FAQ: In Vitro Diagnostics (IVDs)

Question & Answer with IVD Expert, Cortez McBerry, PhD

The Future of IVDs: How Point-of-Care Testing and Diagnostic Miniaturization Are Transforming Healthcare 

In vitro diagnostics (IVDs) are rapidly reshaping the future of healthcare, making diagnostic testing faster, more accessible, and increasingly patient-centered. Advances in point-of-care testing (POCT), miniaturized diagnostic technologies, wearable devices, and connected health solutions are enabling clinicians to deliver timely insights closer to the patient than ever before. As these technologies continue to evolve, they also introduce new technical, manufacturing, and regulatory considerations that developers must address to bring innovative diagnostic devices to market.

In this Q&A, we explore some of the most significant trends influencing the IVD landscape, including the rise of diagnostic miniaturization, the expanding role of point-of-care testing, and the challenges innovators face as they develop the next generation of diagnostic technologies.

What is an area in MedTech that you see growing exponentially?

Dr. Cortez McBerry: Point of Care testing (POCT) and diagnostic miniaturization are two areas that are growing exponentially with the market expected to reach 80.75 billion by 2033. Diagnostic medical devices have become a keystone in the healthcare system that continues to rely more and more on the use of diagnostics in patient care and management. The miniaturization of diagnostics is future-state technology that has arrived and highlights the ever-growing need for novel solutions in MedTech to improve patient access and timeliness of response to changes in an individual’s health.

Would you speak in depth about these two areas – POCT and diagnostic miniaturization?

Dr. Cortez McBerry: Miniaturization of clinical analyzers represents the convergence of technology and engineering and is leading to a new class of compact benchtop analyzers which can perform chemistry, hematology, and molecular in vitro diagnostic tests with improved analytical and technological characteristics. Additionally, wearable devices for continuous measuring and monitoring of biomarkers – including interstitial glucose – are also gaining significant attention. These are burgeoning areas of development in the diagnostic space due to the miniaturization of instrument hardware, improved sensor technology, and portable diagnostic tools - including the use of smart-phone based devices and companion apps - has broadened the reach of POCT and wearable technology has provided more targeted and personalized care.

Where do you think diagnostic miniaturization will be most crucial and impactful?

Dr. Cortez McBerry: Miniaturization of diagnostics is a crucial development for infectious disease analyses, chronic disease monitoring and connected health initiatives in decentralized care settings. While a core tenet of miniaturization of diagnostics is increased access, it has also significantly reduced cost - up to 75% and increased the speed in which healthcare professionals can respond to a patient’s needs, while maintaining the sensitivity (accuracy) of larger test systems. Miniaturization was made possible via the incorporation of new technologies, such as microfluidics, lab-on-a-chip (LOC), nanotechnology, and artificial intelligence smart systems (integrated with smartphone cameras).

What challenges do you see with these technological advances?

Dr. Cortez McBerry: As with all technology, there are challenges – ranging from technical, manufacturing costs, and regulatory hurdles for new, unconventional diagnostic devices that may have new contexts of use. These new technologies provide a multitude of challenges, including for regulators to understand the technologies and potential new indications for use so that they can apply existing regulation or draft new regulations to ensure device safety and efficacy. For developers of novel technologies, validating performance and consistency in manufacturing always presents challenges for quality, reliability, cost, and scalability for wide-scale deployment. 

Looking Ahead: Preparing for the Next Generation of In Vitro Diagnostics

The continued evolution of point-of-care testing, diagnostic miniaturization, and connected health technologies is transforming how healthcare providers diagnose, monitor, and manage disease. As these innovations become more sophisticated and widely adopted, developers must balance technological advancement with rigorous performance validation, scalable manufacturing, and evolving global regulatory expectations.

Successfully bringing next-generation in vitro diagnostics to market requires more than innovative technology. It demands a comprehensive development and regulatory strategy that accounts for changing standards, new intended uses, and the unique challenges associated with novel diagnostic platforms.

Whether developing a point-of-care device, wearable diagnostic, or another innovative IVD solution, understanding the trends shaping the market today can help organizations anticipate future challenges, reduce development risk, and accelerate the path to commercialization.