Innovating in Biomedical Technology
Course Number 2185
Professor Regina Herzlinger
Visiting Professor Kevin Schulman
Fall; Q2; 1.5 Credits
From the artificial heart to the wonders of genomics, medical technology has been a key factor in the advance of modern medicine. This course requires completion of Innovating in Health Care (IHC), an intensive course offered in the early Fall.
Health care technology innovation requires a specific application of the Six Factors framework of the IHC course with a focus on global regulation of medical technology products and extensive and expensive development timelines (public policy, accountability factors ); unique market adoption (structure, consumers factors ); reimbursement (financing) challenges; and life cycle management (technology). Innovating in the life sciences thus requires an assessment of business, clinical, managerial, and regulatory risk; creation of a portfolio of simultaneous multiple strategies (development, acquisition, divestment); as well as a clear understanding of valuation milestones, to properly assess opportunities. The ethical implications of technology development are an important consideration as well addressed.
For those interested in entrepreneurial biomedical technology management, consulting, or investing.
This course will explore the following specific technology industries within the health sector: biotechnology/pharmaceutical, medical devices, and the emerging health informatics sector. We will build institutional knowledge of the types of challenges facing managers/investors in these industries and how entrepreneurs have met them to enable an understanding of how to create successful innovations.
Content and Organization
Biomedical technology arises through discrete stages: discovery, development, regulatory review, reimbursement assessment, market access/adoption, and life cycle management (product extension efforts).
The course will examine these stages through three sections: biopharmaceutical, medical device, and information technology.
We will discuss cases from each of these segments using the Ten Factor framework for assessing biomedical technology in "Evaluating the Commercial Viability of New Health Care Technologies," for: Unmet Need, Black Box (Technology Solution), Regulatory Pathway (including Depth of Research, Downside Risks), Market Access/Adoption and Competition, Reimbursement Considerations, Patents/IP, Manufacturing and Distribution, Ethical Considerations, and Investment Analysis. For more, see Regina E. Herzlinger, "Evaluating the Commercial Viability of New Health Care Technologies," HBS No. 313-070, Rev 2014 (Boston: Harvard Business School, 2010)
Final Project Requirements
Students will form teams to develop an investment assessment for a new medical technology. Teams can take one of three perspectives: entrepreneurs seeking investment capital, established firms assessing an internal investment or an acquisition, or an investment professional assessing a life sciences investment (VC, PE, or buy side).
The assessment will address each of the ten factors including a financial analysis of the investment and expected return over a 5-10 year period (as appropriate to the technology).
The final assignment should be in the form of a PowerPoint presentation of up to 20 slides and can include up to 2 supplemental tables in Excel. All data sources must be fully cited.
Students are expected to attend every class unless they have been excused in writing by the instructors. Class participation will account for a significant percentage of your final grade. The remainder of the grade will be based on your final project including an evaluation of your role in your project team as assessed by your teammates.
Meetings with Professor Herzlinger can be made through her faculty assistant, Frank Malafronte, 617.495.6647 or by emailing firstname.lastname@example.org. Appointments will be made on a first come, first serve basis. All appointments will require a resume and an agenda two business days prior to the meeting or they will be cancelled. Be sure to cc Mr. Malafronte on all e-mails.
Meetings with Dr. Schulman can be arranged by contacting Joy Lopez at 919-668-8593. Dr. Schulman will generally hold office hours on the day of the class.