the Life Sciences Vision Healthcare Missions – targeting dementia and neurodegeneration, cancer vaccines, novel vaccine discovery, cardiovascular diseases, respiratory diseases, aging, mental health conditions.
• The eight devices chosen for the IDAP pilot are:
  • A blood-based biomarker test for Alzheimer’s disease from Roche Diagnostics Ltd, less invasive than testing cerebrospinal fluid and less expensive than PET-CT imaging;
  • An algorithm-based infection predictor from Presymptom Health Ltd which can help identify patients that don’t have infection and cut down on overuse of antibiotics;
  • A focused ultrasound liver cancer treatment from HistoSonics Inc, offering a safer alternative to surgery, radiotherapy and thermal ablation;
  • An oxygen-measuring technology not affected by skin pigmentation from Earswitch Ltd that is used in the inner ear canal which has no pigmentation in persons of any skin color;
  • A multiple sclerosis fatigue app by Avegen Ltd that helps with balance exercises, cognitive behavior therapy and physical activity programs to self-manage MS-fatigue in the absence of NHS capacity;
  • A portable diagnostic device for stroke identification from Upfront Diagnostics Ltd that quickly identifies people with large artery blockage to triage those requiring thrombectomy;
  • A self-diagnostic device for neutropenia from 52 North Health that allows patients to self-test for neutropenic sepsis at home, thus avoiding unnecessary antibiotic treatment and identifying at-risk patients earlier;
  • An artificial intelligence to predict patients at risk of chronic obstructive pulmonary disease (COPD) by Lenus Health Ltd, which will use machine learning models to identify those at increased risk of hospital admission and switch from a reactive model to a proactive one.
• Another benefit of selection is funding. The developers of the eight devices types will receive a combined £10 million to help bring their devices to market.
• According to a press release published by MHRA and the Department of Health and Social Care, the ultimate goal of the pilot program is to accelerate access to “groundbreaking technology.” According to MARC BAILEY, the Chief Science and Innovation Officer of MHRA: “This is designed to explore how support from the regulator, UK health technology organisations and NHS bodies can accelerate the development of transformative medical devices from their initial proof of concept through to uptake in the NHS. The pilot criteria prioritises patient need in all aspects of decision-making and, by supporting innovative medical technologies, will ease pressure on the healthcare system.”

Other IDAP updates

• Four guidance documents updated: In addition to revealing the technologies selected for the pilot, the MHRA updated the guidance documents associated with the IDAP program. The regulator updated the IDAP main guidance to note that it had updated the guidance documents on the IDAP pilot phase, pilot application, and the patient and public involvement and engagement page.
• Changes to the pilot phase document: The new document notes that IDAP came from the Life Sciences Vision, published in July 2021, and that it plans to “inform the wider development of an end-to-end innovation pathway, as per the Medical Technology Strategy published in February 2023.” The new page notes that the program accepted applications from commercial and non-commercial developers in the U.K. and abroad.
• The regulator overhauled the IDAP pilot application guidance to note that the pilot is now closed to new applications. Other amendments added that the firm must be certified to ISO 13485 or an equivalent quality management system (QMS). The document now contains the NICE definition of what a ‘near final’ prototype spans – that an operational prototype has been developed and lab studies and design verification have been conducted, and performance evaluation and/or pre-clinical studies are underway.
• Scope, criteria and more on how the eight products were chosen: Products that were improvements of existing technologies were in scope for the pilot, as long as they met the criteria, as were companion diagnostics, though drug-device combinations were out of scope. MHRA plans to update the criteria for the formal IDAP launch in 2025, as well as how technologies will be prioritized after the pilot – which the pilot will inform. The eight technologies in development were chosen for the pilot were chosen using a portfolio approach in selecting technologies in different clinical areas, development stages and organization size.
• Future planned program improvements: MHRA is scoping a QMS audit tool to assist developers of innovative technologies. While UKCA marks are not required to participate in IDAP, MHRA is exploring how to work with UK Approved Bodies within the IDAP process, since the U.K. uses a third-party device approval system. The regulator notes that Emergency Use Authorization (EUA) timeframes will be product specific.
• The guidance on patient and public involvement and engagement in IDAP now includes the link to the webinar that took place in October 2023.

Analysis:

• Shepherding these eight technologies and products through the IDAP will likely help establish the formal innovative device access pathway. While the criteria to participate in the pilot were narrow, the regulators expect the pilot to help establish a wider set of criteria for the final program, planned for release in 2025. This program intends to set up the U.K. as a strong supporter of innovation, helping developers not only through the regulatory approval process but also in gathering sufficient clinical evidence and reimbursement strategies, with the aim of shepherding the products from prototype to market adoption.
• The pilot program comes ahead of the new U.K. medical device regulations. MHRA and the British government have been working on new device regulations since Brexit in 2020, releasing a draft in late 2021 and its response to public feedback on the draft in mid-2022. After a series of delays, last month the regulator published a roadmap of the next steps in realizing those regulations, with post-market and vigilance requirements being published in 2024 and the remainder of the regulation in place by 2025.
• A new blog post from MHRA talks about the roadmap and the future regulations. While the post-market instrument was initially expected last year, we recently learned that the Fall 2023 publication of the draft text raised issues that MHRA didn’t see raised in its PMS workshops, leading the regulator to commit to hammering out concerns with the regulations before releasing draft legal text going forward, as well as to increased transparency.

To contact the author of this item, please email Corey Jaseph.
To contact the editor of this item, please email Alexander Gaffney

Key Documents and Dates

• Press release: Funding for game-changing tech which could destroy cancers and predict disease, published February 14, 2024.
• Guidance: The Innovative Devices Access Pathway (IDAP), updated February 14, 2024.
• Blog: MedRegs: MedTech Regulatory Reform: The first steps toward a new framework for medical devices in the UK, February 13, 2024.