Formal NHS Scotland partner InnoScot Health continues to expand its regulatory offering, helping to ensure support and peace of mind for innovators looking to navigate often complex routes to market

Over more than 20 years, the organisation has built up and shared considerable knowledge – and has just made a fresh appointment to further enhance its ability to offer greater support in medical device development, from initial selection through to commercialisation.

Representing a highly experienced addition to the team, Quality Manager Lauren Brophy will work closely with Head of Regulatory Affairs, Elaine Gemmell, to help accelerate the development of innovative products and technologies with NHS innovators, partners and clients.

She will be responsible for maintaining InnoScot Health’s Quality Management System (QMS) and supporting its quality and regulatory activities.

Accredited regulatory framework

InnoScot Health believes that ensuring awareness and compliance with legal responsibilities and supporting the design and development of products under an accredited regulatory framework is essential to success.

Medical devices including diagnostics, therapeutics and software play a key role in delivering new products that benefit the NHS, the economy and above all, patients. The supply of safe, effective, and innovative medical products is underpinned by a robust regulatory framework.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the Competent Authority responsible for regulating all medicines and medical devices in the UK, the European Commission has overall responsibility for regulation of medical devices in Europe through Competent Authorities in each member state, while the Food and Drug Administration (FDA) holds responsibility in the US.

The medical device industry has experienced unprecedented growth over recent years; and changes to the regulatory landscape have been significant, meaning it is vital innovators get the right advice, support and signposting to develop effective and innovative healthcare products.

InnoScot Health’s services continue to support compliance with new regulations as they evolve.

Strong record of protecting interests

The organisation has a strong record of protecting the interests of NHS Scotland and operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive.

The addition of Lauren – having worked closely with distributors around the world and registered medical devices in countries including Thailand, India, and Taiwan – marks a further tier of knowledge for the regulatory team.

Elaine commented on the new appointment: “With six years’ experience in the medical device industry, successfully managing Quality Management systems and ensuring all is maintained and controlled, Lauren is a valuable addition to our regulatory team.

“With her strong track record of working closely with suppliers on approvals, we expect she will also play a leading role in achieving InnoScot Health’s overarching aim of identifying, protecting, developing and commercialising healthcare innovations to improve patient care.

“Part of her remit will be engaging with health and social care staff across NHS Scotland, SMEs and universities to provide strategic advice and assist in the implementation and maintenance of ISO 13485 QMS, the harmonised standard across the medical device industry. This is an important part of our work and an area in which Lauren is a certified auditor.

“She will further provide training, offer regular communication with clients to provide important updates on regulatory changes that could affect their businesses, and conduct awareness activities around what we can offer.”

Proven credentials in regulatory affairs

Elaine added: “We are delighted to welcome Lauren and are certain she will flourish in her new role thanks to proven credentials in quality management that will take our offering to the next level.

“I believe she will be instrumental in expanding our regulatory services and providing high-quality advice and support to innovators across Scotland as they navigate often complex regulatory frameworks to ensure the supply of safe, effective and innovative medical products.

“She strengthens our ability to offer those benefits to NHS Scotland, companies, and universities working with experts from the very start when undertaking the regulatory journey.”

Lauren was previously with an Edinburgh-based medical technology company for six years in the position of Quality, Regulatory & Training Coordinator.

There, she developed substantial experience of implementing ISO 13485:2016 – the medical industry’s optimal medical device standard which ensures that all medical devices meet the proper regulatory compliance laws and customer needs – and in the compilation and review of technical documentation for UKCA/CE marking.

Fresh ideas and collaborations

She said: “I’m excited to have this opportunity of lending my knowledge to InnoScot Health’s already comprehensive offering in providing quality/regulatory services to the NHS, industry, and academia, in turn encouraging fresh ideas and collaborations.

“I believe my 20 years of experience in customer service and 14 years of project management and honing organisational skills within a corporate environment can be useful in that regard.

“Ensuring the presence of an appropriate regulatory framework for the development of products or technologies disclosed to InnoScot Health is vital to success, and it’s an area I hope to work with the organisation on further strengthening.”

The organisation makes consultancy, training and advice easily available to all NHS health boards, plus companies or universities working in partnership with NHS Scotland to develop medical devices.

Last year, Elaine was conferred the title of honorary professor in Heriot-Watt University’s School of Engineering and Physical Sciences.

The award reflected her service and contribution to Heriot-Watt, and close ties forged between InnoScot Health and the university’s Medical Device Manufacturing Centre (MDMC), which helps Scotland's SMEs translate medical device concepts into commercial products.

A five-year collaborative partnership was signed by InnoScot Health and Heriot-Watt University in 2022 to help fast-track innovation in medical and healthcare technologies. As Chair of the MDMC Advisory Group, Elaine is pivotal to the development of this strategic relationship, supporting ongoing projects, training, and development.

With more than 20 years’ experience in medical device development, Elaine is a certified ISO 13485/ISO 9001 Lead Auditor and has experience of regulatory approval and CE marking for medical devices.

The InnoScot Health team offers skilled regulatory experts, dispensing advice and support to healthcare innovators across Scotland, while facilitating and underlining the country’s reputation as a centre of excellence for medical device innovation.