Modern image analysis techniques based on artificial intelligence (AI) have great potential to improve the quality and efficiency of diagnostic procedures in pathology and to detect novel biomarkers. Despite thousands of published research papers on applications of AI in pathology, hardly any research implementations have matured into commercial products for routine use. Bringing an AI solution for pathology to market presents significant technological, business and regulatory challenges.
This paper provides a comprehensive overview and advice on how to address these challenges. It outlines how research prototypes can be transformed into a product-ready state and integrated into the IT infrastructure of clinical laboratories. Furthermore, business models for profitable AI solutions and reimbursement opportunities for computer assistance in pathology are discussed. In addition, it explains how to obtain regulatory approval so that AI solutions can be introduced as in vitro diagnostics. Thus, this paper provides informaticians, software companies and pathologists with a roadmap for turning prototype AI solutions into commercial products.
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