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

MAIN TOPICS WILL COVER:

  • 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

TARGET AUDIENCE:

Small to medium companies, Start-ups, and Academics with interest in translating an idea to a medical device 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. The specific learning objectives are:

LEARNING OBJECTIVES:

  • Familiarize participants with technology assessment in the medical device arena 
  • Teach relevant aspects of intellectual property, including patenting and licensing routes 
  • Describe methods to fund commercialization of innovation 
  • Discuss key regulatory considerations and steps 
  • Present risk management considerations and quality control procedures 
  • Explain how mature companies (should) evaluate internal and external ideas and inventions 
  • Discuss principles of exit strategies and business growth plans for medical device companies 

CONTEXT:

Bringing new medical devices to today’s global markets is an extremely complex process involving high financial and legal risks. Products must meet strict safety and quality regulations, as well as specific requirements set by regulatory bodies in different geographical markets. Investments to initiate the journey of bringing a medical device to market are only worthwhile if there is an appealing market opportunity which is addressed by a solid business plan. The market opportunity and business plan need to be adequately communicated to potential investors while understanding the pros and cons of each potential investment. Typically, investors wish to see a prototype which needs to be developed to illustrate the concepts and technological solution. Investors should also interrogate the company plans of risk management concerning financial, regulatory, intellectual property and marketing milestones. To systematically build a good company, there needs to be a clear process of developing intellectual property portfolio, know-how, record of scientific evidence and overall, a product narrative. Likewise, a company should develop quality control procedures for R&D activities internally and externally. After crossing the barriers of seed investments and initial R&D, the phase of testing and design of clinical trials typically begins, during which partnering with the most suitable persons and institutes is absolutely critical. In addition, already at the very early stage, a company should develop a strategy for visibility and presence in the field, which promotes commercialization in the future. Good commercialization strategy and related legal work would increase the likelihood of a successful business outcome, either an exit or a growth in sales and company size.

 

We have collected the world-renowned global experts to address the breadth and depth of the above journey, in a first-of-its-kind course that focuses on translational work to cross the chasm between a good idea and a commercial product. The contents have been carefully developed by the faculty of this course to provide the unique practical knowledge and useful tips that may save millions to a company in its early days. The course will be useful for start-up companies in the medical device arena; for small to medium-size companies wishing to train management in commercialization; for academics, scientists and engineers who are interested in translational work and in innovation towards commercialization, and for management in large companies outside the medical device field - wishing to make investments in or create spin-offs of medical device businesses.  

Trans Comet 2019 is endorsed by:

Trans Comet 2019 chairs

Prof. Amit Gefen, Tel Aviv University

Assoc. Prof. Daphne Weihs, Technion - Israel Institute of Technology


24 - 26 April 2019

KU LEUVEN

Arenbergkasteel- Kasteelpark Arenberg 1, 3001 Heverlee

Leuven, Belgium



Pictures from www.visitleuven.be/en