The Juvenile Diabetes Research Foundation (JDRF) has recently encouraged FDA to speed development of new treatment options for diabetes. In researching this issue, MD+DI contacted Cynthia Rice, who is the vice president, government relations for JDRF. The questions we posed are in bold while her answers immediately follow:

What is holding FDA back from approving the use of low-glucose suspend systems in the short term?
For many years, FDA was not clear about what studies manufacturers would need to conduct in order to receive approval for low glucose suspend systems in the United States. As recently as November 2010, when FDA hosted a public workshop on artificial pancreas systems, the FDA requirements were not yet clear. Thus, devices which were approved in Europe in 2008 are still not approved in the United States. The FDA...

August 21st, 2011
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Here are some stories that caught my eye when scanning the Web. Last week, we ran a story on medical device hacking. That story is getting some renewed attention from lawmakers, as described in Wired today (check out the bottom link). In other news, there's an interesting story on a virtual scalpel and the possibility of a light-controlled pacemeker.

  • How a Virtual Scalpel Overcame Real-World Challenges (EMDT)
  • FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices (Qmed)
  • Wireless Medical Device Coexistence (MED)
  • New Heart Cell Stimulation Technique Could Result in Light-Controlled Pacemaker (medtechinsider)
  • Medical device companies get scant Wall Street love (MinnPost.com)
  • Lawmakers Call for...
August 19th, 2011
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By Nancy Duarte-Lonnroth

A climate of anxiety is brewing in the medical device market as manufacturers brace for the impact of the FDA’s review of the 510(k) process.

   Duarte-Lonnroth

Manufacturers have been anticipating new requirements from the FDA’s 510(k) process for some time and have been working closely with the government to design a balanced solution between stronger public health protection and efficiently delivering devices to the market. Not surprisingly, the industry went on high alert when the Institute of Medicine (IOM) suggested last month that...

August 19th, 2011
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Scheduled for September 13–14, the MEDevice Forum will take place at the San Diego Convention Center. The event will examine recent trends in biomaterials, implants, and nanomedicine.

To learn more about the event, I recently spoke with the Marta Villarraga, PhD, a principal at Exponent who will be chairing the conference session there. My questions are in bold and her answers are below:

Why do you feel this conference is timely?
Marta VillarragaWhat we’ve done here is try and capture topics that are of interest to the industry right now. Innovation is starting to resurface everywhere we look. It’s really pushing our limits. In the medical device industry, we’re...

August 18th, 2011
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Please forgive the slightly hyperbolic headline. But the medical device industry has clearly seen better days. About a week ago, Goldman Sachs predicted a gloomy future for the industry and downgraded stocks of big firms like Zimmer and Medtronic. A recent piece from The Boston Globe described the outlook of healthcare companies as “complicated,” citing the implications of government involvement in healthcare. Today, financial newspaper Barron’s explained (in the opening text of a positive appraisal of CareFusion) that the “medical-device industry has been...
August 17th, 2011
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This week at mddionline.com, Bryan Campbell discusses how process validation can be an OEM's best friend, TÜV Rheinland and GreenSoft join forces ahead of coming changes to RoHS and REACH regulations, advances in materials research may lead to biocompatible electronics, and a reader decries the lack of innovation in the device industry.

  • Product Development Insight: Validation Can Make a Device Launch a Sure Thing
  • TÜV Rheinland, GreenSoft Enter into Partnership Agreement
  • Panel Pressures FDA to Expedite Development of Artificial Pancreas
  • Soft Memory Device May Lead to Biocompatible Electronics
  • DeviceTalk Blog: Internal Innovation Is Practically Non-Existent in the Medical Device Industry
August 16th, 2011
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Yes, we're still talking about that darn IOM report on the 510(k) process. But in our defense, it keeps giving us reasons to. 

Yesterday, Cardiovascular Business posted an interview with IOM chairman David Challoner on its Web site. Regarding what was so politely framed as industry's "opposition" to the IOM's recommendation to scrap the 510(k), Challoner had this to say:

“The device industry will tell you—even before you give them a conclusion—that any change from current practice is going to kill innovation. Well that’s just nonsense,”...

August 16th, 2011
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Vesta, a provider of silicone and thermoplastic contract manufacturing for medical device OEMs, now offers thermoplastic extrusion. The company’s new Quick Turn service caters to designers and engineers who need small quantities with short lead times for characterization, evaluation, and design iterations during product development. Small extrusion lots in single- and simple multi-lumen configurations with standard tolerances are now available. Vesta uses dedicated extrusion equipment and standard stock thermoplastic polymers. Lead times for widely available medical-grade materials are normally two weeks or less, according to a release.
 

August 16th, 2011
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Uncertainty is the enemy of innovation, said Ian Spatz, of Manatt, Phelps & Phillips at a recent conference on social media and mobile healthcare. And indeed, regulatory pressures and uncertainties are pushing an innovation spiral.
 

But its not only regulatory uncertainty that is costing medical device makers. The lack of innovation going on in the industry started even as devices reached a market high in 2006, I was recently told by a medical device supplier. “Once drug-eluting stents came out, everyone just stopped to watch their stocks rise, and they didn't get back to work on new ideas,” an ultraprecision laser cutting expert told me. That sentiment was echoed in a recent letter to one of our editors, which says industry has been resting on its laurels.

It's not all bad, of course. VCs want to invest...

August 16th, 2011
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I was in San Jose and San Francisco last week, visiting medical device suppliers. Through several conversations, a trend emerged: that device makers continue to want to work with supplier companies that are local, particularly in the medtech hotspots. Minnesota firms want to work with suppliers in Minnesota, Boston OEMs still look to partners on the eastern seaboard, and device companies in the Silicon Valley want neighbors as well (anything west of the Mississippi will do).

It makes sense. There are regional differences in expectations and in business approaches. It’s also simply more convenient to work with a partner that is 20 minutes down the road rather than 3000 miles away.

Smart suppliers are taking advantage of this trend, finding success by catering to their local OEMs. It's not a new trend, but I was surprised that with the technological advances OEMs have at their disposal and increasing consolidation, the approved vendor lists continue to be based,...

August 15th, 2011
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