The document serves as a guide for entrepreneurs seeking to partner with healthcare providers, derived from insights gained through interviews with various stakeholders in the healthcare space. It outlines the challenges and strategies for startups to effectively conduct pilot programs that validate their digital health innovations, emphasizing the importance of aligning goals and understanding the healthcare ecosystem's complexities. As a living document, it encourages ongoing contributions to improve the guidance provided for future partnerships.

1. A R O C K R E P O R T B Y
THE ENTREPRENEUR’S GUIDE !
TO HOSPITAL PARTNERSHIPS
A R O C K R E P O R T B Y

2. This document should serve as a guide for entrepreneurs as they navigate partnering with health
care providers. This first draft was compiled after 22 interviews with entrepreneurs, hospital
administrators, investors, lawyers, clinicians and researchers. This is a living document, intended
to grow and improve with your input.
Authors:
• Sasha Buscho, Harvard MPH
• Christina Chang, Harvard MBA
• Aenor Sawyer, MD, UCSF Clinician
Editor
• Halle Tecco, Rock Health CEO
• Malay Gandhi, Rock Health Mentor-in-Residence
• Adam Dole, Mayo Clinic
About this Guide
ROCK HEALTH is powering the future of the digital health ecosystem, bringing together the
brightest minds across disciplines to build better solutions. Rock Health funds and
supports startups building the next generation of technologies transforming healthcare.
ROCK HEALTH partners include Alexandria Real Estate Equities, Boehringer Ingelheim,
Fenwick & West, GE, Genentech, Harvard Medical School, Kaiser Permanente, Kleiner
Perkins Caufield & Byers, Mayo Clinic, Mohr Davidow Ventures, Montreux Equity Partners,
NEA, Ogilvy Public Relations, Qualcomm Life and UCSF.
LEARN MORE AT rockhealth.com

3. How can startups and health
care providers partner more
effectively to pilot and
commercialize digital health
innovations?
A R O C K R E P O R T B Y

4. BACKGROUND
Scope of Guidelines
The goal of the pilot is two fold:
validation and progression to full-
scale commercialization
The digital healthcare pilot is defined
as a product implementation trial with
end-users / potential customers
Definition
Goal
A R O C K R E P O R T B Y

5. KEY CHALLENGES
Divergent Risk Profiles
Health care providers have many priorities
including health outcomes, patient safety
and security and best practices research.
Startups prioritize new practices, adoption
and growth
A R O C K R E P O R T B Y

6. KEY CHALLENGES
Divergent Risk Profiles
Differing Motivations
Health care providers have many priorities
including health outcomes, patient safety
and security and best practices research.
Startups prioritize new practices, adoption
and growth
Some “motivators” for provider
participation, including shared intellectual
property, equity, and key metrics, may not
align with startup goals
A R O C K R E P O R T B Y

7. KEY CHALLENGES
Divergent Risk Profiles
Differing Motivations
Distinct Cultures
Startups and providers have significant
differences in availability, team size,
decision-making dynamics, and overall
timelines
Health care providers have many priorities
including health outcomes, patient safety
and security and best practices research.
Startups prioritize new practices, adoption
and growth
Some “motivators” for provider
participation, including shared intellectual
property, equity, and key metrics, may not
align with startup goals
A R O C K R E P O R T B Y

8. KEY CHALLENGES
Divergent Risk Profiles
Differing Motivations
Some “motivators” for provider
participation, including shared intellectual
property, equity, and key metrics, may not
align with startup goals
Distinct Cultures
Startups and providers have significant
differences in availability, team size,
decision-making dynamics, and overall
timelines
Complex Regulations
Institutions enforce a multitude of
regulations, both internal (e.g. IRB) and
external (e.g. FDA), which are difficult to
interpret without internal champions
Health care providers have many priorities
including health outcomes, patient safety
and security and best practices research.
Startups prioritize new practices, adoption
and growth
A R O C K R E P O R T B Y

9. Deployment Strategy: Pushing a product or service to
the patient for testing is different than getting hospitals
or clinicians to adopt and distribute technologies
themselves
KEY CONSIDERATION:
Consumer-Facing VS. Enterprise Solutions
Purpose: Pilots for B2B startups are needed to
demonstrate outcomes that motivate enterprise buyers
while B2C startups can gain significant brand
recognition from validation within a provider setting
A R O C K R E P O R T B Y

10. Hospitals have many established
systems that if leveraged properly,
can represent significant distribution
channels for new technologies.
Whether you’re a B2B or B2C, it is
important to consider how a
startup’s product or service could
be integrated into the existing
hospital systems.
- Adam Dole, Mayo Clinic
A R O C K R E P O R T B Y

11. KEY CONSIDERATION:
A device startup likely follows a rigorous timeline, runs pilots that
require IRB/human subjects approval, patenting, publishing,
FDA clearance and approval
Medical Devices VS. Digital Health
A digital health startup may be eligible for an expedited or
exempt IRB and less-rigorous regulatory process. BUT they
may also have a harder time connecting with a provider, due
to difficulties such as clinician workflow integration, difficult to
measure outcomes, IT infrastructure issues and misaligned
incentives
A R O C K R E P O R T B Y

12. Clinical evaluation focuses on product usability, adoption and/or
impact. This can require rigorous scientific methods and often a
longer, more intimate relationship with the hospital partner
Business evaluation measures how the market values a
company’s products and services. This requires clear
negotiations upfront around the hurdles and milestones
necessary to move from pilot to commercialization
Clinical Efficacy VS. Business Model Evaluation
KEY CONSIDERATION:
A pilot should test both the clinical efficacy and business model of the
product or service. But these tests can be quite different:
A R O C K R E P O R T B Y

13. PILOT TIMELINE

14. LAUNCH
customer building
BUILD
validation
SCALE
growth
MATURE
sustainability
CONTEXT
I. Pre-Pilot
II. Pilot Design
III. Iteration
IV. Validation
startup lifecycle
4 PHASES
4-8 weeks
2-4 months
3-6 months
ongoing
pilot start
6-12 months for
large scale testing
A R O C K R E P O R T B Y

15. PHASE 1:
PRE-PILOT
The startup has to involve
clinical guidance early and
often, starting from the
early brainstorming portion.
From experience – we will
have startups that focus so
much on the tech-side,
then come to the frontlines
to test it, and we realize it’s
a mismatch for the
problem.
-- Aenor Sawyer, UCSF

16. I. Pre-Pilot
II. Pilot Design
III. Iteration
IV. Validation
Clearly define what unmet need startup is looking to impact.
Target Appropriate Hospital System (teaching hospital, a general
hospital, a specialty hospital, or a clinic)
§ Consider the goals of your pilot
§ Does the payment system (pay-for performance vs. fee-for-service) matter?
Understand how decisions are made, and who makes them
§ How is the leadership structured?
§ Who needs to be on-board to approve decisions?
Find a Champion
§ Network in your field, and find the right person(s) for your partnership. Discuss
their interests, availability and commitments
§ Champions are typically found through personal contacts or literature searches
for researchers working on a related topic
Complete HIPAA training, IRB / research training and scope out relevant
FDA regulations
File for a provisional patent
Decide if the hospital partner will be an inventor-contributor or a data
collector
A R O C K R E P O R T B Y

17. The pilot successes we've had happened
when we did all of the legwork for our
internal champion upfront—preparing for
the IRB, designing a sufficiently powerful
study—versus trying to figure out ways
around it.
- Joseph Abrahamson, CTO of Reify Health

18. Collaboration in healthcare
often leads to co-ownership
of the patents, which
sounds great but will scare
off investors (since the
hospital can license your
competitor).
One solution is to file a
provisional patent
application before starting
the collaboration.
-Jeffrey Schox, Startup Patent
Lawyer

19. PHASE 2: PILOT DESIGN
The start-up needs to figure out who their customer is, and what
evidence they need to sell to those customers.
Digital healthcare startups can generally be classified as adding value to the healthcare
system either on the delivery or administration side.
Pilots for administrative startups need to create a business case
about improving bottom-line performance of the health care
provider, e.g. higher productivity, lowered costs, improved
revenue or cash flow.
Startups focused in the delivery side require comparison data
on integration, usability and clinical outcomes. Here – depth of
rigor and scientific analysis are critical. A randomized-control
trial is not always feasible, but generally considered the gold
standard for reliable clinical evidence.
A R O C K R E P O R T B Y

20. Pre-Pilot
Pilot Design
Iteration
Validation
Determine: Roles, scope, incentives
§ Incentives for hospital involvement can include: publishing rights, equity, revenue-
share, licensing, training opportunities for clinicians on mHealth
§ Collaborate with partners to outline how much time is required by individuals from
both groups…get specific.
§ Clearly define the relationship. Is this a pilot? Partnership? Advisory position?
Design Study
§ Define the purpose of the study, and the appropriate research methods for that
purpose. The pilot should be designed to directly test hypotheses. What is your
study design (e.g. RCT, observational)?
Set goals and metrics
§ Measure the right processes and outcomes to test your driving hypotheses.
Substantiate a case for moving from pilot to full-scale commercialization.
Create timelines
Complete institutional regulatory forms
§ Including: IT Security Compliance / Confidentiality Agreement / IRB Approval /
HIPAA certification
Determine disclosure policies
§ If you’re not ready to “go public” with the product, prepare an NDA
Set budget and formalize all cost-sharing

21. What can really take a long
time inside of a healthcare
institution, is coordinating the
terms of the relationship and
structuring the agreement.
Every time a decision needs to
be made many stakeholders
need to be consulted.
The more proactive and
insightful a startup can be
about what they want to get
out of their relationship with the
clinical partner the faster the
relationship can move.
- Adam Dole, Mayo Clinic

22. The biggest challenge we faced
was scheduling time with the
clinicians. We really depended
on our internal champion to
stay enthusiastic and engaged,
and to share the product with
his colleagues.
- Michael Pan, Nephosity

23. PHASE 3: ITERATION
During Phase 3, the initial small-scale roll out grows. Feedback
and input on the product are discussed and incorporated.
Evidence accumulates. The evolving product is tested in larger
populations.

24. Pre-Pilot
Pilot Design
Iteration
Validation
Relationship management:
§ Once the pilot launches, the partners need to monitor and analyze data together,
which involves regular communication
§ Consider how the hospital staff is interacting with your technology, and adjust pain-
points to facilitate ease of use
Stage expansion plans
§ Set check-points as the pilot grows. How many people will be included in the pilot?
When will they be contacted? How many times will you iterate?
§ Note that iterations may require further IRB and regulatory approvals
Data analysis
§ The pilot should test hypotheses you have already formed. Know who will lead the
data analysis, and set a schedule to check results
File for a patent
§ The patent application should be filed within 12 months of the provisional
Acquire appropriate funding to fuel growth
A R O C K R E P O R T B Y

25. PHASE 4: VALIDATION
The startup should have sufficient evidence to sell to their
customers, allowing the pilot to transform into full-scale
commercialization
“Sufficient evidence” can take many forms, depending on the pilot design (see Phase 2)
Administrative pilots will find useful validation metrics in the
changes in bottom-line performance of the hospital, provider
usage, and user satisfaction
Clinical pilots will find validation through rigorous and
repeatable scientific research. Publication in a peer-reviewed
journal is one reliable validation of clinical studies
A R O C K R E P O R T B Y

26. Pre-Pilot
Pilot Design
Iteration
Validation
Finalize validation criteria specific to your product or service
Draft and publish a final report
§ Who will be included as authors?
§ How will the relationship be described?
§ Which results are included in the report?
§ Who is the target audience for the publication?
File for FDA approval if product claims to treat or diagnose
§ Inform FDA at least 90 days in advance of marketing a medical device
A final report allows you to stick a flag in your research. If it’s truly
novel and successful then it's going to cause a splash when it's
published and your team should be prepared for that. Understand
that research papers are important components of the domino
effect.
– Reify Health
A R O C K R E P O R T B Y

27. § Target appropriate
hospital system
§ Study hospital
structure/processes
§ Find a champion
§ Conduct research
§ Determine: purpose, roles,
scope, incentives
§ Set goals and metrics
§ Create timelines
§ User recruitment
§ Sign: BAA, Letter of Intent
§ Staging expansion
plans
§ Data analysis
§ Final Report
Relationship
Management
§ HIPAA training
§ IRB training
§ FDA scoping
§ Conflict of interests
§ IT Security Compliance
§ Confidentiality Agreement
§ IRB Approval
§ HIPAA certification
• Text
•
•
Privacy/
Regulatory
§ File provisional
patent application
§ Consider disclosure policies
(NDA if necessary)
§ File for patent
(within 12 mos)
Legal
§ Seed funding
§ Grant Application
§ Budget
§ Budget with hospitals
§ Cost-sharing if applicable
§ Acquire
appropriate funds
Fund-
raising
KEY
Startup
Startup / Provider
collaboration
SUMMARY
Pre-Pilot
Pilot Design
Iteration
Validation
§ File for FDA clearance
if applicable

28. Stories from the trenches
Product development and pilot testing can take many forms. Below are some
creative ways entrepreneurs have hacked the system...
Before we invested time and resources in a pilot, we
recruited users on Craigslist to test our products and
give us feedback. Once the product was developed
and tested, we took it to the hospitals.
We just gave the doctors iPads, and in return they
agreed to give us feedback. We got the pilot running
at that hospital in two weeks...
Researchers at Mass General were interested in
running these trials and publishing the results,
because we were taking a proven scientific
mechanism, and applying it to digital health. It could
have major scientific implications.
A R O C K R E P O R T B Y

29. § Find a champion:
CEO utilized his
network, connected
with an interested
psychologist at
HMS / Mass Gen.
§ Researcher incentives: career
advancement, publishing
§ Survey design: pre/post test
§ Timelines, scope and roles
set, BAA discussed
§ Users recruited from clinic
§ Expansion: second
pilot with
randomized control
trial
§ Data analysis and
first publication led
by PI
§ First paper to be
published in peer-
reviewed journal
Relationship
Management
§ HIPAA: made product
and data anonymous
§ IRB: used previously
successful proposal
§ Conflict of interest:
Researcher opted-out
of medical advisory &
stock options
§ IT Security Compliance approved
§ Confidentiality Agreement: Drafted
between hospital and patients,
data stored anonymously
§ IRB Approval: Takes 1.5 months
Privacy/
Regulatory
§ Grant Application:
Jointly filed, with
researcher as PI and
startup CEO as
“advisor”
§ Received grant to cover
research costs
Fund-
raising
KEY
Pre-Pilot
Pilot Design
Iteration
Validation
A Successful Partnership:
Cognitive Health Innovations & Harvard Medical System
§ Received second grant for a
3rd trial
§ Patent not currently
in process
Legal
A R O C K R E P O R T B Y

30. APPENDIX
A R O C K R E P O R T B Y

31. Purpose
§ What is the purpose of the partnership / pilot?
§ What user needs does this product fulfill?
§ What are you trying to validate with this partnership / pilot?
Scope
§ What is the expected timeline for this pilot / partnership?
§ How will this project be funded?
§ What specific actions / access / deliverables do you need from the health care
provider? (Specify practice area / specialty, content, clinical protocol, etc.)
§ What types of specialists or sub-specialists will be needed? What part of the
technology will the specialists evaluate?
Roles
§ Who are the members of the startup and provider teams, and what are their specific
roles (teach, train, data collection etc.)?
Before approaching a hospital, prepare answers the questions below. Consider this a
collaborative process and working document.
DO YOUR HOMEWORK
A R O C K R E P O R T B Y

32. Roles (cont)
§ How will each stakeholder benefit from this pilot?
§ How will the startup describe their relationship with the provider to external parties?
Is this a “partnership?” A “pilot?” A “co-investigation?”
Incentives:
§ Why should the provider invest time and resources in this? Will they benefit in terms
of physical content (articles, etc), specific clinical protocols, advisory roles, etc.?
§ How, specifically, can the provider add strategic value to this product?
§ What, if any, advisory role will the provider play?
§ What patents does the startup have that would attract the health care provider?
(Remember to discuss patent and IP rights early)
§ What benefits will the hospital receive? (equity, revenue share, licensing, etc)
§ Is there a transition where the provider / customers will start to pay for the product?
When? Will the pilot providers get a deal?
§ Who will have access to the data? Who can publish the data?
DO YOUR HOMEWORK (cont)
A R O C K R E P O R T B Y

33. § Business Associates Agreement
§ Proposal of Scope Examples
§ IT Security Compliance Checklist
§ HIPAA Compliance Checklist
§ Confidentiality Agreement
§ Non-Disclosure Agreement
§ IRB Process and Guideline Examples
rockhealth.com/resources
RESOURCES
A R O C K R E P O R T B Y

34. § Darren Hite, Aberdare Ventures
§ Aman Bhandari, Health and Human
Services
§ Greg Downing, Health and Human
Services
§ Patti Weber, National Institutes of Health
§ Adam Dole, Mayo Clinic
§ Jeffrey Schox, Schox Patent Group
§ Mike Holland, Kaiser Permanente
§ Jeffery Groom, University of Michigan
Medical Innovation Center
§ Veenu Aulakh, Center for Care
Innovation, Tides Foundation
THANK YOU!
§ Maria Ly, Skimble
§ Borna Safabakhsh, Agile Diagnosis
§ Ryan Panchadsaram, Pipette
§ Rachel Kalmar, Senstore
§ Andrey Ostrovsky, Care at Hand
§ Michael Pan, Nephosity
§ Amy Sheng, CellScope
§ Sean Duffy, Omada Health
§ Brian Chiko, Cognitive Health Innovations
§ Jonathon Feit, Beyond Lucid
§ Shenly Glenn, New Company
§ Founding team, Reify Health
Thank you to the following people for their valuable insights:
A R O C K R E P O R T B Y