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.