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How Can You Ensure that Your Device Is Sterile?

Sterility assurance is necessary for guaranteeing microbe-free medical devices. But to achieve it, how many devices do you really need to test?

By Bob Michaels

To determine the probability that a sterilization process will sterilize a device successfully, the medical device industry relies on a statistic known as the sterility assurance level (SAL). The standard recommended SAL is 10-6--meaning that there is a one in a million probability that a single microorganism will survive on a medical device after sterilization. But is 10-6 always appropriate or necessary? Maybe not, says Martell Winters, senior scientist at Nelson Laboratories (Salt Lake City). Winters will be speaking on this topic at the upcoming MD&M Texas and MD&M East events.

What Is SAL?

Sterility test bottles, some with obvious microbial growth and some without.

"The need for sterility assurance arises from the fact that if I sterilize a batch of products and then test 20 of them to determine whether they are sterile, the lack of microbial growth on any of them indicates only that these 20 devices are sterile," Winters explains. "I cannot take this information and apply it to the rest of the devices in the batch because the products that I have tested have all received the same sterilization cycle." This information could be applied to the rest of the batch only if all of them were tested, which would leave no products available for sale.

Rather than testing all the devices in a batch, validations for any type of sterilization process--including radiation, ethylene oxide (EtO), hydrogen peroxide, or steam--involve performing sterility testing on products after a short cycle--also known as a fractional cycle, half cycle, or, in the case of radiation, a verification dose. If short-cycle sterility testing passes, a longer cycle is used to sterilize more of the products. In radiation sterilization applications, a verification dose represents a dose in which one nonsterile sample is expected out of the total number of samples tested, which usually amounts to either 10 or 100 samples.

"Let's say that I take a radiation dose and say that it should be a good 10-6 dose," Winters comments. "It should provide a one in a million probability of having a nonsterile product." Instead of testing one million devices to ensure that only one is nonsterile, a low dose can be performed that is closer to 10-1 or 10-2. In such cases, there will be a one in 10 or a one in 100 probability that a sample will be nonsterile. "It is easier to test 10 or 100 samples than many more samples," Winters says. "If we apply a low dose and get the proper number of positives, which is usually one sample with microbial growth, we can extrapolate that a higher dose will provide a one in a million probability of microbial growth, or the standard target of 10-6 SAL. This is the basis of sterility assurance." Although the testing approaches for radiation and other sterilization methods differ somewhat, the concepts are the same.

Why 10-6? For years, 10-6 has been the standard sterility assurance level, according to Winters. An arbitrary number, it was not the result of scientific research. Nevertheless, everyone eventually adopted it for the purposes of assuring medical device sterility. A thorough review of the history of SALs can be found in ANSI/AAMI ST67:2011, Annex A.

But things are changing. With the emergence of devices that are more sensitive to sterilization processes, there has been a growing desire in the medical device community to understand statistically which SAL is necessary to ensure patient safety. Based on actual inspection data--data derived from patients that underwent surgical procedures resulting in infection--the Centers for Disease Control have learned that sterilized single-use devices do not cause infections in patients. Rather, hospital personnel, surgical procedures, or reusable medical devices are generally the culprits. Thus, it would appear to be unnecessary to always hold single-use devices to the 10-6 standard.

"Based on these data, my colleagues and I were able to determine that under the right circumstances, altering the sterility assurance requirements for medical devices would not start to impact patients until about 10-4, or one in 10,000," Winters remarks. "And even then, it isn't really until 10-3, or one in 1000, that the potential to impact patients begins to increase significantly. Thus, while 10-6 is not always necessary from a data standpoint, it is generally necessary at this time because this is what people expect. These concepts are developed in two papers by Sopheak Srun and colleagues."

Shortening Sterilization Cycles

A sterility test being performed on aseptically processed bone.

With the emergence of more-complex and innovative devices, the need has arisen to create flexible and innovative sterilization opportunities. For example, because medical devices containing biologics, drugs, or specialized polymers can be too sensitive to be sterilized to 10-6 SAL using a single type of sterilization, companies sometimes have no choice but to subject them to aseptic processing. When they are aseptically processed, all the parts that comprise the device are sterilized in different ways, and then the device is assembled aseptically, Winters remarks. However, setting up a full-scale aseptic process and validating it properly costs on the order of millions of dollars. Because of the setup costs and the great deal of testing involved, it's often so expensive that it inhibits products from coming to the market.

"We don't want companies to develop innovative medical devices and then find that they cannot be sterilized because one or another component might be sensitive to sterilization," Winters notes. "Moreover, we don't want devices to become so cost-prohibitive through aseptic processing that they have to be scrapped. Thus, we are trying to help medical device manufacturers understand that they have options." One such option for shortening sterilization processes and making it easier for companies to use them is to validate alternative SALs, such as 10-4 instead of the current industry standard of 10-6. Currently the only standard that provides information on this approach is ANSI/AAMI ST67: 2011. However, the International Organization for Standardization is currently considering developing a similar standard for international use.
 

Bob Michaels is senior technical editor at UBM Canon.

bob.michaels@ubm.com

When Medical Device Companies Bend the Rules

When Medical Device Companies Bend the Rules

What don't medical device makers do because they have figured out how to get away with not doing it?

By William A. Hyman

Back in the ancient days of 2006, I wrote a commentary in MD+DI entitled “What Wouldn’t You Do If FDA Didn’t Make You?” That piece arose from the multiple times I had heard medical device professionals and researchers suggest that they would take a faster (i.e., riskier) course if not for FDA stopping them or, perhaps, catching them.

Learn how to avoid regulatory pitfalls with early clinical involvement at MD&M Texas, May 7–8, 2014, in Fort Worth, TX.

My favorite example comes from the artificial heart arena. A presenter at a national conference said, “We would be implanting these today if FDA wasn’t making us prove that it was safe and effective.” This perhaps implied that safety and efficacy are not of fundamental concern to the developers—or at least not of sufficient concern to actually acquire proof. Perhaps this comment is at the cusp of the regulatory debate: Too much regulation stops some devices from reaching the public, but too little regulation can allow bad devices to reach the public.

I have heard and seen medical device professionals use and advocate strategies to reduce FDA scrutiny of their devices and processes, and thus improve their marketing opportunities while not necessarily improving their products. This can take the form of a do-as-little-as-possible attitude, coupled with not being forthcoming about the true nature of their medical device’s issues.

The no-510(k) rationale for device changes offers an example. This scenario arises when manufacturers make a change in their 510(k)-cleared product and must decide whether that change requires a new 510(k) and if so what kind. The use of the no-510(k) rationale can cover a spectrum from forthright, honest, and probably correct to “What do we have to argue to get away this?”

FDA regulations and guidances address this question, notably in the 1997 “Deciding When to Submit a New 510(k) for a Change in an Existing Device Guidance Document.” While nominally formulaic, the questions actually require a great deal of local interpretation. If the decision to seek a new 510(k) is made, then the manufacturer proceeds with the 510(k). If the manufacturer decides not to seek a new 510(k), it writes a memo explaining its rationalization, in effect explaining its rationale to itself because that memo does not go to FDA. FDA did propose in a 2011 draft guidance that it be notified of such a change, but that draft was withdrawn in 2012 by congressional mandate. While a new draft has not been reissued, FDA has held workshops on the issue.

Other arenas for doing less versus more arise in performance testing, biocompatibility, validation, risk management, and related design and test issues. Is the preferred strategy to do as little as possible or to apply a comprehensive good-engineering approach that while meeting the inherently minimal FDA requirements goes beyond, or proceeds independently of, these requirements to provide further assurance that the resultant device is as good as you could reasonably make it?

The PMA process also offers the opportunity for regulatory strategies that can cover a range of behaviors. One strategy that might fall into a gray zone is using a series of PMA supplements to do something you didn’t think you would get away with in a single supplement. For example, you have design A and want to revise it to design E, but you think that if you did a supplement from A to E that FDA would think the leap was too great and ask for a new PMA. The strategy then is to go from A to B, from B to C, from C to D, etc. with each change being relatively small but the end effect being design E nonetheless. With this approach, you don’t even have to actually market B, C, and D, just get them approved. A good anecdotal example of this that I once heard is that all of the functions of design E had already been built into the electronics of design A, but not all of the features had been turned on. These new functions were enabled one at a time with successive supplements. A similar strategy can be to gradually expand indications for use with the knowledge that if you had gone for the broader indications from the onset, you might have met resistance.

Are these approaches just operating within the rules, or are they cheating? Or if not outright cheating, is it what we want to happen—especially if we put on our future patient hats? In this regard, there was a recent analysis that concluded that in the cardiac device arena 77 original PMAs accumulated 5839 supplements. More than one-third of the supplements involved a change to a device’s design or materials, and in the majority of these cases, the supplements were approved without FDA requiring submission of new clinical data.

Similar issues are presented in FDA’s February 2013 draft guidance on enhancements versus recalls. Here, too, the manufacturer makes the initial decision, and if the decision is, for example, that the withdrawal of one device with replacement by another is not a recall, then FDA receives no direct notification. This kind of decision can have a strong or weak justification, with the basis being primarily patient safety, primarily business interests, or somewhere in between. Of course, business interest is a valid parameter, but perhaps not when it overshadows safety considerations. More generally, various field activities may or not be labeled a recall by the manufacturer, and if deemed to not be a recall, FDA need not be notified. Again, this may be a fair assessment or deliberate withholding of information to avoid the recall label and associated tribulations. Medical device reporting (MDR) can also challenge the system when manufacturers make nonreportable decisions, which by definition means that FDA doesn’t directly learn of the associated events.

Most rational people agree that there is a right degree of regulatory burden, and if that degree is found, manufacturers should fully comply with it without bending the rules. At some faraway end of the spectrum is the notion that FDA regulations are all burden and no value, and that this justifies finding the quickest and easiest path—even if that involves some creative avoidance. Where do you stand?

Learn how to avoid regulatory pitfalls with early clinical involvement at MD&M Texas, May 7–8, 2014, in Fort Worth, TX.

William A. Hyman is a professor emeritus in the department of biomedical engineering at Texas A&M University and adjunct professor of biomedical engineering at the Cooper Union.

[image courtesy of BOAZ YIFTACH/FREEDIGITALPHOTOS.NET]
 

Irish Eyes Are Smiling at New Ethicon Plant in Limerick

Ethicon Biosurgery will construct an EUR80 million, 60,000-sq-ft manufacturing facility  that will provide about 270 permanent positions and an additional 150 temporary jobs during the construction of the new facility, the company announced.

The new facility will be located at the National Technology Park in Plassey, County Limerick, Ireland, and is expected to open in 2015.

Ethicon Biosurgery, a Johnson & Johnson company, specializes in hemostasis products. The company makes lines of absorbable hemostats, including proprietary oxidized regenerated cellulose hemostats, absorbable gelatin powder and sponges, a hemostatic matrix, topical human thrombin, and human fibrin sealant.

According to an article in The Irish Times, the Irish Minister for Jobs, Enterprise and Innovation, Richard Bruton, met senior Johnson & Johnson executives and discussed this project as part of a recent IDA investment mission to the US. Bruton is reported to have said,

"Manufacturing is a central pillar of the Government's Action Plan for Jobs, and we have put in place a series of measures to help reverse the decline in employment in this area in the past. Today's announcement that Ethicon Biosurgery, a world-leading company in the medical devices sector, is establishing a manufacturing facility in Limerick with the creation of 270 high-end jobs is brilliant news."

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

The Limerick facility will manufacture Evarrest Sealant Matrix, a new product that helps stop bleeding during surgery. At the IDA Ireland announcement ceremonies at the Strand Hotel in Limerick, Dan Wildman, Worldwide President, Ethicon Biosurgery, said, "The decision to manufacture Evarrest Sealant Matrix in Ireland was due to the unique clustering of medical device manufacturing, automation and biomanufacturing skill sets across the Johnson & Johnson companies already operating in Ireland."

Evarrest Sealant Matrix is a component of the Evarrest Fibrin Sealant Patch that was approved by FDA in 2012. The Johnson & Johnson website describes the patch as "a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery."

"Unexpected and uncontrollable bleeding during surgery poses a significant challenge to surgeons," Johnson & Johnson says, "and in some surgical procedures can raise the patient's mortality rate to 20%. Evarrest has been indicated for use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic and non-cardiac thoracic surgery, when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical."

Stephen Levy is a contributor to Qmed and MPMN.

Abbott Tests Bioresorbable Scaffold in Hope of FDA Approval

Abbott bioresorbable stent
Abbott's new Absorb bioresorbable scaffold (Courtesy Abbott Laboratories)

First there were stents. Then came drug-eluting stents. Now the latest battleground in the cardiovascular intervention field is in bioresorbable scaffolds.

Abbott's Vascular division was first to debut their product, the Absorb, which, having done its job, dissolves harmlessly in about two years. Absorb was granted CE Mark approval in 2011, but has yet to get the nod from FDA.

However, Absorb is no longer alone in the marketplace. Tiny Elixir Medical Corp. (Sunnyvale, CA) has also garnered the CE Mark for its DESolve fully bioresorbable DESolve scaffold for coronary artery disease, and in January announced the device's first commercial implant. Significantly, perhaps, Elixir says its offering dissolves in one year versus the two-year lifespan of Abbott's product.

Meanwhile, Abbott has concluded enrollment for its Absorb III 2000-patient trial, data from which the company hopes will be sufficient to convince FDA to give its approval. The company has also completed enrollments in similar studies in China and Japan. Abbott says it has an eye towards commercial launches in the three countries that account for more than half the stents implanted worldwide.

Abbott explains that Absorb works by opening a blocked vessel and restoring blood flow to the heart similar to a metallic stent. However, unlike a metallic stent, Absorb dissolves over time, potentially leaving behind a more flexible vessel because it is free from a permanent metallic stent which cages the vessel.

Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a metallic stent, which is a permanent implant. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

Abbott's Absorb III randomized clinical trial will evaluate the potential benefits of Absorb in people with coronary artery disease, a narrowing of one or more arteries that supply blood to the heart. The primary endpoint of Absorb III is the rate of target lesion failure (TLF) at one year. TLF has been defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization. TLF rates are a combined measure of the safety and effectiveness of Absorb, which Abbott intends to compare with the company's Xience family of drug-eluting stents.

"The rapid completion of enrollment in the Absorb randomized trials is a testament to the interest among doctors and patients in advancing new options to treat heart disease," said Gregg Stone, MD, director, cardiovascular research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, in Abbott's press release announcing the completion of enrollment. "Absorb represents an entirely new approach to helping people with heart disease by doing the job of a metallic stent, but then disappearing after its work is done, giving people the opportunity to live their lives free of a permanent metallic device implanted in their arteries."

Stephen Levy is a contributor to Qmed and MPMN.

The Past, Present and Future of Wearable Technology (infographic)

The Past, Present and Future of Wearable Technology (infographic)

If the concept of wearable technology has lately entered your consiciousness and you believe that it is a 21st Century phenomenon, you would be dead wrong.

In fact the infographic below, presented by Vandrico Inc., traces the first instance of wearable technology back to 1644 when the Qing Dynasty miniaturized the abacus and put it in a ring. Even back then, they got it right about what constitutes a true wearable - it needs to be controlled by the user/consumer.

Learn more about the new era of consumerization and usability at the MD&M East Conference and Expo, June 9, New York City. 

The abacus-in-a-ring was wearable technologies' past, but how about the future? Vandrino seems to believe that wearables will become commonplace in the workplace eventually. For more, check out the infographic below:

wearable_technology

[Feature Photo Credit: iStockPhoto.com user mindscanner]

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

6 Products St. Jude Medical is Banking On in 2014

 6 Products St. Jude Medical is Banking On in 2014

St. Jude Medical reported a solid first quarter Wednesday beating analyst estimates of earnings per share by a penny. The Minnesota medical device maker had revenue of $1.36 billion in the quarter ended March 29, up 2% from $1.34 billion it garnered in the same quarter a year ago. Profits climbed to $249 million, or 96 cents per share from $223 million, or 94 cents in the quarter.

But St. Jude Medical wants to do even better in the rest of the year domestically, which includes improving its sales growth rate. For that, it is banking on six products. They are:

CardioMEMS - CardioMEMS is a closely-watched startup that St. Jude is acquiring before mid 2014, which many believe has developed what could be a game-changing technology to manage congestive heart failure patients who rack up huge bills for repeated hospitalizations. Hospitals today are being penalized by Medicare if these patients are readmitted in the hospital within 30 days of discharge.

The CardioMEMS device is an implantable sensor that is able to monitor intracardiac pressure and alert physicians of any change, who can respond appropriately, thereby preventing hospitalization of these patients. The promising solution is based on a wireless sensing and communication technology for the human body. After initially rejecting the device’s premarket approval application, analysts believe that FDA will now approve it. The approval is expected to come by mid year.

Here is what Daniel Starks, CEO of St. Jude Medical described the product in an earnings conference call Wednesday:

As we have communicated previously, this product launch will be supported by clinical data from the landmark CHAMPION trial that shows Class III heart failure patients whose medical therapy is guided by a CardioMEMSsystemenjoy a higher quality of life and are hospitalized less often. Reimbursement already is in place in the United States for the implant procedure.Patient monitoring already can be facilitated by our Merlin.net remote monitoring system

Assurity, Endurity and Allure Quadra CRT-P - FDA recently approved these three cardiac rhythm management products, St. Jude announced in March 24. The Allure Quadra CRT-P brings quadripolar pacing technology for the first time to the U.S. and allows allows physicians more pacing configurations within the heart that are not possible through traditional bipolar systems.

Starks remarked that revenue from low-voltage devices in the U.S., that include the above product actually fell 9% in the quarter on a constant currency basis, which can partly be attributed to the fact that these same devices were launched internationally in the first quarter of 2013 making a difficult comparison to the first quarter of this year.

“We expect the difference in international and U.S. sales growth rates to narrow as we launch products in the United States that already have been launched in key international markets in 2013,” Starks said.

TactiCath Force-Sensing Ablation Catheters - This product, like CardioMEMS, comes from an acquisition. In 2013, St. Jude Medical bought Endosense, based in Geneva, which pioneered the force-sensing TactiCath irrigated ablation catheter that can tell physicians in real time how much force they are applying to a heart wall during a cardiac ablation procedure to repair cardiac arrhythmias. That knowledge is key to understanding the efficacy of the ablation being done.

Too much force can cause tissue injury and procedure complications, while too little force can lead to incomplete lesion formation, which essentially means that atrial fibrillation can recur down the road requiring a repeat ablative procedure.

Starks said the company expects FDA approval for this line of products in the second half of the year.

Protege Line of Spinal Cord Stimulation Devices - St. Jude expects to launch these SCS devices in the latter half of the year following FDA approval earlier in April. Starks noted how Protege is the “world's smallest and longest-lasting rechargeable device to treat chronic pain.”

It is also the first neurostimulator that can get approved SCS technology upgrades via regular software updates so passe in the the tech world.

[Photo Credit: iStockphoto.com user draco77]

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

GUDID Submission Methods: Which One’s Right for You?

GUDID Submission Methods: Which One’s Right for You?

(click to enlarge)

A few short months from now, manufacturers of Class III medical devices must comply with FDA’s unique device identification (UDI) rule. Part 1 of this series focused on the need for companies to start planning now for UDI and GUDID compliance. In a conversation with Gary Saner, senior manager of information solutions—life sciences at Horsham, PA–based Reed Tech, Part 2 will get into the nitty-gritty of how to submit data to the Global Unique Device Identification Database (GUDID).

MDDI : UDI and GUDID compliance is upon us. What resources exist for helping companies to make the leap?

Saner: Six months ahead of the first deadline for new federal labeling and data submission requirements, many medical device manufacturers are still deciding how to comply with the new mandate. Fortunately, resources are available to help device manufacturers navigate the requirements of FDA’s final rule on unique device identification.

Published last fall, the new UDI rule is designed to help identify and track medical devices used in the United States by requiring standardized product labels. It also requires that manufacturers collect information on their devices in the publicly available Global Unique Device Identification Database. The new regulations are expected to increase patient safety and healthcare system efficiency.

One of the biggest challenges manufacturers face is collecting, processing, and submitting data to the GUDID. Companies will have to gather substantial amounts of data for each individual product they make. Each product entry will require 55 data values, while FDA’s system will generate an additional seven, for a total of 62 data fields.

Transmitting such vast amounts of data to FDA is a daunting prospect, and time is running out. For example, labelers of Class III medical devices must comply with the UDI label and GUDID submission regulations by September 24, 2014.

The primary components of any UDI compliance solution are a software platform and human resources. The first GUDID submission option involves entering data into FDA’s GUDID Web interface. Manufacturers may submit data to FDA using one of four methods: FDA’s GUDID Web interface, build/buy custom software, a vendor-provided software-as-a-service (SaaS) system, or an outsourced service. Each method requires that labelers first create a free GUDID account, which is currently limited to Class III manufacturers. They can access the site using Microsoft Internet Explorer 9 or 10 or Mozilla Firefox versions 17 to 27. Google Chrome is not currently supported.

MDDI : How does FDA’s GUDID Web interface work?

Saner: FDA’s free GUDID Web interface is an access tool that allows medical device makers to manually enter UDI data directly into the database through a secure online portal. After creating a GUDID account, a user can gain access to the interface tool. While the use of the GUDID Web interface is free, companies will have to shoulder the staff costs and time required to enter data.

The absence of a direct price tag may be tempting to companies whose UDI compliance budget does not afford them as much flexibility as they had hoped. In practice, however, using FDA’s portal to enter UDI information is practical only for companies with a small number of product offerings. Companies with a product catalog of more than 100 devices will have to organize and staff a significant data entry project totaling more than 5500 values. Based on the number of products they offer, even midsize manufacturers will likely have to enter significant quantities of data. And in order to avoid data entry errors, manufacturers will have to budget for a quality check. Companies will also incur ongoing maintenance costs to manually update their records in multiple places should their information change.

MDDI : Could you go into the custom software option?

Saner: Some of the largest companies affected by the new requirements may respond to the looming deadline by developing or purchasing in-house UDI software solutions. Such custom software solutions will require that companies provide both the platform and the staff. Internal systems will allow corporations to bring their existing product catalogs into compliance and to accommodate future needs as their product offerings continue to expand. The investment of time and resources involved in developing an in-house UDI software system, however, could be expensive, making it out of reach for most small and medium-size companies. With the initial compliance deadline of September 24 quickly approaching, it may be too late to begin this type of effort.

MDDI : What about SaaS systems?

Saner: Device manufacturers with a substantial number of products will need to submit larger volumes of data to FDA. Thus, they could benefit from a software program that collects data electronically, converts it into the structured product labeling (SPL) format required by FDA, and submits it electronically to FDA through the electronic submissions gateway (ESG). The advantage of such a system is that it effectively eliminates the costs associated with performing in-house data entry and quality control operations. One such method is the SaaS model, an option that allows companies to ‘rent’ the software solution.

A major difference between the custom software model and the SaaS model is who hosts the software and maintains the system. In the custom software model, the medical device manufacturer is responsible for providing the IT platform, installing and validating it, creating backups, performing maintenance updates, and training users. In the ‘rented’ model, on the other hand, the SaaS vendor provides these services, while the user manages the product data in the SaaS database. SaaS databases can feature search fields or incorporate special fields for entering proprietary information or information required by non-FDA regulatory bodies. Another difference between the two models is cost: Custom software models are generally less cost-effective than SaaS models.

MDDI : What do you have to say about outsourcing the entire process?

Saner: Some companies may choose to outsource their entire GUDID submissions process to a vendor that has the infrastructure, capabilities, and experience to perform this type of work. Using this approach, medical device manufacturers utilize an external provider with a UDI compliance solution and the appropriate experience, such as Reed Tech. This service provider, in turn, processes and submits the data to FDA.

This approach eliminates the need for internal resources to perform GUDID data entry and subsequent maintenance. Vendors can provide accurate data processing services, UDI data validation, experience in SPL and ESG submissions, and the ability to efficiently maintain the data record.

Choosing which GUDID submission approach will work best requires a careful analysis of the time and expertise a company possesses in-house, as well as the costs associated with each of the four options described here.

Bob Michaels is senior technical editor at UBM Canon.

bob.michaels@ubm.com

4 Ingenious Medical Devices That Help Hospitals Save Cash

Medical device makers are actually a lot like textbook publishers.

Textbook publishers managed to score significant profits by frequently publishing new editions of their books that were only marginally different than the previous versions while convincing their customers to upgrade anyway.

All the while, the costs of textbooks skyrocketed, increasing by 82% from 2002 to 2013, according to the Government Accountability Office.

The same type of thing happens with a big-ticket, cutting-edge medical gizmo such as a surgical robot. It is an end-all-be-all for many health providers, and all medical device companies have had to do was engage in incremental improvements in order to keep or inflate the price tag high for such devices.

It is little wonder that during a similar time period--2002 to 2012--U.S. health expenditures grew by 70.5%, to $2.8 trillion, according to the Centers for Medicare and Medicaid Services--though that growth was driven by an array of factors.

But times are changing now that healthcare takes up nearly a fifth of U.S. gross domestic product, spurring a health reform with reimbursement mechanisms that promote more efficient patient population management. Now the emphasis is on affordability, and improved patient monitoring to catch serious health problems before they crop up.

This doesn't mean that medical devices are getting boring, though. The reality is far from it.

In the same way that physical books are so last decade--with students reading on Kindles and iPads--the technologies that will save the health system money and improve the health of patients can be pretty innovative.

From a zipper-like wound closure device to a telemedicine robot, many of the finalists in this year's Medical Design Excellence Awards (MDEA) have the potential to dial down overall healthcare expenditures in ways that are mind-boggling. (The winners of the contest will be announced at MD&M East in June.) Here are four examples:

1. Zip

Zipline
The Zip provides a method of closing an incision that is reportedly 57% faster than stitches.

Manufactured by ZipLine Medical Inc. (Campbell, CA), Zip is a noninvasive surgical skin closure alternative to sutures and staples. Zip boasts time-savings, better cosmesis, and greater patient comfort. To apply the device is a simple matter: a physician places two adhesive strips next to the wound, and then closes it with ratcheted plastic ties. The device reportedly cuts the time to close an incision by 57% compared with stitches. It also could potentially save the health system money by cutting infection risk. A single incidence of surgical site infection costs an average of $25,546, according to one study. In addition, the ZipLine device spares patients from having to go back to have stitches removed; they can do it themselves at home. Supply and design credit to Innovative Drive LLC (Redwood City, CA).

2. RP-VITA 

RP-Vita
In the long run, telemedicine systems such as the RP-VITA can be used to boost the efficiency of physician-patient interaction.

A robot seems like a pretty big-ticket item. But if a patient can get a health problem taken care of sooner with a specialist because of this remote presence telemedicine robot, it could prevent many serious and costly health problems down the road.

Manufactured by InTouch Health Inc. (Santa Barbara, CA), RP-VITA provides high-acuity telemedicine consults. It also does away with the need for telemedicine-specific staffing because it can actually drive itself around an emergency room or intensive care unit. Its intuitiveness, ease-of-use, and safety features encourage physician adoption and clinical use. (Supply and design credit go to iRobot of Bedford, MA.)

InTouch has actually been engaged in remote-presence telemedicine for a decade. "The whole idea of this remote presence is to enable the right clinical expertise to be at the right place and the right time. If you can do the right thing on sick patients on a timely basis, you can improve quality and reduce costs. ... The objective is to make it easier and easier for the physician expert to perform the tasks they would do as if they were there," says InTouch Heaalth CEO Yulun Wang.

It can be a hindrance, however, for a physician to access a telemedicine robot on the go if they need to pack along a joystick to navigate the robot to wherever it needs to be inside a hospital. What iRobot was able to do for InTouch with the RP-VITA was to combine multiple types of sensors and sophisticated software algorithms that enable the robot to drive itself from its docking station to wherever it needs to be, and then back. 

An infrared grid, invisible to the human eye, is projected through the health care facility, which the RP-VITA picks up with its own infrared camera to engage in navigation. Simultaneously, the robot is also utilizing light- and sound-based sensors to further understand its positioning, Wang said.

Specifically, the RP-VITA uses a fusion of date from LIDAR, sonar, and PrimeSense sensors to map, avoid obstacles and navigate autonomously.  

InTouch employs a razor-razorblade strategy with the RP-VITA, charging $5000 to $6000 a month to service and support a single robot. But the robot would pay for itself if, say, a stroke was caught early in just one patient because a specialist was able to remotely access them in an ER. Long-term care costs would then be avoided.

"We're trying to figure out how to provide higher quality at a lower cost. That's the objective here," Wang said. 

3. FreeStyle Optium Neo

Freestyle
The FreeStyle device from Abbott Diabates Care can boost the efficacy of diabetes care while helping patients avoid expensive complications.

Manufactured by Abbott Diabetes Care Inc. (Alameda, CA), this blood glucose and ketone monitoring system is a great example of the type of intuitiveness and ease of use that people take for granted with smartphones--but still sorely lack with medical devices. Diabetics who are better able to manage their condition avoid expensive complications over the longterm, too. By streamlining management of diabetes, the device can help patients as well as hospitals and clinics save money. The FreeStyle Optium Neo actually guides patients through their diabetes and insulin management. Set up by a healthcare provider, the meter stores, displays, logs, and suggests insulin dose adjustments. There are also notifications when it comes to high or low blood glucose levels and trends. (Note here: This is not for sale yet in the United States.) Supply and design credit to Bridge Design (San Francisco).

4.MuV Patient Transfer System

MuV Patient Transfer System
The MuV patient transfer can help reduce costly injuries stemming from moving patients in a clinical setting.

A patient population that is healthier overall could greatly reduce healthcare expenditures. The same goes, however, when it comes to preventing workplace injuries in clinical settings. As many a nurse will tell people, moving patients can take a heavy physical toll. Made by CEGA Innovations LLC (Sioux Falls, SD), the MuV patient transfer system is lightweight and ergonomically designed to not only reduce patient stress but also lessen the burden for hospital workers during patient transfer. It reduces workplace injuries and increases efficiencies and reimbursement criteria. (Entry submitted by and supply and design credit to Kablooe Design of Blaine, MN.)

"It was a challenge to design a device that was not simply better than existing technologies; it had to be significantly better and cost-effective," said Aaron Emerson, CEGA Innovations' president.

CEGA had the basic concept behind the device when it approached Kablooe more than a year ago, said Matthew Rust, director of product development at Kablooe. Versus other methods such as using the sheets underneath the patient, sliding a plastic board underneath the sheets, or using balloons to help ease a bed transfer, CEGA's device would employ rollers. It would be partially slid under the patient's torso and lower back, and then a clean absorbent sheet stuck on the belt and rollers would be pulled to move the patient across the MuV and onto the new bed. 

What Kablooe was able to do was employ its industrial design and materials know-how to ensure it could be easily assembled in a plant and easily used and maintained in a medical setting. The MuV needed to weigh less than 15 pounds so that a nurse or other health staff person could easily carry it around, but it had to be able to withstand the weight of a 300-pound patient if need be.

Rust says Kablooe turned to computer modeling to design the MuV's aluminum frame and supports in much the same way that an engineer designs a modern bridge, to channel weight and stress so that the frame could be as minimal as it could be while supporting the most weight possible. 

Another engineering challenge involved the belt material, which had to be sticky and waterproof on the outside to provide grip, but sleek on the inside so that the belt would easily move. Kablooe settled on a sleek nylon fabric that could be coated with an adhesive polyurethane coating on the outside. The metal back underneath the rollers and belt is painted with a sleek powder coat material that allows the belt to continue to slide by. Lines are also painted on the belt so that medical staff can easily line up the sheet when sticking it on the belt.

Another Kablooe idea involved placing handles on each side of the belt and rollers so that they can easily be popped out of the frame for cleaning. The belt itself can then be slid off the rollers and replaced.

"There are just so many parts and pieces that have to act as a system ... a lot of considerations," Rust said.

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

JNJ Beats Estimates, Device Sales Flat

The common stock of healthcare and medical device giant Johnson & Johnson (JNJ) soared to recent highs following the company's announcement of first quarter results that beat analysts' estimates. The company's robust performance was driven by new and existing drug sales. JNJ reported that, before currency adjustments, its worldwide pharmaceuticals were up 12.2 percent for the quarter. Standout performers on the pharma side included Stelara, for plaque psoriasis and psoriatic arthritis, up 32% year-over-year to $456 million and Zytiga, for metastatic castration-resistant prostate cancer, sales of which were up 49% to $512 million. Remicade sales were up slightly to $1.6 billion for the quarter. Reduced production and administration expenses were also credited with improving the bottom line.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.
Consumer products experienced declines in revenue and medical device revenue was flat, the company reported in its press release covering the quarter. JNJ said its Worldwide Medical Devices and Diagnostics division sales of $7.1 billion were flat compared to the prior year. Although the company experienced an operational increase of 1.8%, this was offset by a negative currency impact of 1.8%. Domestic sales decreased 1.6%. International sales increased 1.3%, which reflected an operational increase of 4.6% and a negative currency impact of 3.3%. Primary contributors to operational growth were sales of products in the Orthopaedics business; the Specialty Surgery business; and Biosense Webster's electrophysiology products in the Cardiovascular Care business. Earnings per share came in at $1.54, easily outpacing the Zacks Consensus Estimate of $1.48 and the year-ago earnings of $1.44. Revenues rose 3.5% to $18.12 billion, trumping the Zacks Consensus Estimate of $17.99 billion, said Sweta Killa, writing for Zacks.com. According to Killa, JNJ is trading at its highest level in more than 34 years. The stock has gained 21% over the past one-year period, he said. Putting the icing on the cake, JNJ also raised its full-year earnings outlook in expectation of strong continued performance. Looking forward, FDA has recently approved the company's Thermocool Smarttouch Catheter for treatment of patients suffering from drug-resistant paroxysmal atrial fibrillation. Also during the just-ended quarter, JNJ accepted a binding offer from The Carlyle Group to acquire the Ortho-Clinical Diagnostics business for approximately $4.0 billion. The transaction is expected to close toward the middle of the year, upon satisfaction of customary closing conditions.

Stephen Levy is a contributor to Qmed and MPMN.

Can Flash Glucose Monitoring Disrupt Diabetes Care (and Revive Abbott’s Diabetes Business)?

Can Flash Glucose Monitoring Disrupt Diabetes Care (and Revive Abbott’s Diabetes Business)?

Abbott Laboratories, like other device makers, has seen its diabetes device business fall on hard times, thanks at least in part to the competitive bidding program CMS rolled out last July in the United States.

Learn how to design next-generation medical devices in a conference session at MD&M East on June 9, 2014, in New York City.

According to the company’s most recent earnings report, diabetes care sales dipped 9.5% globally. The 4% growth in the segment internationally wasn’t enough to counteract a 27.6% dive in the United States.

But in an earnings call today, Abbott CEO Miles White sounded confident that the company will be able to turn those numbers around soon.

“…[T]his is one unit, I am actually, I am very excited about,” White said, according to a Seeking Alpha transcript of the call.

He lauded the company’s defensive strategy in the face of tough headwinds for diabetes devices but added that Abbott is about to go on the offensive with a "next-generation sensing technology."

"...[I]t hasn’t had a lot of visibility yet. It will in the coming months," White said. "We keep referring to what is next-generation. But, frankly, it’s quite a creative product. And I think ... it’s going to have a lot of impact on the business.”

But what exactly is this "next-generation sensing technology"?

At last September’s European Association for the Study of Diabetes Conference, Abbott introduced the concept of flash glucose monitoring, a method of monitoring blood glucose levels that eliminates the daily finger-prick calibrations required for traditional continuous glucose monitoring.

Jared Watkin, divisional vice president of technical operations for Abbott Diabetes Care, told the conference that the system consists of a reader, a sensor, and a sensor applicator. The sensor is factory-calibrated, so it does not require finger-prick calibration by users, and can be worn for 14 days. Users scan the color touchscreen reader over the sensor to obtain a report that includes current glucose level, a trend arrow based on the prior 15 minutes of data, and a graph of the previous eight hours of data. The system uses RFID technology for transmission. In an early feasibility study, the flash glucose monitoring system’s accuracy compared well with traditional continuous glucose monitoring and YSI draws, according to Watkin. 

Abbott has been hinting at this new technology for a while now, so when might it actually come to market? 

Watkin said last year that the company would be starting trials for a flash glucose monitoring product. And while White didn't mention the technology by name, he said in today's call that Abbott expects its “next-generation sensing technology” to be CE Marked in the second half of this year and and to launch in Europe in late summer. 

Learn how to design next-generation medical devices in a conference session at MD&M East on June 9, 2014, in New York City.

Jamie Hartford, managing editor, MD+DI
jamie.hartford@ubm.com

[image courtesy of PAT138241/FREEDIGITALPHOTOS.NET and altered by MD+DI