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Center for
Social Innovation

Center for Social Innovation

Biodesign Innovation

Biodesign Innovation: OIT 581/3

Stefanos A. Zenios, Charles A. Holloway Professor of Operations, Information, and Technology and Professor of Health Care Management, Dr. Paul Yock, Martha Meier Weiland Professor of Medicine and Professor of Mechanical Engineering, by courtesy
Topics: Healthcare

Stakeholders and Market Research

The two-quarter Elective Course series provides lectures from a diverse group of faculty that expose students to the practical aspects of technology invention and development. The class features a presentation or discussion from one of the guest speakers or faculty. Students work in small project teams in the Biodesign prototyping lab or bench space, collaborating with the fellows of the program. Lectures and practical discussion from faculty and outside experts.

Elective Course Structure

  • Needs Assessment
  • Research
  • Intellectual property
  • Biomedical ethics
  • Brainstorming
  • Assessing Clinical and Market Potential
  • Developing patent strategies
  • Prototyping
  • Regulatory Strategies

A: Needs Finding and Concept Creation

Two quarter sequence. A systematic approach to inventing new medical technologies. The first quarter class details the process of validating medical needs including market assessment and the evaluation of existing technologies; techniques for analyzing intellectual property; basics of regulatory (FDA) and reimbursement planning; brainstorming and early prototyping for concept creation. Course format includes expert guest lecturers and interactive practical discussions with faculty. Four unit students will work in project teams, which will prepare a final report and presentation.

B: Concept Development and Implementation

The second quarter focuses on how to take a medical device invention forward from early concept to technology translation and implementation planning. Topics include technology research & development; patent strategies; advanced planning for reimbursement and FDA approval; choosing translation strategies (licensing vs. start-up); ethical issues including conflict of interest; fundraising approaches and cash requirements; essentials of writing a business or research plan; strategies for assembling a development team. Four unit students will work in project teams, which will prepare a final report and presentation.

Course information