National Yang Ming University Business Center of Industry-Academia Liaison Serial Events of Bio-navigator -- Corporate Keynote Speech
Medeon – Tips for Successful Commercialization of Innovative Medical Devices
The chief executive officer Monica Bey of the Center for Academia and Industry Collaboration has specially invited a member from Bioladies, Medeon’s chief strategy officer Shuling Cheng, to the Lecture to give a speech.
Possessing over 20 years of product development and technology licensing experiences, Medeon’s chief strategy officer Shuling Cheng has been specially invited by the chief executive officer Monica Bey of the Center for Academia and Industry Collaboration, ational Yang Ming University Business Center of Industry-Academia Liaison Serial Events of Bio-navigator -- Corporate Keynote Speech on the 11th of April. She was to give a speech on “Research & Development of Medical Devices and Strategies for Successful Commercialization” at the Lecture. Currently, in charge of strategic planning, technology licensing, and corporate partnerships at Medeon, Dr. Cheng has inspired the audiences by discussing Medeon’s successful product commercialization cases.
Dr. Cheng talked about one of Medeon’s practical cases – how Medeon successfully provided authorization to Terumo, an international medical device company, and earned $50 million (USD) in return.
Though established for less than ten years, Medeon has already shown outstanding accomplishment in the research, development, and manufacturing of medical devices, where their focus lies. Medeon received the U.S. Food and Drug Administration (FDA) clearances for two laparoscopic surgery products and one orthopedic equipment. In 2018, Medeon successfully provided authorization to Terumo, the fifth leading global cardiovascular medical device company, to use Medeon’s own products. Medeon also assisted in the follow-up product development, clinical trials, regulatory certification, and product supplies for its large bore suture-mediated vascular closure device.
Medeon’s senior manager, Dr. Yuan-Ming Hsu, at the Biomedical Research and Development Department talked about how investors facilitate a due diligence process.
Dr. Cheng claimed that the factors influencing investors’ target choices include the provision of the product’s clinical trial data, the product market competition, the product value approved by doctors, and whether the product is patented and regulated. Most importantly, investors would check whether the quality of the product being manufactured meet the standards. The sellers also need to assess the investors’ ability to carry out the follow-up product development, the clinical trials, the regulations, and the marketing channels and so on. Only this way, a successful deal can be made between the investors and the sellers.
The audiences asked questions with enthusiasm. Left photo: Vice-president Jen-Chuen Hsieh; Right photo: Prof. Woei-Chyn Chu of the Department of BioMedical Engineering.
Having acquired enough funds from providing authorization to companies, Medeon uses these funds not only to find corporate partners, but also looks for other products, and invests in new technologies, new platforms, and new companies. For those companies that have their own thoughts about the early phase medical device development, but haven’t yet been able to show the products, the critical assessment criteria Medeon uses to preliminarily assess them is whether their products meet the unmet medical care needs.
Prof. Yen-Yin Lin of the National Tsing Hua University specially came to Taipei to attend today’s speech
The process of cultivating an idea to closing a deal, Dr. Cheng adviced the audiences, involves the signing of NDA (non-disclosure agreement) in the beginning phase, numerous executions of interaction assessment and documentation audit in the middle phase, and the signing of Term Sheet in the end phase when both parties have the intention to corporate. Dr. Cheng considered the signing of Term Sheet the most crucial step and reminded the audiences not to neglect the risks hidden in it; both parties better reach an agreement on the details laid out in the Term Sheet, for it would be hard to modify them later when signing the contract.
The vice-president Jen-Chuen Hsieh attended the entire Lecture and awarded a certificate of appreciation to each participant
After the Lecture, Prof. Ying Chang asked about how Medeon reaches out to doctors to interview them? Dr. Cheng responded that Medeon’s team would initially do a phone interview with the doctors, and contact KOL (Key Opinion Leader) through attending conferences. What is unique about medical devices, she pointed out specifically, is that each country has different pragmatic ways. With the products’ positioning in European and American markets, for instance, Medeon would principally rely on the local KOL’s opinions, and design products from the local users’ perspectives.
The Lecture covered a lot of ground and was truly outstanding. The audiences were enthusiastic in learning by asking questions after the speech