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Articles from 2014 In September


2 Mistakes You Should Avoid with Medical Plastics Sterilization

With 15 years of experience consulting on polymers in the medical device field, Stephen Spiegelberg has spotted plenty of mistakes to avoid when it comes to sterilizing medical plastics.

Here are two major mistakes that Spiegelberg, president of Boston-based Cambridge Polymer Group, says you should avoid:

1. Choosing the Wrong Sterilization Method

There are three major sterilization methods: ethylene oxide, gamma radiation, or electron beam radiation.

"The common issue we see with companies new to this sort of process is that they'll plunge into one of the ionizing radiations, either gamma or electron beam, without consideration of what it is doing to the plastic itself," Spiegelberg says.

See Spiegelberg discuss failure analysis of medical plastics on Thursday, October 16, at MD&M Chicago.

Use ethylene oxide, and the packaging will need to have permeability to the ethylene oxide, and some devices just don't lend themselves to ethylene oxide, which is more of a surface sterilization process.

The radiation sterilization might be cheaper, too.

But Spiegelberg says the advantages to be had from using radiation sterilization could be more than cancelled out because brittleness or other changes to the properties of the plastic could potentially crop up, immediately or over the longterm, with such radiation exposure.

2. Placing Sterilization above Clean

Your plastic medical device parts might be sterile, but are they clean?

That question became much more important after the roughly $1 billion in lawsuit settlements that Sulzer Orthopedics, now part of Zimmer, made over a decade ago over faulty hip and knee implants.

Spiegelberg was involved with a taskforce that examined what went wrong.

"They changed their manufacturing process, which resulted in a series of things that happened downstream. At the end of the day, it resulted in some manufacturing residue, some lubricants, being left on the medical product that led to an adverse biological response," Spiegelberg said.

The Sulzer issues changed the climate.

"Up until that point, manufacturers were certainly aware that how clean medical device components are is important. But it certainly was second tier to how sterile medical products are. ... As we say, ''You can have sterile dirt, but it's still dirt,'" Spiegelberg said.

Spiegelberg says the solution is more control and understanding of the manufacturing line: "They need to know how much their residue load is--both in quantification and identification--so that if there's a problem down the road, they can get ask if residue levels changed."

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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Medtech Biocompatibility Testing Is Seeing a Major Shift

There's been a change afoot in the medical device industry in the way companies test for biocompatibility--with a shift away from animal tests toward chemical characterization tests in the laboratory, according to Thor Rollins, a biocompatibility expert at Nelson Laboratories

Nelson Labs

Nelson Labs analyst using a GC-MS to perform chemical evaluations. (Image courtesy of Nelson Labs)

"It was only .... in the last year and a half that there has really been a strong push by the FDA to get involved. ... It wasn't until the FDA started asking for it that people have been doing it routinely," said Rollins, who is discussing biocompatibility and sterilization requirements during a series of sessions October 16 at MD&M Chicago.

The FDA's push for more chemistry behind leachables not only involves permanently implantable medical devices (implanted over 30 days) but also IV sets and sleep apnea devices that are passing fluid or air into the body, Rollins said. Class II and II is more of a concern than Class I.

Setting more standards for such testing was a top subject for a meeting of the Technical Committee 194 of ISO 10993 that Rollins attended last April.

The changes come amid greater concerns over the chemicals that leach into the body. One of the most notorious situations of leaching going badly involved metal-on-metal hip implants releasing cobalt and chromium into the body--producing tragic results in patients and billions of dollars in lawsuit payouts.

Leaching is likely to become even more of an issue because the more active babyboomer generation is needing medical device implants earlier, at the same time that it is expected to live longer. Devices, then, are going to be inside the body longer than in the past.

Animal tests are limited when it comes to figuring out whether chemicals leached from a device safe over a patient's lifetime, according to Rollins.

"We were limited on how aggressive on the solvents we could use in the animal tests, because we can't do something that's toxic in the animal. We have to use things like saline and oils. ... They're not very aggressive solvents," Rollins said.

With chemical tests, on the other hand, aggressive solvents such as methylene chloride can be employed to really stress the materials and determine worst case scenarios.

Tests use to chemically analyze materials include gas chromatography-mass spectrometry (GC/MS), liquid chromatography-mass spectrometry (LC/MS), ICP Mass Spectrometry (ICP-MS), and Fourier transform infrared spectroscopy (FTIR).

See Rollins and other experts speak at MD&M Chicago, Oct. 15-16 in Schaumburg, IL.

ISO 10993 includes guidelines to help.

"You get a good fingerprint of what your device is, versus just extracting it in water and injecting it in a rabbit and crossing your fingers," Rollins said.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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FDA's Device Approvals Come Under Fire, Again

A recent study concludes that most medical devices cleared via FDA's 510(k) and PMA processes lack sufficient evidence to show they are safe and effective. The report, which was published in JAMA Internal Medicine, concluded that the 42 of 50 medical devices studied did not have sufficient data backing their use.

In 2011, the Institute of Medicine (IOM) reached a similar conclusion regarding FDA's 510(k) process, which is used to clear the vast majority of non-Class I medical devices in the United States. The IOM argued that the 510(k) process was so problematic that it should be scrapped entirely and replaced with a new regulatory framework.

The United States' regulatory approval process has come under fire from all sides in recent years. The process is too slow and inefficient, according to industry. Many medical devices designed and developed in the United States are first commercialized in Europe and elsewhere several years before they hit the market here. Meanwhile, patient advocates claim that FDA's process clearing/approving devices is dangerous. In 2012, Consumer Reports released a report alleging that most medical implants are not sufficiently tested. Especially controversial, in Consumer Reports' eyes, is FDA's 510(k) premarket notification system, which enables many devices to be marketed owing to their "substantial equivalence" to products already on the market.

"A lot of these are high-risk devices that get on the market with no studies at all," said Rita Redberg, MD, medical professor at the University of California, San Francisco, and chief editor of JAMA Internal Medicine in the Wall Street Journal. "When there are studies, they're not available" to review.

FDA has announced that it will retool the 510(k) process to address these concerns.

In recent months, the FDA itself has noted that the approval process should do a better job ensuring medical devices are safe from a cybersecurity standpoint. Sister publication Information Week reports that FDA is conventing "a collaborative industry-wide effort to bolster medical device cyber security."

In addition, the FDA is mulling new regulation regarding the promotion of medical devices, following a 2013 reorganization at CDRH.

Refresh your medical device industry knowledge at MD&M Chicago, October 15-16, 2014, and MD&M Minneapolis, October 29-30, 2014.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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After Patient Deaths, Thoratec Reinstates Former CEO

Thoratec Corp. has replaced CEO Gary Burbach with the man who previously led the company for a decade.

New president and CEO Keith Grossman served in those roles at the Pleasanton, CA-based company from 1996 to 2006, when Burbach took over. The shakeup follows the deaths of four patients and reduced blood flow or lost consciousness in five others while using the company's HeartMate II left ventricular assist device. The company and the FDA said the device was not at fault; rather, it was patients' misunderstanding of how to use a new controller.

The company announced in March its plans to update labeling and training materials for the HeartMate II LVAS Pocket System Controller because some patients and caregivers had trouble with the process of changing from a primary system controller to their backup system controller.

HeartMate II
HeartMate II, as shown on Thoratec's website

Of these nine cases of death or serious injury, eight occurred in patients who began using the Pocket Controller after having been trained on an older model, the EPC System Controller, according to a Qmed report. Two of the deaths involved patients who attempted to exchange system controllers while alone and, contrary to the labeling, without contacting the hospital first.

Thoratec announced the release of an updated version of the Pocket System Controller on September 18.  The company said it would provide the latest version free of charge to cardiac centers and patients upon request. The exchange could cost it up to $11 million pretax in the third quarter.

In August, Thoratec's stock fell to a six-month low of $24.05, after having peaked in July at $24.71. It has slowly regained momentum, with an uptick to $27.74 following the announcement of Grossman's return.

Burbach left his executive and board roles but will remain an advisor to the company through the first quarter of 2016, according to a Thoratec statement.

Grossman has worked in the healthcare industry for 30 years, most recently as president and CEO of Conceptus, Inc. The Mountain View, CA-women's health medical device company's market value tripled as its sales and profits grew during Grossman's tenure, Thoratec said. Bayer Healthcare LLC purchased Conceptus in 2013.

During Grossman's previous turn at Thoratec's helm, the company made advances in the mechanical circulatory support market, boosting revenues and market value significantly, the company said.

Grossman has continued to serve on Thoratec's board since leaving the company. From 2007 to 2011, Grossman was a managing director at private equity firm TPG, where he initiated and co-led the medical device venture investing effort, and served as a senior advisor to the firm's buyout fund.

Refresh your medical device industry knowledge at MD&M Chicago, October 15-16, 2014, and MD&M Minneapolis, October 29-30, 2014.

Nancy Crotti is a contributor to Qmed and MPMN.

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DIY Engineers Hack Healthcare

The do-it-yourself (DIY) movement is exploding, and intrepid consumers are developing custom code and hardware for everything from smartphones to televisions. In recent years, the practice has made its way into the medtech industry, as patients began opening the hood on devices like glucose monitors, insulin pumps, hearing aids, and heart monitors just to name a few. These hackers aren't only tweaking devices for themselves; they're illuminating the light bulb for the rest of the industry, sparking innovation and improvement.

Take Jason Adams for example. The Wall Street Journal recently ran a piece detailing him and his daughter Ella. She has Type 1-diabetes, and wears a glucose monitor made by Dexcom. The device measures her blood sugar every five minutes and displays the information on a nearby receiver, providing Jason with a huge advantage in helping him monitor his daughters condition for any dangerous spikes or potentially fatal drops in blood-sugar levels. Unfortunately, the device cannot transmit the data to the Internet, limiting the portability of the monitoring device.

Jason Adams
Jason Adams' SmartWatch device

That is, until Adams found NightScout, a system patched together by software engineers--many of whom have diabetic children of their own--who refused to settle for the limitations of current technology. The open-source system essentially hacks into the Dexcom device and uploads the data to the Internet, which allows Adams to view his daughters blood-sugar levels on a smartwatch, regardless of her location. However, the solution is far from perfect. It drains battery power with great efficiency, cuts out at times, and does not have any sort of approval from the Food and Drug Administration. It does, however, serve a need that many patients have been left without, and serves as a foundation for how the technology can be improved in the future.

Of course Jason isn't the first take matters into his own hands. Do-it-yourselfers have been inventing and modifying medical devices for years, leading to advancements and improvements to devices across the industry. From patients tweaking hearing aids to play music, to a cystic fibrosis patient crafting a device to help treat his clogged airways, users across the globe continue to invent new devices, or revamp existing technologies to improve treatments. There is also the case of the Argentine mechanic, who developed a device that could save millions of lives. And then there is the British boiler engineer who created a device to fix a pumping problem with his heart.  

Chest Master
Innovator Marten deVlieger engineered this device to treat cystic fibrosis.

Regardless of the process, patients clearly are not willing to settle for less if they have the power to improve devices on their own.

These DIY efforts are mostly a symptom of frustration, stemming from the lengthy approval process for updated and newly invented devices. A new Medtronic pump that can communicate with a glucose monitor and suspend insulin delivery when blood-sugar levels are low wasn't approved in the U.S. until 2013, despite being available and in use in Europe since 2009. There's also a new version of an Animus insulin pump that uses a Dexcom monitor that was submitted for approval in April of 2013 (and is still awaiting said approval), despite the device being in use in Europe since 2011. The FDA has acknowledged the frustrating process, and certainly doesn't want to be seen as a barrier to innovation, as it continues to work toward a more proactive, functioning process for regulatory approvals.

Chronic diseases such as asthma, diabetes, and heart conditions have become an early focus for Dexcom as they look to work efficiently with the FDA to deliver devices with more functionality and innovation to patients actively seeking the best technology available. All the while being gently nudged by hackers and do-it-yourselfers like Jason Adams, who don't need a string of approvals to make their medical devices as efficient as possible.

Refresh your medical device industry knowledge at MD&M Chicago, October 15-16, 2014, and MD&M Minneapolis, October 29-30, 2014.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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Medtech Will Favor Google Over Apple, Analysts Predict

Medtech Will Favor Google Over Apple, Analysts Predict

If the fanfare over the iPhone 6 has proven anything it's that Apple's customers are just as loyal and rabid as ever. Meanwhile, the last time people waited in line for hours for a Google product was...well, it hasn't ever happened.

However, in a piece for Forbes, writer Dan Munro argues that Apple's popularity won't necessarily give the company a leg up in the healthcare space—especially given how deeply Android phones have penetrated the market. While Apple may be a top selling brand, it's the only one with iOS phones. Phones that run on Google's Android OS outnumber iPhones 2-to-1 according to estimates.
 
Munro argues for three key reasons Google will win out over Apple in the healthcare space:
 
1.) Google is winning with software
 
As mentioned, Android has a large piece of the market. Munro says that even though developers may begin creating apps for iOS, they must acknowledge the majority market uses Android.
 
In the app ecosystem, while there continues to be an increase in the amount of time we spend using apps, the capacity for either Apple or Google to make this experience unique or vastly different from each other is very limited. In fact, mobile app developers themselves are keenly focused on creating a similar end-user experience regardless of the hardware device. They often lead with development on iOS - and Apple is the more lucrative source of revenue for developers - but that has limited applicability on the enterprise side.
 
2.) Enterprise Healthcare isn't bound by exclusivity
 
Apple may have a lot of big healthcare partners, but Munro argues that none of this partnership implies exclusivity.
 
Enterprise healthcare solutions looking to engage patients aren’t looking to generate revenue with mobile apps - and similarly - any app development they do is an enterprise cost associated with large IT budgets. This isn’t remotely comparable to an early stage software venture eager to impress venture capitalists with simple download and usage metrics.
 
3.) iPhones are expensive
 
When it comes to mass adoption who do you think will get their first? The iPhone which retails righ tnow at $649 and $849 respectively for the two versions of the new iPhone 6, or Android which boasts phones which can retail for under $200?
 
Do you agree with this assessment? Read the full article at Forbes.
 

Learn about the latest developments in wearbles and sensor technologies at MD&M Chicago. Oct. 15-16, 2014
 
[image via www.techvoize.com] 
 
-Chris Wiltz, Associate Editor, MD+DI
Christopher.Wiltz@ubm.com

How Google Could Transform Medtech—and Cheat Death

How Google Could Transform Medtech—and Cheat DeathUpdated December 9, 2015Google’s cofounders may have once downplayed that they’re interested in turning the tech giant into a healthcare company. But their company sure hasn’t been acting that way these days.While Apple has had some hiccups when it comes to its goals of becoming a go-to place for health tracking and data, Google has made waves with far more focused medical device innovations—not to mention an effort to reverse the effects of aging.Even Google Glass, better known as an accessory for creepy tech types before its initial version was retired, still turned out to be a pretty useful tool for surgeons—with Stanford University researchers extolling Glass’ benefits.Now Google’s foray into the life sciences has grown into a sister spin-off company called Verify, with details continuing to come out about new technologies in the works. The new structure, in which "moonshot" ventures such as Verify are separated from Google under the new Alphabet parent company, could give Google founders Larry Page and Sergey Brin more room to experiment, with investors less worried because Google is more sheltered from the risks. Verily’s mission is to “bring together technology and life sciences to uncover new truths about health and disease, according to the company's website.Read on to find out about the work Google (now consolidating its life science activities under Verify) has been doing.Continue>> Learn more about cutting-edge medical devices at MD&M West, February 9–11 at the Anaheim Convention Center in Anaheim, CA. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker. Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.Like what you're reading? Subscribe to our daily e-newsletter.

How Google Could Transform Medtech—and Cheat Death

Updated December 9, 2015

Google’s cofounders may have once downplayed that they’re interested in turning the tech giant into a healthcare company. But their company sure hasn’t been acting that way these days.

While Apple has had some hiccups when it comes to its goals of becoming a go-to place for health tracking and data, Google has made waves with far more focused medical device innovations—not to mention an effort to reverse the effects of aging.

Even Google Glass, better known as an accessory for creepy tech types before its initial version was retired, still turned out to be a pretty useful tool for surgeons—with Stanford University researchers extolling Glass’ benefits.

Now Google’s foray into the life sciences has grown into a sister spin-off company called Verify, with details continuing to come out about new technologies in the works. The new structure, in which "moonshot" ventures such as Verify are separated from Google under the new Alphabet parent company, could give Google founders Larry Page and Sergey Brin more room to experiment, with investors less worried because Google is more sheltered from the risks. 

Verily’s mission is to “bring together technology and life sciences to uncover new truths about health and disease, according to the company's website.

Read on to find out about the work Google (now consolidating its life science activities under Verify) has been doing.

Continue>>

Learn more about cutting-edge medical devices at MD&M West, February 9–11 at the Anaheim Convention Center in Anaheim, CA.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarkerBrian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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2014 Medtech Company of the Year Finalists: Vote

  See last year's
Manufacturer of the Year finalists 

2014 Medtech Company of the Year Finalists: Google

Google

 Google recently licensed its smart contact lens technology to Novartis.

Though Google's founders have expressed frustration with HIPAA and the current regulatory environment, that hasn't stopped the company from developing innovative technologies with health and medical applications.

While hipsters are using Google Glass as a fashion statement, forward-thinking doctors and clinicians are using the augmented reality device to perform surgeries during which they can interact with, train, and remotely monitor fellow surgeons and students. The company has also maintained a presence in the mobile health space with Google Fit (Google's answer to Apple's HealthKit), which will bring health and fitness apps to consumers via a variety of Android-compatible devices, including some forthcoming watches to be released by LG and Motorola, among others.

But what's most exciting about Google is its ability to think forward beyond even the consumer health space. In 2013, Google established a biotech R&D arm, Calico, that will focus on biotechnology and life extension. This year, the company licensed its smart contact lens technology, which can noninvasively monitor glucose levels, to Novartis, which will take up the task of commercializing the product. 

   

[image courtesy of GOOGLE]

2014 Medtech Company of the Year Finalists: Zimmer

Zimmer

 Zimmer's announcement that it would purchase crosstown rival Biomet was big news in April 2014.

Zimmer Holdings’s announcement this past April that it had agreed to purchase crosstown rival Biomet sent shock waves through Warsaw, IN, where both firms are located, as well as the orthopedic devices sector as a whole.

The $13.35-billion deal nixed Biomet’s planned initial public offering and will make Zimmer the second-largest orthopedic devices manufacturer by sales (after Johnson & Johnson) if the deal goes through as expected early next year. Both European and U.S. regulators are currently reviewing the merger.

By jumping on the consolidation bandwagon, Zimmer will increase the breadth of its product line (gaining a foothold in the fast-growing sports medicine space), cut costs by an estimated $270 million per year by 2018, and be better-positioned to resist pricing pressures as hospitals continue to tighten their belts.  

   

[image courtesy of ZIMMER]