Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell, explores the trajectory of medical device innovation prior to MDMC Conference

Here in Scotland and across the UK, I believe that there are positive signs to indicate that we are increasingly getting the regulatory balance right for medical device innovators.

The path to getting products into patients’ hands remains tricky to navigate in many respects, particularly in terms of international harmonisation, but globe-straddling ambitions are being supported and barriers broken down.

Improvements are being realised all the time with the Medicines and Healthcare products Regulatory Agency (MHRA) making sustained efforts to help further innovation aspirations and provide a clear ‘roadmap’ for the development of new and robust regulations in the UK.

Right now, it is more important than ever that we forge ahead to allow innovative healthcare trailblazers to take advantage of an ever-broadening spectrum of technologies and breakthroughs.

Patients must also continue to get access to the devices they need as quickly as possible – but of course safety must always come first, the MHRA’s top priority.

Scotland undoubtedly offers a world-leading environment for MedTech innovators working within a regulatory framework which fully recognises their needs in tandem with patient-centred requirements – from opening up fresh horizons for accelerating preventative and proactive care, to honing transformative tech such as artificial intelligence (AI) and implantable devices.

The MHRA has a firm eye on keeping pace with AI, while its ‘roadmap’ has a key focus on patient inclusion which is very positive for ambitions to ensure success as the process moves forward.

I am also pleased to see MHRA’s commitment to strengthening the requirements for quality management systems (QMS) and technical documentation, as well as plans for better aligning essential requirements for medical devices in Great Britain with those of the EU.

Underpinning it all is the incredible power of collaboration across NHS, industry, and academia, whether pooling innovation-led know-how and resources, or overcoming challenges together and tapping into opportunities for making cutting-edge medical devices both viable and available for deployment.

Today’s exciting MedTech advances continue to evolve – and the regulatory framework is ready to continuously improve around them with expert guidance close to hand if sought through the right channels.

These key themes will be among those explored at the at the 3^rd annual Medical Device Manufacturing Centre (MDMC) Conference, held at the Glasgow University Union on 23 May.

Elaine is chairing the morning session of the conference, which will bring together “expert speakers from industry, NHS and academia to drive life sciences and healthcare innovation”.

The MDMC is a consortium of institutions including Heriot-Watt University – where it is headquartered – the University of Edinburgh, the University of Glasgow, and Robert Gordon University.