I'm going to talk about what my company, Boston Scientific, and others are doing with medical technology and some of the implications of technological innovation. Some technologies you'll be familiar with; others will be new to you.
Broadly, there are two types of innovation. One, sustainable technology, is incremental and involves changes within a framework that make things a bit faster and easier to use. The second is disruptive technology, which leads to fundamental changes in the people who use or control it, the infrastructure, the financial implications, and so on. Clayton Christensen, from the Harvard Business School, describes the phenomenon of disruptive innovation in his book The Innovator's Dilemma: When New Technologies Cause Great Firms to Fail, and in a later book called The Innovator's Solution.
Thirty years ago—maybe before you were born, but really not that long ago—we didn't have a lot of things you take for granted today. Take the ATM, for example, the automated teller machine. Do you know when and where that technology started? It was in 1970 in North Carolina. People didn't like ATMs. They wanted to talk to a human, not a machine. It took about 12 years for this disruptive technology to become accepted—and now, people prefer to talk to a machine (for their financial transactions). Seeing interesting things displayed on screens is now part of our culture.
In theory, the factor that promotes a technology's acceptance is that the user—the customer or patient—gets added value. In the most complicated scenario, the entire system might change. In medicine, that might mean you get taken care of at home. Maybe you dial up the Web and say, “I've got this pain,” and the person or software on the Web diagnoses it. That's happening in some places today. What are the implications? If something goes wrong, whose fault is it?
In health care, developments are constantly being made that reduce the cost and complexity of techniques. The advantage is that you can make care available to more people at less cost. The challenge is that the rate of technological development continues to accelerate. Technology is advancing faster and faster because the tools available to people for developing it are becoming more innovative, powerful, intuitive and widespread. Technology is being democratized. It used to be that the great powers in society—big business, government, academic institutions—could, in effect, hoard knowledge. They can't do that anymore. Now any one of us can have access to research and to individual researchers. Research is much more spread out and is occurring on a lot more levels. When Apple Computer got started in the late 1970s, one of its strategies was to get the computer to be better understood, particularly for the non-business user. So they gave away—this is the old Apple II— hundreds of computers to schools all over the country. It was an extraordinary experiment. The result was students figured out computer applications that experts had been saying were impossible. Students invented all sorts of new applications, including games. They created new markets.
Some medical technologies have led to fundamental changes, and some haven't—but just wait until tomorrow. One example is telemedicine. In theory, a physician using videoconferencing or Web conferencing can educate—maybe even treat—patients elsewhere. This is being done today, but on a fairly limited level. Do you know what one of the biggest barriers is to its more widespread use? Financial. How does the physician get paid? If a hospital in one state beams telemedicine into another state, what are the regulations? What credentialing process is involved? These things haven't been solved yet.
Now let's look at some examples of medical technology that have led to change, starting with imaging. Imaging means things like x-rays, Computed Tomography, Magnetic Resonance Imaging, ultrasound—techniques that look inside your body so you can see the organs more clearly. They're high-resolution and/or three-dimensional – three dimensions are pretty common now. “Fusion imaging” means taking many different modalities and squeezing them into one. The user can manipulate them, adding or subtracting in a way that gives them insight and information heretofore inaccessible. It's extraordinary. The real home run—only starting to become available—will be biological imaging. In biological imaging, you're not just looking at morphological information—shape, anatomy, things like that—you'll be able to see chemical interactions at the cellular level…to visualize the biological response to a drug or medical intervention, for example. The ability to do that without surgically taking the body apart will change how medicine is practiced.
Three dimensional Computed Tomography (CT), creates cross sectional “slice” images of the body. When a bunch of these slices are stacked together and intervening tissue or organs are electronically subtracted, one can visualize a patient's organ as if they were an anatomy model (for more information, see: http://www.nlm.nih.gov/research/visible/visible_human.html). In the case of a patient with damage to the aorta (the main artery leading away from the heart), it is possible for the physician to see the problem and guide stents (expandable perforated metal cylinders) into position to repair the damaged vessel.
Much of this technology has benefited from the advancement of imaging in video games.
A “fusion” image is made up of several modalities of imaging, for example CT and Magnetic Resonance Imaging (MRI). By coregistering these separate images, one can see tissue, bone, blood flow and other attributes that would not be visible with only one modality. In trying to precisely define a brain tumor, for example, these tools allow the physician to locate the tumor, determine its shape and extent and which treatment might be most appropriate for its removal.
Orthogonal polarization spectral imaging magnifies and penetrates tissue far enough to let you see blood cells flowing in capillaries.
Capsule Endoscopy enables the physician to get an imaging record of the entire (nine meters long) digestive tract. The patient swallows a multivitamin size “pill” which contains a miniature video camera, battery and antennae. It's along the lines of Isaac Asimov's book Fantastic Voyage, which was made into a movie in the mid-1960s. In the story a submarine, with people in it, is shrunk to microscopic size and injected into an injured person's bloodstream to find a blockage and save the patient's life.
The number of ideas for taking pictures inside the body seems limited only by the imagination. After the Kobe earthquake in Japan, people were trying to find bodies under collapsed buildings. They said, “You know, after these great earthquakes, we always see lots of roaches. Can we harness that?” So people at Kobe University came up with the idea of wiring roaches. They put electrodes on his shoulders and little TV cameras on the body and they could control whether the roach turned left or right. Now if we could only convince patients to swallow a roach.
The field of molecular biology is also changing quickly. You can customize treatments, develop gene therapies, combine drugs and devices—actually rebuild a person from the inside out. This is all pretty much experimental.
At the Max Planck Institute for Psycholinguistics in the Netherlands, scientists have connected a snail's brain to a silicone chip with the ability to have a very crude form of communication. One can certainly imagine putting memory stick slots in one's head to enable memorization of names and facts that we seem to lose as we get older.
I had a stroke about two years ago and lost my entire right side—no motion, no feeling. It was a hemorrhagic stroke. There was no blocking of blood flow with a clot; it wasn't an aneurysm; I just bled from capillaries. The left side of the brain controls the right side of the body, and vice versa. I was fortunate—I regained balance after about a year, but I'm still semi-paralyzed on my entire right side. I hope one of you will figure out how I can get my feeling back. In my case, I don't think growing new brain cells via stem cells is the answer, nor a memory stick. Instead, I need to program the brain cells I've got, so they'll understand what the signals coming from my right side are all about.
Tissue engineering is even more intriguing. There are people walking around healthy today who had advanced cancer of the bladder. They took healthy bladder cells from these patients, put them in Petri dishes, and grew a new bladder in the laboratory. Well, it wasn't quite that simple—but basically they put the new bladders back into the patients, and four years later there is no trace of cancer. That's exciting stuff. We don't know, however, what the by-product of that process might be.
Another example of tissue engineering is seen in the famous picture of a rabbit with an ear growing on his back. The cells that formed into that ear knew they belonged to an ear, and so they created that structure. Many of the principals of growing new organs are explained in a Scientific American article (for more information, see http://www.sciam.com/mastertech/langer.pdf ).
One of the biggest killers is heart disease—more specifically, heart failure. The heart is an efficient pump; in a lifetime, it will pump enough blood to fill Yankee Stadium. When you have a myocardial infarct, you've lost part of the muscle tissue in your heart; you have less energy and life is a bit tougher. Can you get that muscle back? There's a technique in which a needle is used to put muscle cells back into the damaged heart and regrow the tissue. They had semi-success very early on, but a lot remains to be learned.
By now you get the idea of how creative you can get with medicine and technology. Now we're beginning to ask the question “Where do you stop?”
How many of you have heard of an electroactive polymer? Boston Scientific is looking at it; we've built some things to try it out. It contracts when you stimulate it electrically. If you do it just right, in the same space a muscle occupies you can get a hundred times the contractual force. Now, do you use that technology to repair a sick person, or to make someone into a super athlete?
Artificial hip replacement has become a relatively common procedure. This is the stem that goes down into your femur, and there's a little ball up there with a cup it rotates in. This performs the function of a hip. Tons of these were done. The invasiveness of it has been reduced; now they put it through a couple of two-inch incisions, one up here and one on the side. I'm having this done in three weeks, and the theory is that I will actually go home the same day. Compared with a traditional hip replacement, that's quite a difference (for more information, see http://www.zimmer.com).
Our ability to do these medical procedures with minimal interference to the body is getting better and better. Ideally, medical therapy—from my point of view and that of a lot of physicians—is to do the least necessary, to let the body heal itself. This is an extraordinary mechanism that we live in. The body has many redundancies. For example, something like a hundred separate mechanisms have been documented that influence your body temperature.
NANOTECHNOLOGY, MATERIALS AND ROBOTICS
With the advent of improved chip making techniques, the ability to make micro sensors has exploded. You don't need to limit yourself to just one sensor—you can have many sensors. The military is excited about this technology because they can cast a lot of them out over a battlefield and tell who's going where, what they're doing, all that sort of stuff. In the body, you can just insert a micro-sensor and leave it there to assist with future medical procedures. One can measure pH, pressure, temperature, motion, position and a host of other variables.
What has been called robotic surgery is actually a misnomer. The robot is not autonomous but remote and guided by a surgeon. With the use of video guided instruments a surgeon can perform a procedure like gall bladder surgery, or even cardiac surgery, from across the room, or from across the Atlantic Ocean. Procedures have been done from Paris to New York and vice versa.
One of the more extraordinary electronic/biological interface developments has occurred in attempts to help the blind see. The patient's glasses incorporate a little video chip that is connected to his optic nerve. The brain interprets the signals from that video chip, so he can see. Not very well—he's only got about sixty pixels—but compared to zero that's an enormous improvement. With sixty pixels, you can see where the door is; you know when people are around. It's pretty good, and it's going to continually get better. Who should get that and who shouldn't? What's right?
There are so many questions. How do you evaluate new technological developments? When do you use animals? How does the technology affect the environment? How does it affect people? How do you communicate about it? What are the ethics regarding the first patient a medical student practices on?
Lots of people write about the future and its exciting developments, but they observe that these developments aren't necessarily always good. Technology has a life of its own, and it sometime s requires that you look at it from very different perspectives. Virginia Postrel, author of The Future and Its Enemies, believes that every time a new technology comes out, it creates conflict. People will fight about it because of patents or money, or because they think it may harm our society or our environment. And there's the issue of ownership of new technologies. Genes are a good example. Can people own life forms? Some people have patents on life forms today, but we don't know if they'll hold up—it hasn't gone to the Supreme Court yet. It may someday. Patenting new ideas has traditionally been thought of as good, because patents protect inventions. Perhaps, though, that concept can be carried too far. That's an issue we have to worry about.
Bill Joy has affirmed the importance of facing these questions. He was the technical guru for Sun Microsystems—their philosopher-in-residence, I guess you could say. A brilliant guy. He's the father of Java™, the programming language. He wrote an article titled Why the Future Doesn't Need Us about his concerns that the twenty-first century technologies of genetics, nanotechnology, and robotics (GNR) could have unintended consequences—up to and including the elimination of the human race by robots. There are the issues of uncontrolled self-replication and of accidents and abuses by individuals and small groups. People accused Joy of being a Luddite, but he's just saying, “Hey, time out. We need to talk about this. We need a dialogue.” I hope you have that dialogue in connection with all of these issues.
Technology's coming faster and faster, but our ability to assess it is not moving faster. The first people involved in a technology frequently end up controlling it. No rules apply to new technology because it wasn't anticipated. You're always going to have conflicts of interest, no matter what the subject is. Financial conflicts, obviously—also professional conflicts, turf conflicts, regulatory conflicts, and ethical dilemmas. What are the ethics of letting something very, very new lie fallow? In the medical world, there are conflicts between the physician, whose sacred duty is to protect the health of the patient, and the scientist, whose sacred duty is to protect the integrity of the data. I assure you, these two frequently don't line up.
The term “consensus science,” coined by Michael Crighton, refers to the concept of determining what “truth” is by taking a vote. The majority wins. It is when politics gets into the science as opposed to understanding the data, principles, and assumptions. True science is wonderfully non-partisan. But, unfortunately, politics influences science a lot.
In the world of device technology, these are the things we have to worry about:
How are new technologies and the procedures they spawn to be assessed?
How can physicians best be trained to employ new technologies and how do they stay current?
How are conflicts, and turf battles, to be addressed?
Who's going to pay for the technology and the assessment?
With regard to the ethics of new medical technology development, whether a physician is involved, a company, an engineer or somebody in government, I have series of simple “tests” that I use to help guide me towards the best decision:
Golden Rule. Would I want this done to me?
Medical Golden Rule. Put your Mom, Dad or child in the patient's shoes.
Public Disclosure. How would I feel if this action were published in tomorrow's newspaper? Or what would I say if I was asked to explain it on 60 Minutes?
Role Model. What would a person I respect do in the same circumstance?
Categorical Imperative. What is everyone behaved this way? Would the world be a better place?
Saturday Night Live test. Would this situation make a skit on Saturday Night Live? Or the Simpson's? If so, rethink what you're doing.
Frequently there may be a choice of several imperfect treatment options, and sometimes the process that offers the most benefit is also the one that has the most risk attached. How do you decide?
Whether you're in technology or you're a dancer or an artist, you'll run into these conflicts. That's just life. One thing we hope to learn in the process of communicating with each other is how to address these issues more fairly, objectively, and honestly. There are many more decisions than just the technical ones. Part of your experience here at Olin is learning to deal with all these issues. These challenges are perhaps best summed up in the Serenity Prayer:
God grant me the serenity to accept the things I can not change,
The courage to change the things I can,
And the wisdom to know the difference.
After Mr. Abele's remarks the audience was eager to ask questions. Here are a few of the answers Mr. Abele provided to the questions asked by students, faculty, and invited guests.
[Inaudible question from the audience]
ABELE RESPONSE: You're asking if there's a way to avoid ridiculing technologies as they first come out. I don't think that's a problem. The Segway human transporter came out of the IBOT™, the stair-climbing wheelchair that Dean Kamen developed. He is a big thinker—he thought the Segway would transform transportation. His idea was that in cities, everyone would ride on Segways instead of driving three-ton vehicles. The problem wasn't that it isn't a great idea; the problem was that expectations about its application were way out of line. Still, the Segway has a lot of applications. Tons of discoveries were associated with it.
Serendipity and mistakes are where great discoveries get made, you know, from penicillin on down. I think creative people recognize relationships that others don't see. When a medical project starts out, you think it will have application A, and suddenly it has application B, C, or D. Or maybe the discovery isn't the original product; it's what develops from it. The Segway probably wasn't really well thought out, but that's okay. The important fact is that he did it. An awfully lot of interesting ideas, whether they're inventions or great books or movies, come from seeing relationships in things that frequently come out of faith, from constant exploration and trying things out.
Many people believe—this, again, is the issue of politically correct science—that great risk should only be taken by the so-called brightest among us. The danger of that line of thinking is that all of us are idiot savants. The brighter you are in one area, the more of an idiot you may be in other areas. In our FIRST robotics competitions, some very brilliant robotics designers collaborated with some street-smart kids who had little or no scientific education. But they had gut sense, and in terms of strategy they blew the experts away.
Q: What's your outlook for the continued collaboration between pharmaceuticals and medical devices?
ABELE: Obviously I'm somewhat of a biased responder here. We've been saying that this is a natural partnership. The greatest breakthroughs come with the interaction of different fields and sciences. Organizations that develop drugs are so different from the organizations that develop devices—it's really quite amazing. Almost a new language is coming out of some of these interactions. I mean, let your imagination run. Remember that slide I showed earlier of the guy with the video camera connected to his optic nerve? Imagine being able to access a compact flash slot in your brain where you store all your friends, with pictures and stories about them. People are working on that today. It presents tons of ethical issues, but people are talking about brain implants.
Q: How do you think bio-ethics has changed over the past 40 years?
ABELE: First of all, it has certainly come into being as a term. This doesn't mean there haven't always been people who thought ethically. But in fact, when the first heart valves were developed, the physicians simply put them in people—didn't even tell them first. They just did it. The first hundred or so people didn't make it. Now, they were going to die anyway. A lot of physicians feel that bio-ethics is rather academic and naïve. My wife is a minister. She has worked in hospitals with patients and physicians, helping people understand that dying is part of life. Some doctors seem to think that unless they can keep people alive forever, they're misinterpreting the Hippocratic Oath. I'm sorry to say that we've developed some things—the feeding tube is one of them—that have kept people alive probably much longer than they should have been.
Bio-ethics is much more visible today. It's a profession that is actually mushrooming, largely because of liability issues. I think that's very dangerous, because the law sometimes forces people to do very unethical things. What we want is a dialogue that gets outside of that—and it's happening more and more often. Sessions like this one are happening, where people are talking about the fundamental ethical issues—not what we can do (we can do lots of things we probably shouldn't do), but how to decide what is appropriate to do. One statistic says that half of all health care money is spent on people who are in the last year of their lives. Some say the percentage is higher. It's certainly surprisingly high. This is an American thing; our culture says we can live forever. And you know—surprise, surprise—God keeps winning out.