What is it about?
Many medical technologies fail to reach patients quickly, not because they are unsafe or ineffective, but because the evidence supporting them does not meet the needs of hospitals and payers. Understanding the evidence supply chain may help reduce barriers to adoption and improve patient access to innovation.
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Why is it important?
This paper introduces the evidence supply chain, a new framework for understanding why medical technologies often struggle to gain adoption after regulatory approval. As FDA QMSR implementation and the EU MDR increase emphasis on lifecycle evidence, the framework provides a practical way to align regulatory, reimbursement, and hospital decision-making requirements to improve adoption and patient access to innovation.
Perspectives
I wrote this paper because I believe the healthcare industry is underestimating the growing importance of lifecycle evidence. As FDA implements QMSR and global regulators continue to expand evidence expectations, organizations that treat evidence as a strategic resource rather than a compliance exercise will be better positioned to support innovation, adoption, and patient care.
Dr. Beth A. Fiedler
University of Central Florida
Read the Original
This page is a summary of: Total Product Lifecycle: The Creation of a New Mandate for Clinical Engineers, Journal of Clinical Engineering, March 2026, Wolters Kluwer Health,
DOI: 10.1097/jce.0000000000000754.
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