by Staci J Kearney, PhD, RAC, Elevation Strategic Development, LLC


The expansion of precision medicine has placed a greater focus on the need for pathology insights that can enhance patient care. This increased need requires delivering high-quality digital pathology tools and applications to pathologists for the benefit of patients. However, bringing advanced diagnostic devices to the clinical market takes significant time, resources, and a commitment to meeting multi-layered regulatory requirements. Navigating the regulatory process requires skilled regulatory affairs and clinical affairs (RACA) professionals who focus on fulfilling these regulatory requirements throughout a product’s life cycle.


Members of the Digital Pathology Association (DPA) who represent practicing pathologists and industry developers recently collaborated on a publication that describes the critical role of RACA professionals in the delivery of innovative digital imaging devices and software. The collaboration was motivated by a shared commitment to increase understanding of the regulatory process behind digital pathology tool development in order to advance delivery and adoption of these tools. The article describes how the regulatory landscape shapes the delivery of clinical products and establishes a mutual vocabulary to facilitate understanding of the application of regulatory requirements. Both are intended to bridge the gap between the mindsets of the developer and the end user.


Please visit Frontiers in Medicine to read the publications entitled, Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs (RACA) in the Total Product Life Cycle (TPLC) of Pathology Imaging Devices and Software.


Disclaimer: In seeking to foster discourse on a wide array of ideas, the Digital Pathology Association believes that it is important to share a range of prominent industry viewpoints. This article does not necessarily express the viewpoints of the DPA, however we view this as a valuable point with which to facilitate discussion.