What Is Clinical Utility and Why Should We Care?

Broadly speaking, utility is a measure of the personal benefit that someone has from an intervention, outcome, product, or process. “Clinical utility” is a term that is widely used in medicine to describe the relevance and usefulness of an intervention in patient care .

Who Cares? and Why ? are probably the most fundamental questions that MedNest asks to its clients from oversees, … often perceived as disturbing questions! Simply said, stakeholders in healthcare want to know the benefits offered by a novel medical technology are valid and useful in the context of the U.S. Healthcare practice.

The question of evidence generation to support clinical utility is key, as the clinical utility of a medical device or a medical software solution (for instance) is often context-dependent.

When it comes to diagnostics, “Clinical utility refers to… the value of information to the person being tested. If a test has utility, it means that the results provide information that is of the value to the person, because he or she can use the information to seek an effective treatment or preventive strategy. Even if no intervention are available to treat or prevent a disease, there may be benefits associated with knowledge of a results” [1].

There is an obvious link between clinical utility and intended use, which ties the “value proposition” with the FDA regulatory pathways. This important relationship is often misunderstood by foreign MedTech companies resulting in significant mistakes in the definition of product concepts and their related regulatory pathways. MedNest’s programs address these important questions to reduce the risk and cost of a U.S. Market entry plan.


[1] What Is Clinical Utility and Why Should We Care?Larry Lesko, I Zineh, S-M Huang December 2010 Clinical Pharmacology & Therapeutics 88(6):729-33 DOI:  10.1038/clpt.2010.229 - Weblink / ResearchGate