BIODESIGN UPDATE
John Linehan
June 4, 2015
Mission Statement
Train the next generation of leaders
in medical technology innovation
EDUCATE COLLABORATE INNOVATE
Heading into year 15…
needs invent
med tech patent
license collaborate
cost effective
surgical innovation
license Stanford
FDA discovery
technology transfer
ethics & policy prototype reimbursement
specialty innovation teamwork outcomes
Biodesign Fellow teams 2014-15
Red Team
WhiteTeam
SpecialtyTeam
Biodesign fellow alums…
BRÜN
CAYDIAN CAYDIAN Lymph/Axis
DAN AZAGURY Assistant Professor, Surgery TODD BRINTON Associate Professor, Cardiovascular Medicine DAVID CAMARILLO Assistant Professor, Bioengineering VENITA CHANDRA Clinical Assistant Professor Vascular Surgery BIODESIGN FELLOWS now on Stanford Faculty
BRYANT LIN Internal Med, Stanford SID SINHA Clinical Instructor, GastrointesJnal Medicine RYAN VAN WERT Clinical Instructor Pulmonology JAMES WALL Assistant Professor, Surgery ROSS VENOOK Lecturer, Bioengineering UDAY KUMAR Founder, iRhythm CEO, Element Science NISH CHASMAWALA Founder & CEO, Consure MARIE JOHNSON Founder & CEO, AUM Cardiovascular FLETCHER WILSON Founder & CEO, Intervene KEN MARTIN CEO, Cibiem BIODESIGN FELLOW CEOs (selected)
BRIAN FAHEY Founder & CEO, Niveus MICHAEL ACKERMANN Founder & CEO, Oculeve MATTHEW CALLAHAN Founder & CEO, LymphAxis VICTOR MCCRAY Founder & CEO, Ocular Dynamics KATE GARRETT Founder & CEO, Ciel Medical Biodesign Faculty Fellows, 2015 Robson Capasso Clinical Assistant Professor, Otolaryngology Member, Stanford Center for Sleep Sciences and Medicine Peter Li Clinical Assistant Professor, Otolaryngology Mintu Turakhia Markus Covert Associate Professor, Bioengineering Cindy Kin Assistant Professor, Surgery (Colon and Rectal Surgery) Assistant Professor of Medicine (Cardiovascular Division) Health Research and Policy, PA Veterans Affairs (courtesy) Shreyas Vasanawala Associate Professor of Radiology (Pediatric Radiology) Curriculum Development
2nd edition text– Feb ‘15
Companion Website
200+ Videos
For More Information…
Videos “on demand”
•  Video discussing team building:
http://ebiodesign.org/video/teamdevelopment/#mpf-popup@//
www.youtube.com/watch?v=lcJSD7j1mKI||
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Biodesign Courses
•  Biodesign Innovation.
This two-quarter
course provides students with skills essential for
the development of new biomedical technologies
and enables them to take the critical first steps in
invention, patenting, early prototyping and
development of new concepts. Includes an
introduction to brainstorming development
processes and business strategies.
Biodesign Courses
•  Global Biodesign. This course provides
an overview of medical technology development
in regions such as Europe, East Asia and South
Asia.
Biodesign Courses
•  Technology Assessment and
Regulation of Medical Devices.
Regulatory approval and reimbursement for new
medical technologies as a key component of product
commercialization. The regulatory and payer
environment in the U.S. and abroad, and common
methods of health technology assessment.
Framework to identify factors relevant to adoption of
new medical devices, and the management of those
factors in the design and development phases. Case
studies; guest speakers from government (FDA) and
industry
Biodesign Courses
•  Biodesign for Mobile Health. T
This seminar examines the emerging Mobile Health
industry. Innovations in this area promise
solutions to the need for universal access to
affordable and effective health care by enabling
consumers to take charge of their health, creating
affordable ways to manage aging and chronic
conditions, moving care from the hospital into the
home, improving treatment options by providing
transparency of measurable clinical outcomes,
and shifting the focus from “sick care” to “health
improvement” and prevention.
Biodesign
Innovation
Fellowships
Taking
Stock
Summer, Fall 2014
•  Interviews and focus groups with
fellow and student alums
•  Discussions with industry leaders
•  Faculty/staff subcommittees on
fellowship, global, academic priorities
Biodesign
Innovation Fellowships
Assessment
•  Biodesign serves an ongoing need-plan for sustainability
•  Renew focus on Stanford fellows and
students (and faculty)
•  Significant adjustments needed for
new healthcare environment
Biodesign 2020+
3 areas of focus:
•  The new economics of health
technology innovation
•  Enabling health care outside of the
hospital
•  Technology innovation to address
global health needs & markets
The new economics of health
technology innovation
•  In the US, changes in the healthcare
ecosystem are definitely considerations for
new products.
•  The cost of care relative to its quality is
now a primary consideration in driving the
evaluation of a business.
The new economics of health
technology innovation
•  In the biodesign fellowship program, we
are pushing the concept, within today‘s
value-oriented environment, that products
that significantly– not incrementally–
generate measurable savings while
providing acceptable (or better) quality will
be the ones with the clearest path forward.
Global Outlook
PWC Medical Technology
Innovation Scorecard
January 2011
“In 2015, do you believe that the
attractiveness of the
commercialization opportunity [in
medtech] will become much
worse, worse, same, better or
much better?”
No mountain is insurmountable
when you have the right approach