If the numbers around the size of the market are a moving target, just think about how to gauge the validity and efficacy of the products that are behind all of those billions of dollars in spending.
Andy Coravos, the co-founder of Elektra Labs, certainly has.
Coravos, whose parents were a dentist and a nurse practitioner, has been thinking about healthcare for a long time. After a stint in private equity and consulting, she took a coding bootcamp and returned to the world she was raised in by taking an internship with the digital therapeutics company Akili Interactive.
Coravos always thought she wanted to be in healthcare, but there was one thing holding her back, she says. “I’m really bad with blood.”
That’s why digital therapeutics made sense. The stint at Akili led to a position at the U.S. Food and Drug Administration as an entrepreneur in residence, which led to the creation of Elektra Labs roughly two years ago.
Now the company is launching Atlas, which aims to catalog the biometric monitoring technologies that are flooding the consumer health market.
These monitoring technologies, and the applications layered on top of them, have profound implications for consumer health, but there’s been no single place to gauge how effective they are, or whether the suggestions they’re making about how their tools can be used are even valid. Atlas and Elektra are out to change that.
The FDA has been accelerating its clearances for software-driven products like the atrial fibrillation detection algorithm on the Apple Watch and the ActiGraph activity monitors. And big pharma companies like Roche, Pfizer and Novartis have been investing in these technologies to collect digital biomarker data and improve clinical trials.
Connected technologies could provide better care, but the technologies aren’t without risks. Specifically, the accuracy of data and the potential for bias inherent in algorithms that were created using flawed data sets mean there’s a lot of oversight that still needs to be done, and consumers and pharmaceutical companies need to have a source of easily accessible data about the industry.
”The increase in FDA clearances for digital health products coupled with heavy investment in technology has led to accelerated adoption of connected tools in both clinical trials and routine care. However, this adoption has not come without controversy,” said Coravos in a statement. “During my time as an Entrepreneur in Residence in the FDA’s Digital Health Unit, it became clear to me that like pharmacies which review, prepare, and dispense drug components, our healthcare system needs infrastructure to review, prepare, and dispense connected technologies components.”
The analogy to a pharmacy isn’t an exact fit, because Elektra Labs currently doesn’t prepare or dispense any of the treatments that it reviews. But Atlas is clearly the first pillar that the digital therapeutics industry needs as it looks to supplant pharmaceuticals as treatments for some of the largest and most expensive chronic conditions (like diabetes).
Coravos and here team interviewed more than 300 professionals as they built the Atlas toolkit for pharmaceutical companies and other healthcare stakeholders seeking a one-stop shop for all their digital healthcare data needs. Like a drug label, or nutrition label, Atlas publishes labels that highlight issues around the usability, validation, utility, security and data governance of a product.
In an article in Quartz earlier this year, Coravos made her pitch for Elektra Labs and the types of things it would monitor for the nascent digital therapeutics industry. It includes the ability to handle adverse events involving digital therapies by providing a single source where problems could be reported; a basic description for consumers of how the products work; an assessment of who should actually receive digital therapies, based on the assessment of how well certain digital products perform with certain users; a description of a digital therapy’s provenance and how it was developed; a database of the potential risks associated with the product; and a record of the product’s security and privacy features.
As the projections on market size show, the problem isn’t going to get any smaller. As Google’s recent acquisition bid for Fitbit and the company’s reported partnership with Ascension on “Project Nightingale” to collect and digitize more patient data shows, the intersection of technology and healthcare is a huge opportunity for technology companies.