biodesign innovation

© 2016 Stanford Byers Center for Biodesign

Biodesign Program:Training approach and outcomes

NAE 2018 Annual MeetingPaul Yock


The concept -- 2001

EDUCATION TRANSLATION

MED

TEC

H

Design Thinking

Entrepreneurship

Seed Funding

Mentoring, FacilitationO

ther

Ver

tical

s

Presenter

Presentation Notes

This approach isn’t new. It’s based on the same principles as design thinking, which advocates for starting with the user and building solutions to address what that user wants and needs most. Design thinking, which was popularized in the consumer products space, makes a lot of sense for products and technologies with a single end user.


Innovation training philosophy…

Technology-push

0Technology 0Need

Need Pull


Design thinking

empathize

define

ideate

prototype

testuser-centered


What if your “user”is the 8-headed monstercalled healthcare?

Salon.com

© 2016 Stanford Byers Center for Biodesign© 2016 Stanford Byers Center for Biodesign

To deal with this complexity…

“The Biodesign Process”


A well-characterized need is the DNA of a great invention!

Our mantra

Josh Makower

Todd Brinton Lyn Denend

Uday Kumar Jay Watkins Stefanos Zenios

Process & TrainingArchitects…


Biodesign fellow teams

Identify >200 needs

Presenter

Presentation Notes

Our fellows and students typically work in multidisciplinary teams that ideally include individuals with backgrounds in medicine, engineering, and business.


Need screening

Screen to the best few needs

Presenter

Presentation Notes

The next step in the process is all about becoming an expert in the needs that have been identified so that you can begin to determine which ones have the greatest chance of resulting in a solution that can reach patient care. The way this works is to let the needs “compete” against one another on a series of critical factors so that the ones that are the most risky or fraught with problems falls aide and the ones with the greatest potential rise to the top of the list.


Need statement

A way to solve a specific problem…

in a well-characterized population…

in order to achieve a measurable outcome


“A better way to detect potential rhythm disturbances

in non-hospitalized patients with suspected arrhythmias

to improve the patient experience and reduce the cost of diagnosis”

Need statement


NOW it’s time to invent!

“Given enough time, sugar and caffeine, you will invent something!”

Presenter

Presentation Notes

So after all of that work, which in the case of our fellows can take 3-4 months, it’s finally time to think about inventing! As we like to say, given enough time, sugar, and caffeine, our teams are sure to come up with great ideas.


Brainstorming the Zio patch…


Concept screening

Then filter down to the most promising ideas


Final phase: Implementation planning


Stanford Biodesign trainees

161Innovation Fellows

since 2001

1,700Stanford students

since 2001

111Global Fellows and Faculty since 2005

38Stanford Faculty

Fellows since 2012


Learning resources…

ebiodesign.org

Presenter

Presentation Notes

This is a very quick overview of a rather complicated process. For more information about what we teach, please check out the Bidoesign textbook and visit ebiodesign.org. Thank you.

© 2016 Stanford Byers Center for Biodesign 19

Stanford-India Biodesign


Singapore


Japan


Translational Outcomes

Kate Garrett (‘12)Founder, CEO, Ciel MedicalVP Airway Technologies, Vyaire Medical


Presenter

Presentation Notes

Background on Olin & Pathway; why I sought out Biodesign (access to clinical observation, learning early side of medical device innovation and how to identify problems to solve)


1NEJM 2014; 370:1198-2082Crit Care Med 2011; Vol. 39, No. 12

3Rello et al., CHEST 2002; 122:2115–21214Infect Control Hosp Epidemiol 2014;35(8):915-936

One of the most common ICU infections1, leading to:• 10% increased mortality2,4

• 6 extra days in the ICU• Broad spectrum antibiotics • Hospitals held accountable for the $40k treatment

cost

Ventilator Associated Pneumonia (VAP)

3.5M patients at risk for VAP annually in USA


Saliva build up

Aspiration

#1 cause of VAP is aspiration of secretions that are pooled above the endotracheal tube cuff.

Minimizing pooled secretions above the cuff has been shown in

13 randomized controlled studiesto reduce the risk of VAP by 55% and the average

ICU stay by 1.5 days.

I n f e c t i o n C o n t r o l a n d H o s p i t a l E p i d e m i o l o g y . A u g

2 0 1 4 , V o l 3 5 , N o . 8 .

Known Pathophysiology

Presenter

Presentation Notes

Impossible to get down there with a standard suction catheter


Catheter coils in mouth

Aspiration risk persists.


An improved endotracheal tube to reduce the risk of aspiration in ventilated patients

Need statement


BUT, only a small percentage of patients require long-term ventilation.

Broad upfront utilization of specialized ETTs is expensive.

Existing technologies are focused on one solution: specialized endotracheal tubes (ETT)


A way to reduce the risk of aspiration in long-term intubated patients that can be applied post-intubation.

An improved endotracheal tube to reduce the risk of aspiration in ventilated patients.

Need statement


Sherpa Suction SystemTM


Clinical Studies / Early Customer Adoption

R&D / Manufacturing FDA

Animal studies

30+ cadavers

Injection mold tooling

Commercial Launch

V&V

Biocompatibility

Sterility

Documentation

Product evaluations

Poster presentations

Value analysis assessments

Multi-center trials

Acquisition by Vyaire Medical

April 2017


The best measure of translational impact:

premiermhc.com; ahrq.gov; consultqd.clevelandclinic.org

Patients Reached!


Lymph/Axis

BRÜNSo Far…


Our “product”

BRYANT LINInternal Med, Stanford

VENITA CHANDRAClinical Associate Professor

Vascular Surgery

ROSS VENOOKLecturer,

Bioengineering

TODD BRINTONClinical Professor,

Cardiovascular Medicine

RYAN VAN WERTClinical Assistant Professor

Pulmonology

DAN AZAGURYAssistant Professor,

Surgery

DAVID CAMARILLOAssistant Professor,

Bioengineering

SID SINHAAssistant Professor,

Gastrointestinal Medicine

JAMES WALLAssistant Professor,

Surgery

Biodesign fellow alums now on Stanford faculty

JANENE FUERCHClinical Assistant Professor,

Neonatology

Bryant LinClinical Assistant Professor,

Medicine


DukeNandan Lad

Cornell Akhilesh Sista

OregonJonathan Steinberger

MinnesotaMarie Johnson

NorthwesternS Gnanashanmugam

UC San DiegoGarrett Smith

Cleveland ClinicShubhayu Basu

Alums who have started & lednew Biodesign-like programs

Alumni pool includes 30 current start-up CEO’s…


Challengesahead…


• new technology is driving healthcare expense!

• diminished venture funding

• weak pipeline of technologies for patient care

A perfect storm for medtechinnovation…


Value-Based Innovation

Can we develop a discipline of inventing biomedical technologies with a focus on maximizing value (health benefit:cost?)


Adjusting the process…

Value Proposition


Adjusting the process…

Value exploration!


Practice-Based value signposts

Shorten length of hospital stay

Change to less expensive venue

Lower number of staff

Reduce procedure time or resource use

Shift intervention to lower cost provider


patient withpalpitations

internist

cardiologist

electrophysiologist

Holter

The economic need


Saving $620 perAF patient per year


Challenges, continued

Team dynamics…including diversity issues


The Biodesign “Shrink”Doug Rait, PhDDirector, Team Learning & Design

Team dynamics


Mix of engineers and physicians

• Different perceptions of risk (medical, technical)

• Different approaches to decision making

• Stress is compounded by flat team structure


Mix of academic and industry culture

• Learning a process… or inventing a product?

• Exploring openly… or delivering on milestones?

• Sharing discoveries… or protecting I.P.?


Gender-based issues

22% of fellows experienced (and 41% observed) problematic workplace issues – largely gender based—during the year.

Anonymous survey of alumni fellows, 2017:

Biodesign Diversity Task ForceKate Garrett, Chair


The opportunity for Biodesign…


2018-19 Innovation fellows


Questions…comments?

biodesign innovation

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