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Articles from 2012 In April

Wireless Medical Devices Are Poised to Cut the Cord

The May issue of Medical Product Manufacturing News (MPMN) will be publishing an article on the growing ability of medical device designers and manufacturers to incorporate sensors with wireless connectivity into a range of medical devices, from ECGs to pulse oximeters. This capability represents an important step forward for the medical device manufacturing industry because it enables physicians and patients alike to dispense with cords and cables, which get in the way of medical care and prevent patient mobility.

Coinciding with the appearance of this article will be a conference focusing on Wireless Connectivity in Medical Devices. Produced by Medical Device and Diagnostic Industry in association with MD&M, DesignNews, and EE Times, the conference will be held July 25-26 in San Jose. Presentations are designed to

  • Clarify regulatory requirements from FDA, FCC, and international agencies.
  • Evaluate custom and standard networks to determine the best fit for the medical device operating environment.
  • Tackle technical challenges such as radio-frequency interference, designing for low power, and extending battery life to improve device functionality and efficiency.
  • Inspire innovative design and development of wireless medical devices meeting end-user needs.
  • Implement effective strategies for data protection and security to ensure patient information privacy.

The two-day conference program is designed to provide a fundamental understanding of the wireless medical device market and address the challenges specific to wireless medical device design and development. Comprehensive, in-depth presentations will provide the foundation for medical device manufacturers to enter the wireless medical device industry--from concept to market. In addition, participants will be able to engage in face-to-face networking with wireless industry experts and top innovators. Regulatory guidance, practical case studies, and innovative strategies will be presented for overcoming technical challenges in designing, developing, and commercializing a wireless medical device. And an exclusive workshop will be held on the unique environment for developing medical mobile apps and how to capitalize on this business opportunity. --Bob Michaels

Usability, Gilbert Ryle, and the Wizard of Oz: Adventures in Medical Device Usability

Usability, Gilbert Ryle, and the Wizard of Oz: Adventures in Medical Device Usability

Stephen B. Wilcox, Ph.D., FIDSA

Since quite a few people who don’t have a behavioral-science background are having to struggle with human factors issues—to do validation research, for example—I thought I would use a discussion of word choices to communicate the complexity of some of the issues that arise when doing research with people.

The central (although not necessarily explicit) objection to the term usability, is that use of such an everyday term devalues the discipline of human factors by failing to convey the technical, scientific nature of human factors engineering, which is “so much more than usability.”

I remain unconvinced by the objection.

I certainly agree that there are (at least) 2 ways in which the tasks of a human factors professional can be too narrowly defined:

1. Focusing exclusively on ordinary device use rather than cradle-to-grave issues, which include setup, maintenance, disposal, and so on. It is unmistakably true that there can be devastating human factors flaws in those aspects of a device that have to do with maintenance, just as there can be such flaws with how a device is used in everyday clinical practice.

2. Focusing on ease of use without including safety, effectiveness, efficiency, etc.
 

Read all Adventures in Medical Device Usability by Steve Wilcox

However, I don’t see what’s wrong with including all of this under the umbrella of usability. Can’t we talk about the usability of maintenance functions or setup functions? And if ordinary use of a device entails errors that endanger people, isn’t it fair to say that the device isn’t adequately usable? Can we honestly say that a device has good usability but isn’t safe? It strikes me that we might call such a device “falsely usable”—it appears to be easy to use but actually isn’t, because users make hidden errors that endanger patients.

Frankly, even the discussion about usability strikes me as a psychological Wizard-of-Oz argument. By Wizard of Oz, I mean the attempt to dazzle by exaggerating the power and majesty of the expertise involved. In the case of psychology, it takes the form of playing to the common misconception that the psychologist can “look deeply into the human mind”. It goes back to Freud, who characterized the mind as having all sorts of surging forces in the “unconscious”. “Cognitive Science” has replaced Freud’s Id and Superego with “unconscious cognitive processes”, but it shares the idea that there are hidden phenomena that the expert can find by digging deeply enough into the mind. This Wizard-of-Oz approach is aided and abetted by replacing ordinary terms like “performing” and “doing” with technical-sounding terms like “emitting behaviors”. People don’t see, they “engage in perceptual processing.” They don’t recall past events, they “retrieve schemas from long-term storage”.

Now, don’t get me wrong. I can list, right off the top of my head, lots of things that we human factors professionals know that most people don’t—details of body dimensions and how they vary in the population, what types of errors are most likely under various circumstances, how to tell whether observed differences are real or just statistical artifacts, which IFU layouts are demonstrably more effective, how peripheral vision changes when you panic, and so on. We know how to conduct a valid usability test and many of us know how to conduct a valid hazard analysis.

However, little of this practical stuff actually requires the razzle-dazzle of a particularly esoteric vocabulary.

Of course, human factors, like any technical discipline, does need some technical terms to achieve adequate precision. We talk about “pronation and supination”, for example, rather than “turning the forearm inward and outward” because the former leaves less room for ambiguity. However, there are some powerful arguments for being very cautious when creating a technical vocabulary for mental terms. I’m going to go out on a limb here and try to explain one of these arguments—a line of reasoning presented by Gilbert Ryle in his book, The Concept of Mind. Ryle first published the book in 1949, but, in my opinion, it’s as fresh and enlightening (not to mention entertaining) today as it was then.

Ryle asks the simple question of what mental terms like perceive mean. Let me focus on that particular word to make the point. He concludes that perceive is an “achievement word” rather than a “feeling word” or a “process word”. What he means is this: to say that we perceive something is to say that we’ve achieved the ability to act appropriately toward it—the word doesn’t exactly name the behavior; it names the achievement of a capability (what he calls a “disposition”) that has behavioral implications. If we perceive something, we don’t bump into; we can accurately answer questions about it; we can pick it up; if it’s a chair, we can walk up to it and sit in it, etc. There is often a feeling associated with perceiving a chair (I’m using feeling here to mean something like conscious awareness), but there may not be. For example, we may be carrying on a conversation and have no conscious awareness of the chair that we plop into, but we would still say that we perceived the chair because we acted appropriately toward it.

This notion of perceive as the name for an achievement contrasts with the view that’s embedded in modern psychology (which, in turn, comes from traditional British philosophers like John Locke) that terms like perceive refer to a feeling or a process—an “internal” mental phenomenon—a “feeling” if you think it’s conscious, a “process” if you think it’s unconscious.

Here’s Ryle’s argument for why perception is about achievements rather than conscious awareness: if a person has the feeling of perceiving a chair but can’t keep from bumping into it, can’t describe it, etc., we would generally agree that the person doesn’t, in fact, perceive the chair; at best we might characterize the person as “thinking incorrectly” that he or she perceives the chair. So we can perceive without a feeling, and we can have the feeling without perceiving. It follows that perceiving doesn’t have to do with feelings at all (although feelings often accompany perceiving), but rather with a certain type of achievement. The idea that mental language names feelings is what Ryle called a category mistake, like the mistake made by the prospective student visiting the college campus who says “I’ve seen the classrooms and playing fields, but I haven’t yet seen the college.”

Now, cognitive psychologists who recognize this dilemma—that words like perceive don’t seem to name feelings—try to get around it by claiming that mental words name processes, unconscious cognitive processes—you have an experience, just not a conscious experience. If you ask me, though, as soon as you go down that path, you’re getting awfully close to angels dancing on the head of a pin. You have mental processes that you aren’t aware of. Yes, the psychologists often provide behavioral evidence for their cognitive processes, but why should you believe that behavior x demonstrates the existence of cognitive process y? In fact, you have to essentially accept the premises on faith in order to accept the psychologist’s interpretation of the data.

In a nutshell, then, Ryle’s point is that those who study the mind have a long history of getting it wrong when they try to be scientific or analytical about the object of their study. As he points out, the irony is that we don’t seem to have any trouble knowing what we’re talking about when using mental terms in everyday life. However, we get ourselves tied up in knots when we try to step back and analyze what we mean by ordinary terms. So, from Ryle’s point of view, when we use terms like unconscious cognitive process, we quite literally don’t know what we’re talking about. And don’t say that you don’t care what ordinary mental terms mean, that we can simply replace them with better, more precise technical terms. As Ryle argues, the only tool we have for building a technical vocabulary is ordinary language. In other words, any technical language we create has to be communicated by ordinary language, so it rests on a foundation of ordinary language; if the latter is flawed, so is the former.

My conclusion: when we’re dealing with human phenomena, it’s safer to stick with terms that have proven useful in everyday life or at least that are only slight extensions of ordinary terms, terms like usability, that allow us to know what we’re talking about even if we’re not so good at understanding what we mean when we step back and try to analyze what we’re talking about. Of course, it behooves us to be clear and to explain what’s included and excluded, by a particular term, but this doesn’t mean that we need to make up a new technical vocabulary. Because, when we replace our everyday vocabulary with a technical vocabulary, we may be building in fundamental errors, errors like thinking that perception is a cognitive process, when it isn’t. Indeed, if Ryle is right—that the whole notion of cognitive processes is, as he puts it, “a barking up of the wrong tree”—it would explain why there seems to be such a shortage of predictive usefulness from cognitive science, which defines itself as the study of cognitive processes.

There are certainly lots of smart people from the discipline of cognitive science who do great human factors work (mostly, in my opinion, by unlearning much of what they were taught), but try to find the link between the content (not the methods) of cognitive science and actual real-world prediction. You can find a link between effective human factors work and the rigorous experimental methodology one learns in cognitive science, certainly. But try to name one real-world phenomenon that you can now predict once you learn everything there is to know in cognitive science. I’ve repeatedly offered this challenge without receiving any convincing replies.

So, in sum, we human factors professionals are doing a lot of good work. The academic community has created a powerful body of knowledge by direct empirical study of things that we practitioners are interested in—what types of warnings people actually follow, how electronic systems of all kinds can be made easier to learn, how much force people can exert, how long it takes to react under various circumstances, what sample size it takes to find a given type of use error, etc., etc.

But doing good work in human factors doesn’t generally require us to play the Great and Powerful Oz by using a hyper-technical vocabulary when ordinary language works just fine.

+++++++

Stephen B. Wilcox, is a principal and the founder of Design Science (Philadelphia), a 25-person firm that specializes in optimizing the human interface of products—particularly medical devices. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He has served as a vice president and member of the IDSA Board of Directors, and for several years was chair of the IDSA Human Factors Professional Interest Section. He also serves on the human engineering committee of the Association for the Advancement of Medical Instrumentation (AAMI), which has produced the HE 74 and HE 75 Human Factors standards for medical devices.


 

It’s Not Just about the Money: The High Cost of the Sunshine Act

U.S. Centers for Medicare and Medicaid Services (CMS) has yet to release its final ruling regarding the implementation the Physician Payments Sunshine Act, which is intended to shed light on the financial relationships between physicians and industry. There is a good chance, however, that the legislation will be expensive for drug and medical device manufacturers—in more ways than one.

CMS estimates that the legislation could cost $224 million to implement in the first year alone. MedCity News reports that the cost of implementation per organization in the first year is estimated to be $195,288 per organization and require the equivalent of 1.74 full-time workers.

The effects of the legislation could be especially harsh on smaller firms that lack the deep pockets. “The legislation could accelerate the trend where you see companies, especially early-stage start ups, go outside of the United States to do their product development work and to bring their products to the market,” says Stefanos Zenios, PhD, a professor at Stanford University (Palo Alto, CA).

While everyone seems to agree that transparency is generally a good thing, the regulatory burden imposed in the current Sunshine legislation could be especially difficult for young device companies to bear.

Another consideration is that the law proposes that any payment $10 or higher made to a physician must be reported. In January, this prompted Thomas Stossel, MD to pen an op-ed in the Wall Street Journal titled “Who Paid for Your Doctor's Bagel?” which criticized the burden the legislation would impose and mocked the low threshold it prescribes for payment to be reported.

The principle behind the Sunshine Act is good, Zenios stresses. “Relationship between companies and physicians could, under certain circumstances, lead into undesirable outcomes for patients,” he acknowledges. “But, on the other hand, relationships [between the two parties] can also lead to very desirable outcomes for patients,” Zenios adds. Clinicians frequently work to develop or refine medical device technology in ways that improve patient outcomes. For instance, a physician might observe that a give procedure is performed in an unsatisfactory manner and either invent a new technology or collaborate with an engineer to help refine an existing device to improve its clinical utility.

“As the legislation is now written, there is an exclusive focus on the undesirable consequence on the patient without an emphasis on the potential for positive consequences for patients or for relationships between physicians and manufacturers,” Zenios says. “And the worry is whether the focus on too much of the undesirable consequences will eliminate some of the desirable consequences.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Tracking and Transparency: The Keys to Improving Medical Device Quality

Nora Iluri

Qmed has partnered with Clarimed to provide DeviceMatters, providing access to and analysis of medical device approval specifics, postmarket safety performance, and typical failure modes. The intention of the partnership is to help medical device professionals to better understand the regulatory and medical device landscape. Qmed/MPMN editors recently spoke with Nora Iluri, founder and CEO of Clarimed and DeviceMatters, on the current spike in adverse events, industry reporting compliance, barriers to quality improvement, and other pressing issues related to medical device quality and safety.

MPMN: What do you believe are the most effective ways to spur improvements in the medical device industry?

Iluri: Traditionally people have tried to drive improvements in medical device quality either by proposing stricter testing and regulations or by proposing fewer regulations to help incentivize greater innovation and more-rapid delivery of improvements to the market. Truth is, this is a very careful balancing act, but these are not the only levers that can impact device quality. The biggest issue that I see is a lack of transparency into quality performance across the industry. We have a lot of anecdotes about unsafe devices and new advances, but no one has been able to show a metric that tells us whether people are indeed safer or healthier using medical devices today. Physicians and patients are forced to make their choices based on old data, anecdotes, and brand reputation. Improved postmarket quality metrics could help provide transparency into how devices actually perform in market conditions and drive quality-based purchasing and quality-based market competition.

MPMN: What does the industry need or what does it need to do in order to overcome these issues?

Iluri: From a philosophical perspective, the industry needs to recognize that it is in its best interest to fight for improved quality transparency, which could help get it recognized for its performance and reduce anecdote-based credibility risks. Furthermore, we need greater regulatory and public demand for improved quality transparency, not just more regulation.

From a more tactical perspective, there are two main challenges to tracking medical device quality. First, low levels of reporting quality remain a significant obstacle, for which we need simpler and clearer postmarket reporting requirements. Second, is the lack of normalization data for adverse events, such as the number of devices in use.

We need to establish better--and publicly transparent--ways to track high-value and high-risk devices currently in use. This approach would enable the industry to distinguish between concerning and natural trends and to evaluate how devices perform in real market conditions. If we can track cars in the United States using vehicle identification numbers, there is absolutely no reason why we should not be centrally tracking pacemakers and hip implants.

MPMN: How would you generally describe the medical device industry's current quality of reporting?

Iluri: Quality reporting is improving rapidly, but it's still very poor. Reporting has doubled over the past three years, yet in 2011, fewer than 30% of device reports associated with death or injury contained a valid reason for failure. For most devices, it should be possible to identify the reasons for failure in the majority of cases, and this information should be reported to FDA. Reporting categories and requirements are also messy and confusing. Standardized 'keys' should be used for critical information, such as company and product names, and we need improved standardization and reporting guidelines around device failure reasons and similar metrics. For example, 'implant removed' should not qualify as a failure reason in my opinion.

MPMN: The number of adverse event reports--and serious adverse event reports, in particular--have increased dramatically in recent years. To what would you attribute this trend?

Iluri: Yes. Adverse event reports doubled in the last three years, and serious patient outcomes associated with these events tripled during the same time. I believe that this trend can be attributed to several factors. Among them are improved reporting rates, especially driven by increased awareness and focus on medical device quality; medical device prevalence growing even faster than the 6 to 9% market growth due to increased use of long-term implants; increased device complexity, especially in the growing use of software and electronics; and greater use of devices in higher-risk populations, such as the elderly. None of these factors necessarily mean that we are less safe today, but they do imply that there is a need for greater awareness and transparency in understanding medical device risk/benefit tradeoffs.

MPMN: How did the idea for Clarimed and DeviceMatters come about?

Iluri: We were trying to answer the question: "How do you drive radical improvements in the medical device industry?" Improvements in the approval process and regulations have all been tried without great success. With this in mind, I recommended that we should explore data transparency and the concept of a ratings agency for the medical device industry. After all, the presence of a ratings agency has been the most radical driver of quality improvements in other industries, such as the automotive market. Transparency helps to align economic incentives with quality and patient outcomes without increasing the financial hurdle to innovation through regulation.

MPMN: What does Clarimed and DeviceMatters offer to the medical device market?

Iluri: DeviceMatters aims to deliver postmarket safety data to medical device professionals, among other helpful regulatory and approval information that can help them spot concerning trends, focus R&D on the most impactful device issues, and guide management to develop a product roadmap that targets the most pressing safety concerns in the industry. Hopefully, as the data improve, we can also start to offer relative ratings of devices to help guide physician and patient choices.

MPMN: Who can benefit from Clarimed's DeviceMatters reports and analysis?

Iluri: The information we provide can benefit several key groups of industry professionals.

  • Medical device engineers can learn when and why things go wrong postmarket with a particular product type in order to improve the next-generation product or to spur innovation of radically new solutions.
  • Quality professionals can use the information to spot adverse event trends as an early warning system for potential issues. They can also easily and quickly identify the product categories associated with the greatest patient risk, where quality improvements can have the greatest impact on patient outcomes. Finally, the data can assist with identifying device failure modes across categories that might be indicative of broader, systemic issues, rather than specific product design or manufacturing concerns.
  • Strategy teams and consultants can employ the information to optimize future product roadmaps by better understanding issues faced within a particular area or to assist with defining patient needs and spotting adverse event trends that can help identify opportunities for safer, next-generation solutions. Furthermore, from a safety perspective, such information can help better define product differentiation than the market can.
  • Marketing teams and consultants can track and compare safety performance of like devices--such as strengths and weaknesses and impact on subpopulations--to help refine the intended target populations and marketing messages for existing products.
  • Corporate management and investors can look at adverse event trends as an indicator of safety performance and risk for the company. Management can also use the information for benchmarking and goal-setting purposes.

MPMN: What type of information is included in Clarimed's DeviceMatters reports?

Iluri: DeviceMatters is currently the only site that provides adverse event reporting of medical devices based on unbiased and independent FDA data, among other sources. We also offer standard information on regulatory requirements and the current medical device landscape, including approval specifics.

MPMN: How can such information ultimately help manufacturers improve medical device quality?

Iluri: In the future, improved transparency into medical device quality can hopefully help drive development and purchasing patterns. In turn, this trend will hopefully result in a radical improvement of medical device quality across the industry, similar to what happened when J.D. Power first began rating cars for the automotive industry.

MPMN: What is the potential overall business and patient impact of increased awareness and tracking of quality information?

Iluri: I truly believe that transparency helps align economic incentives with quality and patient outcomes without increasing the financial hurdle and time-to-market for innovation through regulation. In fact, increased transparency will help improve the reputation of high-quality manufacturers, enable the industry to celebrate improvements and successes with facts and metrics, drive quality improvements by forcing companies to compete on measurable quality performance and make it much easier for regulators to spot and react to issues in the marketplace, dramatically reducing negative patient outcomes and regulatory costs. Of course, we will still need premarket regulations to ensure that medical devices entering the market have been adequately tested. But through improved transparency, it will become a lot clearer what would be required of newer-generation devices and which requirements might not make a difference for patients.

From Origami to a Prototype Stent

If you are in Los Angeles between now and August 26 and have an unfolding interest in origami and medical technology—they are not mutually exclusive—you might want to pencil in a visit to the Japanese American National Museum. An exhibition titled "Folding Paper: The Infinite Possibilities of Origami" includes a fascinating glimpse into how the Japanese artform has inspired medical technology engineers. One of the exhibits shows a prototype of a collapsible cardiac stent using the water-bomb base origami technique, a rounded cube form that folds flat and is inflated via a hole in a corner of the construction.

Developed by a British-Japanese team from Oxford University, the stent origami was used "to create a prototype from stainless steel that can be reduced from a width of 23 to 12 mm," writes Susan Bell of the LA Weekly. The roots between origami and advanced research run deep, she adds. Exhibition advisor Robert J. Lang, who holds a doctorate in physics from the California Institute of Technology (Caltech) in Pasadena, CA, gave up a "career as an eminent physicist and mathematician with NASA's Jet Propulsion Laboratory to devote himself full-time to his passion for folding paper," writes Bell.

After its run in Los Angeles, the exhibition moves to the Leigh Yawkey Woodson Art Museum, (Wausau, WI; January 26 to April 7, 2013); Crocker Art Museum (Sacramento, CA; June 22 to September 29, 2013); and Peoria Riverfront Museum (Peoria, IL; January 31 to April 27, 2014).

Photo courtesy Norman Sugimoto.

— Norbert Sparrow, @emdt_editor
 

Ontario, Canada: Taking Medical Device Manufacturing to a Higher Level

Tofy Mussivand and a colleague inspect a microfluidics device used for cell electroporation and lysis. (Photo courtesy of MDI2)

Last week, I conducted an interview with Tofy Mussivand, director and CEO of the Medical Devices Innovation Institute (MDI2) at the University of Ottawa. The purpose of the conversation was to inform my Regional Focus article on Ontario scheduled for the May issue of Medical Product Manufacturing News (MPMN). However, readers may enjoy a sneak preview of Mussivand's candid portrayal of the problems facing Canada's medical device industry and his prescriptions for putting it on the path of progress. --Bob Michaels

MPMN: What is the role of the Medical Devices Innovation Institute at the University Ottawa? What do you do?

Mussivand: The Medical Devices Innovation Institute brings together many institutes, hospitals, and universities--including those in Ottawa and those across Ontario and Canada. It also brings industry, researchers, government, and those interested in medical devices together to focus on medical device discoveries, development, manufacturing, marketing, commercialization, and utilization in patient care. That's the main purpose of MDI2. Of course, to do that, you have to train experts in medical devices. That's one area that we focus on, not only at one hospital or one university, but we share it with industry and many other institutes.

MPMN: Does that mean training experts in the use of medical devices or in the development and manufacture of medical devices?

Mussivand: We focus on all aspects of the medical device industry, including manufacturing, discovery, use, regulatory approval, development, commercialization, testing, and so on. The other area that we are interested in is to help the medical device industry with its needs. For example, if companies need medical device approval, we help them with Health Canada, FDA, European, Japanese, Chinese, Indian, or other national approval organizations. We have experts not only in Canada but also in other parts of the world that collaborate with us.

MPMN: On what types of devices are the members of the institute working? What is their focus?

Mussivand: At this time, the Institute is working on approximately 20 technologies, an example of which is a portable DNA detector device. This device makes life easier for healthcare providers to detect and diagnose disease and to determine DNA use for development of potential treatment methods for disease. In addition, this technology has forensic applications for use by the police. Another application is to sequence the DNA of individuals. We have been working on that, and there is a lot of excitement about this application.

Another project we're working on is an artificial heart that we have developed. We are also working on related technologies that have been sold and are being used the world over. Other agencies that are working on various technologies collaborate with us. At this time, there are more than 150 technologies that we are aware of and collaborating on. Such technologies include medical devices related to many different areas, including cardiovascular devices such as stents, artificial hearts, and pacemakers. But we're also working on infection or bacterial treatment technologies and high-throughput sequencing for stem cell development.

Basically, we define medical devices as any tool, instrument, or equipment being used in healthcare that is either used for detection, diagnosis, treatment, rehabilitation, collection, and analysis acquired through monitoring applications. Without medical devices, we believe that healthcare, as we know it, would be impossible. The thermometer is a good example of a medical device. Monitoring devices such as blood pressure monitors and imaging equipment are also examples. And of course, we're also involved with developing devices for orthopedic applications, such as hip and finger joints. Robots and surgical tools--these are also various technologies that we are involved with.

MPMN: Could you describe how you interact with medical device companies in Ontario and beyond and say a few words about your approach to training medical device experts?

Mussivand: We are working together with universities, hospitals, and industry to train not only students, fellows, doctors, and nurses but also industry people and experts. For example, this is the third year in which we are organizing the Medical Devices Summit, which brings people together from across Canada from various disciplines. One of the major areas in which we are working is training industry people in regulatory requirements and issues. If you are a medical device manufacturer, you have to get approval from Health Canada, FDA, or European standards organizations. We try to help companies to learn what to do, where to go, how to apply for getting approval, how to perform clinical trials, how to conduct in vitro and in vivo testing, and so on.

MPMN: What is an example of a successful project in which your institute has helped to develop and manufacture a device that has found its way to the market or will soon be marketed?

Mussivand: Several years ago, we developed a method for sending power from outside of the body to inside the body without making an incision. This technology is needed for devices that require power inside the body, such as artificial hearts. Right now, many artificial hearts around the world are using the technology that was developed at the University of Ottawa Heart Institute and its associated hospital partners. This technology was eventually sold. Now industry is using it, and patients all over the world are benefiting from it.

A technology that we believe is on the verge of being commercialized is a method for screening patients that enter the hospital based on the smell of their breath or saliva. Another example of the type of work coming out of our institute, this method could be used to triage patients prior to performing many other more-expensive tests. The many technologies we are involved with are in various stages of development.

MPMN: Have these projects been joint collaborations with companies?

Mussivand: Our devices are the products of work internal to our institute and of collaborations with companies in Ontario, Canada, and beyond. The technology we developed for sending power into the body involved a collaborative effort among eight partners and companies from the United States, Canada, Europe, and Japan.

MPMN: How do you view the state of the medical device sector in Ontario? How has it gotten to where it is today, and where do you think it's headed in the context of the global medical device industry?

Mussivand: Unfortunately, I must say that medical device development and manufacturing in Canada is not what it could be. For various reasons, our medical device industry is not working at capacity in terms of development, commercialization, and marketing. In fact, among industrialized nations, our medical device development and export activities are nearly in last place, just before Norway.

MPMN: Why do you think that is, and how do you think this situation can be improved?

Mussivand: There are several reasons for this state of affairs: lack of medical device experts, lack of incentives, lack of a national strategy, lack of international focus, and lack of sufficient investment in medical devices. Countries in many regions throughout the world, including the United States, Europe, Japan, and China, have placed a high strategic priority on developing medical devices. Canada does not have this, and we have been pushing to establish that priority and get politicians and decision makers here to think about this.

For example, no company is going to produce medical devices just for Canadians. Our population is small, and the market is not large enough to sustain a medical technology sector strictly for domestic use. However, that should not be the reason that we are not a medical device leader. Switzerland, which has been the first country to develop a variety of medical device technologies, is smaller than Canada. Thus, the small size of the population should not stop us from advancing to a higher level.

In terms of funding and investment opportunities, my experience shows that when you want to develop technologies and you need funding, you mainly have to go outside of Canada to bring capital in from outside. I think that this needs to be changed.

MPMN: Do you see any movement to rectify this state of affairs?

Mussivand: Yes. An example is the annual summits that we have held. The first of these Invitation-only events that I organized were held in 2010 and 2011. While we expected between 100 and 140 people, more than 500 attendance requests flooded in, and many people had to be turned away. Thus, there is much interest from all sectors--not only from hospitals and universities but also from industry and government. There is a positive movement afoot. Nearly the entire medical device industry supports our initiatives and has been working with us not only to advance these technologies but also to set medical device development and manufacturing as a strategic priority for Canada.

This Week in Devices [4/27/12] Latest MIT Development to Prevent Implant Failure— Diagnostics with a Single Drop of Blood— Medical Devices Vulnerable to Wireless Interference?— Low-Income Nations Get a Medical Device Wiki— Samsung Wants Your Brain

This Week in Devices [4/27/12]

 

MIT Develops Nanoscale Films to Promote Bone Growth in Implant Patients

  • Researchers at MIT have developed a nanoscale film coating for medical implants that could help better adhere them to bone and reduce the risk of premature implant failure
    Via: Medical News Today

 

Forget Hacking, Watch Out for Interference!

  • Concerns over medical device hacking are running rampant. But the proliferation of wireless signals from portable devices, and the interference they cause, could pose a much greater, and more plausible, threat.
    Via: Med City News
  

A Medical Device Wiki for Low-Income Nations

  • Students at the University of Michigan have created, Appropedia, an open-source wiki platform focused entirely on medical devices that are useful for developing countries.
    Via: Medgadget
 

Samsung Wants Your Brain 

  • The communications company has just filed a patent for a medical implant capable of wirelessly transmitting vital information. Given much of Samsung’s business comes from the cellphone market it’s not hard to imagine where this might be headed.
    Via: CNET
 

Blood Tests with a Single Drop

  • The PDMS is a new device that allows for diagnostic tests using only a single drop of blood. Researchers hope the device can also be used to directly administer drugs to diseased or damaged cells within the body.
    Via: The Huffington Post

The PDMS wraps around a single liquid droplet to prevent evaporation

 

 
 
 

Congress Gets Along on User Fee Reauthorization

Related Content:
Massachusetts Congressman Calls for 510(k) Reform Provisions in User Fee Act

Congress is being praised for its bipartisan efforts in its markup of the user fee reauthorization. The current user fee program will expire in September.

AdvaMed seems happy with this week's developments, as president and CEO Stephen Ubl stated, "Mark up is an important milestone in the reauthorization process, and we are encouraged by the bipartisan support this legislation has received."

"The user fee agreement recently reached between the agency and the medical technology industry is a potential game-changer that could help accelerate the development and approval of safe and effective treatments and diagnostics," Ubl stated in an association release.

Maria Fontanazza is managing editor at UBM Canon. Follow her on Twitter @MariaFontanazza.

Medical Trade Group Honors Sen. Scott Brown for Working to Repeal Medical Device Tax

The Alliance for Regenerative Medicine named U.S. Sen. Scott Brown (R-Mass.) legislator of the year last week for working to repeal the 2.3 percent excise tax on medical technology included in Barack Obama’s Patient Protection and Affordable Care Act. The trade group honors one Republican and one Democrat each year for their work on medical innovation policies.

The medical device tax has become an issue in the U.S. Senate race in Massachusetts as both Brown and his Democratic rival Elizabeth Warren have both denounced it. According to a report released by medical device technology advocacy group AdvaMed, the tax would impact more than 1,800 jobs in Massachusetts alone.

"It is an honor to be recognized by the many medical companies devoted to advancing healthcare, particularly the Massachusetts companies that are members of ARM," Brown said in a statement. "In Massachusetts, we are very proud of the role we play in cutting edge research and developing the latest medical treatments. I am committed to being an advocate for basic and transitional research, and bringing the results of that research to the American people so it can improve their lives."

In 2011, Brown was also honored by the Medical Device Manufacturers Association for his work to repeal the tax.

–Yvonne Klöpping

Dr. Eric Topol on IBM's Watson, Twitter, and the "Medical Cocoon"

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MD+DI: What are the main factors behind what you term “the medical cocoon,” which slows the ability of technology to transform healthcare?

Topol: I think this whole concept is reminiscent of the Gutenberg printing press and the high priests. [Ed note: Before the advent of the printing press, reading was largely relegated to priests and to their educated patrons.]

The information era has gotten to a point now where a lot of data can be processed with algorithms, and we can extract big data sets that are meaningful for an individual patient. Any consumer will be able to get this information. It is going to be commonplace eventually; it is just a matter of when—not if.

There are so many different disciplines in medicine that are getting directly threatened by [advances in digital technology]. If you are an optometrist, you have patients who can get their eyes refracted using a smartphone. If you are a dermatologist, you have patients who could have skin lesions analyzed on their smartphone. And if you are an ENT (ear, nose, and throat)  doctor, you have patients who can analyze the whole oral cavity through the OScan. All of this is without the patients having to see a doctor.

There is, however, no Watson, no artificial intelligence that is going to replace the physician’s judgment, wisdom, and experience gained over the years. That is irreplaceable and it has become the precious aspect of the physician of the future.

MD+DI: The guys over at IBM have said that Watson should act more like a nurse who asks physicians if they remembered to go through all of the steps in a procedure. They have stressed that physicians are indispensible yet Watson will help them to be more objective and more educated than ever was possible before.

IBM's Watson
Healthcare will be the first commercial application of IBM's Watson. (Picture from John Tolva.)

Topol: Exactly. Why wouldn’t every doctor want to have Watson’s support? Watson can comb through two million pages of content in three seconds. I don’t know any physician who can do that. If you have a challenging patient and you don’t know what is going on, why wouldn’t you access a supercomputer?

I think [clinical use of Watson] is going to become commonplace. Right now, it is only at a few cancer centers and Wellpoint, but tomorrow, it will be used across the board. That will be an expectation—that you would consult a supercomputer to look at all of the data up to the moment and you couldn’t possibly do that before. You didn’t have the time or the capability. There is just an absurd amount of information to try to process. No human being can do that in an acceptable unit of time.

But, go back to that physician who has got years of wisdom, savviness, experience, clinical judgment—that is something that Watson will never be able to replicate. Qualities like those are what separates the digital age and the true medical profession.

MD+DI: What are your thoughts on the regulatory environment with respect to drugs and devices? I’ve heard some anecdotal information that FDA has made some progress in speeding approvals of innovative products.

Topol: I actually admire the folks at FDA because I think they are on a noble mission and there are a lot of bright committed people there but I think it is kind of a bureapathic agency and that makes it very hard to get things done. There are not enough innovative ways [being implemented] to do clinical trials. 

There are various ways to streamline the clinical development of devices or drugs or diagnostic tests. The time lag from an innovation to actually helping patients is unnecessarily long.  

Also, in the wireless sensor world, we have got this FCC and FDA government bureaus working almost against each other, it seems, to try to get stuff out. Recently, they have tried to express that they are working together and hopefully, we will get over that. But that has been an unnecessary obstacle along the way. 

MD+DI: I had a similar conversation recently with Thomas Fogarty, MD who has had a change of heart recently with respect to the FDA and timelines. I’m paraphrasing, but he said that he thinks that the agency is responsive to the notion that innovative technology should be sped to the market because of its ability to improve the standard of care.

Topol: In recent times, I have also become more optimistic because I do believe they are trying. The problem, however, is that this past year, we have seen politicization of the FDA like we have never seen before—with this whole thing with the Plan B and so on. I think they are actually trying to rev things up to be more pro-innovation. But there are more drugs that have been approved in the last six months than there have been in many of the past years. So we are seeing genomically guided drugs get some accelerated handling. That is encouraging. That is just one area of medicine, but it speaks to the individualized era. It might even in itself help speed up the whole process.

“Every significant paper that is published now has a Twitter instant reaction. It is great to see that. It is really all part of the democratization of information and medicine.”

The whole concept of having “overwhelming efficacy” of a device, or a drug, or a diagnostic test hasn’t been embraced enough. If we have that, learning about safety could be done on a conditional approval basis. If we were willing to let things go out into the real world under a probationary status, every single individual could be monitored electronically to watch the the device, the drug, the test in question. That would be a whole new way to expedite things in the future.

MD+DI: How do you think social media outlets like Twitter will play in the transformation of the healthcare paradigm?

Topol: Twitter has been for me an extraordinary way to get information that I would not otherwise see in the same time frame. I use it to find what I can consider highly relevant information in terms of my interests, whether they be in sensors, genomics, and individualized medicine, and the digital world. It is just so striking to have that crowdsourcing and mindsharing—that ability, in 140 characters, to even express an opinion and to get that exchange of ideas. Every significant paper that is published now has a Twitter instant reaction. It is great to see that. It is really all part of the democratization of information and medicine.  

Eric Topol, MD participated in the opening keynote address for the January 2012 Consumer Electronics Show in Las Vegas. In it, he demos the AliveCor iPhone ECG, developed by David Albert, MD. Topol used the iPhone ECG to diagnose while onboard a cross-country flight to diagnose a significant heart attack in a passenger complaining of chest pains, leading to an emergency landing. The patient survived the ordeal. 

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