Elaine Gemmell

Chair

Elaine holds a BSc in Electronic Engineering and BEng (Hons) in Engineering and is Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University. Since joining InnoScot Health in 2002, she has gained more than twenty years’ experience in all aspects of medical device development and fifteen years in regulatory approval. She is a certified ISO 13485 /ISO 9001 Lead Auditor and has experience of regulatory approval in United Kingdom, Europe and USA. She has held roles at Director and Senior Management levels in two InnoScot Health spinout companies. 

Dr. Kate Cameron

Kate founded Cytochroma after her successful career in academia. She is a driven entrepreneur and has achieved significant recognition in numerous international business awards, grants, and competitions. Cytochroma is a reagent and service company that commercialises human stem cell-based products and services to the pharmaceutical drug discovery market. The company is making a meaningful impact in drug discovery in critical areas, including obesity, diabetes, and cardiovascular disease.

Prof. Joyce Tait

CBE, FRSE

Joyce Tait (Director, Innogen Institute, University of Edinburgh) (www.innogen.ac.uk) has an interdisciplinary systems analysis background linking natural and social sciences to support the delivery of innovative technologies with economic and societal benefits. She works on: industry strategic planning for innovation; responsible innovation; policies, regulation and standards; and new approaches to stakeholder engagement about technological innovation.

She is currently a member of the Regulatory Horizons Council (RHC) and other recent appointments include: the Prime Minister’s Council for Science and Technology; the Synthetic Biology Leadership Council (and Chair of its Governance Subgroup); and Governing Board of the Industrial Biotechnology Innovation entre, University of Strathclyde. She has been involved in the development of the RHC reports on Regulating Quantum Technology Applications, The Regulation of Hydrogen Fuel Propulsion in Maritime Vessels, Neurotechnology, Genetic Technologies, and The Governance of Engineering Biology. She was also technical author of the BSI PAS 440 Guide to Responsible Innovation and also authored the BSI White Paper on the PAGIT Framework.

Dr. Les Levin

Dr. Levin practiced as an academic medical oncologist, has participated in numerous clinical trials, and has extensive research experience in cancer immunology and biochemistry. He has held leadership positions in academia, healthcare administration, government and evidence development and is a recognized international leader in moving the evidence agenda to facilitate adoption of new technologies through early collaborative interactions between companies and payers/health systems. He is the Founder, CEO and CSO EXCITE International and has played a leadership role in evidence development for over 125 health technologies during his secondment to the Ontario Ministry of Health from 2000 to 2010 to inform policy decision making.

Mairi MacFadyen

Mairi MacFadyen brings over 30 years of experience in the medical device sector, specializing in senior quality and regulatory management roles. She has led regulatory strategies for products across cardiology, gynaecology, oncology, dermatology, and podiatry, securing market approval in regions including the U.S., Europe, Canada, and Japan. Mairi has designed quality management systems compliant with global medical device regulations and provided regulatory support for clinical trials in Europe and the USA. Her extensive expertise has been instrumental in successfully launching innovative medical products worldwide.