A medical device regulation workshop taking place in Dundee next month is set to offer cutting-edge knowledge and insights, bridging the gap between product compliance and commercial success

On Wednesday 3 June, the training 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.

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 agency InnoScot Health and will take place at the Discovery Point venue on Dundee's regenerated waterfront — from 10am-4pm.

The event is expected to attract a diverse 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 looking to raise investment.

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Regulatory readiness is one of the most decisive 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 articulate their regulatory strategy in commercial terms or align it convincingly with funding milestones.

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell said: “This comprehensive, training-led workshop is designed to bridge that vital gap in knowledge.

“The event will reframe regulatory strategy so that MedTech propositions can be seen through an investor lens. Participants will gain first‑hand insight into how MedTech investors assess regulatory preparedness during screening, valuation, and due diligence.

“It is aimed at Scottish healthcare startups, academic spinouts, and SMEs preparing for external investment, especially those which want to make an impact on the Tayside region.

“Fundamentally, if a device does not gain regulatory approval, it will of course not make it to market, and while the workshop encompasses insights around how regulation affects route to market and investment timelines, it will also move significantly beyond it.

“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 3 June.”

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
• Prepare an investor-ready pitch deck presentation that is customised for the MedTech or HealthTech sectors
• Access support networks and resources to advance innovation, compliance, and commercial readiness

Marc Desmulliez, co-lead of the THT project added: “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. This approach is quite unique.”

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

Other sessions will be titled ‘Regulatory strategy, what should you be considering?’; ‘Aligning Regulatory and Investment Milestones’; ‘Investor Insights: What Investors Look for in Regulatory Readiness’; and ‘Practical next Steps for Innovators’.

The day will further feature real-world case studies, a panel discussion, networking opportunities, as well as coffee and lunch breaks.

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.