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Quick Stats: CDRH Releases Annual Complaints Report

Industry wasn’t shy about lodging complaints to CDRH this year. The center released its annual report today.
Among 461 reported contacts (53% of which were complaints or disputes), 278 of those came from industry.

Some other numbers you might find interesting: 

CDRH types of complaints 2012

CDRH reasons for contacting Ombudsman 2012

Gems Sensors & Controls adds a new medical processing area

Gems Sensors & Controls recently opened a 4000ft.2 medical processing area at its Plainville, CT headquarters. The additional space is part of a recent expansion and indicates the company’s commitment to the medical industry.

The addition lets the company improve manufacturing layouts providing better material/product workflow to address the specific needs of customers in the medical industry while providing safer working areas for employees.

Gems provides ISO13485-certified products for the specialized fluid control and handling requirements of the medical device, diagnostic, life science, and biotechnology market segments.

Richard Nass

Blog: State of the Union Address Hits Home for Medical Device Manufacturers

Blog: State of the Union Address Hits Home for Medical Device Manufacturers

The domestic medical device manufacturing industry, like many other manufacturing sectors, has suffered from devastating job losses, outsourcing to Asia, and a lack of skilled, high-tech workers in recent years. So, President Obama's State of the Union Address hit pretty close to home. And while he skirted the issue of healthcare reform, Obama did lay out a blueprint for bringing manufacturing and high-tech jobs back to our shores that served up some serous food for thought to medical device OEMs.

Aiming to achieve a "renewal of American values," Obama identified American manufacturing as the linchpin of a broad strategy to rebuild the nation's economy. He then pointed to the auto industry as a shining example of how American manufacturing can be restored, if the proper measures are put in place. Emphasizing that the American auto industry was essentially knocking on death's door just a few years ago, the president noted that the industry has since rebounded significantly despite initial debates as to whether the country should allow the industry to fend for itself and crumble.

"We can't bring every job back that's left out shores. But right now, it's getting more expensive to do business in places like China; meanwhile, America is more productive," he said. "We have a huge opportunity at this moment to bring manufacturing back. But we have to seize it. Tonight, my message to business leaders is simple: Ask yourselves what you can do to bring jobs back to your country, and your country will do everything we can to help you succeed."

The issues of outsourcing and offshoring are particularly poignant to the medical device manufacturing industry, especially as medical device companies plan for the impending excise tax. However, Obama proposed several steps that should be taken to ensure that more jobs and industry are not lost. Among these recommendations were to modify the tax code so that manufacturers no longer receive tax breaks for relocating overseas, to require every multinational company to pay a basic minimum tax, and to strive to lower taxes for companies that opt to remain in the country.

"If you're an American manufacturer, you should get a bigger tax cut," he added. "If you're a high-tech manufacturer, we should double the tax deduction you get for making products here. And if you want to relocate in a community that was hit hard when a factory left town, you should get help financing a new plant, equipment, or training for new workers. My message is simple: It's time to stop rewarding businesses that ship jobs overseas, and start rewarding companies that create jobs right here in America."

Reinvigorating the 'made in America' spirit and restoring American manufacturing are indisputable concepts. But are all these proposed tax breaks and support for American manufacturers empty rhetoric? That's the million-dollar question. For the medical device industry, after all, one of the most-significant cited drivers of job loss and relocation is the medical device tax—a fact that Minnesota Congressman and cochair of the Congressional Medical Technology Caucus Erik Paulsen emphasized in a statement released after the address.

"In his speech, the President expressed the need to encourage more domestic manufacturing and keep jobs here in America. The first place he should looks is medical device manufacturing, which provides more than 35,000 jobs in Minnesota alone," he said. "This American success story has come under assault fro our own government and unelected bureaucratic agencies. As a result, American jobs are being forced overseas. We need to repeal the President's new tax on medical devices and modernize FDA so we can keep innovation, manufacturing, and jobs here in the United States."

If President Obama is serious about his commitment to high-tech American manufacturing, repealing the medical device tax would be a strong show of faith to the profitable medtech sector. But the chances of that happening are looking increasingly grim. As for Obama's most-recent ideas, they're inspired. Until Congress puts its money where its mouth is, however, they're just pipe dreams. If the government is as concerned as it says it is about companies shipping jobs and manufacturing overseas, something needs to be done—and fast—as medical device companies continue to flee from burdensome taxes and what they view as innovation-stifling regulation.

For more information and perspective about the State of the Union Address, check out "President's Proposals in State of Union Address Could Impact Industry," from our sister site, Medical Electronics Design. --Shana Leonard

Bionic Arm Offers Hope to Stroke Patients

Bionic Arm Offers Hope to Stroke Patients

According to data from the World Health Organization, an estimated 15 million people suffer strokes worldwide annually. Up to 80% stroke survivors have difficulty with arm movement, says Stephen Page, PhD, FAHA, a faculty member in Health and Rehabilitation Sciences at the Ohio State University Medical Center.

Traditionally, clinicians have assumed that the potential for rehab to help these patients was limited—especially as the time after the patient suffered a stroke increased. These patients’ prospects may be better than was thought previously, says Page. Citing neuroplasticity—the brain’s ability to rewire itself—Page believes that a neuroprosthetic device could be used to help stroke victims retrain their brain to move the arm on its own, irrespective of when the patient suffered a stroke.

To test that hypothesis, Page is overseeing a National Institutes of Health–funded study to determine the efficacy of a bionic arm in improving arm motion in stroke patients. “We are a year into the study right now, and we are still collecting data, but our pilot data have looked promising,” Page says.

The device is essentially a high-tech elbow brace, which makes use of electrodes attached to a patient’s biceps and triceps to detects electromyography (EMG) signals. The technology, which is worn as a freestanding unit on the arm, was developed at MIT and is already commercially available.

It is capable of detecting even a user’s slight intention of movement. “While everybody has EMG activity, in stroke survivors, it is less than what is normal,” he says. The device, when worn on the arm, amplifies the signal from the muscle to facilitate a patient’s arm motion. “There is a signal filtering and amplification program that is inside the device. When the person tried to, say, reach out and turn on a light switch, the bicep, since that is a curling motion, would put out EMG activity.” Based on the needs of the user, the device can amplify the signal a lot or a little. “And that EMG is hooked into a robot. Depending on the level of assistance the patient needs, the robot is going to kick in and provide them with an assist as they try to perform a movement at the elbow joint,” Page says.

The Power of Apps

The functionality of the device can be further extended by using it in conjunction with apps for mobile devices. “The app facet really adds a lot to the commercially available product,” Page says. “The cool factor is that it is tablet driven and that has got the ‘wow, I-can-use-my-apps’ thing,” Page says. “But, as an end user, I am excited about it because it gives me a lot of flexibility,” he adds. “If I am just interfacing with a device with some buttons on the device, that is okay, but if I have actually got an app that goes along with it that tells me what is happening at the muscle level and I can modulate it using 20 different settings using an app, that gives me a heck of a lot more control.”

Using the technology with apps also opens up other possibilities Tablets, because they have cameras embedded in them, could enable the bionic arm to be used for remotely based rehab pops up. It also opens up the possiblilty of doing game-based rehab. “This could be used if someone moves x number of degrees, the tablet figures that out and maybe moves like an avatar on a screen, or you build it into a game,” Page says.

Traditional rehab is often boring for many patients. “But with game based therapies, patients can lose track of time,” Page says. “And when you have got people with brain injuries, there are sometimes issues with motivation or other factors that may compromise their full participation.” Game-based rehab can become inherently appealing or it can be made more rewarding by adding competitive or social aspect to it.

AdvaMed Issues Statement Regarding State of the Union Address

In the State of the Union Address, President Obama stressed the importance of rebuilding the U.S. economy. To that end, he recommended reinvigorating the U.S. manufacturing sector, training workers, and increasing domestic energy production.

State of the UnionIn an announcement, Stephen J. Ubl, president and CEO of AdvaMed, applauded president Obama for emphasizing the importance of manufacturing. "[M]edical technology companies support his efforts to boost manufacturing growth, especially through increased exports and lower trade barriers," Ubl said.

Ubl also urged Obama to repeal the medical device tax, which "is already causing layoffs and will make [the U.S.] tax system even more uncompetitive. Congress should repeal the tax this year.” 

Wanda Moebius, AdvaMed vice president, policy communications, explains further: 

We are pleased the president emphasized U.S. manufacturing and reforming tax policies to support it and spurring domestic research and development in his State of the Union address. We look forward to reviewing the specific policies that would support these recommendations. Repealing the device tax is an essential first step in supporting continued growth in the medical technology sector.

In other AdvaMed-related news, the trade association has launced a website for its AdvaMed2012 conference. The association is also accepting program panel proposals. The event will be held at the Boston Convention & Exhibition Center in Boston on October 1–3, 2012.

—Brian Buntz

Related Content:

Japan's Medtech Regulatory Body Goes Back to School

Change seems to be afoot in Japan's regulatory approach to medical technology. Nothing dramatic yet, but, as Japan Medical Design and Manufacturing Technology Editor Miki Anzai has reported on medtechinsider, the government seems to be more receptive to streamlining the product approval process and encouraging innovation. For example, a strategic council was established in January 2011 to promote medical innovation, a key policy goal under the nation’s new growth strategy, and the government has made some efforts to improve the regulatory system to encourage exports and secure a more stable supply of medical devices within Japan. The outreach continues, as the Pharmaceuticals and Medical Devices Agency (PMDA) enters into a collaboration with Gifu University to promote education and research involving medical technology.

Under the agreement, students at Gifu University’s United Graduate School of Drug Discovery and Medical Information Sciences can attend classes taught by PMDA staff and have an opportunity to spend time working at PMDA headquarters and getting an in vivo view of the medical device review process.

"The move is part of PMDA’s efforts to expedite the review process for drugs and medical devices by strengthening regulatory science and cultivating professionals who can evaluate the safety and efficacy of products more quickly," writes Anzai on the medtechinsider blog, where the full article is posted.

— Norbert Sparrow

IBA, SK Capital Partners join to accelerate radio-pharmaceutical business

IBA (Ion Beam Applications) and SK Capital Partners have entered into an agreement to create IBA Molecular Imaging, a jointly-owned new company derived from IBA’s molecular imaging division. The parties will equally share the development cost of the current pipeline of new molecules.

Molecular imaging is one of the most advanced and exciting fields in medical diagnostics. The SK Capital involvement will reinforce IBA’s molecular imaging capabilities by enhancing its manufacturing capabilities, generating new products, and expanding its geographic coverage. The new tracers will help to identify kidney cancer and Alzheimer’s disease earlier than before.

IBA’s molecular imaging division has 57 sites in Europe, the U.S., and Asia, and a significant manufacturing facility in Saclay, France.

Richard Nass

The Quantified Self, Big Data, and Medicine

One prominent device that exemplified this self-information-gathering trend is the Fitbit pedometer. The device not only keeps track of the number of steps a person walks but it can also estimate distance walked, calories burned, and even how well one sleeps.

Countless other examples abound: There is the iPhone ECG and non-medical device examples such as the Withings Wifi Bodyscale, and the Zeo Personal Sleep Coach. And there are numerous apps for mobile phones that are contributing to this trend as well, which, as you might guess, is leading to an explosion of data.

IBM Watson data
The above image was drawn from an IBM infographic on Watson.

As a recent article in the Wall Street Journal explained, the field of medicine is undergoing a similar transition. That paper quotes Shamus Husheer, CEO of Cambridge Temperature Concepts saying that traditional medical information "is massively skewed. It is highly biased by the people who go to doctors; the ill, the hypochondriacs and the elderly."    

But that's beginning to change as the power behind Big Data becomes clear. The logic of all behind this is obvious: more data is more useful, and less biased, than less data. But, as the Wall Street Journal article points out:

Acquiring medical data has, historically, been problematic. It is wrapped in layers of regulations and stringent safeguards and is expensive to collect.

Husheer's company, Cambridge Temperature Concepts, is doing its part to reverse the trend and help produce data that can be useful for female patients facing infertility problems. The company has created the DuoFertility sensor that is worn 24 hours a day that measures movement and changes in body temperature to pinpoint medical problems that might interfere with ovulation. 

Brian Buntz

Don't Believe the Hype: Boston Sci Isn't the Only One Experiencing Shrinkage

Boston Scientific (Natick, MA) isn't exactly shrinking from recent criticism regarding instances of longitudinal stent deformation in its thin-strut Ion paclitaxel-eluting platinum-chromium (PtCr) coronary stent system. Instead, the medical device giant has posted an informative--though unlisted--video on YouTube titled, "Beyond the Hype: Longitudinal Stent Deformation," which emphasizes the rarity of longitudinal compression as well as the fact that all thin-strut drug-eluting stents are susceptible to the design flaw. But can the Ion restore its reputation?

Boston Scientific Ion Stent
The Ion PtCr thin-strut DES from Boston Scientific drew fire for its observed vulnerability to longitudinal compression.

Longitudinal compression proved to be among the most-talked about topics in stent design this past fall, quickly escalating from a discussion in a case series in the medical journal EuroIntervention to the subject of several last-minute conferences at TCT and intense scrutiny. Several companies' thin-strut stent platforms were initially identified in the case studies as having demonstrated this type of stent deformation, including Biosensors International's biolimus-eluting BioMatrix stent, Boston Scientific's everolimus-eluting Promus Element stent, and Medtronic's zotarolimus-eluting Endeavor stent.

But Boston Scientific was dealt a further blow in November when Cindy Grines, a cardiologist and editor of the Journal of Interventional Cardiology, singled out the company's Ion stent as an especially worrisome offender. In addition to an article attributing a heart attack directly to the deformation of an Ion stent, Grines wrote an editorial in which she described the product's shrinkage as "disturbing." The Ion stent, according to Grines, exhibited deformation, accordioning, and shortening of approximately 35%.

Since the initial frenzy, the issue of longitudinal compression seems to have lost some steam as experts at TCT and elsewhere have attempted to slow the runaway panic train. As I noted in a recent editorial: "While presenters at TCT relayed anecdotes of longitudinal compression in various stents, most downplayed the issue as relatively rare and cautioned against getting caught up in the hype. Several speakers also noted that stent design may not be the sole culprit--surgical technique may also be a factor."

While surgical technique may be a factor in longitudinal compression, the flaw is still primarily chalked up to stent design as medical device companies strive to achieve products with ever-thinner struts. And that could pose a significant problem for the Ion and, to a lesser degree, the Promus Element stents moving forward.

With this in mind, Boston Scientific quietly posted a short video on YouTube earlier this month in a subtle form of damage control. "Although [longitudinal compression is] a rare phenomenon, today's thin-strut stents are all susceptible to longitudinal stent deformation," the video notes. This angle from the company is a smart one. Although Abbott would be quick to refute this claim, noting that its Xience stent has had "virtually no reports" of such stent deformation, other brands have experienced longitudinal compression. So, it makes sense to try and deflect--or at least share--the negative attention. There's definitely enough to go around, after all.

And of course there's the spin. "Improved radiopacity with the PtCr platform allows for better identification of longitudinal stent deformation compared to other, less-visible stents," the video states. "Improved identification allows a physician to respond if it occurs."

In the wake of the longitudinal compression hysteria, it's a prudent move by Boston Scientific to reassure customers and patients that longitudinal deformation is rare and is not unique to the company's PtCr platforms. But the video prompts several questions: What impact, if any, will the longitudinal compression debate have on Boston Sci's PtCr stents? Will the company's stents' reputation (and sales) suffer? And, perhaps most importantly: Will the company reevaluate the geometric design of its stents for next-generation products? It will be interesting to see how this all pans out.

Do you think the issue of longitudinal compression being brought to light will impact Boston Sci or any other thin-strut stent manufacturers? Can you see "beyond the hype?" Let us know in the comments section below. Also, check out Boston Sci's video and bone up on longitudinal compression in recent pieces from MPMN's archives, "Design Flaw Poses Potential Threat to Shrinking Drug-Eluting Stents" and "The Skinny on Thin-Strut Stents." --Shana Leonard

Process Integrates Complex 3-D Parts into a Single Device

Plating conductive structures onto plastic parts can reduce the number of components and overall size of a medical device. But the 2-D processes used for plating flat parts cannot accommodate the smaller, more-complex interconnect designs now desired by design engineers. Addressing this market need, Molex has introduced the MediSpec process, which combines 3-D molded interconnect device (MID) capabilities with laser direct structuring (LDS) technology to enable the integration of complex mechanical and electrical features into compact medical applications.

Molex Medical MID/LDS Process
MID/LDS capabilities from Molex enable medical device designers to integrate complex electrical and mechanical features into compact applications.

Working closely with LPKF Laser & Electronics AG to implement the patented technology, Molex has developed a scalable process that it claims combines the versatility of MID capabilities with the speed and precision of LDS. MID manufacturing has traditionally employed either two-shot molding or LDS methods for plating plastic parts. But by integrating these two options, the MediSpec process can produce a single molded device that combines fine-pitch 3-D circuitry with shielding while expediting time to market.

The MediSpec process is simple and can result in greater cost savings than many other prototyping techniques, according to Anthony Kalaijakis, strategic medical market manager for Molex. To create a single molded interconnect, a mold tool fabricates the interconnect body while a laser fixture holds the molded part for ablation. The plating process is then used to add traces. Software features are designed to facilitate modifications to the placement of traces and shielding; changes can be applied by simply altering the position of the laser, thereby avoiding the high prices often associated with tooling changes.

Promoting miniaturization, the LDS technology allows microline electronic circuitry to be imaged onto a variety of RoHS-compliant molded plastics using a three-axis laser. In high-volume production, lines and spaces down to 0.10 mm and circuitry pitch down to 0.35 mm can be achieved. Numerous material combinations for the plating or molded parts are available as well, offering flexibility for medical device designers, according to Molex.

The use of MIDs can reduce the materials and number of components in medical applications such as drug-delivery systems, pulse oximeters, blood glucose meters, neurostimulation controllers, and remote patient-monitoring systems. The MID/LDS technology is ideal, Kalaijakis notes, for the creation of 3-D circuits or metallization in key areas to provide EMI shielding and grounding.

"There are a few first-mover applications for this technology in the medical market today in both the two-shot and LDS configurations," Kalaijakis says. "Industry trends are making it more interesting to the medical market space."

Molex Inc.
LISLE, IL