JACR: Imaging companies face tougher regulations

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Sruthi Valluri, DOTmed News | February 11, 2011
Manufacturers in the United States must overcome increasingly complex regulatory hurdles to develop and introduce imaging device technology to the market, according to a recent article in the Journal of the American College of Radiology.

The U.S. is the "largest and most influential adopter of advanced imaging," according to the study, so any regulatory changes made by the Food and Drug Administration may have a global impact.

"The United States is the leader in medical innovation," said Dr. Donald Rucker, chief medical officer at Siemens Healthcare and one of the authors. "If we make innovation more difficult, whether that's by changing the regulatory climate or by changing the economics, you can expect some of that innovation will shift elsewhere."

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The article, which appeared in the February issue of the journal, outlines five phases of an imaging device's life cycle, from development to full adoption, and the clinical requirements at each stage. The authors-all members of imaging technology manufacturers-intended the article as a guideline for investors and manufacturers when weighing the benefits of investing in new imaging technology.

"This is a process of incremental innovation," Rucker said. Technological advances are built on previous achievements, so complex regulatory and evidentiary requirements may have lasting impacts, according to Rucker.

"The challenge is that evidentiary requirements are far slower than technological advances," Rucker said. "If someone is discouraged from pursuing a certain line of research or innovation, you may be cutting off a whole chain of evolution."

Many of the difficulties that manufacturers face are largely due to the regulatory and reimbursement environment of the U.S. market. Clinical evidence is mandatory at every stage, and the manufacturer's reimbursement is influenced by a variety of outside factors, such as physician adoption of the device and its coverage by insurance.

In a statement, coauthor Dr. Richard Frank, vice president of global clinical strategy and policy at General Electric Co., said there is a "critical need" for the roadmap to full adoption that the article provides. "Only with full adoption does the patient population truly gain access to the benefits of innovation," Frank said.

The process to reach full adoption might be made even more complicated in coming months, as the FDA considers alterations to its 510(k) clearance process. Under the new rules, announced in January, some new product submissions would require further clinical evidence.

Given these complexities, a manufacturer's investment in new medical technology is a balancing act. The process, according to Rucker, is long and riddled with fine print. The article is an attempt to "tease out" the finer details of in a product's life cycle.

"We need to understand the nuances of development," said Rucker. "But we also have to make sure that there is continued innovation in these technologies."