Developing commercially successful diagnostic devices
Look beyond the assay - a parallel development approach that factors in the instrument, consumable, and context of use will ensure optimal alignment of a technology with the target market. Article by Paul Wilkins, SVP Medical at Sagentia, published in IVDT.
When developing an IVD device, typically the first thing that comes to mind is the assay: what is the sample being tested for and how is the target detected? This is the central thinking of most companies, whether they are setting out to extend a product’s lifespan or to bring a disruptive new technology to market. However, while the assay is core, focusing exclusively on this can significantly minimize the potential market scope and lead to commercial failure.
In this article, we will evaluate a more comprehensive development approach that starts with the assay but also considers the instrument, the consumable and the context of use—an oft-neglected theme that warrants its own discussion. It will become clear that all of these themes are intricately linked and cannot be considered in isolation, requiring parallel development with regular input from all key stakeholders.