Wednesday, November 17, 2021

Very Brief Blog: "Bridging the Gap" - Regulatory Affairs, Reimbursement, Product Life Cycle - Focus on Digital Pathology

There have been a number of interesting lab industry policy articles originating from, or associated with, MGH in the last few months.  See an article on the costs of implementing VALID Act, Huang et al., here.  See an article on FDA, regulatory innovation, COVID regulation, and insights for the NEXT era of FDA lab regulation, Marble et al., here.

Add a third one.  This one is on the interface and interaction between regulatory affairs, reimbursement, and product life cycle management -- with a focus on the rapidly progressing digital pathology industry.  

Find Kearney et al, "Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software," open access, here.

By the way, their Figure 2, showing "regular LDT" and "FDA approved LDT at one site" and "IVD" is a nice one:

Kearney 2021 Fig 2
Enjoy - 

Below the break: Abstract and first paragraph.

Manufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits each stage of the TPLC. RACA professionals are important contributors to product development and deployment strategies because these professionals maintain an understanding of the scientific, technical, and clinical aspects of biomedical product regulation, as well as the relevant knowledge of regulatory requirements, policies, and market trends for both local and global regulations and standards. Defining a regulatory and clinical strategy at the beginning of product design enables early evaluation of risks and provides assurance that the collected evidence supports the product's clinical claims (e.g., in a marketing application), its safe and effective use, and potential reimbursement strategies. It is recommended to involve RACA early and throughout the TPLC to assist with navigating changes in the regulatory environment and dynamic diagnostic market. Here we outline how various stakeholders can utilize RACA to navigate the nuanced landscape behind the development and use of clinical diagnostic products. Collectively, this work emphasizes the critical importance of RACA as an integral part of product development and, thereby, sustained innovation.


Pathology is the cornerstone of patient care, providing diagnostic, prognostic, and therapy-predictive information to a health care team. In the era of precision medicine and digital health, digital pathology tools and applications, including artificial intelligence (AI)-based applications, are enabling pathologists to deliver high-quality care to patients. However, more innovation is needed. The delivery of high-quality care to patients continues to become more and more complex in the rapidly evolving age of digital health, personalized medicine, and value-based care. Digital pathology, both hardware and software, is no exception. Streamlining the regulatory process to get innovative digital tools into the hands of practicing pathologists is in the best interest of patients.

Manufacturers of pathology imaging devices and associated software should engage regulatory affairs and clinical affairs (RACA) professionals throughout the total product life cycle (TPLC) of these innovative medical devices......