16/11/2022
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Elyas Bozan, Global Practice Head Life Sciences at Morgan Philips Group, spoke with Dr. Thomas Meininghaus, who has more than 20 years of experience in the medical device industry in various management roles, change management and leadership.
EB: Thomas, with your broad experience in the medical device industry, what have been the major transformation drivers within the last five years?
TM: The whole industry is currently under a severe stress test. The Medical device regulation MDR has required all Medtech players to extend their process landscape and revise their product documentation. The requirements were known since 2017 but underestimated by almost all market participants that distribute products in Europe. In parallel the global supply chain issues have forced the industry to source alternative components for their products which in many cases divert from the original design and thus require re-qualification, re-validation and in some cases new declaration of conformity. To make things worse the complexity of regulatory requirements increase due to such deviations like UK’s Brexit and Swiss termination of the Mutual Recognition Agreement MRA.
EB: From a leadership and change management perspective what are your main objectives in your current role?
TM: We embrace change as an opportunity to establish systems that allow scalable and compliant growth. Having said that it is important to keep in mind that such kind of transformation into a “new way of doing things” might trigger fear and uncertainty within the team as we usually have to leave our comfort zone in such situations. Strong leadership behavior anticipates and appreciates this: iterating to find a solution is ok, making mistakes is ok - as long as we learn from them.
EB: Isn’t that a challenge for managers especially under the “remote work” situation?
TM: Yes and No! Remote work follows the same management and leadership style that has been successfully established in matrix structures. Let’s say a manager is responsible for RA topics in a number of sites. He cannot be in all sites at the same time. So he has to manage them remotely, led by clearly defined objectives, anticipate the required effort and support. We have that experience in many companies already today and need to ensure to share this. If we manage to utilize and expand these management principles effectively, companies will benefit from a larger pool of managers that have already qualified for higher ranking positions later on. So, it’s a great chance for all parties!
