The essential partnership: Laboratory medicine professionals as drivers of in vitro diagnostics innovation

The rapid evolution of in vitro diagnostics (IVD) and clinical laboratory testing demands a sophisticated level of partnership between commercial manufacturers and the clinical laboratory community that leverages their combined strengths. Laboratory medicine professionals must be recognized not simply as end-users of diagnostic tools, but rather as co-producers of diagnostic quality and innovation. These professionals play a pivotal role in the healthcare system by providing services that are critical to patient well-being, diagnosis, treatment, and management. In particular, they can support vendor product development across four primary dimensions: clinical problem framing, design collaboration, evaluation partnership, and post-market data generation.

Labs as problem identifiers and innovators

Laboratory professionals are often the first to identify clinical needs that commercial solutions fail to address, thereby serving as problem framers for future vendor roadmaps (1). CLIA-designated high-complexity laboratories create laboratory developed tests (LDTs) either because a suitable Food and Drug Administration (FDA)-cleared IVD is unavailable, or because the lab needs to extend or modify existing kits to meet a specific clinical requirement. This process is common in rapidly evolving fields such as genetic testing, toxicology, and pediatric testing where the pace of scientific discovery often outruns the lengthy FDA review process.

In such cases, LDTs may serve as early prototypes for tests that could eventually be submitted to FDA for commercial authorization. This is one of the many ways in which laboratories actively fill gaps that vendors could address more effectively by routinely engaging with laboratorians in a wide variety of environments.

Labs as co-designers and evaluators of technology

The FDA’s requirements for IVD clinical performance studies implicitly position clinical laboratories as essential partners in both study design and execution. As a result, IVD manufacturers rely heavily on clinical laboratories to demonstrate the reliability and robustness of new assays through reproducibility and performance studies. In particular, manufacturers are often dependent on clinical laboratories for essential needs such as access to clinical sites, patients, and specimens, as well as the timely and rigorous execution of clinical trials. Laboratory professionals are also critical in guiding vendors on real-world workflows, clinically relevant endpoints, and precise sample handling protocols (2).

Labs as stewards of interoperability and data quality

In the contemporary healthcare ecosystem, diagnostic data must flow seamlessly between laboratory analyzers, laboratory information systems (LIS), and electronic health records. However, nonstandardized encoding practices used by IVD manufacturers and other vendors lead to significant challenges in managing and analyzing laboratory data. Studies have shown that the integrity of data moving from the analyzer to the LIS can drop to as low as 59%, resulting in an actual data integrity rate of only 22%-68% throughout a single lab data lifecycle round-trip (3). This poor data integrity is often caused by manual transformation and translation errors.

To overcome these obstacles, the Association for Diagnostics & Laboratory Medicine (ADLM) supports efforts to improve the interoperability of laboratory test results and calls for collaboration among healthcare providers, manufacturers, informatics vendors, and payers to establish a common framework for information standards (4). Laboratory experts need to be involved early in product design to define what standardized data elements are needed to ensure that information is consistently structured and interpreted across different settings.

The FDA’s Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) collaboration exemplifies this approach, bringing together academic, federal, and industry partners to develop comprehensive solutions for clinical and semantic interoperability of IVDs across the entire data lifecycle (5). SHIELD aims to build a publicly accessible infrastructure to improve the quality, interoperability, and portability of IVD laboratory data.

Partnerships for implementing novel solutions

Laboratories have high expectations for collaborations with IVD manufacturers regarding the adoption and implementation of artificial intelligence (AI) and machine learning tools. Laboratory professionals widely predict that AI will have a dramatic impact on current diagnostic testing processes. The greatest immediate potential cited for AI applications is increased operational efficiency, achieved through automating repetitive tasks, mitigating manual labor, and improving diagnostic test utilization (6). This requires laboratories to guide vendors on validating AI-enabled products using outcomes data and real-world evidence to demonstrate clinical utility.

Tips for getting started with vendor partnerships

To initiate the process of collaborating with vendors and shaping product development, laboratory medicine professionals should focus on consistently providing meaningful feedback and engaging in structured dialogue with manufacturers. One direct pathway is participating in surveys commissioned by vendors and market research organizations, which seek input on laboratory needs, concerns, and expectations regarding new technologies.

Beyond formal research, professionals should seek other opportunities to convey diagnostic testing needs and offer input on workflow requirements. This engagement can occur during scheduled sales calls, where laboratories can provide meaningful feedback and discuss areas where commercial solutions may be lacking, thereby acting as clinical problem framers. Similarly, interactions at tradeshows can be leveraged to establish and refresh relationships with industry, helping to accelerate the pace of development and translation of advancements into routine clinical practice. The goal of this consistent engagement is to foster an interactive, bidirectional relationship that involves the exchange of ideas, resources, and expertise to accelerate diagnostic advancements.

In conclusion, the partnership between laboratory medicine professionals and IVD vendors must move beyond a transactional relationship to a fully integrated collaborative model. By embracing the critical roles of problem framers, co-designers, and data quality stewards, laboratory professionals ensure that regulatory requirements are met, innovation is fostered, and diagnostic tools achieve the highest levels of safety and clinical utility for patients.

References

1. The Pew Charitable Trusts. The role of lab-developed tests in the in vitro diagnostics market. https://www.pew.org/en/research-and-analysis/reports/2021/10/the-role-of-lab-developed-tests-in-the-in-vitro-diagnostics-market (Accessed December 4, 2025).
2. Durack DT, Dunn JJ. Fostering partnerships between industry and the clinical microbiology laboratory. J Clin Microbiol 2011; doi: 10.1128/JCM.01064-11.
3. Bernstam EV, Warner JL, Krauss JC, et al. Quantitating and assessing interoperability between electronic health records. J Am Med Inform Assoc 2022; doi:10.1093/jamia/ocab289.
4. ADLM. Interoperability of clinical laboratory results. https://myadlm.org/advocacy-and-outreach/position-statements/2023/interoperability-of-clinical-laboratory-results (Accessed December 15, 2025).
5. FDA. SHIELD. https://www.fda.gov/medical-devices/diagnostic-data-program/systemic-harmonization-and-interoperability-enhancement-laboratory-data-shield (Accessed December 4, 2025).
6. Rabbani N, Kim GYE, Suarez CJ, et al. Applications of machine learning in routine laboratory medicine: Current state and future directions. Clin Biochem 2022; doi: 10.1016/j.clinbiochem.2022.02.011.

Frederick G. Strathmann, PhD, MBA, DABCC (CC, TC), is senior vice president of global business and MOBILion Systems in Chadds Ford, Pennsylvania and additionally serves as a part-time CLIA lab director for multiple organizations. +Email: [email protected]