Maxon Precision Motors Releases Right-Angle Gearheads

A manufacturer of motion-control products for the medical industry has released a line of 22-mm and 32-mm right-angle gearheads developed to provide an adjustable 360Ëš right-angle output. The gearheads incorporate Spiroid technology, which offers high torque transmission, high stiffness, and low deflection with large applied loads, compact size, low backlash, and quiet operation. The output shaft can be oriented 360Ëš at any time and absolute output shaft position is achievable with an encoder mounting option. The gearheads have a contact ratio of up to 3:1 and are available in back-drivable (4:1) and nonback drivable (31:1) versions that may be mounted directly onto many of the company’s brushed and brushless motors or stacked on different ratios of its GP22 and GP32 planetary gearheads, resulting in a range of achievable gear reductions. 
Fall River, MA

Renal Denervation: All the Rage in Europe

Renal denervation (RDN) was among the most prevalent and buzzed-about topics pumping up the crowd at this year's European Society of Cardiology (ESC) Congress 2012. And in light of the parade of presentations focused on validating or making new claims of safety and efficacy for the still-nascent technology, it's becoming evident that the hypertension-treatment method may just live up to the hype.

St. Jude EnligHTN renal denervation
St. Jude Medical's EnligHTN renal denervation catheter-based ablation system. Image provided courtesy of St. Jude Medical, Inc.

Boasting the potential to become a $5-billion market, renal denervation is an area actively being pursued by such medtech powerhouses as Medtronic, St. Jude, and Covidien because of the high volume of hypertension patients that do not respond to drug treatments. Patients with refractory, or resistant, hypertension, which is defined as not experiencing appropriate blood pressure reduction when on at least three antihypertensive drugs at the optimal doses, account for approximately 12% of all hypertensive patients, according to ESC presenter Johannes Mann.

Employing a radiofrequency- or ultrasound-based catheter, the minimally invasive technology targets renal sympathetic nerves, which have been identified as being hyperactive in refractory hypertension. Doing so, researchers claim, can lower blood pressure and improve arterial stiffness with few or no complications observed. And while further studies are needed, renal denervation may, in turn, reduce the risk of myocardial infarction and stroke.

"Besides peripheral blood pressures, RDN improved central blood pressures and arterial stiffness, i.e. pulse wave velocity (PWV)," notes Klas Franzen, an ESC presenter from the University Hospital of Schleswig-Holstein. "According to age-adjusted reference values, the improvement of approximately 1m/s PWV observed in our study could be interpreted as a blood vessel rejuvenation of almost 10 years. This suggests that RDN might be a fountain of youth for blood vessels in patients with therapy resistant hypertension."

In addition to potentially being a fountain of youth for blood vessels, renal denervation also shows promise for patients with advanced heart failure. Presented at ESC, results of the Olomouc I pilot study indicated that the contractile function of the left side of the heart improved from 25±12% to 31±14% (p<0.01) after one year in patients with advanced heart failure treated with renal denervation and a standard pharmacological treatment. Patients that received drug treatments alone, in contrast, did not demonstrate any changes in contractile function.

"The improvement of the contractile function of the left side of the heart by more than 10% in patients after renal denervation was a surprise," comments presenter Milos Táborský of the University Hospital Olomouc. "This parameter has practically not changed in patients treated by the classic drugs. The difference in response might be explained by a continuous decrease of the renal sympathetic activity in the complex pathophysiology of heart failure." Renal denervation, he notes, could help to stabilize advanced heart failure in patients.

Medtech's Reputation (infographic)

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Prize-Winning Pigs and...Pacemakers?

The University of Minnesota's Medical Devices Center will be on hand today to show off the innovative work it's doing. Along with the Minnesota Supercomputing Institute and the Visible Heart Lab, the center will exhibit rapid prototyped parts and devices, and allow fairgoers to check out body part models and visible heart demonstrations. At 5 p.m., they take their show to the big time with an on-stage presentation. 

U of M exhibits also include a telemedicine stand and a booth by the school's department of integrative biology and physiology, where patrons can get an EKG.

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.

Weekly Vitals: At the Heart of ESC 2012

The European Society of Cardiology (ESC) Congress was held in Munich this week and served as a platform for announcing the launch of various products and the results of exciting trials, particularly for medtech powerhouses such as Medtronic and St. Jude. Hot topics such as fractional flow reserve and renal denervation played a prominent role at the conference. Read more about some of the big news to come out of ESC in our weekly roundup below.

Stryker Biotech Case Exposes Risks in Physician-Manufacturer Relationship

It was an emotional moment for me and my client William Heppner (former Stryker Biotech vice president of sales) earlier this year, when the U.S. Department of Justice (DOJ) announced that it was dropping all criminal charges against Bill and other defendants shortly after the start of what was expected to be a fiercely fought six-week trial. Just days earlier, the government had settled with Stryker Biotech for a single misdemeanor plea and a $15 million fine—a paltry sum compared to fines of several hundred million dollars and even billions of dollars that the federal government has secured in other drug and medical device cases (most recently the record $3 billion settlement with GlaxoSmith Kline). Indeed, when the Stryker trial abruptly ended, it seemed that much of the entire medical device industry breathed a collective sigh of relief.
But before anyone gets too complacent, the Stryker Biotech case exposed certain potential vulnerabilities inherent in the relationships between medical device companies and physicians that should receive the industry’s full attention. The decision of the Boston U.S. Attorney’s Office to wrap up its case so early in the proceedings temporarily precluded any public airing of these issues.
However, given broad public concerns about potential doctor-industry conflicts of interest and the quality and cost of healthcare, aggressive law enforcement, legislative action, and civil litigation against medical device firms are not going away any time soon. While working with policy makers, the medical device industry would help itself greatly by addressing some of the difficult questions posed by the Stryker case and other legal proceedings. Fundamentally, our legal system must balance the need to insulate physicians from undue industry influence with the fundamental role that industry-physician collaboration plays in research, innovation, and the safe and effective use of medical devices.

Background on the Stryker Biotech Case

In 2009, the Boston district of the U.S. Attorney’s Office  indicted Stryker Biotech and four of its managers on conspiracy, wire fraud, and felony misbranding charges arising out of the alleged off-label promotion of Stryker’s two products. Specifically, the Boston U.S. Attorney’s Office, which has been at the forefront of prosecuting device and drug companies during the past two decades, accused the company and its managers of illegally promoting the combination of OP-1, Stryker’s bone morphogenic protein, and Calstrux, a bone void filler that serves as scaffolding for the protein. OP-1 and Calstrux were FDA-approved products, but the agency had not approved their use together, and it specifically cautioned against the mixing of Calstrux with other products. Notwithstanding this caution, surgeons routinely mixed OP-1 with Calstrux and other bone void fillers (there were approximately 60 brands on the market), which they have authority to do in the exercise of their own medical judgment. Regardless, FDA charged Stryker with illegally promoting the joint use of the products and deceiving orthopedic surgeons into believing that they had been either approved for use together or that they were a single product.
In bringing criminal fraud charges, the government created for itself the highest possible burden—and one that it could not meet. Several of the surgeons whom the U.S. Attorney accused Stryker and its employees of conspiring to defraud were prepared to testify that they in fact had not been deceived and understood the distinction between OP-1 and Calstrux. Moreover, it was implausible that the Stryker representatives, whose effectiveness as salespeople depended on establishing strong credibility with surgeons, would intentionally seek to deceive them, especially when their financial success hinged on expanding use of OP-1, a game-changer in orthopedics, and not Calstrux, the commoditized bone void filler.

Relationships between Physicians and Medical Device Reps

The government clearly overreached in bringing fraud charges against Stryker and four of its managers. But had the defense team not succeeded in undermining the government’s case at the outset and the trial continued, the case would have featured the close working relationships that exist between medical device sales representatives and surgeons. These relationships differ from those between pharmaceutical sales representatives and doctors.
After spending almost three years on the Stryker Biotech case, it is clear to me that most members of the public, and many government officials, do not fully understand the relationship between surgeons and medical device sales representatives. Based on the nature of medical devices as compared to drugs, surgeons and medical device representatives often forge a closer working relationship than most doctors form with pharmaceutical sales reps. With both drugs and devices, the patient is the end user. But the physician’s role is limited to that of an intermediary in prescribing a drug, whereas with a medical device, the surgeon physically works with the product. Medical devices also can be extremely complex for physicians to use, particularly in the context of real-time, high-pressure surgical procedures in which someone in the operating room must have complete knowledge of the product.
Thus, it should not be surprising that surgeons depend more on medical device sales representatives than most doctors depend on pharmaceutical reps. Nor should it be surprising that surgeons will often request that medical device reps accompany them in the operating room, in the event that they have any questions about the device or need immediate access to additional supplies. Testimony during the Stryker trial would have revealed that surgeons relied on sales reps in the operating room for their knowledge of OP-1 and bone void fillers.
The real-time need that surgeons have for product information also has ramifications for the ability of medical device companies to completely separate their promotional and educational functions. Most large medical device and pharmaceutical companies have a medical information department designed to provide fair and balanced responses to physician questions about uses of the company’s products (including off-label use). These departments typically occupy different office space than sales and marketing, and employee compensation has little, if any, connection to sales volume, in contrast to the compensation of a typical sales representative. In the case of a drug, physicians can almost always wait to direct questions to a manufacturer’s medical information department. In contrast, surgeons often don’t have the luxury of time and must rely on someone in the operating room for precise information about a product. A medical device sales rep in the operating room who tells the surgeon to call 1-800-MED-INFO during the next day’s business hours can expect an annoyed reaction. In fact, that is precisely how many surgeons react when medical device sales reps are precluded by company policy from responding to surgeon questions during surgery if the device is being used off-label, which is how many medical devices are used.
The depth of relationships between medical device companies and doctors is further reinforced by the vital role of surgeons in developing, testing, and improving devices. Most innovation in the medical device world comes from manufacturers who work closely with clinicians and engineers to develop new therapies and treatments. The development of new medical devices is distinctive from the development of pharmaceuticals. In drug development, insights generally emerge from pharmacological testing in the laboratory, whereas the idea for a new or improved medical device often originates with a surgeon who, over the course of his or her practice, has identified an unmet clinical need. In other situations, biomedical engineers may collaborate with a physician to assist in product development. Device companies are highly dependent on surgeons for insight into how a device functions and could be improved. Without close industry-physician collaboration, the pace of innovation would almost certainly be slower, and the safety and effectiveness of medical devices could be compromised.
Understandably, surgeons expect to be paid for their innovations and the role that they play in developing and improving medical devices. Medical device companies are allowed to pay physicians who use their products the fair market value of their innovations and consulting work. Fair market value is often an amount of money that, to many people, seems inconsistent with maintaining one’s independent judgment about using the products of a company for which the surgeon is consulting versus a competitor’s products.

Implications for Medical Device Companies

The relationships between medical device companies and surgeons can raise significant conflict- of-interest concerns. Over the past 15 years the federal government has targeted many practices employed by drug and device manufacturers, most notably providing physicians with expensive meals, lavish entertainment, and travel. Regulators and industry have made valid efforts to circumscribe these practices. But the baby should not be thrown out with the bath water. These relationships serve important purposes and should not be restricted in ways that impede research, innovation, and the safe and effective use of products that benefit patients.
Despite the outcome of the Stryker case, federal and state prosecutors and other regulators will continue to scrutinize sales practices and other relationships between physicians and industry, bringing civil and criminal enforcement actions when they believe that federal statutes have been violated. To minimize the risk of government enforcement matters and the civil law suits that inevitably follow, the medical device industry can help itself greatly by fostering relationships with surgeons that benefit both industry and the public, and limiting the relationships that raise concerns about undue industry influence on the medical profession.
Over the past decade, attention has increasingly focused on industry gifts to physicians, including its potential harmful effects. In April 2007, a widely read New England Journal of Medicine article addressed this issue in detail.1 Survey results published in the Archives of Internal Medicine reveal that drug companies are curtailing their spending on drug rep details, and fewer physicians are taking gifts from the industry.2 These are healthy trends.
At the same time, it is crucial not to curtail physician-industry relationships that lead to research, innovation, and safer and more effective use of drugs and devices. To foster these important relationships, the medical device industry must demonstrate that it understands public and government concern about undue industry influence on the medical profession, and that it is acting responsibly. Many medical device companies have adopted the AdvaMed Code of Ethics to guide their interactions with healthcare professionals. However, the code does not specifically address the behavior of sales representatives in operating rooms. The device industry should promulgate guidelines that govern such interactions, just as the device industry has established regulations on gifts to physicians. There have been several sets of guidelines issued by healthcare organizations, including the American College of Surgeons and the Association of Perioperative Registered Nurses, that recognize a legitimate need for sales personnel in the operating room and seek to define the limits of that role. Some top teaching hospitals have adopted their own guidelines on the presence of company representatives in the operating room as well. Adopting these regulations, and establishing a process for training and certifying sales representatives, would go a long way towards allaying public concern about sales reps in the operating room. They would also provide a potential defense against government enforcement actions that sought to present these interactions as nefarious.


The Stryker Biotech trial was an important victory for the medical device industry, but it hardly marks the end of federal and state efforts to scrutinize suspected improper marketing activities and conflicts of interest between physicians and medical device companies. Prosecutors will continue to carefully probe the prescribing practices of doctors for evidence of patterns suggesting improper influence or illicit marketing practices. Medical device companies need to get ahead of the curve and establish industry standards and best practices relating to relationships between industry representatives and physicians. Industry also needs to continue educating government officials about the relationships that medical device sales representatives have with surgeons and work with them in agreeing on accepted standards of behavior. Long-term and close working relationships between surgeons and medical device companies are critical to the development of new devices and to enhancing the safe and effective use of existing products. Protecting these powerful and beneficial collaborations will require proactive industry efforts. Without such efforts, increasingly aggressive federal action can be expected.


1. E Campbell, et al., “A National Survey of Physician-Industry Relationships,” New England Journal of Medicine 356 (2007): 1742–1750.
2.  E Campbell, et al., “Physician Professionalism and Changes in Physician-Industry Relationships From 2004 to 2009,” Archives of Internal Medicine 170, no. 20 (2010): 1820–1826.
Robert L. Ullmann is a partner, trial lawyer and Chair of the Government Investigations and White Collar Defense Practice Group with the law firm of Nutter McClennen & Fish, LLP.

Noninvasive Biosensor Could Eliminate Needles from Blood Glucose Monitoring

Developing an alternative approach to blood glucose monitoring that does not rely on lancets and pinpricks has been a primary goal of diabetes device R&D in recent years. Contributing to this effort, researchers at Purdue University have engineered a noninvasive, low-cost biosensor capable of detecting glucose in concentrations as low as 0.3 micromolar in blood, urine, saliva, and tears.

Purdue glucose biosensor
SEM images show nanosheets that are key components of a new type of biosensor that can detect minute concentrations of glucose in saliva, tears, blood, and urine. Image: Purdue University photo/Jeff Goecker

Although sensing devices have previously been developed that can measure glucose in blood, the Purdue biosensor is the first technology capable of detecting glucose in saliva, tears, and urine in addition to blood, according to the researchers. Such a unique platform, they state, holds promise for ultimately reducing or altogether eliminating the need for lancets and pinpricks in glucose monitoring.

An additional advantage of the biosensor is that it is relatively inexpensive to produce because it requires few processing steps. "Typically, when you want to make a nanostructured biosensor, you have to use a lot of processing steps before you reach the final biosensor product," says Purdue doctoral student Anurag Kumar. "That involves lithography, chemical processing, etching, and other steps. The good thing about these petals is that they can be grown on just about any surface, and we don't need to use any of these steps, so it could be ideal for commercialization."

The biosensor was constructed from layers of graphene nanosheets that resemble tiny rose petals, platinum nanoparticles, and the enzyme glucose oxidase. "Each petal contains a few layers of stacked graphene. The edges of the petals have dangling, incomplete chemical bonds, defects where platinum nanoparticles can attach. Electrodes are formed by combining the nanosheet petals and platinum nanoparticles. Then, the glucose oxidase attaches to the platinum nanoparticles. The enzyme converts glucose to peroxide, which generates a signal on the electrode," according to a university press release.

While initial development of the biosensor has focused on glucose monitoring, the biosensor could potentially be employed for other medical tests by simply swapping out the enzyme. Using glutemate oxidase in lieu of glucose oxidase, for example, could enable testing for such conditions as Parkinson's or Alzheimer's, the researchers note.

Rock Health Innovation Summit Preps Attendees for a Healthcare Revolution: Part I

Rock Health Innovation Summit Preps Attendees for a Healthcare Revolution: Part I

“Healthcare is old & scary,” reads the front of a flyer at the Rock Health Innovation Summit, which was held August 27–28 in San Francisco. That sentiment was tempered by a bright optimism at the event. The healthcare entrepreneurs, investors, and others across the healthcare spectrum attending the event seemed to agree that, when it comes to healthcare, it is time for some real upheaval.

Healthcare is old and scaryKey in this transformation is the digital revolution, which is steadily making inroads in medicine. Rock Health, the first seed accelerator for digital health startups, is itself playing a role in this transition. Founded and headquartered in San Francisco, the incubator just graduated its first class of startups in Boston. The organization just announced that it is increasing the amount of seed funding offered to incoming startups from $20,000 to $100,000. Startups are also offered mentoring, office space, and other support.

A Keynote from Intel Pioneer Andy Grove

The Rock Health Innovation Summit kicked off with a keynote address from Intel cofounder and Silicon Valley legend Andy Grove. In his talk, Grove advocated for a medical equivalent to a manufacturer's suggested retail price for cars. Before the use of the MSRP, the markups on cars were arbitrary. Now, it is easy to determine the price of a car’s standard configuration. In healthcare, cost analysis is rarely taught in medical school. And the ability of clinicians to mine medical data from the past and anticipate future costs is poor. In order to improve healthcare, we must learn to accurately measure it, Grove stressed. He drew loud applause by concluding his talk with a slide proclaiming: "Job 1 in healthcare is to 'Free the Data!'"

Rethinking Healthcare Delivery

Following the keynote was a panel discussion titled “Healthcare Delivery Redelivered” moderated by Abbe Don who coleads the Health Systems practice at IDEO. Rounding out the panel were Thomas Lee, MD, medical director of One Medical Group, and practicing internist Jordan Shlain, MD.

Thomas Lee, MD

“The healthcare system is terrible and has been for decades because it is not designed with the consumer orientation in mind,” opined Lee. His One Medical Group seeks to address that by making concierge-style medicine affordable and covered by insurance.

Another consideration is that healthcare has been slow to adapt and take advantage of groundbreaking technological breakthroughs. “It is hard not to be influenced in technology in the Bay Area. But the question is why is it not permeating healthcare more thoroughly?” Lee asked. “Device technology has permeated healthcare very well, but information technology has not.”

Shlain’s assessment of the state of healthcare was similar. After growing tired with “treadmill-style medicine,” he became a concierge physician for a hotel. There, he saw firsthand the advantages of taking a proactive role in his patients’ healthcare.

Another consideration Shlain pointed out was that it is rare for patients to frame their health as an asset. Just having health insurance, he said, is not enough. “It is for when the wheels come off.”

Setting Software Loose on Healthcare

The next panel discussion was titled “Code for Health: How Software is Eating the (Healthcare) World” moderated by Jennifer Pahlka, founder and executive director of Code for America. The panel included Tim O’Reilly, a tech guru and founder of O'Reilly Media, and John Mattison, MD, the chief information officer of Kaiser Permanente.

Tim O'Reilly

The panelists were nearly unanimous in their statements, arguing that we are on the cusp of a huge revolution when it comes to healthcare. Digital health is poised to substantially improve the quality of healthcare and cut costs, if only we could heed the call to free health data and use massive computational power to drive better care. By using data, we clearly understand the quality improvement cycle for healthcare.

Genomics will play key roles in this transformation as their use becomes more widespread. “In a short period of time, it will be malpractice for doctors not to treat patients without their full genomic sequence,” Mattison said. The pharmaceutical industry, which is now one of the least trusted sectors in medicine, could use data gleaned from genomics to essentially guarantee that their products will work for specific patient populations. Still, privacy concerns linger and sophisticated methods for deidentification of data are required.

John Mattison, MD

Both Mattison and O’Reilly issued calls to entrepreneurs to drive the healthcare industry forward. “The biggest point about the Maker movement is that sense of permission to innovate,” O’Reilly explained. That same spirit is needed in healthcare as well, where disparate bodies such as medical device companies, pharmaceutical companies, hospitals, doctors, and so forth have aligned incentives to keep costs high to preserve profit margins. “There are opportunities in healthcare to allow the market to innovate but in order to do that we really need to start over,” he said.

Entrepreneurs should have a maniacal focus in cutting costs out of the healthcare system, Mattison added. Without doing that, “you are going nowhere,” he quipped, adding that the biggest entrepreneurial opportunities are in disintermediation—displacing high-cost providers of healthcare products and services.

Mattison also pointed out the huge gap that exists between how well motivational science has been implemented in healthcare compared to clinical science. Motivation, he explained, can go far in addressing our most pressing healthcare needs. “If you eat well, sleep well, exercise, and take care of your spiritual health, you will do far more for your longevity than medical science has to offer,” Mattision said.

Can QS go to Main Street?

Experimental man David Ewing Duncan, a bestselling author who has amassed hundreds of gigabytes on himself, chaired a session on the Quantified Self (QS) movement. Joining him were Leslie Saxon, MD, the chief, division of cardiovascular medicine at the Keck School of Medicine of the University of Southern California and Sridhar Iyengar, PhD founder and CTO of AgaMatrix, a diabetes / mHealth technology firm.

Leslie Saxon
 Leslie Saxon, MD

Saxon explained how she was interested in how technology can bring patients a sense of security by allowing them to participate and feel cared for. Sensing technology can help shift healthcare from its traditional paternalistic model to a more participatory one, she said. For this to be effective requires a shift away from the fragmented approach that has been traditional in medicine. Contrast that with her Everyheartbeat website, for instance, which Saxon hopes will eventually capture heartbeat data across the world, measuring every heartbeat—“at least once.”

Iyengar backed into the QS movement from the device industry. He had experience making glucose meters and realized that patients didn’t use the data gleaned from the devices. He eventually went on to help develop the first FDA-cleared glucose monitor that connects to the iPhone. The smartphone can help patients annotate data and see how their health metrics change over time.

Iyengar’s medical device background has given him an appreciation of the validation that FDA clearance can give medical products. “Many entrepreneurs want to create products that are ‘consumer enough’ to avoid FDA. Instead, they should embrace FDA and use regulatory clearance as an advantage,” he said.

“Many entrepreneurs want to create products that are ‘consumer enough’ to avoid FDA. Instead, they should embrace FDA and use regulatory clearance as an advantage.”

As for the broader QS movement, a central question remains: Do we know what to do with all of the data gathered from it? The problem is mirrored in genomics, where data sets are massive. In the future, developing an “interpretome” may prove to be as important of a landmark as sequencing the human genome—the costs of which are decreasing so quickly that they may one day be practically free to perform. Therefore, most of the profits will likely be in interpreting genomic data rather than generating it.

It follows that, in the near future, patients (and their doctors) will know more about their health than they ever have. “We view educated patients as a way to make everybody happier,” Saxon said. “The great thing about wireless health is you can leverage healthcare over the world,” she added. “You can deploy experts wherever you want.” 

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

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FDASIA Is More Than Just User Fees

Shapiro told me that a key staffer for a high-ranking member of the House on a committee with FDA oversight has said that there will likely be more reform legislation in the pipeline. “Congress on both sides of the aisle seems intent on further FDA reform, including the Device Center,” says Shapiro. 

"FDA user fees charged to pharmaceutical and device companies are expected to increase by about $3.2 B in the 2013-2017 time period. This represents a 103% increase over 2008-2012 fees. User fees for medical devices more than double in FDASIA..." — Our Perspective: 2012 Food and Drug Administration Safety and Innovation Act, PwC

FDASIA aims to solve FDA’s eternal underfunding, with a significant boost to user fees. User fees will more than double from $277 million in 2008-2012 to $609 million in 2013-2017. The funding adds 200 full-time equivalents (a.k.a., employees) involved in device approvals by 2017.

“If history is an indicator, increasing user fees helps manufacturers get to market faster,” says Joseph Markmann, manger in PricewaterhouseCooper’s Pharmaceutical and Life Sciences R&D Advisory Services. PwC released a 5-page overview of the key aspects of FDASIA. “The funds increase resources that FDA can devote to ensuring timely submission approvals and clearances,“ he explains.

The act introduces some significant statutes for devices. Among the key changes is a revamping of the device approval process, particularly in assigning risk categories and holding FDA to strict deadlines in the appeals process.

Shapiro, whose firm released a 75-page analysis of FDASIA, says he is pleased with an amendment to the appeals process. “The appeals process has been notoriously unpredictable and lengthy,” he says. “It is a daunting process, especially for smaller device companies.”

FDASIA says that if FDA issues a significant decision regarding an IDE, 510(k) or PMA, it must document the scientific and regulatory rationale. The statute introduces an expedited supervisory review appeal process. An appeal must be filed within 30 days. Then, FDA must issue a decision within 30 days if the appeal is by phone or within 45 days if an in-person meeting is held. The concept is that FDA has a mandatory timeline. “Even the maximum, 75 days to decision, is reasonable compared with the 6-8 months it sometimes has taken,” he explains.

Another key change is that FDA can now reclassify devices by administrative order rather than by regulation. In the past, reclassification has been rare, because although there are numerous methods to reclassification, they have proven slow and cumbersome. FDASIA states that any proposed order to reclassify must be published in the Federal Register and is subject to a classification panel meeting.

Shapiro says that giving FDA a simpler path to reclassification improves efficiency. Of course, Shapiro notes, it remains to be seen whether FDA will put its new authority to good use. Nonetheless, he views it as a step forward.

Markmann says another step forward is the emphasis on harmonization, particularly in premarket studies. “Data from studies conducted outside of the United States can now be shared with FDA,” he says.

A possibly alarming change enacted by FDASIA is an adjustment to the Sentinel program, by which FDA monitors field use of devices. Markmann notes that FDA will soon use commercial and insurance data to help with device monitoring. “FDA can monitor passively collected data, rather than rely on adverse event reporting from physicians.”

Overall, however, Markmann says that FDASIA puts great effort into establishing an FDA partnership with industry. “FDA is more accessible. The relationship reduces the burden of uncertainly of what FDA needs to make a decision.”

Both Shapiro and Markmann agree that, although this legislation does not “fix” FDA, it is a positive move. “The regulation reflects that FDA and Congress have heard the concerns from the patient community and manufacturers,” says Markmann. 


Heather Thompson is editor-in-chief of MD+DI

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U.S., European Patients Access Innovative Technology Equally: Study

Noting that FDA critics often claim that the agency takes longer than its European counterparts to approve new technologies and move them to patients, the FDA authors say that a fair comparison should look at three criteria: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. What happens, they say, is that patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States.

The authors detail the FDA medical device approval process and the processes followed in the major European countries and the time it takes the U.S. Centers for Medicare and Medicaid Services to make a reimbursement decision compared with the time it takes agencies in various European countries. They note that the difference in time to market access is even greater when it comes to private insurers (which cover the majority of the U.S. population) that often make reimbursement decisions within a few months after FDA approval.

To make their case, Basu and Hassenplug compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States. The case studies indicated that the average time to market access for the devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States, they say.

“These numbers may not fully capture the reasons why a device reaches the market more quickly in one country than another and do not reflect experiences with all innovative, high-risk devices,” they conclude. “However, unless one uses equivalent standards in terms of the level of risk, the start and end points of the process, and the key end point of market access, accurate comparisons cannot be made.”

Meanwhile, at almost the same time, an Internet PLoS Medicine study was released evaluating medical device regulation in the United States and European Union (EU). It suggests that policy reforms are necessary for both systems, including classification of devices in the United States and promoting transparency and post-market oversight in the EU.
The study, by Sanket S. Dhruva and Rita F. Redberg, reports that assessment of regulatory performance in both settings is limited by a lack of data on post-approval safety outcomes. “Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting,” it concludes.

The authors, from Harvard Medical School and two Boston hospitals, acknowledge that the U.S. and EU regulatory systems are very different, but point out that there is a critical level of dissatisfaction with both device approval and post-market evaluation systems.

“While FDA has been criticized for its cumbersome requirements and delay in approval,” the report says, “the system in the EU has been charged with failing to gather meaningful data.”

The researchers say that their systematic review of empirical data evaluating U.S. and EU medical device approval and post-market surveillance systems found quality problems in pre-market submissions in the United States, provided snapshots of post-market experiences in the United States and EU derived from recall analyses, and reported findings from surveys of some industry leaders.

The reports that were studied indicated that FDA could improve oversight of device approval in important ways, the authors say. In general, however, they found that the outcomes addressed by the studies in their review limited the ability to draw conclusions from them. It remains unclear, the authors say, whether the U.S. or EU approach achieves better outcomes for patients receiving devices.

The assessment is further complicated by the multiple stakeholders—including patients, payors, physicians, and manufacturers—whose perspectives on system performance vary by virtue of how they weigh the importance of outcomes such as cost, speed, safety, and effectiveness.

Any future changes to device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of these outcomes in both the U.S. and EU settings, the authors caution. “Until there is a more sustained commitment to developing these data, policymakers will continue to struggle to provide regulatory solutions,” they say.