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Training surgical innovators: Early experience with the Stanford Surgical Innovation Program Bilal M. Shafi General Surgery Resident, University of Pennsylvania Biodesign Surgical Innovation Fellow, Stanford University “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 STANFORD biodesign 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 STANFORD biodesign Stanford Biodesign - Mission To develop leaders in biomedical technology innovation Educate. Collaborate. Innovate. STANFORD biodesign Innovation Innovation is a process and, as such, can be learned. “Innovation is not simply invention; it is inventiveness put to use.” Harold Evans STANFORD biodesign Biodesign Surgical Innovation Program Biodesign SIP Innovation Next Generation of Innovators New Medical Devices STANFORD biodesign Team 2005 - 2007 Jessica Connor, MS Gary Binyamin, PhD Gabriel Sanchez, MS Mechanical Engineer Chemical Engineer Mechanical Engineer Bilal Shafi, MD, MSE Carlos Mery, MD, MPH Surgical resident Biomedical Engineer Surgical resident Public Health STANFORD biodesign Innovation Process Needs Top Needs Concepts Need Concepts Need Concepts Need Need Need Need Need Need Need Concepts Brainstorming Top Concepts Concepts Concepts Concepts Concepts Concepts Need Concepts Need Concepts … 387 … > 200 Concepts STANFORD biodesign Needs finding - Clinical immersion STANFORD biodesign An abundance of needs… STANFORD biodesign Need validation and specification • Consult literature • Talk to experts • Detailed need specification – Background info – Current solutions – Need statement – Design criteria STANFORD biodesign 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! STANFORD biodesign Concept organization STANFORD biodesign Reward Concept selection Risk STANFORD biodesign Prototyping STANFORD biodesign Business / project planning • • • • • • Intellectual property / patents Reimbursement R&D strategy Regulatory strategy Funding Business / project plan STANFORD biodesign Intellectual Property • OTL • Patentability • Freedom to operate STANFORD biodesign Research & Development • Bench testing – Efficacy • Animal testing – Efficacy – Proof of Concept – Safety STANFORD biodesign Funding • Grants – National Collegiate Inventors and Innovators Alliance (NCIIA) • Angel investors • Venture Capitalists STANFORD biodesign Our “product” Biodesign Innovation Fellows and Alumni – June, 2006 STANFORD biodesign “The best way to predict the future… is to invent it.” Alan Kay Xerox PARC STANFORD biodesign