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Articles from 2015 In April


2015 MDEA Finalists: Intimina KegelSmart Personal Pelvic Trainer

Intimina KegelSmart Personal Pelvic Trainer

 

The Intimina KegelSmart Personal Pelvic Trainer, designed by Intimina (Sweden), automatically chooses exercise routines based on the user’s ability, guides the user through the routine with vibration, and measures and tracks gains in pelvic-floor strength and responsiveness.

Supply/design credit: Suzhou Armocon Technology Co. Ltd.

          

Why Healthcare Is Like Aviation in the 1970s

Why Healthcare Is Like Aviation in the 1970s

Despite a bad year in 2014, the airline industry has never been safer. The medical device industry could learn a lot from the reforms that industry has made in the past several decades.

Brian Buntz

In many ways, the aviation industry in the 1970s is like the healthcare system now. Decades ago, pilots more or less had the discretion to fly as they wanted to, sometimes downplaying feedback from air traffic controllers. Consistency among pilots was uncommon then while crashes happened all too often. Then, a horrific crash on March 27, 1977 shook things up. On that day, two packed Boeing 747s slammed into each other on the runway on the remote island of Tenerife, killing 583 people. It remains the deadliest aviation disaster in history.

The catastrophe eventually paved the way for sweeping reform in the industry--in part by instituting more standardization. Pilots internationally adopted uniform protocols. Communication was standardized as well to avoid miscommunication. English began being used more extensively as a shared language. The industry adopted a protocol known as Crew Resource Management, which made it easier for more junior flight crew to question their superiors if they spotted something amiss.

Since then, increased standardization in the aviation industry, along with an improved focus on roles and responsibilities, has made the aviation industry vastly safer. Despite the press that crashes continue to get, and the uptick in airline crashes last year, the number of commercial aviation deaths globally continues to fall each decade. The field of aviation continues to refine the protocols it uses to manage safety and they continue to work well. The annual average for the first four years of this decade had half as many air accidents as the annual average in the 1970s.

Healthcare is in the throes of undergoing a similar transition. The field is becoming more systems-oriented and less hierarchical. The notion that 'doctor knows best' is falling out of favor as did the idea that pilots shouldn't be question softened in the 1970s. While physicians continue to play a vital role, more emphasis is being placed on improving outcomes and making the healthcare field more efficient.

The traditional approach to medical device design is moving in the same direction; it is becoming more integrated, more team-oriented, and more systems-based. The proverbial silos are coming down.

The most innovative medical devices demonstrate this. They are not only designed to help make the healthcare industry overall more efficient--they are themselves byproducts of a systems-based approach to product development that assumes nothing and questions everything.  

Take for instance, Medtronic's tiny Micra pacemaker, whose development exemplifies this approach. Recently winning CE Mark approval, the Micra is one tenth the size of the company's previous pacemaker. The point of the making the device so small was not only to make it less invasive but to simplify the procedure used to implant it. The device can be implanted using a catheter and has no leads.

Like the aviation industry's reform in the late 1970s, the key to the device's development is how its engineers focus on how its different pieces fit together. Given a mandate to make radical changes to the pacemaker and to eschew using any components used in earlier products, the group was free to build an entire system anew. "What we decided as a technology group is that in order for us to make a major breakthrough, we can no longer afford to treat everything as a component and wire it together at the end," says Mark Phelps, senior program director, diagnostics and monitoring at Medtronic. "Prior to that, everyone focused on their area. They focused on integrated circuit design or packaging of the electronics or the design of the electronic modules or the battery technology or the casing or leads in the case of a pacemaker."

The development of the device wouldn't have been possible without an increase in collaboration between the members of the engineering team. "What we had to to do to miniaturize the pacemaker was to shrink all of its components. Everything now is connected to everything else," Phelps says. "We combined the outer case of the battery to the outer case of the device because we couldn't afford to put it into another can."

The key driver of the Micra's small size is its ultra low power capability, which also created a collaborative approach to pull of. "We had to partner with our integrated circuit manufacturer to redesign some of their processes so that we can make our electronics as low power as possible," Phelps says.

"We had to partner with our integrated circuit manufacturers to redesign some of their processes so that we can make our electronics as low power as possible. The way we had to do that was to have a deep understanding of how their processes worked," Phelps says. "We had really good models to be able to design the integrated circuits and that partnership made our suppliers better because we are down in areas that most people don't care about. We also see variation or any problems before anyone else does. We have become sort of a canary in the coal mine in spotting variation that no one else is looking at."

While teamwork, standards, and safety protocols are by no means new to the medical device field or healthcare industry at large, it seems clear that both are upping the ante to deal with the pressures of healthcare reform, globalization, cost pressures, and a global epidemic of chronic disease.

Medical device professionals would be wise to look to other industries to see how they are handling similar challenges.

The field of aviation already seems to be having an influence on the healthcare field. Notice the uptick in books, training courses, and journal articles seeking to apply lessons from aviation to everything from clinical practice to surgical training.

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

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

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Zimmer Skipping Robotic and Value Implant Trends

Zimmer Skipping Robotic and Value Implant Trends

A Zimmer executive explains to analysts why his company has so far steered clear of two major trends in orthopedics: robotics and value implants. 

Marie Thibault

While many of their peers have turned toward technologies like robotics or to cost-saving offerings like value implants, it seems Zimmer plans to stay away from those hot trends, at least for now.

This is notable because some of Zimmer's biggest competitors—Stryker, Smith & Nephew, and Johnson & Johnson—have either entered or announced plans to enter the robotic space. In addition, hospitals are supposedly looking for less expensive orthopedic implants, either as pared-down versions of higher-priced options, or by removing the service component from the purchase.   

After prodding from analysts on the company's April 30 earnings call, an executive discussed Zimmer's stance on robotics. According to a Seeking Alpha transcript, James Crines, Zimmer's chief financial officer, said:

"We have been developing technologies that we believe are smaller, cheaper, faster to bring about better clinical solutions and reproducible solutions in a cost efficient way...We don't think that going backwards in procedure time for example for changing the work flow in a fundamental way is going to lead to better patient outcomes..."

A Stryker executive recently called the robotic Rio System, which came to the company through its acquisition of MAKO Surgical, an "investment" that should attract more patients to a hospital.

While most of the discussion on the analyst call revolved around the anticipated May close of the company's Biomet acquisition, another analyst pointed out that he had heard of competitors trying out the value implant trend. Crines responded by pointing out improved pricing stability over the past couple years and warning of a potential risk of the trend:

"The data points that I think are worth emphasizing is the stability of the pricing environment...by way of price experience, we’re continuing to maintain price and retrieve mix opportunities for our premium technologies and all those price points...It’s going to be the case, however, that if one of these so called value implant providers cause harmful effects to patient outcomes that with the movement away from fee for service in jurisdictions like the United States and the cost of re-admissions or complications in those cases being internalized relative to the provider they are going to care deeply about making sure that they get [it] right for the patient as they should. So if someone is out to save a little bit of money in exchange for not delivering the right kind of patient outcome, the economic system is going to penalize that provider in a material way in a much more significant manner than it has historically."

Zimmer's combination with Biomet, initially announced a year ago, is now expected to close in May, instead of April as previously expected. Executives describe the transaction as offering increased scale and filling out the product portfolio.

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.
Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of BOYKUNG/FREEDIGITALPHOTOS.NET]

Could This Rapid DNA Test Replace PCR?

Could This Rapid DNA Test Replace PCR?

Nancy Crotti

Researchers in Massachusetts have developed a rapid technique to detect disease-causing DNA in the field, without the need for sophisticated and expensive PCR equipment. They say the inexpensive method could help detect neglected tropical diseases, such as river blindness.

The technique, developed at New England BioLabs (NEB), Inc. (Ipswich, MA), works by removing the buffer normally used in PCR testing and adding a robust enzyme to a sample, be it blood, serum, or human skin. The reaction produces multiple protons, changing pH levels dramatically to indicate large quantities of amplified DNA made visible by traditional dyes, according to the researchers. An article on their research appeared in the journal BioTechniques in February.

Researchers at NEB’s DNA enzymes division, led by scientific director Tom Evans, PhD, prefer the loop-mediated isothermal amplification (LAMP) method for this testing. LAMP requires no thermocycler (PCR machine or DNA amplifier), provides rapid DNA amplification, and tolerates inhibitors found in dirty samples more likely to be collected in the field, according to Clotilde Carlow, PhD, scientific director of the division of genome biology at NEB. Tanner described the thermophilic bacteria that NEB cloned about 30 years ago as “a biotechnology workhorse enzyme” that works well at tropical temperatures and in LAMP testing.

The technique may be used on samples from humans, animals, and insects, according to Carlow. A graduate of the London School of Hygiene and Tropical Medicine, Carlow and others on Evans’s team are working with scientists from Cameroon and Ghana to detect several forms of filariasis, including onchocerciasis, or river blindness, which is caused by insects transmitting parasitic worms to humans.

Such field tests would allow healthcare workers to collect information to determine where such diseases are being transmitted, Carlow says. Although developed to work in tropical conditions, the test could also detect Lyme disease in ticks in more temperate climates, she added.

NEB probably will not develop a kit to test for a particular disease, according to Nathan Tanner, staff scientist in NEB’s DNA enzymes division. (Tanner appears in a video describing the testing method.)

Evans’s team plans to continue developing the technology, publish its results, and collaborate with institutes and scientists in countries where these diseases are prevalent. Its goal is to train individuals to perform the tests and work with local governments to transfer the technology, Tanner explains. The team has been working on this method for about two years.

“The idea is to be able to have a test that you can accurately perform in the field, not in a laboratory … and get a result very quickly,” Carlow says, “a result that’s easy to read and simple to interpret, and be able to make a decision right then and there as to what you want to do next.”

Does NEB hope to displace PCR testing? Evans’s team is not saying, but the study authors filed a U.S. patent application describing their method two years ago and followed with a full patent application a year ago, according to Tanner.

“We didn’t discover the fact that DNA polymerases can change pH,” Tanner says. “We’re just using it in a new way.”

“Our goal is not to make money,” Carlow adds. “It’s to get the science out there, to make it easy, affordable, and to help control these nasty diseases.”

Other scientists are also eagerly studying isothermal amplification, Carlow says.

“This type of a test has a very specific niche. It’s very adaptable, so it can detect more than one type of disease,” she says. “We’re hoping to transfer this technology to monitor and diagnose all different kinds of infections.”

Keep up on on trends in the medical device and diagnostic industry by attending the MD&M East conference and exposition June 9–11, 2015, in New York City.

 Nancy Crotti is a freelance contributor to MD+DI.



[image courtesy of COOLDESIGN/FREEDIGITALPHOTOS.NET]
 

2015 MDEA Finalists: Evzio

Evzio, manufactured by Kaleo Pharma Inc. (United States), is the world’s first and only take-home, hand-held, single-use naloxone autoinjector for immediate administration as emergency treatment of known or suspected opioid overdose.

Supply/design credits: JR Automation, Nypro-FinPack, Medivative Technologies  

          

Why Metal Finishing Matters in the Medtech Industry

Metal finishing removes burrs, improves corrosion resistance, increases part longevity, and creates an ultraclean, sanitary finish.

Bob Michaels

Metal finishing processes are crucial for manufacturing titanium screws.

The medical device industry faces multiple challenges when it comes to manufacturing reliable, hygienic, and compliant parts and devices, remarks Tom Glass, president of Able Electropolishing (Chicago). Thus, medical device manufacturers should perform a range of finishing operations to ensure optimal performance. Here's what Glass has to say about the importance of metal finishing in the medical device industry.

*     *     *     *     *

How Can I Meet Biocompatibility Challenges?

Many industries utilize finished metal parts in their processes, machinery, or end products, and the medical device industry is no exception. In the medtech world, metal finishing is an important final step in the manufacture of devices and components.

Take the question of biocompatibility, for example. Composed of metal components, orthopedic devices such as knee, hip, shoulder, and elbow implants and cardiovascular implants such as defibrillators, pacemakers, and artificial heart valves confront biocompatibility challenges. Manufacturers can address these challenges by employing a variety of metal finishing operations with the goal of removing surface imperfections.

What's in It
for the Manufacturer?

SEM images of metal pieces before (top) and after (bottom) undergoing a metal finishing step.

Whether you manufacture pacemakers or hip implants, metal finishing addresses a variety of part imperfections acquired through the manufacturing process. Quality metal finishing offers a host of advantages, including the removal of burrs, improved corrosion resistance, increased part longevity, and the creation of an ultraclean, sanitary finish that inhibits bacterial formation on the part surface. Whether the manufacturer wishes to remove heat tint from welded areas or to eliminate microcracks that can result in premature part failure, metal finishing helps ensure device performance over time. Metal finishing treatments can also address microfinishing and sizing concerns.

In addition to improving part quality and performance, medical device manufacturers must meet stringent industry standards and ensure reliability. Quality processes and quality management systems such as those set forth by ISO 13485 and ISO 9001 enable medical device manufacturers to meet these demands. But in addition to allowing manufacturers to meet industry standards, these certifications ensure consistent results from lot to lot and from part to part. That's where metal finishing operations come in.

What's in It
for the
Patient?

After undergoing implant surgery, patients can suffer from a range of issues, including infections, implant rejection, or prolonged recovery times. By employing a variety of metal finishing processes, medical device manufacturers can improve the quality and performance of their products, benefiting patients as well as their bottom line.

When an implant is rejected, the patient must undergo revision procedures and additional treatments to fight infection or other side effects. While prolonging recovery times, extended treatments can also deteriorate a patient's overall health. In addition to increased medical costs, long hospital stays often cause the patient to suffer from muscle atrophy, increased anxiety, and emotional distress.

Implants that have undergone advanced metal finishing treatments are less likely to be rejected and less likely to cause surgery-related health issues than unfinished implants, improving patients' overall quality of health.

What Metal Finishing Process Are Out There?

Most of the metal finishing processes available to industry as a whole are also available to the medical device industry and manufacturers of surgical instruments. Blasting, tumbling, plating, passivation, and electropolishing are just a few of the metal finishing processes that can improve medical device manufacturing applications.

For example, stainless-steel parts can be passivated in a nitric or citric acid bath to remove free iron and foreign materials from their surfaces. However, while passivation alone can clean the part and effectively remove free iron, it cannot produce a microfinished or a sufficiently corrosion-resistant surface, rendering it inadequate for certain medical device applications.

Microfinishing and corrosion resistance are best achieved using electropolishing, a process by which parts are submerged in a chemical bath and treated with electricity. Although many manufacturers prefer the use of passivation to finish their metal components, this method cannot achieve the same high-quality finish as electropolishing can.

Electropolishing is unique in that it can achieve multiple benefits. It can eliminate surface contaminants, brighten and polish metal, remove burrs, eradicate heat tint and oxide scale, improve microfinishes, and make parts 30 times more corrosion resistant than passivation can. Consequently, electropolishing is the best metal finishing option for medical device applications.

Why Is Process Improvement Important?

Different types of metal parts can undergo a range of metal finishing operations.

Advances in the medical industry such as the use of titanium and nitinol require improved finishing processes. For example, titanium is used widely in the medical device industry because it is lightweight, improves tissue growth, and has a lower rejection rate than other materials. Nevertheless, while titanium alloys are superior to other materials in medical device applications, they must still undergo quality finishing processes, making it incumbent on OEMs to collaborate with metal finishing service providers to produce the safest products possible.
 

2015 MDEA Finalists: EVARREST

EVARREST Fibrin Sealant Patch

 

EVARREST, manufactured by Ethicon (United States), is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis for soft-tissue bleeding during open retroperitoneal, intraabdominal, pelvic, and noncardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical.

          

2015 MDEA Finalists: DuoResp Spiromax

DuoResp Spiromax

 

DuoResp Spiromax, manufactured by Teva Pharmaceuticals Europe (UK) is a dry-powder inhaler for existing medicines for asthma and COPD that uses an intuitive design to minimize the training required for patients and provide consistent drug delivery across inspiratory flow rates.

Supply/design credit: Gerresheimer  

          

2015 MDEA Finalists: Xprecia Stride Coagulation Analyzer

Xprecia Stride Coagulation Analyzer

 

The Xprecia Stride Coagulation Analyzer, manufactured by Siemens Healthcare Diagnostics Inc. (United States), provides a quantitative prothrombin time test for monitoring oral anticoagulation therapy with warfarin, a vitamin K antagonist; the system uses fresh capillary whole blood and is intended for professional in vitro diagnostic use at the point of care.

Supply/design credit: Universal Biosensors Pty Ltd.  

          

2015 MDEA Finalists: True Margin

True Margin

 

The True Margin tool, manufactured by Mohs Precision Tools Inc. (Canada), minimizes tissue waste while obtaining a cancer-free margin of a specimen in Mohs surgeries to resect skin cancer.

Supply/design credit: Clarus Microtech Inc.