Expert Meeting: Agile meets regulations


On September 27th, experts of leading pharma and medtech companies from Switzerland and Germany came together in Basel to exchange views and experiences concerning the use of agile methods in regulatory environment and to discuss possible solutions to bridge the gap between agility and regulatory demands. The framework program showed different viewpoints on methodical approaches and first-hand experiences, leading to a lively and fruitful discussion between all participants (for agenda please see below).

It became clear that agility is not contradictory to regulatory requirements; both can be combined and even synergetic effects appear to be possible. Nevertheless, companies that are used to acting according to the classic V-model face enormous cultural challenges and should consequently concentrate on adapting their business culture to the new procedures. Given the positive feedback from the participants, there is a big interest in following up this issue and getting the transformation started.

We would like to thank all the participants for this informative and interesting day and especially for providing insights into their work and opinions.

Please find presentations below.


15:00 h:

Get Started - Coffee and Welcome

15:15 h:

Keynote: The Future belongs to agile organizations

Prof. Dr. Ayelt Komus, University of Applied Sciences in Koblenz

• Agility is not a choice – it’s just the question how

• Why agility is a substantial way to increasing quality and compliance

• Benefits, spread and variety of agile methodologies

15:45 h:

Transition to an agile product development process for medical devices - an interim report

Dr. Nicolas Schwenck, Technology Platform Leader, PARI GmbH

• background: regulations and goals in the development process of inhalation devices

• The small "V" in the big "V": concepts and measures to use agile methods in the regulated environment

• First experiences: expected and unexpected challenges and wins

16:15 h:

Bridging the gap between Regulations and Agility

Christoph Piller, Business Unit Manager Life Science & Healthcare, msg industry advisors

• Short overview on regulations, including new MDR

• Conflict areas between agile methods and regulatory requirements

• Solution approaches, risk management

16:45 h:

Get Connected - Break with Networking and Collection of open Points & Questions

17:15 h:

The right combination is the key - Realizing the advantages of Scrum in a regulated project environment

Claus-Peter Koch, CEO, Heupel Consultants Schweiz

• Learn about specific hybrid and scaled solution approaches with integrated documentation and review needs

• Benefit from experiences and useful suggestions

17:45 h:

Open Panel Discussion – Agile meets Regulations: clash or synergy

• Find out about the different perspectives of Experts

• Bring in your questions and comments

18:30 h:

Get Connected – Apéro and Networking

with experts from different companies and the speakers


Event in cooperation with msg advisors. Download the flyer here.