Trump Versus Clinton: 'Inversion' Merger Deals

Donald Trump

Trump has said he does not blame companies for wanting to go overseas to save money on their taxes. Instead, he's blamed high U.S. corporate taxes for prompting them to flee. Trump has proposed cutting the top corporate tax ratefrom 35% to 15% percent as a way to lure businesses back to the United States. He has  also proposed a one-time "repatriation tax holiday" that would allow each company that has money overseas to bring it home tax-free. He later changed that proposal to say he'd require them to pay a 10% tax on that money, according to a reportin The Nation.

Hillary Clinton

Clinton's campaign website says the candidate would restrict tax inversions and related transactions through both congressional and regulatory action, and would charge an "exit tax" for companies leaving the U.S. to settle up on their untaxed foreign earnings. She would also impose a 50% threshold for foreign company shareholder ownership after a merger--before an American company can give up its U.S. identity. If Congress does not address inversions and related loopholes, Clinton said she will ask the U.S. Treasury Department to use its legal authority to prevent inversions and restrict the tax loopholes they allow, including cracking down on "earnings stripping," one of the key benefits of inversions.

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[Trump portrait by Michael Vadon, CC BY-SA 2.0. Clinton portrait by Gage Skidmore, CC BY-SA 3.0.]

Trump Versus Clinton: Medical Device Tax

Hillary Clinton

Hillary Clinton has hedged on making the repeal of  the medical device tax permanent, even when she spoke to an AdvaMed conference. Her stance on the tax remained noncommittal this year, too, according to a representative of her campaign. Congress granted the medtech industry a two-year reprieve from the 2.3% tax in when it passed a roughly $1 trillion spending bill in December 2015. The industry has described the tax, which went into effect at the beginning of 2013, as a jobs-killer.

Donald Trump

Trump has spoken broadly about taxes, but not specifically about the medical device tax. He told a conservative group in Colorado in July that he would "eliminate job-killing regulations" and "have massive tax reform and simplification," according to a report in the Denver Business Journal. Former HHS secretary Tommy Thompson, who supports Trump's campaign but does not represent it, told an audience at this year's AdvaMed conference that the tax would likely be repealed if Trump were elected.

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[Trump portrait by Michael Vadon, CC BY-SA 2.0. Clinton portrait by Gage Skidmore, CC BY-SA 3.0.]

Is Trump or Clinton Better for Medtech?

    
2016 Presidential Election

With the U.S. presidential election now upon us, we take a look at where Hillary Clinton and Donald Trump stand on issues that matter to the medical device industry. 

Nancy Crotti

Updated November 7, 2016

Which major U.S. candidate is best for the medical device industry? One clue to answering the question comes from a recent Rand Corp. report published by the Commonwealth Fund. The report found Clinton's healthcare plan would provide health insurance coverage for 9 million more Americans, while Trump's would strip it from about 20 million, according to an Associated Press relaying of the report. 

And while neither campaign responded to a Qmed list of medtech-related questions, previous media coverage of the candidates and their campaigns' own websites provide some additional answers. Here's what we found

Continue >>

(Brush up on the latest medical device industry innovations at BIOMEDevice San Jose, December 7-8, 2016.)

Nancy Crotti is a contributor to Qmed.

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[Illustration by Chris Newmarker/Qmed]

EarPods and EpiPens: The Design Dynamics Behind Permanent Adoption

EarPods and EpiPens: The Design Dynamics Behind Permanent Adoption

Universality inspires commitment from customers, but can also bring rocky relationships. Here's why medical device makers should care about universal design.

Nigel Syrotuck

I've always wanted to open an article with a headline along the lines of "The Paradigm Shift is Happening Right Now." In reality, two news stories in the last month prove that paradigm shifts are the last thing people want. They show that universality makes consumers comfortable in their product relationships and resistant to change, even if that change come from a place of greed.

The first news story was the now-infamous EpiPen price hike, where Mylan increased the price of a set of two from around $100 (a few years ago) to closer to $600 for no apparent reason. For most people who use EpiPens, their relationship with Mylan is not a choice. EpiPens are universally used to treat life-threatening reactions and there isn't an easy alternative to switch to.

The second news story is Apple's controversial wireless EarPods, which are far less evil and have a much smaller impact on people's lives, but are still a good example of how customers who have no substantial reason to be stuck in their commercial relationship will still stick with it through highs and lows.

Hear more from Syrotuck when he and Paul Charlebois discuss "Achieving Universality vs. Simplicity in Design: Why Are Physicians and Patients Demanding Both?" at BIOMEDevice San Jose, December 7-8.

Let's start with the EpiPen. In case you were unaware, the EpiPen is a brand of simple epinephrine auto-injector to treat acute anaphylactic reactions. They own 90% of the market (which may grow since multiple competitors have had recalls), and their name, brand, and industrial design are ubiquitous and easily recognizable. Epinephrine (aka adrenaline) is a hormone, and it's pretty darn cheap, with the price of the amount of epinephrine in an EpiPen being about $1.

So, how did EpiPen get away with this massive price hike? Why doesn't anyone make a different product that is cheaper? Why don't people just walk around with a small vial of epinephrine and a regular syringe in their purse instead of an EpiPen? There are a number of great articles about this that go into detail, but it really boils down to a simple combination of patents and universality.

The design for their auto-injector is patented (until 2025), so no one can copy it, and it's universal, so everyone already knows how to use one. By contrast, the needle and vial seem complicated and foreign compared to the sleek and familiar auto-injector. Parents don't want to trust their children's lives on the assumption that people can figure out how to use another method of delivery, so they feel stuck with EpiPen as long as they can afford it.

The EpiPen brand didn't stumble upon their universality accidentally. They spent a lot of time and money ingraining their product into our lives from a young age, providing EpiPens free to school nurses along with free training. Besides, once everyone is trained and using the device, how can you realistically expect them to learn how to use a second type of auto-injector? Why would anyone ever want to change while the product is easy to get and affordable to buy?

Apple's new wireless headphones are another case of exactly the same thing. Wireless earbuds have been around for a while, but the reason this controversy is suddenly popping up now is choice. Or maybe I should say the lack of choice. Apple isn't offering wireless headphones to people who can choose to buy them if they wish. Like EpiPen, they are imposing a change on their existing consumer base without a viable option and, like EpiPen, they know their customers will stay because they want the universality that comes with Apple products. They are committed to the relationship they have, and Apple customers definitely don't like change.

Though a little off topic, Apple does know what they're doing when they make a move like this. I think they missed the mark completely with these earbuds, but at least they recognize the need to drive change from within to stay relevant, and not let their consumers set the pace. As Henry Ford is widely credited with saying, "If I had asked [my customers] what they wanted, they would have said faster horses." Ford would not be around today if they weren't ahead of the curve. Of course, Henry Ford also built a car with wheels that were actually connected to the vehicle and didn't jack up the price of gas after selling his cars to people who truly needed them.

Where market share drives initial adoption, permanent adoption--like the kind found in these examples--is driven by difficulty in learning new things (and the first-learned advantage). You can always switch from Coke to Pepsi--they have the same type of can and they work the same way--but it is difficult to switch from an EpiPen. Other types of auto-injectors have fundamentally different mechanisms that can be difficult to figure out in high stress, life-threatening situations.

Where consumers are offered choice (like with Apple), most prefer not to learn a new system even if they don't feel like they have to. Have you ever given your grandmother a new telephone? She is lilkely to "just want her old one back" no matter how finicky the rotary dial was. This concept of familiarity is so fundamental to usability that it governs the need for universal standards in thing like gas pedals: if all the brands were different people would either be forced to stick with one automaker or would be slamming on the gas instead of the brake in a moment of panic.

Maybe one day, when the patent has expired, the EpiPen style of auto-injector will be the universal standard--if they haven't been overthrown before that. If they still own the market by the early 2020s, they are very likely to drop the price before the patent expires.

The ultimate goal of medical device manufacturers (besides improving the healthcare system) is to create something simple enough that everyone wants to use it, yet unique enough that you can patent it and your customers will commit to you and your product. If you're lucky, your product will be so universal that it will continue to be the standard long after the patent expires. A good industrial design team, extensive user studies, and the right marketing strategy can get you to a product like that--just try to use your new power over the market for good rather than evil. 

Nigel Syrotuck is a mechanical engineer at StarFish Medical, a medical device design company headquartered in Victoria, British Columbia.

[Image courtesy of BLACKZHEEP/FREEDIGITALPHOTOS.NET]

How to Apply FDA's 3-D Printing Guidance to Medtech Manufacturing

How to Apply FDA's 3-D Printing Guidance to Medtech Manufacturing

FDA gave the medtech industry draft guidance on additive manufacturing earlier this year, but how can manufacturers translate the agency's thoughts into their process validation and quality assurance practices? 

A few months ago, FDA issued draft guidance on additive manufacturing for medical devices. This document offered industry a better idea of the agency's thinking on the use of 3-D printing and additive manufacturing for devices, but didn't give manufacturers an exact map for navigating these relatively new waters.

As a group of legal experts wrote in MD+DI soon after the draft guidance was released:

The draft guidance includes important information about FDA's current thinking, but also stops short of clearly addressing  many key questions raised by the use of AM in medical devices, such as where one draws the line between the manufacturing process and the finished regulated device, considerations for point-of-care manufacturing, or who should be considered the "manufacturer" of the finished device under different scenarios."

Still, the draft document is enough to start changing some practices for device manufacturers. Mark Cola, president and CEO of Sigma Labs, pointed out during an interview this summer that process validation is one part of the manufacturing process that is evolving. Before the guidance, a manufacturing engineer took a slow, meticulous, trial-and-error approach to process validation, he said. That approach focused on the post-process portion of the manufacturing timeline.

Learn more about "FDA Regulations Impacting Connected Health Devices and IoT" at BIOMEDevice San Jose, December 7-8.

"[Manufacturing engineers]  would have to effectively make the parts in one step and inspect them in another. They would make a bunch of parts, destroy them by evaluating their strength, toughness, and other properties, fatigue resistance, as well as measuring the microstructural attributes of the part, including the geometric properties," Cola explained.

That meant that manufacturing and inspection were separate steps, causing a time lag. FDA is aware of the inefficiency and wasted resources associated with this method, Cola said. With the draft guidance, "[FDA is] trying to couple the inspection step with the manufacturing step . . . they're trying to give comfort that the entire manufacturing process is observed and not just a snapshot in time," he explained. 

Sigma Labs' PrintRite3D system allows manufacturing engineers to perform in-process quality assurance.

Performing process validation and acceptance activities means manufacturers must show that the finished part meets design intent. There are three basic attributes--metallurgical, geometric, and mechanical properties--that need to be correct in order to show compliance with design intent.

Sigma Labs' PrintRite3D system targets the metallurgical and geometric properties, ensuring these attributes are correct in a medical device part. "Our software suite is designed to interrogate those attributes and report on every layer of every part of every build," Cola said.

Cola

PrintRite3D gives manufacturing engineers near real-time information. They receive in-process quality details for each layer, giving them the opportunity to "take immediate action," Cola pointed out. After the part is finished, the engineers have an exact record of each layer of the part. "We go the extra step and we basically give the manufacturing engineer insight into the process and it repeatability, build to build and machine to machine," he said.

FDA's draft guidance recommends using test coupons, defined by the agency as "a representative test sample of the device or component," for process validation. Cola said that in that same vein, the PrintRite3D system provides "witness coupons." These "become a record of the build and provide a link back to the quality and repeatability of the process," he explained.

"Our unique selling point comes from the fact that we've gone to the trouble of taking the information we gather and [made] it actionable for the end-user, the manufacturing engineer on the floor," said Cola.

So far, feedback on the system from the medical device industry has been positive, said Ronald Fisher, vice president of business development at Sigma and head of the PrintRite3D operating division. He added that customers have mentioned that the software for monitoring geometric properties has been particularly helpful for a specific application: meeting ASTM standards for the size, shape, and depth of the pores of a surface coating. Porous, rough surface coatings are sometimes applied to implants to encourage bone growth. Some customers are "us[ing PrintRite3D] as a method of ensuring the quality of the pore structure that they're printing and producing in their final part," Fisher said.

While FDA's draft guidance addresses additive manufacturing for medical devices, Cola noted that the mass production implied by additive manufacturing is a large leap from the small volumes 3-D printing is known for. Sigma Labs' software is intended "to bridge that technology chasm and enable . . . [the] end-user to move from 3-D printing and batch production and smoothly transition over to additive manufacturing."

The agency's draft document is also helping to close that gap, Cola said. "Things like the FDA guidelines bascially pave that bridge that we've established with our software."

[Images courtesy of STUART MILES/FREEDIGITALPHOTOS.NET and SIGMA LABS]

Why We Must Apply Lean Startup Principles to Medical Devices

Why We Must Apply Lean Startup Principles to Medical Devices

A medtech entrepreneur explains why more medical device startups need to be run lean and the lessons he learned building a lean device company. 

Dr. Shantanu Gaur 

Tech startups have built a whole culture--practically a religion--around running lean and producing high-quality products with minimal capital expenditures. Medtech startups, on the other hand, tend to take on large amounts of investment early on, often before they know their market or what products will best serve that market. 

Of course, information technology and medicine are two different realms, with specific requirements and limitations. However, there's a lot that medical device companies in particular can learn from tech startups when it comes to running lean and mean. Capital efficiency isn't just a good idea for medical device startups--it's the key to survival and success in today's market.  

Capital-Efficient Doesn't Equal Cheap

Now, when I talk about capital efficiency--about running a lean startup--I don't necessarily mean doing everything on the cheap. It's not about subsisting on ramen or working out of someone's garage. The goal isn't to spend as little money as possible, but rather to spend money as intelligently as possible. In other words, it's about being hypothesis-driven.  

In the world of medical devices, it's often assumed that to test your hypotheses, you need to pump a ton of cash into large-scale clinical trials that focus on a single product or outcome early on. In reality, you're more likely to build a successful business if you test your hypotheses on a smaller scale before taking on major funding or conducting multi-center clinical trials. Otherwise, if your initial hypotheses prove to be incorrect (which is often the case), you're out a ton of money and sometimes back to square one. 

Two Good Reasons to Build Lean

When we started our medical device company, Allurion, we ran it like a lean startup for two reasons: one, we had to, and two, we wanted to.  

We had to because venture investors in our space typically look for a few specific traits when they decide whether to invest in a medical device startup, among them: 

  • An experienced team (which we were not) 
  • An insurance reimbursement strategy (which we did not have or want) 
  • A fast regulatory path (which wasn't going to happen) 

We understood why they valued these traits, but we simply didn't believe they were the right ingredients for our success. 

We had watched other medical device startups with several or all of these traits struggle. In our view, these companies often took on too much funding too early, spending it on extensive clinical trials, huge teams, and high-end offices. All of this long before they had validated their ideas with the market. In our view, the most important thing at the beginning was to distill an unmet need down to a pain point felt by multiple stakeholders in the healthcare system.   

We didn't have the luxury of unlimited cash--but we also didn't want it. My team is a team of outsiders. None of our partners had run a medical device startup before. Three of us have medical degrees and the fourth has a finance background. But, while VCs expected this to put us at a disadvantage, we saw it as a distinct advantage. 

We wanted to deliberately approach the problem we identified (obesity) with humility and without preconceived notions. Now, with promising clinical data and devices in the wild, people give us far less side-eye. They're less likely to ask, "Are you crazy?" and more likely to ask: "How did you accomplish this?"  

Here are four things my team and I have learned about how to apply the lean startup approach to medical devices:  

Pick a Big Problem

As Dr. Theodore Woodward put it, "When you hear hoofbeats, think of horses, not zebras." This analogy is generally applied to an outlandish medical diagnosis given in lieu of a more obvious one. But it also applies to medical device (and other healthcare) startups who are trying to decide what problem to tackle.  

There is so much low-hanging fruit in healthcare today that there's really no need to focus on zebras. Instead, entrepreneurs should focus on disease indications that affect large swaths of people. Yes, there's an ethical argument in favor of this thinking, but there's also a lean startup argument. If you address common problems and look for solutions that are logical (not outlandish), you're much more likely to be successful in the market.  

Take One Risk Off the Table

In medical devices, there are two major gambles with any new product: 

  1. Science Risk: Whether the product will work 
  2. Market Risk: Whether the product will gain traction 

To build a capital efficient enterprise, you need to take at least one of these risks off the table. Otherwise, the capital requirements to mitigate both risks can be astronomical. In our case, the science risk was off the table because there were already weight-loss balloons in the market. The basic principle worked; we just wanted to improve the technology. We also significantly reduced market risk by going after a problem (obesity) that affects a large population. 

Taking the science risk off the table can mean looking at what other people have done before you and building on their success (or failure) with a similar but better, faster, or more effective solution to the problem. It can also mean combining old approaches in a novel way. Bottom line: There is no need to start from square one.  

Let Your Customers Guide You

When it comes to medical devices, the research process often involves engineers and doctors, leaving consumers out of the equation. Why not talk directly to the people who will use the devices? They know better than anyone what they want and need, and if you design for them, you're far more likely to succeed. 

In the world of tech startups, letting customers guide you often involves releasing a minimum viable product. When it comes to medical devices, the threshold for viability (in terms of safety) is higher. But once you have a product that meets it, get it out there and start collecting feedback. Openness and collaboration will help you get to the right solution faster. 

For example, when we decided to address the obesity market via an improved stomach balloon, we went directly to consumers to ask them what they wanted. They told us they wanted to avoid any procedures whatsoever, including endoscopy, surgery, and anesthesia. They preferred to see a primary care or other doctor they already had a trusting relationship with, rather than a random specialist. And they wanted the devices to be reasonably priced. So even though we were first-time medtech entrepreneurs with no engineering background, we knew that if we built a balloon that ticked those boxes, we would have a captive market. 

Rely on Data

Related to the point above, it's vital to collect data before you make decisions. Smart tech startups do this, but in healthcare, when you're dealing with real people's lives, it's an even higher-stakes game. Focusing on the data will help both your company and your customers.  

Now, this can be a little tricky when it comes to medical devices. You do need to do clinical studies; there's no question about that. But you don't have to do a massive clinical trial right out of the gate. In many cases, it's a good idea to get as much experience as possible with your device in the field first, whether that means sequential, iterative, and small-scale trials in the U.S. or testing the product abroad, where time to approval may be shorter.  

We decided early on that we did not want to sponsor huge clinical trials before getting our product into the hands (err . . . stomachs) of our end-users. We already knew that the basic technology was safe and effective, so we wanted to learn from our customers in the field and test hypotheses iteratively before we moved on to a definitive and expensive pivotal trial.  

Patience is a Virtue

The approach outlined above is how I would recommend any medical device startup go about building and sustaining a business today. The trade-off, as you may have surmised, is time. It may take longer to get your product to market, and require extra patience on the part of your team and your investors. But in many cases (including ours) it can actually be a shorter route to market--and regardless of when you get there, you're far more likely to have a product on your hands that (as they say in Silicon Valley) delights your customers. Putting a device out into the market that serves a real and large unmet need and also makes money is what we call a true win-win. 

Dr. Shantanu Gaur cofounded Allurion, where he is now the chief scientific officer. Allurion has developed a procedureless gastric balloon for weight loss.

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Former Starkey Execs Charged With Stealing $20 Million

An indictment unveiled in Minnesota claims a complicated web of sham companies and dummy entities set up to siphon away money from the privately held hearing aid manufacturer and developer.

Chris Newmarker

Ruzicka
Jerry Ruzicka 

A year after the president, chief financial officer, and human resources vice president were fired from hearing aid manufacturer Starkey, a federal indictment charges the three men and two others of running a complicated conspiracy that stole $20 million over nine years. 

The indictment covers former Starkey president Jerry Ruzicka, former chief financial officer Scott Nelson, and former human resources senior vice president Larry Miller, as well as two friends of Ruzicka--Jeffrey Taylor, former president of miniature parts supplier Sonion, and Lawrence Hagen, who also aided in the alleged conspiracy. 

The five men are expected to appear in U.S. District Court in Minneapolis this week. 

Charges in the case range from everything from making financial transactions related to fraud proceedings to conspiring to commit money laundering, wire fraud, and mail fraud. 

"The defendants carried out a complex scheme to accomplish a simple goal: to embezzle funds for their own benefit,"  U.S. Attorney Andrew Luger said in a news release

Ruzicka's lawyer John Conrad responded to media outlets that his client has done nothing wrong and has been dedicated to Starkey since he started working there in the 1970s

The indictment claims Ruzicka and the other defendants stole from the company between 2006 and September 2015, when Ruzicka and scores of other employees at the company were fired. According to prosecutors, the alleged theft was accomplished through a number of strategies:

  • Ruzicka and Taylor created a fake company called Archer Consulting that that received "commission" payments for supposed sales of hearing aid components from Sonion to Starkey. By 2010 the commission payments were reclassified as "consulting fees," with Starkey paying Archer Consulting $75,000 per month. Ruzicka and Taylor were able to steal $7.65 million through the setup, according to the indictment. 
  • Ruzicka, Taylor, and Hagen controlled two dummy entities called Claris Investments and Archer Acoustics. Taylor falsely told others at Sonion that the two entities were Starkey affiliates, allowing the entities to buy discounted components that could then be sold to other companies at a profit. The scheme pulled in $600,000 in profits.
  • Starkey's founder, principal owner, and CEO Bill Austin had created an affiliate called Northland USA in 2002 that acquired and operated retail hearing aid establishments. Ruzicka and Nelson are accused of forging Austin's signature in order to transfer Northland USA's assets to an entity they controlled, called Northland Hearing Centers. Ruzicka and Nelson ended up awarding themselves restricted stock, paying themselves and another individual $15 million to in exchange for terminating the restricted stock grants. 
  • Ruzicka gave himself and others bonuses, concealing the bonuses from Austin by falsifying compensation reports. 
  • In 2014, Ruzicka supposedly embezzeled $200,000 in "officers insurance," using the funds to pay for his state and federal income taxes. 
  • Ruzicka, according to the indictment, took the 2011 Jaguar that the company allowed him to use and transferred ownership to himself. 
  • The indictment also claims that Nelson took $200,000 and used it to buy a condimium where could engage in a secret relationship with a Starkey employee. Nelson also stole $250,000 to restore his investment account after buying a home in Prior Lake, MN.  

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

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Mind-Controlled Exoskeleton Could Help Paraplegic Children

University of Houston researchers aim to leverage a new, noninvasive brain-machine interface system that taps into human brainwaves to control and command a wearable exoskeleton--a technology that could enable paraplegic kids to walk.

Kristopher Sturgis

Exoskeleton University of HoustonA new study out of the Laboratory for Noninvasive Brain-Machine Interface Systems at the University of Houston (UH) has paved the way for a new exoskeleton technology that will be unveiled at Cybathlon in Zurich -- an event where the world's most innovative prosthetic and assistive technologies are unveiled. Jeffrey Gorges, researcher at the university and lead research technician on the project, says that the powered wearable robot has application possibilities for patients of any age suffering from lower-limb paraplegia, but the focus is moving toward a system for children.

"This technology has a wide variety of applications, and a huge potential for aiding patients and clinicians across a broad spectrum," he said. "We are specifically focusing on how we can utilize this technology to benefit children for a couple of reasons. First, there is an unmet need. Thousands of children suffer from many forms of debilitating paralysis or mobility impairments that may affect how they interact with the world, how they learn at school, and how they play with their friends."

Visit with Proto Labs, the company that helped create the exoskeleton prototype, at Booth #707 at BIOMEDevice San Jose, December 7-8, 2016. 

Gorges says that adult exoskeleton technologies have long since been developed and have demonstrated many benefits in therapy and improving accessibility -- but no exoskeleton technologies have been made available for children, despite the fact that children may have the most to gain from such as technology given their state of neural plasticity.

"When we talk about neural plasticity, we're talking about how quickly a person's brain can adapt to new stimulation, new ways of making connections, and new ways to bypass or retrain areas of the brain that may be damaged," he says. "Children who are growing and developing epitomize a state of neural plasticity in which optimized therapies may have the greatest long term impact."

Their latest prototype aims to measure brain activity and use that information to inform mechanical decisions. This suit focuses on a portable, non-invasive method that uses electroencephalography (EEG) through a series of electrodes placed on the head to capture tiny electrical signals from the brain. After years of study, UH researchers have managed to listen to those signals and make inferences about the state of the brain.

"We can then translate that into a command for a computer program or a machine," he said. "For the case of exoskeletons, this means that when the user thinks about walking, the exoskeleton walks. The goal here is to not only make controlling the robotic device more intuitive, but to also gain insight into how the brain is functioning, how it reacts to different therapies, and perhaps also promote that neural plasticity by closing the loop between the robot and the brain."

To help the process along, Gorges and his colleagues teamed up with Proto Labs (Maple Plain, MN), a company that manufactures custom 3-D printed prototypes. Proto Labs manufactured 90% of the custom aluminum components used in the technology, and with their help, the UH research lab was able to take the robot technology from concept to completion in just 10 months time.

"Proto Labs played a big role in being able to push our design forward quickly," Gorges said. "We were able to go from drawing and CAD models to bench testing components within a couple of weeks. Being able to build just a few components, get quick feedback on manufacturability, and still have a real person on the other end to walk us through the process was hugely beneficial."

With Cybathlon on the horizon next month, Gorges says the group is excited to test the hardware and learn from their adult pilots before they begin to scale the system down for children, as well as further enhancing the brain-machine interface.

"We are excited with the progress that we've been able to make thus far with our adult-sized prototype," he says. "Even this prototype system will have a very real impact on the pilots that are testing the system before we ever move to the pediatric scale. It's very important that we learn as much as we can from our adult pilots before we move the system to children. Also, there is still much to be done and many great opportunities for developing this brain-machine interface. Integrating this type of engaging, intuitive, closed-loop control could have a dramatic impact on the healthcare industry--not just for pediatric exoskeletons, but in many other areas as well." 

Exoskeleton Houston Diagram

Kristopher Sturgis is a contributor to Qmed.

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[Images courtesy of Jeffrey Gorges/University of Houston]

How Tiny Are Medical Device Parts Getting? This Tiny

Miniaturization is a major trend in the medical device industry, and a great example could be found at Heraeus's booth at MD&M Minneapolis.

Chris Newmarker

Heraeus (St. Paul, MN) has been machining medical device parts down to the micron level in recent years. Check out this video from MD&M Minneapolis (Booth #2005) to see just how tiny these parts are:

A small correction to the story: One of the millimeter-sized device parts in the video was mistakenly described as rivets. Heraeus corrects that they were actually electrodes. The video nevertheless provides a great comparison between millimeter- and micron-sized medical device parts.

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

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A Better Way to Keep Feet Clean in Healthcare Settings?

Circuit Solutions used MD&M Minneapolis to tout a new device to keep feet from tracking grime into healthcare settings. 

Chris Newmarker

Circuit Solutoins VortexWhile there has been significant progress preventing some types of infections, about one in 25 U.S. hospital patients still suffer at least one healthcare-acquired infection on any given today, according to the Centers for Disease Control.

Circuit Solutions (Minnetonka, MN) used MD&M Minneapolis to roll out its Vortex Air WalkMat, with technology licensed from an undisclosed source outside the United States. 

Todd Werner, Circuit Solutions's president, thinks the Vortex will sweep away the sticky mats that are often used in healthcare and cleanroom settings. Healthcare-acquired infections are such an issue that Circuit Solutions and the Vortex won a spot as a finalist for the MD&M Minneapolis Innovation Prize

Registering the weight of arriving individuals or equipment, retractable balls on the surface of the mat activate a vacuum to remove particles, hair, and debris. The device is set up so that the vacuum only sucks air around the feet. It works on high heels. It works when carts are rolled over it. (Don't spring to buy one of these to put behind your front door, though: The price tag runs into the thousands of dollars.) 
 
Some health providers set the vacuum mat next to a sticky mat, and the vacuum still picked up hair, which doesn't stick well to the mats because it is is covered with oil. "Would you want a ball of hair getting into your operating room?" Werner said. 
 
Here is Werner describing the Vortex at Booth #1340 at the show:

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

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