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

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

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

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

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

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

biodesign STANFORD Team 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

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

biodesign STANFORD Needs finding - Clinical immersion

biodesign STANFORD An abundance of needs…

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

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!

biodesign STANFORD Concept organization

biodesign STANFORD Concept selection Risk Reward

biodesign STANFORD Prototyping

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

biodesign STANFORD Intellectual Property OTL Patentability Freedom to operate

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

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

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

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