Medical Device Link.

Originally Published MX March/April 2003

COVER STORY

Interview by Steve Halasey

It would be an understatement to say that Mae C. Jemison, MD, has a unique perspective on issues relating to the development and application of advanced technologies. In fact, as a chemical engineer, physician, teacher, astronaut, and now a medical device entrepreneur, Jemison combines the visions of a number of rare perspectives.

Physician, astronaut, and device entrepreneur, Mae C. Jemison, MD, on technology, risk, and the limits of public policy.

After completing her medical residency and spending two and a half years with the Peace Corps in Sierra Leone and Liberia, Jemison practiced medicine for CIGNA Healthplans (Los Angeles). She joined NASA in 1987, and became the first African-American woman to fly in space. During her September 1992 flight aboard the space shuttle Endeavour, she conducted biological and materials sciences experiments, and served as coinvestigator for the flight's bone-cell research experiment.

An advocate of science education and technology development, Jemison resigned from NASA in 1993 and founded The Jemison Group Inc. (Houston), a commercial venture intended to research, develop, and implement advanced technologies suited to the social, political, cultural, and economic contexts of developing countries. The group has aided in the development of solar thermal electricity generation systems and a satellite-based telecommunications system to facilitate healthcare in West Africa.

From 1996 to 2001 Jemison was a professor at Dartmouth College (Hanover, NH), where she taught courses on space-age technologies and developing countries. She founded and served as director of Dartmouth's Jemison Institute for Advanced Technology in Developing Countries. She is currently an A. D. White professor-at-large at Cornell University (Ithaca, NY).

Jemison's current project is to build her new company, BioSentient Corp. (Houston), which is dedicated to developing and commercializing a NASA technology called the autogenic feedback training exercise (AFTE) system (see sidebar). BioSentient was created in 1999 by The Jemison Group, which holds the exclusive license to commercialize the AFTE technology.

In this excerpted interview with MX editor-in-chief Steve Halasey, Jemison shares her views on the risks involved in developing and using advanced technologies, and the limitations of public policy for mitigating those risks. The complete transcript of the interview can be accessed via the MX Web site at http://www.devicelink.com/mx.

MX: This is a difficult time for NASA and its extended family. What are your thoughts about the Columbia accident and how the agency handles the ever-present risks of space flight?

Mae C. Jemison: My application for the astronaut program was in progress at the time of the Challenger accident. The process was postponed, but I renewed my application and was very happy to be part of the first class after the accident.

So when I reflect on the recent Columbia accident, I have a flood of thoughts. It reminds us of our fragility and our mortality. And of course, there is a sort of numbness and sadness.

But to me, as an astronaut, there is an even stronger sense of being reminded of something that all astronauts acknowledge: unforeseen problems can happen. But I never had so many smart, dedicated, experienced, skilled people caring about me as when I went up in the space shuttle.

NASA's experience in handling the risks of advanced technologies is unique. What can those in other industries—including the medical device industry—learn from the agency's attitude toward technology?

Physicians are trained to be obsessive-compulsive about their patients and what's being done to them. And I was able to use some of my training and experience as a physician—in terms of how to diagnose problems, for instance—while I was at NASA.

Yet at NASA, I learned more about quality control and safety than I had ever learned anywhere else—including as a physician. I learned how to formalize that process—how to dot all the i's and cross all the t's, and how to do the best possible job thinking things through. These are really methodologies and ways of thinking.

In the aerospace industry the margin for error is very low, so it's essential to minimize error and to think through in advance as many things as possible—with a potential way to correct the problem. But we're human, and there are always going to be instances that we just didn't think of and couldn't foresee. Sometimes, we can't even recognize that a risk exists until after a disastrous event happens.

There must be a tremendous amount of risk analysis and advance safety preparation involved in each shuttle flight. In this regard, is NASA's system transferable to other industries?

Yes. It's important to understand that risk is not carelessness. Risk is a set of statistical probabilities that certain events might occur. I'm not an expert on risk analysis, but the space program does have people with that expertise whose job is to determine what should be looked at and to calculate the related risks to the best of their knowledge.

Risk analysts look at potential failures, such as how a particular experiment might fail. And the vehicle itself undergoes those same kinds of inquiry. So NASA has a very strong system that's worthy of being studied and duplicated in other industries.

Patient Risk

Many medical device manufacturers also design highly advanced technologies whose use may involve an element of risk for the patient. How would you compare the attitudes toward risk and benefit that pertain to advanced space technologies and advanced medical technologies?

I'm not sure that you can draw complete parallels between designing vehicles or experiments and designing medical devices, because they have different missions.

In today's healthcare system, patients who have run afoul of medical risks sometimes want to lay blame on physicians, medical device manufacturers, or others who are providing healthcare services. Frequently, the reason for this is that we have degraded the patient-physician relationship. And it's that relationship that makes the difference.

This isn't just a matter of informed consent. It's actually a fundamentally different notion about the role of the physician, which views the delivery of healthcare in terms of a partnership dedicated to helping patients heal themselves. To cultivate such partnerships, physicians must explain to patients in nonmedical terms what the use of a particular medical device will do to them. And physicians also have to explain the risks involved, and the probabilities related to those risks.

The difference between astronauts and patients is that astronauts know what it means when there is a certain level of probability, however small, that a catastrophic failure may occur.

Medical device manufacturers have long suggested that the healthcare system—including physicians—needs to do a better job of educating patients about the risks involved in using advanced medical devices.

And that should include helping patients understand the potential benefits. Sometimes people become disappointed because the medical device doesn't live up to their expectations—which may have been unrealistic to begin with. They'll say, 'I got this artificial knee, but I can't sprint the way I thought I would be able to.'

A major part of this whole issue revolves around the relationship between patients and their healthcare providers. And the most mistaken notion is that the healthcare system—including physicians, device manufacturers, and others—is totally responsible for creating a cure.

Patients do tend to have the expectation that any intervention will be 100% successful, and that's not always the case. How should that be explained to patients and who should do that?

Oh, it's absolutely the physician. As a doctor, my responsibility to my patients is to help them figure out the best course of action given their own personal circumstances. And those frequently include not only physiologic circumstances, but psychosocial and economic issues, and the patient's expectations for the future. All of those need to be considered in helping a patient decide what they need to do.

These days, counseling can be done in conjunction with a nurse or nurse practitioner. But I think physicians themselves have to take an active part.

Public Policy

AFTE's ambulatory equipment is used to measure and store data from multiple physiological parameters relating to the autonomic nervous system, and to wirelessly transmit them in real time to a remote computer.

Taking together all of these themes of advanced technology, risk and benefit, and the role of physicians, how should these considerations be brought to bear on the development of our public policies toward tort reform and the regulation of medical products?

Once again, the public policy issues that we're dealing with really go back to the relationships that healers have with their patients. And that relationship is one that has been severely tested and traumatized recently. Physicians used to be among the most trusted people in the world, but in recent years that rating has been slipping. I can't help but believe that that slippage correlates in some way to the incidence of malpractice suits—successful or otherwise.

If a physician is employed in a healthcare organization where he or she is only able to tell patients about certain drugs or other therapies that the organization offers, that's a problem. If a physician doesn't see his or her primary loyalty and responsibility as being to the patient, that's a problem.

So I don't immediately jump to thinking that these issues require us to do something in terms of regulations or changed public policies. Long before that, we have to address the fundamental question of what we're trying to do with patients, what we're trying to achieve and accomplish.

There is currently a lot of discussion about malpractice reform going on in Washington and in various state legislatures. Do you think that such reform should incorporate guidelines for how physicians should inform and work with their patients?

Those practices should be learned in medical school, while the physician is still in training.

Using guidelines or regulations to accomplish this task, in effect, absolves people from thinking. And communicating with patients is a fluid, thinking proposition. Physicians must explain things to some people in one way, and to other people in other ways, depending upon their background, education, emotional state, and so on.

I think we have to be very careful about the idea of putting rigid limitations on jury awards in malpractice judgments. Because sometimes people have been careless, and individuals' lives have been ruined because of that carelessness. And that's not the same as evaluating potential risks and benefits.

Liability Tag

Some manufacturers have indicated that the Internet is helping to create a much more informed patient base. Is that a viable mechanism for doing some of what you've talked about, at least in a remedial fashion?

It's helpful in a certain sense, but it depends on the reliability of the information. The Internet is a double-edged sword. On some manufacturers' sites, one might find very specific and accurate information. But in chat rooms and other sites, the value and accuracy of the information may not be quite so wonderful.

It's very helpful for patients to be able to source healthcare information, and to ask about it. But the job of educating the patient still comes down to the relationship between the healthcare service provider and the patient. You can't get away from that.

Manufacturers have expressed the concern that malpractice reform could absolve physicians of their responsibility, making manufacturers the only deep pockets left for plaintiffs' attorneys to go after. Do you think that is a realistic possibility, and what effects would that have on the use of medical technologies?

I'm not a legal expert, but that certainly sounds like a plausible scenario. And that's the reason it's very important that people not have knee-jerk reactions to medical malpractice, but really think about what's going on. Because having device manufacturers become 'it' in an ongoing game of liability tag would have a chilling effect.

I certainly don't have any exact solution. I know it's a crazy idea, but there is such a thing as self-restraint, and it's something that should be practiced by all of us—including lawyers.

Are there specific measures that medical device manufacturers can undertake to aid in professional and patient education, and thereby perhaps avoid becoming the target of litigation?

One strategy is to do what BioSentient is going to try to do: to provide really, really good training to the customers who are going to be providing services to clients. And that training should be more than just teaching professionals how to read the gauge on a piece of equipment. It should deal with some of the psychosocial issues that may come up, and issues they might expect to encounter over a long term.

Under some circumstances—depending on how invasive a technology is, or how integral it is to the patient—it might also be useful for manufacturers to touch base periodically with the healthcare providers who are using the device, or even the patients themselves. Touching base with users and patients will help manufacturers to develop relationships with those people. And that's important because often it's the absence of such relationships that makes people feel so wronged.

The AFTE Technology

Despite all the complexities we've discussed, you've still decided to invest your time and energy in a company, BioSentient, which is devoted to developing a medical product. How did that come about?

I was just particularly excited about this technology, both the equipment and the technique.

You've been involved with this technology since your days in the space program. How would you describe it?

It's called the autogenic feedback training exercise (AFTE) method and system. And it was designed by a researcher, Dr. Pat Cowings at NASA's Ames Research Center, to help astronauts with something called space adaptation syndrome.

What is it that excited you about the technology?

For me to come back 10 years later and decide that I want to spend my money, time, energy, and effort developing this technology means that I believe in it and got some benefit out of it.

The tag line for BioSentient is, "Enhancing health and human performance through physiologic awareness and self-regulation," and that's what the AFTE technology is designed to do. AFTE helps an individual to increase awareness of his or her body.

Among many patients nowadays, there is a trend toward wanting to get well with as little intervention and as few drugs as possible. And that's what I saw with AFTE. It offers the possibility for patients to help themselves, to control their own responses to their environment and its stimuli.

How did the AFTE system work when you were using it?

When I was being trained to use the AFTE system, I was given a series of tasks to perform while seated in a rotating chair that would typically induce motion sickness. Gradually, as I became more adept with the method, I became increasingly capable of staying in the rotating chair while moving my head in and out of the plane of rotation for longer and longer periods of time.

What the AFTE method was enabling me to do was to learn to control some of my aberrant automatic responses to motion. And as I learned to control those harmful automatic responses, I was able to get rid of the symptoms and effects of motion sickness and to improve my performance.

Did you have funding available to obtain the license and start a company to develop the technology, or did you have to go out and find investors?

To this point, I've actually funded all of the development myself. So I'm putting my time, energy, sweat, and money into it. And I think we've done a very, very good job.

Now we're in the process of taking the device to the next stage of manufacturing, and we are entertaining investors. So we're approaching this in a very stepwise fashion.

What have you done to develop the AFTE system?

When we received the technology, it was essentially a 1987 design with 1990s components—including multiple modules, plugs, tape recorders, and wires. But during our development process, we basically condensed all of this into a very small, wireless data-gathering and analysis system that weighs less than a pound. So we spent a lot of time upgrading the equipment.

Once you have received FDA clearance, what is your plan for commercially launching the product? Will physicians be your primary target?

We're taking a two-sided approach. The monitoring equipment itself can be very important and effective for anybody who needs to get good measurements of a subject's autonomic nervous system over a period of time. That category might include a wide range of clinical professionals, such as neurologists, psychiatrists, and rehabilitation specialists.

But the system is also eminently wearable—once a person puts it on they barely know they're wearing it—and that makes it suitable for individuals who are involved in study groups or behavior modification programs. We look at the system as having appeal for both ambulatory monitoring of clinical physiology, and the self-monitoring functions associated with the training technique. And we expect to develop both aspects of the business. In both cases, we will be looking to sell to the providers of these services—not to the patients or clients themselves.

Do you think the AFTE technology can provide the basis for growing a company that will eventually have a full pipeline of related products, or do you see this as a niche, one-off product?

I see BioSentient as a company with a lot of other products coming down the pipeline, some of them based on what we are doing right now. Some will represent a natural progression and advancement, and for others we will have to actively look at other technologies.

We spent a lot of time figuring out the name of the company, BioSentient. We adopted it because we think that the next very important trend in human biology is the individual's awareness of his or her own physiology—bringing to consciousness, to sentience shall we say, what's happening in the body.

This trend presents the challenge of how to help the patient or individual become a participant in controlling what's going on in his or her body. This is a very powerful paradigm—a different way of looking at things. But it's also sort of old, too, because there was a time when physicians thought about people helping to heal themselves. And now, we're just coming back around to that way of thinking.

Copyright ©2003 MX