By 2030, all Baby Boomers will be 65 or older, meaning that nearly one in five Americans will be in their senior years. At the same time, a clear majority of older adults say they want to remain in their homes as they age. Research from AARP consistently shows that more than three-quarters of adults 50+ prefer to age in place.
This combination of rapidly expanding demand for care and a strong preference to receive it at home is colliding with another powerful force: the accelerating capabilities of testing and monitoring diagnostics, furthered by connected devices and AI.
As this shift accelerates, a theme keeps resurfacing in conversations with senior leaders: diagnostics are no longer confined to the central lab. Increasingly, forward-looking health tech companies are looking for ways to deploy software, data, and intelligent systems to meet patients where they are—at home, in pharmacies, and across near-patient settings—reshaping how and where care is delivered across the continuum.
Market momentum: why this matters now
Recent analyses make the momentum impossible to ignore. Deloitte’s global health care outlook describes a sector undergoing “unprecedented transformation,” driven by aging populations, technological advancement, and evolving patient expectations, with remote technologies and new care delivery models reshaping where and how care is delivered.1
That shift is already visible in both consumer behavior and provider adoption. Nearly a quarter of consumers say they would switch providers to access virtual care, underscoring rising demand for more convenient, decentralized options. At the same time, more than 350 U.S. hospitals are now delivering hospital-level care at home, reflecting how quickly distributed care models are moving from concept to operational reality.2
Regulatory tailwinds: home as a care hub
In the United States, the FDA’s evolving posture on home-use and direct-access diagnostics is a visible signal of where the industry is headed. The FDA maintains an extensive list of authorized at-home OTC COVID-19 tests and continues to update it in 2026, underscoring that rapid home-based testing is now a durable tier of the diagnostic ecosystem. The agency’s framework for these tests has helped normalize self‑testing as part of routine care, not just emergency response.3
Today’s regulators are increasingly engaging with a wider class of home-use technologies including connected monitoring devices, wearable sensors, and software-enabled tools that interpret health signals outside traditional clinic settings.
Multiplex and rapid platforms are expanding from infectious disease to cardiometabolic markers and other chronic disease applications, often embedded in handheld or mobile-connected devices. Analysts also note that AI‑enabled tools and connected diagnostics are central to the broader healthtech market’s expected growth as health systems seek to move more care out of hospitals and into outpatient and home settings.1,2,4
In April 2026, the FDA’s Center for Devices and Radiological Health launched the READI‑Home (Reducing Readmissions through Device Innovation for the Home) Innovation Challenge as part of its “Home as a Health Care Hub” initiative. The program seeks medical devices that support patients and caregivers after hospital discharge, with the goal of preventing avoidable readmissions and enabling safe care in the home.5,6
At the same time, legal and policy updates on digital health and clinical decision support indicate that the FDA is preparing for AI-driven, software-rich diagnostics that may interpret data with limited human oversight. Commentators emphasize that the 2026 digital health framework increasingly favors companies that can pair regulated devices with robust software, data, and evidence strategies rather than standalone hardware.7
A March 2026 public meeting hosted by the Reagan‑Udall Foundation for the FDA, “Over‑the‑Counter Diagnostics: Advancing Home as a Health Care Hub,” further underscored that consumer use of at‑home tests has become an established element of the health system, reshaping how and where people access information about their health.8
From hardware to ecosystems: new business models for diagnostics
As important as the changes to where diagnostics occur are, how they occur may be even more transformative. Healthtech and medtech outlooks indicate leading companies are shifting from transactional device sales to platform models that bundle instruments, consumables, software updates, and analytics into recurring revenue streams.4,9
For example, clinical stakeholders increasingly expect respiratory and sexually transmitted infection panels to be available as rapid tests in urgent care, emergency departments, and pharmacies, with results flowing into electronic health records and telehealth platforms. At the same time, connected devices, ranging from smart scales and blood pressure monitors to wearable sensors and ambient technologies, are generating continuous streams of patient data that complement and extend traditional testing.
At-home screening and monitoring tools for chronic conditions and certain cancers are increasingly integrated into payer-sponsored care-management programs and virtual care pathways, sometimes combining episodic testing with longitudinal data from connected devices.1,10
Consultancies and industry groups stress that the most successful products are embedded in broader care pathways, such as hospital‑at‑home programs, virtual wards, and chronic disease management, rather than positioned as isolated testing events. This “diagnostics‑as‑infrastructure” view increasingly encompasses both discrete tests and continuous sensing technologies, favoring platforms that support ongoing engagement and longitudinal data capture, rather than single time‑point results.4,9
Real-world signals
Several recent developments illustrate how quickly at‑home, point‑of‑care, and near‑patient diagnostics are reshaping the landscape:
- First fully at‑home STI panel for women
In 2025, the FDA granted marketing authorization for the first fully at‑home test for chlamydia, gonorrhea, and trichomoniasis, enabling women to collect and test samples entirely at home in about 30 minutes. This milestone showcases growing regulatory comfort with complex self‑testing in sensitive therapeutic areas and sets a precedent for more advanced home‑use diagnostics.10 - At‑home COVID‑19 tests as a permanent tier
The FDA’s continued management and updates to the at-home OTC COVID-19 test list in 2026 indicate that rapid home-based testing has become a lasting layer in the diagnostic stack rather than a temporary pandemic response. Health systems and employers are increasingly incorporating these tests into respiratory‑season protocols and outbreak playbooks.3,11 - READI‑Home and the hospital‑at‑home push
Through READI Home, CDRH plans to select up to nine devices for an “interaction phase,” offering enhanced engagement and feedback to accelerate the development of home-use technologies that can reduce readmissions. 5,6 - Virtual wards and near‑patient diagnostics
Analyses of hospital-at-home and distributed-care models suggest that bedside- and home-deployed diagnostics, such as connected glucose monitors, home blood pressure devices, pulse oximetry, and portable analyzers, are becoming the diagnostic backbone of virtual wards. Payers and providers are experimenting with contracts that tie payment to reductions in admissions and emergency utilization, making near‑patient diagnostics and routine monitoring central to value‑based strategies.9,11,12
Key trends executive should track in 2026
- AI‑infused point‑of‑care and near‑patient platforms
Clinical diagnostics experts expect AI to move deeper into real‑time testing environments, supporting smart triage based on POC panels, pattern recognition in signals from wearables, and automated decision support at or near the bedside. Mayo Clinic and other leaders have framed this shift as moving from simple “turnaround time” to “clinical actionable time,” with value defined by how quickly results change decisions.4,13 - Consumer‑grade user experience for clinical‑grade tests
Programs such as READI‑Home and the Reagan‑Udall OTC diagnostics meeting emphasize usability, human factors, and clear instructions as critical enablers of safe home‑based testing and device use. Companies are investing in design, behavioral science, and patient communication to ensure non‑professionals can reliably perform and interpret tests.5,7,8 - Convergence of diagnostics, telehealth, and remote patient monitoring
Market and investment reports highlight the growing intersection between at‑home diagnostics and remote patient monitoring platforms, particularly for cardiovascular, metabolic, and respiratory conditions. Startups are building “intelligence layers” that fuse device data, lab values, and patient‑reported information into prioritized alerts and workflow‑ready insights for clinicians. 4,12 - Investor focus on scale, evidence, and reimbursement clarity
Medtech investment analyses indicate that capital in 2026 is concentrating on companies demonstrating regulatory readiness, payer-aligned value propositions, and early real-world evidence, particularly reductions in acute utilization and improved outcomes in distributed care models. Deloitte also notes that portfolio strategies are shifting toward high-growth, AI-enabled, and outpatient-oriented offerings that support this decentralized model of care.9,11,13
Talent implications: building teams for distributed diagnostics
All of these dynamics converge on a people question: what capabilities do you need to win in at‑home, point‑of‑care, and near‑patient diagnostics? Healthtech talent specialists consistently point to a few critical profiles.
- Clinical‑design and human‑factors leaders who can translate regulatory and clinical requirements into intuitive, safe, and accessible experiences for patients and caregivers in the home or near‑patient environment.5,8
- Software, data, and AI talent capable of building secure, interoperable platforms that integrate diagnostics data, wearables inputs and device-generated signals with electronic health records, telehealth systems, and remote monitoring dashboards. Of course, this all needs to be handled in ways that are cognizant of managing privacy, cybersecurity, and algorithmic transparency.4,12,13
- Market access and reimbursement strategists who understand evolving payment pathways for hospital‑at‑home, remote monitoring, digital diagnostics, and value‑based care, and who can articulate clear ROI to payers and provider groups.9,12,14
Organizations that intentionally blend these capabilities, rather than treating diagnostics purely as a lab or R&D function, are most likely to translate technical breakthroughs into durable commercial success.
Questions for your 2026 roadmap
For health technology leaders planning the back half of 2026, at‑home, point‑of‑care, and near‑patient diagnostics are no longer optional experiments; they are essential components of modern care delivery.
As you refine your strategy, it may be helpful to ask:
- Are your diagnostic products and partnerships designed for the home and near‑patient setting, or only for the lab of the future?
- Do your leadership and functional teams reflect the cross‑disciplinary mix needed to design, deploy, and scale diagnostic ecosystems rather than isolated devices?
The organizations that can answer “yes” to both questions will be the ones shaping how, where, and by whom care is delivered in the years ahead.
Sources
- Deloitte, “The Growing Disconnect Between Virtual Health Availability and Consumer Demand” (Oct 16, 2024)
- The Washington Post, “Bringing Hospital Care to Patients’ Homes” (Feb 25, 2025)
- U.S. Food and Drug Administration, “At Home OTC COVID 19 Diagnostic Tests” (Feb 22, 2026)
- Coherent Market Insights, “Healthtech Market Size, Opportunities & YoY Growth Rate, 2033” (Mar 29, 2026)
- U.S. Food and Drug Administration, “FDA READI Home Innovation Challenge: Reducing Readmissions Through Device Innovation for the Home” (Apr 6, 2026)
- MedTech Dive, “CDRH Targets Hospital Readmissions with Home Device Innovation Challenge” (Apr 8, 2026)
- Nixon Peabody, “For 2026, FDA Signals Shifts in Digital Health Framework” (Jan 26, 2026)
- Reagan Udall Foundation for the FDA, “Over the Counter Diagnostics: Advancing Home as a Health Care Hub (Public Meeting)” (Mar 25, 2026)
- PwC, “Next in Medtech 2025: Prepare to Win in the Future of Health” (Sep 30, 2025)
- U.S. Food and Drug Administration, “FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis” (Mar 27, 2025)
- Fierce Healthcare, “What’s Next for Clinical Diagnostics in 2026?” (Jan 25, 2026)
- Sermo, “Identifying Viable Healthcare Business Ideas for 2026” (Mar 24, 2026)
- Mayo Clinic Laboratories, “Dr. Bill Morice Predicts Clinical Diagnostic Trends for 2026” (Feb 9, 2026)
- Deloitte, “Three Key Trends Likely to Shape Medtech in 2026” (Jan 25, 2026)
About the Author
Paula Norbom is the Founder and CEO of Talencio, an executive search and staffing firm serving health technology companies. She has worked in the health technology industry for over 30 years.