A free medical device regulation workshop taking place in Edinburgh this autumn will be inviting MedTech innovators to learn how to unite product compliance with commercial success through its sharing of cutting-edge knowledge and valuable insights

The deep dive event, entitled ‘MedTech regulatory readiness through an investor lens — bridging the gap to decisive competitive advantage’ is set to bring together medical device innovators, regulatory experts, and the investment community on Wednesday 4 November.

It is expected to attract a wide-ranging MedTech sector audience from across Scotland and beyond, including pre-startup companies and academics who are new to medical device regulations; MedTech startups or spinouts at an early stage of development; and SMEs preparing for external investment.

The workshop has been organised by the Tay Health Tech initiative, funded with the Engineering & Physical Research Council (EPSRC) in collaboration with leading healthcare innovation body InnoScot Health.

It will take place at the COSLA Conference Centre, Verity House — close to Haymarket railway station — from 10am-4pm with interested parties urged to register now and ensure their place due to limited capacity.

• Register to attend

Regulatory readiness is undoubtedly one of the most critical factors influencing MedTech investment decisions, shaping risk, valuation, time to revenue, and the likelihood of NHS and international market adoption.

However, many founders and spinouts struggle to define their regulatory strategy in commercial terms or align it convincingly with funding milestones, making this workshop a vital step in progressing their ambitions.

While the workshop encompasses insights around how regulation affects route to market and investment timelines, it will also move significantly beyond it.

Participants will gain advanced skills including abilities to:

• Understand regulatory frameworks governing medical devices in the UK and EU and their implications for innovation pathways
• Develop a roadmap aligning regulatory milestones with funding rounds and investor expectations
• Recognise investor perspectives on regulatory readiness and risk management
• Apply practical tools and checklists to strengthen regulatory strategy and investment appeal
• Access support networks and resources to advance innovation, compliance, and commercial readiness

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell said: “We believe this insight-led workshop will provide the practical knowledge and support required to bridge a significant gap in understanding which is routinely encountered — making the leap from securing regulatory approval to gaining investor confidence.

“It is particularly important to see issues from the point of view of the investment community, with our event offering first‑hand insight how MedTech investors assess regulatory preparedness during screening, valuation, and due diligence — all potentially critical factors in giving the best chance of success for Scottish healthcare startups, academic spinouts, and SMEs.

“The event will set its sights on learnings which will allow investors to appreciate the value of regulatory readiness, and founders to add value to their pitches with information that investors did not necessarily know they needed. We look forward to welcoming all on Wednesday 4 November.”

Tay Health Tech Project Manager, Vicky Farquhar added: “This will be a very productive, insightful, and valuable day for all involved.

“By the end of the workshop, participants will be able to describe their regulatory strategy in investment‑ready language, anticipate investor diligence questions, and position regulatory readiness as a competitive advantage rather than a cost burden.”

Sessions will be taking place across the day, including a ‘Refresher on Regulatory Landscape for Medical Devices and Implications on Business Plan’ presented by Elaine.

Furthermore, attendees will benefit from the vast knowledge of Vicki Hazley, Associate Director of the Scottish National Investment Bank which regularly invests in life sciences. Vicki is an expert in investment portfolio management.

Director of Portfolio at Eos Advisory LLP, Anne Muir — formerly deputy director for research and innovation services at the University of Dundee — will be sharing candid advice based around the investment firm’s commitment to backing science-based companies and founders developing technologies that can positively impact lives.

Edward Staunton, Director, Regulatory Affairs & Quality, Medical Devices at Clinigen, has also been confirmed to be presenting a session on regulatory strategy and key considerations with the ultimate aim of giving attendees a clear view of what regulatory preparedness looks like.

The day will feature real-world case studies, networking opportunities, as well as coffee and lunch breaks, with more expert speakers set to be confirmed.

Tay Health Tech works with regulators, researchers, and the NHS in Tayside to create an innovation-driven ecosystem in which the use and impact of healthcare technologies in the community is accelerated while health inequalities are reduced.

InnoScot Health is delighted to be part of the initiative’s steering committee and offers a skilled team of regulatory experts.

The Tay Health Tech initiative is led by the University of Dundee and Edinburgh’s Heriot-Watt University and supported by a diverse consortium made up of leading institutions and civic bodies.

These include the University of St Andrews, University of Glasgow, and Edinburgh Napier University, NHS Tayside, Scottish Enterprise, InnoScot Health, Dundee City Council, Angus Council, Dundee and Angus College, SHARE, and BioDundee.