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Cleveland Clinic’s Top 10 Medical Technology Innovations for 2013 and the Message for Medical Device Designers

Cleveland Clinic has announced its top 10 medical technology innovations for 2013, and they’re all about improving the efficiency of healthcare.

The takeaway for medical device designers: To be successful in 2013, medical technologies will need to do more for less.

“The challenge for device innovators is going to be coming up with devices that both have a healthcare benefit but also a demonstrable cost lowering effect,” says Chris Coburn, executive director of Cleveland Clinic Innovations, the corporate venturing arm of the Ohio medical center.

Promising technologies for next year include innovations that address chronic diseases, improve diagnosis, treat conditions less invasively, and reduce patients’ dependence on drugs.

“There’s an emphasis on technologies that allow things to get done quicker and at less cost,” Coburn says. 

One example included in the list is handheld optical scanning for melanoma, which helps dermatologists diagnose this deadly skin cancer without even making a cut. The device uses computer algorithms to analyze an image of a suspicious mole or spot and compare it with images of melanoma and other skin conditions stored in a database—all in less than a minute. The technology detected 98% of the melanomas in a recent clinical trial.

“Early assessment and getting these patients on the path to care should result in better outcomes, ideally bending the cost curve down,” Coburn says.

Bariatric surgery for diabetes is also expected to be a healthcare game-changer next year. A study published in the New England Journal of Medicine this year showed that gastric bypass surgery can rid patients of Type II diabetes or at least reduce their dependence on diabetes medication for at least two years.

 

Another technology included in the list that could reduce the need for long-term drug therapy is neuromodulation for cluster and migraine headaches.

“There’s been an increase in migraine episodes…and the only way to address them had been through relatively unsatisfactory drug regimen,” Coburn says.

Neuromodulation therapy involves the minimally invasive implantation of a small neurostimulator in the upper gum. The device, which is remotely controlled by the patient, delivers on-demand stimulation to the sphenopalatine ganglion nerve, a technique that has been shown to alleviate headaches. Coburn says the simplicity of the implantation procedure and the lack of adverse side effects means doctors will consider neuromodulation therapy at the same time they’re considering prescribing drugs for patients suffering from migraines.

“In comparison to years and years of drug therapy, it’s a bargain,” he says.
 

Other innovations that made the list are:

The top 10 medical technology innovations list is compiled annually based on interviews with Cleveland Clinic staff from a variety of medical specialties. It highlights the innovations they predict will have the biggest impact on healthcare over the coming year. Nominations must show a clinical impact and patient benefit, have high probability of commercial success, show a human interest element, and be available on the market in 2013. 

The entire report can be downloaded via Cleveland Clinic's website

Jamie Hartford is the managing editor of MD+DI.

What the Medtech Industry Should Know about the Election—and Pharma

What the Medtech Industry Should Know about the Election—and Pharma

To learn about the evolving life sciences environment, MD+DI spoke with Todd Evans, a director in PricewaterhouseCoopers Pharmaceutical and Life Sciences Advisory Services Group. For the past six years, Evans has participated in the majority of PwC’s thought leadership reports. He has closely followed Barack Obama’s interest in reforming the U.S. healthcare system after the president first announced he was running for office.

MD+DI: How would you characterize the medtech industry’s approach to preparing for healthcare reform?

Evans: A lot of people tend to take a wait-and-see attitude. Many of them were kind of burned by the 1990s, if you will. But this past year has been very seminal where we had an affirmation by the Supreme Court that a lot of folks were holding out for. And then we had the re-election of the president and his party in the Senate. From my point of view, we are at an inflection point that the wait-and-see strategy is not going to work any more. You have to take things for what they are and you have to respond to them intelligently and you need to begin taking real action. I think the industry is in a position now where they have to move from abstract planning and understanding to practical actions.

MD+DI: Many of the opinions I’ve heard from people in the industry on the Affordable Care Act have been less than optimistic. A number of people seemed to have high hopes for a repeal.

Evans: It is kind of the triumph of hope over reality sometimes, where you have a new regulation imposed on you or there is a law that constrains past behavior and you just don’t like complying with it. These are the laws of the land and, if you are going to do business in the United States, and you are in the industry, you have to be fully cognizant and compliant with them. Complaining is not usually a good strategy. You can seek to shape and reshape the law and that is always open for debate. Given this status quo of the government today, versus a month ago, I just don’t see massive changes to the law that stands today in the immediate future.

MD+DI: There is a LinkedIn post in the Medical Devices Group discussing how the election might affect investment in the medtech space. What are your thoughts on that topic?

Evans: Having certainty is a big deal. Anybody ideologically can classify whether it is good or bad. But uncertainty versus certainty is usually a bad thing. Nobody wants uncertainty. They want to be able to plan. If you are not planning, then by definition, you are opening up yourself to forces of chaos. At this point, the marketplace in the industry in the United States has a very clear idea of what the general outlines of the U.S. healthcare system are going to evolve toward for the next few years, writ large. There are hundreds of thousands or rules and other things underneath that remain to be rolled out. And yes, the devil can be in the details. But I think the premium on uncertainty over uncertainty has now been assigned. The question is: can you start planning because you have enough certainty? The answer is absolutely you can start planning. It doesn’t mean you have to like everything or dislike everything. It is what it is.

MD+DI: The medical device tax and the Sunshine Act provisions of the Affordable Care Act are scheduled to go into effect in 2013. The reforms that would significantly increase the patient pool don’t go into effect until 2014. How well do you think the industry has prepared for this transition?

Evans: So the industry generally has already had to deal with some of the effects of implementing new systems and processes to cope with both the Sunshine and the device tax. This is not something you can react to a week before it goes into effect. And I don’t see wholesale waivers to people that raise their hand and say ‘oops, sorry, I forgot.’ My perspective on this is that preparation is a much better plan than excuse-making. From our exposure to the community of manufacturers across the country, I think there has been a pretty reaction to this. Some are more ready than others, some will pay bigger bills than others, and some will have bigger processes and technology than others. I would say that, since quite some time ago, there has been a widespread recognition that this was coming and you needed to be prepared. If it went away, great. But it is here and it is being implemented and whether you are referring to the device tax or the Sunshine Act, it is going to have its effect.

And there are some things that you see in the marketplace of ideas and communication already saying, ‘gee, we are reacting because we have to right-size our cost structures and personnel are being impacted and there is an indirect cost to this thing that burdens us.’ Be that as it may, the law of the land is dictating that you must comply. It is our perspective that the vast majority of commercialize is well underway in becoming compliant.

MD+DI: I saw the recent PwC Pharma report that came out and noticed a number of parallels between the megatrends facing the medtech and pharma industries. What can medtech can learn by studying the pharma industry?

Evans: A lot of the report is about changes taking place in the market. And the market is first global but it isn’t homogenous and vanilla in nature. It is becoming more and more differentiated both by country and business models that operate within country systems. Our industry in the U.S., whether you are talking about medical device, pharma, or biotech, has traditionally addressed the market in discrete channels with a fairly uniform strategy to address them. What we are seeing is new business models evolve in the customer segments—a convergence and merger of interests, sometimes even legal mergers. That is creating goals that lead to collaboration with other stakeholders—be they outcomes, quality metrics, and measures.

There are a lot of different things that everybody is looking to do that is common now. We have the rule of law that really enshrines the change with some degree of permanency. That was lacking in many of the changes that occurred over the last 15–20 years. Medtech companies, in my view, have to take a very similar view [as pharma] on the premium on the outcomes, positioning their solutions and their products with a new form of value that needs to be identified objectively and then conveyed through business cases. It is no different whether you have a pill, device, or an implantable. At all points, you have to demonstrate superior value to existing therapies in market today. That difference has to be material—not a green stamp.

MD+DI: Where do you see genomics playing a role for the pharma industry? Can we look forward to pharma companies essentially guaranteeing their products will work for people with certain genetic profiles?

Evans: I think there is a step to before thinking about warranties or guarantees on treatment—as nice as those would be. The first step is targeting patients that even have a chance of acquiring one level or another of an outcome benefit. Obviously, I am referring to the clinical piece here.

Harnessing genomics to identify a patient that has the potential to respond to treatment is a phenomenal development both from a cost and the clinical side. From a cost point of view, we would plough through many millions of lives to see if we could acquire some benefit. We didn’t understand, because we didn’t have a [genetic] marker, whether or not that patient was appropriate for the treatment. And we kind of lived with [subpar] results. In the meantime, we sold a lot of units on the way to that endpoint.

Now what we are seeing with the rise of genomics, and its alignment to treatments, is the notion that we can immediately rule out certain portions of the population for eligibility because they are genetically disposed to not respond [to a therapy]. That is a wonderful thing because that obviously saves on the overall dollars that are going to be spent to find the lives that are going to respond, so by definition, a savings. Secondarily, it starts to drive some certainty, which is where you ended up with your guarantee comment. I think it drives certainty of treatment benefit. And then the issue is: how do we stratify those clinical outcomes that range from cure to some marginal benefit, be it quality of life or clinical slowing of the progression of disease. There is a lot of different ways to talk about whether you got clinical benefit or not. I think there are a lot of different shades of gray there. I don’t think it is red-light/green-light, unless it is an outright cure or an outright prevention. That trumps everything.

But if, through studies, you know that you are going to positively influence patients in a treatment that meet minimum eligibility requirements, genomic or not, it is fair to consider a warrantee for a portion of lives treated. The issue is: what is the function of the warrantee or the guarantee and how exactly do we classify good versus great? There is a lot of gray area there but I think we have begun the journey already.

MD+DI: What, in particular, do you think the medtech industry stands to gain by studying the pharmaceutical industry? The regulatory situation in the device space is starting to look more like it does in pharma, with reports of “shifting goalposts” and a longer path to market.

Evans: I think one of our core messages here is addressing the intangible of culture. Pharma lives in a universe where the timeline to Eureka to a commercialized product is on average 10 years. We spend an awful lot of money per candidate in that pipeline. What pharma is learning is that, even if we made decisions three, five years ago for products that are already in the pipeline and now we have to address a “shifting goal post,” we need to develop the agility to repurpose those assets to meet that new definition of value. We have got to break some cultural paradigms to do it.

"I think one of our core messages here is addressing the intangible of culture."

The old processes, the old paradigms, and the old models of how we managed, most, likely need to be adapted. Change is always the big bugaboo. We have to be more open, transparent, and collaborative. We need to understand how to make better, smaller, earlier decisions on whether our candidate products in [development] really should see the light of day. Are they really going to drive the kind of value as it is now being defined? How it was defined five years ago doesn’t matter. If the goal post has moved so far that it is no longer the right decision, than you have to allow the management decision-making discretion to kill the product and focus those precious resources on products that are going to drive value under the new definition. [Granting] permission to do that is a big cultural shift. The reward structure, obviously, has to follow with it. Being open to these sorts of things is very, very important. And developing a model that is highly agile and differentiated to the purpose of a highly fragmented market that is finding its way to new value definitions is an absolute necessity.

One thing you could look at by way of reference is other industries that have gone through similar transformative changes. Look at the aerospace, the automotive, and the high-technology industries from where they started to where they are today. You’ll find that all of them have globalized and all of them have coped with highly differentiated markets, very disruption introduction of technologies and even at the meta-level, national agendas where very interesting collaborations that would have been unheard of in the 1940s, 50s, 60s, and 70s. They are now taken as commonplace. [The life science industry] is globalizing. Healthcare and disease is global but delivery is local. That requires a great deal of agility to design solutions that products play inside that are well adapted to the unique requirements of those local situations.

When we talk about collaborating and how we develop products, maybe run trials and studies, being good at collaboration is a skill. It is not just that you know how to make a phone call. As such, there is a learning curve and an experience curve that the entire industry has started down the road of. Some will mature faster than others; some will have cultures better adapted to being able to collaborate more easily. The bottom line is we are beginning that journey as well. Those that really master that capability, that art, have a leg up on some of their competitors that may be slower to adapt.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.
 

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Researchers Find Inspiration in Butterfly Wings and Rice Leaves

Based on natural rice leaf samples (top), researchers at Ohio State University developed rice leaf replicas (below), which exhibit low drag, resist biofouling, and have self-cleaning ability. (Images by Bharat Bhushan)

Humans have long marveled at the water repellency of lotus leaves and the way sharks glide through water, but a new study shows that butterfly wings and rice leaves combine the favorable surface characteristics of both. Inspired by these natural structures, researchers at Ohio State University (Columbus) have created materials that could someday help reduce friction and contamination in medical devices and even enable them to clean themselves.

Bharat Bhushan, director of the university's nanoprobe laboratory for bio- and nanotechnology and biomimetics, and doctoral candidate Gregory D. Bixler set out to develop surfaces to address three common engineering challenges faced by industries, including the medical device sector: fluid drag, biological fouling, and self-cleaning. They began by studying butterfly wings and rice leaves, which solve these problems naturally.

"Nature does everything down to the nanoscale and even the atomic scale, in some cases," remarks Bhushan, an Ohio Eminent Scholar and Howard D. Winbigler professor in the department of mechanical and aerospace engineering. "So we looked to nature to see how it's done."

The researchers observed the surface characteristics of butterfly wings and rice leaves in order to discover what enables them to reduce drag, exhibit low adhesion, and clean themselves. Butterfly wings, they found, feature shinglelike scales and microgrooves arranged like rays, while the surfaces of rice leaves have sinusoidal grooves and micropapillae topped by waxy nanobumps.

In an article published in the journal Soft Matter, Bhushan and Bixler detail how they created nanostructured materials to mimic these characteristics. Creating silicone rubber negative molds from original butterfly wing and rice leaf samples, the researchers filled the molds with urethane polymer to produce positive replicas. Next, they applied a coating of hydrophobized silica nanoparticles to mimic the lotus effect on the rice leaf replicas.

The researchers then conducted experiments to compare the characteristics of the butterfly wing and rice leaf replicas with their original counterparts as well as with original and replica samples of rainbow trout fish scales and mako shark skin. Experiments showed that the butterfly wing replicas exhibited a 79 to 85% ability to self-clean, whereas the coated rice leaf replicas exhibited a 95% self-cleaning rate. Tests also showed that the coated rice leaf replicas exhibited high contact angles, indicating superhydrophobicity, and an adhesion force of just 0.11 N, the lowest among all of the samples. The butterfly wing replicas showed an adhesion force between 0.3 and 0.4 N, which is lower than the replicas of the fish scales and shark skin. The coating applied to the rice leaf replicas was also shown to reduce drag significantly.

Dubbing the combination of low drag, resistance to biofouling, and self-cleaning ability the "rice leaf  and butterfly wing effect," the researchers comment that their findings could inspire designs in medical device and other applications. For example, materials created to take advantage of the rice leaf and butterfly wing effect would be useful in catheters, biosensors, and drug-delivery devices. "Anywhere you have a fluid flow, this work would be of interest," Bhushan notes.

Especially excited about the rice leaf replicas, the scientists plan to research them further, using modeling to inspire the development of new structures. "We've already created a replica," Bhushan adds. "So the next step is to fabricate structures ourselves, as opposed to using the natural object as a master."

Ortho Implant Production Process Counts on Addition and Subtraction

An additive-subtractive process produces random pores in the surface of a tibial tray in a single process.

One side of orthopedic devices such as tibial trays features a complex geometry with variable pore sizes to promote osseointegration. However, the process of producing a random porous surface geometry on orthopedic implants generally involves a series of painstaking steps, such as spraying on a foam, infiltrating it with titanium, and then burning it away. In contrast, a new method developed by EOS of North America Inc. (Novi, MI), in conjunction with GF AgieCharmilles (Lincolnshire, IL), dispenses with these myriad steps, creating random pores in a single process.

The EOS and GF AgieCharmilles process chain is unique in that it blends both additive and subtractive manufacturing processes, explains Andrew Snow, sales director of EOS of North America. It pairs EOS's additive direct metal laser sintering (DMLS) technology with AgieCharmilles's subtractive electrical discharge machining (EDM) and high-speed milling technologies.

The manufacturing process chain starts with the generation of a 3-D CAD model. Next, a porous randomized lattice structure--known as a tribicular metal geometry--is developed and integrated into the model using software from Within Medical Software (London, UK). Once developed, the part program is loaded into an EOS laser sintering system containing a reservoir of a powdered metal such as low-oxygen-content, corrosion-resistant Ti64. The system then begins to build, or grow, the part layer by layer by repeatedly pushing the powdered material evenly across a flat work plate. Ranging in thickness from 20 to 60 µm, each powder recoat layer is solidified using the system's laser. After each layer is built, the system's table indexes downward so that the next layer can be solidified upon the previous one.

Once the parts are completed, they are cut from the metal work plate using a wire EDM system from GF AgieCharmilles. Using a 0.010-in.-diam brass wire to generate pulses of electricity, the system disintegrates thin layers of material as the wire advances through the part. This method, according to Eric Ostini, product manager at GF AgieCharmilles, helps to shorten the part build times required by the laser sintering equipment because it eliminates the need to add large amounts of cut-off stock. The EOS system typically builds parts with 0.005 to 0.010 in. of extra stock to accommodate subsequent surface finishing operations. "These small amounts of stock help reduce cutting-tool costs while increasing tooling life because parts require only light finishing cuts rather than rough milling," Ostini comments. "This capability is especially beneficial when parts are made from expensive materials, such as titanium, that require costly special tools for rough-machining the material efficiently."

In addition to producing medical implant parts in one process, the new manufacturing method reduces overall production times. "For example, the OES machine can build 12 tibia trays at a time, most likely in less than 30 hours," Snow says. "Manufacturing the implants one at a time using multiple conventional machining methods would take much longer and involve multiple operations, multiple machine setups, and human intervention." Moreover, the new process allows manufacturers to quickly produce diverse patient-specific implants within the same batch run.

Advancements in laser technology have driven interest in DMLS technology, Snow remarks. Thus, when industry transitioned from CO2 to diode-pump single-mode lasers five to seven years ago, EOS was able to process many more alloys than was previously possible. "As a result, manufacturers are changing how they view DMLS, and medical implants are a perfect example." In addition, the increased power and capabilities of today's PCs, as well as improved CAD/CAM and other software systems, has enabled EOS and GF AgieCharmilles to develop their additive-subtractive process, Ostini adds.

The companies are considering implementing their complete process chain in North America and Europe for FDA-approved implant manufacturing applications, Snow says. However, many medical device manufacturers are already using the EOS system to produce patient-matched knee implant tibia trays, acetabular hip cups, and other implants and instrumentation.

AdvaMed, MDMA Press Conference Challenges Medical Device Tax

The medtech industry stands to pay roughly $2.5 billion to comply with the medical device tax, according to a new report from Ernst & Young. That amount represents an almost 30% increase in its federal tax burden. Over the next ten years, the excise tax is expected to increase federal tax revenue by $29 billion, according to the Joint Committee on Taxation.

To bring attention to the issue, AdvaMed (Washington, DC) and the Medical Device Manufacturers Association (MDMA; Washington, DC) hosted their first online press conference on Twitter around the #repealdevicetax hashtag.

When asked how likely a repeal of the tax would be, AdvaMed stated that it is "cautiously optimistic." MDMA added that there is bipartisan support for a repeal and that doing away with the tax would "drive down healthcare costs and create jobs." The two trade associations have partnered with MITA to fly 52 CEOs from across the country to Washington, DC. Executives taking part in the event include Dan Moore of Cyberonics; Don Fowler of Toshiba America Medical Systems; Rob Cascella of Hologic; Caroll H. Neubauer of B.Braun Medical Inc.; and Steve Ferguson of the Cook Group.

When asked over Twitter how the organizations propose that a repeal of a tax would be paid for, MDMA said they would defer to Congress in how to pay for it.

If the tax is not repealed before it goes into effect on January 1, AdvaMed plans to continue working with the IRS on the regulations, adding that a repeal of the device tax is "a down payment on broader tax reform." The U.S. corporate tax rate with the device tax would be among the highest in the world.

On Twitter, Rep. Erik Paulsen (R-MN) pointed to the need for a device tax repeal, pointing to the 400,000 Americans who are employed by the medtech sector--some of whose jobs may be threatened as device firms look to cut costs as their profits shrink or go into the red.  

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

World Diabetes Day: But Are We Any Closer to an Artificial Pancreas?

November 14 is an important day for the estimated 366 million people globally who have been affected by diabetes. Since 1991 World Diabetes Day has served to raise global awareness about diabetes, a condition that affects nearly 26 Americans alone (according to the American Diabetes Association) and will affect roughly 522 million people globally by 2030 according to predictions by the International Diabetes Federation (IDF).
 
The majority of individuals have type 2 diabetes which has shown to be manageable by lifestyle changes including exercise and diet. However the less common, but more dangerous, type 1 diabetes has not been linked to lifestyle or diet. Type 1 patients are required to monitor their blood sugar levels constantly and require insulin injections sometimes multiple times a day. The pharmaceutical industry's stake in this is pretty clear with the plethora of blood glucose-regulating drugs on the market. But one shouldn't ignore the device industry's contribution toward treating, and potentially curing, this condition. While no one can argue that innovation won't be the next big step toward treating type 1 diabetes (discovering insulin itself was considered an innovation at one point), the question looms as to how close we really are to any significant strides.
 
The Paradigm Veo is Medtronic's entry into the artificial pancreas market.
Today FDA has released the final offical draft guidance for an artificial pancreas which "allows for a range of scientifically valid study designs, allowing flexibility that will encourage innovation in technologies for people with type 1 diabetes while ensuring thorough evaluation of such systems before they can be prescribed by doctors." In a press release Jeffrey Brewer, president and CEO of JDRF, a global organization focused on type 1 diabetes research and organizers of the Artificial Pancreas Project, said,"This FDA guidance is an important milestone in improving lives of people with type 1 diabetes. JDRF commends the FDA for its scientific leadership in the area of artificial pancreas systems, which have the potential to be the most revolutionary advance in treating type 1 diabetes since the discovery of insulin."
 
 
The artificial pancreas, several versions of which are currently being developed, presents a sort of holy grail in the fight against type 1 diabetes (the causes of which are still not fully understood). While other versions that use gene therapy and bioengineering are being developed, on the medical device end the artificial pancreas takes the form of an insulin pump under a closed loop control that utilizes real-time data from a blood glucose sensor to regulate insulin levels. Device giant Medtronic has been the biggest name in this arena since it submitted its Paradigm Veo insulin pump for FDA approval in June. If approved, the device will offer patients 24/7 monitoring of their blood sugar levels and will even be able to help prevent severe hypoglycemia by suspending insulin delivery when glucose levels are too low.
 
This week also saw an announcement by JDRF that it has provided grant funding to associate professor Jenny Gunton from Sydney's Garvan Institute of Medical Research and Dr. Nigel Greenwood, founder of the technology company NeuroTech Research. The goal of their project is to test a prototype of an artificial pancreas alongside artificially intelligent software developed by NeuroTech. If the software is able to successfully learn to monitor and treat patients it presents a potentially great leap forward in developing an artificial pancreas. In a statement to MedicalXpress Gunton said the ultimate aim to to have “glucose monitoring and insulin administration in the same machine – with very smart pump software keeping people's blood glucose normal." He continues, "The technology we just tested is revolutionary for a whole lot of mathematical reasons – but the point is that it forecasts a completely new approach to programming insulin pumps, with the results from this preliminary grant being extremely impressive."
 
However there's always a gap between innovation and implementation and while patients wait for FDA to approve the next innovative product, others are dealing with the reality that devices may not be doing enough or even be the most effective means of treating diabetes. A study published in the November 2012 issue of The Annals of Thoracic Surgery has shown that diabetes patients who undergo bypass surgery for coronary artery disease (a leading cause of death in diabetic patients) have a better long-term survival rate than those who received stents instead. While encouraging in the sense that it points to better patient care, study results like these also show a potential shortfall in medical devices for treating diabetes. While a big leap forward will certainly point the way the question becomes not about the need for innovation but the speed at which it can get here.
 
What are your thoughts on the state of medical devices in treating diabetes? Share you thoughts/comments with us!
 
 
Learn more about World Diabetes Day at the IDF Web site.
 
-Chris Wiltz is the Assistant Editor at MD+DI

Researchers to Develop Prosthetic Foot Powered by Propellant

University of Alabama associate professor of mechanical engineering Xiangrong Shen (right) discusses a prototype of a propellant-driven below-the-knee prosthesis with graduate student Molei Wu.

Researchers at the Georgia Institute of Technology (Atlanta), University of Alabama (Birmingham), and Vanderbilt University (Nashville, TN) announced a joint program that would develop ankle prostheses that are powered by a gas or liquid-based propellant. The cornerstone of this program is based on research by Michael Goldfarb, a professor of mechanical engineering at Vanderbilt University. Goldfarb has been working on an exoskeleton for the military research group DARPA.

Electric prostheses have several significant limitations. Since batteries have a limited energy density, an individual using a prosthesis motored by an electric motor will have to recharge the unit on a regular basis. With the use of a propellant, an individual may get several days of power from one canister of fuel.

A monopropellant, the fuel used in the prosthesis, has several advantages over traditional propellants. Unlike traditional propellants, a monopropellant doesn't have to be mixed with a variety of other gases to be used as a fuel source. Instead, only a small amount of a certain catalyst will need to be used.

In addition, the new propellant-powered prosthesis includes a sleeve muscle actuator. The actuator performs the same function as a traditional electric motor. With a monopropellant sleeve muscle actuator, it's possible to achieve higher performance, lower weight, and higher efficiency than with a traditional electric motor.

"This is a relatively new system," remarks Xiangrong Shen, assistant professor of mechanical engineering at the University of Alabama. "There are some problems in putting the prosthesis into clinical use because the components of the prosthesis are still being developed. In our research, the long-term goal is to develop powered prostheses with comparable appearance and functionality as human limbs."

In TAVR Case, U.S. Appeals Court Affirms Infringement Ruling Against Medtronic

Edwards Lifesciences Corp. has won a recent patent suit in the U.S. Appeals Court against Medtronic, agreeing with an earlier ruling in which the Delaware Federal District Court found Medtronic liable for $73 million in damages. The Delaware court, however, dismissed Edwards’ attempt to use an injunction to block Medtronic from marketing the CoreValve in the United States. The Federal Circuit Court, however, advised that an injunction should be reconsidered. 

In an interview conducted earlier this year, Nathan Lowenstein, a partner at Goldberg, Lowenstein & Weatherwax LLP (Los Angeles) explained that an injunction against the CoreValve could be a bigger threat for Medtronic than monetary damages. “That being said, some courts have been reluctant to grant injunctions in cases involving medical devices, such as in the Edwards/Medtronics case,” he said, pointing to the previous ruling by the Delaware Federal District Court . “If a patent dispute results in a running royalty on a device whether by settlement or otherwise, the royalty may affect the product pricing or the profit seen by the manufacturer."

SapienAt issue in this case is the infringement of United States Patent No. 5,411,552, which was issued May 2, 1995. The patent covers a collapsible stent that carries a valve that is inserted into the heart using a balloon catheter. Following the patent's filing, Edwards continued to address “questions such as size reduction, material and design optimization, and stent valve sterilization,” explained co-inventor Lars L. Knudsen in a later report, adding that “much more work had to be done before anybody ever even contemplated using this for a human.” 

This factored into the ruling as this excerpt illustrates:

...if a person of ordinary skill in the art could not make and use the invention disclosed in the patent without undue experimentation, the patent is invalid. However, some routine amount of experimentation to make and use the invention is allowable. 

The patent need not contain a working example if the invention is otherwise disclosed in such a manner that one skilled in the art to which the invention pertains will be able to practice it without an undue amount of experimentation.

The record also recounts how the inventors of the technology, Henning R. Andersen, MD; John M. Hasenkam, MD, and then medical student Lars L. Knudsen initially met skepticism for their pioneering work on transcatheter aortic valve replacement technology, noting that medical journals initially refused to publish their work. Eventually, however, their work was honoered as “most exciting” and was praised by the CoreValve founder and the CoreValve CEO. 

Following the news announcement, Edwards Lifesciences’ shares gained $1.09, closing at $87.75 on November 13. Medtronic stock fell by $0.19 to $41.30. 

This news follows on the heels of FDA's decision last month to expand the indication of the Sapein to treat high-risk aortic stenosis patients  both transfemorally and transapically. Before that decision, the device was only approved in the United States for the treatment of inoperable patients via the transfemoral approach. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 

Could the Southeast Be the Next Silicon Valley for Medtech?

Could the Southeast Be the Next Silicon Valley for Medtech?

All major industries have a central hub. For technology it’s Silicon Valley, and for the automotive industry it’s Detroit. Major industries create hubs naturally for easier collaboration, resulting in increased innovation and, ultimately, greater overall industry growth. Being part of an industry hub means easier access to financing, vendors, and experts in your industry, and the presence of competition increases the drive for companies to create the “next big thing.”

Image by User:Renschi81, via Wikimedia Commons

The United States has traditionally looked to California, Massachusetts, and Minnesota as the hubs for medical device manufacturing and innovation. With the exception of Florida, the Southeast has not been a major player in the industry in recent years. A renewed focus on medical devices, however, is forcing many companies to reconsider the Southeast as a hub for the industry.

Medtech Growth in the Region

Medical device companies in the southeastern region as a whole are growing. In early September 2012, for example, medical device companies led the South Carolina jobs report. The state’s medical devices and equipment industry added 15% more jobs and 13% more companies between 2007 and 2010. During the first three quarters of 2012, 19 deals (meaning buyouts, mergers or acquisitions) were completed in the medical device industry in the Southeast, according to PitchBook, a private equity database. Of those 19 deals, two were acquisitions, and of the 17 remaining deals the average deal size was $9.7 million, based on publically reported financial information.

But South Carolina isn’t the only southeastern state seeing growth in the medical device industry. Georgia and Alabama are also seeing growth, and with its “Research Triangle,” encompassing the cities of Raleigh, Durham, and Chapel Hill, NC, has already proven itself as an integral part of the medical device industry. Georgia is home to more than 300 bioscience companies, about half of which are medical device companies. Birmingham, AL, plays an important role in university research and incubator activities in the industry.

Why the Southeast?

The Southeast provides companies with a variety of resources and support that can help medical device companies get off the ground and gain traction in the space. Benefits of doing business in the region include:

  • Tax Credits and Business Incentives. From a financial perspective, the Southeast, and specifically Georgia, offers medical device companies generous tax credits and incentives. For example, medical device companies performing research and development work in Georgia may be eligible to receive the Research and Development (R&D) tax credit, a lucrative credit that can be monetized even if a company has no revenue and a tax loss. A number of other states in the Southeast offer similar R&D tax credits.
     
  • Infrastructure. The Southeast is a region rich in manufacturing and vocational history. As such, the region already has most of the infrastructure necessary for medical device companies in place. This means an easy and logical transition for medical device companies. The region is also known for its vocational training and boasts skilled laborers to work in the medical device companies.
     
  • Academic and Research Environment. The Southeast is brimming with opportunity for medical device companies, as the state boasts a number of medical schools and one of the country’s top technical institutes, the Georgia Institute of Technology. More importantly, Georgia is home to the Saint Joseph’s Translational Research Institute (SJTRI), a world-class medical device and therapeutics innovation center, and the Global Center for Medical Innovation (GCMI), a state-of-the-art product development center that increases the speed at which medical innovations get from concept to market. Both of these resources allow today’s medical device companies to get a leg up on competitors in other parts of the United States and enable them to get their devices to market more quickly.
     
  • Professional Support. As the Southeast continues to grow in this space it is important that medical device companies are supported in the overall marketplace to promote continued growth and the development of additional resources. This is where organizations such as the Southeastern Medical Device Association (SEMDA) step in. SEMDA is a nonprofit association headquartered in Atlanta that supports and promotes medical device companies throughout the Southeast. The organization provides a means for medical device companies and investors to network and build a community and provides them with the resource they need to grow.
  • Transportation. Medical device exports represent about 20.9% of revenue for companies in the United States, according to market research firm IBIS World, and they are expected to increase. The Southeast provides the ideal location for transportation between the deep-water ports in Charleston, SC, and Savannah, GA, a network of highways and railways connecting the region to other major hubs around the county, and access to the world’s busiest international airport in Atlanta. The airport puts Atlantans within five hours of any city in the continental United States.

As the medical device industry continues to grow and new companies enter the market, a hub for the industry will form in the Southeast. The region provides the innovative resources and professional and financial solutions companies are looking for when determining the location for their medical device company. Could the region become the Silicon Valley of the medical device industry? Yes.
 

Mitchell Kopelman is the partner in charge of the technology and life sciences practice at Habif, Arogeti, & Wynn(Atlanta). He focuses on helping medical device companies with R&D tax credit studies, mergers and acquisitions, and proactive tax and accounting planning. He also works with companies as they expand globally or enter the United States. Kopelman graduated from Georgia State University with a bachelor’s degree in accounting. He can be reached at mitchell.kopelman@hawcpa.com.

Ori Epstein is a tax manager in Habif, Arogeti, & Wynne’s technology and life sciences practice. He regularly speaks at medical device industry conferences on topics such as the excise tax, business trends within the medical device industry, and tax planning and preparation for medical device companies. Epstein graduated from the University of Georgia with a bachelor’s degree in accounting and a master’s of accounting with a concentration in tax. E-mail him at ori.epstein@hawcpa.com 

With CEO Fly-In and Social Media Campaign, Medtech Trade Associations Step Up Efforts Against Device Tax

AdvaMed, MDMA, and MITA are joining forces to push for a repeal of the medical device excise tax provision. The trade associations are hosting a two-day multi-pronged nationwide effort to repeal the tax, which includes an ad campaign, online press conference hosted via Twitter, a CEO fly-in, and a 12-hour tweet-up. Among the executives taking part in the event are Dan Moore of Cyberonics; Don Fowler of Toshiba America Medical Systems; Rob Cascella of Hologic; Caroll H. Neubauer of B.Braun Medical Inc.; and Steve Ferguson of the Cook Group. 

The medical device tax stands to cost medtech and imaging firms $30 billion over the next decade. Poised to go into effect in January 2013, the 2.3% excise tax would be levied on device companies’ sales rather than profits. The tax would be paid even if the devices are sold at a loss. 

To bring attention to the issue, on November 14, at 12:30 EST AdvaMed and MDMA have arranged an online press conference via Twitter with moderator Brian Buntz (@brian_buntz), editor-at-large of MD+DI. The event can be followed on Twitter using the #repealdevicetax hashtag. 

On November 15, 52 medtech CEOs across the United States will fly in from states across the country, including those with large medtech hubs such as California, Massachusetts, Indiana, and Minnesota. “It is a joint effort with the three trade associations and we are going to the Hill to make our case and make sure that people understand the urgency to repeal the device tax because it goes into effect on January 1,” says Wanda Moebius, vice president, policy communications at AdvaMed. 

“We have always said that repealing the device tax was a down-payment on overall tax reform. But our goal for the fly-in is to push for a repeal of the device tax and, if that is part of tax reform but part of a lame duck effort, or whatever legislative vehicle occurs, that is what we are pushing for,” Moebius says.  

In conjunction with the fly-in, starting at 9 a.m. EST, AdvaMed and MDMA will host a 12 hour tweet-up using the #repealdevicetax hashtag.