Desperate to increase cost efficiency after a financially rough 2022, healthcare systems are in varied stages of engagement with the digital health ecosystem. While some are ahead of the curve, many lack the ability to find and assess technologies that promise to tame rising costs and enhance productivity. 

Some former members of Novartis’ innovation team are out to change that. They’ve launched a spinoff company that assists provider networks and life science clients in gathering evidence and vetting digital health technology.

The idea for the spinoff, dubbed DatosX, originated within the Swiss drugmakers’ Biome open-innovation hub. Biome was the conduit for outside entrepreneurs who felt their digital health technology or app could offer value to Novartis’ commercial group. 

The owners of those solutions often weren’t able to produce enough data to convince the manufacturer, though, so Biome staffers came up with their own verification system: the evidence lab.

The lab “was a tool we created to be able to solve one of the critical points of, ‘How do we know that that thing works the way we expect it to work?’” recalled Robin Roberts. Roberts cofounded Biome and served as its COO before cofounding DatosX, which he now leads. 

While some healthcare systems have an innovation team in place, many don’t. Either way, DatosX will systematically test the claims made by makers of digital health apps and other technology to ensure the system has the necessary insights to move forward with a product or solution. It is currently working with a dozen health systems and four biopharma companies.

“We’re not designing this as we go and hoping it works,” Roberts noted. “We’ve already gone through the design, redesign and editing process and run multiple trials and refined it in a way that makes it the most efficient and most important value creation for all parties involved.” 

An inability to back up claims is a common problem among digital health startups. A mere 20% have the data and regulatory filings to substantiate public claims, according to a 2022 analysis

Even if they do have the clinical data, few companies are making such claims, the study showed. These problems make it hard for startups to get matched with the right venture capital — an issue underscored by the digital health funding decline seen over the last two years — or with other end users like physicians. 

But running the studies needed to generate evidence is daunting (or at least that’s been the conventional wisdom). What the evidence lab showed is that providers can partner with a pharma or med-tech company early on for technology studies that aren’t as involved as, say, running a full-blown clinical trial. 

“Understanding whether a technology works or not is the currency digital health needs to maximize impact, access healthcare systems and patients,” said Steve Lindsey, director of innovation partnerships at medical system Banner Health. “Partnering can level up those expectations to be able to say, ‘Instead of taking five or 10 years to build, we can get this done in maybe two to three years.’” 

Part of Lindsey’s job entails vetting the litany of product makers knocking on his door requesting a tryout with his nonprofit network, which operates in six midwest and western states. 

“Everybody recognizes our name,” he said. “Everybody wants to get our logo on their slide deck.”

Banner is one of 12 networks partnering with DatosX, and is among a group of former Biome partners to have reupped with the firm. To help with the tech-triaging process, Roberts’ team leverages skills and expertise to play matchmaker, helping vet inbound inquiries to the systems from startups. It also scans its health system partners to find the best center for studies testing tech in various use cases. 

“We not only identify digital health technology that might be of benefit for that health system, but also we work with them to understand how that fits into the use case that they’re looking to utilize it in,” Roberts explained. 

“On the flip side, there are ways that we can potentially work with DatosX to say, ‘Hey, we’re trying to solve this problem. Who do you guys have, or what is in your ecosystem?’” Lindsey added.

That’s where being a separate entity has advantages. No longer constrained by corporate ownership, DatosX can draw from a wider pool of digital offerings. Some networks that were hesitant to engage under the Novartis umbrella have since come onboard, Roberts reported. 

The firm also attempts to remove risk from the engagement for the healthcare system. That service can be especially helpful to in-house innovation directors like Lindsey who are overseeing the testing of digital health technology in as rapid a fashion as allowable within their system’s guardrails. Setting up these studies requires committing internal resources, and thus assuming risk. 

“We have to be a little less risk-averse to trying some of these things,” Lindsey said. “But we are very selective in how we do things. If a study even remotely touches on the clinical trial level, we will float it to our research team that’s dedicated to that.”

When DatosX presents a study, the network has the flexibility to accept or deny it. If it moves forward, the network then runs the study using the DatosX protocol. 

The innovation team assesses potential pushback on adoption from either patients or providers, the business case for the technology, and whether implementing it makes sense from an operational perspective. It collects anecdotal evidence from providers on patient engagement — and specifically whether they’re interested in accessing the tool’s intended clinical result. 

Through its methodology, DatosX says it can help clinical partners reach those conclusions in a more cost- and time-efficient manner. Sponsors then get access to data that tells them whether the tool in question works or not.

“Health systems can utilize the data to say, ‘Look, we know how well this works, not just in general but in our organization,’” said Roberts. “That kind of data is rarely ever found in a way that’s cost-neutral for an organization.”

In some cases, the collected data is intended for a regulatory submission designed to enable the startup to bolster a marketing claim it can’t currently make.

Other hurdles to health systems working with startups that DatosX aims to solve include “understanding what this technology does, what it doesn’t do and simplifying it in a way that actually resonates with administrators, physician champions and leadership teams,” added DatosX cofounder and COO Dr. Marianne Walwema.

Digital tools that have an internal champion tend to get more traction, but a supporter from among the medical ranks isn’t always forthcoming. In addition to helping startups and external organizations clearly define their ask, DatosX can assist health systems in understanding their own needs.

“Sometimes the value you bring is in having conversations with various stakeholders so they can go through the intellectual exercise of understanding, ‘OK, so I have this health system with this EHR and we have physicians with this problem. Is that the highest-priority problem we have and can we use digital health technology to solve that problem?’” explained Walwema, who formerly held the role of strategy director at Novartis Biome. 

Roberts says DatosX’s current task is to scale up. Because health systems choose the evidence they want to collect, it presents a challenge for his company. “We need to have access to a very diverse group of healthcare systems to be able to cover the array of different digital health technologies out there,” he acknowledged. 

Not that the evidence lab didn’t evaluate everything from algorithms and wearables to apps and more. Lindsey recalled testing the BioButton, a medical-grade wearable patch marketed by device firm BioIntelliSense for continuous remote health monitoring. 

“We’ve been looking at different ways to potentially integrate that into the system,” he noted.

Other technologies, such as generative AI, remain a pipe dream for the vast majority of provider groups. But AI has the potential to relieve pain points like the clinician shortage and physician burnout, not to mention rising costs and inflation. Solutions are needed to optimize clinical workflows and free up clinicians’ time so they can get back to practicing medicine, as opposed to sitting in front of EMRs or handling other administrative tasks.

DatosX plans to continue refining its platform, including its protocol development capability, as it works to sign up health systems and other partners. It’s now utilizing AI to design protocols that tap into external expertise as a complement to its own.

“What we’re doing with DatosX is allowing for digital health tech to be assessed in a more appropriate manner, so that what gets to patients and HCPs is something of value,” Roberts said. “Right now, the industry is doing that a little — but more often than not, they’re just guessing how well something will work.”