Radiology continues to benefit from constant innovation and technological advances. However, for promising new imaging technologies to reach widespread clinical practice, several milestones must be met. These include regulatory approval, early clinical evaluation, payer reimbursement, and broader marketplace adoption. Successful implementation of new imaging tests into clinical practice requires active stakeholder engagement and a focus on demonstrating clinical value during each phase of translation.
Introduction
Medical imaging plays a central role in screening, diagnosis, and treatment management. Imaging technology has advanced at a tremendous pace, and new imaging techniques are being employed in an increasing number of clinical scenarios . Physicians rely on the power of medical imaging to guide diagnoses and treatment plans. Surgeons and interventional radiologists are increasingly using novel imaging techniques to guide percutaneous and intraoperative procedures. However, even after years of corporate development, many novel imaging applications face multiple additional hurdles before widespread clinical adoption. These include regulatory approval, robust clinical evaluation, and third-party reimbursement.
As technological innovation is the cornerstone of medical imaging, radiology investigators should possess a basic understanding of how novel imaging technologies are translated into clinical practice. Individual radiologists can play a critical role in each step of technology development and clinical adoption. To provide an overview of this important topic to the general radiology audience, the Radiology Research Alliance Task Force on Translating New Imaging Technologies into Clinical Practice was convened to produce this white paper. The objectives of this effort were to provide a synopsis of the technology adoption pathway after manufacturer development, and to encourage radiologists to more effectively engage in bringing new advanced imaging techniques to clinical use, further advancing the field of imaging.
This white paper discusses the following four major phases that new imaging technologies must pass through before incorporation into routine clinical practice: (1) federal regulatory approval, (2) early adoption, (3) payment coverage, and (4) broad adoption ( Fig 1 ). For each of these phases, we introduce standard terminology and major milestones, and stress the important roles that radiologists can play in facilitating the translation of new imaging technologies from bench to bedside. We use digital breast tomosynthesis (DBT), a recently adopted advanced imaging technique, as an example across these different phases. Finally, we conclude with a brief discussion of policy-related and political barriers to imaging technology adoption, highlighting the need for active radiologist engagement at the earliest phases of translational research.
Food and Drug Administration (FDA) Approval Phase
Imaging technologies are considered medical devices under the Federal Food, Drug, and Cosmetic Act of 1938 and as amended by the Medical Device Regulation Act of 1976. Under federal regulation, the U.S. FDA, through its Center for Devices and Radiological Health, is tasked with overseeing the domestic production, the distribution, and sales of medical imaging devices. FDA approval is necessary before a manufacturer can distribute and market a new imaging device. Medicare reimbursement also requires FDA approval. Even though the FDA permits off-label use of a device at an individual physician’s discretion, a manufacturer cannot market off-label indications. Additionally, federal reimbursement is often more challenging without approval for specific clinical indications .
Medical Device Classes
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Safety and Effectiveness
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Early Adoption Phase
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Radiology-Industry Partnerships
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Trialability and Compatibility
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Reimbursement Phase
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Code Development
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Service Valuation
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Medicare Coverage and Reimbursement
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Broad Adoption Phase
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Infrastructure and Workflow
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Stakeholder Engagement and Advocacy Efforts
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Demonstrating Value
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Conclusion
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