Outline Designed to Help Assess Benefits of New Imaging Modalities

A new outline provides a blueprint for imaging manufacturers to work through the unique and increasingly complicated US regulatory and reimbursement environment. The report identifies and addresses the five phases of an imaging procedure's lifecycle and the clear-cut clinical evidence needs for each phase.

The article published in the February 2011 issue of the Journal of the American College of Radiology, was authored by Richard Frank, MD, PhD, vice president, global clinical strategy and policy, General Electric Healthcare (Chalfont St. Giles, UK), Donald W. Rucker, MD, chief medical officer, Siemens Healthcare USA (Malvern, PA, USA), Michael A. Ferguson, PhD, global director, clinical outcomes and translational research, Philips Healthcare (Best, The Netherlands), and Terry J. Sweeney, senior vice president, corporate quality and regulatory affairs, Philips Healthcare. "We think there is a critical need for this kind of roadmap, given the current mismatch between the pace of advances and the time required to clear regulatory, reimbursement and adoption hurdles," said Dr. Frank. "Only with full adoption does the patient population truly gain access to the benefits of innovation, for example, in reduction of exposure to radiation or increased compliance with screening recommendations, and hence, earlier detection of disease, better outcomes, and reduction in overall cost of healthcare delivery."

The article closely examined the design, regulatory clearance and approval, early adoption, reimbursement, and full clinical adoption of imaging technology. "Although the development of imaging technology is global, the United States has been the largest and most influential adopter of advanced imaging. Therefore, increases in US evidentiary standards may have a global impact on innovation and access to imaging. It is our hope that this study will help to foster greater certainty for manufacturers and all stakeholders in navigating the concept-to-adoption pathway so that patients can continue to benefit from these innovative and often life-saving technologies," said Dr. Rucker.

"The potential of medical imaging is incalculable, and we need to make sure that the next generation of Americans is able to benefit from transformative imaging technologies in the same ways that we were," added Dr. Ferguson. "We believe that the roadmap we have provided is a strong first step to ensuring that manufacturers are able to invest in such watershed technologies and that as a society we are able to achieve this goal."

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