Stanford University Tom Andriacchi

1. Stanford UniversityTom Andriacchi Forum on Innovation and Entrepreneurship in Biomedical Engineering Education

2. b i o d e s i g n stanford university • Three Courses Medical Device Design • Medical Device Design* ME 294 • Biodesign Innovation* Med 274/374A,B • Medical Device Design and Evaluation ME 392A,B • *NCIIA funded mission: promote the innovation and implementation of new health technologies through interdisciplinary research and education a the emerging frontiers of engineering and the biomedical sciences. technology domains: biomaterials medical devices bioMEMS modeling/simulation biomotion surgical robotics biosensors, transducers minimally invasive techniques design therapeutic delivery systems Image guidance tissue repair & replacement home courses events faculty research contact Relationship: Concepts and Process biodesign.stanford.edu

3. Course Description • Courses are Project Based • Project teams 3 or 4 students • Faculty Mentor

4. Course Description • 1. Medical Device Design (1 quarter) ME 294 • Introductory survey level Undergrad/graduate • Individual “QuickStart” project • Team project • Physician supplied needs • Physician coached • Courses are Project Based • Project teams 3 or 4 students • Faculty Mentor • Novel methods • Design through prototyping • Hands-on, 3-D prototypes expected

5. Course Description • 1. Medical Device Design (1 quarter) ME 294 • Introductory survey level Undergrad/graduate • Individual “QuickStart” project • Team project • Physician supplied needs • Physician coached • Courses are Project Based • Project teams 3 or 4 students • Faculty Mentor • 2.Biodesign Innovation (2 quarters) Med 274/374A,B • Graduate: Engineering, Business, Med. Law, Biosciences • 1st qtr: needs assessment, brainstorming, concept development, regulatory, IP • 2nd qtr: financing, markets, business plans, ethics • Device prototype • Novel Methods • Teams include (Bioinnovation Fellows) • “Innovator’s Workbench” interview series of renown Inventors

6. Course Description • 1. Medical Device Design (1 quarter) ME 294 • Introductory survey level Undergrad/graduate • Individual “QuickStart” project • Team project • Physician supplied needs • Physician coached • Courses are Project Based • Project teams 3 or 4 students • Faculty Mentor • 2.Biodesign Innovation (2 quarters) Med 274/374A,B • Graduate: Engineering, Business, Med. Law, Biosciences • 1st qtr: needs assessment, brainstorming, concept development, regulatory, IP • 2nd qtr: financing, markets, business plans, ethics • Device prototype • 3. Medical Device Design/Evaluation (2 quarters) E 382A,B • Graduate Level Engineering • Real World Projects • Company Sponsored • Single project for 2 quarters • Novel methods • Design through prototyping • Hands-on, 3-D prototypes expected • Novel Methods • Class Organized as company • Form Executive Committees – • IP, Regulatory, Reliability, Tech Resources, • Proj Manage, Design Review • Total of 6 quarters • Fellowship Program

7. How do you measure outcomes? Grades Final Design/Report (verbal/written) Process and Content Other factors • Communications • Presentations • Project Team Conferences • Poster Presentation • Peer Review Stanford University

8. Medical Design Process Content Domains Design Evaluation Scientific Information Product Development Design Principles Medical/Clinical Problems

9. Biology Biocompatibility Medical Design Process Reliability testing Biomaterials Quality Control requires requires Engineering integrates including Anatomy Design Evaluation must consider Scientific Information applies FDARegulations Physiology Is enhanced by Pathology should be applied to precedes Intellectual Property Communication Skills including Product Development must meet Industry Needs Design Principles Medical Economics Needs Finding depends on including should consider often conflicts with to solve Manufacturing Resources may need Human Factors Problem Solving Ethics Entrepreneurship Medical/Clinical Problems

10. Biology Biocompatibility Medical Design Process Reliability testing Biomaterials Quality Control requires requires Engineering integrates including Process Anatomy Design Evaluation must consider Scientific Information applies FDARegulations Physiology Pathology should be applied to precedes Intellectual Property Communication Skills including Product Development must meet Industry Needs Design Principles Medical Economics Needs Finding depends on including should consider often conflicts with to solve Manufacturing Resources may need Human Factors Problem Solving Ethics Entrepreneurship Medical/Clinical Problems

11. Content Depth Biology Biocompatibility Medical Design Process Reliability testing Biomaterials Quality Control requires requires Engineering integrates including Anatomy Design Evaluation must consider Scientific Information applies FDARegulations Physiology Is enhanced by Pathology should be applied to precedes Intellectual Property Communication Skills including Product Development must meet Industry Needs Design Principles Medical Economics Needs Finding depends on including should consider often conflicts with to solve Manufacturing Resources may need Human Factors Problem Solving Ethics Entrepreneurship Medical/Clinical Problems

12. Biology Biocompatibility Medical Design Process Reliability testing Biomaterials Quality Control requires requires Engineering integrates including Anatomy Design Evaluation must consider Scientific Information applies FDARegulations Physiology Is enhanced by 3. Medical Device Design/Evaluation Pathology should be applied to precedes Intellectual Property Communication Skills including Product Development must meet Industry Needs Design Principles 1. Medical Device Design Medical Economics Needs Finding depends on including should consider 2. Biodesign Innovation often conflicts with to solve Manufacturing Resources may need Human Factors Problem Solving Ethics Entrepreneurship Medical/Clinical Problems

13. Example “best practices” Articulated Laparoscopic Surgical Devices Students: Kevin Fine David Miller Sven Newman Coach: Dr. Mark Vierra Stanford University ME294

14. Example “best practices” 2002 National Design Awards 1. Interventional Aortic Repair System Beverly Bangayan, Mariel Fabro and Rajan Pragash 2. Preclinical model for intraventricular therapy in congestive heart failure Ayo Anise, Stephen Meier, Sonar Shah 3. Posterior cruciate ligament function evaluator Eric Bean, Kai Jar, Lampros Kourtis, and Choongsoo Shin 4. Procedural steps and Instrumentation for minimally invasive gastric bypass surgery Mark Bly, Jen Cho,and Jen Lake 5. Prevention of deep venous thrombosis Justin Blanco, Abha Chinubhai, and Eric Tao, and Jay Yin 6. 3D graphical model of knee loading Ravi Nataraj, Mahesh Hardikar, Dave Camarillo, Sharonda Felton

15. Thank You