Originally published September 1996
An Interview with Jack Lemons
Professor of Biomaterials and Surgery, University of Alabama, Birmingham, and Chairman, American Society for Testing and Materials Committee F-4
In the field of biomaterials, attaining adequate support for research and development has rarely been easy. With its experimental beginnings some 50 years ago, the biomaterials industry went from being relatively low-profile to being anything but that in the 1980s, when the industry benefited from an influx of R&D dollars from high-tech companies.
But in the 1990s, public controversies such as those related to the use of silicone-gel breast implants have caused many suppliers to withdraw their products from the medical market rather than risk financial liability and class action litigation. Removal of these materials has led to the increased need for some sort of legislative relief so that biomaterials suppliers will go back to producing and improving materials for medical applications. One recent attempt at such relief fell short last May, when President Clinton vetoed the Common Sense Product Liability Legal Reform Act, of which biomaterials reform was a part.
To address this and other issues surrounding the biomaterials crisis, MD&DI recently spoke with Jack Lemons, chairman of the American Society for Testing and Materials (ASTM) Committee F-4 on medical and surgical materials and devices, at the World Biomaterials Congress in Toronto. While his experience in the medical industry has taken him from university classrooms to professional organizations and standards-writing committees, Lemons has kept his focus on the biocompatibility of synthetic materials for tissue replacements in surgery. In doing so, he has closely followed the growth--and current crisis--in biomaterials research and development in the United States.
What's your impression of the so-called biomaterials crisis, in regard both to the commercialization of devices and to the effect of the crisis on research?
I've followed biomaterials and the evolution of biomaterials and biomechanics from probably every aspect. What's key is that during this evolution, the United States really took a leadership position throughout the world. Unfortunately, that's changing rapidly. The U.S. medical device industry is moving offshore, to Asia and Europe principally, and many factors have caused this to happen. The biomaterials crisis is real. One of the more critical factors that have led to this crisis is the liability issue. Industry in the United States is often put in a no-win situation with regard to investment and return on investment. While these companies need to be safe and efficacious in everything they do, they also need to be able to earn a profit.
Is the biomaterials crisis having an effect on academic research and research programs in general?
Yes, and it's a continuing subject of both professional presentations and private discussions among investigators. It's certainly of grave concern to students who are going through formal academic programs and looking toward a future in this field.
I recently conducted a summer seminar for graduate students in which I reviewed what I've seen happen within past decades, and I tried to make projections about the future. This is the first decade in which it's been very difficult to make projections, simply because everything is changing. So the crisis is real, and though it only comes into focus during certain discussions, it is a real part of what's going on in U.S. universities. Worldwide, research continues, but U.S. funding has decreased significantly, and everyone can feel the effects of change.
How has the relationship between the U.S. device industry and its academic counterparts changed over the past decade?
For many years I've been involved in the development of sources for graduate student and program funding. I've spent a significant portion of the last 20 years interacting with the major U.S. industries, attempting to move forward from where we were in former years, when materials that were intended for other applications were adopted as biomaterials. Such materials were successfully used during those years, but they were originally formulated for other purposes, so we redirected, reconstituted, or surface-modified them.
During the 1980s, companies like DuPont, Dow Corning, Bristol Meyers, and 3M--major sources of high technology--became involved, and researchers were finally constituting, testing, and evaluating new substances as synthetic replacements for tissue. But because of liability considerations and the potential for class action litigation, larger companies have changed and they are no longer becoming involved. Instead, they've backed out of major investment, and unfortunately it's costing everyone significantly.
Certainly there are programs that were started more than five years ago that still exist today, and most people in industry would agree that such programs are important in terms of ensuring the quality of research that can be conducted in the United States. But due in part to the current scarcity of these types of programs, there's no question that U.S. device manufacturers now view moving parts of their companies overseas as a necessary part of doing business. We're going to see the financial and structural effects of that throughout the rest of the 1990s. So while the impact of these moves is not a big factor yet, it certainly will be down the line.
In the future, the need for biomaterials is going to be greater, because we're now talking about combining synthetic materials as matrices for drug delivery and containment, and there's going to be a need for millions of joints, heart valves, tooth-root replacements, and so on. And with an aging population, this need for biomaterials is going to become more urgent. But the high-technology resources that could have been applied to improving what we have today are being compromised. Industry needs to rethink the equation somehow, and President Clinton's veto of the Common Sense Product Liability Legal Reform Act puts this in focus. Companies will no longer be able to make these investments unless they're given incentives to do so.
What's the mission of ASTM Committee F-4 on materials and medical devices?
The primary mission is to develop standards that gain a consensus from all parties involved in using biomaterials--including general-interest groups, industry, patients, government, and regulatory bodies. We convene twice a year, with the goal of determining what standards need to be written. That then leads to the development of accepted standards through a controlled and balanced consensus process that is truly representative. Ultimately, those standards are published as American National Standards, which give those in the discipline a way to ensure a material's properties, characteristics, sizes, dimensions, and tolerances.
Many ASTM Committee F-4 members also participate in technical advisory groups (TAGs) that, in representing their countries' interests, contribute to the globalization of industry. The ultimate goal of the committee is to help businesses become more international, because medical care should not have boundaries.
How do you decide when a standard is necessary in a particular area, and how do you decide when to stop writing a standard for a material or device?
It's very important that many constituencies be represented in the process. That's accomplished by allowing anyone in the organizations concerned with surgical implants to bring a request to one of the committees. For example, we recently had a request from the Association of Operating Room Nurses, Inc., regarding cotton products. Association representatives came to the society and said that national standards were needed in five areas, and we immediately started the procedures necessary to initiate the drafting of standards.
Each draft standard then proceeds through a predetermined voting process, and all concerned parties contribute to the development of the final standard. This leads to the published standard. It is a relatively slow process, taking a year or more to produce a standard that is published by ASTM. Thus, anticipating when a standard will be published is quite difficult.
One problem is that general-interest participants--those who come without any other support except maybe their academic programs--are finding that their resources are being depleted. This makes it difficult for the committee to maintain the organizational balance that can provide a consensus.
We're trying to establish ways in which we can normalize participation and anticipate when a standard may need to be developed. Many ASTM members attend meetings of organizations related to the biomaterials field, listen to the papers, bring back recent results, and contribute these to the working groups. The reverse of that is that we often go to FDA or the National Institutes of Health (NIH) to find out what would be of interest to them in terms of national standards. They then give us ideas that are brought back before our executive committee, and we identify individuals to work in those areas.
What is the relationship between the work of the ASTM standards committee and FDA's regulation of medical devices?
Each of our meetings is attended by a number of people from all levels of government agencies, including the National Institute of Standards and Technology, FDA, and people employed directly by NIH. So there is multidisciplinary participation.
Do you think the committee has adequate representation from device manufacturers? Is there any information they might not be aware of with regard to the standards process?
I firmly believe that the participation of device manufacturers has been critical to the evolution of the process. They participate as actively as possible, but one of the difficulties is that some companies have many international subsidiaries. So as we look toward international harmonization, it's very difficult for them to support groups from the United States exclusively because they also have to deal with agencies in the other countries where they do business.
While obtaining balanced U.S. participation has been difficult, we try to ensure that industry has a proper role that is appropriate within the voting interests. For example, if 10 members are from one industry, ASTM officially recognizes a voting representation that is balanced among membership categories. I've been impressed by the industrial participation, and we try to promote involvement in every way we can. Device manufacturers are key, often having the data that are needed for these standards.
Balanced representation has been a central issue with some of the standards, because segments of the community do not completely agree with one another. And when they do not fully agree, a consensus vote is delayed because of the "negative vote" process. This process gives each member a right to resolution of the negative vote issue prior to the publishing of a standard, thereby ensuring that the interest of any member is not overridden. It's done as fairly as possible. But again, it's incorrect to have a small percentage of the voting population dominating the process.
Do you see the work of the committee helping to contribute in some way to the resolution of the materials crisis?
The standards in and of themselves can contribute from the standpoint of providing baseline information to which anything that's different or new can be compared. Although this committee is not intended to be involved in research, it does clearly recognize the importance of all information related to safety and efficacy. Therefore, when a standard is written, it always includes a rationale to justify writing a standard on that material, device, application, or test method. In addition, we include a precision and bias statement that must be based on statistical significance. This is extremely useful--it contains key information that can further understanding.
Do you have any advice for device manufacturers confronting the potential shortage of materials?
Clearly, all need to participate. I try to encourage companies to continue the process they have been involved in previously--that is, constituting, fabricating, developing, and promoting new and unique biomaterials, as well as improving those that exist. Confronting the potential shortage is extremely important, especially with an aging population, issues of quality of life, and needs in developed countries.
Interest on the part of device manufacturers is there, but how involved they become still depends on executive-level decisions regarding benefit and risk. One aspect of risk is certainly financial. If there is a potential for major litigation, an executive committee must decide how to balance the cost/benefit equation.
Can you see any way around the current dilemma, short of introducing another supplier indemnification bill?
In time, given the globalization of industry, there's certainly the potential for reaching out to a worldwide community for biomaterials or devices. But right now the developed countries of the world have the greatest opportunity to take strides toward significant improvement. I believe that U.S. industry should be in a leadership position, but I'm not sure how this should be accomplished within the current environment.
One way would be through national legislation to properly protect suppliers while still protecting patient and consumer rights. We need to balance the equation somehow and carefully develop meaningful national legislation that can protect all parties while still maintaining the interests of those who have truly been subjected to disservice or malpractice. This will be very difficult to achieve.
There have been suggestions, from the Health Industry Manufacturers Association and other organizations, that the federal government should be more directly involved in basic biomaterials research, and perhaps function as a sort of national supplier. What is your impression of these ideas?
Government has been providing financial support for the special area of orphan materials, for which there is clinical need but not really a significant commercial benefit. Maxillofacial reconstruction is an example where the government, through a grant, provided opportunities to make high-quality materials available for facial reconstruction. Industry could not afford to do this because it would cost too much on a relative basis.
As a part of my role within a medical center, I'm interested in the quality aspects of total patient health. Our intention is not to compromise any aspect of patient health care through a surgical implant or reconstruction--in fact, it's precisely the opposite. So we need to understand both basic and applied phenomena in order to move forward toward understanding all aspects of clinical outcomes research. The Society for Biomaterials and a number of other professional organizations have joined together in an effort to get government more involved in supporting basic research that would in turn help support this entire process. There's a great need for a better understanding of biomaterial/tissue interactions, and how they relate to host interactions.
As a group, we're focusing on more fully understanding clinical outcomes through cause-and-effect relationships, going back to the device, and then going beyond the device to the biomaterials used for its construction. But it's a very complicated series of steps. We're asking NIH and other organizations in government to subsidize this effort through grants.
The Society for Biomaterials has also developed a plan to better understand the roles of analyses of explanted implants, registry tracking, and the analyses of data developed. It is critical to more fully understand the success ratios for devices. In this country, we do not have the denominator; we do not have a full record of device implantations and explantations. Some programs emphasize studies of devices that have not served as intended. However, we need to know what's truly representative, in that we need to know what has happened in total. This process is going on now, and it should be supported.
What are the most interesting developments now occurring in the field of biomaterials?
What's happening is really exciting. For a very long time, biomaterials researchers have been primarily physical scientists--engineers, physicists, and chemists--whose research focused on developing synthetic materials for tissue replacements. Most of us realized, as time went by, that we had to be equally involved with clinicians, biologists, cell biologists, and microbiologists--people who understand events at the molecular-atomic level.
We're moving into a transition phase in which biomaterials will be part of treatment as one component with biologically derived materials of new tissue-engineered products. These will use macromolecular forms, cells, products, and solutions in combination with biomaterials to actually regenerate natural tissues, as opposed to only placing something synthetic. I believe in the next decade we're going to see the opportunity to regrow tissues or organs as analogs of the original and to implant them in a functional form. It's immensely exciting because it's at the cutting edge of fundamental science--understanding not only the physical properties but also the biological properties of the contiguous interface between these different systems.
Can you foresee a "golden age" of biomaterials if we can overcome current legal and procedural difficulties?
Yes, but clearly we have to recognize that there is a very large, significant patient population that needs to be served with standard synthetic materials that function as devices--heart valves, vessels, tooth roots, joint replacements, bone plates, rods, and so on. The need for these is not going to go away, so we have to improve them as much as we can given the limits of our understanding today. We can make quantum-level improvements over what we do now in that sector--dealing with quality-of-life issues in an aging population and with life-and-death issues for some members of that population. So as a group we need to focus on these issues on a continuing basis, while still placing a percentage of our efforts into what's new and what's better.