Legal accusations continue between orthopedic medical device competitors Zimmer and Stryker, with Zimmer now accusing Stryker of a "Trojan Horse" scheme to poach its Amarillo, TX-business. In a lawsuit filed Wednesday in U.S. District Court in northern Indiana, Zimmer's lawyers draw a comparison to Homer's celebrated ancient war because they claim that Cody Stovall, a former Amarillo orthopedic surgery products sales rep, was claiming to leave Zimmer to sell a Stryker biologic plasma spray in the area. Zimmer claims that Stovall's real reason for leaving was to help Stryker poach Zimmer business, with a chance to earn a $30,000 bonus for every $500,000 in deals he converted. In fact, Stovall was conspiring with Stryker while he was still at Zimmer, according to the lawsuit. A Stryker media relations person declined to comment. Stovall could not be immediately reached.

Learn about cutting-edge medtech technologies and trends at MD&M West, which is held February 10-13 in Anaheim, CA.

The lawsuit claims Stovall bragged about his arrangement with Stryker to former colleagues at Zimmer. The selling of the biologic plasma spray was meant to get Stovall into the same surgeries his former Zimmer colleagues were attending, just like the wooden horse of yore that appeared to be a gift for Troy but was instead stuffed full of Greek soldiers, according to the lawsuit filing. The lawsuit said: "Stovall's sale of the biologic product is simply a 'Trojan Horse' to hide Stryker's and Stovall's real actions." This is not the first time that legal accusations have flown between Zimmer and Stryker. The two companies settled a lawsuit last year in which Stryker accused Zimmer of poaching its employees and trade secrets, according to Law360. Also last year, a federal judge ordered Zimmer to pay $228 million to Stryker as part of a patent infringement lawsuit involving Zimmer's Pulsavac Plus, designed to remove organic debris from inside a patient during orthopedic surgeries.

The FDA is considering creating an accelerated approval pathway for novel medical devices designed to treat unmet needs. The expedited pathway would require post-approval studies and would resemble a process already in use for some pharmaceuticals. At present, complex life-sustaining Class III products are approved via FDA's premarket approval (PMA) process, which requires substantial clinical data for new products. The FDA approval process for such devices has been faulted for its slowness and its financial burden on device companies. A Stanford report from 2010 found that costs associated with PMAs averaged $94 million, $75 million of which was linked to FDA requirements. In addition, such devices were approved an average of two years after they had hit the market in Europe. The first-generation Sapien percutaneous heart valve, for instance, was approved by FDA four years after it hit the market in Europe. "A safe and effective technology may take longer to get to U.S. patients, and that's contrary to what we are about," Jeffrey Shuren, MD, director of FDA's CDRH branch, told MedPage Today. Law dictates that PMA products should be approved or rejected within a 180-day approval window. The agency has long struggled to meet that requirement, and the average time it takes for the agency to approve a PMA device has generally increased over the past decade. Last year, however, FDA reported substantial improvements in its timeliness in approving PMA products.

Learn about cutting-edge medtech technologies and trends at MD&M West, which is held February 10-13 in Anaheim, CA.

Speeding the pathway for novel life-sustaining or life-saving devices would have obvious benefits as well as risks, according Shuren. The risk would require greater use of post-market studies. Nevertheless, Shuren acknowledged his frustration with the growing regulatory timelines, which run counter to the agency's mission to ensure that patients have timely access to new products. The agency plans on issuing guidance related to its plans and will request formal public feedback. FDA has also received negative feedback for its PMA-supplement program, which enables some new products to be approved without clinical data. In cases such as these, a new device can be submitted to FDA as a supplement to an existing PMA applications that may be been filed several years--even decades--earlier. A recent study titled "FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012," reports that the agency approved 77 original PMAs and 5829 supplements to PMAs for devices that altered an existing product's design. Examples of products approved as supplements include the Medtronic Sprint Fidelis and St. Jude Medical Riata leads, which were recalled.

Chinese researchers have figured out how to genetically modify research monkeys in a single generation, using a targeted DNA editing strategy, according to a paper recently published in the journal Cell.

The strategy involves special snippets of DNA called Clustered Regularly Interspaced Short Palindromic Repeats (CRISPRs) often found in many bacteria and archaea. 

No, it isn't at Planet of the Apes levels yet. But Chinese researchers have found a way to genetically modify primates for research purposes within a single generation. (Image courtesy of Wikia)

The work--conducted by researchers at Yunnan Key Laboratory of Primate Biomedical Research (Kunming, China), Nanjing Medical University, and other institutions--should produce useful monkeys for medical research studies, and also suggests that there is a potential to use CRISPRs for gene therapy in humans. Here's how MIT Technology Review describes the Chinese researchers' work:

"The Chinese researchers injected single-cell macaque embryos with RNAs to guide the genome-editing process. The team modified three genes in the monkeys: one that regulates metabolism, another that regulates immune cell development and a third that regulates stem cells and sex determination, says study coauthor Wezhi Ji, a researcher at the Yunnan Key Laboratory of Primate Biomedical Research. The researchers found that the genome-editing tools created multiple changes in their target genes at different stages of embryonic development. The infant monkeys are too young for the team to yet determine if the genetic changes have an effect on physiology or behavior, says Ji. But, he adds, "data from this species should be very useful for curing human disease and improving human health."

Robert Desimone, director of MIT's McGovern Brain Institute for Brain Research, tells the MIT publication that he and his colleagues also plan to engage in gene editing in order to modify monkeys. Other researchers are working to get rid of the need of animal testing altogether with in-silico trials and organs on a chip.

Learn about cutting-edge medtech technologies and trends at MD&M West, which is held February 10-13 in Anaheim, CA.

Everyone has, at some point, looked at some new device and wondered, "How do I...?" Usability design seeks to minimize these frustrating moments. Also known as human centered design, this field is rapidly becoming more important as devices become more capable and therefore more complex. The days when common-sense approaches were sufficient, such as a wheel to steer your car rather than a tiller, are fading fast.

Image courtesy of Stanford Center on Longevity

One rueful joke maintains that among new smartphone users the most commonly uttered word is, "Oops!" In the field of medical devices this can't be allowed to happen. Great usability design can save lives, and poor design can cost them. Those devices with some sort of screen interface and multiple modes of operation can be dauntingly complex. And with more and more devices and less and less time to learn how to use them, a merely good user interface can be simply not good enough.

Specifically focused on usability design in medical devices, the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Standards Organization (ISO) have published ANSI/AAMI/IEC 62366:2007/(R)2013, "Medical Devices - Application of Usability Engineering to Medical Devices." This standard is intended "to provide a usability engineering process for medical devices that assesses and mitigates risks caused by usability problems associated with normal use."

As Reade Harpham, Battelle's (Columbus, OH) director of Human Centric Design, wrote on Wired's Web site, "FDA is becoming aggressive with their enforcement of good human factors, and rightfully so. In 1999, the Institute of Medicine released "to Err is Human," which outlined the fact that up to 98,000 deaths resulted from medical error at a cost of $29 billion. Since then, they have been steadily beating the drum, releasing new guidance and tirelessly training companies on how to appropriately incorporate human factors."

And a search of the FDA Web site yields numerous returns for the search terms, "interface design." "Do It by Design - An Introduction to Human Factors in Medical Devices" is likely a good place to start. Other guidance documents include those for software in medical devices and a draft guidance, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design." Though seasoned medical device designers are doubtless quite familiar with these and other FDA guidance documents for usability design, the point is that FDA is paying attention.

Although more general in focus, other government resources include the Department of Health and Human Services usability.govWeb site which offers, among other assistance, its "Research-Based Web Design & Usability Guidelines" in a downloadable PDF guide. Although intended for Internet usability, this guide may offer some additional help for screen interface designers.

Johnson & Johnson has announced its plans to share data from its clinical trials with researchers. The healthcare conglomerate will offer anonymized data shared from clinical trials of medical devices, pharmaceuticals, and consumer products. The plan, which will be orchestrated by J&J subsidiary Janssen Research and Development LLC (San Diego, CA), will involve collaborating with the Yale School of Medicine's Open Data Access (YODA) Project. The Yale body will will independently assess requests from researchers and clinicians seeking access Janssen's data. "Sharing anonymized data from clinical trials is critical to advance public health because it furthers our understanding of diseases, expands the base of knowledge needed to develop new treatments, and generates new insights and more complete evidence to enable better healthcare decisions for patients - all while protecting patient privacy and confidentiality," said Joanne Waldstreicher, MD, chief medical officer of Johnson & Johnson in prepared remarks. According to Johnson & Johnson, this is the first time that a healthcare firm has decided to partner with an independent third party to review and make decisions regarding its clinical-data. Last year, Medtronic announces its own collaboration with Yale University, which performed an independent study of the company's INFUSE bone graft. After questions were raised about the product's safety, Medtronic reached out to Yale in 2011 to review the clinical data related to the device. Also in 2013, pharmaceutical giants Glaxo SmithKline and Pfizer revealed plans to open up clinical trial data, while stopping short of permitting an independent third party to review data requests. Pfizer also changed its clinical trial data access policy, opening up anonymized patient-level data from trials of approved pharmaceuticals to scientists.

Remote patient monitoring will be the most important medical device trend of 2014, according to an informal survey of MPMN readers.

As of about 3 p.m. Pacific time on Friday, 22 out of 59 respondents voted for remote patient monitoring. Second place went to 3-D printing, with 19 votes.

The results of the other categories were as follows: six for reinventing diagnostic devices, five for healthcare IT expansion, three for nanotechnology, and one each for next-gen user interfaces and medical imaging equipment. 

Two responses were in the "other" category, for "sharing clinical trial data" and "womens health care"

Google is developing a contact lens to measure glucose levels in diabetics.

In some ways, it makes sense why telehealth would be so important to MPMN readers, because its importance is growing as the United States attempts to shift a growing amount of healthcare delivery from more-expensive venues like hospitals to less-expensive venues like the home. Just last year, Medtronic demonstrated its faith in the remote patient monitoring space with the acquisition of Cardiocom LLC.

The potential for medical wearables continues to expand, too. Google, for example, is developing a contact lens to measure glucose levels in diabetics. And Apple appears to be hiring medical device professionals to help with development of the iWatch.

In order to find out more about the other categories, check out our recent slideshow.

Learn about cutting-edge medtech technologies and trends at MD&M West, which is held February 10-13 in Anaheim, CA.

It seems pretty logical: Hearts beat, movement is energy, and electricity produced off the movement could power an implantable medical device such a pacemaker.

But over the decades, there has never been an energy-harvesting strategy that really met medical device designers' needs--until now. Enter flexible electronics pioneer John Rogers, PhD, of the University of Illinois-Champaign with a super-thin silicone-encased, bendable energy harvester that can be affixed to a beating heart.

Rogers and colleagues have placed the device on the surface of hearts beating inside anesthetized cows and sheep, demonstrating that it can produce up to 1.2 ?W/cm², according to a paper Rogers and his colleagues recently published in the Proceedings of that National Academy of Sciences. 

A millionth of a watt or two is not a lot, but it is enough electricity to power a pacemaker, Rogers told MPMN on Thursday. Embed more flexible components inside the silicone, and it might even become a complete pacemaker. 

Rogers and colleagues have placed the energy harvester on the surface of hearts beating inside anesthetized cows and sheep, demonstrating that it can produce enough electricity to power a pacemaker.

The energy harvester, though, still needs long-term trials to show it can hold up inside animals, Rogers acknowledges. Human trials could be a decade or more away in the United States.

Still, it is now tantalizingly possible that medical device designers will one day be able to power their creations using the natural movements of the patient using the device--including heartbeat-powered pacemakers and potentially defibrillators if flexible batteries are packaged in.

That means much tinier, less invasive devices for the hundreds of thousands of heart disease patients presently using pacemakers and defibrillators.

The challenges that Rogers and his research partners had to overcome over two and a half years, though, demonstrate why it is only now that powering a device off a beating heart seems even remotely possible.

Rogers, who co-founded Cambridge, MA-based flexible electronics maker MC10 and other ventures, has plenty of experience creating bendable silicon circuitry and other flexible electronic. He suspected that the field might have an answer for power generation because previous schemes, such as harvesting energy from blood flow or taking advantage of temperature changes, relied on watch-like devices with moving parts.

"I think anything that involves a moving part is going to be extremely challenging," Rogers says. He thinks the need for moving parts is what has caused medical device designers to rely on batteries versus power generation.

Rogers latched onto the idea of instead using a piezoelectric substance, a material that generates electricity when it is moved, to create an energy harvester. He ended up opting a crystalline, ceramic compound called lead zirconate titanate, called PZT for short, because it is already commonly used.

"We prefer a solid-state type of construction that eliminates any moving components inside the device," Rogers says.

Three major challenges then occupied much of Rogers' and his colleagues time:

They needed to produce PZT layers that were actually flexible.

The answer was similar to what Rogers latched onto for flexible silicon circuitry: Make it really thin. The New Yorker recently described the years Rogers and colleagues spent years figuring out how to bake thin silicon circuits on a silicon base or substrate, chemically wash away the silicon surface underneath the circuit, and then use a specially designed rubber stamp to ever-so-gently transfer the thin circuit away to a flexible base. The same type of thing had to be done with PZT, which is also baked on a silicon substrate and then transferred off so it could be embedded inside the silicone.

Rogers thinks it is really this transference process--this ability to remove circuits and other electrical components from the silicon they are baked on in a reasonable, reliable way--that is enabling the power generator and many other flexible electronic innovations.

Power generation needed to be super efficient.

A beating human heart only produces 2 to 3 watts of energy, and Rogers knew the energy harvester would only be able to harvest a tiny fraction of that if it was to avoid damaging the heart. These were PZT layers embedded in silicone and integrated with rectifiers and millimeter-scale batteries. Research partners at Northwestern University ran countless computer simulations to figure out the optimal layering of PZT that would produce the most energy. "We worked hard with our theoretical partners at Northwestern to put together a model, experimentally validated, that really captures all the quantitative details about how current is produced when you build a device of that type with any materials combination," Rogers says.

It also needed to avoid damaging the heart.

The more external pressure the energy harvester places on the heart, the more electricity it will produce. But it is also more likely to cause arrhythmias as other damage that defeat the purpose for having the device there in the first place. "It requires very careful attention to how the device is interacting with the organ it is mounted on," Rogers says.

A good start was to make sure the energy producer put less pressure on the heart than the natural pericardium encasing it. Next were the open heart experiments on the live cows and sheep conducted at the University of Arizona. As a result of the experiments, Rogers suspects it is safe to produce a few microwatts off a beating heart, though not much more.

More electricity might be possible off lung movement, abdominal movements or even muscle movement. But with the heart, a few microwatts is a safe range if designers are to avoid disrupting the beating of the heart, according to Rogers.

"A heart is kind of a critical organ, so we have to be careful. ... You could push it, but you have to do careful studies. ... I don't think you want to be anywhere near where bad things might start to happen," Rogers says.

See Princeton University's John McAlpine discuss bionic nanomaterials on the Center State at MD&M West, February 10-13 in Anaheim, CA.

For Rogers and his colleagues, the next step with the energy generators will be to implant them for half a year inside living cows and sheep and see how well they hold up.

Batteries inside some of the tiny, next-generation leadless pacemakers such as St. Jude Medical's Nanostim or Medtronic's Micra can last for 10 to 13 years, so the flexible electronics power generator will have to last even longer, Rogers says.

"We need to do the longer term survivability on the animals. ... By definition it needs to last for more than 10 years," Rogers says.

An actual energy generator operating on the surface of a human heart is probably a decade away.

"I don't have a lot of concerns with the device itself. It's really how the device is interacting with the body ... the biological responses. ... You have to be conservative on those types of things," Rogers says.

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