What defines a medtech company – and where does healthtech fit in?
As digital solutions, devices, and hybrid innovations become increasingly integrated, the traditional boundaries between medtech and healthtech are no longer clear-cut. Yet, the way your solution is classified can have significant implications – from regulatory pathways and clinical evidence requirements to funding opportunities, go-to-market strategies, and ultimately market access.
At this seminar, we will explore the evolving landscape of medtech and healthtech and address one of the key questions facing innovators today: Where is the line – and does it matter?
Together with industry experts, companies, and regulatory specialists, we will examine:
- How classification impacts regulatory requirements, including the role of MDR
- The implications for funding: does being medtech unlock different opportunities?
- The costs and considerations of clinical studies
- Strategic trade-offs in positioning your company and solution
- Real-world perspectives from companies navigating these decisions
Through concrete cases and practical insights, participants will gain a deeper understanding of how classification is not just a technicality – but a strategic decision that can shape the future of your company.
Join the MVA Medtech Network for an afternoon of insights, discussion, and networking across the Medicon Valley ecosystem.
Date: Tuesday, 25th August 2026
Time: 14:00 – 18:00
Venue: Medeon Science Park, Per Albin Hanssons väg 41, Malmö
Program
| 14.00 | Registration and Networking |
| 14:30 | Welcome Anette Steenberg, CEO, Medicon Valley Alliance Malin Bornschein, CEO, Medeon Science Park |
| 14:40 | Wellness, Healthtech or Medical Device? Why Classification Changes Everything Claudia Dannehl, QA/RA and clinical specialist, GBA Key2Compliance |
| 15:00 | The gap that holds a lot of women’s health innovation back – Femtech is pushing healthcare forward Jacqueline Nuwame, Chief Estrogen Officer, Minimal App |
| 15:20 | Clinical Study Considerations for Medical Devices, with perspectives on Health Tech Elin Ibsted, Sr Clinical Study Manager, Veranex |
| 15:40 | Digital Diabetes Daniel Möller, CEO, Infodiab |
| 16:00 | Networking break with coffee and cake |
| 16:30 | Your Regulatory Route Is Also an IP Deadline Jenny Landberg Clementson, Associate Partner and European Patent Attorney, Høiberg European Patent Attorneys |
| 16:40 | From Device to Digital: Rethinking Business Models in Medtech Niklas Fossum, Partner, Simon-Kucher Johan Raberg, Director, Simon-Kucher |
| 17:00 | Panel discussion: Does It Matter? The Real Impact of Being Medtech or Healthtech
Moderated by Malin Bornschein, CEO, Medeon Science Park |
| 17:45 | Networking, Drinks and Snacks |
| 18:30 | End of meeting |
Speakers
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Claudia Dannehl is a QA/RA and clinical specialist at GBA Key2Compliance, with more than a decade of experience in the medical device industry. She holds a background in physics and a PhD in biophysics and has worked closely with both startups and established companies on regulatory strategy and clinical requirements. Claudia supports companies in navigating the European regulatory landscape, with a strong focus on practical, actionable solutions. |
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Jacqueline Nuwame, CEO & Founder of Minimal, has embarked on a deeply personal mission to revolutionize the way society addresses menopause, a topic often shrouded in silence and stigma. Driven by her own experiences and the collective challenges faced by women worldwide, she leveraged her expertise to create Minimal’s pioneering AI pattern-predictive technology, aimed at empowering women to embrace menopause with confidence and support. Her journey into entrepreneurship is complemented by a proven track record in marketing and brand engagement. |
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Elin Ibstedt is a bioentrepreneur with over 10 years of clinical research experience in the medical device industry. She serves as a Sr Clinical Study Manager at Veranex, leading multicenter pre- and post-market studies across multiple therapeutic areas. Elin specializes in end-to-end study execution, team leadership, and regulatory and operational excellence. She holds an MSc in Bioentrepreneurship from Karolinska Institutet. |
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Daniel Möller is a diabetes nursing specialist, sports scientist and athlete with type 1 diabetes. He offers digital consultation with diet and exercise plans for people with type 1, 2, LADA and prediabetes. His company Infodiab is navigating how to improve health for people with diabetes through the digital wellness space. |
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Niklas Fossum is a Partner in Simon-Kucher’s Stockholm office, a member of the global Healthcare practice, and leads the firm’s Life Sciences activities in Sweden. With nearly a decade of consulting experience at Simon-Kucher, he has worked globally across all aspects of commercial excellence, including front-end pricing, launch management, growth strategy development, and revenue management systems (such as CRM, CPQ, and CLM implementation). He has led a wide range of projects, from short-term opportunity assessments to long-term solution development and implementation. Within Healthcare, Niklas has extensive experience across Medical Technologies and Healthcare B2B. He holds a Master of Science in Corporate and Financial Management from Lund University. |
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Johan Raberg is a Director at Simon-Kucher, focused on driving commercial excellence in the MedTech and Diagnostics space. He helps companies optimize pricing, shape go-to-market strategies, and successfully bring innovative technologies to market. |
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Thomas Unt is Head of Medeon Incubator at Medeon Science Park. With extensive experience in innovation, venture capital, and entrepreneurship, he is dedicated to helping companies develop strategies and development that enable their innovations to reach the market. Before joining Medeon, Thomas spent ten years at SmiLe Venture Hub, where he served as Deputy CEO and CEO of SmiLe Inject Capital. He has also held leadership roles in several startups across Southern Sweden. Thomas holds a Master of Science in Business and Economics from Lund University. |
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Malin Bornscheinis CEO of Medeon Science Park in Malmö. She is experienced both in the dynamic startup ecosystem in Lund and in production and commercialization within the CDMO cluster in Malmö and the surrounding region. Her background also includes political engagement and international work, with postings in Germany, Sweden, Denmark, and France. Malin is a life science – and particularly medtech – nerd, with an academic foundation mainly in life sciences (MSc & PhD), complemented by studies in business administration and marketing (BSc). |
Deadline for registration is 24th August
Combine your participation in the seminar with a visit to TechBBQ in Copenhagen on 26th and 27th August. MVA members get a 25 % discount.
Read more about TechBBQ and sign up with MVA discount
The Network
The MVA MedTech Network is a professional network for Medicon Valley Alliance members from industry, academia and the health care sector with an interest in the MedTech field. Joining the network is free of charge but is limited to Medicon Valley Alliance members. However, non-member organizations and companies are welcome to attend one network event to evaluate if joining the network is relevant. If so, becoming a member of Medicon Valley Alliance will automatically allow you to join the network.
If you have any questions please reach out to Network Manager Katrine Brems Olsen at kbo@mva.org
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