Blog | 9/29/2025
The Lab of the Future (Issue 3): From Reactive Testing to Predictive Intelligence
By Donna Hochberg, PhD, Chris Karras, Martha O’Neill, Rebecca Podolsky, and Laura Ory
Imagine a clinical laboratory that doesn’t just confirm disease, it forecasts it. A lab that functions like a command center for human health, predicting adverse events before symptoms arise, guiding interventions before crises unfold, and reshaping the very fabric of healthcare delivery. This is not science fiction, but the quickly emerging Lab of the Future, which is being shaped by a rapidly changing macro environment in healthcare and is poised to redefine diagnostics, care pathways, and business models across the healthcare ecosystem.
For IVD product companies (OEMs), this transformation represents the next battleground for growth. OEMs will be expected to supply the instruments, assays, automation, and software that enable predictive, decentralized, and value-based diagnostics. But the role of OEMs will not end there. To adapt to the new reality, companies will need to take on a greater role in partnership with the Lab of the Future to navigate shifting business models and integrate their solutions into the laboratory ecosystem.
In our third issue of our Lab of the Future series, we dig in on how OEMs can best prepare for the long term. If you missed the first two posts in the series, you can find them here:
Post 1: Winds of Change: The Forces Reshaping the Clinical Lab
Post 2: Lab of the Future Panel at ADLM – Full Recording
1. Shifting Business Models: From Fee-for-Service to Value-Based Care
The traditional reimbursement model is under strain across the globe. Declining reimbursement rates, payer incentives for large commercial labs, and the shift to value-based care are squeezing margins and impacting the bottom line. Smaller labs face the biggest challenges, with staffing shortages and limited access to capital further impacting their sustainability. Labs are looking for operational efficiencies and embracing new revenue streams to combat this effect.
Value-based care demands that labs demonstrate their impact on clinical decisions, care optimization, and cost avoidance. This requires a fundamental shift: labs must explore fundamentally different business models, moving away from transactional testing and toward strategic risk stratification. For example, US labs are exploring alternative models—subscription-based reimbursements, cash-only systems, and partnerships with “payviders” to align incentives around outcomes.
Implications for OEMs: To thrive, OEMs must link testing financials to patient outcomes with alternatives to traditional reagent rental and cost-per-reportable models. For example, subscription and risk-sharing contracts tied to specific metrics (e.g., reduced admissions or improved population health) may better resonate with payers, providers, and most importantly labs.
2. Collaboration and Ecosystem Partnerships: From the Basement to the Boardroom
The Lab of the Future cannot evolve in isolation. Collaboration across the healthcare ecosystem is essential, where clinicians, payers, pharma, tech firms, and startups all must play a role. Where historically labs have worked alone, they now must move beyond the basement to assume a seat at the table, co-designing care models, sharing data, and aligning incentives around outcomes.
Early-stage partnerships, especially those involving longitudinal data and biological samples, are unlocking massive value in biomarker discovery and digital diagnostics. Engaging with other entities across the healthcare industry will enable labs to leverage the data they already produce to expand their reach and improve patient outcomes.
Implications for OEMs: OEMs must move beyond transactional relationships and position themselves as strategic collaborators. By co-developing solutions with labs, payers, pharma, and digital health innovators, OEMs can unlock new revenue models, accelerate biomarker discovery, and solidify their role at the heart of the diagnostic ecosystem.
3. Decentralization and Consumer-Driven Diagnostics: New Customers to Serve
We are seeing the growing democratization of patient care. As care moves closer to the patient and medical deserts shrink, the Lab of the Future will no longer be confined to centralized facilities. Testing needs to be flexible enough to be performed at the pharmacy on the corner, local community sites, or in the patient’s home. Disposable over-the-counter testing, wearables, and novel sample types & devices (e.g., saliva, sweat, tears, and breath) are expanding access to diagnostics, driven by consumer demand for convenience, privacy, and control over health data.
Direct-to-consumer models are expanding, offering patients the ability to self-collect samples and receive results without clinical intermediaries. While this trend introduces challenges, it also creates new opportunities for labs to serve as confirmatory hubs and consultative partners. But patients represent an entirely new customer segment for labs, which don’t historically have experience here. Therefore, labs will need to partner with OEMs to launch holistic solutions that integrate a convenient customer experience with clearly interpreted results, transparency with out-of-pocket costs, and a convenient path to clinical follow-up.
Implications for OEMs: Companies should expand their CLIA-waived and home-testing offerings, with strong connectivity to central labs. Strategic alliances with retail health, telemedicine, and wearables firms will be critical to drive the future vision, since the optimal offering must provide a convenient end-to-end solution for the patient from test ordering through result interpretation and clinical next steps.
4. Preventive Medicine: The Future Lab’s Strategic Role
Healthcare is increasingly shifting from reactive treatment to proactive, preventive care, focusing on early detection, lifestyle interventions, and personalized wellness strategies to improve outcomes and reduce long-term costs. To keep up, the Lab of the Future must become a partner in care. By leveraging longitudinal data and predictive analytics, labs can identify disease risk, guide early interventions, and support population health strategies. This positions labs as first responders in care triage, capable of dictating who needs to be seen, when, and why.
Genomic analysis, liquid biopsies, and cell-free DNA testing are expanding the scope of preventive diagnostics, especially in oncology and chronic disease management. As labs integrate with multidisciplinary care teams, their role in shaping clinical protocols and therapeutic decisions will grow.
Implications for OEMs: The opportunity for OEMs lies in developing preventive assays and generating evidence that links early detection to savings in healthcare costs—vital for payer coverage and customer adoption.
5. Integration of Multimodal Data: Toward Holistic Diagnostics
As ‘big data’ gets bigger, individual lab results will no longer stand alone. Each result will be taken in combination with wearables data, radiology findings, patient genomics, and the patient’s EMR history to deliver synthesized, holistic insights. AI will play a central role in managing and interpreting this data, enabling precision medicine and personalized care.
Plug-and-play platforms are emerging to cleanse, integrate, and capitalize on lab data, often developed by external innovators rather than labs themselves. This raises strategic questions for lab leaders: should they build internal capabilities or partner with tech firms? How can they ensure data portability, privacy, and interoperability?
Implications for OEMs: Developing interoperable software and data platforms that serve as “diagnostic operating systems” will position OEMs at the center of holistic diagnostics. OEMs should think beyond traditional in vitro solutions and look to diversify their portfolios to include other diagnostic verticals, such as digital biomarkers or software solutions.
6. Rise of AI-Driven Automation: Enabling Operational Efficiency
While the growth of AI-driven analytics and interpretation is clear, AI is also enhancing efficiency by optimizing laboratory workflows. Laboratories are increasingly adopting automation to combat labor shortages and rising test volumes. From specimen handling to test performance and data integration, automation is streamlining operations and reducing human error.
“Lights-out” labs—fully automated facilities requiring minimal human intervention—are no longer theoretical. They are currently being piloted, and if successful, represent scalable solutions for high-volume testing. As AI becomes embedded in quality control, operational systems, and diagnostic algorithms, the skill set of lab professionals will shift toward IT competence and biomedical engineering.
Implications for OEMs: Instrument design must be modular and AI-ready, with seamless integration into LIS, EMR, and existing track systems. Providing open APIs and data-science toolkits will be a key differentiator.
7. Evolving Roles and Skills: The Digital Laboratorian
As technology transforms lab operations, the workforce must evolve. Traditional bench scientists are being replaced—or complemented—by mechanical engineers, data scientists, and bioinformaticians. The rise of digital pathology and remote diagnostics is enabling “Uber-style” pathologists to work globally, untethered from physical labs.
Training programs, online certifications, and interdisciplinary education are essential to bridge skill gaps and attract new talent. Labs must also advocate for professional recognition, fair reimbursement, and leadership roles for clinical lab scientists to elevate their visibility and influence.
Implications for OEMs: Beyond selling instruments, OEMs can provide workflow advancements, digital training tools, embedded analytics, decision support tools, and virtual service models that reduce workforce strain and accelerate adoption.
Conclusion: A Call to Action for IVD OEMs
The Lab of the Future is not a distant vision—it is unfolding now. For in vitro diagnostic OEMs, the imperative is clear: build adaptive platforms, consider outcome-linked business models, embrace AI and data-driven tools, and forge partnerships across the healthcare ecosystem. Companies that remain test suppliers will risk commoditization, but those that reposition as enablers of predictive, integrated, and value-based diagnostics will shape the next decade.
As we stand at this inflection point, the question is not whether labs will change, but how fast and how far. The opportunity for OEMs is immense. This transformation will demand leadership, strategic foresight, and a willingness to challenge entrenched norms. The question is whether OEMs will be the ones driving change and shaping the future or simply reacting to it.
The risks are real. And the time to act is now.
If you’re interested in learning more on how to prepare your organization’s strategy for the future, please contact us at diagnostics@healthadvances.com.