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

2. stanford university b i o d e s i g n 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: biomaterialsmedical devices bioMEMSmodeling/simulation biomotionsurgical robotics biosensors, transducersminimally invasive techniques designtherapeutic delivery systems Image guidancetissue repair & replacement home courses events faculty research contact biodesign.stanford.edu Three Courses Medical Device Design 1.Medical Device Design*ME 294 2.Biodesign Innovation*Med 274/374A,B 3.Medical Device Design and EvaluationME 392A,B *NCIIA funded Three Courses Medical Device Design 1.Medical Device Design*ME 294 2.Biodesign Innovation*Med 274/374A,B 3.Medical Device Design and EvaluationME 392A,B *NCIIA funded Relationship: Concepts and Process

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

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

5. Course Description Courses are Project Based Project teams 3 or 4 students Faculty Mentor 1. Medical Device Design (1 quarter)ME 294 Introductory survey level Undergrad/graduate Individual “QuickStart” project Team project Physician supplied needs Physician coached 1. Medical Device Design (1 quarter)ME 294 Introductory survey level Undergrad/graduate Individual “QuickStart” project Team project Physician supplied needs Physician coached 2. Biodesign Innovation (2 quarters)Med 274/374A,B Graduate: Engineering, Business, Med. Law, BiosciencesGraduate: Engineering, Business, Med. Law, Biosciences 1st qtr: needs assessment, brainstorming, concept development, regulatory, IP1st qtr: needs assessment, brainstorming, concept development, regulatory, IP 2nd qtr: financing, markets, business plans, ethics2nd qtr: financing, markets, business plans, ethics Device prototypeDevice prototype 2. Biodesign Innovation (2 quarters)Med 274/374A,B Graduate: Engineering, Business, Med. Law, BiosciencesGraduate: Engineering, Business, Med. Law, Biosciences 1st qtr: needs assessment, brainstorming, concept development, regulatory, IP1st qtr: needs assessment, brainstorming, concept development, regulatory, IP 2nd qtr: financing, markets, business plans, ethics2nd qtr: financing, markets, business plans, ethics Device prototypeDevice prototype Novel Methods Teams include (Bioinnovation Fellows)Teams include (Bioinnovation Fellows) “Innovator’s Workbench” interview series of renown Inventors“Innovator’s Workbench” interview series of renown Inventors Novel Methods Teams include (Bioinnovation Fellows)Teams include (Bioinnovation Fellows) “Innovator’s Workbench” interview series of renown Inventors“Innovator’s Workbench” interview series of renown Inventors

6. Course Description Courses are Project Based Project teams 3 or 4 students Faculty Mentor 1. Medical Device Design (1 quarter)ME 294 Introductory survey level Undergrad/graduate Individual “QuickStart” project Team project Physician supplied needs Physician coached 1. Medical Device Design (1 quarter)ME 294 Introductory survey level Undergrad/graduate Individual “QuickStart” project Team project Physician supplied needs Physician coached Novel methods Design through prototyping Hands-on, 3-D prototypes expected 2. Biodesign Innovation (2 quarters)Med 274/374A,B Graduate: Engineering, Business, Med. Law, BiosciencesGraduate: Engineering, Business, Med. Law, Biosciences 1st qtr: needs assessment, brainstorming, concept development, regulatory, IP1st qtr: needs assessment, brainstorming, concept development, regulatory, IP 2nd qtr: financing, markets, business plans, ethics2nd qtr: financing, markets, business plans, ethics Device prototypeDevice prototype 2. Biodesign Innovation (2 quarters)Med 274/374A,B Graduate: Engineering, Business, Med. Law, BiosciencesGraduate: Engineering, Business, Med. Law, Biosciences 1st qtr: needs assessment, brainstorming, concept development, regulatory, IP1st qtr: needs assessment, brainstorming, concept development, regulatory, IP 2nd qtr: financing, markets, business plans, ethics2nd qtr: financing, markets, business plans, ethics Device prototypeDevice prototype 3. Medical Device Design/Evaluation (2 quarters) E 382A,B Graduate Level Engineering Real World Projects Company Sponsored Single project for 2 quarters 3. Medical Device Design/Evaluation (2 quarters) E 382A,B Graduate Level Engineering Real World Projects Company Sponsored Single project for 2 quarters Total of 6 quarters Fellowship Program Novel Methods Class Organized as company Form Executive Committees – IP, Regulatory, Reliability, Tech Resources, Proj Manage, Design Review Novel Methods Class Organized as company Form Executive Committees – IP, Regulatory, Reliability, Tech Resources, Proj Manage, Design Review

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

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

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

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

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

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

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

14. 2002 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 National Design Awards

15. Thank You