The Imaging Product Lifecycle: Why Does it Take So Long?

You may wonder why it takes so long to get new imaging technologies into the radiology suite.

The authors of an article in the February issue of Journal of American College of Radiology lay it out: Escalating U.S. government requirements mean that imaging advances take even longer to push through than in the past. This is thanks to increasing regulation, plus reimbursement and adoption issues. Also, compared to the earlier introductions of radiology staples (X-ray, CT, MRI, and ultrasound), innovations now are more incremental in scope. Developers have to prove why the updates are better than those currently approved and used.

It’s not just the academic researchers who are impacted by the imaging product lifecycle, but front-line radiologists as well.

“Practicing radiologists are concerned with every aspect of innovation, from work flow and radiation exposure for patients or technicians, to novel features, applications, and quantitation,” said Richard Frank, the article’s co-author and vice president of medical affairs and clinical strategy at General Electric. He added that due to uncertain or burdensome regulation, “delay or deferral of the next wave of innovation…would only be perceived gradually as radiologists begin to realize that basic science is not being translated into product features or applications that improve or expand procedures to help patients.”

Co-author Michael A. Ferguson, PhD, said that the article will help radiologists understand the rigorous review process that new technologies go through to advance patient care. “The greater the innovation, the higher the level of evidence will be required by various stakeholders, and this entry barrier will only increase as time goes on,” said Ferguson, global director for clinical outcomes and translational research at Philips Healthcare.

In the article, “Evidence Requirements for Innovative Imaging Devices: From Concept to Adoption,” the authors focus on the five steps of a product lifecycle, identifying what types of clinical evidence are required for each stage, and how to get that evidence. The five steps are: product design and introduction, regulatory clearance and approval, early adoption, reimbursement, and full clinical adoption. It’s like a roadmap for imaging manufacturers to make their way through the U.S. regulatory and reimbursement system.

While imaging technology is a global endeavor, the authors argue in the article that the United States “has been the largest and most influential adopter of advanced imaging,” and so this country’s evidentiary standards have a weighted impact on global innovation and availability of new technologies. The rate of innovation, thanks to computing advances, is much faster than the ability to get new technologies through the costly regulatory and adoption process.

The authors, from General Electric, Siemens Healthcare USA, and Philips Healthcare, also note that reimbursement and coverage issues are now more open to interpretation. In the past, these were effectively controlled by CMS, who traditionally pays only for what’s deemed “medically necessary.” Value and clinical utility, however, are being added into the equation, because of demands by patients, employers, nongovernment payers and politicians.

While imaging knowledge is increasing quickly, getting that translated into helpful, useable products is challenging in this climate.