when digital meets medical: the next generation clinical trial

WHEN DIGITAL MEETS MEDICAL: THE NEXT GENERATION CLINICAL TRIAL Celine Pering

NOVEMBER 07, 2014MEDICAL DEVICE DESIGN CONFERENCE, IDSA

When Digital Meets Medical, IDSA Medical Device Design Conference November 07, 2014 2Twitter @ProteusDH

Small ingestible sensor

Sensor is embedded within your medication


Part of a multi touch-point system

PatientPatch

Your Medication

See Daily PatternsVia a Mobile Device

Patient

Doctor


A complex ecosystem of stakeholders


Cross-pollinating clinical research with consumer research can open up a whole new discipline ripe for exploration

CALL TO ACTION1

There is a new product paradigm occurring at the intersection of the medical and consumer worlds

Photo Credit: Google

Patients don’t know the line between unregulated and regulated apps

Photo Credit: Health Xchange

Yet these devices are trying to influence health behavior

Photo Credit. Todd Hamilton

These are two very different industries



Consumer Products Medical Devices


Self-directed purchase


Consumer Products

Prescribed

Medical Devices



Payor is the end user


Consumer Products

Prescribed

Payor is a separate stakeholder

Medical Devices




Straightforward path


Consumer Products

Prescribed


Interdependent ecosystem

Medical Devices





Lightning fast


Consumer Products

Prescribed



Slow moving

Medical Devices





Lightning fast

Partially regulated


Consumer Products

Prescribed



Slow moving

Heavily regulated

Medical Devices





Lightning fast

Partially regulated

Status symbol


Consumer Products

Prescribed



Slow moving

Heavily regulated

Stigmatizing symbol

Medical Devices

These industries also use very different research methodologies

A mature field based on a long history of drug development

Clinical research

Saving Lives Safety Checks and Balances Regulation Targeted Medicine

1740 1930 1940 1970 1990 2000 Future

Sailor ScurvyJames Lind

FDA FormedElixir Sulfanilamide

War CrimesNuremberg Trial

Pharma GrowthStronger Patents

Personalization Technology Advancement

Design problems are quickly becoming more complex

Product design


1740 1930

Physical, Singular Products Social Systems

1940 1970 1990 2000 Future

Genius DesignPhilip Stark






Industrial DesignHenry Dreyfuss

Design Thinkingd.school

Product DesignSmart Design

Social InnovationSocial Problems

Evolving at a fast pace while regulation is still being defined

Medical device regulation


1740 1930


1940 1970 1990 2000 Future











Medical Device ActDalkon Shield IUD

HF Requirements FDA Regulations

Regulatory Gray AreamHealth, today

Working at the cutting edge presents new opportunities

Today


1740 1930


1940 1970 1990 2000 Future











Medical Device ActDalkon Shield IUD

HF Requirements FDA Regulations

Regulatory Gray AreamHealth, today

CALL TO ACTION12 OPPOSITE ENDS OF THE SPECTRUM

Exploring the world, discovering nuanced differences and subtle similarities

Photo Credit: Jan Chipchase

Design research is experiencing itsWild West

Photo Credit: Jan Chipchase

In contrast, ethics committees assess compliance in clinical research

Photo Credit: Credit Willis Ryder Arnold

Interpreting written regulation is time intensive

Photo Credit: GoPixPic

Generative

Opposite ends of the spectrum

Design Research

Evaluative

Clinical Research

Generative

Empathetic


Design Research

Evaluative

Prescriptive

Clinical Research

Generative

Empathetic

Adaptive


Design Research

Evaluative

Prescriptive

Systematic

Clinical Research

Generative

Empathetic

Adaptive

Personal


Design Research

Evaluative

Prescriptive

Systematic

Double-blind

Clinical Research

Intersection presents a new opportunity

Design Research + Clinical Research = ?

CALL TO ACTION1

EXPLORATION AS A METAPHOR32 OPPOSITE ENDS OF THE SPECTRUM

We are charting new territory using skills from existing practices

Photo Credit: National Geographic


Boundaries12345

Principles

These 5 major principles enabled us to cross-pollinate best practices

Stretching

Collaboration

Umbrellas

Constraints

1Where do the boundaries exist when disciplines are mixed?

Can you take photos?

Can you know people’s names?

PRINCIPLES

Boundaries

Photo Credit: Christine Genius

2This work is not business as usual. This requires stretching past comfort zones all around and getting your extended team onboard.

PRINCIPLES

Stretching

3Sharing the study design across departments helps cross-pollinate ideas.

PRINCIPLES

Collaboration

4Strategic protocol umbrellas help provide wiggle room. By setting these up in advance, sub-studies are quicker to conduct and get faster IRB approval.

PRINCIPLES

Umbrellas

5Work within the constraints. There are ways to be creative even within restrictive bounds.

PRINCIPLES

Constraints

CALL TO ACTION1

EXPLORATION AS A METAPHOR3A NEW DISCIPLINE4

2 OPPOSITE ENDS OF THE SPECTRUM

A simplified design process

DesignFreeze

510K

Commercial Launch

ResearchDevelopment

EvidenceDevelopment

There is an opportunity to commingle methods before prod-ucts are put into the formal clinical process

Design Research Clinical Research

We have developed two new methods that enable the convergence of design and clinical research

Design Research Clinical Research

Methodology #2 “CLUE”

Methodology #1 “RCS”

“RCS” studies (Research for Component Selection)

An umbrella clinical protocol used for usability testing or engineering experimentation


QUESTIONS:

“RCS” Methodology:Research for Component Selection1What form factor stays on the body longest? What feels the most comfortable? How does the wear experience change over time?

CHALLENGE:

Anything that is stuck on the body needs IRB approval. There is no replacement for living human skin.


SAMPLE FINDINGS:

“RCS” Methodology:Exploring the effectiveness of different prototypes1

Wear time of prototype is 4 days compared to 7 days with the control.

The “banana slug” was the least favorite. Too rigid.

The more flexible form factor was preferred.


CONTEXTUALIZED:

“RCS” Methodology:Working with prototypes, quickly and cheaply 1

User Preference Testing

RCS

Clinical Research

ON THE BODY REAL USE R&D

“CLUE” studies (Clinical User Experience)

Allow design researchers to work directly with clinical trial participants, allowing us to quickly try out the market


QUESTIONS:

“CLUE” Methodology:Clinical User Experience2How does this “beta” product work in real, live use? Do people understand it “in the wild?” What is the vulnerable population’s experience using the product?

CHALLENGE:

This is very expensive research.


SAMPLE FINDINGS:

“CLUE” Methodology:Understanding emotions, attitudes and behaviors2

Frustration with the on- boarding experience

“Green light” provides re-assurance

Concern about discretion with a slinky black dress


SAMPLE FINDINGS:

“CLUE” Methodology:Mapping the emotional experience2

Emotional highs and lows


CONTEXTUALIZED:

“CLUE” Methodology:Gaining insight into real use while still in a clinical context 2

Ethnography

CLUE

Clinical Research

ON THE BODY REAL USE ATTITUDES & BEHAVIOR

R&D

CALL TO ACTION1

EXPLORATION AS A METAPHOR3A NEW DISCIPLINE4TAKEAWAYS5

2 OPPOSITE ENDS OF THE SPECTRUM

This is a form of integrating insight and evidence-building methods

Staying ahead of the curve by being nimble, yet structured

And thinking through the implications of our methods before problems occur

Seeing the opportunity in the ambiguity

Contact me: Interested in forming a workgroup to compare best practices? Celine Pering

Director, Human Factors and User [email protected]

Proteus Digital Health2600 Bridge Parkway, Suite 101Redwood City, CA 94065

Thank You!

Celine PeringDirector, Human Factors and User [email protected]

Proteus Digital Health2600 Bridge Parkway, Suite 101Redwood City, CA 94065

when digital meets medical: the next generation clinical trial

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clinical research

consumer worldsphoto

consumer research

health behaviorphoto

regulated appsphoto

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