A free to attend workshop taking place in Edinburgh next month is encouraging MedTech innovators to advance their knowledge on how to successfully align regulatory compliance with commercial growth thanks to the latest insights

The full day event in the capital will take place on Wednesday 4 November, uniting medical device innovators with regulatory experts and the investment community for a multi-faceted deep dive which is designed to help accelerate market entry, build trust, and drive stronger revenue.

Entitled ‘MedTech regulatory readiness through an investor lens — bridging the gap to decisive competitive advantage’, it will invite interested parties to the COSLA Conference Centre, Verity House — adjoining Haymarket railway station — from 10am-4pm.

The workshop — organised by the Tay Health Tech initiative, funded with the Engineering & Physical Research Council (EPSRC), in collaboration with leading healthcare innovation body InnoScot Health — will provide the practical knowledge and support required to gain investor confidence by better understanding and appreciating regulatory approval.

Directly addressing that significant gap, leading experts from the investment community will offer first‑hand experience of how MedTech investors assess regulatory preparedness during screening, valuation, and due diligence.

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 also be sharing candid advice based around the investment firm’s commitment to backing science-based companies and founders.

Further joining the workshop will be Chief Executive Officer at Vivolution, Mark Roger who works alongside investors, acquisition vehicles and founders to help businesses perform better, navigate change and realise value. His background spans commercial strategy, investment planning, growth funding and business transformation.

With more expert speakers yet to be confirmed, the day will start with a welcome from Tay Health Tech Co-Lead and Director of the Medical Device Manufacturing Centre (MDMC), Duncan Hand.

He will be followed by two insightful sessions from InnoScot Health experts — ‘Regulatory Overview & Recent Changes’ presented by Head of Regulatory Affairs, Elaine Gemmell, as well as ‘Quality Management Systems as a Value Creation Tool’ presented by Quality Manager, Lauren Brophy.

Rounding off the morning will be Director of Regulatory Affairs & Quality at Clinigen, Edward Staunton who will be presenting a session on ‘Regulatory Strategy – What You Should be Considering’. Edward is a highly experienced regulatory affairs and quality expert specialising in in vitro diagnostics (IVDs), medical devices and their inclusion in clinical trials.

Further key segments of the day will include ‘Clinical Evaluation Essentials’ presented by InnoScot Health Regulatory Manager, Paula Sweeten, a panel discussion on ‘What Regulatory Preparedness Looks Like in MedTech’, as well as two real-world case studies.

A further panel discussion will analyse ‘What Investment Ready Looks Like in MedTech’, including Executive Chair of InnoScot Health, Graham Watson who has extensive international investment banking experience of working with SME clients, delivering business development and strategic planning programmes, and leading change initiatives.

The workshop — which includes networking opportunities — 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
• SMEs preparing for external investment

Interested parties are 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.

Participants will gain advanced skills including how 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

InnoScot Health’s Elaine Gemmell said: “This is a valuable event for MedTech innovators, chiefly conveying the importance of regulatory readiness while providing knowledge exchange that will lead to more effective pitching with vital investors. We would urge you to benefit by registering for Wednesday 4 November.”

Tay Health Tech Project Manager, Vicky Farquhar added: “Seeing regulatory readiness as a competitive advantage rather than a cost burden can open up many new exciting avenues, making you significantly more investor ready. This free workshop represents a fantastic way to boost your ambitions.”

Tay Health Tech supports researchers and entrepreneurs, working with the NHS in Tayside and other academic and civic partners 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 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.