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Will the United States maintain its position as a world leader in medical technology?

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Conflict-of-interest statement
I am seriously conflicted. You may assume that
I have a financial interest and conflicts with any
emerging med-tech company you choose. In addition,
I actually take royalties when possible and encourage
innovation and entrepreneurship in others.

As an inventor, my perspective on financial relationships with medical technology companies is quite different from the one presented by Dr. Arnold Relman in his earlier keynote address. Although I agree with him that the state of medicine is indeed a mess, the mechanism by which that mess can be cleaned up is debatable. I believe strongly that the mechanism advocated by Dr. Relman— prohibiting financial rewards (outside of salaries) to physicians involved in innovation—will do nothing to benefit patients.

My assessment of the topic I am charged with addressing—will the United States maintain its preeminence in medical technology?—is that it will not. I will use this talk to present the reasons for that assessment in the hope that you will understand that we are going the wrong way in American medicine today.

THE NATURE OF INNOVATION

True innovation requires broad acceptance

Innovation, invention, and technology development are not simple or single occurrences. They represent an iterative process requiring reduction to practice and, most important, acceptability by others. An inventor does not determine the worth of his invention; his peers do. Self-proclaimed inventors are numerous and multiple, and the technologies that they put forward rarely receive broad acceptance. Everybody wants to be an inventor, recognizing that it brings attention and reward, but it also brings a lot of baggage, which I will discuss shortly.

What’s wrong with a medical-industrial complex?

Dr. Relman and others may object to the term “medical-industrial complex,” but to do so is to deny reality, because health care in the United States simply is a medical-industrial complex, but one devoted to optimal patient care.

The process by which optimal patient care is delivered involves relationships among a whole host of people. In my view, the key players are the engineers and physicians coming together to develop a technology intended to benefit patients—this relationship is a critical element of invention and innovation. At the same time, patients are the most important individuals involved in any process of innovation. Without patients, we simply could not innovate. Of course, other players have roles as well: institutions, the government, industry, entrepreneurs, lawyers, payors, investors. And in the middle of this mix we have chief executive officers of industry, whose job is to make sure all these players are talking to one another and collaborating for the benefit of patients.

CHALLENGES TO INNOVATION

Challenges to innovation are abundant, and some of them have been with us for decades. I have outlined some major challenges below.

Technology evaluation

There are many ways that technology can be evaluated. We hear a lot about evidence-based medicine, which is ideal if used appropriately, yet too many people demand it in a knee-jerk way. In the field of surgery, level I evidence is often impractical, extremely costly, and sometimes not even possible, and attempts to use it may lead to inaccurate conclusions. If applied too broadly, the demand for level I evidence can impede innovation, so it is important to recognize that evidence-based medicine is only one way to get answers about a technology, especially in the surgical specialties.

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