Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software.

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.

Infected wound model development of an in vitro biomaterial-protected wound infection model to study microbial activity and antimicrobial treatment through microdialysis.

OBJECTIVE: Skin injuries provide a favorable environment for microbial infection if left untreated. This is problematic especially in nosocomial situations having a high prevalence of Staphylococcus aureus that can cause suppuration of wounds, systemic disease, and toxic shock. The objective of this investigation was to use a wound model system to study the interactions between microbial activity, host tissue, therapeutic treatments, and wound biomaterials. DESIGN: An in vitro wound model was developed using Sykes-Moore chambers filled with 1 of 2 biomaterials used for wound treatment (1% alginate and dialyzed HyFil hydrogel (B. Braun Medical, Inc, Bethlehem, Pennsylvania) and seeded with fibroblasts. The chambers were inoculated with S aureus, and half were later treated with antibiotics through in situ microdialysis tubing. MAIN OUTCOME MEASURES: The chambers were monitored by obtaining fluid samples and biomaterial samples at specific time intervals (0, 2, 8, and 24 hours) and were analyzed for (1) S aureus protein A (SPA) concentration, (2) viable S aureus numbers, and (3) fibroblast numbers and viability. Chambers containing each biomaterial with and without antibiotics were compared to controls. MAIN RESULTS: There was an inverse relationship between postinfection S aureus numbers and fibroblast viability. S aureus numbers were usually consistent with SPA concentration, which may have been underestimated because of SPA interactions with the biomaterials. CONCLUSION: This wound model may be useful to gain an understanding about the interactions between microbial activity, host tissue, therapeutic treatments, and wound biomaterials. Hypotheses about wound treatments derived by means of this model may direct future in vivo studies.