Will FDA Regulation Kill the Medical Tricorder?

I somehow missed the announcemenf for the Tricorder X Prize earlier this month. The idea is to move beyond "stone knives and bear skins" to create a medical diagnostic device much like the Tricorder wielded by Dr. McCoy in Star Trek. The idea is to get beyond the yucky and painful cutting and needling involved with so many of our current diagnostic technologies. The press release describes the goal:

The X PRIZE Foundation, the leading nonprofit organization solving the world's Grand Challenges of our time by creating and managing large-scale, global incentivized competitions, today announced a collaboration with Qualcomm Incorporated to design the Tricorder X PRIZE, a $10 million prize to develop a mobile solution that can diagnose patients better than or equal to a panel of board certified physicians. The X PRIZE Foundation and Qualcomm seeks to achieve this by combining advancements in expert systems and medical point of care data such as wireless sensors, advancements in medical imaging and microfluidics.

The Tricorder X PRIZE aims to incentivize consumer empowerment in healthcare by extending the reach of health information and services to more people. This prize will bring understandable, easily accessible health information and metrics to consumers on their mobile devices, pointing them to earlier actions for care.

Can't wait. However, Technology Review warns that something could derail commercialization of any winning technology. Three letters: FDA. 

As Technology Review reports:

The regulatory environment could present problems for any such device. "The Food and Drug Administration has stated that it will not certify tech that makes a diagnosis directly," said Ross Mitchell, the author of a study published last week that shows that strokes can be diagnosed with the aid of a smart-phone application with the same degree of accuracy as with a hospital computer.

[Eileen] Bartholomew, [a senior director at the X Prize Foundation], says that because of FDA restrictions, the contest could lead to innovations that might only be used outside the United States.

An article, "Medical Devices: Lost in Regulation," by retired medical device researcher Paul Citron in the Spring 2011 Issues in Science and Technology [downloadable here] argues:

Although the United States is still home to numerous medical device companies, these companies no longer bring cutting-edge innovations to U.S. patients first. And U.S. clinical researchers now often find themselves merely validating thea pioneering work that is increasingly being done in Europe and elsewhere in the world. Worse still, seriously ill patients in the United States are now among the last in the world to receive medical innovations that have secured regulatory approval and clinical acceptance elsewhere in the developed world.

Citron cites several cases in which European patients benefited from early access to new medical devices: Deep brain stimulation to treat Parkinson's disease by 44 months; a ventricular support device to improve circulation by 29 months; a pacemaker device to manage irregular contractions in failing hearts by 30 months. Why is this happening? Citron maintains:

What's behind this erosion of leadership and late access to innovations? Simply stated, an overreaching, overly burdensome, and sometimes irrelevant Food and Drug Administration regulatory process for the most sophisticated new medical devices.

Earlier this week, researchers at Northwestern University released at a National Press Club session their results from a survey of 356 respondents working in the medical device industry. Among other results, 79 percent rated the importance of regulatory requirements in making the decision to invest in a new product at the top of the list (21 percent) or one of the top three factors (58 percent). Sixty-eight percent rated the importance of regulatory process predictability for the decision about the first country for launching a new product as "critically important." When asked "within the last 3 years, if your company chose to first bring to market a specific device outside the U.S., what was the major reason?" Unpredictable FDA regulatory requirements were cited by 49 percent and the cost of clinical trials was cited by 22 percent. More dishearteningly, 64 percent considered the European Union has having the "most predictable regulatory system" compared to just 8 percent saying the same thing about the U.S.

Perhaps Americans will be able to buy the new Tricorders from France. Jean-Luc Picard was from France, wasn't he?