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Limiting the Imagination

May 25, 2011

I do occasional work with people who refuse to be limited by anything other than their own imagination.  Of course, some imaginations are pretty limited, but you get the point.  But when you allow a group of people to let fly on their ideas, you generally get something good out of it.  It’s effectively Management 101: Tell people what you want them to do and give them freedom and control to do it.  Reason Magazine has a good example of how that might work today, courtesy of the X-Prize Foundation:

$10 million in prize money will be offered in the “Tricorder X PRIZE” competition, which will be launched sometime early next year (2012). The idea is to take advantage of the increasing power of mobile devices to make health care more accessible and easier to understand. With the equivalent of a board of physicians in your pocket, wireless sensors and imaging, you will be able to assess health and determine health care needs with a device in the palm of your hand.

Hey, great idea.  Find and fund ideas that enable people to better handle their own health.  I thought WebMD was a good start at that, and enabling better diagnostic capability could only help.  The Technology Review magazine picked this up, and they like it too.  But they also point out that for every imagination-fomenting organization like X-Prize, there’s a government agency to make sure that the will of the people will be crushed. Go read the article, by the way, since it has practical examples of what technology can do when not limited.  As to limits…

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.

(Sr. Direction at X-Prize, Eileen) Bartholomew says that because of FDA restrictions, the contest could lead to innovations that might only be used outside the United States.

Woo!  Let’s do something that makes a ton of sense and then bog it down by having to submit it to an agency that will do everything it can to make it safe instead of life-saving.

Having worked with some medical device organizations on occasion, I’ll tell you that they generally are somewhere in the area of three to five years back in comparison to current technology.  It takes that long to get through the government red tape.  Yes, that red tape ensures that everyone is safe.  Wonderful.  It also ensures that people die.  I can remember endless debates in my Philosophy classes about killing one man for the greater good.  Here, the FDA decides it for us.

So a government agency deciding that you can’t ship something will result in companies deciding not to invest in a technology that heads in that direction.  As a result, whole areas of research are closed to investigation.  I call that limiting the imagination.  So congratulations, Mr. Government.  You’ve failed Management 101.  Go take your remedial course in Restriction of Freedoms, and we’ll give you the math credit later.

4 Comments leave one →
  1. May 26, 2011 11:13 am

    My comment didn’t take earlier, apparently…

    I don’t think I said the government doesn’t fund things. They do. I often wonder whether similar investment from private enterprise wouldn’t produce more. To Ellen’s point, the costs and time associated with the approvals end up making the product potentially uncompetitive in an open market.

    Of course, there’s no open market, so I guess it’s just the way business is done.

  2. Ellen D. permalink
    May 25, 2011 2:41 pm

    The FDA regulations are so cumbersome that the medical technology companies have to hire experts to figure out how to get their devices through the approval process. One company had a large room (probably a minimum of 1000 sqft.) full of notebooks with regulations and paperwork they had to fill out for their drug trials. It’s no wonder drugs in the US are so expensive. It would be interesting to figure out what percentage of the drug cost is the cost of getting through the FDA approval process.

    • May 25, 2011 3:05 pm

      They are cumbersome indeed. The last numbers I have is that each drug takes an average of $1.2 billion for approval.

      ===|===============/ Level Head

  3. May 25, 2011 10:43 am

    Oho! This is one of my own fields.

    The US government offers hundreds of millions of dollars to build just such devices. These grants come from various agencies of the NIH, and from DARPA.

    Here’s an example — one that I just assisted with a proposal for that went in last week. DARPA’s description:

    DARPA is soliciting innovative research proposals for the development of on-site critical diagnostics tailored for rapid, self-performed tests in limited resource settings.

    In practice, the device must be effective, portable, and relatively inexpensive.

    It can be in a wide variety of health areas, from detecting infectious diseases to chronic conditions to the effects of radiation in a danger zone.

    While DARPA thinks in terms of soldiers, the equivalent NIH branches are more general. And any such device that works for the military can potentially work for others. The required end results include a thorough test of the device’s effectiveness, and an engineering study of exactly how they would be built in quantity (including the final device weight and battery life).

    This is an active area of development. There are regulatory issues, but they have a path to navigate, and are not show-stoppers.

    For example, the FDA has a subgroup called the Office of In vitro Diagnostics (OIVD). That group uses several standard approval processes, many of which are focused on safety and avoiding false positives. The 501(k) path sounds like an IRS technique, but it is actually one of multiple federal processes to go through this specific set of regulations if you have a device analyzing cells.

    Unfortunately, the OIVD’s front page is largely a series of complaints to stop people from doing diagnostics. I understand their point, but it presents a front “image” in agreement with the article you quoted.

    I’m no fan of burdensome regulations! Nor, for that matter, in billions of dollars in taxpayer funds being given away, generally, though I work professionally in this field. But I suggest here that, happily, the real situation on medical device development is better than the first impression would suggest.

    Unquestionably, the Fed is a stupid and slow beast — but it has more legs on the ground in this area that you might have thought. And it is making progress, and encouraging the work of others.

    ===|==============/ Level Head

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