Cleveland Clinic Clashes With Ortho Surgeon

Cleveland Clinic Clashes With Ortho Surgeon

Arundhati Parmar

Earlier this month, Dr. Raymond Horwood, an Ohio orthopedic surgeon, created a bit of a stir when his practice sent a letter to patients informing them that he was moving his practice from Cleveland Clinic's Fairview Hospital to another hospital because the "Cleveland Clinic Foundation has instituted cost-cutting measures which limit the implant options for joint replacement surgery to just two vendors."

Those two are Stryker and Zimmer.

The letter went on to say that Dr. Horwood has used implants from DePuy, a unit of Johnson & Johnson, for 28 years and does not "feel in good conscience that he can jeopardize his patients by changing to an unfamiliar implant system simply to save money for a hospital system."

The story, reported by Cleveland.com, brings to light the clash that can occur as large healthcare systems move to a value-based paradigm accelerated by the Affordable Care Act.

On the one hand, there are healthcare providers like Cleveland Clinic that feel the need to aggressively rein in costs and provide good, clinical outcomes by reducing treatment variation.

On the other there is the physician, in this case an orthopedic surgeon—specialists known to be fiercely independent, used to having their preference for tools and products respected, used to being the sole decision maker on what is best for patients, and who are suddenly seeing their realm of choice narrow and their influence wane.

At Cleveland Clinic, about 60% of the physicians are employed by the hospital, while the rest are independent practitioners.

So how did Cleveland Clinic come to consolidate the number of orthopedic vendors from seven, though the majority of the expenditure was with five vendors, to two?

Cutting implant choice followed a similar process and trajectory and the same philosophy used to standardize in other categories, explained Simrit Sandhu, executive director of supply chain management at the Cleveland Clinic.

“All decisions are made by a peer of physicians who evaluate all relevant literature prior to making any standardization choices,” Sandhu said in an interview. “We’ve been doing this systematically over the years in all our service lines be it cardiac or orthopedic or neuro. And the goal has been trying to make care the most effective and the most affordable for our patients. In doing so, the decisions haven’t been made by supply chain executives or supply chain professionals. We facilitated the process but a peer group of physicians based on their evaluation of the product line and literature have helped standardize the offerings where applicable.”

Sandhu noted that all contracts also have clauses that state that exceptions will be granted if it is determined that patients will benefit from it and when there is a clinical cause to deviate from the standardized product.

But perhaps the most important element of a successful transition to a standardized system is training of physicians.

“When we make a physician standardize to an implant that he may not necessarily have a lot of experience with, getting the physician adequate training and time to get used to the new product line has always been part of our process,” Sandhu said.

The effort to consolidate vendors in total joint replacement category began last year and spanned nine months, said Allen Passerallo, senior director of sourcing at Cleveland Clinic.

Physicians involved in joint replacement were invited to participate in meetings to chart the course forward and review clinical literature. The technologies being reviewed were placed under three broad buckets—total hips, total knees and revision hips.

After those meetings and the review of the literature “the thought was that all of the five major suppliers in orthopedics in total joints had similar levels of technology and were equally supported in the literature one way or the other in terms of quality,” Passerallo said.

Five implant vendors were also invited through a RFP process to explain their value propositions and why they should be selected to win the contract.

In the end, Stryker and Zimmer were chosen for the three-year contract and Cleveland Clinic saved 18% overall. Passerallo declined to provide the actual savings figure, noting that it was several millions of dollars and that Cleveland Clinic could have saved even more had it chosen a different vendor group.

“I will be completely transparent in saying that there was additional savings opportunities to go with another supplier, but there was some concern from a technology standpoint that they didn’t meet our needs, so therefore we did not go down that path,” he declared. “We went with the second-greatest value financially because it was the best value from a quality.”

The contract was awarded June 1.

“We have a 60-day ramp-up period for training and education, and the contract start date was Aug. 1,” he said. “We had made a clinical decision that with the right training level that it would take about 60 days for surgeons to feel comfortable in converting and that happens through table top displays as well as bone saw labs and what have you."

Dr. Horwood, who has used DePuy implants for 28 hours apparently chose not to train.

“The break happened prior to giving it a try. It wasn’t as if that individual went through the 60-day training period,” Sandhu said.

She added that physicians who are in their mid- and late 50s who may not have been exposed to the standardized product—whether in ortho or other categories—and are concerned about moving to a new product undergo the training and then convert.

“The bottom line is that the majority of the physicians in that demographic chose to convert, chose to train, chose to make the decision,” Sandhu said. “In the last eight to nine years, we have seen more collaboration than deviance.”

An administrative assistant to Horwood declined to make him available to answer questions even via email.

Horwood is a member of the American Academy of Orthopaedic Surgeons, which has embraced accountable care wholeheartedly.

Alexandra Page, chair of AAOS’s Health Care System Committee, said that such conflicts between physicians and health systems need to be reviewed on an individual basis.

On the one hand, part of being a physician and an orthopedic surgeon is life-long learning. You can’t say, 'This is the way I have learned to do it in residency and fellowship so this is the way I am going to do it for the rest of my life' or you wouldn’t learn how to do things arthroscopically and minimally invasively or anything new that comes down the line. So there should be some flexibility in your ability to learn and that can be to learn a new implant as well as a new technique. On the other hand, if the physician feels that it is the right implant for them, they feel extremely comfortable and confident that this is the one that in their hands is the best outcome for the patient, that remains their decision.

Nonetheless, Page also advocated a collaborative approach to achieve what everyone should be striving for: getting the same quality of care at a lower price.

“Our message to our members is you need to find a way to work collaboratively with the hospital, with the nursing home, with everybody involved in the care,” Page said. “If you can say I can get the same quality at a lower price, there’s your value and that’s what works best from every point of view.If there were any doubts about this, the proposed rule from CMS mandating a single, bundled payment for the entire episode of a TJA in 75 markets around the US tells us collaboration and alignment is a necessity, not an option...”

DePuy Synthes did not responds to queries for comment. Page said that the current focus on cost may in the end spur true innovation in the orthopedics industry—an industry that has often been accused of only engaged in incremental innovation.

“If you have come up with an implant that is going to last 20% longer, that is worth more than a 20% increase in implant costs and the associated costs. Because of the associated costs and patient morbidity of revision surgery, 20% longer implant life has much more value than 20% increase in the cost of the implant," Page said. " That’s the kind of innovation we need rather than something new and shiny that doesn’t change patient outcomes."

 Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb.

[Photo Credit: iStockphoto.com user michaelquirk]

To learn more about medical devices and trends in the marketplace, attend the two-day MD&M Minneapolis conference, Nov. 4 and 5 at the Minneapolis Convention Center. 

What Other Companies Could Medtronic Buy With its War Chest?

What Other Companies Could Medtronic Buy With its War Chest?

Medtronic has been gobbling up companies and technologies in the past 15 months and the pace may quicken further. What companies could be in its radar?

Arundhati Parmar

On Monday, Medtronic took a $500 million charge recording a one-time income expense as part of an internal restructuring that frees up $9.3 billion in cash, net of taxes.

"Based on cash as of end of [fiscal first quarter of 2016 Medtronic] now has access to $12.5 billion in cash with $5.5 billion still trapped overseas," wrote Danielle Antalffy, a research analyst with healthcare investment bank Leerink Partners, in a research note on Tuesday.

The first priority would be to do what good public companies do - pay down debt and return cash to shareholders in the form of dividends or share repurchase plans. But some of that money will also go toward buying up other companies, the third financial priority that the Irish medtech company has.

"[Medtronic] now has the financial flexibility to more easily deliver on all 3 financial commitments, which we believe could set the stage for more aggressive M&A going forward," Antalffy wrote.

Medtronic has been a very active buyer even after closing the $50 billion Covidien deal shattering all previous notions of how its acquisitions capability would be reduced as it digests that firm.  Since announcing plans to acquire Covidien in June 2014, Medtronic has acquired 14 companies, according to a review of its press releases

One can only imagine what "more aggressive" might mean in the future.

So what categories could Medtronic be interested in?

One area is cardiology of course and Antalffy believes Medtronic may make a play for an LVAD (Left Ventricular Assist Device) technology. After St. Jude Medical swallowed up Thoratec, the other major player in the field is HeartWare.Then there is Abiomed, which has a percutaneous VAD, Antallffy wrote. Both LVADs and percutaneous VADs are considered to be high-growth areas.

Antalffy believes Medtronic could also dip its toes in imaging technology as well as in minimally invasive technologies.

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb

 [Photo Credit: iStockphoto user alengo]

To learn more about medical devices and trends in the marketplace, attend the two-day MD&M Minneapolis conference, Nov. 4 and 5 at the Minneapolis Convention Center. 

Device Makers Take Note: Cyber Attacks Are Already Hitting Healthcare

Device Makers Take Note: Cyber Attacks Are Already Hitting Healthcare

Find out why some medical device manufacturers aren't adequately protected against cyber attacks and what companies can do to increase cybersecurity.

Marie Thibault

Cyber attacks aren't merely a threat of the future for healthcare companies and hospitals. In recent months, hospitals all over the country—California, Indiana, Kansas—have reported cyber attacks on their network systems that store patient information. The personal data of millions of patients may have been compromised.

Stephanie Preston, cyber embedded systems engineer at Battelle, says that she is aware of various instances of ransomware attacks on hospital systems and malware being found on medical devices. And as MD+DI has reported, the FBI and FDA have issued alerts and safety communications about cybersecurity for medical devices.

Fortunately, there are signs that all of these headlines and alerts are hitting home for medical device manufacturers.

Knowing Is Half the Battle

Preston says that she has noticed more awareness in the medical device community about the need for cybersecurity. "I think we're still at the beginning, but I think I'm really optimistic that we're moving in the right direction . . . There's still a lack of knowledge, but there's a huge area of interest, which I find a great sign," she says.

As more evidence that cybersecurity is becoming a hot topic for the device industry, an upcoming conference being hosted by the Massachusetts Medical Device Industry Council (MassMEDIC), "Preventing the Unthinkable: Issues in MedTech Cyber Security—Trends and Policies," is devoted to the topic. The event, taking place on October 1, was conceived to put regulators, security experts, and medtech professionals in one room "to come together to talk about common trends and policies and best practices, to share with a larger audience from the medical device community," says Tom Sommer, president of MassMEDIC.

Where's the Talent?

Preston, who will be speaking at the conference, says that the increasing level of education about medical device professionals is lifting one of the barriers to better defenses against cyber attacks. But more education isn't enough, Preston notes. Lack of talent is another hurdle. "All industries that need cybersecurity professionals are struggling to find enough people who understand security to fill those roles," she says.

As someone who spends her days reverse engineering systems, Preston says that she and most other security professionals are self-taught. "I'm hoping that [the talent shortage] will start to be cured as more and more universities adopt cybersecurity programs," she says.

Long Development Cycles

Unlike the tech and software industries, medical device companies have years-long product development timelines. It is not uncommon for companies to have a five to seven year horizon on commercializing a new device. And once the device is being used by or implanted in a patient, it may have a very long life. That can be another challenge for manufacturers looking to prevent cyber attacks. Preston says, "That's something that's a little unique to the medical device community. I hear people draw correlation between the financial industry and payment processing, credit card swipe machines, but the truth is, those machines have a much shorter life cycle both from development and in the field . . . it really makes medical devices that much more unique—and challenging, truthfully."

What to Do?

So how can a medical device maker keep up with the latest cybersecurity defenses? It's critical to have someone who has both detailed knowledge of hackable weaknesses and the medical device's features. Preston explains, "Say I see a new attack that comes out for Bluetooth, or a certain mode of Bluetooth. Well, if I'm ingrained in the design team, I know, 'Hey, these are the three devices that could essentially be vulnerable to that new exploit.'"

While the lack of talent may make finding that expert difficult now, it's becoming more and more essential, not just for patient safety and company reputation, but also for manufacturers' pocketbooks. Preston points out that some purchasing agreements and discussions with hospitals are beginning to incorporate the issue of security vulnerabilities and putting the onus on device manufacturers. Whether this will become a larger trend remains to be seen.

One thing that device makers should definitely do? Stop using outdated technology. "Everytime I hear something like "this device is running Windows XP," it honestly—if I were hooked up to some kind of heart rate monitor, you would see it spike—because that terrifies me," Preston says.

Preston recommends manufacturers consider investing in fuzz testing, which automates testing of the device against hundreds of thousands of pieces of data in order to identify problems. She says she thinks fuzz testing offers the "best price per pound," but does point out that a security professional is needed to help companies analyze the results of the testing.

Sommer notes that device companies are putting more focus on the software components of device design. "We're seeing elevated interest in these issues and sort of a new aspect of product development, which is software development, the code writer . . . becoming that much more heightened because of these incidents," he says.

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie 

[Image courtesy of SHEELAMOHAN/FREEDIGITALPHOTOS.NET]

A Biomimetic Dental Material As Strong As Tooth Enamel

Swiss scientists have developed a technique that enables them to imitate miniature geometries found in biological composites with teeth and seashells. The breakthrough could ultimately lead to the development of synthetic materials with strength comparable to some of the strongest materials in nature.

Brian Buntz

Tooth
A cross section electron microscope image of the artificial tooth shows the geometric orientation of ceramic platelets in its enamel and dentin. Image form Hortense Le Ferrand/ETH Zürich.

Scientists have only discovered fairly recently why natural structures such as tooth enamel and sea shells are so strong. In the case of teeth, a basket-weave-like microstructure in the enamel helped prevent tiny cracks in the enamel from spreading, making teeth naturally resist cracking despite the fact that enamel is about as brittle as glass. Meanwhile, a pattern of tiny interlocking 'bricks' helps give sea shells their strength.

Now, researchers from ETH Zürich have taken inspiration from the tiny layers of microstructures that gives such natural materials their strength while also allow replicating the complexity of the structures found within them.

Led by ETH professor André Studart, the researchers were able to produce a complex natural material composed of multiple layers of micro-platelets with an identical configuration in each layer.

To accomplish that, the researchers used a technique known they call magnetically-assisted slip casting. The technique required the researcher to first make a plaster cast mold into which was poured a liquid with magnetized ceramic platelets. Because plaster is porous, it gradually absorbs the liquid in the suspension, enabling the platelets to settle. They can fine tune the orientation of the particles through the application of a magnetic field, which enables the ceramic platelets to be aligned with the magnetic field when the mixture is still in liquid form.

Sintering the final materials densifies and hardens them further.

The technique, which the researchers say is roughly similar to 3-D printing but cheaper and faster, could also be used to make dental prostheses.

To demonstrate the promise of MASC for dentistry, the researchers created an artificial tooth with microstructures that mimic those of a natural tooth. "The profile of hardness and toughness obtained from the artificial tooth corresponds exactly with that of a natural tooth," Sudart said in a statement.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

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NeuroSigma Withdraws IPO Plans

NeuroSigma, an epilepsy treatment company, has withdrawn its plans for its initial public offering through which it was expecting to raise $50 million.

On Friday, the Los Angeles company quietly pulled back its regisration statement with the Securities & Exchange Commission.

On Monday, a gentleman who answered the phone said NeuroSigma is not commenting on reasons for withdrawal.

In filing for an IPO last August, the company explained that it has developed the Monarch eTNS system, a non-invasive external trigeminal nerve stimulation system to be used as an adjunctive therapy to drug-resistant epilepsy and major depressive disorder whose disease is not controlled by one kind of treatment alone.

The eTNS is a disposable patch that a patient can wear on the forehead to administer the therapy by themselves at home during sleep with the help of a pulse generator.  The pulse generator is the size of a cell phone. The product is approved in Canada, EU and Australia, and NeuroSigma is developing a second generation of the therapy.

In January, FDA granted a Humanitarian Use Device designation to the eTNS system, considered to be the first step in obtaining a HUD exemption.

"Our eTNS system may become an attractive adjunctive treatment for many children with Lennox-Gastaut Syndrome.  It is a non-invasive neuromodulation system that these children and their families can use in the home if an HDE is approved," said Ian Cook, M.D., NeuroSigma's Chief Medical Officer in a press release at the time. "Many patients still suffer from the symptoms of this devastating condition despite best current medical practice.  We have already begun collecting the human clinical data necessary to apply for the HDE," said Ian Cook, NeuroSigma's Chief Medical Officer."

Meanwhile,NeuroSigma is progressing along its path to also leverage TFN(thin film nitinol)-based endovascular devices. In May the Mayo Clinic reported that NeuroSigma's TFN flow diverter had achieved good results in 13 rabbits with simulated aneurysms.

"The current first generation flow diverters typically take many weeks or months to achieve complete aneurysm occlusion, even after placement of multiple devices. In contrast, NeuroSigma's TFN flow diverter has thus far shown rapid aneurysm occlusion after placement of a single device," said Colin Kealey, Director of Advanced Development and Medical Affairs at NeuroSigma in a May news release.

The initial registration statement which spelled out NeuroSigma's plans for an IPO had, however, very litle information on this stent technology.

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb

[Photo Credit: iStockphoto.com user Elenarts]

To learn more about medical devices and trends in the marketplace, attend the two-day MD&M Minneapolis conference, Nov. 4 and 5 at the Minneapolis Convention Center. 

How a Doctor Saved a Child with a MacGyver Medical Device

A robotic surgeon got creative rigging together ordinary objects into a nebulizer when a child suffered an asthma attack on a transatlantic flight.

Guru DIY Nebulizer
Khurshid Guru, MD, and his do-it-yourself nebulizer. (Image courtesy of Guru)

Brian Buntz and Chris Newmarker

While flying from Spain to the United States, the physician Khurshid Guru learned there was a toddler on board having an asthma attack. While the child had asthma medicine, it was stowed away with the plane's checked luggage.

Guru, MD--who is director of robotic surgery at Roswell Park Cancer Institute in Buffalo, NY--rigged together a nebulizer using an empty water bottle, a plastic cup, some tape, and an oxygen tank, according to media reports on ABC News, Fox News, and elsewhere.

The doctor was able to find an adult with an asthma inhaler so that the 2-year-old could receive oxygen and medication at the same time through the makeshift nebulizer, which ensured that the medicine was effectively delivered to the child's lungs. Guru's actions on the September 18 Air Canada flight are credited with helping to save the child, whose oxygen levels were falling to dangerously low levels.

Some compared Guru's actions to MacGyver, the fictional U.S. government agent in the 1980s and '90s TV show who shied away from guns and instead solved problems with devices created from ordinary objects. One of the greatest hacks of all time involved NASA engineers figuring out how to use random objects (and a lot of duct tape!) to fit a square carbon dioxide scrubbing canister into a round hole in order to save the Apollo 13 astronauts.

At the end of the affair, the child's oxygen levels had rebounded to a level of 94%.

It is but the latest example of necessity creating some do-it-yourself medical device creation. (Discover five reasons DIY medical device innovation happens. See our features on clever DIY medical devices and top DIY medical devices for more examples of DIY innovation.)

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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

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Do You Really Understand the Problem You're Trying to Solve?

If I were to tell you it's important to understand a problem before you start trying to solve it, you might reply with something like "nice one, Einstein" (sarcastically, of course...). Well then, did you know that one of the most common failures of entrepreneurs and startup companies--whether in the medical technology field or in other sectors--is not understanding the problem they are setting out to solve? And worse, that many of them had every intention of understanding the problem, but never managed to achieve it?

Geoff Rogers

Geoff Rogers
Geoff Rogers, PhD, is the director of IntelliMedical, which has developed a robotically steerable guidewire for use in interventional procedures.

In this article, I will attempt to show you how to assess your level of understanding of your own problem, determine what's important (and what's not), and take corrective steps ASAP, if necessary. If you're unsure how this article fits into the bigger picture, check out my recent "vitals list" post.

First, let's draw a line in the sand and remove a potential mental barrier. Right now, in this moment, whether you've started down the solution path already or you've yet to begin, it's irrelevant. What matters is that you have an opportunity to stop the clock for a moment, step back, and take stock. So forget your solution or idea for now, and let's get started!

What Does It Look Like to Truly Understand a Problem?

The best strategy I've found is to reduce everything down to one or more discrete "use cases."What's a use case? Say you intend to develop a solution, a use case is the complete description of when, where, why, and how your solution would be used to solve the problem. It's about putting yourself in your end user's shoes. Someone who truly understands their use case will be able to have a conversation with someone who has no knowledge of the problem, and clearly articulate the series of events that lead to the occurrence of the problem. As Einstein reportedly said: "You do not really understand something unless you can explain it to your grandmother."The particularly nice thing about this approach (other than understanding the problem!), is that it's fundamentally user centric.

Do You Understand Your Problem?

Test yourself. Take a step back and see if you can completely articulate your use case(s). In doing so, you should be addressing most, if not all, of the following questions:

  • When and where does the problem occur?
  • What series of events or factors lead to the occurrence of the problem?
  • Who is present/responsible when the problem occurs?
  • Who is affected by the problem? How?
  • Are there any other stakeholders associated with the problem?
  • Can the entire problem be addressed by a single solution, or is it more complex?
  • Are there any constraints or considerations that would prevent the problem from being solved?

There may be other questions you need to ask for your particular problem, but this list provides a good starting point.

Holy Cow! I Don't Understand My Problem. What Should I Do?

If you find that you don't know the answer to some or all of these questions, and thereby don't understand your problem as well as you could, get to work on finding answers ASAP! Make sure this process incorporates thorough consultation with your end users, and be sure to really drill down on all pertinent points. Don't just take things at face value; seek to gain the deepest possible understanding, like you would have if you were the world-leading expert in the discipline. The ultimate goal is to be able to clearly and concisely articulate your use case(s) to both end users and non-users without fault and with an answer for every conceivable question.

Finally, adopt an attitude of continual learning. There's always more you can learn, especially as the field of medicine is constantly changing and developing with the latest best practices.

Geoff Rogers, PhD is a medical engineer and entrepreneur, who specializes in the development and commercialization of next-generation medical devices. He has successfully cofounded and led a number of medtech companies. He is most widely known as the founder of IntelliMedical.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

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Is Medtech Still a Good Career Choice?

Is Medtech Still a Good  Career Choice?

Medical device and diagnostic companies have traditionally offered higher-than-average salaries and growth prospects, but is medtech still a good industry in which to stake your career?

Jamie Hartford

Each year when we conduct our Medtech Salary Survey, we ask respondents the same question: Do you think the medical device and diagnostic industry is still a good career choice? The answers mostly range from “yes” to “absolutely”—and that’s largely for good reason.

The most common justification respondents give to back up their claim is the industry’s high compensation. Medtech industry professionals enjoy a median annual salary of $107,000, according to our data. That’s more than double the $47,230 mean annual salary for all U.S. workers reported by the U.S. Bureau of Labor Statistics (BLS). And that figure doesn’t even include the $10,000 median bonus medtech workers report receiving annually.

Respondents also say medtech is a great industry to work in because it offers relative job security. Sure, there were tough times during the Great Recession and immediately following it, but in general the medtech industry weathers the ups and downs of the global economy better than many other sectors. This year, more than 84% of the respondents to our survey said their job security is higher than or about the same as it was last year.

Many who believe medtech is still a great career choice also cite the fact that the industry is growing at a fast rate. Currently valued at about $350 billion dollars, the market for medical devices and diagnostics is predicted to reach $440 billion by 2018, according to EvaluatePharma. Moreover, the industry’s 4.4% growth rate is expected to outpace that of the pharmaceutical industry.

But there are always a few people whose outlook on the industry is not quite so rosy. As one survey respondent who said medtech is no longer a good career bet told us, “The industry is saddled with more and more regulation. Both regulatory and compliance reporting requirements are expensive and heavy burdens on companies. Additionally, the medical device tax is another burden.”

Another respondent bemoaned that the recent wave of mergers and acquisitions is impacting the industry for the worse, saying “job stability has significantly decreased” as a result of consolidation among companies. More than a third of respondents to our survey said their company has gone through a merger or acquisition over the past 12 months. Among those, job satisfaction was slightly lower (3.8 vs. 3.9) and job insecurity was slightly higher (18.3% vs. 15.7%) than for medtech employees overall. More of those whose company has undergone an M&A also said they’re actively looking for a new job (15.1% vs. 13.4%).

A number of respondents also cited job stress as a reason the industry isn’t as appealing as it used to be. “A ‘do more with less’ mantra has made my job very stressful,” one person told us, while another pointed to “unrealistic” workloads.

The industry may also not be such a great place to work if you’re a woman. Men outnumber women four to one at medical device and diagnostic companies, according to our survey. The ratio is even more akilter for jobs in general and corporate management and product design engineering, where men outnumber women by around nine to one. Men also outearn women in the industry, with women’s salaries standing at about 82% of men’s—the same gender pay gap seen in the U.S. labor force as a whole, according to the BLS.

Minorities, too, are underrepresented and underpaid in medtech. While minorities account for 37.8% of the U.S. population, they account for only around 22% of employees in the medtech industry, according to our survey. Members of minority groups also make only about 88% as much as their white counterparts.

Still, while everyone’s prospects in the industry might not be equal, many of the respondents to our survey said medtech is still a good career choice for reasons that go beyond the numbers. “It’s very rewarding to know your products are helping people, and in many cases saving their lives,” one person wrote. Or, as another put it, “The world can do without another microwave oven but not the next medical device.”

Find out how your compensation compares with that of your peers in medtech with our free 2015 Medtech Salary Survey report.

Jamie Hartford is MD+DI's editor-in-chief. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie.

[image courtesy of MASTER ISOLATED IMAGES/FREEDIGITALPHOTOS.NET]

More Limits for Bayers' Controversial Essure Device?

Some women are less suitable for the Essure device, according to an FDA panel, which examined thousands of complaints over the past decade.

Chris Newmarker

A U.S. FDA advisory panel is recommending more limited use of Bayer's Essure contraceptive device amid complaints of health problems from thousands of women.

The nickel and titanium Essure coils are implanted in women's fallopian tubes. The panel agreed that such hysteroscopic sterilization should remain an option for women who are not good candidates for laparoscopic or general surgery, such as women who are obese or can't tolerate anesthesia.

But the panel also said the Essure device should be considered less suitable for patients experiencing other problems including known metal allergies, autoimmune disease, a history of pelvic inflammatory disease, and/or a history of abnormal uterine bleeding, according to an FDA summary of the meeting last Thursday.

FDA is not bound by its panels' advice, but often follows such recommendations.

The FDA's Obstetrics and Gynecology Devices Panel heard sometimes emotional testimony on Thursday as a string of women blamed a Bayer's Essure contraceptive device for ruining their health, according to media reports.

For example, 33-year-old Chandra Farmer said she experienced muscle weakness so severe that she collapsed in front of her kids; she finally had a hysterectomy to remove Essure last year, according to The New York Times. Gabriella Avina once worked for the company and helped explain Essure to women, she has since changed her mind after going through celiac disease and myasthenia gravis.

Planned Parenthood and the American College of Obstetricians and Gynecologists still back the device, saying there have been few problems overall. And Bayer argues that complications have been rare.

About 750,000 women have had Essure implanted since FDA approved it in 2002, according to The Associated Press.

FDA has received nearly 6000 reports of problems related to Essure. The advisory panel on Thursday discussed Essure-related complaints including persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, allergy or hypersensitivity reaction, and cases of pregnancy still occurring. Such problems have sometimes required device removal.

Many panel members agreed that a randomized controlled trial of Essure, while ideal, would be impractical. They instead suggested that ongoing trials be reviewed, with some panel members calling for the creation of a registry to follow implanted patients.

Other recommendations included more information and access to health services for women getting Essure implants, as well as the need for additional physician training.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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

What You Need to Know about the ISO 9001:2015 Revision

What You Need to Know about the ISO 9001:2015 Revision

The International Organization for Standardization has released its 2015 revision of the ISO 9001 quality standard. Check out all the major changes here.

Marie Thibault

The ISO 9001 quality management system standard has been revised and published by the International Organization for Standardization. The 2015 version replaces the 2008 version of the standard, and companies who were certified using ISO 9001:2008 have three years to meet the 2015 requirements.

In a press release announcing the publication of the revision, Kevin McKinley, acting ISO secretary-general, said,

“The world has changed, and this revision was needed to reflect this. Technology is driving increased expectations from customers and businesses. Barriers to trade have dropped due to lower tariffs, but also because of strategic instruments like International Standards. We are seeing a trend towards more complex global supply chains that demand integrated action. So organizations need to perform in new ways, and our quality management standards need to keep up with these expectations. I am confident that the 2015 edition of ISO 9001 can help them achieve this.”

For a quick overview of the major revisions to the standard, this infographic from Advisera's 9001 Academy is a useful resource.

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Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie 

[Infographic courtesy of ADVISERA. Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]