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[2019/05/31] Bio-Navigator - Corporate Keynote Speech: Medeon’s Tips for Successful Commercialization of Innovative Medical Devices

Dr. Cheng talking about one of Medeon’s cases from a practical point of view, namely how Medeon successfully provided authorization for Terumo, an international medical device company, and earned $50 million in return.


Possessing over 20 years of product development and technology licensing experience, Medeon’s chief strategy officer, Shuling Cheng, was specially invited to give the Corporate Keynote Speech on the 11th of April by the chief executive officer of the Center for Academia and Industry Collaboration, National Yang-Ming University Business Center's Industry-Academia Liaison Bio-navigator Series of Events, Monica Bey. She gave a lecture on “Research and Development of Medical Devices and Strategies for Successful Commercialization”. Currently, Shuling Cheng is in charge of strategic planning, technology licensing, and corporate partnerships at Medeon. Dr. Cheng inspired the audience by discussing Medeon’s successful product commercialization cases.


Although the company has been established for less than ten years, Medeon has already shown outstanding accomplishments in the research, development, and manufacturing of medical devices, which is where the company's focus lies. Medeon has received the U.S. Food and Drug Administration (FDA) clearances for two laparoscopic surgery products and one other type of orthopedic equipment. In 2018, Medeon successfully provided authorization for Terumo, the fifth leading global cardiovascular medical device company, to use one of Medeon’s own products. Medeon has also assisted in follow-up product development, clinical trials, regulatory certification, and product supply for its large bore suture-mediated vascular closure device.


Dr. Cheng claimed that the factors influencing investors’ target choices include the provision of product’s clinical trial data, the product's competition in the market place, the product's value in terms of approval by doctors, and whether the product is patented and/or regulated. Most importantly, investors checks whether the quality of the product being manufactured meet the appropriate standards. The sellers also need to assess the investors’ ability to carry out follow-up product development, carry out clinical trials, the products relationship with any relevant regulations, the marketing channels available and a number of other issues. Only in this way, can a successful deal be made between the investors and the sellers.


Having acquired enough funds by helping to provide authorization for companies, Medeon uses these funds not only to find corporate partners, but also to looks for new products and to invest in new technologies, new platforms, and new companies. For those companies that have their own ideas related to early phase medical device development, but have not yet been able to produce a product, the critical assessment criterion that Medeon uses is one involving a preliminary assessment as to whether the product meets an unmet medical care need.


The audiences asked questions with enthusiasm.


Dr. Cheng advised the audience that the process begins with cultivating an idea and ends with closing a deal. It should include the signing of a NDA (non-disclosure agreement) initially, followed by numerous interactive assessments via progress and documentation audits, which forms a middle phase, and then, finally, the signing of a “Terms Sheet” during the end phase, which is when both parties have formed the intention to cooperate. Dr. Cheng considered the signing of the “Terms Sheet” the most crucial step and reminded the audiences not to neglect the risks hidden in this document. Both parties need to have reached a full agreement on the details as laid out in the “Terms Sheet” because this document is difficult to modify at a later stage, namely when signing the contract.


After the lecture, Prof. Ying Chang was asked about how Medeon reaches out to doctors and interviews them. Dr. Cheng responded that Medeon’s team would initially do a phone interview with the doctor, and contact KOLs (Key Opinion Leaders) by attending conferences. What is unique about medical devices, she specifically pointed out, is that each country has different ways of treating such devices, and these differ pragmatically. When positioning products in the European and American markets, for instance, Medeon principally relies on local KOLs' opinions, and designs the products to fit the local users’ perspectives.


Dr. Cheng photographed after the lecture with Vice-President Hsieh and CEO of the Center for Academia and Industry Collaboration Monica Bey.