InnoScot to analyse changes in UK regulatory landscape

Preparing for regulatory and technological change across the medical device landscape will be the topic of InnoScot Health’s next webinar.

The NHS partner’s fourth webinar in its ongoing series looking at a range of innovation topics is taking place from 12 until 12.45pm on Wednesday 24 May.

The session will be an opportunity for attendees to learn about the importance of ensuring the supply of safe, effective, and innovative medical products against a backdrop of substantial reform to the current regulatory framework.

It will also offer fresh insights on what can be expected in medical device innovation in the near future, particularly the application of artificial intelligence (AI) in healthcare.

InnoScot Health, which has a strong record of protecting the interests of NHS Scotland, believes it is crucial for innovators to get the right regulatory advice, support, and signposting – and that understanding the implementation and transition plan for new medical device legislation is a key asset.

The session will be introduced and led by InnoScot Health’s head of regulatory affairs, Elaine Gemmell and project manager Paula Sweeten. They will be joined by senior clinical advisor, software and AI, of the Innovative Devices Division at the Medicines and Healthcare products Regulatory Agency (MHRA), Dr Paul Campbell.

Gemmell will aim to prepare attendees for significant change by outlining what the regulatory framework is expected to look like for medical devices in the UK going forward. New legislation will require a marked transition that she believes must be effectively planned for, with medical devices and diagnostics playing a key role in delivering new products that benefit the NHS, the economy, and above all, patients.

Sweeten will speak on the potential benefits that AI offers to improve both patient outcomes and in the detection and diagnosis of disease.

He will discuss the current regulatory requirements around AI as a Medical Device (AIaMD) and the global challenges and opportunities facing regulators to ensure safe and effective AIaMD deployment in the UK..

Those who’d like to attend can register here.

Gemmell said: “The UK government recently announced its first-ever medical technology strategy to ensure that our healthcare system can reliably access safe, effective, and innovative medical technologies, helping to deliver the best possible outcomes for the NHS and its patients.

“That government recognition couldn’t have come at a better time. Using medtech effectively will be critical in reducing waiting lists for treatment given its potential to speed up diagnosis and deliver new and improved ways to treat and support patients. However, there is much work still to be done.

“The medical device industry saw unprecedented growth over the course of the pandemic and regulators were required to become far more flexible against the backdrop of fast-changing collaboration-led advances in science and technology.

“That momentum must now be maintained during the recovery period and extended beyond it too. There is therefore an onus on helping to realise that.

“At the same time, the medical device landscape is in a state of flux with new legislation so it’s more important than ever that innovators are able to access good advice and a range of expertise and support. This session is a great place to start.”

Sweeten added: “We know that AIaMD will play an important role in health and social care, with the potential to bring benefits to patients in many different ways.

“We're committed to helping safe and effective innovations reach patients, and the MHRA's Change programme aims to support that for AI/SaMD by considering the opportunities, challenges and key reforms in the area.

“I look forward to taking part in what promises to be an interesting discussion and feedback session, in partnership with the medical device innovation community.”