Stanford Biodesign Innovation for Engineers and Managers Training by Tonex
This immersive 1-day course introduces engineers and managers to the Stanford Biodesign Innovation Process, a proven framework for identifying unmet clinical needs, inventing impactful health technologies, and implementing solutions in the real world. Participants will work through hands-on exercises and team projects to internalize the process of health tech innovation, from need identification to concept evaluation and strategic planning. The course emphasizes the technical, clinical, regulatory, and business dimensions of health tech development and prepares professionals to lead or contribute meaningfully to multidisciplinary innovation teams.
Learning Objectives:
By the end of this course, participants will be able to:
- Apply the Stanford Biodesign Innovation process to real-world health challenges.
- Identify and characterize meaningful, unmet clinical needs using structured observation and stakeholder interviews.
- Invent and evaluate technology-based solutions, considering clinical, technical, business, and regulatory perspectives.
- Recognize and manage risks unique to health technology innovation, including adoption hurdles, reimbursement challenges, and regulatory pathways.
- Collaborate effectively on a multidisciplinary innovation team, leveraging diverse perspectives and skills.
- Explore career pathways in health technology innovation and entrepreneurship.
Target Audience:
- Biomedical, mechanical, electrical, and software engineers
- Engineering managers and R&D leaders
- Product managers and innovation officers
- Entrepreneurs in medtech and digital health
- Regulatory and clinical affairs professionals exploring innovation roles
Course Modules:
Module 1: Need Finding and Characterization
- Introduction to the Biodesign Process
- Clinical immersion and stakeholder mapping
- Techniques for need observation and need statements
- Prioritizing needs based on impact and opportunity
- Workshop: Create and refine a need statement
Module 2: Invention and Concept Generation
- Brainstorming for quantity and quality
- Filtering ideas through criteria (need fit, feasibility, novelty)
- Concept refinement using technical and clinical feasibility
- Intellectual property and freedom to operate
- Workshop: Invent and select promising concepts
Module 3: Implementation Strategy and Innovation Readiness
- Prototyping for feedback and iteration
- Regulatory strategy (FDA, CE, SaMD considerations)
- Reimbursement pathways and health economics
- Business models and adoption strategies
- Team dynamics and leadership in health tech innovation
- Workshop: Develop a high-level innovation plan (Reg, Biz, IP, Adoption)
Final Project (Team-Based):
Participants work in multidisciplinary teams to:
- Identify a clinical need
- Generate and filter invention concepts
- Develop an early implementation and go-to-market plan
- Present their innovation in a final pitch session
Exam Domains (Final Evaluation for the Optional Certification):
Domain Weight
1. Clinical Need Identification & Prioritization 25%
2. Technology Invention & Concept Development 25%
3. Implementation Strategy (Regulatory, Biz, IP) 25%
4. Teamwork, Communication, and Innovation Pitch 25%