Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, looks back on the organisation’s journey after receiving long service award

It’s incredible to think it’s been 20 years since we first started life as Scottish Health Innovations Ltd (SHIL) – from being hosted by Greater Glasgow Health Board (GGHB) in Glasgow’s Bath Street to Gartnavel General Hospital on Great Western Road, the Golden Jubilee Hospital in Clydebank, and then back again to Glasgow city centre.

Now it’s our anniversary and we have a modern, welcoming new face as InnoScot Health, including a stronger digital presence that’s designed to encourage even more health and social care workers to come to us with their innovative ideas. It’s part of our renewed focus on empowering NHS Scotland staff to unlock the healthcare solutions of the future.

InnoScot Health has a strong track record of working in partnership with NHS Scotland to inspire, accelerate, and commercialise impactful healthcare innovations.

Our long-standing senior management team has collectively accrued almost 50 years of service with the organisation, including myself who helped to establish it.

Continuously involved in shaping our direction since 2002, I have since gained more than 15 years’ experience in medical device development, becoming a certified ISO 13485/ISO 9001 Lead Auditor with expertise in regulatory approval and CE, UKCA marking for medical devices.

Previously working with Motorola Semiconductors, where I gained valuable knowledge of manufacturing, design, and technical marketing, I joined one of our spinout companies, Clear Surgical, as a Director, Head of Regulatory Compliance and laterally Chief Operating Officer, helping to establish it with ISO 13485 accreditation and launching two innovative devices – The Oplight™ and Cannulated Forceps – onto the market.

I joined pharmaceutical company and InnoScot Health spin out Aurum Biosciences as Director of Quality and Operations (2018-2022) and have taught MSc and BSc modules on regulatory affairs at Dundee University for the last 8-10 years.

I also sit on the Advisory Board for the EMERGENCE Healthcare Technologies Network and sit on an ethics committee.

I am now focussing on expanding InnoScot Health’s regulatory affairs offering for medical devices – a major growth area for the organisation. Having first-hand experience of getting a medical device onto the market is really valuable. It is a process that is readily understood by people who have been through it many times, but if you’re starting from scratch, it can be quite a minefield so it’s vital to speak to someone who has experience and can offer a guiding hand.

The changing regulatory landscape that is significantly in flux during the Brexit transition period also requires robust advice and support to be available to NHS innovators.

It is an area I’m hugely passionate about and I constantly monitor and share my knowledge on what is happening across the fast-moving regulatory landscape, whether that be The Medicines and Healthcare products Regulatory Agency (MHRA) review of how it engages with healthcare professionals, or The Department of Health and Social Care’s review of equity in medical devices.

It is an expansive area and building networks and collaborations across the sector is another important aspect of my work. I was part of the recent announcement of InnoScot Health and Heriot-Watt’s Medical Device Manufacturing Centre (MDMC) five-year collaborative partnership which aims to fast-track innovation in medical and healthcare technologies and better understand clinical and nursing needs in Scotland. In order to do that effectively, I am part of the MDMC Advisory Group.

This strategic relationship will initially focus on identifying new healthcare technologies and the development of prototype medical devices by engaging with clinicians, doctors, nurses, and engineering students.

Based at Heriot-Watt University’s Edinburgh campus, the MDMC is a consortium including the University of Edinburgh, the University of Glasgow and Robert Gordon University and helps Scotland’s SMEs to translate medical device concepts into commercial products. Offering free expert advice on, and access to, manufacturing engineering, regulatory issues, and funding, its staff provide technically supported access to its £2M specialist manufacturing facilities.

In addition to the new partnership's research and development ambitions, both InnoScot Health and the MDMC will work to develop joint Continual Professional Development (CPD) and training programmes that further develop staff from both organisations in regulatory issues relating to medical devices.

In the 20 years since its inception, InnoScot Health has formed seven spin-out companies, evaluated over 2000 ideas, and successfully integrated 250 of them into healthcare settings in Scotland and around the world, including Structured CRitical Airway Management (SCRAM™), a portfolio of emergency airway bags that enhance the performance of emergency airway management and tracheal intubation, reducing the time to treat critically ill or injured patients and Clear Surgical, a medical device company focussed on the design and manufacture of innovative medical devices for use in surgery.

I have worked with our long-standing senior management team on countless breakthrough ideas including a range of medical devices, products, and technologies commercialised for use in hospitals, care homes and on-scene emergency settings.

Recently receiving a long service award has allowed me to reflect on what a privilege it has been to work in partnership with NHS Scotland and help bring hundreds of game-changing healthcare innovations to market.

I am so proud of everything we have achieved and how we have helped to improve the patient experience both nationally and globally by inspiring, encouraging, and supporting the NHS to help translate ideas into innovative products and services that are making a real difference to the lives of patients here in Scotland but also around the world.

It is humbling indeed to consistently see that depth of expertise in action, and it is testament to the talent and capabilities we have here in Scotland.

We recognise that NHS Scotland has a significant challenge ahead in meeting its recovery plan aims, capitalising on new ways of working, maximising fresh technologies, and achieving net zero carbon emissions by 2040.

At InnoScot Health, we are now striving ever harder to encourage innovation – simple or complex – from all levels of the NHS and help shape a better future for all.

We believe we have a unique role to play in encouraging new ideas from NHS Scotland staff, the importance of which has been hugely underlined by the pandemic and the significant health care system pressures which it has created.

It is now vitally important to unlock the know-how and first-hand experience of NHS staff to improve treatment and patient care.