Post on 17-Dec-2015
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