Tag: InnoScot Health

InnoScot Health and Heriot-Watt University bolster relationship through honorary professorship award

NHS Scotland partner InnoScot Health and Heriot-Watt University have further strengthened their strategic relationship through the award of an honorary professorship. 

Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, has been conferred the title of Honorary Professor in the Edinburgh-based university’s School of Engineering and Physical Sciences in recognition of her expertise.

The award reflects Elaine’s service and contribution to Heriot-Watt, and the close ties forged, particularly with 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 last year to help fast-track innovation in medical and healthcare technologies. As part of the MDMC Advisory Group, Elaine is pivotal to the development of this strategic relationship, supporting ongoing projects, training, and development.

Commenting on the award, Elaine said: “I am both surprised and delighted to be awarded the title of Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University.

“I enjoy a strong relationship with the university and share its ambition to accelerate medical device innovation across Scotland and beyond.

“I am privileged that my contribution has been recognised in this way and will continue to share my knowledge, experience, and expertise in medical device regulation to support healthcare innovators across Scotland.

“When we come together and pool our expertise, the impact is greater; so, I look forward to continuing my work with the University and building further networks and collaborations across the sector.”

Elaine joined InnoScot Health in 2002 and helped establish the organisation. With more than 20 years’ experience in medical device development, she is a certified ISO 13485 /ISO 9001 Lead Auditor and has experience of regulatory approval and CE marking for medical devices.

Elaine led InnoScot Health spinout company Clear Surgical, helping to launch two innovative devices – The Oplight™ and Cannulated Forceps – onto the market; and previously worked with Motorola Semiconductors for 20 years, gaining experience in manufacturing, design, and technical marketing.

Elaine now provides extensive regulatory expertise to NHS, academia, and industry. She sits on a range of advisory boards and provides training, presentations, and expert comment on a range of medical device related topics.

Executive Chair of InnoScot Health, Graham Watson, said: “This honour is a testament to Elaine’s valuable regulatory expertise, and commitment to sharing that knowledge to drive forward healthcare innovation in Scotland.

“Elaine’s knowledge and experience of medical device regulation is invaluable in the fast-moving world of innovation and is a vital driver of our commercialisation work at InnoScot Health.

“As one of our original staff members, Elaine has been continuously involved in shaping the organisation since 2002 and this award is incredibly well deserved. Congratulations Elaine!’

Heriot-Watt University and InnoScot Health set to strengthen partnership with joint presentation at medical device webinar

InnoScot Health and Heriot-Watt University are set to further solidify their partnership with representatives from both organisations set to perform a joint presentation explaining the classification of medical devices and related regulations to a range of businesses.

The two organisations recently signed a five-year agreement which will see Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) collaborate with InnoScot Health to help bring new ideas and innovations from healthcare professionals to life.

In a further step in the organisation’s relationship, InnoScot Health’s Head of Regulatory Affairs Elaine Gemmell and Prof. Marc Desmulliez, Manager of the MDMC will help to lead a free online event entitled ‘‘What is a medical device?’ which is taking place on Thursday 22 September at 10am.

The combined technical seminar will feature Elaine, Marc, and also Ms Melissa Siah, Director of Syntacog.

Together, the trio will be presenting on:

  • The legal definition of a medical device
  • The classification of a medical device and its impact on the regulations that need to be satisfied by this device
  • Case studies of devices which lie at the boundaries between classes of devices 
  • The presentation of a software that automatically provides information on the classification of a medical device and lists the regulation documents to be filled in. A live demonstration of the software will also be provided

Elaine said: “We expect this combined technical seminar to be of interest to manufacturers with little prior knowledge and experience of medical devices, as well as established businesses seeking more information on the automation of classification of medical devices.

“Joining the event will allow you to better understand the definition of a medical device, its classification, and the resulting medical device regulations for which the device needs to comply to.

“Before the pandemic, there was already movement towards increased governance around medical device innovation. Now, however, far-reaching new regulations are having a significant impact on everyone involved with medical devices – from their manufacture to their use.

“A strong understanding of regulatory compliance must therefore be intertwined with the development process early on when attempting to harness the true potential of new innovations.

Elaine joined InnoScot Health, formally Scottish Health Innovations, in 2002 and helped establish the organisation. With more than twenty years’ experience in medical device development, she is a certified ISO 13485 /ISO 9001 Lead Auditor and has experience of regulatory approval and CE, UKCA marking for medical devices.

Joining SHIL spinout company, Clear Surgical, as a Director, Head of Regulatory Compliance and laterally Chief Operating Officer, she has helped to establish the company with ISO 13485 accreditation and launch two innovative devices onto the market.

Prof. Marc Desmulliez has been involved in medical devices manufacturing for over 15 years. From his previous research interests in Microelectromechanical Systems (MEMS), and in collaboration with his former PhD student, Dr. Suzanne Costello, he developed some in situ sensors to look at the gas and moisture ingress in encapsulated packages.

The work culminated in a monograph (“Hermeticity Testing of MEMS and Microelectronic Packages, Artech House Pub.). His current research interests include microwave sensing and nature inspired engineering.

Melissa Siah co-founded Syntacog, a regulatory startup in mid-2020. The company subsequently won the regulatory challenge in the 2021 Singapore Airlines AppChallenge and more than £500k in Innovate UK grant funding to develop its regulatory compliance technology.

Melissa’s passion for making regulations easier to understand comes from a decade in regulatory law and policy with the Australian government, and seven years leading the development of legal tech and AI products in the UK and Australia.

The webinar will be hosted on Zoom, with a link provided to attendees following registration here.