11th ExEx constraint driven innovation in medical devices

The ExEx symposium, organized by the SWAPP Task Force Medical Device (TFMD), was kindly hosted by the Swiss Integrative Center for Human Health SA (SICHH) in Fribourg on 8 March 2018. The symposium was a big success, bringing together more than 70 professionals of both Medical Devices and Medicinal Products to Fribourg. After a visit of the SICHH the symposium held in the afternoon offered a varied overview on innovations and regulatory changes in the field of medical devices. The symposium was opened by Daniela Gunz, Member of the Board, SwAPP (Bern, CH) and Jean-Marc Brunner, CEO, SICHH (Fribourg, CH).

The plenary session was opened and moderated by Marie Gaumet, member of the board, SwAPP. First key note speaker was Bradley Nelson, Professor of Robotics & Intelligent systems, Director of Multi-Scale Robotics Lab, ETHZ (Zurich, CH) who gave a wide insight into new fields of robotics and new uses of medical devices. Successful developments from bench to patients have been demonstrated. Impressive research on micro robotics were presented.

Ulla Grauschopf, Head of Device Development Europe, F. Hoffmann-La Roche Ltd (Basel, CH) followed in the key note session and detailed the collaboration between medicinal product  and medical device development within one company. Early communication and common understanding between medicinal product  and medical device departments is key for success and learnings can be made by both sides.

The key note sessions were closed by Bassil Akra, Vice-President, TÜV SÜD Product Service GmbH (Munich, D) in a talk about the European Medical Device Regulation: Timelines and Impact. He clearly showed the importance of the industry to carefully consider the new regulations and to take actions immediately in order to comply with the new regulatory demands.

 

Three workshops followed the key note speeches. Workshops with a mixed auditorium were challenging but were well conducted and excellently moderated by Eckhart Wildi, Medical & Regulatory Affairs Merz Pharma (Schweiz) AG, Dominique Pioletti, Laboratory of Biomechanical Orthopedics, EPFL, Lausanne Switzerland and Dorothee Heer, Managing Director, SwAPP.

Priscilla Brunetto R&D Project Leader, University of Fribourg (Fribourg, CH) and Vanya Loroch, CEO Loroch CTLS (Essertines-sur-Rolle, CH) presented in a first workshop how the Biomaterials used in medical devices can interact with Body Biological Barriers.

Christa Spitznagel, Sr Regulatory Affairs Manager Alpine, Allergan AG (Zurich, CH) and Ivo Schauwecker, Manager Clinical Services, AO Foundation (Zurich, CH) held the second workshop on Medicinal Products versus Medical Devices: Reaching the Market. Difference between medicinal product and medical device development were explored.

The third workshop was about Strategies in Clinical Evaluations held by Kathrin Abegg, Clinical & Regulatory Affairs Manager, ISS AG (Biel, CH) and about Person Responsible for Regulatory Compliance: Roles & Responsibilities, held by Rainer Voelksen, Co-Chair RAPS EU Advisory Committee (Geneva, CH). The two topics were ideal examples to show some of the new challenges the medical device industry is facing nowadays.

The closing remarks were performed in a very clearly manner by Michel Weber, Head Clinical Services, ISS AG (Biel, CH). He also outlined planned activities in medical devices by SwAPP.

 

SwAPP would like to thank Marie Gaumet, chair of the task force medical device and the members of the task force, Laetitia Galea, Rainer Voelksen and Michel Weber for organising the 2018 ExEx Event.

MG