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Articles from 2013 In June


How UDIs Can Make Device Companies More Innovative

The medical device industry has historically lacked a consistent system for tracking their products with standard unique identifiers. The need for such a system has been reinforced in recent years with the high-profile failures of metal-on-metal hip implants and ICD leads. In 2007, Congress approved legislation instructing FDA to implement a unique device identifier (UDI) system. Now, nearly six years later, such a tracking system is poised to go into effect soon, now that FDA has sent a final rule on UDIs to the Office of Management and Budget for review. So what will the import be for the device industry?

A UDI system has the potential to help medical device companies improve their entire ecosystem--both downstream and upstream, says Dave Medina, vice president of QAD Life Sciences. This fosters innovation because it enables them to gain a better understanding of their supply chain, helping them to gain a better understanding of how and where items are used across the ecosystem.

FDA is primarily concerned with the downstream element, which directly relates to patient safety. From a manufacturer's perspective, the downstream element also applies to brand protection and management. 

The upstream perspective applies internally to a manufacturer--not just from a compliance perspective for recall management but also to traceability, Medina explains. The upstream component includes components, supply chain, and visibility all across the line. In order to do that, you have to have the UDI system embedded in the business and manufacturing processes, Medina says. That enables the ability to track batches and lots forwards and backwards across the supply chain. It provides device companies another method of measuring the quality of components from suppliers.

The device industry has the tendency to view UDI as a labelling issue. By contrast, "we see it as an embedded process issue," Medina says. "Embedding it in the process simplify compliance while giving you a lot more functionality. If done correctly, UDIs can link you to your patient base on an individualized base, all the way back through to your quality processes."

"There is one perspective where you can say 'I have a device and I have a problem in a patient so I need to initiate a recall,'" Medina says. "If you think of it as a labelling issue, now you bring it back and have identified the device. For instance, if it is a nonconformance issue that has caused a problem with one patient, the next step is to look at the batch of related devices. 

"The other element is taking it all the way back," Medina says. The UDI that gets tracked to the manufacturing batch and lot enables the problem to be pinpointed. "Let's say I have a probe that was made from a bad batch of resin or there is an electrical problem. I need to have exposure to my components." A UDI compliance system would simplifies the process of going back to the components, raw materials, specifications, and deciding if the test specifications and design controls are in order. "With a holistic UDI perspective of embedding it into the process, you get to that information quicker," Medina says. "If you treat it as a labelling issue, then you view UDI as a label on a finished device. Although you can track the process, you don't get the same advantages."

The subject of UDIs will not be limited to solely the United States. The European Union has also recommended a UDI system, which would be harmonized across the continent. Similar to the U.S. requirements where companies are responsible for issuing their own UDIs, which would be included in a central database.

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

What Does It Take to Be a Top Molecular Diagnostics Firm?

Last month, our sister site IVD Technology (IVDT) published a ranking of the top 10 molecular diagnostics companies. Unsurprisingly, Roche Diagnostics led the pack, followed by Qiagen Netherlands (including Digene), and Becton Dickinson. 

This month, IVDT is back with an analysis of what made the molecular diagnostics firms on the list rise above the competition. 

Just 14 companies control 85% of the market for molecular tests, the site reports. To learn more about what it takes to grab a piece of the molecular diagnostics pie, read more on IVDT.

—Jamie Hartford

Chemical Resistance and Stress Cracking in Polyurethanes

The use of polyurethanes in medical devices continues to increase, owing to characteristics such as high strength, availability in a broad range of durometers, and bio- and hemocompatibility. Although the polyurethane family of polymers is often considered homogeneous, there are arrays of chemistries that dictate both the performance characteristics of each polymer and its individual resistance to degradation by various chemicals. This article discusses polyurethane benefits and challenges, and also provides a test case for a proprietary aliphatic polycarbonate (ALC) polyurethane. The test provides analysis for the material’s oxidation and alcohol absorption, as well as it’s resistance to environmental stress cracking.

 

Medical Device Recalls on the Rise

Figure 1. Recall rates in the United States have risen steadily.

The nature of the medical device manufacturing market requires companies to manage complicated product designs and adhere to a strict and sometimes burdensome regulatory oversight.  Included in this oversight is increasing regulatory scrutiny and low tolerance for medical device failures.  In response to this increased scrutiny, the rates of medical device recalls have been steadily rising in the United States (Figure 1).

While many of these failures occur when a device is used according to its instructions for use, manufacturers are still responsible for device failures when they are used off label or exposed to conditions that were not initially anticipated.  One of the ways in which medical device manufacturers can improve the robustness of their products is to work with materials that are reliable across a broad spectrum of chemicals that may be encountered during use of the device.

Major Classes of Polyurethanes for Medical Devices

Polyurethanes are plasticizer-free, segmented polymers comprising alternating soft and hard segments. In life science applications, the soft segments are typically formed from polyester, polyether, or polycarbonate diols with low glass transition temperatures. The soft segment provides flexibility to the polymers and allows them to forgo plasticizers. The hard segments are composed of high glass transition temperature aliphatic- or aromatic-based diisocyanates, linked by a diol chain extender of low molecular weight, and are responsible for the strength characteristics of polyurethanes.

The first polyurethanes used for medical applications were based around polyester chemistry.1,2 The polyester-based urethanes have excellent mechanical properties but are severely limited by their susceptibility to water hydrolysis and esterase degradation. In response to the poor water compatibility of polyester urethanes, polyether-based urethanes became more predominant for medical applications. Although the polyether urethanes are much more resistant to hydrolytic cleavage, they were found to be prone to oxidative degradation, resulting in cracking of the polymer when left in vivo for prolonged durations.1,3

The 3rd generation of polymers designed for life science applications were the polycarbonate soft-segmented polyurethanes. The polycarbonate urethanes combine the best of the characteristics of both polyester and polyether urethanes, with better hydrolytic stability than the polyesters and better oxidative stability than the polyethers.4

Aromatic, hard segmented urethanes are based on diisocyanates with benzene ring structures and possess the best mechanical properties, providing high tensile and burst strength, high melting points, and increased degradation temperatures. However, the aromatic polyurethanes are unstable in light and can yellow over time, giving the visual impression that the device is deteriorating or going bad. There is also concern over the use of aromatic polyurethanes due to the potential formation of carcinogenic compounds upon degradation. When the urethane linkage in aromatic polyurethanes is cleaved, carcinogens such as 4,4’ methylenedianiline can be formed.

In response to concerns over the degradation of aromatic polyurethanes, aliphatic polyurethanes have become more prevalent. The aliphatic polyurethanes have lower mechanical properties than their aromatic counterparts, but in medical applications, this loss is almost never sufficient to impact the integrity of the device. Additionally, aliphatic polyurethanes degrade to potentially safer end products and do not discolor upon exposure to light. However, along with the decreased mechanical properties, aliphatic polyurethanes are more prone to a physical degradation process termed environmental stress cracking (ESC) than their aromatic counterparts.

Environmental Stress Cracking

ESC can occur when a polymer is placed under tensile stress in the presence of an active chemical agent. The stresses can arise from multiple sources, many of which are difficult to identify and to control. Stresses on the polymer may be intrinsic due to arrangement of the hard and soft segments within the polymer, applied to the polymer in use, such as bending or kinking, or incorporated into the polymer during the manufacturing process, due to exposure to large temperature differentials over a short period of time.

Test Materials and Methods

Polyurethane tubing was loaded with 20% BaSO4 by weight, extruded with a 10 F outer diameter and a 0.030 in. wall thickness and cut to 4 in. lengths. A single 0.0625 in. hole was cut through one wall into the lumen at the mid-point of the tube and the tubing was bent in half with the hole on the outside of the bend. The folded tube was then inserted into a 0.5 in. long glass tube with a 0.03125 in. inner diameter to hold the bend in place.

Once secured, the tubes were immersed into 3 aqueous solutions at 50°C: basic 8M KOH, acidic 2M HCl, or neutrally buffered saline. The tubes were removed at 24-hour intervals, rinsed in distilled water, and allowed to dry for 24 hours before testing mechanical properties on an Instron Universal Material Tester.

Straight 4 in. lengths of tubing were also submersed into 100% isopropyl alcohol or ethanol at 37°C. The tubes were then removed from the alcohol solutions at the indicated time points and weighed after blowing the alcohol from the surface and lumen of the tube.

Chemical Degradation of Polyurethanes

Figure 2. Mechanical properties for all tubes were consistent when immersed in hydrochloric acid. 
Figure 3. In a neutral saline solution, tubes softened, but did not lose tensile strength.
Figure 4. Rapid degradation was seen in tubes under exposure to alkaline chemicals, except for the proprietary formula.

Polyurethane polymers undergo degradation by a number of chemical methods, with hydrolysis and oxidation acting as the predominant mechanisms of decomposition for in vivo applications. We analyzed the performance of several aliphatic polycarbonate (ALC) urethanes, including Parker Hannifin’s proprietary formulation and two commercially available formulations. For comparison, we also tested the chemical resistance of two aliphatic polyether (ALE) formulations. The ALC and ALE urethanes were loaded with 20% barium sulfate and extruded to a 10 F outer diameter with a 0.030 in. wall thickness. These tubes were then kinked to create a stress riser and exposed to acid, alkaline, or saline solutions at elevated temperatures. These conditions were chosen to cover a comprehensive array of chemical exposures that are commonly encountered with in vivo use of polyurethane medical devices.

Immersion of stressed tubes in hydrochloric acid revealed that most tubes experienced little decrease in tensile strength over time. Many of the materials softened after immersion, but this softening is expected from hydrated urethanes and can actually serve to improve patient tolerability of medical devices that are implanted or inserted. Most importantly, all tubes from the ALC and ALE classes maintained their mechanical properties well above a range that would indicate potential device failure in most applications (Figure 2).

 
Figure 5. After exposure to potassium hydroxide, stress cracks formed.
 
Figure 6. A potassium hydroxide solution caused discoloration in the test samples.

Samples immersed in a neutral saline solution showed similar results to those seen with the tubes exposed to acid. Many of the tubes softened from their initial pull strengths but again maintained tensile strengths well above those required for most devices (Figure 3).

On exposure to alkaline conditions, however, shortcomings in ALC compatibility began to manifest. As seen in Figure 4, most ALC urethane tubes are prone to rapid degradation when exposed to alkaline chemicals. Most of the ALC formulations quickly degraded and ultimately failed before 5 and 7 days. Parker Hannifin’s proprietary ALC formulation, however, showed no significant change after initial softening over the course of the testing.

Visual inspection of the competitive ALC tubes revealed that stress cracks formed as early as 24 hours after exposure to potassium hydroxide (Figure 5). Environmental stress cracks, once formed, are known to propagate rapidly if the tube remains exposed to the active chemical environment. As is evident from the photos, even a small amount of cracking can result in loss of material. Depending on the application of the device, the loss of this material while the device is in a patient could result in serious complications. While the other ALC polyurethanes begin degrading under alkaline conditions immediately, Parker’s proprietary ALC polyurethane withstood the exposure, showing no major stress cracking over the duration of the test.

As expected under conditions where hydrolytic degradation predominates, the polyether ALEs showed no significant decrease in tensile strength in any of the solutions tested. However, in the potassium hydroxide solution, discoloration and yellowing of the tubes was observed (Figure 6)

While the relative resistance of polyethers to hydrolysis is well known, their degradation under oxidative conditions can be a limiting factor for in vivo applications. In addition to this potential limitation to their use, polyether urethanes are also less compatible with alcohols than their polycarbonate counterparts.

Swelling of Polyurethanes Due to Alcohol Exposure

Figure 7. In comparing polyether polyurethanes and polycarbonate soft segment urethanes, notice the rate of swelling in alcohols. 

Polyurethane medical devices can be exposed to alcohols in day-to-day use. This exposure can be short, such as through simple wipe down, or can be prolonged, such as with complete immersion. Many hospitals are now recommending the use of ethanol locks with central venous and peripherally inserted central catheter (PICC) lines to prevent catheter-related bloodstream infections. To perform an ethanol lock, a 70% or higher solution of ethanol is introduced throughout the entire length of the catheter and allowed to dwell for time periods that can exceed 2 hours. Ethanol locks are gaining in popularity due to their simplicity, effectiveness, and the dual antimicrobial and fibrinolytic protection they provide for catheters.

Performing an ethanol lock is an especially harsh exposure for polyurethanes as the entire length of the catheter is submersed in a highly concentrated ethanol solution at 37°C. Certain polyurethanes are more susceptible to swelling when submersed in alcohols. Polyether polyurethanes absorb alcohols quickly and significantly when compared to polycarbonate soft segment urethanes (Figure 6). This rapid absorption also results in swelling of the device both radially and longitudinally.

Figure 8. Again, swelling and absorption are seen with polyether urethanes at a quicker rate than with the polycarbonates.

As seen in Figure 7, the polyether-based ALE-based urethanes absorb ethanol much more rapidly and to a greater extent than do the aliphatic polycarbonate-based urethanes. Within 1 hour, polyether urethanes absorb approximately 60% of their weight in ethanol and almost 70% by 2 hours. Conversely, the polycarbonate urethanes absorb only approximately 20% of their weight at both 1 hour and 2 hours. After the 2-hour time point, both the ALC and ALE urethanes did not absorb much more alcohol through 72 hours. Reaching this peak absorption at 2 hours is particularly noteworthy for venous catheter applications, as this is a commonly recommended ethanol lock dwell time in hospitals.

Direct exposure to isopropyl alcohol (IPA) by submersion is rare, but IPA is one of the more common cleaning agents used to sanitize medical devices. The polyether urethanes again swell much faster and absorb IPA faster than the polycarbonate urethanes (Figure 8).

In only 15 minutes, over 10% IPA by weight is absorbed into the ALE polymer. Care should be exercised in choosing a urethane if it is known that the device will be exposed to IPA, and especially if devices will be exposed to IPA over multiple cleaning sessions.

Conclusion

Deciding which polyurethane formulation to use for a medical application is a multifaceted challenge and requires consideration of many factors. Details such as the desired mechanical properties of the end polymer to the chemicals that the device will encounter should be taken into account to ensure the product will perform its intended function over its entire lifespan. In addition to these factors, the inherent stresses within the material and external stresses that may be placed upon the material during use may also factor into the material considerations. Parker Hannifin has developed an aliphatic polycarbonate polyurethane. Its proprietary formulation delivers consistent performance through a wide range of chemical exposures and provides improved stability when the material is placed under external stress.

References

  1. K Stokes, R McVenes, and JM Anderson “Polyurethane Elastomer Biostability,” Journal of Biomaterials Applications 9 (1995): 321–54.
  2. GT Howard “Biodegradation of Polyurethane: A Review,” International Biodeterioration & Biodegradation 49 (2002): 245–252.
  3. K Stokes and MW Davis “Environmental Stress Cracking in Implanted Polyurethane Devices,” Advances in Biomedical Polymers (1987): 147–158.
  4. RJ Zdrahala and IJ Zdrahala “Biomedical Applications of Polyurethanes: A Review of Past Promises, Present Realities, and a Vibrant Future,” Journal of Biomaterials Applications 14 (1999): 67–90.

Arlo N. McGinn, PhD, and Val C. Comes are senior chemists for Parker Engineered Polymer Systems (EPS).

Is 3M Being Audited By the IRS For Its Medical Device Tax Payments?

Is 3M Being Audited By the IRS For Its Medical Device Tax Payments?

[Story has been updated by comment from AdvaMed]

Reporters loathe mysteries, and I am no exception to the rule.

On Monday, Debra Rectenwald, President and General Manager, 3M Infection Prevention Division, appeared as a panelist at an event hosted by LifeScience Alley in Minnesota, and made this startling admission when the topic of the 2.3% medical device tax arose: 3M was being audited for its medical device tax payments. Rectenwald was part of a panel in which two Minnesota startup CEOs participated with AdvaMed President and CEO Stephen Ubl playing moderator.

Wow, I thought. I suppressed my initial desire to tweet the information. I thought this was a story that needed a little more context and elaboration. I let a few days slide as I wrote other stories based on an interview that Medtronic CEO Omar Ishrak gave on-stage at the same event following the panel in which Rectenwald spoke.

On Thursday, I was still a bit stunned by the revelation and decided I want to check with co-panelist to make sure my ears weren't lying. So I contacted John Dinusson, CEO of OrthoCor Medical who sat next to Rectenwald as she spoke Monday. Dinusson confirmed that he had also heard the same thing - that 3M was being audited. 

So I contacted 3M spokeswoman Jacqueline Berry to know when the company was informed of an audit and what 3M is doing to resolve the situation. Berry called back and said simply: "I contacted the tax department and we are not under any audit."

I was stunned. She ventured that Rectenwald was probably referring to a first-quarter regulatory filing that 3M made informing the public about the new tax and the potential for future audits. Rectenwald was traveling and Berry said she would try and get a comment from her. I asked Berry if she could send me the filing.

She later told me that the document she was referring to wasn't a public document. In other words, I couldn't take a look at it.

I contacted AdvaMed's Stephen Ubl, but he did not respond. The group's spokeswoman, Wanda Moebius, said, "We've said all along that the tax is burdensome. But we can't comment on an individual company's situation."

I then turned to tax experts. If the mystery of 3M can't be resolved, perhaps they could say whether the device industry would see a several companies get audited because of the new 2.3% tax.

Ori Epstein, a tax manager at Habif, Arogeti, & Wynne’s technology and biosciences practice, said that there are two ways a company can get audited - an excise tax audit and an income tax audit. In an email, he went on to say: 

While one type of audit can lead to the other, the current audit rate for companies is around 1% and I would be very surprised to hear that companies were being selected for income OR excise tax audits simply because they had begun filing excise tax returns.

However, he did say that tax is complex and can result in confusion. Here are three examples of what can perplex device makers, Epstein explained:

Responsible Party Determination - Determining who is responsible for paying the tax is very confusing and has caused a great deal of dialogue between medical device companies and their customers. People are intuitively thinking about the medical device excise tax as a sales tax.  In reality, it is more like a reverse sales tax.  Essentially the tax is assessed at the lowest price point: manufacturer to distributor, for example.  

Taxable Product - Another area driving confusion is what device is actually taxable.  The IRS regulations refer to the FDA registration database.  At the same time, the regulations also provide exemptions for specific devices (e.g. hearing aids, eyeglasses) and devices that qualify for the “retail exemption”.  For example, a pacemaker device would be taxable, but latex gloves may not be taxable.  This is a very simple example of  a very confusing aspect of the medical device tax.

Many companies assume that the medical device tax only applies to tangible devices.  However, many software companies are subject to the tax on their license fees when the software is regulated by the FDA. Take, for example, a company that  produces imaging software that is required to be registered with the FDA as a medical device. Although the related equipment used to run the software may not be a registered medical device, the registered software is considered a taxable medical device.

I look forward to a chat with Rectenwald to clarify whether 3M is being audited in relation to its device tax payments. Meanwhile Epstein says companies need to ensure that they register with the IRS, make their semi-monthly payments to the agency and work with a qualified CPA to make sure that they are in compliance, to avoid being audited.

Whether 3M is being audited or not, its pretty clear there is confusion over the device tax and many companies could soon be under IRS scrutiny. 

[Photo Credit: iStockPhoto.com user VCTStyle] 

 —By Arundhati Parmar, Senior Editor, MD+DI

Russia's Medtech Market

In 2011, Russia had the world’s ninth largest GDP and the highest per capita spending on healthcare of all the BRIC countries.[1] In sheer size, it is the largest of the BRIC countries, covering nine time zones and 17 million square miles. Russia is an upper middle class country with a highly educated workforce and a population of roughly 143 million discerning consumers.[2]
 
 Data from the Lighthouse Group shows the breakdown of Russia's medical device market by segment in 2010. 
The Russian market for medical equipment and supplies is estimated at $6 billion. This puts the country's healthcare market among the top 20 in the world, although per capita spending remains low by European standards, at around $42.3 About 73% of the market is supplied by imports, with Germany, the United States, Japan, and China the leading suppliers. The value of imports greatly increased until 2008, when the country was hit hard by the global recession. The Russian market, however, remains strongly reliant on products from abroad, as domestic producers are small and undercapitalized.
 
Regulatory Climate
The Russian healthcare system is divided into national, regional, and municipal levels. The national government controls the budget, policy, and registration of technologies, while regional and municipal governments have control over their facilities and budgets.
 
Since 1996, the Russian government has provided free healthcare to all its citizens under the Mandatory Medical Insurance Initiative.[5] The national government collects taxes and distributes funds to the regional and municipal levels through Mandatory Health Insurance funds. This covers about two-thirds of the cost of procedures. To make up the difference, Russian citizens also have access to voluntary health insurance and private medical care. This system continues to evolve.
 
In 2010, the government implemented the Strategy 2020 initiative to attract investment, create jobs, produce safe and effective products, and reduce the country's dependence on foreign healthcare products to a maximum of 50% by 2020.[4]
The Russian health agency responsible for medical devices, Roszdravnadzor, recently published new regulations for medical devices.[6] The regulations took effect January 1, 2013, and have only been published in Russian, so the rest of the world is trying to figure out just what the changes consist of for the industry. However, allegations of bribery by senior officials and the resulting review of past medical device registrations has put new medical device registrations on hold at Roszdravnadzor, furthering the country's image as being opaque and corrupt when it comes to healthcare policies and practices.7
 
Challenges
 
The Russian market is full of potential for medical device manufacturers, but it also poses a number of challenges.
Size and Infrastructure. Russia is a large country, but it has a seriously underdeveloped infrastructure that poses significant challenges to market access, particularly outside major cities.
 
  • Strategy 2020. The high level of imports has fueled the government’s plan to attract healthcare investment, including jobs and manufacturing, via the Strategy 2020 initiative. It is intended to boost innovation, accelerate start-ups, sustain R&D into the future, and open Russia and other international markets to newly developed healthcare products.[4]
  • Healthcare Reform. An incomplete transition from national to regional and municipal oversight of healthcare delivery has also led to poorly implemented delivery across the nation. The old communist ideal of healthcare equality for all is a good theory. However, inefficiencies and corruption abound, and life expectancy is decreasing, so further reform must occur.[8, 9] Unfortunately, it looks like the Russian government is going to cut its healthcare budget and require citizens to pick up the tab on services not covered by the compulsory health insurance standard package.[10]
  • Corruption. Recent issues associated with senior-level bribery have led to significant turnover at Roszdravnadzor, the Russian health agency. At the moment, Roszdravnadzor remains closed while staff is replaced and all past medical device registrations are reviewed.
 
Opportunities
  • An Underserved Market. Russia has 143 million people and a wealth of natural resources. The population is driving the demand for affordable and sophisticated healthcare technologies. As mentioned previously, the Russian market is supplied primarily by imports, and the Strategy 2020 initiative will stimulate R&D and the addition of manufacturing operations within Russia to supply the country’s needs. But even if Strategy 2020 is successful, demand will continue for leading-edge healthcare technologies that Russia will likely not be able to supply itself.

  • Expanding Infrastructure. As rural cities become better connected through improvements in infrastructure, access to rural healthcare markets will increase. In addition, overall healthcare spending, as well as per capita spending, will increase in Russia.

  • Challenges Become Opportunities. The current shake-up in Roszdravnadzor could ultimately lead to less corruption, more transparency and even application of law, and an overall improvement in the healthcare sector of the Russian market.
 

Conclusion

That Russia has the highest per capita healthcare spending of all the BRIC countries indicates that there is money available for healthcare opportunities in the country. While the majority of Russia's healthcare needs are supplied by imports, the country is enacting initiatives to stimulate internal R&D and manufacturing inside its borders. Outsiders looking to invest in the Russian market may find growth opportunities in the country's large, underserved population and expanding infrastructure. However, corruption and lack of transparency at the regulatory level could hinder innovation.
 
 
References
1. World’s Largest Economies, [online] (Atlanta, GA: CNN Money, 2013); available from Internet: http://money.cnn.com/news/economy/world_economies_gdp/.
2. Doing Business in Russia: 2013 Commercial Guide for U.S. Companies, [online] (Baltimore, MD: Export.gov, 2003]; available from Internet: http://export.gov/russia/doingbusinessinrussia/index.asp.
3. The Medical Device Market: Russia, [online] (New York, NY: Reportlinker.com, 2013) available from Internet: www.reportlinker.com/p0203014/The-Medical-Device-Market-Russia.html.
4. Norbert Sparrow, “Russia Seeks Parity with Medtech Economies by 2020” in medtechinsider [online] (November 2011); available from Internet: http://medtechinsider.com/archives/25933.
5. Russian Healthcare System Overview, [online] (Community of Practice); available from Internet: http://cop.health-rights.org/files/f/6/f68e677a2e9b501660f093c5c11b62a3.pdf.
6. “Russia Introduces New Medical Device Regulations” in QMed [online]; available from Internet: www.qmed.com/news/russia-introduces-new-medtech-regulations.
7. Stewart Eisenhart, “Staff Shakeup Underway at Russian Medical Device Regulator”[online] (Austin, TX: Emergo Group, May 2013); available from Internet: www.emergogroup.com/blog/2013/05/staff-shakeup-underway-russian-medical-device-regulator.
8. Maria Danilova (Moscow Times), “Despite Oil Wealth, Russia Faces Huge Health Care Problems” in New York Times [online]; available from Internet: www.nytimes.com/2007/06/28/business/worldbusiness/28iht-russhealth.4.6394606.html?_r=0.
9. Boris A. Rozenfeld, “The Crisis of Russian Healthcare and Attempts at Reform” [online] (Santa Monica, CA: Rand Corporation) available from Internet: www.rand.org/pubs/conf_proceedings/CF124/CF124.chap5.html.
10. Varvara Petrenko, “Russian Authorities Plan to Cut Health Spending in 2013” in Russia & India Report [online] January 2013; available from Internet: http://indrus.in/articles/2013/01/15/russian_authorities_plan_to_cut_health_spending_in_2013_21635.html.
 
 
Joel Gorski is director of R&D at NAMSA Inc. (Northwood, OH). He has been on the AAMI board of directors since 2006 and served for more than 15 years on the NAMSA board of directors. He has been a member of the MD+DI editorial advisory board since 2006. Contact him at joelgorski@namsa.com. 

This Week in Devices [6/28/13] : Could We Conduct Clinical Trials on Artificial Humans?

Every week MD+DI curates content from all over the Web to share some of the most interesting articles, longreads, and videos with the medical device community.

This week: The ethics of building a functional brain inside a computer. The escalating battle against Lyme disease. The resurgence of research into psychedelic drugs. Saving lives with cells from aborted fetuses. And a crowdfunding campaign to create a robotic, 3-year-old boy.
 
 
 
Would it be Evil to Build a Functional Brain Inside a Computer?
 
As Obama's BRAIN initiative gears up along with the $1.6 billion Human Brain Project in the UK, an examination of the ethics of creating artificial humans and using them for testing and trials [io9]
 
"Lyme disease is the most commonly reported tick-borne illness in the United States, and the incidence is growing rapidly. In 2009, the C.D.C. reported thirty-eight thousand cases, three times more than in 1991. Most researchers agree that the true number of infections is five to ten times higher. "
 

The Lyme Wars
 
As Lyme disease infections grow, the battle against the disease escalates [The New Yorker]
 
"Lyme disease is the most commonly reported tick-borne illness in the United States, and the incidence is growing rapidly. In 2009, the C.D.C. reported thirty-eight thousand cases, three times more than in 1991. Most researchers agree that the true number of infections is five to ten times higher." 
 
Psychedelic Academe
 
Research into psychedelic drugs is making a comeback. [Chronicle of Higher Education]
 
"You don't have to spend much time at the six-day second international Psychedelic Science conference in downtown Oakland to learn that not all its 1,900 attendees are academic scientists, and that few are strangers to the power of mind-bending drugs."
 
Cell Division
 
The history of the controversial WI-38 cell strain, which has arguably saved more lives than any other...but is also harvested from aborted fetuses. [Nature]

"The woman was four months pregnant, but she didn't want another child. In 1962, at a hospital in Sweden, she had a legal abortion. The fetus — female, 20 centimetres long and wrapped in a sterile green cloth — was delivered to the Karolinska Institute in northwest Stockholm. There, the lungs were dissected, packed on ice and dispatched to the airport, where they were loaded onto a transatlantic flight. A few days later, Leonard Hayflick, an ambitious young microbiologist at the Wistar Institute for Anatomy and Biology in Philadelphia, Pennsylvania, unpacked that box."
 
Building a Robot with the Intelligence of a 3-Year-Old
 
A team of researchers have started an Indiegogo campaign to create the world's smartest robot. Dubbed Adam Zi, the robot will have the intelligence level of a 3-year-old child. [io9]


"Hanson Robotics has launched a new Indigogo campaign to create "the world's smartest robot." Named Adam Z1, the robot will eventually be able to speak, play with toys, draw pictures, and respond with emotions." 

Irvine Remains Attractive for NAMSA

Southern California is one of the more desirable hubs for life sciences, with a combination of large cities such as Los Angeles and San Diego and suburban enclaves. One of the many attractive locations is Irvine, a city of over 220,000 people that houses large companies such as Masimo and Edwards Lifesciences.

When NAMSA opened a lab there in 1977, there was no way to imagine the city would become as large as it is now. Gina Skolmowski, NAMSA’s vice president of operations, moved to the city in 1998 and lived there for seven years. “I’ve watched it grow tremendously in that short amount of time,” she says.

The company’s specialty since it was founded 45 years ago in Northwood, OH, includes sterility assurance and biocompatibility. They work with a variety of medical device manufacturers from large industry leaders to small start-ups.


NAMSA is also expanding in Irvine, growing their laboratory facility by 20,000 sq ft, growing the usable capacity by nearly 50%. The company is growing many of its facilities, as there is an increase in demand for in sterility assurance and analytical services. Skolmowski says that, with FDA looking at more information on materials and their characterizations, not to mention how they are used in medical devices, the demand for these services are growing.

“As more and more information becomes available, it leads them to ask more and more questions,” Skolmowski says. “That seems to be driving more characterization data.”

Irvine is one of NAMSA’s laboratory facilities throughout the world, which include two labs in the Minneapolis area and one in Lyon, France. It has additional offices throughout the world, including in China, Japan, and Germany.

Irvine is a planned suburban community in Orange County, central to both the greater Los Angeles and San Diego areas. It is known for being a strong business hub, with headquarters for a variety of industries, including life sciences. It also has a pool of talent coming from advanced learning institutions such as the University of California, Irvine.

One of the biggest improvements that NAMSA has taken on in the Irvine expansion is the U.S. Green Building Council’s Leadership in Energy and Environmental Design, or LEED, standards. NAMSA built their facility to fit a silver qualification, and although the company didn't seek the ranking and the improvements don’t relate to the services that the supplier offers, Skolmowski says that the company feels that it’s important to be environmentally conscious.

“We considered those factors in the building of that facility, and the building activities that occurred with that facility,” she says.

As for the future, NAMSA intends to keep playing to its strengths, as well as expand several of their other laboratory facilities, including the location in Lyon. They also expect to hire additional staff, as there is more work to be had in the expansion.

Reina V. Slutske is the assistant editor for MD+DI.

MD+DI's Most Popular Content in June 2013

Here's a list of the articles that resonated with our readers this month.

MDEA 2013 Winners 
The winners of the Medical Design Excellence Awards competition, sponsored by MD+DI, were announced earlier this month at the MD&M East conference and exposition in Philadelphia.

10 People Who Changed the Medtech Industry
We highlighted the people who have had a lasting impact on the medical device industry—for better or worse.
 

Widespread Layoffs Leave MedTech Professionals Shaky on Job Security
Sizable layoffs this year from the likes of Medtronic, Boston Scientific, and Abbott Vascular, among others, have undeniably rattled the medical device industry. But to what degree?
 

Will Masimo's Million-Dollar Gamble Pay Off? Covidien Doesn't Think So
Masimo has raised the stakes in its escalating pulse oximetry-focused feud with competitor Covidien. And the game is beginning to get interesting.
 

The Asia-Pacific Medtech Market Will Grow 10% Over the Next 3 Years, Mostly in Cardio
The Asia Pacific market is valued at $55 billion, about a quarter of the total $230 billion medtech market.
 

The Medical Device Market in China
Demand for quality healthcare from a growing middle class and aging population will continue to create opportunities for medtech entrepreneurs.

MDEA 2013 Coverage
Full coverage of the Medical Design Excellence Awards, the premier awards program honoring advancements in medical product design and engineering.
 

CEO of American Medical Device Company Held Hostage in China
Chip Starnes was held captive for six days by workers at Specialty Medical Devices’ Beijing factory who were demanding severance packages. 

T:Slim Insulin Pump from Tandem Diabetes Wins MDEA Readers' Choice Award
Apple-inspired design, including a color touchscreen, helped the Tandem Diabetes' product come out on top in our Readers' Choice poll. 
 

Boston Scientific, Other Employers Win As Supreme Court Strikes Down Defense of Marriage Act
Boston Scientific was among more than 270 employers who filed an amicus brief arguing that DOMA should be ruled unconstitutional. The Supreme Court struck down the law on June 26, 2013. 

Boston Scientific Buys C.R. Bard's Electrophysiology Business

Boston Scientific Buys C.R. Bard's Electrophysiology Business

Boston Scientific announced Friday that it is acquiring the electrophysiology business of C.R. Bard for $275 million in cash.

The company expects the transaction to close in the second half of the year.

Based in Lowell, Massachusetts, Bard EP had sales off $111 million in 2012, and has 180 employees. The division makes advanced therapeutic catheters, diagnostic catheters, electrophysiology recording systems and intracardiac access devices. 

In a news release, Boston Scientific said that the global electrophysiology market is worth $2.5 billion and growing at a 10% clip annually.

"We expect this acquisition to accelerate the expansion of our global electrophysiology business and we are pleased to welcome Bard EP to the Boston Scientific team," said Mike Mahoney, president and chief executive officer, Boston Scientific.  "We believe the innovation and global reach that Bard EP delivers will meaningfully advance our position in this fast-growing market, enabling us to more effectively serve the needs of patients who suffer from cardiac arrhythmias."

In a research note issued after Boston Scientific's announcement Senior Analyst Glenn Novarro with RBC Capital Markets wrote that the acquisition gives "BSX a bigger presence in the EP market, which is one of the fastest growing markets within medtech" increasing at around 10% per year.

Novarro added:

Bard EP’s business generated sales of $111M in 2012 which were actually down in 2012 but we believe BSX will be able to better direct their attention and resources toward achieving stronger growth. Bard’s portfolio is very complimentary to BSX and there’s not very much overlap

By Arundhati Parmar, Senior Editor, MD+DI

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Patent Wars: The University of Minnesota and AGA Medical’s Clash Over Septal Occluders

Since medical device related patent applications often describe multiple inventions, the parent applications often are divided into several subsequent patents, each describing a particular invention. When the inventions described in a parent patent application are divided into multiple subsequent patent applications, the use of previous disclaimers of scope to overcome subsequent prior art anticipation allegations will not be effective unless there is a substantial similarity among the patents’ claim limitations.

Among other issues reviewed, in Regents of the University of Minnesota v. AGA Medical Corporation, the US Court of Appeals for the Federal Circuit held on June 3, 2013 that “a prosecution disclaimer will only apply to a subsequent patent if that patent contains the same claim limitation as its predecessor.” With this in mind, this recent decision affects how applicants and attorneys can cross-pollinate disclaimers among the various patent family applications.

The University of Minnesota owned US patent 6,077,281 (the ‘281 patent) directed to septal occluders for blocking holes in the septum and repairing the heart. As a defense to allegations of infringing the ‘281 patent, AGA Medica

AGA Medical argued that the ‘281 patent was unenforceable because it was invalid as being anticipated by prior art patents. The ‘281 patent used a means-plus-function style claim with the function of “moving the member from a compressed orientation to an expanded orientation.” For purposes of such a means-plus-function claim, “an equivalent of the described structure merely performs the same function as the disclosed structure, in substantially the same way, with substantially the same result.”

AGA Medical alleged that a prior art patent had a springy “radial” frame that indeed performed the same function, insubstantially the same way, with substantially the same result as that described in the U of M patent.
In response, the University argued that during examination of its prior patent in the same family, it specifically disclaimed the use of a radial frame as an equivalent of the peripheral frame. This disclaimer was effective to overcome a prior art rejection in this prior patent. However, the relevant claim in this prior patent did not include a means-plus-function element as does the ‘281 patent. Moreover, the basis for distinguishing the prior art in the prior patent was not the same as how this new prior art is being applied to the ‘281 patent. And, the scope of the ‘281 patent is not the same as the claim in the prior patent.

For these reasons, the court decided that because the language in the later ‘281 patent claim was significantly different from the prior patent, the disclaimer did not apply. Accordingly, in order for disclaimers to carry over to subsequent patents, it is “necessary to support the inference that the patentee’s earlier arguments are also applicable to the claim limitations of the patent-in-suit.”

Clark A.D. Wilson is a Partner at the Atlanta, Georgia based Intellectual Property law firm Gardner Groff Greenwald & Villanueva PC. Prior to joining Gardner Groff, Clark was a corporate Patent Attorney for a medical device unit of Novartis. Clark holds a Master of Engineering (M.Eng.) in Bioengineering from the University of Maryland and is Board Certified in Intellectual Property law by the Florida Bar Association.