CRAASH Out of the Lab to Improve Healthcare
February 14, 2018

CIMIT’s Mission:
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by:
Facilitating collaboration
among:
Clinicians, technologists,
entrepreneurs & Co’s
in:
Creating novel HealthTech
products, services and
enabled procedures
to:
Accelerate the healthcare
innovation cycle
Improve patient care

Codifying Experience: The Healthcare Innovation Cycle
Innovation:
The process by which an
unmet need is addressed
by stimulating and then
translating ideas and/or
technologiesinto
sustainable products or
services.
Idea
Proof of
Concept
Proof of
Feasibility
Proof of
Value
Initial
Clinical
Trials
Validation
of Solution
Approval
& Launch
Clinical
Use
Standard
of
Care
Clinical
Need
Basic
Science
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Innovation Experiences:
Image Reality
An innovator starts on a
challenging journey that:
• They are often not prepared for
• Requires many risky steps
• Presents frustrating barriers
• Needs a wide range of expertise and
capabilities
A innovator has an idea that
changes the world!
… then changes the world! Page - 4
It is harder than it looks…

What often really happens …
Inexperienced
teams often make
avoidable mistakes
that doom, derail or
stall promising
innovations
Too
Complicated
Inexperienced
Team
Published
&
Lost IP
Too
Expensive
Resistance
to Change
Lack of
Awareness
Too Good,
Too Special
Does not fit
Workflow
Regulatory
“Wall”
No IP
“Freedom to
Operate”
No Advocates,
“Lead Users”
Idea
Proof of
Concept
Proof of
Feasibility
Proof of
Value
Initial
Clinical
Trials
Validation
of Solution
Approval
& Launch
Clinical
Use
Standard
of
Care
Clinical
Need
Wrong Data Page - 5

CIMIT facilitates the process helping navigate milestones and key domains…
Idea
Proof of
Concept
Proof of
Feasibility`
Proof of
Value
Initial
Clinical
Trials
Validation
of Solution
Approval
& Launch
Clinical
Use
Standard
of
Care
Clinical
Need
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 Follow a
sequence of
milestones
 Complete
deliverables at
each milestone
in four key
domains
 Use best
practices to
complete each
deliverable
Key Concepts:
 Most healthcare
innovators know
medicine and tech
 “Learn by trying”
innovation is
inefficient in
Healthcare
 Instead:
• “Learn by
doing it right”!
• By a guide
who knows the
journey
Key Concepts:

Follow
To study and improve the outcomes as well as the process
Find
The CIMIT Model to improve translational research …
Fund
Facilitate
 “Follow” first implemented in 2010 Clinical Impact Study (CIS):
• Self-study of all projects supported since CIMIT’s founding in 1998
• Have repeated the study several times since
• Shows significant results in clinical, academic and commercial dimensions and extracted
several key take-away’s/lessons learned Page - 7

One metric of success: 78 solutions* commercialized with more than 85%
still in business or acquired
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Relationship/Company Type Status
Product in Market?
*Note: Represents 1/3rd of solutions,
from >600 projects CIMIT supported
that addressed >230 Solutions

Key lessons learned from CIS:
Innovation in healthcare is a learnable, teachable process that – like any
other – should be quantified and measured to improve
Most academic investigators have no training in innovation and “learning
by trying” is a very inefficient way to learn in healthcare
Actively facilitating teams (pre- and post-funding) with experts in the
process:
• Improves commercialization success rates and speed
• Provides efficient “learning by doing it right” for team members
However:
While good facilitation is very cost effective overall, it is expensive and
hard to scale … CRAASH was developed to add scale Page - 9

CRAASH: Commercialization Readiness Assessment and Accelerator for
Solutions in Healthcare
 Based on CIMIT’s 20+ year’s of experience & NSF/NIH iCorps basics
 For teams that…
• Have a technology at or past the “Proof of Concept” stage
• Are interested in solving a problem – not doing more research
• Keep their day-jobs while putting in the time for interviews and assignments
 Assumes the technology “works” and focuses on:
• Who your customers are, and what they want, need, and value
– Users
– Economic buyers, etc.
• If and how a sustainable business can be built around a solution
• Why your next funder will make an investment in you Page - 10

CRAASH helps teams think differently to climb the “Investment Staircase”
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Not all good technologies
make good products
• Need?
• Cost?
• Value?
Not all good productsmake
good businesses:
• Profit?
• Scale?
• Protection?
Not all good businesses make
good investments:
• Cash needed?
• Time to exit?
Science/
Technology
Product
Business
Investment
?
?
?
Funding for:
• Novelty
• Quality
Idea/
Hypothesis
Innovator
Investor
Different
Perspectives

CRAASH helps teams think like an investor to survive the “Valley of Death”…
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PrivateFunding
~100%
PublicFunding
~100%
Basic
Research
Translational
Research
Start-up
Companies
Growth Stage
Companies
“Valley of Death”
Where the Basis
of Funding
Decisions
Change … and
getting
bigger /
tougher to
survive:
Be Prepared!

… which is even harder in Healthcare than most industries:
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Challenge Healthcare
Regulatory Pathway
Which pathway to show “innovation”
is safe and equivalent or better?
Objective standards
Culture No mistakes, do as trained. Give it a try
Funding
Requirements
$10Ms to $100Ms $100Ks to single digit $Ms
Buying Dynamics
Who makes the decision and how is
it made in this institution?
User is the buyer
Reimbursement
Complexity
Who pays how much for what and
who benefits?
User pays what it he/she feels it is
worth
Most Industries

CRAASH: Approach
Faculty:
 Experienced MedTech entrepreneurs (Boston and Europe based)
 Work one-on-one with teams each week (assignment based on expertise)
 Act as a “board” in providing feedback to team presentations each week
Content:
 Curated content
 Available on secure website (CoLab, a secure team collaboration site)
Teams:
 Read/review content each week
 Interview stakeholders (>100 over program, with as many in person as possible)
 Develop and present materials each week to three other teams and Executives
 Participate in content session to prepare for next week
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Selection criteria …
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Problem/Need
The proposed
HealthTech
solution is ranked
on the importance
of the need
addressed - a mix
of severity and
number of people
impacted.
Maturity/
Readiness
The prior work is
of high quality and
demonstrates that
the proposed
solution is at or
beyond “Proof of
Concept” stage
Pathway to
Impact
Assuming the
solution works as
intended, the
project has a
probable pathway
(regulatory,
reimbursement,
switching cost,
etc.) to reach
patient care in
under 3 to 5
years.
Team/
Resources
The team has, or
has access to, the
right mix, quality
of skills at the
project’s maturity
level and has a
clear interest in
commercialization.
Endorsement
The team has
support from the
institution that
controls the IP to
participate (applies
if the IP is held by
an institution such
as university,
hospital, etc., and
not a company).

CRAASH works …
 Trajectory:~1/3rd of teams …
• Find they do not have a viable product or business
• Make a substantial “pivot”, defining a new path to market/minimal viable
product (MVP)
• Accelerate the path they were on
 Funding:
• Of the 2/3rd that decide to move forward, almost all get funding (beyond any
CIMIT funding)
• On average, they get ~$1M in funding within a year
 Learning:
• Often few team members have any business experience
• All report that the time was a valuable learning experience
• They also have resource/network to ask for help Page - 16

Thank You
Questions?
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Contact: John Collins
Chief Operating Officer
JCOLLINS11@MGH.HARVARD.ORG