1. Bilal M. Shafi General Surgery Resident, University of Pennsylvania Biodesign Surgical Innovation Fellow, Stanford University Training surgical innovators: Early experience with the Stanford Surgical Innovation Program

2. biodesign STANFORD “The abdomen, the chest and the brain will forever be shut from the intrusion of the wise and humane surgeon” Sir John Eric Ericksen Surgeon-Extraordinaire to Queen Victoria, 1837

3. biodesign STANFORD The Problem Technology is becoming more complex Physician views are narrowing –Specialization –“Treadmill” mentality There is a “crisis” of physician / innovators There is an increasing gap between technology and clinician needs

4. biodesign STANFORD Stanford Biodesign - Mission To develop leaders in biomedical technology innovation Educate. Collaborate. Innovate.

5. biodesign STANFORD Innovation “Innovation is not simply invention; it is inventiveness put to use.” Innovation is a process and, as such, can be learned. Harold Evans

6. biodesign STANFORD Biodesign Surgical Innovation Program Innovation Business People Clinicians Engineers Biodesign SIP Next Generation of Innovators New Medical Devices

7. biodesign STANFORD Team 2005 - 2007 Jessica Connor, MS Mechanical Engineer Gary Binyamin, PhD Chemical Engineer Gabriel Sanchez, MS Mechanical Engineer Bilal Shafi, MD, MSE Surgical resident Biomedical Engineer Carlos Mery, MD, MPH Surgical resident Public Health

8. biodesign STANFORD Innovation Process … 387 … > 200 Need Concepts Brainstorming Needs Top Needs Top Concepts

9. biodesign STANFORD Needs finding - Clinical immersion

10. biodesign STANFORD An abundance of needs…

11. biodesign STANFORD Need validation and specification Consult literature Talk to experts Detailed need specification –Background info –Current solutions –Need statement –Design criteria

12. biodesign STANFORD Brainstorming Defer judgment Encourage wild ideas Build on the ideas of others Stay focused One conversation at a time Be visual Go for quantity Have fun!

13. biodesign STANFORD Concept organization

14. biodesign STANFORD Concept selection Risk Reward

15. biodesign STANFORD Prototyping

16. biodesign STANFORD Business / project planning Intellectual property / patents Reimbursement R&D strategy Regulatory strategy Funding Business / project plan

17. biodesign STANFORD Intellectual Property OTL Patentability Freedom to operate

18. biodesign STANFORD Research & Development Bench testing –Efficacy Animal testing –Efficacy –Proof of Concept –Safety

19. biodesign STANFORD Funding Grants –National Collegiate Inventors and Innovators Alliance (NCIIA) Angel investors Venture Capitalists

20. biodesign STANFORD Our “product” Biodesign Innovation Fellows and Alumni – June, 2006

21. biodesign STANFORD “The best way to predict the future… is to invent it.” Alan Kay Xerox PARC