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The Entrepreneur's Guide to Hospital Partnerships by @Rock_Health
 

The Entrepreneur's Guide to Hospital Partnerships by @Rock_Health

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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

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    The Entrepreneur's Guide to Hospital Partnerships by @Rock_Health The Entrepreneur's Guide to Hospital Partnerships by @Rock_Health Presentation Transcript

    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • PILOT TIMELINE
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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.
    • 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
    • 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
    • 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
    • §  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
    • 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
    • §  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
    • APPENDIX A R O C K R E P O R T B Y
    • 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
    • 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
    • §  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
    • §  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