So many digital health startups, so little time.
That’s one of the challenges entrepreneurs face when it comes to finding a healthcare organization to try out their new technologies. But a pilot study is often the best way for these companies to validate their products and business models in order to move into full-scale commercialization. So how do you land a coveted partnership with Mayo Clinic or Massachusetts General?
To offer some guidance, Sasha Buscho and Christina Chang of Rock Health, along with Dr. Aenor Sawyer of UCSF, interviewed entrepreneurs, hospital administrators, investors, lawyers, clinicians and researchers and put together a startup’s guide to hospital partnerships.
They organized the process into four phases: pre-pilot, pilot design, iteration and validation, with each part requiring specific considerations, research and actions on the part of the startup.
It’s easier for some than others. Agile Diagnosis, for example, said in the report that it took only two weeks to get a pilot going — the team just offered doctors iPads, and the doctors agreed to give feedback in return. On the other hand, Omada Health recruited users on Craigslist to test its product before taking it to hospitals.
In planning a pilot, B2C companies should understand that they can gain great brand recognition from validating their products this way. B2B companies, meanwhile, should consider how they could best motivate providers to use their product, for example, by demonstrating increased productivity, lower costs, or improved clinical outcomes.
All the while they must make sure they are complying with patient safety, data security and internal and external regulations.
Below are some key takeaways from the guide.
- The first step in planning a pilot is to clearly define the unmet need you’re impacting.
- Use personal contacts or literature searches to find a clinical champion who can provide early input.
- Determine the end-user of your product and consider the best setting in which to get the technology into his or her hands.
- Research the institution’s leadership and decision-making process
- Understand HIPAA, IRB and U.S. Food and Drug Administration regulations for your technology before doing a pilot.
- File a provisional patent application if applicable; within 12 months after doing so, file a patent application.
- Consider what incentives you might offer a provider for involvement (publishing rights and authorship, equity, revenue-sharing, licensing, etc.).
- Lay out specific terms of the collaboration: How much time is required by individuals from both parties? Is an NDA needed? Will costs be shared? Who will write the final report?
- Design a study that directly tests hypotheses, and set check-in points.
- Know what institutional regulatory forms you need to complete, like IT security compliance, confidentiality agreements, IRB approval, HIPAA certification.
- When drafting a final report, consider who is the target audience for publication when deciding which results to include.
View the entire guide here.