Stanford University

Tom Andriacchi

Forum on Innovation and Entrepreneurship in Biomedical Engineering Education

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:

biomaterials medical devices

bioMEMS modeling/simulation

biomotion surgical robotics

biosensors, transducers minimally invasive techniques

design therapeutic delivery systems

Image guidance tissue repair & replacement

home

courses

events

faculty

research

contactbiodesign.stanford.edu

Three Courses Medical Device DesignThree Courses Medical Device Design1.1. Medical Device Design*Medical Device Design* ME 294ME 2942.2. Biodesign Innovation*Biodesign Innovation* Med 274/374A,BMed 274/374A,B3.3. Medical Device Design and EvaluationMedical Device Design and Evaluation ME 392A,BME 392A,B

*NCIIA funded*NCIIA funded

Three Courses Medical Device DesignThree Courses Medical Device Design1.1. Medical Device Design*Medical Device Design* ME 294ME 2942.2. Biodesign Innovation*Biodesign Innovation* Med 274/374A,BMed 274/374A,B3.3. Medical Device Design and EvaluationMedical Device Design and Evaluation ME 392A,BME 392A,B

*NCIIA funded*NCIIA funded

Relationship: Concepts and ProcessRelationship: Concepts and ProcessRelationship: Concepts and ProcessRelationship: Concepts and Process

Course Description

Courses are Project BasedProject teams 3 or 4 students

•Faculty Mentor

Course Description

Courses are Project Based •Project teams 3 or 4 students•Faculty Mentor

11. Medical Device Design (1 quarter). Medical Device Design (1 quarter) ME 294ME 294Introductory survey level Undergrad/graduate

• Individual “QuickStart” project• Team project

Physician supplied needsPhysician coached

11. Medical Device Design (1 quarter). Medical Device Design (1 quarter) ME 294ME 294Introductory survey level Undergrad/graduate

• Individual “QuickStart” project• Team project

Physician supplied needsPhysician coached

Novel methods•Design through prototyping•Hands-on, 3-D prototypes expected

Novel methods•Design through prototyping•Hands-on, 3-D prototypes expected

Course Description

Courses are Project Based •Project teams 3 or 4 students•Faculty Mentor

11. Medical Device Design (1 quarter). Medical Device Design (1 quarter) ME 294ME 294Introductory survey level Undergrad/graduate

• Individual “QuickStart” project• Team project

Physician supplied needsPhysician coached

11. Medical Device Design (1 quarter). Medical Device Design (1 quarter) ME 294ME 294Introductory survey level Undergrad/graduate

• Individual “QuickStart” project• Team project

Physician supplied needsPhysician coached

2.2. Biodesign Innovation (2 quarters)Biodesign Innovation (2 quarters) Med 274/374A,BMed 274/374A,B

• Graduate: Engineering, Business, Med. Law, BiosciencesGraduate: Engineering, Business, Med. Law, Biosciences

• 1st qtr: needs assessment, brainstorming, concept 1st qtr: needs assessment, brainstorming, concept development, regulatory, IPdevelopment, regulatory, IP

• 2nd qtr: financing, markets, business plans, ethics2nd qtr: financing, markets, business plans, ethics

• Device prototypeDevice prototype

2.2. Biodesign Innovation (2 quarters)Biodesign Innovation (2 quarters) Med 274/374A,BMed 274/374A,B

• Graduate: Engineering, Business, Med. Law, BiosciencesGraduate: Engineering, Business, Med. Law, Biosciences

• 1st qtr: needs assessment, brainstorming, concept 1st qtr: needs assessment, brainstorming, concept development, regulatory, IPdevelopment, regulatory, IP

• 2nd qtr: financing, markets, business plans, ethics2nd qtr: financing, markets, business plans, ethics

• Device prototypeDevice prototype

Novel MethodsNovel Methods•Teams include (Bioinnovation Fellows)Teams include (Bioinnovation Fellows)•““Innovator’s Workbench” interview series of renown InventorsInnovator’s Workbench” interview series of renown Inventors

Novel MethodsNovel Methods•Teams include (Bioinnovation Fellows)Teams include (Bioinnovation Fellows)•““Innovator’s Workbench” interview series of renown InventorsInnovator’s Workbench” interview series of renown Inventors

Course DescriptionCourses are Project Based

•Project teams 3 or 4 students•Faculty Mentor

11. Medical Device Design (1 quarter). Medical Device Design (1 quarter) ME 294ME 294Introductory survey level Undergrad/graduate• Individual “QuickStart” project

• Team projectPhysician supplied needs

Physician coached

11. Medical Device Design (1 quarter). Medical Device Design (1 quarter) ME 294ME 294Introductory survey level Undergrad/graduate• Individual “QuickStart” project

• Team projectPhysician supplied needs

Physician coachedNovel methodsNovel methods

Design through prototypingDesign through prototypingHands-on, 3-D prototypes Hands-on, 3-D prototypes

expectedexpected

2.2. Biodesign Innovation (2 quarters)Biodesign Innovation (2 quarters) Med 274/374A,BMed 274/374A,B

• Graduate: Engineering, Business, Med. Law, BiosciencesGraduate: Engineering, Business, Med. Law, Biosciences

• 1st qtr: needs assessment, brainstorming, concept 1st qtr: needs assessment, brainstorming, concept development, regulatory, IPdevelopment, regulatory, IP

• 2nd qtr: financing, markets, business plans, ethics2nd qtr: financing, markets, business plans, ethics

• Device prototypeDevice prototype

2.2. Biodesign Innovation (2 quarters)Biodesign Innovation (2 quarters) Med 274/374A,BMed 274/374A,B

• Graduate: Engineering, Business, Med. Law, BiosciencesGraduate: Engineering, Business, Med. Law, Biosciences

• 1st qtr: needs assessment, brainstorming, concept 1st qtr: needs assessment, brainstorming, concept development, regulatory, IPdevelopment, 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,B3. 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,B3. 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

How do you measure outcomes?

Final Design/Report (verbal/written)

Process and Content

Other factors• Communications

– Presentations

– Project Team Conferences

– Poster Presentation

• Peer Review

Stanford University

Grades

Medical/ClinicalProblems

Design Evaluation

MedicalDesignProcess

Design Principles

ScientificInformation

ProductDevelopment

ContentDomains

Medical/ClinicalProblems

CommunicationSkills

Engineering

Biology

Biomaterials

Anatomy

Physiology

including integrates

tosolve

Ethics

ProblemSolving

NeedsFinding

HumanFactors

Isenhanced

by

applies

Reliabilitytesting

FDARegulations

Biocompatibility

QualityControl

shouldbe

applied to

including

requires

mustconsider

Design

Evaluation Design

Evaluation

IndustryNeeds

ManufacturingResources

dependson

Entrepreneurship

may need

Intellectual Property

mustmeet

including

shouldconsider

MedicalEconomics

oftenconflicts

with

MedicalDesignProcess

Design Principles

Design Principles

ScientificInformation

ScientificInformation

ProductDevelopment

ProductDevelopment

requires

precedesPathology

Medical/ClinicalProblems

CommunicationSkills

Engineering

Biology

Biomaterials

Anatomy

Physiology

including integrates

tosolve

Ethics

ProblemSolving

NeedsFinding

HumanFactors

applies

Reliabilitytesting

FDARegulations

Biocompatibility

QualityControl

shouldbe

applied to

including

requires

mustconsider

Design

Evaluation Design

Evaluation

IndustryNeeds

ManufacturingResources

dependson

Entrepreneurship

may need

Intellectual Property

mustmeet

including

shouldconsider

MedicalEconomics

oftenconflicts

with

MedicalDesignProcess

Design Principles

Design Principles

ScientificInformation

ScientificInformation

ProductDevelopment

ProductDevelopment

requires

precedesPathology ProcessProcess

Medical/ClinicalProblems

CommunicationSkills

Engineering

Biology

Biomaterials

Anatomy

Physiology

including integrates

tosolve

Ethics

ProblemSolving

NeedsFinding

HumanFactors

Isenhanced

by

applies

Reliabilitytesting

FDARegulations

Biocompatibility

QualityControl

shouldbe

applied to

including

requires

mustconsider

Design

Evaluation Design

Evaluation

IndustryNeeds

ManufacturingResources

dependson

Entrepreneurship

may need

Intellectual Property

mustmeet

including

shouldconsider

MedicalEconomics

oftenconflicts

with

MedicalDesignProcess

Design Principles

Design Principles

ScientificInformation

ScientificInformation

ProductDevelopment

ProductDevelopment

requires

precedesPathology ContentContent

DepthDepthContentContentDepthDepth

Medical/ClinicalProblems

CommunicationSkills

Engineering

Biology

Biomaterials

Anatomy

Physiology

including integrates

tosolve

Ethics

ProblemSolving

NeedsFinding

HumanFactors

Isenhanced

by

applies

Reliabilitytesting

FDARegulations

Biocompatibility

QualityControl

shouldbe

applied to

including

requires

mustconsider

Design

Evaluation Design

Evaluation

IndustryNeeds

ManufacturingResources

dependson

Entrepreneurship

may need

Intellectual Property

mustmeet

including

shouldconsider

MedicalEconomics

oftenconflicts

with

MedicalDesignProcess

Design Principles

Design Principles

ScientificInformation

ScientificInformation

ProductDevelopment

ProductDevelopment

requires

precedesPathology

11. Medical Device Design . Medical Device Design 11. Medical Device Design . Medical Device Design

3. Medical Device Design/Evaluation3. Medical Device Design/Evaluation3. Medical Device Design/Evaluation3. Medical Device Design/Evaluation

2. Biodesign Innovation2. Biodesign Innovation2. Biodesign Innovation2. Biodesign Innovation

Articulated Laparoscopic Surgical Devices

Stanford University

Students:

Coach:

Kevin FineDavid MillerSven Newman

Dr. Mark Vierra

ME294

Example “best practices”

Example “best practices”2002

1. Interventional Aortic Repair SystemBeverly 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 thrombosisJustin Blanco, Abha Chinubhai, and Eric Tao, and Jay Yin

6. 3D graphical model of knee loadingRavi Nataraj, Mahesh Hardikar, Dave Camarillo, Sharonda Felton

National Design Awards

Thank You