Regulatory expert to dispense key learnings at evidence generation bootcamp this month
InnoScot Health’s Head of Regulatory Affairs will be offering key insights and practical guidance to help inspire ambitious digital health innovators at a special event taking place later this month
Elaine Gemmell will be a session leader, offering her in-depth expertise in how to accelerate digital solutions as part of an Evidence Generation Bootcamp, hosted by the Digital Health Validation Lab (DHVL) at Glasgow’s Hotel Du Vin.
She will speak on the topic of ‘Medical Device Regulation: Regulatory approval, common challenges and potential solutions’ at the in-person gathering.
Taking place across both Monday 25 and Tuesday 26 November, the bootcamp is specifically designed to help healthcare innovators navigate their evidence generation pathway towards successful adoption.
Organisers say attendees will gain essential tools to effectively approach the specific complexities of evidence generation in the digital health landscape.
Each session will delve into a different key aspect, with innovators invited to “learn directly from experts, expand your network, and gain key insights that will help you to refine your product-to-market strategy”.
Elaine said: “This hands-on event is aiming to promote heightened knowledge around what can be a complex area, advising on collaborative tools to create the critical evidence required for digital health innovations, in turn leading to greater confidence in navigating towards successful adoption.
“Medical device regulation is a vital facet in building a tailored roadmap for that evidence generation journey, helping to ensure patients and healthcare workers’ safety is placed first, high-quality digital solutions have received approval, and are ready for entry to the market.
“I believe the event will provide an excellent opportunity for innovators to delve deeper and get the answers they need to progress their ambitions.”
Other sessions include learnings around procurement, Patient and Public Involvement and Engagement (PPIE), evidence requirements to determine and demonstrate value, and validating AI and data-driven solutions.
Joining Elaine will be:
- Professor David Lowe: Clinical Director of Innovation University of Glasgow and Digital Health Validation Lab and Clinical Lead Health Innovation CSO ScotGov
- Adriana Roemmele: Innovation and Improvement Lead - National Procurement. NHS National Services Scotland (NSS)
- Professor Olivia Wu: William R Lindsay Chair of Health Economics and co-Director of Health Economics and Health Technology Assessment (HEHTA) at the University of Glasgow
- Albert Nicholl: Experienced MedTech Non-Executive Director
- Professor Neil Hawkins: Professor in Health Technology Assessment (HTA) at the University of Glasgow and member of the National Institute of Health and Clinical Excellence Diagnostics Advisory Committee
Complying with medical device regulation
InnoScot Health offers a skilled team of regulatory experts. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive.
Consultancy, training and advice is available to all NHS health boards, plus companies or universities working in partnership with NHS Scotland to develop medical devices. We ensure awareness and compliance with legal responsibilities and support the design and development of products under an accredited regulatory framework.
Chat