The medical device industry’s anxiety over pending changes to the FDA’s 510(k) process is clear to see amid a slowly unfolding process that’s forcing OEMs to rethink entirely how they will operate on a changing landscape. With the industry awaiting guidance, manufacturers are mired in a holding pattern. But the story does not end there, unfortunately.

Beyond the spectra of 510(k) changes, manufacturers are experiencing similar angst over coming changes to the industry's IEC 60601-1 standard governing the safety and reliability of electro-medical equipment and systems. So the alarming reality now for the industry, with both the 510(k) process and the IEC 60601-1 standard in a state of flux, can be sadly summed up in two words: uncertainty reigns.

Duarte-Lonnroth

The IEC 60601-1 standard has been revised from Edition 2 to Edition 3, with the new edition being even more prescriptive on what OEMs need to do to prepare a device for market. FDA has not adopted IEC 60601-1 Edition 3 yet and there is no clear guidance on when this will occur. Mandatory adoption dates have been set as follows: Europe and Canada June 1, 2012; the U.S. July 1, 2013. But some specific product may have earlier adoption dates and the mandatory adoption dates themselves may change based on regulatory body decisions.

FDA, for example, is declaring its intention to adopt the changes in 2013 but has not confirmed that this will actually happen. With FDA appearing to sit on the fence over this significant initiative, the issue is certainly getting plenty of attention. Amid the confusion, what guidance can we offer to OEMs these days?

Our advice is to start at square one: OEMs should acquire and become familiar with the IEC 60601-1 Edition 3 changes covered in a document that is several hundred pages long. Having gained an understanding of the changing standard, OEMs should then start to integrate changes where possible into their processes.

The revised standard, as I have noted, is very prescriptive, adding a variety of new controls and testing and documentation requirements that OEMs will need to comply with prior to moving a device into production.

Why act now on the revised IEC 60601-1 standard? For starters, depending on the timing of the revised standard’s adoption, companies with products coming to market may face the challenge of going back into their design files to ensure the standard is met—a costly and disruptive process to say the least.

What OEMs can begin doing now, for example, is create a work-around in areas concerning product components that could become obsolete over the next few years. Ultimately, it will fall to OEMs to ensure all device components in use are safe and reliable under the new standard—so the sooner manufacturers get required changes in gear, the better their chances of success. This is doubly true for smaller players, who will face greater risks than the larger and more resourceful major players amid the changing regulatory landscape.

The risk and change management issues now looming for manufacturers can be seen to underscore the importance of having a reliable partner to provide expertise and guidance throughout the design, testing and production process. Companies like Celestica are doing their part to assist industry partners by providing ongoing support in all areas, so as to help OEMs successfully manage the significant risks that many of them are facing today.

Preparing now to meet the new standard can pay significant cost and time dividends in the future. And failing to act can only create even greater risks for industry players.

Duarte-Lonnroth is director of quality, regulatory affairs, healthcare for Celestica (Toronto, ON, Canada).

Masataka Imura and a team of engineers from Osaka University (Japan) have made fiction into reality. The team has developed a display and demonstrate it in this video with the image of a rabbit. Users can interact with the image, which is projected from 3 cameras into a foggy mist designed to make the light visible. Such devices could be used for diagnostic imaging. Click on the bunny to go to a video demonstration of the technology.

I assume my time machine (paradox free, of course), is on the horizon. Also, can't wait for my laser stunner.

—Heather Thompson

The 3863 CR dc micro motor from Faulhaber is designed with ZHN48 magnet material for benchmark torque performance of 150 mNm at 8000 RPM. Available from Micromo, the motor is available in 12, 18, 24, 36, or 48 V and can be equipped with a three-channel encoder (also available in a line-driver design) as well as combined with a wide range of precision gear heads.  The SC5008 speed controller and MCDC 3006 motion controller can be used to control the micro motor’s speed or to manage it when deployed as a positioning drive.

Additional features include low-friction torque and high thermal resistance, which allows for continuous current of 6.9 A in the 12-V version. The 3863-CR can be assembled with a wide range of gear heads and encoders (up to 1024 lines of resolution).

Richard Nass

This VP has his eye on reducing risk, but his raison d'etre is really the end user. "Someone you know who has been treated for a disease or health problem has probably used a J&J product—we take that responsibility seriously," he told attendees.

"Medical devices and diagnostics is a changing landscape, that is  complex and the sector has inherent risks," he said. McCarthy was asked by J&J management to prove that PLM helps reduce those risks and helps patients.

So McCarthy showed that design and manufacturing failures account for 50% of quality incidents in medical devices. Of these failures, 50% are from devices in the cardiovascular sector or home use.

One of the solutions J&J's enacted was a move to a "superplant" for manufacturing. Soon, all of Johnson & Johnson products will be manufactured and shipped from one facility. By changing the supply chain and retaining higher levels of control, J&J hopes that patient safety will increase.

It's not an easy venture, to put it mildly. The plan involves bringing more than 70 manufacturing sites under one roof.

This month McCarthy will be presenting his ideas in a Webcast for MD+DI's audience in a Webcast "PLM and the Patient," sponsored and hosted by Dassault Systèmes. I hope you'll join me to get a first hand access to McCarthy, and well as PLM expert, Jean Colombel, vice president of the life sciences industry at Dassault Systèmes.

—Heather Thompson 

Designed for the recirculation and transfer of fluids in medical devices, magnetically coupled centrifugal pumps feature components that are integrated into a compact, lightweight unit. The design of the Integrity series eliminates the need for motor bearings and leaves the impeller assembly as the only moving part. The magnetic-drive pumps weigh approximately 10 oz and are driven by a 12-V brushless dc motor. With a maximum system pressure of 75 psi, they offer flow rates to 2 gpm and 12 ft of head. Standard pumps handle fluids ranging from 140° to 180°F; custom systems are available for higher temperatures.

Gorman-Rupp Industries
Bellville, OH, 419/886-3001

Uncertainty in the medical device space is not an avenue you want to go down too often. This is particularly true when you’re dealing with FDA regulations and other regulatory issues/bodies. To try to steer you in the right direction, we’ve put together a webcast called “PLM and the Patient.” It’s scheduled for December 13, at 10:00 AMEST.

In this webcast, you’ll hear from Jean Colombel of Dassault Systemes. Colombel will discuss the latest in 3D Product Lifecycle Management (PLM) collaborative solutions and how the technology lets the design engineer navigate a tricky, yet required, path.

You will also hear from Johnson & Johnson, one of the obvious leaders in healthcare, about how that company is leveraging PLM solutions to develop its products. That process also covers regulatory reporting with transparency throughout the product development and quality assurance cycles. The speaker from Johnson & Johnson will be Steve McCarthy, Vice President Quality Management Systems.

Overall, what you’ll learn by attending this webinar is an understanding of industry challenges and limitations of current approaches to PLM, and an understanding of how a lifecycle management approach merges the product and the process from conception to commercialization.

At the end of the presentation, you’ll have an opportunity to ask questions of the speakers and get answers in real time.

Richard Nass

New features are available in an all-in-one coil joiner. The Infinite Web system incorporates automatic laser cutting and welding into a single head and uses a noncontact process for splicing coils. The system can splice titanium coils on a 15° bias as an alternative to forming perpendicular joints. Requiring only an electrical input and minimal operator involvement, the safe, user-friendly coil-joining system is a mobile stand-alone machine that can serve multiple converting lines, automatically preparing coil ends and delivering precision welds in cycles of less than three minutes. Its industrial PC–based control system features a touch screen interface, predefined programs for selected alloys, and proprietary self-diagnostics to maximize uptime.

Joining Technologies Inc.
East Granby, CT, 800/266-1966

Wanna know where the hottest established and emerging biomed hubs are located? You're in luck, because "Global Life Sciences Cluster Report--2011," a new report by Jones Lang LaSalle, is chock full of information about the world's leading industry clusters in the United States and beyond.

Here are some highlights. The United States was the leading destination for direct investment in the Americas and globally, receiving more than $38 billion in inward investment between 2003 and 2006 (13 times the global average for the period) and $73 billion between 2007 and 2010. Approximately 25% of the investment in the United States was in R&D.

In the period in question, the top five medical technology clusters in the United were Boston, New York/New Jersey, the San Francisco Bay Area, Los Angeles, and Washington DC/suburban Maryland.

Of particular note is that Puerto Rico took second place in inward direct investment levels in the Americas. Between 2003 and 2006, the island received just over $14 billion in direct investment, a figure almost five times the global average. The growth between 2003 and 2006 was 68%, although investments dropped significantly during the 2007-2010 period to just over $3.5 billion. Manufacturing constituted 97% of all investment in Puerto Rico. Although Puerto Rico is trying to organize around R&D and advance its value proposition, the data suggests that it has not yet been successful.

In the Americas, Canada was the next largest recipient of inward investment over the period, receiving just under $14 billion in direct investment between 2003 and 2010, while Brazil came in number 4 with inward investment levels slightly lower than those of Canada.

Inward investment in Asia between 2003 and 2010 was concentrated in a few countries led by China, Singapore, and India. Other countries with a biomed sector of note included Malaysia, South Korea, and Taiwan.

In Europe, Ireland was the largest recipient of inward direct investment, receiving more than $50 billion between 2003 and 2010. Next up was Germany, with more than $25 billion in inward investment, followed by France, Spain, and Italy.

In its concluding remarks, the report has the following to say:

"We conclude that established clusters within the United States and Europe will continue to report activity surrounding "core" functions in the form of small requirements from start-ups and the occasional right-sizing or re-locating of headquarter operations. Our analysis shows real estate activity is most prominent in cornerstone locales, such as the Bay Area, the New York/New Jersey corridor, San Diego, Boston, Seattle, Philadelphia, the United Kingdom, France, Switzerland and Germany, and we predict these clusters will remain leaders in "core" aspects of the value chain. It should be noted, however, that established clusters have reported a notable decline in speculative construction of laboratory facilities, demonstrating market awareness of constricted demand following the closing of many start-up operations during the recession.

Meanwhile, it is interesting to note the progress of emerging clusters among the global regions. Within the United States, several emerging clusters have been on the radar for some time, but have failed to reach a critical tipping point into becoming an established cluster. Some clusters, like Chicago and Houston, have very strong intellectual capacities and research institutions, but struggle to translate innovation from bench to marketplace due to lacking fiscal support or programming. While others, like Florida, Minneapolis and Indianapolis, have strong industry representation but remain challenged by fragmented framework, most notably lackluster funding from NIH and VC sources."

A story from Fox News explains that hospitals are agressively renegotiating prices for implantable medical devices, such as knee replacements, stents, and even heart valve replacements. Manufacturers are being pushed against a wall to lower the prices of mature products, as well as highly priced cardiovascular devices such as defibrillators and pacemakers.

Is it fair for hospitals to ask for transparency in pricing, not to mention cost comparisons akin to Amazon.com, as Christopher Baskel asks in the story? Baskel is supply chain director at Spectrum Health Hospital Group.

—Heather Thompson