• English

Welcome to the 1st Course on Translational Research and Commercialization of Medical Devices

The Trans Comet course is meant to take the participants through the process of bringing ideas from the concept stage to the prototype stage and towards commercialization. The course will provide a holistic understanding of the translational research process in the medical devices arena.

Trans Comet 2019 organizers and co-chairs



James Nolan

CEO, InClinica, United States

Jeffrey N. Gibbs

Director, Hyman, Phelps & McNamara FDA Law Firm, United States

Tal Karplus

Partner, Shibolet & Co. Law Firm Corporate Law Firm, Israel

Jos Vander Sloten

Vice Dean for International Affairs, KU Leuven, Belgium

Martin Burns

2018 Entrepreneur of the Year, Biometrics Industry (North America)

Bruin Biometrics LLC, United States


Small to medium sized companies, start-ups, and academics with an interest to learn how to translate an idea to a product.

Participants will deep-dive into the manifold aspects of medical device technology innovation, routes for commercialization, and business strategies. The course will provide both theory and practical tools for turning ideas and inventions into a medical device business.



  • Introduction and review of current challenges and opportunities 
  • Determining a market opportunity 
  • Development of a business plan 
  • Seeking investments 
  • Development of an early prototype 
  • Risk management 
  • Quality control 
  • Medical device testing and design of clinical trials 
  • Differences between the pharmaceutical and medical device markets and regulatory pathways 
  • Filing patent applications and development of protection of intellectual property 
  • Specific regulatory considerations and safety requirements 
  • Coordination of engineering team work 
  • Choosing the best industry experts as partners and consultants 
  • Establishing presence and visibility in the market 
  • Commercialization strategy and agreements 
  • Case scenario 
  • Exit strategies



Trans Comet 2019 is endorsed by:


First announcement is now available HERE.


Early registration deadline: 15 August 2019

Application deadline: 15 September 2019

6 - 8 November 2019


Arenbergkasteel- Kasteelpark Arenberg 1, 3001 Heverlee

Katholieke Universiteit Leuven, Leuven, Belgium


Pictures from www.visitleuven.be/en