How to get out of digital pilot purgatory

Digital health startups face some major hurdles when it comes to dissemination and implementation. One is finding a provider partner who is willing to pilot the solution, since the digital health catch-22 depends on your validating the claimed endpoints. But, most hospital innovation centers or group practices don't want to be bothered unless you have a solution that has validated endpoints.

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The issue with pilots is that there is often not a defined next step once the pilot is finished, or there are no specific metrics that the pilot is judged on. Having goals from the onset is key.

Are you doing a minimally viable pilot?

Plus, according to Gallup, 70% of all change initiatives fail. One in six IT projects have an average cost overrun of 200%. Failure is indeed an option.

What's a physician digipreneur to do?

Here are some possible ways to get out of pilot purgatory:

1. Apply for an SBIR/STTR grant
2. Do a deep dive into your local hospital system care innovation center and their requirements. Identify the barriers and overcome them. Remember that your solution needs to solve a clinical, workflow and business problem.
3. Find an incubator or accelerator that has a connection to a hospital system partner
4. Find a connector in your local ecosystem who can open doors
5. Connect to a regional translational science institute that offers iCorps training
6. Apply for grants that are looking to fund digital health research outcomes research
7. Apply for foundation grants
8. Connect to a private practice interested in partnering as a test bed or put them on your advisory board
9. Rethink your value proposition, business model canvas and sustainable competitive advantage
10. Think globally
11. Work with medical associations or trade groups

12. Work with the FDA

13. According to Chris Laping, author of People Before Things, some IT project success tips include:

14.Put people (change management and leadership) before things

15.Be sure your followers are willing and able to complete the project

16.Be sure you have the right champion, team and sponsor/investor internally

17.Explain why the project is important (WHY), that the implementation is easy to understand (HOW), and that you dedicate the necessary time, people, money and effort to the project (WHAT)

18.Recruit a coalition of the willing by educating, engaging and activating

19. Create a minimally viable pilot

20. Meet the needs of the IT team, the business team, the clinicians and the operations teams.

Pilots that scale successfully possess common success factors. Here are seven based on McKinsey research and observations:

1. Secure CEO support. IoT projects that scale positively have a CEO leading the push. Support from the CEO shepherds a project past the bumpy spots and defends it throughout the organization.
2. Start simple, execute relentlessly. Sustaining momentum requires wins. Be wary, though, of declaring victory too early. Pick a simple use case and follow through relentlessly until you capture value. Successes help land support of frontline employees and expose vulnerabilities around the need for process reengineering, talent, culture and alignment, and go to market.
3. Ponder outcome vs. technology. Rather than becoming enamored by technology, ask more nuanced questions around the business model before choosing a pilot:Value proposition: What is the offering? What user needs does it address? Why is it better? How does it create customer value?Delivery model: What is the go-to-market model? What parts of the value chain and functions must change? Which ecosystem partners must unite to deliver this?Economic element: It is easier to see the link to value for operational use cases (e.g., smart factory-related) than it is for companies seeking to drive revenue growth through IoT offerings. Our research shows most value created becomes consumer surplus, leaving a portion for a provider ecosystem to capture. Companies must ask: What portion of this value will the customer share? How many people in the value chain will lay claim to this? What portion of this value flows to the bottom line? What are direct and indirect ways to monetize this?During the pilot stage, testing the business model and the technical viability will improve confidence in delivering value.
4. Focus on people. Companies that scale IoT enlist employees with an entrepreneurial bent and who embrace change. They help set a transformation’s pace and tone. Also required: cross-functional collaboration among those with deep process knowledge, analytical acumen, and digital and IT experience. “Business-building leadership” assists in translating technology to business outcomes and commercial opportunities. Recruiting and retaining this talent is hard, especially in bureaucracies.
5. Treat data as a transformational asset. Properly used data creates a sustainable business advantage and innovative business models. But consider the data sources. One company couldn’t perform analytics on its equipment because it didn’t own the data.
6. Bring clarity around your technology stack. With today’s plethora of IoT platforms, picking the right one proves hard. Ask a set of clear questions around five areas – applications, data management, infrastructure needs, security and edge process/control – to select the right platform.
7. Build an ecosystem of tech providers, not a logo collection. Few website logos reflect meaningful relationships. One company invested $1 million in a test plant after a handshake between its CEO and technology provider. The result: a science experiment that could not scale. Meaningful relationships require a clear value proposition for each party, skin in the game, common objectives, and successes in delivering joint value.

Here is an example of how one company piloted their solution with the Mayo Clinic:

Here are more tips on how to pilot your minimally viable product

??While launching and then scaling a pilot is a well-established approach to innovation, there is plenty of evidence that shows that even successful pilot projects often don’t lead to successful scaled implementations. These authors suggest a better?approach to scaling successful pilots. Rather than requiring that new teams replicate the pilot exactly, share with them what you’ve learned from the pilot and then challenge them to find their own solutions that could work as well — or better — in their own contexts.

Pilots and IRBs are essential to digital health entrepreneurs attempting to build a clinically validated product and scale it within a health system. But it should also meet the needs of the company. Here's some more advice on how to avoid the landmines. You should also avoid these pitfalls of design sprints.

But they are also a royal pain. Here are some tips on navigating IRBs

Your inability to find a partner that can clinically validate your solution can put you in pilot purgatory. Since there are few digital health clinical trial ecosystems, getting out can be a challenge. However, be persistent and talk to others who have walked in your shoes. They found the solution and so can you.

Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs on Substack