On Wednesday 13 April I organised a seminar and realtime webinar at my firm about M&A in the medical devices sector, to discuss the legal and regulatory implications of an M&A project in the medical devices industry, what mistakes are typically made and how to prepare a medical devices company for an M&A transaction, whether it is a target or a buyer. A topical subject, now that M&A activity seems to be picking up again, for example with J&J eyeing Synthes presently.

Speakers were Hans Dulmen, CEO of Dulmen Regualtory Services, Jan van Lochem, Vice President Healthcare at BSi and myself. The full presentations of the seminar are here.

Hans van Dulmen gave a detailed account of the possible impact of an M&A project on a medical device’s quality system and about how to prepare a company, device or product line to be sold to another company with the least regulatory and organisational surprises. I think he also gave some good due diligence tips, both for seller and buyer due diligence.

Jan van Lochem addressed M&A transactions from the perspective of a notified body and emphasized a timely assessment of the impact of the acquisition on a company’s quality system and planning of the necessary assessment of the changes by the company’s notified body. Poor planning can cause problems, notably if the acquired devices cannot be integrated in the acquirer’s quality system timely and may not be covered by the seller’s declaration of conformity anymore.

I myself spoke about the legal issues that may arise, such as regulatory warranties, due diligence and possible renegotiation of distributor, agent and supply contracts, what to look for in a due diligence of a medical devices company from a medical devices specialist point of view (with specific emphasis on FCPA and anti-bribery law) and transitional service agreements for handover of a device from one quality system to the other.

The general conclusion of the seminar was that the issues discussed unfortunately often do not get the attention they deserve, often leading to unnecessary and costly problems and hold-ups.

It was all well attended and well rated seminar. We are currently remastering the full webinar recording, which I will also post when the work on it is done.