Key considerations when implementing new diagnostic technologies in routine practice.

Background: The field of pathology is evolving with the integration of advanced and artificial-intelligence-powered diagnostic technologies. However, there remains a significant gap in clearly outlining the key considerations for the effective implementation of these innovations into clinical care.

Objectives: The aim of this review was to identify and address the essential aspects required to bridge the implementation gap of new diagnostic technologies in pathology.

Material and methods: This review synthesizes key elements from relevant scientific journals, organizational websites, and practical examples from pathology practice. The findings are presented as a structured framework of six key elements, supported by an infographic and illustrative cases from clinical settings.

Results: The key elements are: (1) Innovation depends more on the people driving it than on the work it demands, highlighting the importance of team collaboration and communication; (2) in-depth knowledge of the delivery system emphasizing the importance of care, IT, and administrative layers is crucial; (3) data-driven decision-making in healthcare transformation is central, with an emphasis on the process of converting real-world data (RWD) into actionable real-world evidence (RWE); (4) a proven approach for practice transformation uses a structured (utilization management strategy, UMS) framework; (5) a balanced approach toward financial sustainability, including local and systemic financial strategies, is important; and (6)  ensuring safe and effective progress requires a new, collaborative definition of regulatory science, aligning innovation with regulatory oversight to support technological advancements.

Conclusion: These key aspects offer a foundational framework for integrating new technologies into healthcare. Although not exhaustive, overlooking them would miss a significant opportunity to enhance patient care.