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Lawmakers Concerned About Medical Device Safety

Representatives Edward J. Markey (D-Mass.), Diana DeGette (D-Colo.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) today sent a letter to the Commissioner of the Food and Drug Administration (FDA) raising concerns about flaws in the agency’s 510(k) process for clearing medical devices for the market. Congress is expected to debate the Medical Device User Fee Act, a law that addresses FDA’s responsibilities for the approval and clearance of medical devices, which is set to expire in 2012.
Under the 510(k) provision, a manufacturer of a device does not need to provide clinical trial data to FDA, if they can prove that the device is “substantially equivalent” to another device already on the market. However, over the existence of this program, there have been several instances in which a device has been recalled due to serious safety concerns, calling into question all of the devices that were cleared for market based only on being equivalent to the recalled device.
The letter points to the recent example of a surgical mesh implant that Johnson & Johnson had to recall after the material used to make the device caused serious injuries in hundreds of women. FDA had cleared the mesh product because the company had shown that it was similar to a previously approved surgical mesh produced by Boston Scientific Corporation, despite the fact that this original mesh had already been recalled for serious safety concerns more than a decade earlier. “This example is one of several that elucidate a fundamental flaw in the 510(k) device clearance process,” the lawmakers write to FDA’s Commissioner Margaret Hamburg.

As Medical Technology Evolves, So Does Intellectual Property Law

“It’s said that at the time of Socrates, it was possible for one person to possess all of the knowledge of mankind. At that point, one person could know all of the astronomy, math, physics, anatomy, and so forth, that was known,” says Gerard von Hoffmann, a partner at Knobbe Martens Olson & Bear (Irvine, CA). Von Hoffmann provided that fact to help give perspective on medical technology and intellectual property law—both of which grow more sophisticated as science progresses. “Of course, total human knowledge doubles over a unit of time. And the rate of doubling of total human knowledge is increasing.”

Gerard von Hoffmann

The result of the rapid growth of human knowledge is that fields of study become increasingly specialized. At a certain point in time, it was no longer possible for a single-smartest person in a village to practice medicine and law, von Hoffmann explains. “And within the medical profession, meaningful specialization did not occur until following the Civil War as the growth of medical knowledge became too vast for one person to master.” In humanities such as law, the same dynamic is inevitable but rate of knowledge doubling occurs more slowly than in science. “In patent law, however, we are driven by technical knowledge. And a consequence of the rate of evolution of technical knowledge has simply been the recognition that patent practitioners need to specialize as well—at least on the client practice side.” Ultimately any remaining patent generalists will be left behind.

“[Silicon Valley] has to be the center of the world in terms of medical innovation”

Von Hoffmann explains that this broad trend was behind Knobbe Martens’ decision two decades ago to establish a distinct medical device practice area; the firm now has at least 61 attorneys specializing in medical technology IP law. Over the last decade or two, within its medical device group, the law firm has identified a number of expertise subgroups such as cardiovascular technology, neurointerventional, orthopedics, and medical electronics. Another one of those divisions is medical IT, which has long made up a portion of the firm’s business. “But only within about the last year, I think we’ve observed a sufficient rate of growth in medical IT innovation to justify recognizing it as a distinct practice area even apart from its cousin medical electronics,” von Hoffmann said. “Although inevitable, that’s breaking news at the moment.”

The growth of the health IT sector and the depth of the startup medical device industry generally are part of the reason that Knobbe Martens recently decided to open an office in Palo, Alto—just blocks away from the Stanford campus. This area “has to be the center of the world in terms of medical innovation,” von Hoffmann says. “And it could well be the center of the world in terms of IT innovation. So they are both in the same place and increasingly cross pollinating to produce new diagnostic and therapeutic technologies.”

The Direction of Medtech Evolution

The directional evolution of medical technology is from passive mechanical-based products to intelligent, interactive ones. For instance, there are now interactive implants that send out diagnostic information or receive signals to adjust therapy, von Hoffmann says. “You can wirelessly program a variety of implants such as cardiac rhythm devices and export data from implanted or wearable sensors to a remote location for processing.”

A result of all of this technology is a huge uptick in patient data. “That data is flowing out somewhere to be interpreted, drive diagnostic or therapeutic responses, and create vast databases for research purposes” von Hoffmann says. “Medicine in general is evolving towards a tremendously more information dominant rather than simply device dominant universe.” It is therefore natural for a place like Silicon Valley to take a lead on integrating the data manipulation and management as it applies to medical applications.” As a result of these market trends, a growing number of venture funds are becoming interested in medical IT applications. To help fledgling medtech entrepreneurs, Knobbe Martens has also launched In addition to directing viewers to relevant IP resources, it also provides a range of other information to help early stage medtech firms. “We see entrepreneurs making life changing decisions at the napkin or prototype stages, like ‘Does this technology have a right to exist?,’ 'Does it satisfy a clinical need?', ‘Is this something around which a company could be founded?’, ‘Is this technology likely to be financeable?’, or ‘How predictable are reimbursement and the regulatory pathway and timeline for commercialization in the United States and abroad?” We can't answer all of those questions. But we want to understand them, and to help provide access to information that may facilitate the decision making process.

All of society benefits from the commercialization of new technologies. But many technologies will never see the marketplace without substantial investment, and that investment will often not be available in the absence of appropriate IP protection. As the complexity of the technology continues to increase, so too must the expertise of the team developing that technology. "When a serious 'NewCo' wants to optimize its IP position, we want to be on the short list," von Hoffmann concludes, "and that requires sensitivity to dynamics outside of our narrow legal specialty."

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Bill Would Boost FDA Role in Recalls

U.S. senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) have introduced the Medical Device Patient Safety Act. The legislation would give FDA “important tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices.” In addition, the measure would allow the agency to order post-marketing clinical studies for 510(k) devices that pose potential safety risks. It would also implement Government Accountability Office recommendations for improving recalls and give FDA new authority to require conditional clearance pending safety studies for 510(k) devices.

FDA“This reform legislation should be part of the reauthorization of the medical device user fee law next year,” Grassley said. “The reforms incorporate well-founded recommendations from the Government Accountability Office and reflect the value of having a robust post-market surveillance operation in the FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better.”

The senators say they recently sent “investigative letters” to five companies that recalled faulty medical devices requesting detailed information about how the companies conduct post-market surveillance and how the companies manage recalls when a product is pulled from the market. Letters were sent to Johnson & Johnson for its DePuy metal-on-metal hip implant; Medtronic for its Infuse product; Boston Scientific for Guidant's defibrillators; CR Bard for vaginal and hernia mesh products, and; Zimmer Holdings for its knee replacements.

Reacting to the bill, AdvaMed executive vice president Janet Trunzo said: “We believe expanding the FDA’s authority to require post-market studies as a condition of 510(k) clearance is unnecessary given the agency already has broad authority to require manufacturers to conduct post-market studies for higher-risk devices cleared via 510(k). Regarding the bill’s provisions to implement recent Government Accountability Office’s (GAO) recommendations to improve the FDA’s handling of medical device recalls, we believe, consistent with GAO recommendations, the FDA could do more to enhance the clarity and consistency of its recall process, and we are pleased that the agency has a number of initiatives underway in this area.”

Getting Real: The Consulting Version of "Good, Fast, or Cheap—Which Two Do You Want?"

Last week, at the Biomedevice conference in San Jose, at a presentation titled "Speed to Market for Medical Devices," panel member Stacey Chang, healthcare director of design firm IDEO had an interesting perspective on how many companies fool themselves with unrealistic expectations during product planning. 

"A conversation we commonly have with our clients is one we call project anchors. It’s the consulting version of the good, fast, or cheap—which two do you want?" he said. In this method of viewing a project, there are four anchors, Chang explained: the product cost, product features, project cost, and project timeline. "You don’t get all four," he explained. Instead, companies should identify which attributes are the most important. "One you optimize for, another is immutable, one you have a lot of float, and the other you are going to compromise on entirely," he shared. "And it’s a pretty obvious conversation but we find that clients don’t typically have with themselves because they want them all. They fool themselves into thinking they can have it all. And so, usually, it’s a nice provacation to the conversation that’s overdue."

—Brian Buntz

Affordable Care Act Sunshine Rule Increases Transparency in Healthcare

The Centers for Medicare & Medicaid Services (CMS ) announced a proposed rule that will increase public awareness of financial relationships between drug and device manufacturers and certain health care providers.  This is one of many steps under the Affordable Care Act designed to increase transparency in the health care system, which can lead to better care at lower costs.

“When people are faced with the difficult task of choosing the right doctor, they need all the information they can gather. If your doctor is taking money from manufacturers of prescription drugs, suppliers of wheelchairs or other devices, you deserve to know about it,” said Peter Budetti, M.D. CMS deputy administrator for Program Integrity.  “Disclosure of these relationships will discourage the inappropriate influence on clinical decision-making that sometimes occurs while still allowing legitimate partnerships.”

The proposed rule would require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report to CMS payments or other transfers of value they make to physicians and teaching hospitals.  The proposed rule would also require manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.

This increased transparency is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals might face as a result of their relationships with manufacturers.

Drug and biologic manufacturers, medical device or supply manufacturers, and GPOs would be affected by the new reporting requirements. These organizations, as well as the physicians and teaching hospitals, would be allowed an opportunity to review and correct information prior to its publication.

The Affordable Care Act provides that violators of the reporting requirements will be subject to civil monetary penalties (CMPs), capped at $150,000 annually for failing to report, and $1,000,000 for knowingly failing to report.

CMS is proposing that data collection will not begin on Jan. 1, 2012 and that manufacturers and GPOs do not need to begin data collection until final regulations are issued.   Depending on the timing of the final rule, CMS is proposing that manufacturers and GPOs will be required to submit a partial year on Mar. 31, 2013.  Once the data has been submitted, CMS will aggregate manufacturer submissions at the individual physician and teaching hospital level, provide them with a 45-day period to confidentially review and, if necessary, correct the data, and make the data publicly available by Sep. 30, 2013.

CMS will accept comments on the proposed rule until Feb. 17, 2012, and will respond to them in a final rule to be published in 2012.

The Roadblock May Not Be the FDA After All

A colleague and I visited with a startup company last week, one that was designing a product that can detect certain ailments through your breath. Named Menssana Research, the company is housed across the street from the New Jersey Institute of Technology, in a building owned by the college (which just happens to be my alma mater).

One test that company claims to have perfected is a non-invasive breath test for markers which can predict the probability of a Grade 3 rejection in heart transplant recipients who received their transplants in the preceding year. Called the Heartsbreath, it consists of a breath collection apparatus (BCA) that resembles a small telescope.


The BCA collects volatile organic compounds found in a person’s breath using a sorbent trap. You can see it in action in this clip, showing MD+DI Managing Editor Maria Fontanazza breathing into the BCA.

At the same time, the device collects a separate sample of room air. An analysis of the two samples is performed by gas chromatography and mass spectroscopy. Hence, a patient may not have to go through an invasive endomyocardial biopsy. The data collection is shown in the next video clip.

The company received what it thought was great news when it obtained FDA approval as a Humanitarian Device. Unfortunately, that news was shortly followed by news from Medicare, who denied the request for reimbursement from patients making use of this procedure. Medicare claims that additional testing is needed before they will approve the procedure.

Here’s the summary from The Centers for Medicare and Medicaid Services (CMS):

The Centers for Medicare and Medicaid Services (CMS) has reviewed Menssana’s request for a national coverage determination (NCD) for the Heartsbreath diagnostic test used as an adjunct to the endomyocardial biopsy to detect grade 3 heart transplant rejection in patients who have had a heart transplant within the last year and an endomyocardial biopsy within the prior month. We believe that the available evidence does not adequately define the technical characteristics of the test nor demonstrate that Heartsbreath testing to predict grade 3 heart transplant rejection improves health outcomes in Medicare beneficiaries. Therefore, we are proposing that the Heartsbreath diagnostic test is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.

So what gives here? It’s good enough for the FDA but not good enough for Medicare. I was led to believe that the FDA was Big Brother. But in the case of Menssana Research, that’s not the case.
The current biopsy is performed in roughly 2500 patients per year who receive a heart transplant. The test is not a simple one for the patient, and costs about $3500, according to Dr. Michael Phillips, President and CEO of Menssana.

The bottom line is that Medicare wants Menssana to do more testing, which it is currently doing. So even though it’s good enough for the FDA, it’s not good enough for Medicare.

Richard Nass

Medical Device Gets Regulatory Nod in 17 Days

Robert Perry, MD, a resident at University of Oklahoma Medical Center, has developed a simple device to help clinicians locate vasculature. The EZ Vein device, which  works similar to a blood pressure cuff, redirects blood flow from deep tissue to a selected vein near the surface in order to simplify injection. Unlike tourniquets, the device works in the absence of a pulse. FDA approved the device in only 17 days, reports the Daily Oklahoman.
Perry, a practicing physician develops devices in his spare time. He explained that his product ideas are born out of his practice, where he identifies product needs. “I have a machine shop at house,” Perry told the Daily Oklahoman. “I would see a need and think about, build a prototype and test it and then talk to people in the field, file a patent and come up with a business plan.”
The EZ Vein is elegant in terms of its simplicity. Designed for ease of use and cost effectiveness, the device could be especially useful for patients who have veins that are difficult for clinicians to locate. “There are a lot of patients who have veins that aren’t very noticeable who require up to 10 sticks to get a good draw,” says Jeffrey Groom II, a biomedical engineer and design engineer at UofM Medical Innovation Center. “And that is associated with a lot of vascular damage and possibly infections. Getting a good access point is really important.”

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Combination Products: Engineering and Biologics Make Good Bedfellows

No topic can be more current or more misunderstood than the expanding world of combination products, notes the Medical Development Group (MDG; Waltham, MA). To stay current and promote understanding, MDG is sponsoring a forum early next year under the catchy title, "Combination Products--It Takes Two to Tango." The event will take place on January 4, 2012 at the Foley Hoag Emerging Enterprise Center in Waltham, MA.

Designed to address the science, materials, market opportunities, and product costs associated with combination products, the forum will examine a range of concerns facing medical device, pharmaceutical, and biologics companies, such as how to efficiently and effectively manage limited resources over a diverse and technologically complex area. Speakers and panelists will include Peter Norris, executive chairman of Tomophase Corp. (Burlington, MA); Hari V. Sundram, medical director and vice president of Medical Capital Advisors LLC (Woburn, MA); Sudha Kadiyala, senior director for business development and strategic planning and senior director for process and product development at Advanced Technologies and Regenerative Medicine LLC (Raynham, MA); Sherin Abdel-Meguid, founder of Shifa Biomedical Corp. (Malvern, PA); and Paul Hartung, CEO of Neuroptix Corp. (Acton, MA).

Defined as the partnering of a medical device with a biotechnical or pharmaceutical product, combination products are predicted to take off in the next few years, equaling perhaps 50% of all U.S. medical device activity. However, developing new combination products will face an uphill battle unless medical device engineers and molecular biologists can combine their widely divergent talents. That's part of the message that Michael Drues, president of Vascular Sciences Inc. (Grafton, MA), will deliver as the forum's keynote speaker. To provide a preview of what Drues will tell his audience, MPMN had the following conversation with him.

MPMN: In what sense would you consider combination products to be the most current, yet the most misunderstood, topic in the medical device arena?

Drues: I've been saying that combination products, in general, are the future of medicine for almost 20 years. Slowly--it's been taking a very long time--but slowly, the rest of the world is coming along to this realization as well.

Probably the best-known example of a combination product at the moment is the drug-eluting stent, although I would argue that the drug-eluting stent is a very primitive, almost childlike example of a combination product. But it is an example nonetheless.

The quintessential example of a combination product is what we're now starting to do in the area of tissue engineering. In terms of timeliness, I think that the development of combination products for tissue-engineering applications is really, to a certain degree, a natural progression. It represents the future because the single biggest advantage of combination products, especially applications like tissue engineering, is the ability to restore function that was lost because of illness or injury. A simple example: If a patient has a heart attack and a portion of the heart becomes necrotic, the simple reality is that you can do an angioplasty, you can put in a stent, you can put in a hundred drug-eluting stents if you want to, but from the perspective of the cells in the heart that have died, have you accomplished anything? Absolutely not.

The best outcome that you can hope for with current technologies is preventing the problem from getting worse--what we call palliative relief. In the absence of something better, palliative treatment is OK, but we've faced that limitation in medicine for decade, and it's about time that we get past it. Thus, I don't want to simply prevent a medical problem from getting worse; I want to erase the damage in the heart caused by the heart attack as if the patient never knew that he or she had a heart attack to begin with. I want to be able to erase the damage in the brain caused by ischemic stroke or Parkinson's, or Alzheimer's, or multiple sclerosis as if the patient never knew that he or she had those diseases or injuries to begin with. I want to erase the damage in the pancreas caused by insulin-dependent diabetes mellitus, or so-called type 1 diabetes. This is not the next evolutionary advance in medicine; this is a revolutionary advance, a change in the whole ethos of how we approach medical problems.

MPMN: To repair damaged tissue in the heart, for example, what new technology challenges face designers and manufacturers of medical devices and components in developing combination products?

Drues: There are plenty of challenges to go around on all front--clinical, regulatory, intellectual property, manufacturing. The list is endless. But specifically with regard to the technology challenges from the device perspective, the most obvious would be getting whatever it is that you're trying to get to wherever it is that you trying to go. That's probably the first thing that engineers are going to be thinking about. But that, in many ways, is the easy part. Dealing with drugs or especially very finicky molecules like biologics and therapeutic proteins, or delivering genes inside of a virus on a medical device to turn on angiogenesis or apoptosis, for example, is just the beginning of the discussion.

When dealing with drugs or biologics, there are all kinds of sterilization, shelf life, and stability testing issues. For example, how to you sterilize a plain old medical device such as a bare-metal stent? You can hit it with whatever you want--EtO, gamma, heat--and the stent is not going to change. But once you put a drug on it--or especially, once you put a biologic on it--all bets are off. It's almost nuts to even ask the question of sterilizing a therapeutic protein or a gene inside of a virus on a medical device. Thus, how we deliver these kinds of things is really going to change.

This is a different conversation, but many new therapeutics are going to be put together at the patient's bedside immediately prior to being administered. Thus, the whole notion of putting together a product in a manufacturing facility and shipping it across the country or around the world and then putting it into a patient is going to change. I think that many industry professionals are going to be in for a bit of a paradigm shift because they're going to find that they're not going to be able to do that so easily anymore.

MPMN: In other words, there will be some type of a platform, say a stent, and the pharmaceutical will be applied right in the hospital?

Drues: To use a very simple metaphor: It's like a drug in a syringe. Setting preloaded syringes aside, the idea of the current drug-eluting stent is like loading the drug into the syringe in advance and then shipping it. What I'm suggesting is that we should supply the stent and the drug separately. This is not so much of a concern for drugs, but it's going to be a huge concern for biologics and applying them to the device at the patient's bedside the moment before they're administered. There are already ways for doing that. Intellectual property covering such technology, some of which I've developed myself, already exists. Thus, this is a solvable problem. However, the first thing that has to happen is that people have to think differently.

Take the question of shelf life, for example. What's the shelf life of a plain old medical device like a bare-metal stent? Packaging issues aside, perhaps a million years? Nothing's going to happen to the stent. But once you put a drug on it or, especially, once you put a biologic on it such as a therapeutic protein or a gene inside of a virus, what then? The whole notion of putting something like that on a device and putting it into a package and then placing it on a shelf for days, weeks, or months is nuts. Thus, things are going to have to change in terms of considering how to combine a device and a therapeutic agent at the patient's bedside rather than in a manufacturing facility somewhere.

MPMN: How are medical device and components manufacturers going to be forced to retool to be able to collaborate with the pharmaceutical companies that are developing combination products?

Drues: First of all, let's be very clear: I think you're limiting your audience tremendously by focusing just on pharma. While pharma brings some advantages, I think that the most significant advantages will come from the biologic or biotech side. The whole notion of combination products involves all three elements: devices, drugs, and biologics. Thus, be careful about drawing lines in the sand like that. That's number one.

The first and most important thing--and in some ways, the only thing--medical device and components manufacturers are going to need to do is to educate themselves. And that's also going to be the most difficult thing. Because right now, there is no common language between medical device manufacturers and developers of drugs and biologics.

Engineers are used to looking at the world from an F = ma perspective, or force equals mass times acceleration, which is the governing law of dynamics. Molecular biologists, on the other hand, are used to looking at the world from an a, t, g, and c perspective, or adenine, thymine, guanine, and, cytosine, which are the four bases in DNA. There's not a lot of overlap between F = ma and a, t, g, and c. Thus, engineers are going to have to learn to speak some molecular biology, and molecular biologists are going to have to learn to speak some engineering.

This is not a trivial problem. I remember going into a stent company 15 years ago or more and trying to sell it on the idea of using a stent as a delivery system for gene therapy when they didn't know what a gene was. This was long before the advent of the drug-eluting stent. On the flip side, it would be equally difficult going to a biotech company today to make the same argument about using the stent as a delivery vehicle for gene therapy if they don't know what a stent is. Therefore, there's a tremendous amount of education that's needs to happen, both in industry and FDA, in order to put these kinds of technologies together.

That, in my opinion, is the first, most important, and most challenging task. Many people are starting to be dragged kicking and screaming into this because it can be a little overwhelming, a little intimidating. I understand that. It won't be easy to accomplish this step, and that's one of the reasons why developing combination products is taking so darn long. It's taking much longer than it should, but that's start.

MPMN: What new technologies, materials, or systems will medical device design engineers need to develop to be able to accommodate or to deliver biologics?

Drues: The devil's in the details, of course, but I can provide some general ideas. The delivery systems that we're using today, which are basically just very small modifications of existing medical devices, are sufficient--but not ideal by any means--for what we've been trying to do thus far. But what we've been doing thus far is really the lowest of the low-hanging fruit, in my opinion. It's the easiest stuff. To get to the much more valuable much more challenging stuff, we're going to have to come up with some totally new tools.

Here's a metaphor that hopefully much of a medical device audience can relate to. In product development, there are two strategies: evolutionary vs. revolutionary. Most product development, whether in the engineering or medical field, is evolutionary--in other words, incremental improvements. But the problem with this is that the light bulb did not evolve from the candle; the car did not evolve from the horse. Thus, every once in a while you need to have a revolutionary leap--what Clayton Christensen at Harvard University calls a disruptive technology--to kick things up a few notches. And that, I think, we need to see more of. We need to see delivery systems that are not simply retrofits of medical devices that originally were designed to do one thing and now we're trying to tweak them to do something else. Instead, what we're going to need is truly new, truly novel delivery systems that were designed first and foremost to deliver whatever it is that we're trying to deliver.

MPMN: Can you foresee what such a delivery may eventually look like? What is it going to be made out of? Are we talking about polymers here, or nitinol? How should we tell an engineer to think about revolutionary technologies?

Drues: For example, it's problematic for many reasons to make permanently implantable medical devices such as bare-metal stents out of biostable materials like metals. In other words, why put a permanent implant into patients' bodies for their rest of their lives if they don't need it for the rest of their lives? Again, allow me to refer again to the best-known example of a combination product at this time--the drug-eluting stent. To pick on Cordis's device, which was the first to hit the market, 80% of their drug comes off the stent after 30 days, and 100% of it comes off after 90 days. So after three months, what do you have? You don't have a drug-eluting stent; you don't even have a bare-metal stent. You have a stent with a bunch of polymer gunk left on it that's going to be in the patient's body for the rest of his or her life. It shouldn't take an MD or a PhD to appreciate that this whole idea is nuts.

What we should be doing is making such devices out of bioabsorbable materials so that once the drug goes away, the stent goes away. Or, if you want to make the device out of a biostable material, design it to be sort of rechargeable. In other words, after the drug is gone, shove another catheter into the patient and inject more drug, perhaps suspended in some sort of a gel, that gets absorbed into the stent and starts to elute all over again.

What we're doing right now in these areas is so primitive, so childlike, that it's almost laughable compared with what we could be doing. And a lot of this is directly related to evolutionary vs. revolutionary product development. Because if we continue to simply tweak existing products, which happens the vast majority of the time, we're going to limit ourselves. Going back to the horse-automobile metaphor: If you lived in the olden days, you could keep tweaking the horse to end up with one that was faster, more efficient, or stronger, but you'd never end up with a car no matter what you did. Thus, the question is, how long are we going to continue to try to tweak the horse before acknowledging that while the horse has been very useful historically and perhaps it can continue to be used for certain things, how can we come up with something totally new that is designed to do what we're trying to do? What possibilities can we come up with? That's the kind of mindset that I think we need.

I fully appreciate that there is a tremendous number of challenges. And I don't mean the technical ones because the technical, the scientific, the engineering, and even the regulatory challenges are among the easiest problems to solve. First and foremost on the list of the much more difficult challenges is the convergence challenge--getting people to think and to think differently. And second, there are business challenges, because most companies are used to evolutionary kinds of development. For example, companies design devices such as balloon catheters and then tweak them to make them a little longer, a little shorter, a little narrower, a little thinner, a little fatter. Then, in a couple of months or less, they create a whole other product. That's like tweaking the horse, but coming up with a new car takes a little more effort.

MPMN: As the keynote speaker at the upcoming forum on combination products, what types of people do you hope will attend and what do you hope they will come away with?

Drues: Traditionally, such an event will draw a medical device audience--people coming from the technical/engineering side. But regulatory, marketing, and clinical folks should also attend. Thus, it will be a pretty broad audience.

In terms of what they should come away with, my presentation will be very short. It's almost laughable to try to cover such a broad topic like this in such a short period of time. Nevertheless, what the forum overall hopes to accomplish is to give a sense of what combination products are and what they're not. There are a heck of a lot of examples of products that, by definition, are combination products. There's no question about it. But many of them are not regulated as combination products. Thus, there's a tremendous amount of confusion in this area, and, unfortunately, we have brought much of this confusion upon ourselves.

Other goals of the forum will be to address some of the challenges to achieving convergence: How do you get an engineer and a molecular biologist to have an intelligent conversation together--in other words, to play nicely together in the same sandbox? That's not an easy thing to do, but we can't start seeing the synergistic benefits of combining these disciplines--a 1 + 1 = 3 kind of thing--unless we start to better understand what is being offered from the other side. And quite frankly, there aren't many folks out there that have broad enough experience in all of these areas to really see how to put the pieces together to achieve a synergistic effect. In other words, most people are used to working only in devices or only in drugs or only in biotech, and while they might know their particular area fairly well, they probably don't know the other areas well or perhaps not at all. So, how do you even imagine what you can do when you start combining products if you don't understand at least a little bit about what's being offered from the other side of the table?

Senators Seek to Improve Medical Device Safety

U.S. Senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduced legislation to help protect patients from unsafe medical devices and improve the management of recalls.  

The Medical Device Patient Safety Act would give FDA important tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices.  

The bipartisan legislation would allow FDA to require postmarket clinical studies for medical devices that pose potential safety risks, if they were approved through the expedited 510(k) review process. The bill also would implement Government Accountability Office (GAO) recommendations for improving recalls and give FDA new authority to require conditional clearance pending safety studies for devices reviewed under the fast-track, 510(k) approval process.   

"This reform legislation should be part of the reauthorization of the medical device user fee law next year," Grassley said. "The reforms incorporate well-founded recommendations from GAO and reflect the value of having a robust postmarket surveillance operation in FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better."  

"Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices – causing significant costs to our economy as well as health," said Blumenthal. "This bill will help protect people from dangerous unsafe medical devices by demanding more consumer safeguards, improving recall management, avoiding costly recalls, and preventing irreversible injury to patients. By removing unsafe devices from the market more quickly and efficiently, we're preserving a faster approval track for safe and effective products to reach patients."  

"Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients," Kohl said. "This legislation will help ensure that FDA can act quickly and decisively when there's a problem, and that the drive toward getting new technologies to market won't come at the risk of patient safety."  

Grassley, Blumenthal and Kohl have also sent investigative letters to five companies that recalled faulty medical devices requesting detailed information about how the companies conduct postmarket surveillance and how the companies manage recalls when a product is pulled from the market. Letters were sent to Johnson & Johnson, for its DePuy metal-on-metal hip implant, which was the subject of a worldwide recall and an April 13, 2011 hearing of the Senate Special Committee on Aging; Medtronic for its Infuse product; Boston Scientific for Guidant's defibrillators; CR Bard for vaginal and hernia mesh products; and, Zimmer Holdings for its knee replacements.  

"As the Special Committee on Aging's recent oversight hearing detailed, effective postmarket surveillance practices allow companies to recognize problems with medical devices in a timely fashion, preventing expensive recalls later, and can also save lives and prevent unnecessary suffering," the letters state.

The Medtech Industry’s PR Problem

Not too long ago—a few decades to be somewhat imprecise, the healthcare industry in the United States was much less regulated than it is today, and was essentially market based. Over time, the FDA began to acquire increasing authority. "The 'drug' industry was lightly regulated from 1906 to 1938 when new drug approval for safety became the requirement for entry into interstate commerce," explains pharmacist and device attorney Larry Pilot. In 1938, FDA was given the power to regulate pharmaceuticals. The act that gave the agency that authority also defined the term “device” for the first time and imposed regulatory burdens associated with device adulteration and misbranding violations, Pilot explains. In 1962, efficacy rules were enacted, which led to a further expansion of FDA authority. Oddly enough, the medtech industry was essentially unregulated until 1976, when the Medical Device Amendments were enacted.

According to Biodesign, the amendments resulted, in part, from problems caused by the Dalkon shield, which injured thousands of women. According to Wikipedia, the commercialization of the Dalkon shield resulted in a "huge scandal." Pilot explains, however, that this information is incorrect. "The 1976 Device Amendments were not prompted at all by the publicity surrounding the Dalkon Shield. There was no scandal at the time and the safety problems were not known by the Robins Company," he explains. "While at the FDA, I had a direct responsibility for investigation of this pre-1976 experience. As a matter of fact, Robins ‘withdrew’ the device from the market, and the FDA determined that it could not characterize this ‘withdrawal’ as a ‘recall’, because there was insufficient evidence to support that a violation of law had occurred." 

In any event, the broader opinion of the companies involved in the healthcare industry began to sour much earlier than the mid-1970s. Carl Schramm, president of the Kauffman Foundation, explains that the public’s view of pharmaceutical companies began to go downhill somewhere between 1910 and 1930, when a meme entered into society, suggesting “that people who chose to make their way in certain industries—such as pharmaceuticals—were perhaps not as benign and kind as the rest of us,” Schramm said in a lecture. Instead, many people began to believe that the pharmaceutical industry had an unnatural urge to "put adulterated things into us," Schramm explained. It is, however, worth mentioning that the image of the pharmaceutical industry was on the upswing in the period beginning in the late 1940s and, in particular, during the 1960s.
Smith Bros.Before the opinion of the pharmaceutical industry grew bleak in the eyes of much of the public, most people had basically an “elementary school kid’s view of, let’s say, the Smith Brothers (referenced in the image on the right), who wanted to help you if you had a cough,” Schramm said in the aforementioned lecture. “They concocted something in the back of their pharmacy and put it on the market,” he adds. The basic understanding was that the Smith Brothers were providing a valuable service, and that they would only market their invention if it was safe and effective. 

Too Much Input from Naysayers

Such a positive view of the industry—whether we are talking about pharma or medical device makers—is rare these days. Companies active in the medical device and pharma sectors are often painted, in some way or another, as "bad guys." Despite that, I subscribe to the notion that most of the people in the medtech industry are well intentioned and truly want to see their innovations go on to help people.

“The industry hasn’t done their job in advocating for [itself].”

These days, however, mainstream media coverage is often sensationalistic, harping on the negative: product recalls, adverse events, and so forth. Personal injury lawyers sometimes see opportunity in FDA recalls, using it to drum up business. And, as Schramm puts it, "[our culture is] now trolling for every possible known disease," and looking for someone to blame.  
“The industry hasn’t done their job in advocating for [itself],” says device attorney Larry Pilot. The industry is often loath to talk about devices recalls—many of which have no affect on patient safety. The reason for this, one PR insider told me, is because they are simply fearful of giving credence to it. But companies that refuse to clarify the facts often lose out. “No company should be reluctant to speak to the press, and to answer sometimes difficult questions,” Pilot says. Without a successful PR strategy, dealing with negative events can often have a disastrous impact for companies, as illustrated, for example, by Toyota's recent clumsy PR response to allegations of faulty brakes.
There are, of course, bad players in medtech too, as there are in any industry, but the majority of players do far, far more good than harm. “There isn’t any concentrated effort to get the good word out,” Pilot said. The advice to do a better job at PR doesn’t, however, mean that it is a bright idea to, say, twist the results of clinical data to look more promising than thet really are. Given all the great players in the industry, a strong objective case can be made to show the medtech industry for what it is—an innovative force that generally helps people live longer and better lives. Why doesn't that happen more often?
Note: This text was edited on December 15 to fix inaccuracies regarding FDA history.  

Brian Buntz