A living document and initial guide for entrepreneurs as they navigate partnering with health providers, initially compiled after 22 interviews with entrepreneurs, hospital administrators, investors, ...
A living document and initial guide for entrepreneurs as they navigate partnering with health providers, initially compiled after 22 interviews with entrepreneurs, hospital administrators, investors, lawyers, clinicians and researchers
The Entrepreneur’s Guide to Hospital Partnerships by @Rock_HealthPresentation Transcript
THE ENTREPRENEUR’S GUIDE TO PARTNERSHIPS WITH HEALTHCARE PROVIDERS
About this GuideThis document should serve as a guide for entrepreneurs as they navigate partnering with healthproviders. This first draft was compiled after 22 interviews with entrepreneurs, hospitaladministrators, investors, lawyers, clinicians and researchers. This is a living document, intendedto grow and improve with your input. Authors:• Sasha Buscho, Havard MSc, Rock Health• Aenor Sawyer, MD, UCSF• Christina Chang, Harvard MBAEditors:• Halle Tecco, Rock Health CEO• Malay Gandhi, Rock Health Strategist-in-Residence• Adam Dole, Mayo Clinic Rock Health is a nonprofit foundation focused on the intersection of healthcare and technology. We support the next generation of health entrepreneurs through a startup accelerator, open-source research and public events. Rock Health partners include Aberdare Ventures, Accel Partners, Fenwick & West, Genetech, Harvard Medical School, Mayo Clinic, Merck, Microsoft, Mohr Davidow Ventures, NEA, Nike, P&G, Qualcomm, Quest Diagnostics, Silicon Valley Bank, United Health and UCSF. For more information, visit rockhealth.com
How can startups and healthcare providers partner more effectively to pilot andcommercialize digital health innovations?
BACKGROUND Scope of Guidelines The digital healthcare pilot is defined Definition as a product implementation trial with end-users or potential customers The goal of the pilot is two fold: Goal validation* and progression to full- scale commercialization* Note: The term validation in this document refers to the act of verifying that a new product or service meets the needs of its end-users
KEY CHALLENGES Healthcare providers’ priorities include established “best practices” for care and research, patient safety, data security, andDivergent Risk Profiles constrained schedules. Startups prioritize new practices, adoption, and growth
KEY CHALLENGES Healthcare providers’ priorities include established “best practices” for care and research, patient safety, data security, andDivergent Risk Profiles constrained schedules. Startups prioritize new practices, adoption, and growth Some “motivators” for provider participation- including research goals,Differing Motivations shared intellectual property, and equity- may not align with startup needs
KEY CHALLENGES Healthcare providers’ priorities include established “best practices” for care and research, patient safety, data security, andDivergent Risk Profiles constrained schedules. Startups prioritize new practices, adoption and growth Some “motivators” for provider participation- including research goals,Differing Motivations shared intellectual property, and equity- may not align with startup needs Startups and providers have significant differences in availability, team size, Distinct Cultures decision-making dynamics, and overall timelines
KEY CHALLENGES Healthcare providers’ priorities include established “best practices” for care and research, patient safety, data security, andDivergent Risk Profiles constrained schedules. Startups prioritize new practices, adoption and growth Some “motivators” for provider participation- including research goals,Differing Motivations shared intellectual property, and equity- may not align with startup needs Startups and providers have significant differences in availability, team size, Distinct Cultures decision-making dynamics, and overall timelines Institutions enforce a multitude ofComplex Regulations regulations, both internal (e.g. IRB) and external (e.g. FDA), which are difficult to interpret without internal champions
KEY CONSIDERATION:Consumer-Facing VS. Enterprise Solutions Deployment Strategy: Pushing a product or service to the patient for testing is different from getting hospitals or clinicians to adopt and promote a technology themselves 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
KEY CONSIDERATION:Medical Devices VS. Digital Health A device startup likely follows a rigorous timeline, runs pilots that require IRB/human subjects approval, patenting, publishing, FDA clearance, and approval A digital health startup may be eligible for an expedited or exempt IRB and less-rigorous regulatory process. But they may have a hard time connecting with a provider due to difficulties such as clinician workflow integration, difficult-to- measure outcomes, misaligned IT infrastructure, and incentives
KEY CONSIDERATION:Clinical Utility VS. Business Model EvaluationA pilot should test both the clinical utility and business model of theproduct or service. But these tests can be quite different: 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
PILOT TIMELINE
CONTEXT 4 PHASES pilot start I. Pre-Pilot II. Pilot Design III. Iteration IV. Validation 4-8 weeks 2-4 months 3-6 months ongoing 6-12 months for large scale testing LAUNCH BUILD SCALE MATURE customer building validation growth sustainability startup lifecycle
From our experience on the frontlines ofhealthcare, startups that incorporateclinical input “early and often” are moresuccessful in both targeting true unmethealthcare needs and in designingsolutions that are useful. Be sure to reachout for clinical input, even in thebrainstorming stage, to avoid anunintended mismatch between problemsand solutions.-- Aenor Sawyer, MD, UCSF
I. Pre-Pilot II. Pilot Design III. Iteration IV. Validation Clearly define what unmet need your startup seeks to impact Find a clinical champion for early input § 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 Define your end-user and appropriate setting in which to “test” your technology (e.g. hospital system, inpatient or outpatient provider, etc) § Consider the goals of your pilot § Does the hospital’s payment system (fee-for-service vs. capitation) matter? Understand institutional leadership and decision-making processes Consider the “relationship options” you may form with clinical partners (i.e. co-inventor, advisor, researcher, consultant) Complete pertinent training on HIPAA, IRB, research methodologies and scope out relevant FDA regulations for your technology File for a provisional patent when applicable
The pilot successes weve had happenedwhen we did all of the legwork for ourinternal champion upfront—preparing forthe IRB, designing a sufficiently powerfulstudy—versus trying to figure out waysaround it.- Joseph Abrahamson, CTO of Reify Health
Collaboration in healthcareoften leads to co-ownershipof the patents, whichsounds great but will scareoff investors (since thehospital can license yourcompetitor).One solution is to file aprovisional patentapplication before startingthe collaboration. -Jeffrey Schox, Startup PatentLawyer
PHASE 2: PILOT DESIGNThe start-up needs to figure out who their customer is, and whatevidence they need to demonstrate usefulness and sell theirtechnology to that customerDigital healthcare startups can generally be classified as adding value to the healthcaresystem either on the care 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 on the care delivery side require comparison data on integration, usability and clinical outcomes. Here, scientific rigor and detailed analysis are critical. A randomized- control trial is not always feasible, but generally considered the gold standard for reliable clinical evidence
Pre-Pilot Pilot Design Iteration Validation Determine: roles, scope, incentives § Incentives for provider involvement can include: publishing rights and authorship, 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 and metrics 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 § Measurethe 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 pilot budget and formalize all cost-sharing
What can really take a longtime inside of a healthcareinstitution is coordinating theterms of the relationship andstructuring the agreement.Every time a decision needs tobe made, many stakeholdersneed to be consulted. The more proactive andinsightful a startup can beabout what they want to getout of their relationship with theclinical partner the faster therelationship can move.- Adam Dole, Mayo Clinic
The biggest challenge we facedwas scheduling time with theclinicians. We really dependedon our internal champion tostay enthusiastic and engaged,and to share the product withhis colleagues.- Michael Pan, Nephosity
PHASE 3: ITERATIONDuring Phase 3, the initial small-scale roll out grows. Feedbackand input on the product are discussed and incorporated.Evidence accumulates. The evolving product is tested in largerpopulations.
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 the hypotheses you have 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
PHASE 4: VALIDATIONDuring the pilot, the startup should gather sufficient data todemonstrate the usefulness of a product or service and facilitatethe transition from pilot to full-scale commercialization“Sufficient data” 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, while not always necessary, can add credibility to the clinical study
Pre-Pilot Pilot Design Iteration Validation Complete validation metrics specific to your product or service Draft and publish a final report § Define writing roles and clarify authorship. 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 deviceA final report allows you to stick a flag in your research. If it’s trulynovel and successful then its going to cause a splash when itspublished and your team should be prepared for that. Understandthat research papers are important components of the dominoeffect.– Joseph Abrahamson, CTO of Reify Health
SUMMARY KEY Pre-Pilot Pilot Design Iteration Validation § Find a champion § Determine: purpose, roles, § Stage expansion § Release final report ManagementRelationship § Target appropriate scope, incentives plans end-user § Set goals and metrics § Analyze data § Study hospital § Create timelines structure/processes § Recruit users § Conduct background § Sign: BAA, Letter of Intent research • Text Regulatory § HIPAA training § IT Security Compliance § File for FDA clearance Privacy/ § IRB training § Confidentiality Agreement • if applicable § FDA scoping § IRB Approval • § Conflict of interests § HIPAA certification Legal § File provisional § Consider disclosure policies § File for patent patent application (NDA if necessary) (within 12 mos)raising Seed funding Budget with hospitals Acquire appropriate Fund- § § § § Grant Application § Cost-sharing if applicable funds Startup § Budget Startup / Provider collaboration
Stories from the trenchesProduct development and pilot testing can take many forms. Below are somecreative 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 Successful Partnership: KEY Cognitive Health Innovations & Harvard Medical System Pre-Pilot Pilot Design Iteration Validation § Find a champion: Researcher incentives: career Expansion: second First paper to beManagement § § § Relationship CEO utilized his advancement, publishing pilot with published in peer- network, connected § Survey design: pre/post test randomized control reviewed journal with an interested § Timelines, scope and roles trial psychologist at set, BAA discussed § Data analysis and HMS / Mass Gen. § Users recruited from clinic first publication led by PI § HIPAA: made product § IT Security Compliance approved and data anonymousRegulatory § Confidentiality Agreement: Drafted Privacy/ § IRB: used previously between hospital and patients, successful proposal data stored anonymously § Conflict of interest: § IRB Approval: Took 1.5 months Researcher opted-out of medical advisory & stock options § Grant Application: Received grant to cover Received second grant for araising § § Fund- Jointly filed, with research costs 3rd trial researcher as PI and startup CEO as “advisor” Legal § Patent not currently in process
APPENDIX
DO YOUR HOMEWORKBefore approaching a hospital, prepare answers the questions below. Consider this acollaborative process and working document.Purpose§ What is the purpose of the partnership / pilot?§ What user needs does this product fulfill?§ What are you trying to substantiate in 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.)?
DO YOUR HOMEWORKRoles (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?
RESOURCES§ Business Associates Agreement§ Proposal of Scope Examples§ IT Security Compliance Checklist§ HIPAA Compliance Checklist§ Confidentiality Agreement§ Non-Disclosure Agreement§ IRB Process and Guideline Examplesrockhealth.com/resources
THANK YOU!Thank you to the following people for their valuable insights:§ Darren Hite, Aberdare Ventures § Maria Ly, Skimble research@rockhealth.org§ Aman Bhandari, Health and Human § Borna Safabakhsh, Agile DiagnosisServices § Ryan Panchadsaram, Pipette§ Greg Downing, Health and Human § Rachel Kalmar, SenstoreServices § Andrey Ostrovsky, Care at Hand§ Patti Weber, National Institutes of Health § Michael Pan, Nephosity§ Adam Dole, Mayo Clinic § Amy Sheng, CellScope§ Aenor Sawyer, UCSF § Sean Duffy, Omada Health§ Jeffrey Schox, Schox Patent Group § Brian Chiko, Cognitive Health Innovations§ Mike Holland, Kaiser Permanente § Jonathon Feit, Beyond Lucid§ Jeffery Groom, University of Michigan § Shenly Glenn, New CompanyMedical Innovation Center § Founding team, Reify Health§ Veenu Aulakh, Center for CareInnovation, Tides Foundation
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