Boutique medtech-focused ﬁrms Swiss Peak Technologies SA and DeNovo Legal have joined forces to publish a series of legal brieﬁngs on the key lessons that they have drawn from their respective practice.
Both ﬁrms are active in a European medtech hotbed: Switzerland and Ireland, both countries housing a rich eco-system of successful multinational medtech ﬁrms, SMEs, startups and investors.
The series will illustrate how the success of their medtech clients -- entrepreneurs, mature ﬁrms and investors– results in no small measure from an ability to navigate through the hard rules and soft laws of the medtech space. Both Swiss Peak Technologies and DeNovo Legal specialise in providing practical commercial and legal advice for the day-to-day operational needs of medtech players.
To take a medtech company to its next success requires vision. To make this vision a reality also requires swift execution. For smaller ﬁrms, having access to a dedicated and aﬀordable medtech “outside legal counsel” can be a game-changer – to anticipate rather than react, to soundboard prior to deciding and to execute swiftly as both opportunities and issues arise. For other medtech players, project-speciﬁc advice and support from an independent medtech insider can prove critical.
In the experience of the co-authors, medtech companies need a formula for external legal support that combines four key features: (i) medtech industry insight, (ii) a sense of urgency, (iii) regular follow ups and (iv) an aﬀordable and transparent fee structure.
In the ﬁrst of these brieﬁngs the authors will illustrate what is meant by “medtech law”, i.e. the specialized area of legal practice in which medtech ﬁrms operate. They will give a number of concrete examples of medtech law impacts on the results of players in the space, both large and small.
The second brieﬁng will illustrate how some key changes brought about by the new European Medical Device Regulation (MDR) will have concrete impacts on the way medtech ﬁrms operate with respect to their commercial contracts.
Look for our ﬁrst brieﬁng in the coming weeks!
Sylvain Poitras is the founder and Managing Director of Swiss Peak Technologies SA (www.sptsa.com), a ﬁrm based in Geneva that provides medtech legal traction. Sylvain has been providing medtech law advice and support in Europe and beyond for some 20 years working with and for Big Medtech (Medtronic, Cardinal Health), SMEs and investors, including EU-US cross-border issues. He is qualiﬁed as an attorney-at-law in the US (NY) and Canada (QC) and holds a Master of Public Health (MPH) in health-sector management from Harvard University. He has been a lecturer on European medtech law (CE-marking, innovation, contracting practices, compliance) at two leading Swiss universities (EPFL & UNINE) since 2010. Since its creation in 2016 Sylvain has been a health-sector mentor and judge with leading start-up accelerator MassChallenge Switzerland.
Kevin Moore is the founder of DeNovo Legal (www.denovolawﬁrm.com). In 2011, Kevin became the only lawyer in Ireland or the U.S. to be selected to participate in the aﬃliated BioInnovate Ireland and Stanford Biodesign Fellowships. He established DeNovo Legal, a bespoke practice for the life science sector having gained a unique understanding of the I.P., compliance, ethical and funding challenges facing medical devices companies. Kevin also lectures in Medical Device Law and Regulation at NUI, Galway, a module which he created and ﬁrst began teaching in 2016.