Will FDA Regulation Kill the Medical Tricorder?


From science fiction to science reality if the FDA will permit

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?

NEXT: Reason Writers in on the Plot: Matt Welch's Hour-Long Conspiracy Chat With Michael Shermer and Minnesota Public Radio

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  1. Picard was from a France where everyone spoke with an English accent, so I assume that sometime around the time of the Khan wars the English extirpated the French culture from Europe and took over that land.

    1. Actually, they just re-claimed the land that was wrongly taken from the Plantagenets. Because it is wrong to hold land that was taken by force.

    2. If that’s true, then why did the Brits adopt the fruity French names? No Englishman would name his son “Jean Luc” unless he hated him. I think it’s better to assume that the British colonized France and forced the backwards natives to adopt their ways, including the British mode of speech.

  2. Like a full body scan, a tricorder is always going to find some spot or anomalous reading to diagnose and use as an excuse pad its bill with expensive follow-up procedures.

  3. TSA must never learn of this.

  4. Fuck the tricorder, you can’t even trust Americans with spell check

    1. According to this, you’re heart beat is just a blinking 12:00 .

      1. I referenced the spelling errors in the story, and you give that answer?
        I guess some do call you Tim but more call you slow

        1. Spelling errors bother me, but the reference to “stone knives and bear skins” was from Spock, not McCoy, as implied by the pic and first paragraph. Then again, people here have gone off on The Next Generation. Why worry?

          1. they got the hint, and they’re gone

    2. I am more worried about who the author of the article was.

      That poor poor nameless bastard.

  5. In my experience most government bureaucrats have huge egos and tiny brains. As a result of this if they can’t comprehend something (which is often), rather than admit their ignorance they simply put the kibosh on it.

    1. How dare you! We are public servants who have spentour lives being public servants while you greedy capitalist pigs keep insisting on endangering public servants’ jobs by creating new technology that we haven’t had a chance to regulate yet and selling rabbits to each other without proper permits! Ingrates!

  6. “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.”
    yet another reason for single payer like the EU

    1. Please explain how single-payer will cuase the FDA to be less onerous, arbitrary and capricious.

      1. Because more government makes things better.

        The solution to a onerous, arbitrary and capricious regulatory system is more regulations.

        You see, if you find yourself in a hole the first thing you do is double your efforts. The only way to get out of a hole is to dig more.

        1. No, you dig up, stupid!

      2. cuz it will b more predickable and more lifes will b safed

        1. HURR DURR

  7. I am waiting for the we have the best health care in the world, and everyone comes here for treatment crowd to explain this one

    1. Medicare, Obamacare and the FDA destroyed the best health care in the world….

      1. yes dear

  8. If the FDA had been around when Bayer first marketed aspirin, we’d still be waiting for approval.

  9. “The Food and Drug Administration has stated that it will not certify tech that makes a diagnosis directly.”

    AEDs diagnose shockable heart rhythms, and they’re not only approved by the FDA, they’re everywhere now. Granted, this is a pretty narrow diagnosis, and a condition that needs treatment RIGHT NOW. I’m in no way saying the FDA isn’t capricious and idiotic, but it’s worth mentioning.

    1. The quote is something I don’t get, and I used to be in medical device R & D. FDA doesn’t certify the safety or effectiveness of any device, they only license it for marketing in interstate commerce. In fact, the letter they send you specifically disclaims any approval of the item itself, only your being allowed to market it. That way there’s no gov’t liability.

      If he’s saying FDA won’t license such an item, either he’s mistaken or it means that FDA has decided that the process of making a dx itself does not make an item a medical device. The device could output a code that you’d then look up in a book that would give the dx, and probably FDA is saying the book would be a medical reference, outside their jurisdiction, rather than a medical device.

      1. As long as there is a step in there that forces you to pay a certified, licensed doctor, they’ll approve it.

    2. They should just call diagnosis tech an herbal remedy and ignore the FDA entirely.

  10. Given the sensitivity of the Tricorder, and most sensors in the Trek universe, the Federation far outstrips the TSA for rights violations. Hell, they can spot your location and read your vitals from orbit. Also, they can render a holographic replica of you if they want. The Fed also has access to proven memory-erasure tech and known methods of time-travel. How can true heroes like Cyrano Jones and Harry Mudd make an honest living in such an environment?

  11. The FDA is just about as useless as the TSA. Almost.


    1. The TSA is merely a nuisance that makes air travel less convenient. The FDA actively prevents terminally ill people from trying experimental medications that might be dangerous.

  12. And it is going to get worse. The FDA is preparing to start regulating laboratories (which they have no clue about how to do). It is likely that when this happens, lab tests that have been performed for years with no adverse affects but are not FDA-cleared will no longer be allowed.

    Furthermore, the FDA cannot keep up with the advancing pace of molecular technology to screen, diagnose and prognose disease, not to mention many of the pharmacogenetic possibilties. A recent FDA clearance for an HPV screening test from Roche had a clinical trial of over 47,000 participants.

    The FDA is basically going to freeze laboratory tech in the US at late 1990s, early 2000s levels. I have already seen laboratory examples of the devices listed in this article (European/South American release before US).

    /yes, I am a molecular biologist and a lab director.

  13. Tort lawyers will never let something like this come to pass. Reliable, accurate self-diagnosis tools in the hands of ordinary individuals would eliminate too much of the medical uncertainty that their profession so dearly depends upon.

  14. Will FDA Regulation Kill the Medical Tricorder?

    “It’s dead, Jim.”

  15. Why are we running our own medical regulatory agency when we could be piggybacking off of Europe’s for free? Just say anything approved in the EU is automatically approved in the US. Lord knows they’ve been freeloading off of our military since WWII.

  16. For those of you concerned about the cost of clinical trials, we do them in Panama, cheap. Cx me at robgood@bestweb.net

  17. So who is this “I” who “somehow missed the announcemenf for the Tricorder X Prize earlier this month”?

  18. this goes in your mouth, this goes in your ear, this one goes in your ass…oh wait.

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