In this collaborative series between Salesforce and Astound Health, we’ll look at three areas where the industry is exploding with potential: diagnostics, digital therapeutics, and connected health technology.
Diagnostics: The First Step in Proactive Care
The first step of most journeys in the health system, diagnostics has traditionally relied on a monolithic infrastructure: you go to the doctor, the doctor refers you to get a test, the phlebotomist takes your blood, you get sent to a specialist, and so on. As anyone who’s experienced this knows, this isn’t a journey that focuses on engaging the consumer. The amount of information and decision-making power you have depends almost entirely on how—and whether—your healthcare system involves you in the process.
Today, people can be more proactive about their health and the tests they need, when they get them, and where they get them, at a price that makes sense. In short, Theranos had the right idea—well, not on the whole engaging in fraud and faking the science bits. But there’s a reason why smart investors were so eager to pour money into the company: from a healthcare delivery perspective, in terms of solving America’s systemic issues surrounding access and affordability, the vision of cheap, convenient testing was spot on.
Big Players Embracing D2C
Lab giant Quest Diagnostics recognizes the major potential of D2C testing, which the company anticipates will become a US$2 billion market by 2025, and is acting accordingly. Launched in 2016, the company’s D2C arm, QuestDirect, has expanded to offer over fifty tests directly to health consumers, ranging from basic blood work and allergy panels to infectious disease detection and cancer screening. Its easy-to-use platform allows users to order tests, schedule lab appointments where necessary, and securely access, share, and monitor their results. All tests tack on a physician fee to cover an optional teleconsultation about results, and some of the infectious disease tests offer RX solutions for those who test positive. Although QuestDirect doesn’t allow for insurance reimbursement (at least not yet), it offers consumers the freedom, flexibility, and price transparency notably lacking in the traditional testing system. Clearly, they’ve tapped into a powerful need: QuestDirect’s non-COVID-related revenue has doubled since 2019.
Navigating the Risk Factor
As medicine and technology allow a wider variety of diagnostic tests to be delivered D2C, developers are faced with pressing questions about when and how to involve a provider. The answer is: It depends on what you’re offering. Some companies don’t require doctor approval for certain low-risk screening tests. Others prompt users to fill out a questionnaire during the order process, which is then reviewed by a qualified physician to determine eligibility. For high-risk tests where a one-on-one virtual or telephone consultation might be advisable, companies like PWN Health (recently acquired by Everlywell) offer an extensive telehealth network that developers can enlist to connect health consumers with providers.
Inspiration Across Borders and Markets
Looking to international markets can hint at what’s on the horizon, because—in some ways—the US is actually behind the curve, especially relative to the UK. One promising area of development is subscription-based testing, where users can track their results at regular intervals. In the UK, companies like Thriva allow you to order a monthly collection kit to test cholesterol, vitamin deficiency, or thyroid function and get actionable information through an app on how to improve your health. While the FDA doesn’t necessarily preclude this as a possibility in the US, no one has decided to go ahead and offer routine blood chemistry tests directly to American consumers. At least, not yet.
And subscription-based testing could serve as a jumping-off point for more comprehensive health offerings. It’s easy to imagine these companies expanding to provide relevant interventions directly to consumers: for instance, if a test revealed a vitamin deficiency, the app could prompt the user to purchase the appropriate supplement. In fact, advanced supplement companies like Elysium Health and Thorne are already making the connection between supplements and testing. Elysium, which specializes in products to support healthy aging, sells a proprietary at-home Biological Age Test that can help health consumers track whether their supplements are working.
Lower Barriers Driving Innovation
There are no two ways about it: The regulatory landscape surrounding the health industry is uniquely complicated. But the good news is that barriers to entry for diagnostic test developers are actually lower than ever. Right now, there are two main paths to market. In the first, developers package their product and ship it to any diagnostic lab that can run the test. The second option is to offer testing through dedicated CLIA-certified labs. Here, companies like Everlywell and others are offering white-label testing to help developers move to market fast. For these Lab Developed Tests (LDTs), developers don’t need to wait for FDA approval—as long as they go through the necessary validation steps to demonstrate their test’s utility.
The management of protected health information (PHI) also raises regulatory concerns. Fortunately, Salesforce Commerce Cloud is a HIPAA-compliant solution that allows healthcare and life science companies meet these stringent requirements—and Astound Health has in-depth knowledge of FDA and international regulations for diagnostic testing and therapeutics, so we can help companies understand what’s required for compliance. By combining Astound’s industry expertise and Commerce Cloud’s out-of-the-box capabilities, health innovators can accelerate speed to market.
Where We Go From Here
For the next articles in this series, we’ll look at developments in the fields of health consumer technology and digital therapeutics. In the meantime, we’d love to hear from you. Reach out to learn more about how partnering with Salesforce and Astound Health can help you understand health consumer needs, create seamless user experiences, and architect compliant solutions that advance human health.