Bilal M. ShafiGeneral Surgery Resident, University of Pennsylvania

Biodesign Surgical Innovation Fellow, Stanford University

Training surgical innovators:Early experience with the Stanford

Surgical Innovation Program

biodesignSTANFORD

“The abdomen, the chest and the brain will forever be shut from the intrusion of the wise

and humane surgeon”

Sir John Eric EricksenSurgeon-Extraordinaire to Queen Victoria, 1837

biodesignSTANFORD

The Problem

• Technology is becoming more complex

• Physician views are narrowing– Specialization– “Treadmill” mentality

There is a “crisis” of physician / innovatorsThere is an increasing gap between technology

and clinician needs

biodesignSTANFORD

Stanford Biodesign - Mission

To develop leaders in biomedical technology innovation

Educate. Collaborate. Innovate.

biodesignSTANFORD

Innovation

“Innovation is not simply invention; it is inventiveness put to use.”

Innovation is a process and, as such, can be learned.

Harold Evans

biodesignSTANFORD

Biodesign Surgical Innovation Program

InnovationBusiness People

Clinicians

Engineers

BiodesignSIP

Next Generation of InnovatorsNew Medical Devices

biodesignSTANFORD

Team 2005 - 2007

Jessica Connor, MSMechanical Engineer

Gary Binyamin, PhDChemical Engineer

Gabriel Sanchez, MSMechanical Engineer

Bilal Shafi, MD, MSE Surgical resident

Biomedical Engineer

Carlos Mery, MD, MPH Surgical resident

Public Health

biodesignSTANFORD

Innovation Process

… 387 … > 200

Need

Need

Need

Need

Need

Need

Need

Need

Need

Need

Need

Concepts

Concepts

Concepts

Concepts

Concepts

Concepts

Concepts

Concepts

Concepts

Concepts

Concepts

Brainstorming

NeedsTop

NeedsTop

ConceptsConcepts

biodesignSTANFORD

Needs finding - Clinical immersion

biodesignSTANFORD

An abundance of needs…

biodesignSTANFORD

Need validation and specification

• Consult literature• Talk to experts• Detailed need specification

– Background info– Current solutions– Need statement– Design criteria

biodesignSTANFORD

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!

biodesignSTANFORD

Concept organization

biodesignSTANFORD

Concept selection

Risk

Rew

ard

biodesignSTANFORD

Prototyping

biodesignSTANFORD

Business / project planning

• Intellectual property / patents• Reimbursement• R&D strategy• Regulatory strategy• Funding• Business / project plan

biodesignSTANFORD

Intellectual Property

• OTL• Patentability• Freedom to operate

biodesignSTANFORD

Research & Development

• Bench testing– Efficacy

• Animal testing– Efficacy– Proof of Concept– Safety

biodesignSTANFORD

Funding

• Grants– National Collegiate Inventors and

Innovators Alliance (NCIIA)• Angel investors• Venture Capitalists

biodesignSTANFORD

Our “product”

Biodesign Innovation Fellows and Alumni – June, 2006

biodesignSTANFORD

“The best way to predict the future…

is to invent it.”

Alan KayXerox PARC