Fall 2023 | |||
Topic | MBP1408H: Medical Device Commercialization Essentials | ||
Credits | 0.25 credits | ||
Coordinators | Dr. Graham Wright, Dr. Brian Courtney, & Dr. Ahmed Nasef | ||
Day & Time | Thursdays, 5:30 – 7:00 pm Orientation is scheduled for Wednesday Sept. 6 at 5:00pm (M6-502) | ||
Location | Sunnybrook Health Sciences Centre, M6-502 | ||
Recommended Prerequisites | Medical Device Innovation & Entrepreneurship is a co-requisite (must be taken at the same time) | ||
Module Goals | Not all medical device innovations will make it into patient care. Without a compelling, accessible market, a sustainable business model and operating plan, a well-thought-out plan for acquiring and managing intellectual property, and strong regulatory and reimbursement strategies, even the seemingly most important medical innovations are unlikely to be commercialized. The Medical Device Commercialization Essentials course complements the Medical Device Innovation and Entrepreneurship module and provides students with an experiential connection to the process of commercializing novel medical discoveries. The course focuses on systematic examination of issues and factors that directly affect the financial viability and sustainability of a medical device innovation and impact the innovator’s ability to successfully commercialize a solution. The delicate and frequently conflicting interplay between intellectual property, regulatory environment, reimbursement mechanisms, business strategy and financial modelling are explored with hands-on exercises and interactive workshops. The module is recommended for students who would like to: (1) catalyze innovation in major medtech companies; (2) build their own medtech start-ups; (3) draw on world-class innovative research conducted in Canadian universities, research institutes and hospitals; and (4) lead translational research projects. | ||
Evaluation Method | In the Medical Device Innovation & Entrepreneurship module, students present a systematic review of significant clinical challenges and propose novel medical device solutions that address the gaps in these challenges. In this commercialization module, students are required to incorporate the analysis of the prospective novel medical device concepts from assignment 1 into a high-level funding or a business case proposal. Students are to assume that this high-level proposal will be reviewed by a commercialization manager at Sunnybrook’s technology transfer office. The commercialization manager will assess the potential of financially supporting the commercialization of this technology and determine whether an adequate market opportunity exists to support the development of an innovation. The students should draft the business case proposal within this commercialization context. The business case proposal should include the following sections to demonstrate commercialization potential: technology overview, market opportunity, industry analysis, business model/value proposition, cost and revenue structure, investment requirements, and associated preliminary IP and reimbursement strategies. Grading Scheme: Class participation (10%), Group Report (90%). | ||
Schedule | |||
Date | Instructor | Lecture | |
September 6 (Wednesday @ 5:00 pm in M6-502, Sunnybrook) | Orientation | ||
September 14 | Jonathan Toma | Needs & Gaps Analysis | |
September 21 | Leon Wahler | Market Analysis Workshop | |
September 28 | Kasey Dunn | Design Thinking Workshop | |
October 5 | Nick Kuryluk | Business Case Analysis Workshop | |
October 12 | Yolande Dufresne | Patent Search Exercise | |
October 19 | Jayson Parker | Regulatory Workshop | |
October 26 | Mark Smithyes | Reimbursement Workshop | |
November 9 | TBD | Raising capital workshop | |
December 7 | Final Report Due | ||