Punishing health-care innovation – part 1

pacemakerAmerica is the world leader in medical device innovation, producing more new medical devices annually than any other nation. Its medical technology industry is responsible for nearly two million jobs and is one bright spot in a health-care system with many flaws. Yet, as I’ll discuss here and in my next post, if the health-care reforms presently advancing through Congress are enacted, the medical technology industry as we know it may be severely cut down.

Let’s begin with the good.

What exactly does the medical technology industry do? It designs and manufactures products ranging from stethoscopes to artificial knees to drug delivery systems to imaging machines. These devices better the lives of everyone who steps into a doctor’s office or hospital. They facilitate the delivery of medical care; they reduce the need for surgery and cut recovery time; they make living with chronic diseases manageable; they keep people from dying prematurely.

Most often, these devices are unnoticed and underappreciated. They’re implanted in patients and unseen by others (e.g., pacemakers); they’re used exclusively by single patient groups (e.g., insulin monitors for diabetics); they’re used by doctors to perform treatments that years ago would have required invasive surgery, and we take for granted that it’s always been that way (e.g., cancer detection). Here’s a small sample of new products made by U.S. manufacturers listed on the first few pages of Medgadget, a blog about emerging medical devices: an advanced pulmonary valve for heart defects (Minnesota); a pill-sized electronic device for monitoring gastrointestinal activity (New York); a device for delivering vaccines through the skin (Maryland); CT scan and MRI imaging software for PCs (Washington); an ear-based drug-delivery system (Massachusetts); a more accurate glucose testing system for diabetics (Minnesota); a platinum coronary stent used to treat heart disease (Massachusetts).

Thanks in large part to devices like these, Americans have the highest cancer survival rate in the world, and have seen deaths from heart attack and stroke be cut nearly in half over the last twenty years.  But despite this vitality, America’s medical technology industry is a fragile one. Its products are developed predominately by small companies (80 percent of medical device companies employ fewer than fifty workers) funded by venture capitalists. To bring an advanced device to market can cost hundreds of millions and take a decade or more of development and testing.

And through it all, there are no guarantees. Complications might arise in the design of the device. The Federal Drug Administration might demand endless tests or forbid the company from selling it. And funding may be exhausted before these problems can be solved, resulting in countless lost days and dollars. Should a company succeed, the rewards can be great—both monetarily and in lives improved. But many projects, and companies, do not succeed.

That’s why one of the concerning aspects of the current health-care reforms is the effect they would have on the medical technology industry. As I’ll discuss in my next post, the various health-care bills currently making their way through Congress would discourage future advancements in medicine by making the development of new medical devices even more difficult and risky than it already is. If the legislation is passed in any form, the medical technology industry is sure to shrink and medical innovation is sure to stagnate.

Image: Pacemaker. n28ive1 on Flickr.

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