Medtech ﬁrms operate in a highly regulated environment. This environment differs in several respects from that of other industries, including its “cousin” -- the pharmaceutical industry.
In addition to applicable laws (hard rules), medtech-speciﬁc contractual practices and so-called “soft laws” not found in legal codes and statutory laws should be followed.
To foster smooth execution and maximize their opportunities, medtech players are well advised to ensure that “medtech law” oversight is part of their operation plan.
Below are 4 examples of what is meant by “medtech law”:
In Europe as elsewhere, medical devices cannot simply be made available and sold. They must be “CE-marked” prior to being offered for sale and use. This means that they must comply with a number of applicable regulatory requirements. The involvement of a certiﬁcation body known as a “notiﬁed body” might be needed in which case a corresponding agreement must be concluded. The CE-marking process can be time-consuming and should be planned well in advance and budgeted. It requires that sufficient scientiﬁc data be gathered. This may delay product launch if not properly addressed.
Agreements with key players such as R&D ﬁrms, suppliers, distributors and potential new partners should align with good medtech contractual practices and requirements. Negotiating these agreements at fair market value and ensuring that they are drafted in line with medtech industry customs will have a direct inﬂuence on the future success of a venture. This will not only ensure that the best possible deals are negotiated but will make things smoother whether the plan is scaling up or an exit with a strategic medtech player.
• Promotional practices
Promoting medical devices for sale is regulated. Breaches can lead to serious sanctions. Firms must be compliant with several applicable rules, such as those limiting incentives that can be offered to healthcare providers. These “soft laws” are not typically known to those unfamiliar with the medtech space. Internal policies and procedures that comply are needed but those should be balanced so as to not unduly undermine promotional efforts.
• Health claims
Health claims about the indications and beneﬁts of using a medical device are tightly regulated. There are several “dos” and “don’ts” applicable to claims about the performance of a medical device that are made in websites, promotional brochures, instructions for use and oral presentations. Review and clearance of those prior to use is a good de-risking practice.
Day-to-day SME medtech operation is about delivering on commitments to investors through swift and focused execution in a regulated environment. This involves several key negotiations and judgment calls. These require a combination of entrepreneurial boldness and balanced de-risking. The role of the legal counsel for a medtech SME is to help achieve the correct balance.
This is the second of a series of legal briefings from boutique medtech-focused ﬁrms Swiss Peak Technologies SA and DeNovo Legal on the key lessons that they have drawn from their respective practice.
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 on 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 affliated 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 has also lectured in Medical Device Law and Regulation at NUI, Galway, a module which he created and ﬁrst began teaching in 2016.