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

Cost

Cost is one of the most significant deterrents to innovation. The accelerating cost of innovation is difficult to imagine. For example, the first embolectomy catheter cost about $3,000 to develop back in the early 1960s. As its developer, I can tell you that it cost so little because I stole or borrowed—on a permanent basis—most of the equipment needed to make the catheter systems, which I sterilized in a preparation of glutaraldehyde (Cidex) and reused. Compare that cost to the cost of developing the drug-coated stent. If the costs of the drug, the device, and the clinical trials are all included, Johnson & Johnson’s total cost of developing its drug-coated stent was more than $1 billion.

What is often not acknowledged, however, is that technology may be a solution to accelerating costs. Many startup companies fail to obtain funding simply because venture capitalists do not believe they will be able to make money based on the cost of product development and dissemination. Therefore, many potentially valuable technologies that could address large patient populations may never see the light of day. This is a very significant problem that must be addressed. Overregulation, when analyzed, is extremely expensive.

‘Committeeism’

Another obstacle to innovation is likely to be familiar to all: what I call “committeeism,” or the expansion or growth of multiple committees for multiple purposes. It is rampant not only among universities but within industry as well.

There is an overabundance of committees involved in technology evaluation and acceptance at hospitals in the United States, including the institutional review board (IRB), the conflict-of-interest committee, and committees in charge of everything from ethics to contracts to adjudication. The IRB is clearly the most valuable, but it is only as effective as its members. Through the Federal Register, the federal government has outlined what the functions of IRBs should be.¹ However, I have personally polled IRB members and found that very few are aware of these Federal Register guidelines for IRBs. As a result, individual IRBs come up with their own concepts for what they are supposed to do, and often they do not correlate with the Federal Register’s concepts, which obviously creates problems.

Of course, committees are necessary to some extent and they can bring value. In my experience, however, committees usually consist of a group of the unwilling picked from the unfit to do the unnecessary. Too often we come out of committee meetings with little more than the date and time of the next committee meeting—or perhaps with a newly created subcommittee, whose members are typically culled from those absent from the committee meeting. If we honestly reflect on the effectiveness of most committees, we will usually conclude that it is fairly marginal.

From the standpoint of the inventor or innovator, committees and consensus can constitute a significant deterrent. Invention is not done by committee. Patients are not treated by committee. Many committee members have never been involved in patient care, yet physicians are encumbered by committees and a point is often reached where the patient is not being served in the best way. Of course, oversight is needed, and we still need some committees, but the overall number and value of committees needs to be reevaluated throughout the health care system. My experience suggests that fewer committees and smaller committees would serve us all better.

Confict of interest

Conflict of interest represents yet another challenge to innovation. The dictionary definition of conflict of interest is “to be at odds.” My practical definition is that it involves trying to serve more than one master.

Who has got conflict of interest? We all do. If you do not have conflict of interest, you are not doing very much. Should we get rid of our conflicts? We cannot—it is impossible to get rid of conflict of interest if you are going to be a productive human being.

Conflict of interest exists in practice. When a surgeon operates on a patient, is he or she doing it to benefit the patient or to make money? The honest answer is that it is probably for both reasons.

Likewise, conflict exists when physicians are involved in research, either basic or clinical. Why do we do research, and why do universities encourage it? In the case of basic research, is it done for discovery, or to pay for direct and indirect overhead? The reality is that it is done for both reasons. Similarly, clinical research is conducted for many reasons. One is to benefit patients. Another is to gain notoriety as someone who has benefited patients through innovation. A third reason is financial. In most cases, clinical research is probably done for all three reasons, and the particular emphasis will differ according to the individual.

The concept of making money while benefiting patients is egregious to many academic medical centers today. But the reality is that if you develop useful technology, you will make money. That is just the American way. Should medical innovators start out with the motivation of making money? No, although some do. However, if their innovation provides a real service to humanity, there is nothing wrong with that approach, although financial rewards should come only as a byproduct of benefiting patients.

Institutional conflicts are present as well. Historically, institutions have had significant conflicts of interest, but only recently have these conflicts been scrutinized. Advertising of services is an example of an institutional conflict, with the goal being to attract patients to increase revenue. Whether or not this is bad depends on whether there is an overriding benefit to patients in the big picture, as well as on how the advertising is done.

Finally, there are personal conflicts as well. How much time do you spend at the institution? How much time do you spend seeing a patient? Doing clinical research? Spending time with your family? All of these things are technically in conflict with one another, and occasionally they can represent serious conflicts. Conflicts are inescapable, so to say that you do not have any is simply not consistent with reality.

Academia

The way that some major academic centers have responded to concerns about conflicts of interest has actually turned some of these academic centers— which are supposed to promote exploration and innovation—into deterrents to innovation. To innovate at these institutions has become extremely cumbersome, costly, and inefficient. I do not believe that these institutions—which include prestigious teaching centers such as my institution, Stanford University, and Harvard Medical School—really understand the effects that some of their policies are having. Nevertheless, these policies are taking a toll as these institutions do less and less in the way of medical innovation. In the process, the institutions are failing to fully serve their missions. An example of the mentality behind such policies is laid out in the following section.