Medical Device Innovation
Course Description
This seminar explores the process by which new medical technologies are designed, evaluated, and adopted for clinical use, and addresses key questions relevant to aspiring healthcare innovators. How are medical needs identified, and solutions devised? How do clinical trial design, FDA regulation, insurance reimbursement, and intellectual property impact startup and commercial success? What do healthcare venture capitalists look for in an investment? Guest lecturers include medtech inventors, entrepreneurs, investors, and other domain experts. Hands-on design projects will challenge students to invent and prototype their own device-based answers to existing clinical needs. No previous engineering training is required.
Meet the Instructor: Ryan Pierce & Joseph Mandato
Ryan Pierce
Ryan Pierce is a Lecturer in Bioengineering and the Co-Founder and CEO of Nine. In earlier roles, Ryan served as VP of Design and Innovation at Ventus Medical, VP of Business Development at Loma Vista Medical, a healthcare investor at De Novo Ventures, Rock Health, and SV Health Investors, and a product designer at Concentric Medical and The Foundry/Zephyr Medical. An inventor on over 30 issued U.S. patents, Ryan has designed FDA-cleared devices to treat sleep apnea and stroke. Ryan earned a BS in Mechanical Engineering from MIT, an MS in Mechanical Engineering from Stanford University, and an MBA from Harvard Business School.
Joe Mandato
Joseph Mandato is a Lecturer in Bioengineering, and a General Partner and Managing Director of De Novo Ventures, a local venture capital firm investing in the life sciences. Before working at De Novo, he was an entrepreneur and served in a variety of executive positions in the medical device industry. He has also co-founded or been involved in the development of several well-known companies, including Align Technologies and Guidant Corporation.
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