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Navigating the Healthcare Innovation Cycle
John M. Collins, Ph.D. Chief Operating Officer, CIMIT
VI Annual Conference of the Biomedical Research Technology Platforms: Innovative Medicines Nanomedicine Health Technology and Biotechnology Markets Promoting Innovation in Health
20/03/2013 - 21/03/2013
Agenda…
2
1 Introduction to CIMIT
2 CIMIT’s Innovation Experiences & Priorities
3 The CIMIT Accelerator
CIMIT’s Mission …
by:
Facilitating collaboration between:
Clinicians, technologists, entrepreneurs & co’s
in:
Creating novel products, services and procedures
to:
Accelerate the healthcare innovation cycle
Improve patient care Page - 3
The CIMIT Consortium: a “living lab” for Open Innovation
1998
Page - 4
2000 2002 2004 2006 2008 2010 2012
A Center at
VA Boston
Other US Collaborators
Affiliates
Evidence that CIMIT works: Sample results from CIMIT’s “Clinical Impact Study” Scale of Investment:
• Over $67M funding for more than 860 projects • 600 of the projects cluster into130 “Packs”
Patient Impact: • Commercial: Over 3 dozen new companies/product lines • New Practices/Procedures/Improvements: Still counting
Publications and Patents: • Over 800 peer reviewed articles • Over 480 issued US patents, with over 320 applications pending
Enabled Funding: $
Each Dollar Invested in a
Portfolio of Projects (at least 2 yrs old)
$ $ $ >$3 to fund PIs Enables
$ $ $ $ $ $ >$9 of Comm. Invest. $ $ $ $ >$12 Total $ $ $ $ $ $ $ $ $ $ $
5
Innovation Experiences: The “Healthcare Innovation Cycle”
Page - 6
Actual Standard of Care
Challenges & Opportunities
Proof of Principle
Proof of Value
Products, Services & Procedures
Best Practices
Impact (Disseminate)
Insight & Ideas
Import Improve
Implement
Impact (Commercialize)
Enabling Technologies
Invent
Innovation: The process by which an unmet need is addressed by stimulating and then translating ideas and/or
inventions into sustainable products or
services.
Inform
Innovation Experiences: It is harder than it looks…
Image Reality An innovator starts on a challenging journey that:
• Requires many steps • Encounters many barriers • Needs to coordinate dispersed
expertise and capabilities • Overcomes misaligned “cultures”
A innovator has an idea that changes the world!
… then changes the world! Page - 7
Products, Services &
Procedures to Transform
Patient Care
“Technical”
“Commercial”
“Clinical”
Innovation requires building
sustainable relationships
Innovation Experiences: Creating and sustaining the needed collaborations does not happen naturally
Page - 8
Too Busy, Too Good,
Too Special
Missing Skills
Not Invented
Here, Never Knew No
Appreciation
Regulatory “Wall”, Published & Lost IP,
No IP “FTO”
Too Expensive
Resistance to Change
The Narrow “Expert”
Need: Help diverse teams
collaborate in navigating the
multiple innovation related processes to
accelerate and maximize impact
Innovation Experiences: What often really happens …
Actual Standard of Care
Challenges & Opportunities
Proof of Principle
Proof of Value
Products, Services & Procedures
Enabling Technologies
Best Practices
Lack of Awareness
Page - 9
1) Innovation Grants: Address unmet clinical needs by Finding, Funding & Facilitating ideas to Proof of Concept
2) Accelerator: Move promising ideas to commercial exit in 12-18 months
3) CoLab: Facilitate the
healthcare innovation cycle
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CIMIT’s functional priorities…
Actual Standard of Care
Challenges & Opportunities
Proof of Principle
Proof of Value
Products, Services & Procedures
Best Practices
Impact (Disseminate)
Insight & Ideas
Import Improve
Implement
Impact (Commercialize)
Enabling Technologies
Invent
Inform
CoLab: A cloud-based platform enabling institutions to encourage, manage and measure innovation.
Page - 11
Powered by: Secure, structured,
web-accessible information; links,
documents, ratings, decisions, etc.
Content
User configurable, codified workflows
for collaborative practices, like the
“CIMIT Model”.
Process Engine
Projects and activities organized
for reporting and management
oversight
Portfolios
Individuals and groups linked in
dynamically defined, collaborative roles
Content Communities
CoLab: Examples and growing list of users and networks
Existing applications … Needs and ideas solicitations Proposal process management Impact planning Project tracking & reporting Workgroups Under Development … Connector & funding finder Impact registry Best practice curator Procurement manager Regulatory master filer Intellectual Property manager
Thematic Networks
Boston Hub (CIMIT)
Kaiser Hubs
NSH Hub
Singapore Hub
Spain Hub?
CIMIT Innov. Grants
Accelerator Industry
DES
PAIR
EC
STAS
Y
The CIMIT Accelerator and the innovation journey …
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We have a fix
It works
It doesn't always
New costs are better
Time
Failures reported in the field
We need documen-tation???
Failures in field trial
It‘s too expensive
The investor hates the project
The investor wants how much?
We don't have enough resources
The market estimate was all wrong
No, he loves it!
We have an order!
We‘re behind schedule
We'll make it
Users like it Costs are better
Documentation is done!
We can make it reliably Regulatory approval!
We have enough
More orders!!!
I have an idea!
It works!
Someone else cares!
It's already patented
No, it isn‘t!
The field trial worked!
We have a problem
It was just an installation problem
Source: R. J. Saldich
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Funding & expertise to
drive to a successful exit
Licensable Technology Platforms & Businesses
• Accelerated Impact on Patient Care
• More Successful investigators
• Financial Return
• Increasing Flow of Ideas
Results
The CIMIT Accelerator: A group of seasoned executives working closely with investigators to accelerate impact
Innovative, clinically validated
ideas, 1- 1½ years from commercial
funding
Collaborative Impact Planning
Process
CIMIT Accelerator
The team “de-risks” projects at every step, redirecting and pausing as needed before reaching a “commercial exit”
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Integrated Accelerator Team • Technical/Clinical Team • Accelerator “Prime Mover” • Entire Accelerator Team
Angels/VCs Strategics Customers
Contract Engineering Sources
Non-Dilutive Funding Sources
Risk Capital Community
Entrepreneurial Community
Professional Advisors (IP,
regulatory, etc.)
Strategic Partners
Customers/ Users
Managing implementation risks …
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“ [T]here are known knowns; there are things we know that we know. There are known unknowns; that is to say there are things that, we now know we don't know. But there are also unknown unknowns; there are things we do not know we don't know” — United States Secretary of
Defense, Donald Rumsfeld
Level
Low
High
Risk - Elements Accelerator Risk Mitigation
Work with leading experts in the field(s) Find experts in related field(s) Integrate experience from people who have “been there”
Comfort
High
Low
CIMIT Accelerator Program… Objectives: Find, fund and facilitate projects that can have a commercial exit or
widespread military or clinical adoption within 12-18 months Attributes:
• Staffed by former CEO’s of med-tech companies – not academics – their experience, contacts, etc. are a key strength/advantage
• Each brings unique skills – and act as a team on all projects • Work closely with and complements the member institutions with extensive
business development, planning, and deal structuring, etc. • Treated as an investment, with the proceeds split based on simple formula
Approach: • Collaboratively develop an “Impact Plan” to assess and manage project • CIMIT invest cash for resources and people to “de-risk”
Benefits: • Increases probability of success for an innovation to impact patients • Helps “rising star” PI’s – they see impact from their work and even if they
don’t get selected, the process adds value to their work • Provides financial return to Stakeholders (institutions, Pis, investors)
Page - 17
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What is an Impact Plan?
Starting point for evaluation • Initially about 3 pages of “knowns”
Very much a “Living Document” • Starts sparsely populated (knowing what you don’t know is good!) • Evolves into a fundable business plan by end of project
Accelerator team (or equivalent) will likely need to help a lot • Find and synthesize input from experts in related fields • De-risks, explores unknown unknowns!
Contains: • Project Name
• Project Champion • Executive Summary • Problem Description • Solution Description • Contribution of Solution • Current/Competitive Solutions • Clinical Impact (# patients) • Current Patent Position
• Overview of other peoples patents • Market size and assumptions • Go-to-Market Strategy • Three customers we can talk to • Regulatory approvals required • Cost and Pricing of Solution • Tasks needed to reach exit • Estimates of development costs • Work plan by month
Elements of an Impact Plan (see www.cimit.org) 1. Summary: A brief layman’s description of the opportunity and unique
advantages of the proposed approach/group. (target <100 words) 2. Problem Description: A description of the scope and nature of problem,
or “job to be done.” Define the “customers” and the context in which they want the problem solved. Describe the criteria they use in selecting a solution and the implications of addressing the problem. (target <250 words)
3. Solution Description: Provide a description of the proposed solution. Keep it simple; this is the place to put one single figure if you have one. (target <250 words)
4. Contribution of Solution: Provide a list of the benefits offered by the proposed solution to customers. (target ~5 items)
5. Current/Competitive Solution to Problem/Unmet Need: List the competing approaches to address the “job-to-be-done.” Remember to consider the different ways in which customers can get the job done. Candidates can include products, services, or compensating behaviors — “work-arounds” that customers follow because no existing solution adequately gets the job done. (target 3 competing approaches, <200 words each) 19
Elements of an Impact Plan (see www.cimit.org) 6. Clinical Impact: Estimate the number of patients impacted annually and/or
the severity. 7. Project’s Current Patent and/or Know How Position: Describe the
status of the intellectual property (target <100 words). Also include a list of invention disclosures, patent applications, issued patents, papers (published and in process) as well as a unique proprietary “know-how.”
8. Patent Landscape: Give an overview of other people’s patents that may address the same customer and problem. Note any specific patents we need to examine closely. (target <250 words)
9. Market Size and Assumptions: List the major assumptions and resulting total market size estimate. (target <250 words)
10.Go-To-Market Strategy: Describe the approach to introduce the product to the market, generate revenues and what, if any, “exit” strategy exists. Describe any discussions that have taken place with potential partners or investors. (target <250 words)
11.Three Potential Customers: List at least three specific individuals (and contact details) that are representative of customers that are willing to be interviewed.
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Elements of an Impact Plan (see www.cimit.org) 12.Regulatory Approvals Required: List the regulatory approvals required
and any unique issues or feedback available to-date. 13. Initial Thoughts on Costs and Pricing: Provide an estimate of the cost to
deliver the solution (product and/or service) and pricing options in one or more business models (purchase, subscription, etc.).
14.Tasks Needed to Reach Exit: Outline the major tasks needed to reach the desired “exit,” defined as point at which financially motivated investors become involved.
15.Work Plan and Development Costs: Provide a month-by-month plan and associated estimate for development costs.
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This is how CIMIT evaluates the potential: The product of …
22
Criteria 3 2 1 0 PI’s Willingness
Worked with CIMIT staff before, excited by both project and CIMIT, buys-in to accelerator vision
Worked w/ CIMIT staff before, is relieved to go along with accelerator vision
Unknown PI or has to be convinced to work with accelerator
Doesn't buy-in to accelerator vision
Patient Impact
Over 10M patients across life of project, or something that is not now curable
Over 1M patients Over 100K patients Less than 10K patients with existing cure
Market Size* Over $1B Over $500M Over $20M Less than $10M
IP Position Patents issued Patents filed but pending
No or weak patents No freedom to operate
Competition No direct competitors Competitors exist, but minimal market penetration
Many or entrenched competitors
One dominant competitor who rejects the concept
Exit Strategy Licensee identified and agrees or NewCo team in place
Licensees or NewCos in discussions
No exit defined yet Exit requires more money than we have
Customer Validation
Three or more identified who are ready to buy
Identified but haven't indicated a willingness to buy yet
None identified
No customers
Customer ROI Less than 1 year
Between 1 and 3 years
Over 3 years
None
CIMIT Return >10x investment
>5x investment
>3x investment
<1x investment
Summary … Go change the world!
Innovation is a process that can be learned, but … • Expect the unexpected • Practice “Irrational persistence”
Get help from people who have taken the journey • The MedTech journey is different from others • Recognize that the skill mix changes as the journey
proceeds – but get diverse input early, don’t wait!
Be as proud of what you don’t know as what you know • Keep talking with customers/users – across the globe! • “Do only what only you can do” – get collaborators!
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