The Leapfrog Effect: New Tech Moves Tests, Treatments Out of the Clinic

Image: Nan_Got/Shutterstock

For a lot of people these days, medical clinics are no longer the center of the healthcare equation like they were in the past: their smartphones are now the point of focus.

An astonishing number of medical tests, treatments, and services have jumped out of the clinic and into peoples’ daily lives via their computers, phones, and wearables.

Call it the Leapfrog Effect

The trend has been building for decades, driven partly by health enthusiasts, biohackers, and ‘empowered’ patients eager to take greater responsibility for their wellbeing, and by tech companies equally eager to sell them the gizmos and apps to do so. But even within mainstream medicine, there’s been a strong, steady pressure to move disease management out of costly clinic settings and into patients’ lives.

The outpatient care model of the 80s and 90s paved the path for today’s retail-centric walk-in clinics and self-care modalities. Though retail medicine has gone through some gnarly fiscal gyrations in the last few years —exemplified by Walmart’s move in April to shutter its in-store clinics in five states—the convenience care model is here to stay, in one form or another.

And of course, there’s telemedicine—another trend that built slowly over decades and then surged during the Covid pandemic.

If you look around, you’ll see plenty of examples of this Leapfrog Effect.

The Liberation of CGM

Consider the recent launch of over-the counter, non-prescription continuous glucose monitors (CGMs).  A technology which was formerly the province of physicians treating type 1 diabetics is now a retail item that people can use on their own, in many cases without the involvement of a healthcare professional.

Over the summer the FDA approved Dexcom’s Stelo CGM for people with type 2 diabetes who are not yet on insulin, as well as two CGM systems from Abbott: Libre Rio a head-on competitor with Stelo, and Lingo—the first CGM approved for non-diabetic people who are simply concerned with their health and wellbeing.

FDA’s recent approval of non-prescription CGM systems opens self-guided glucose monitoring technology to a massive population of non-insulin dependent type 2 diabetics as well as non-diabetic health enthusiasts (Image: Goffkein/Shutterstock)

All three systems are linked to users’ smartphones. All of them liberate people from the burden of clinic visits and prescriptions. They’re HSA/FSA eligible, and accessible at friendly price points. Abbott’s Lingo sells for $49 per sensor, a package of two for $89, or six for $249. Stelo costs $99 for a pack of two, or users can subscribe for $89 per month to receive two new sensors every 30 days.

CGM is already a multibillion-dollar industry, and it is just getting started. According to 2023 data, roughly 70% of the 2.4 million current CGM users were type-1 diabetics, while only 3-4% had type 2. CGM’s growth potential among type 2 diabetics is staggering, and that’s not even counting the vast market of people with metabolic syndrome who hope to prevent progression to diabetes, or the non-diabetic health enthusiasts and biohackers who can now freely embrace CGM.

Ear Buds? No, Hearing Aids

Consider Apple’s new lineup of mobile devices, which the company announced in September.

This year’s “Glowtime” event showcased the new iPhone 16 series, the Apple Watch Series 10, and the AirPods 4, and a new operating system which integrates “Apple Intelligence”—that’s Mac-talk for “AI”—into the new gear.

The company’s offerings evoked a jaded yawn from the tech world and Wall Street—no major hardware redesigns, incremental but not revolutionary software improvements, and AI capabilities that at this point are more promise than actuality.

But from a healthcare perspective, Apple’s current lineup is a prime example of the Leapfrog Effect.

The new devices are packed with health and fitness features. The Apple watch includes an ECG monitor to detect atrial fibrillation and, potentially, other heart problems.  It can monitor sleep and detect apnea. It can ID a woman’s ovulation time. Its motion sensors can tell if an elder has a sudden fall or accident. And of course, the new watches and iPhones can host an astonishing array of self-tracking apps.

But what really caught my attention is the fact that the new AirPods Pro can detect hearing loss, and if needed, transform themselves into clinical grade hearing aids.

Sumbul Ahmad Desai, MD, VP of Apple’s Health division during the company’s 2024 “Glowday” product launch broadcast.

“The World Health Organization estimates that more than 1.5 billion people are living with hearing loss,” said Dr. Sumbul Ahmad Desai, VP of Apple’s Health division, during the September broadcast. She added that, “a staggering 75% of people diagnosed with hearing loss haven’t received the assistive support they need.”

That’s in part because conventional hearing aids are expensive, require multiple office visits, and the audio quality isn’t all that great. With its new AirPods Pro 2 selling at $249, and packed with self-adjusting audiometric features, Apple aims to solve this problem.

Paired with an iPhone, the system offers a simple, clinically-validated, 5-minute hearing test users can take at home. The app turns that data into a personalized hearing profile which, in turn, can modulate the function of the ‘pods, making them into customized hearing aids, “boosting the specific sounds you need in real time,” explained Dr. Desai.

This system is the result of Apple’s major investments in audiology research. The Apple Hearing Study is a huge collaboration with the University of Michigan that involves more than 160,000 real-world participants. Apple’s engineers used data from the project to develop its AirPods hearing aid system.

Apple’s AirPods Pro2 sells for $249 and can be converted into customized hearing aids without audiologist visits.

What’s notable here is that we’ve got a tech company that: A) invested heavily in clinical research; B) created a less expensive, more convenient, direct-to-consumer solution to a common health problem; and C) gave people a way of circumventing an entire segment of healthcare professionals—in this case audiologists—who up ‘til now had a strong lock on a specific medical problem—in this case, hearing loss.

DIY Diagnostics

Or, how’bout the now ubiquitous Covid test? There was a time, not so long ago, that polymerase chain reaction (PCR) testing was an esoteric fiefdom of geneticists, virologists, drug developers, and the like. Along came a global pandemic which pushed highly sophisticated virological tools out of the research world and into the nation’s medicine cabinets and kitchen counters with astonishing speed.

So common are Covid tests at this point, we easily forget just how revolutionary this was.

Many other types of tests have moved out of clinical settings and into drugstores and online retail outlets. For years now, people have been able to get their complete genomes read for the price of a good sushi dinner, all on their own without seeing a medical professional. Microbiome test kits are widely available in retail pharmacies and myriad online outlets, and there are plenty of online options for analysis and interpretation, all without involvement of a clinician.

There are DTC risk assessments for an ever-widening number of disorders. The FDA has approved several at-home tests for different types of cancers, as well as DTC tests to detect HIV and other sexually transmitted diseases. 

Functional medicine “specialty” testing is also moving into the DTC market.

Last year, under the guidance of Mark Hyman, MD, a company called Function Health emerged with a comprehensive bundle of more than 100 sophisticated biometric tests, selling directly to “wellness” consumers for $499. There is, for sure, a practitioner component to Function’s business model. But a quick glance at the company’s marketing shows without doubt that Function aims to engage non-practitioner customers.

Function Health bundles a wide range of sophisticated functional medicine tests and biometrics into an appealing, inexpensive, and consumer-friendly package for people interested in “taking charge” of their health.

It’s not just tests that have jumped out of the clinic box and into the marketplace.

A prime example: FDA’s recent approval of a self-administered version of AstraZeneca’s FluMist influenza vaccine. FluMist, which contains attenuated live flu viruses, has been on the market since 2003. But until now, it had to be administered by licensed practitioners. Not anymore. FluMist still requires a prescription, but people can take it at home. It’s a safe bet that we’ll soon see other types of self-administered vaccines. And it’s not a big leap to imagine that such things could eventually go non-Rx.

Rush to Retail

In the dietary supplement world, the rush to retail has been in full effect for years. This has always been consumer-centric industry. But 20 years ago, there were dozens of brands that sold exclusively through licensed practitioners. With a few exceptions, these brands were not available DTC.

That began to change around 2010, when online retail disrupted the cozy ecosystem that had evolved between ‘practitioner’ brands and “alternative” medicine clinics.

Brands that wanted to maintain practitioner-only exclusivity faced a huge challenge: unauthorized resellers who acquired stockpiles of practitioner-only products (usually via an incentivized clinician) and sold them DTC on Amazon and other platforms, usually undercutting practitioner prices. “Channel leak” is what industry executives called it. And though unethical, there are no laws or even any legal principles that prohibit this.

After a decade of relentless effort to eliminate or at least contain the unauthorized DTC resale, most clinic-focused brands came to accept the hard truth that people love convenience and low prices.

Only a handful of companies still maintain a true practitioner-only position and refuse to sell directly to online customers. Most now have their own DTC retail strategies, whether online or brick-and-mortar, though they continue to serve practitioners, and their clinical pedigree remains an important aspect of their appeal. 

America’s Love-Hate with Doctors

The leapfrogging of products and services out of the practitioner realm and into the consumer market is influenced by many things, not least of which is the schizoid love-hate relationship many Americans have with doctors.

On one hand, “Doctor-recommended,” “Clinically proven,” and variants of such language are among the most common tags marketers like to put on their products. And for good reason: most people still view physicians as skilled, knowledgeable experts. Yes, they want to feel in charge of their health decisions, but they also want a doctor’s blessings on their choices.

Yet public esteem for the medical profession has dimmed over the decades, and recent consumer surveys suggest consumer trust in practitioners is at an all-time low—especially when it comes to nutrition, supplements, and wellness.

At Nutraceutical World’s recent Health and Longevity conference in New York City, market research consultant Carly Fink noted that only 31% of consumers she surveyed said they seek advice about health, wellness, and supplements from medical professionals. By contrast 49% get their advice from social media, and 47% from friends and family.

In a recent survey of more than 2,300 US consumers by Pure Branding, 29% of respondents said their trust in the medical system has decreased in recent years, while only 19% said their trust has increased. According to this survey, the number of people who view the medical system as “Seriously flawed” or “Extremely corrupt and harmful” went from a combined total of 22% before Covid to 34% this year.

Concurrently, 58% of Pure’s cohort say their “desire to take charge of my own health” has increased.

In a sense, the Leapfrog Effect is the logical outcome and full flowering of the “empowered patient” trend that began in the 1960’s, and which accelerated 20 years ago with the expansion of the internet. “Self-care” and “Health Freedom” have long been the rallying cries of this movement that encouraged people to take greater responsibility, and to question medical authority.

In an insightful blog post earlier this year, Pure Branding’s founder Yadim Medore notes that the Covid pandemic “created a more critical and informed supplement consumer. Whether they actually are more knowledgeable or not, they think they are.”

This raises an important point: the rapid proliferation of DTC tests, tools, and products gives people access to an unprecedented amount of real-time data about their own physiology, as well as new and often powerful tools for influencing it.

But do people really know what do with all of this information? Will it lead to the better health? Will it optimize disease management, and improve longevity like the tech companies promise? To what extent can ordinary people without medical training intelligently manage their health? Where does self-care end and stupidity begin?

And importantly, are today’s clinicians up to the task of helping patients make sense of the wealth of data and treatment options now available to them? 

There are still many tests, treatments, and services that can only be obtained from physicians and other qualified, licensed professionals. So, it’s safe to say that practitioners will remain an important part of many peoples’ lives for the foreseeable future—especially people who are dealing with serious diseases.

But it is also obvious that nature of patient-practitioner relationships–and the technologies and interpersonal dynamics that shape those relationships–are all in flux. And all of this will no doubt get faster and weirder as AI systems enter more deeply into healthcare.

Practitioners who ignore or shy away from the Leapfrog trend do so at their own peril.

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