Arizona State UniversityTempe Main Campus

Harrington Bioengineering ProgramSchool of Biological & Health Systems Engineering

Team MembersUS: VP & BME/ASU & Community Mentors

GLOBAL: VP & Jan Snyder BME/ASU & External Mentors African Partners: Malawi, Kenya, Zambia, Uganda

SCHOOL OFBiological and HealthSystems Engineering

HARRINGTONBiomedical Engineering Program

ASU Bioengineering Program => Goal Now[BS, MS, PhD, PhD/JD]

Program/Courses/# ProjectsUndergraduate Program: Highly Qualified BME Graduates/Meet ABET

Enter MDDI, Grad & Professional Schools, GOV (FDA, USPTO)

Product Design & Development Courses- BME 100, 300, 417/490, 484 Design Spine-Product Design & Development Skill Sets

Capstone Projects: Real World Medical Device Product Development- Year Long Effort in Dedicated BME Design Center- MDDI Product Design & Development Best Practices [QSR]- Interdisciplinary & Multidisciplinary [Teams & Mentors]

- For Profit: Mostly Functional Prototypes - Non-Profit - Finished Devices (~25% of Total/Yr) Empowering Africans with Disabilities- ~50 since

2003

SCHOOL OFBiological and HealthSystems Engineering

HARRINGTONBiomedical Engineering Program

ASU Bioengineering Program => Five Year Vision[BS, MS /Prod Design/Certificates, PhD, PhD/JD/MD]

Program/Courses/# Projects & VenturesUG: Innovative & Entrepreneurial Globally Trained BME Graduates

More Entreprenurial Start Ups - Global Health Social VenturesProduct Design & Development UG/Grad Curricular

Retool UG: Flexible, Modular, Experiential Design Theory & PracticeEarly Culture of Innovation & Entrepreneurship Best Practices

Projects => More Ventures Via New 4+ 1 Master in Product D&DCertificates-Proj Mgmt, Regulatory Sciences, Entrepreneurship

Capstone Projects & Product Ventures- Bioengineering Global Health Product Development- Inter/Multi/TransdisciplinaryTeams & Mentors- For Profit: Functional Prototypes to Validated Medical Devices- Non-Profit: Sustainable Social Entrepreneurial Ventures

SCHOOL OFBiological and HealthSystems Engineering

HARRINGTONBiomedical Engineering Program

LEARNING OUTCOMESProficient in Real World Medical Device

Product Design and Development Using Best Industry Practices [QSR]

[Whether Regulated or Unregulated]

Meets All ABET Outcomes• an ability to design a component, device, system or process to meet desired needs• an ability to apply STEM principles to engineering product design and development• an ability to use techniques, skills, and modern engineering tools for BME practice • an ability to design and conduct tests and experiments, as well as, analyze and interpret

data.• an ability to function on multi-disciplinary design teams.• an ability to identify, formulate, and solve engineering design problems.• an understanding of professional and ethical responsibilities in engineering design.• an ability to communicate design activities effectively.• an ability to understand the impact of engineering design activities in a global & societal context • a knowledge of contemporary issues in the practice of biomedical engineering design

SCHOOL OFBiological and HealthSystems Engineering

HARRINGTONBiomedical Engineering Program

ACTIVITIES

Medical Device Product Design & Development Project Management PrototypingTeam Building Design of ExperimentsBrainstorming Engineering Economic

Analyses Quality Functional Deployment Cost EstimationIndustry Analyses / Technology Trends Design for Manufacturing FDA Regulatory Practices Fabrication TechniquesCase Studies Rapid PrototypingEthical Scenarios StandardsDesign Control Implementation DocumentationHuman Factors Design History File Patent Searches/ Intellectual Property Device Master RecordModeling and Simulation (SolidWorks) ForecastingFailure Mode Analyses/Product Business Plans Design Reviews FDA Product Submissions

SCHOOL OFBiological and HealthSystems Engineering

HARRINGTONBiomedical Engineering Program

School of Biological & Health Systems Engineering

i n g

State-of-the Art Biomedical Engineering

Design Studio & Resource Center

UserNeeds

Design Process

MedicalDevice

DesignOutput

DesignInput

Review

Verification

Validation

Best Industry

Practices

Develop a Culture for Innovation

PEOPLE

SCHOOL OFBiological and HealthSystems Engineering

HARRINGTONBiomedical Engineering Program

SWOT AnalysisStrengths

Medical Device Product Design & Development - Expertise & ResourcesResources- BME Design Center; New EPICS Program/Design LabASU Resources: TVC/Tech Transfer, Entrepreneurial Courses & FundingStrategic Fit with ASU: Innovation, Social Embeddedness, Global ImpactGlobal Health: Gained Experience => Low Resource Disability Sector

Weaknesses Many Gaps => Low Commercialization / Spin Out Record Social Entrepreneurship Supply Chain Business Model Development Social Entrepreneurship Network: ID Players & Logistics

Opportunities Many Capstone Projects with Market PotentialBioengineering Global Health Strategically Aligned - Grand ChallengesEvolving Funding/Resources Internal/External - Social Entrepreneurship

Threats Roadmap to Sustainable/Scalable Social Entrepreneurships Unclear

Diadility

SCHOOL OFBiological and HealthSystems Engineering

HARRINGTONBiomedical Engineering Program

HARRINGTONBiomedical Engineering Program

SCHOOL OFBiological and HealthSystems Engineering

Bioengineering World HealthEmpowering Africans With Disabilities

Ntchisi woman who suffered a disability from a childhood accident where she fell into a cooking fire.

Impact

HARRINGTONBiomedical Engineering Program

SCHOOL OFBiological and HealthSystems Engineering

Empowering Africans With Disabilities

IMPACT

ASU Commencement May 2009