BIOE 374A/B: Biodesign Innovation
(MED 272A/B, ME 368A/B, OIT 384/385)

Graduate or postdoctoral students from the Schools of Business, Engineering, Humanities & Science, Law and Medicine are invited to participate in the Elective Course, BioE 374A (Winter) and BioE 374B (Spring). Note: Students who have completed the A quarter will be given preference for the B quarter.

Course is also available online through the Stanford Center for Professional Development: Winter Quarter; Spring Quarter [NOTE the course is known as BIOE 375A/B within SCPD - this is due to differences in credit offerings.]

Elective Course Structure

• Needs Assessment
• Research
• Intellectual property
• Biomedical ethics
• Brainstorming
• Assessing Clinical and Market Potential
• Developing patent strategies
• Prototyping
• Regulatory Strategies
• 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 Knight Management Center's NGP CoLab and the Biodesign Prototyping Studio, collaborating with the fellows of the program.

Lectures and practical discussion from faculty and outside experts. Two sessions per week. Lecture on Thursday, project class on Tuesday. Enrollment capped at 40 students.

A: Needs Finding and Concept Creation

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;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. 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; techniques for analyzing intellectual property; 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. Students will work in project teams, which will prepare a final report and presentation.

Course Content

Course content (syllabus, homework assignments, etc.) is maintained on the Stanford CourseWork website. Once a student is enrolled in the course, access is given to the coursework pages.

• A Quarter CourseWork page (for students and faculty)
• B Quarter CourseWork page (for students and faculty)

Course Expectations

Attendance is mandatory and head count will be taken the first 15 minutes of class. We consider attendance essential to the structure of the course and only one unexcused absence will be permitted. Additional absences will result in a deduction from your final grade.

Students are expected to take both quarters of this class. Since class size is limited and admission to the class requires an application process, we do request that applicants indicate on their form that they will be taking the course both quarters.

Faculty & Course Support

This course is taught and supported by a host of faculty and staff. Due to the intensity of a project-based course of this type there are a number of people who will facilitate the student's participation:

Primary Faculty

• Paul Yock, MD
• Todd Brinton, MD
• Jay Watkins

Course Advisors

• Milt McColl, MD
• Mike Laufer, MD
• Deb Kilpatrick
• Maria Sainz

Course Mentors

• Carla Liebowitz, Lead
• Biodesign Innovation Fellows

Biodesign Educational Coordinator

• Andrea Mattison