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Articles from 2013 In July


Why and How to Use Gas Plasma Technology For Surface Treatment in Medical Devices

Not all types of plasma are equivalent. The difference between some naturally occurring plasmas can be quite distinct. For example, a lightning bolt contains an apparently high density of electrons, whereas a coronal mass ejection is better categorized by high temperature. Yet both are denoted as plasma.

The same is true for the plasma employed in manufacturing tasks (e.g., corona, flame, atmospheric, and low pressure). When choosing a plasma operation that’s right for the application, consider stability, form factor, and the necessary surface functionality.

Atmospheric and low-pressure plasmas produce the greatest density of energetic species. Atmospheric plasma jets use clean, compressed air for the cleaning and activation of metals and polymers. In most cases, treatment is line of sight, the residence time is short, and the jet nozzle is integrated in-line with relative ease.

Another clean, work-horse material is low-pressure gas plasma, also known as cold gas plasma. This method requires a controlled volume, vacuum pump, and a choice of gas or vapor species. The control over the gas composition enables the greatest versatility in surface chemistry addition, and the low-pressure method is suitable for batch operation and the treatment of complex 3-D geometry. Both the atmospheric jet and low-pressure plasma chamber provide angstrom-level precision in their surface treatments.

Energy Source

All plasma starts with an energy source, most commonly a pair of electrodes supplying radio frequency or microwave energy to a volume of gas. Molecules trapped within the high frequency (13.56 MHz) electric field attempt to flip-flop within the oscillating current. Some of these particles soon become excited, or ionized, as their electrons are shed and plasma is sustained. Some of these charged species become unstable or meta-stable molecules. To return to thermal equilibrium, energetic species form covalent bonds with other particles or surfaces present within a plasma chamber.

Rough vacuum systems are used to increase the intensity of energetic species while avoiding elevated temperatures. This makes low-pressure plasma best suited for modifying thermally sensitive materials such as plastics. At lower pressure, particles have larger distances to travel before their energy is lost in collision or friction. The operating pressure for most commercial low-pressure plasma processes is 50–500 mTorr.

An attractive attribute of low-pressure plasma in life sciences is the ability to tailor surface chemistry. Chemists and engineers introduce specific gas or vapor combinations into their plasma reactor. Liquid and gas flow is regulated by a respective mass flow controller. Only a modest number of species is typically required for complete exposure of a surface. The process is extremely lean and the consumables negligible in contrast to a wet or dip processes. The exact chemical formulation of gas plasma may vary from simple to complex, and there is rarely a single route to achieve a desired surface functionality.

Surface Modification

There are three primary variables that govern surface modification: plasma chemistry, energy per mol, and residence time. A judicious selection of these process conditions yields high quality surface treatment of both organic and inorganic substrates. A low-pressure plasma reactor is a complete chemistry toolbox for manufacturing.

The study of plasma-modified materials is possible through a multitude of analytical and spectroscopic techniques. X-ray photoelectron spectroscopy (XPS), also known as electron spectroscopy for chemical analysis (ESCA), is able to quantitatively determine the chemical state of a surface to the topmost 10–100 angstroms. Table I illustrates the elemental fractions detected on a gold surface after the plasma deposition of an organic amine compound. The native gold surface is masked by a dramatic rise in nitrogen and carbon content. A suppressed gold signal suggests a modification much thicker than a few monolayers. This process of depositing ultrathin coatings using a plasma reactor is termed plasma enhanced chemical vapor deposition (PECVD).

Ultrathin coatings offer a permanence that other plasma methods may not provide because polymeric surfaces usually have some degree of chain mobility or rotation that effectively reduces the surface treatment over time. Reorientation of polymer chains disturb the accessibility of surface functionality.

Some materials such as elastomers and thermoplastics contain small molecules and low-molecular weight species such as plasticizer and oligomers. Trace amounts are able to migrate to the surface and effectively block the established surface groups. A substrate bound to a contiguous ultrathin layer is more likely to retain uninterrupted surface chemistry.

Table I. An x-ray photoelectron spectroscopy survey of elements on a gold surface shows before and after a gas-plasma amine chemistry.

Table I also compares a plasma-coated gold surface before and after solvent wash. The elemental nitrogen content remains almost unchanged—confirming the surface layer is permanently bound to the substrate as opposed to a freestanding film. The chemistry of a surface is accessible to reaction with environmental or biological systems. The accessibility enables immobilization of protein and other communicative molecules. Some of the common compounds that can be grafted to a surface using plasma include amine, carboxyl, hydroxyl, vinyl, and thiol. Adsorption and conjugations of species can occur.

Figure 1 compares methods for loading heparin on an elastomeric copolymer. Only the plasma-grafted surface exhibited no loss in heparin density following seven-day incubation. All trials show initially good heparin loading compared with the control surface. Methods in which plasma was not employed experienced at least a 50% reduction in heparin over the period. The plasma-modified surface demonstrates process stability.

Figure 1. Heparin density is compared, following gas plasma conjugation and liquid-phase conjugation of a cardiovascular graft, after undergoing 7-day incubation in a bioreactor.

Wet Versus Gas

Although wet chemistry methods exist for the modification and grafting of species, gas plasma offers superiority in cost, modification of inert surfaces, and scalability into commercial production. A gas- or vapor-phase plasma requires only marginal amounts of species for interaction with the surface. These have only a short residence in the reactor vessel before reaching the chamber exhaust.

A wet bath such as liquid-phase silanization, on the other hand, requires that a silane be dissolved in a solvent and then a clean substrate be added to the solution for durations sometimes exceeding hours.1 A liquid-phase silanization is not easy to control either, mainly due to difficulty in restricting the amount of water present in the solution. An absence of water results in incomplete monolayers and an excess of water results in homopolymerization or surface aggregation.2

In a gas-phase deposition using low-pressure plasma, moisture is controlled, eliminating unwanted surface formation. The high permeability of gas molecules allows function of nano-scale features or porous structures where access to the liquid solution is limited by capillary forces.

Surface Morphology

Varying the energy applied to gas plasma affects the surface morphology. At high energy, ablation dominates, and the substrate becomes rigorously etched or nano-roughened. At lower power regimes, gas plasma is a primarily additive process and the conditions are amenable to film formation.

Figure 2. A 5 × ­5­–μm contact mode AFM image of topography demonstrates the different surface morphology resulting from continuous [left], low-pulsed [middle], and high-pulsed [right] plasma power conditions on a PECVD coating.

An ultrathin PECVD coats surface features with an atomically smooth layer. If the energy is delivered in pulsed periods, the plasma yields nano-patterned film morphology. Figure 2 compares atomic force microscopy images of three PECVD fluorocarbon coatings on a glass microscope slide. The pulsed power conditions yield bumpy textures. In a PECVD of fluorocarbon, a surface pattern increases the surface area, thereby providing greater hydrophobicity.

Contact angle measurements using deionized water results in approximately 110° for the continuous power process and greater than 130° in the case of a pulsed power condition. Fluorocarbon coatings are noted for their properties of super hydrophobicity, resistance to protein adsorption, and anticorrosion.3 Morphology plays a big role in these surface interactions.

Another attribute of low-pressure gas plasma is its ability to develop custom PECVD surface chemistry that resembles conventional material systems. Polyethylene glycol (PEO) is a polyether compound with applications in manufacturing and medicine. Characteristics include biocompatibility, nonfouling, and nonimmunogenicity.4

Inspection via FTIR-ATR confirms an ether content of greater than 80%. The coating is both hydrophilic and resistant to protein adsorption. PECVD of a PEO-like film offers the advantages of being conformal, covalently bound, and chemically cross-linked for improved wear resistance. Other experiments have reported application of comparable PECVD chemistry in combination with lithographic patterning for directed cell growth.5 Cell attachment may be both assisted and inhibited by surface treatment.

Conclusion

Gas plasma for manufacturing isn’t new. Early adopters of large-scale commercial operations date back more than two decades. But gas plasma has remained one of industry’s best-kept secrets.

Today’s economic climate drives the need for a manufacturing process that is leaner, greener, and more efficient than ever before. Consumers demand lower cost and greater ecological responsibility. Medical and diagnostic devices are at the point of care. Product evolution drives greater accessibility to end-users and further into the realm of fast moving consumer goods. Surface solutions, such as gas plasma, can transform commodity plastics into smart materials. The operation is lean, efficient, and highly versatile.

References

  1. CM Halliwell and AEG Cass “A Factorial Analysis of Silanization Conditions for the Immobilization of Oligonucleotides on Glass Surfaces,” Analytical Chemistry 73, no. 11 (2001): 2476–2483
  2. AY Fadeev and TJ McCarthy “Self-Assembly Is Not the Only Reaction Possible Between Alkyltrichlorosilanes and Surfaces: Monomeric and Oligomeric Covalently Attached Layers of Dichloro- and Trichloroalkylsilanes on Silicon,” Langmuir 16, no. 18 (2000): 7268–7274
  3. V Kumar et al “Fluorocarbon Coatings via Plasma Enhanced Chemical Vapor Deposition of 1H, 1H, 2H, 2H- Perfluorodecyl Acrylate -2, Morphology, Wettability and Antifouling Characterization,” Plasma Processes and Polymers 7 (2010): 926–938
  4. S Kane “Surface Modification of Ultrahigh Molecular Weight Polyethylene to Improve Lubrication in Total Hip Replacements,” University of California, San Francisco with the University of California, Berkeley, 2008
  5. CW Chang and D Sretavan, “Novel High-Resolution Micropatterning for Neuron Culture Using Polylysine Adsorption on a Cell Repellant, Plasma-Polymerized Background,” Langmuir 24 (2008): 13048–13057.

Khoren Sahagian is a materials scientist involved in process development and research for gas plasma technologies at Plasma Technology Systems (Belmont, CA). In 2008 he was awarded the R&D 100 award, given to the 100 most significant innovations of the year. 

Stephen Kaplan is the founder of Plasma Technology Systems and currently serves as a technology consultant for the company. He previously founded Plasma Science Inc., which pioneered the development of large chamber low pressure primary gas plasma systems for industry. Stephen is a polymer chemist with 50 years of experience in the plastics industry focused on interfacial and surface properties of polymers. 

Mikki Larner is the vice president of sales and marketing for Plasma Technology Systems and has 13 years of experience in plasma surface modification. She is an active member in the Surfaces in Biomaterials Foundation, the Society for the Advancement of Materials and Process Engineering, and the Society of Plastics Engineers. 

Medtronic Sued for Pushing Off-Label Use of Infuse Bone Graft

Medtronic's controversial Infuse bone graft is attracting renewed criticism and litigation. The Spine Journal detailed concerns regarding the product's safety in 2011. A sizable number of lawsuits followed and continue to pile up. Most recently, a man filed a new lawsuit related to the product in Los Angeles Superior Court, alleging that Medtronic pushed off-label use of Infuse to generate revenue and gave kickbacks to physicians using the product. The 85-page complaint asks for compensatory and punitive damages. While FDA approved the product for use in a procedure in a single spinal area, Medtronic allegedly disregarded regulatory warnings that the product could be unsafe when used for off-label uses. In the most recent litigation, the plaintiff reports having spinal surgery in September 2011 and subsequently developed bone overgrowth in the neck. In addition, he reported that his nerves close to his spine were compressed. The man eventually underwent a series of surgeries to address the problem. In early July, the product was the subject of an editorial in the Chicago Tribune titled "The danger of rigged medical research," which argues that when the product debuted, it was hailed as a breakthrough; now, its value is in question, over a decade after the product debuted in 2002. From between 2002 and 2011, FDA received hundreds of complaints related to the product.

Creganna-Tactx Medical Names Former Abbott Vascular President as CEO

Minimally invasive device specialist Creganna-Tactx Medical (Galway, Ireland) has selected Robert B. Hance as its CEO. Hance will take the reins in September, replacing Helen Ryan, who had served as CEO for the past eight years. Now an entrepreneur in residence at the FDA, Hance had also worked for more than 23 years at Abbott Laboratories. Hance was the president of Abbott Vascular, nearly doubling that division's sales between 2007 and 2011. "I am committed to Creganna-Tactx Medical's vision to be a leading global medical technology company," Hance said in a statement. Creganna-Tactx operates divisions in Minnesota, California, Ireland, and Singapore.

Obama's Tax Proposal Is Positive For Most Medtech Companies

Obama's Tax Proposal Is Positive For Most Medtech Companies

It's 100% for Johnson & Johnson. And 93% for Medtronic.

They represent the percentage of overall cash that is housed overseas by these large medtech corporations. For both companies, the amount kept in foreign locations is more than $5 billion.

That may change significantly if President Obama's tax proposal moves forward.

Glenn Novarro, senior medical device analyst at RBC Capital Markets, believes the plan is on the whole is good for medtech companies. Here are some details of the proposal that:

  • reduces the corporate tax rate to 28% from the current 35%
  • has an effective tax rate for manufacturers of no more than 25%
  • has a minimum tax on foreign earnings
  • a one-time tax on foreign earnings to fund infrastructure, manufacturing and community colleges to boost middle class jobs

If this becomes a reality, the company's that will most benefit are those that have more than 50% of their "cash balances trapped overseas," Novarro said in a research note Wednesday. And these companies are Medtronic, Zimmer, Abbott, Becton Dickinson and Stryker, Novarro said.

But it's also an overall positive for smaller companies like NuVasive, Wright Medical Group, Tornier and Integra Lifesciences because it increases their chances of being acquired. And that's because larger companies like the ones mentioned before will have more cash to make U.S. acquisitions with if they choose. Over time the lowering of the tax rate on manufacturing would also might help to bring back manufacturing jobs, Novarro believes.

One company that won't see much of a benefit from the proposal is Covidien, which is based in Ireland.

While the proposal appears to be good for most domestic firms, small and large, there are many unanswered questions about Obama's plan as Novarro points out. For instance, will lowering the corporate tax rate, while closing loopholes and other tax breaks to corporations to raise some revenue add to the deficit in the future?

But companies that are based abroad but have operations in the U.S - like Covidien - won't benefit as much from the proposal.  

[Photo Credit: iStockphoto.com user stevanovicigor]

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com
 

Alere Faces Shareholder Rebellion Following Steep Q2 Losses

Alere's board may face an ousting after the company released poor Q2 results. An activist shareholder claims that the company's decisions are ruinous.

For the second quarter, the company posted revenues of $764 million. While this represented growth of 9.1%, a significant increase in costs left the diagnostic systems manufacturer with net losses of $65.9 million. In Q2 of 2012, the company reported losses of $18.2 million. In total, sales of professional diagnostics increased to $599.6 million, an 11.7% gain. However, the company's Health Information Solutions segment fell to $134.8 million, a 2.8% decrease.

Coppersmith Capital Management, an investment firm, questions some of the company's recent decisions. While recent acquisitions by Alere added $47.4 million to the company's diagnostic revenue growth in the last quarter, Coppersmith questions the cost of this added revenue.

Coppersmith owns 7% of Alere in total. As of late, the financial group fees that the company's shopping sprees have had a negative impact on shareholder value. The financial group wants the company to sell its Health Information Solutions segment. In addition, Coppersmith is demanding the dissolution of a joint venture with Procter & Gamble. Alere's toxicology unit may also be shown the way out if Coppersmith gets its way.

In total, Coppersmith's requested sales would generate $4 billion. These funds could be used to pay off the company's debt. In addition, this could increase share prices by 136%, according to the financial group.

To make this happen, Coppersmith has nominated three allies to Alere's board. Shareholders will vote next week.

KCI Buys Wound Care Portfolio from Systagenix in Half-Billion-Dollar Deal

Kinetic Concepts (San Antonio, TX) announced the purchase of Systagenix (Gatwick, United Kingdom) on Tuesday. Under the deal, KCI would gain access to Systagenix's diverse wound care product portfolio for a price tag of $485 million.

Systagenix distributes a variety of wound care products like contact layers and foams. In total, the company distributes 20 million wound dressings around the globe every month. Overall, the company employs 800 people. Before a buyout in 2008 by One Equity Partners, Systagenix was a J&J Ethicon segment.

Under the deal, KCI will pay One Equity for the company's wound care portfolio. Following this, One Equity will push out Systagenix's diagnostic segment into its own company. KCI believes that the acquisition will be completed by the fourth quarter of the year.

With the buyout. KCI gains a solid position in the wound-care market. According to information released by KCI, the global wound-care market is worth $3.4 billion. KCI currently manufactures negative-pressure devices for wound therapy.

Europe’s Demand for Medtech Connectivity On the Rise

In the face of economic uncertainty and severe budgetary restrictions, the European markets for video and related surgical equipment saw moderate decline in the last few years. Market expansion resumed in 2012, but at a slower rate of growth—a few countries are still mandating budgetary restrictions. Although growth rates are expected to pick up slightly in the future, the outlook for the medtech market remains meager until public finances in Europe are restored, especially in the southern member states. However, despite overall stagnancy in the market, technological advances and reconfiguration within a variety of specific markets are driving significant growth for new products. The market for video, surgical scopes, and operating equipment, for example, remains driven by technological innovation. When this market resumes its prerecession level over the next six years, as is all but guaranteed by the ageing of the European population as well as the increase in MIS procedures and the need for real-time access to data, it will comprised a more advanced array of products than was in place before 2009.

Integrated OR Components

One market in which important reconfigurations were apparent in the last year was the market for integrated OR systems. In 2012, this market was worth over €64 million and experienced the largest growth out of all other segments. Historically, companies that provide integrated systems such as Karl Storz, Olympus, and Stryker have dominated this market. Their products offer centralized control of the entire OR with the ability to maneuver and manage endoscopic equipment and peripheral devices such as tables, booms, and lights to enable surgeons to view, display, and document information from video and other data sources in and out of the OR. However, budgetary restrictions and customer needs have reshaped and segmented the OR integrated market.

There has been increasing adoption of products that help medical workflow through connectivity of the OR. These systems transport images and patient data over existing IT networks via the video-over-IP route. These products aid in maximizing OR efficiency, staff communication, and connecting all imaging modalities to one centralized video management platform.

In 2012, unit sales of the connected integration component and the full integration component markets saw growth at almost 10%, which demonstrates the current popularity of digital OR integration components. However, the trend over the forecast period will shift towards full integration component systems because they provide an extra level of efficiency in the OR to increase turnover rate and, as a result, maximize the use of hospital budgets.

Scandinavia Leads the Market

The Scandinavian market includes Denmark, Norway, Sweden, and Finland. These countries have chosen a common approach to social welfare and were able to recover quite quickly from the economic recession compared to other regions. Due to the fact that the Scandinavian countries have large sparsely populated areas (with the exception of Denmark), hospitals are increasingly becoming highly specialized treatment centers and simpler cases are being dealt with on an outpatient basis. In general, the Scandinavian countries, especially Sweden, are slow at adopting new technologies and as a result have had slower market growth over 2012 than other regions. However, due to hospitals and treatment centers being out of date and relatively old, governments in the various countries have begun construction of new hospitals. The first wave of completed hospitals is expected in 2015. As a result, the market in Scandinavia is expected to grow significantly starting in 2013 as hospitals look to equip themselves with the most up-to-date technology. As more hospitals near their completion date, the market will be sustained by the constant need to furnish these healthcare facilities.

Within the next 5 years, the Scandinavian markets are expected to see almost double-digit growth supplemented by the installations of integrated ORs. As the region switches to the model of specialized treatment centers, there will be an emphasis on constructing efficient ORs. We predict that integrated OR components will grow the fastest. Both the full and digitalized integration component markets are expected to have growth in double digits till 2019. Consequently, the image capture and recording device market will experience the second largest growth over the forecast period. The need to furnish the ORs with equipment such as booms, lights, tables and cameras will result in these markets experiencing sufficient growth over the forecast period as well. Essentially, the installation of operating theatres will drive the other markets and maintain steady high growth over the forecast period.

Karl Storz Leads But Faces New Competition

Karl Storz held approximately a one-fifth share of the European markets for video and surgical microscopes. In addition, the company led six of the 10 market segments. As the demand for integration and HD technology continues to increase across Europe, Karl Storz is expected to maintain a strong presence in the market. Olympus was also a major competitor in the total market in 2012 due to the company’s participation in half of the markets in video and scope equipment. However, its relatively higher prices along with new competitors in the 1-chip surgical camera segment saw its market share being challenged. Stryker, a company based in the U.S., was a strong competitor in the European markets in 2012 and was able to gain market share. Due to its aggressive pricing and breadth of product offerings, as well as the low exchange rate of the U.S dollar, Stryker is expected to continue to increase their market share in Europe.

The integrated component market experienced an influx of new companies that offer digital OR components. MAQUET, a leading competitor in lighting, surgical tables, and equipment booms market, now provides telemedicine and digital connectivity. Through it’s partnership with Richard Wolf, MAQUET can offer fully integrated options. Starkstrom is a strong player in the UK, which started out as a provider for isolated power systems, but now offers a fully integrated component called the S-equiP system. Steris, a competitor in the lighting, surgical table, and equipment boom market, is also an emerging player in the integrated OR market. It it provides an integrated OR solution called the Harmony iQ™ 2000 and 3000. Steris has gained market share in the Benelux region and as purchasing facilities continue to demand product bundling, the company’s market share is expected to increase. S-CAPE is another company that has entered the digitalized OR component market with the S-CAPE video control system. The system among the more expensive,, however, it provides signal processing along with a DICOM link and storage, through PACS. Companies such as Barco and eSaturnus offer more budget-friendly digital systems such as the Nexxis and NUCLeUS respectively. BORh options are designed to provide a “video-over-IP” system for data management, including images and video.

Note: The information contained in this article is taken from a detailed and comprehensive report published by iData Research (www.idataresearch.net) entitled “European Markets for Video and High Tech Markets.”

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Kamran Zamanian is president, CEO, and a founding partner of iData Research Inc. (Vancouver, BC). He holds a bachelor’s degree in engineering from the University of Dundee and earned master’s and doctorate degrees in market research and technology from the University of Manchester. Reach him at kamran@idataresearch.net.

Karlo Kordic is the lead analyst for iData’s global series on the video, hi-tech, and integrated OR markets. While completing his bachelor of science in cell biology and genetics at the University of British Columbia, Karlo worked at the B.C. Cancer Research Centre as a co-op student before joining the iData team.

On the Grind: The World of Do-It-Yourself Implants

The Web site, one of many like it, is devoted to grinding. Grinders, as they call themselves, represent a unique niche of the do-it-yourself (DIY) culture. These are people who experiment on their own bodies, creating their own implants—often for recreation, but also with a true spirit of academic experimentation. The message is clear: Implants are the future, and some people aren't waiting around for FDA or the medical device industry.

If you don't have access to a university hospital and want to get a magnet implanted in your finger, the best place to visit is a tattoo, piercing, or body modification shop, where an artist will place a subdermal magnet into your finger—likely using ice instead of anesthetic for legal reasons. Once healed, the magnet provides a sixth sense, allowing you to feel the presence of magnet fields. You may be tempted to ask why, but for grinders and researchers the answer is, why not? For people with the implant, it becomes as viable as taste or sight and even opens up a potential for new, enhanced senses.

Rich Lee, a grinder, describes the sensation. “It feels like it has a texture. It's a localized feeling. It's something there at all times. But unless you focus on it you don't feel it much,” Lee says. He describes being able to perceive the magnet fields in electronics around him. “With my old cellphone, for example, I'd know when it would ring beforehand because I'd feel the magnets inside it going off.” And yes, you can use the magnet to pick up tiny metal objects with your finger. 

While putting magnets into your fingers may have started as the latest trend for piercing enthusiasts, the idea of using implants to modify, replace, and even enhance our senses has been the focus of serious academic work for quite some time. Kevin Warwick is professor of cybernetics at the University of Reading, England, where he carries out research in artificial intelligence, control, robotics, and biomedical engineering. He's considered the world's foremost expert on cybernetics and has spoken on the subject at TED events. 

By implanting a chip into his arm, Kevin Warwick was able to remotely control a robotic arm.

In 1998, Warwick became the world's first cyborg when he briefly implanted an RFID chip into his arm that allowed him to identify himself within his building at Reading. As they picked up the RFID signal, lights would automatically come on and machines would greet him as he walked through the halls. In 2002, Warwick took his work a step further and implanted an electrode array into his arm that allowed him to remotely control a robotic arm via the Internet. 

Today, Warwick and his students are continuing their research into implants that can be used to help the disabled and augment the rest of us. “It's interesting sometimes because we're trying to write scientific papers, but the research we start with is more from the artistic side, so we have to translate it," Warwick says. He describes one student who has used finger magnets as a form of sensory enhancement, connecting them to an infrared sensor, which allows him to perceive the temperature of objects remotely. The military application for this is immediate, Warwick says. “If you're a soldier and you're about to go into a room and you don't know if there's anybody there or not, you can push your finger around a corner and scan.” Another researcher, Paul Bach-y-Rita, has developed a system for the blind that converts images from a camera into electrical pulses that trigger receptors in the tongue, allowing the patient to communicate and perceive shapes in space.  

Warwick says research even as simple as the finger magnets has great implications for the disabled. “The magnet creates a touch sensation. If you were to, say, link it with ultrasonic signals, you could effectively feel how far away objects are,” he says of a type of implant that could assist the blind. “It wouldn't affect their sight, but they would know how far objects away are.” 

A few years ago, Rich Lee awoke to find that he had lost most of the vision in his right eye overnight. Doctors tell him he could lose sight in his other eye at any time. His only option is a cornea transplant, which Lee says he cannot afford right now. But Lee, a grinder and entrepreneur, has embraced a homebrew solution to his ailment. He's implanted electronic earphones into both ears (in the tragus). As Warwick explained, by connecting his implants to an ultrasonic rangefinder, Lee can use them to detect the proximity of objects without using his sight. While the feat is nothing new for a cutting-edge device maker, consider that Lee has no professional background in science or engineering. His background is in finance, and he's self-taught from free online courses on engineering and medical implants offered by the Massachusetts Institute of Technology and the University of California, Berkeley. Lee built his implants using instructions freely available on YouTube and the DIY Web site Instructables.com

Rich Lee can use his earphone implants to listen to music and for a variety of other purposes.

Although his device doesn't offer true echolocation yet, Lee, who has several DIY implants in his body (including a finger magnet), says he's working toward it. One idea he has found is to connect a pair of glasses capable of sending an electronic signal to his implants. He has also done other experiments. For example, he found that by connecting his earphone implants to a contact microphone he can enhance his own hearing—allowing him to hear longer distances and even through walls. “That one creeped out a lot of people,” Lee laughs. 

Lee is one of the figures at the forefront of the grinding movement, a passion he says grew out of his longtime fascination with futuristic technology. “I got into it around 2008. My grandmother passed away and left me a big tub of old magazines. I looked through it and found a bunch of medical and technology articles from the '50s, '60s, and '70s that depicted this Jetsons-like future where you were going be a cyborg and live forever,” Lee says. “I just had one of those moments where I thought this might not ever come, especially with the FDA rules on medical implants. I don't know if recreational cybernetics is going to be commercially available anytime soon. It's something I've always wanted, but I figured I'd launch myself into it and start going the DIY route.”

Rules and regulations come up a lot in these discussions. Lee says he and the various groups and individuals he works with have come up with a variety of prototypes for medical and recreational purposes. Among the boldest prototypes is a modification to an artificial lung that is capable of regulating body temperature by heating and cooling blood as it passes through the device. An online-based group called Grindhouse Wetwares is currently developing an implant codenamed Circadia, which, if successful, will read biomedical and vital sign data and transmit it wirelessly to a smartphone or computer. The implant could even be capable of providing warnings via text to your smartphone or LED lights embedded beneath the skin. A representative of Grindhouse Wetwares declined to be interviewed for this article, but stated in an e-mail that the team is working around the clock on its latest project. Lee expects the group to try the first Circadia implant in October. 

Another project involves a subdermal EEG implant that allows people to communicate and even display their moods through a computer interface. Lee has consulted with companies that think the device would be perfect for patients with locked-in syndrome (a form of waking paralysis) and would allow them to communicate with the outside world.

However, as feasible as some of their ideas may sound, Lee says he and other individuals have had trouble finding companies to get on board and embrace what they're trying to do. “A lot of these things we're cranking out are so niche and experimental that I could really see FDA just turning their nose up at it,” Lee says. When asked about the most popular of the various device prototypes he has developed, Lee shyly states that it's an “adult-themed” device: a vibrator that can be implanted in the pelvic region. “I have a surprising amount of interest in the female version in France and a few other places, but men worldwide have expressed interest in a male version and will often e-mail me for updates.” Lee says he even approached two device companies about designing the product and getting it up to FDA code but was shot down by both. “They just didn't want to be anywhere near it,” he says. “They say it's doable, but they just don't want it in their product portfolio.” 

Warwick has experienced similar apprehension from the industry even in his academic work. “Maybe [companies] are a little bit scared about publicity,” he says. “Our first RFID experiment used a chip from an American company, but they said, 'Don't mention our name; don't tell anyone it's our product.' They were happy to get results, but they didn't want to be associated with it because the material the chip is made of hadn't been used as an implant before.” 

However, Lee adds that there are plenty of individuals in the device industry who are involved in grinding but prefer to remain anonymous to preserve their or their company's reputation. “I consult with a lot with professionals in the field,” Lee says. “I'll send e-mails and ask questions all the time, and they don't necessarily know what I'm doing, but they're usually happy to answer questions. I think I've got a good set of advisors who've managed to get devices through FDA and critiqued me here and there.” He says biologists and engineers often anonymously post on grinder forums and Internet chatrooms looking for novel functions for implants and offering guidance. 

Based on estimates he has received, Lee believes it would take five years and require rougly $1 million in investment to get his devices through FDA. 

But why the impatience, particularly in a landscape with more and more innovative medical device companies emerging every year? What is it that compels people like Lee and Warwick to put their own bodies at risk for the sake of moving the technology forward? “There is kind of an impatience in part because a lot of people feel the same way I do in that the government is never going to catch up,” Lee says. “If you're a kid and everyone's telling you that you'll be a cyborg someday and able to do all these cool things and the technology is there, but you can't have it because no one will sell it to you, because the government hasn't caught on to the concept of these elective devices, it makes a lot of us in the do-it-yourself crowd impatient.” Lee also points out that self-experimentation is nothing new in the medtech industry. In the early days of implant and biomaterials research it was not uncommon to hear about a researcher implanting a dog, or even himself, to test a material. 

The grinding community wants to extend an olive branch to device companies and regulatory bodies, letting them know that the culture isn't about subverting the industry and that grinders aren't out to give a middle finger to FDA. Lee says he and other grinders would love and welcome participation or even coaching from the medical device community, even if it's just casual direction or design assistance. “Of course I'd like to see the government lighten up, but of course with some devices like an artificial lung or artificial heart, I think those things should go through some rigorous tests, especially if it's a lifesaving device,” Lee says. “But if you're talking about devices that are subdermal and are just going into your skin and not your organs, as long as they're designed soundly, I think it'd be awesome if there were some sort of express lane for these things.” 

Lee says he would encourage FDA to allow the public to assume more of its own risk when it comes to recreational implants. “Some guidelines along the lines of, 'This implant is approved for subdermal applications for six-month periods.' ”

Warwick agrees that regulation is necessary, but also encourages device companies to be more active in this arena. “[Regulation] does put roadblocks in the way, but I think they are appropriate roadblocks that make you stop and think,” he says.

“At this stage, from a research point of view, realistically, we're trying one-off experiments. We're not about to produce 6000 products. So, from a manufacturer's point of view, one-off experimentation would be helpful and wouldn't do any harm,” Warwick adds. “Certainly in the UK maybe it's easier with the device agency approval. Device agencies are probably a bit tougher in the United States. Clearly, the legal side of things in the United States is a bit different if you get it wrong there, whereas you might not get litigation in the UK.”

Rich Lee discusses his headphone implants

 But while subcultures and academics are quick to embrace implant technology, the question still remains: What would it take to get the general public interested? Skeptics point out that there are plenty of external devices that are noninvasive and still capable of doing what many implants could do.

The key in Warwick's mind is generating an overall sense of acceptance among the public. “Helping people with disabilities is the short-term fix, as it were, that's pushing on the technology to an extent," he says. "When people are ethically happy with a technology, it moves things forward.” He points out that there are already several devices, such as deep-brain stimulation implants for Parkinson's patients and others for sensory replacement and remote control, that have been readily embraced.

“Look at cellphones for example,” Warwick says. “First it was a geeky thing and these brick-sized things with poor reception. But enough people pushed it and they got smaller and cheaper until now, you can't be without it. And if you haven't got one, what's wrong with you? It’s a very short space of time, within 25 years, during which cellphone technology went from nonexistent to a necessity,” says Warwick.

While grinders have no illusions that they're coming from the fringes, ulimately what Lee and his fellow grinders would like is for industry and regulators to be less dismissive of their activities. If researchers like Warwick have their way, we might not have a choice. It could sneak up on us before we know it.

“If socially there's a number of people using the technology and it's being pushed forward, then I think everyone will say 'I should be a part of that,'" Warwick adds. "There will be a stage, a sort of social tipping point, where there will be a number of those and it becomes more of a commercial reality and people feel they have to go for it.” 


Learn from the Industry's best subject matter experts on the design and manufacture of implantable medical devices! 

Design of Implantable Devices Conference- Sept. 26-27, 2013

-Chris Wiltz, Associate Editor, MD+DI
Christopher.Wiltz@ubm.com

Bionic Medical Devices: What's Holding Them Back?

Bionic Medical Devices: What's Holding Them Back?

Bionic prostheses, which use electronics to restore biological functions that have been lost or compromised, are among the most exciting medical devices. Thanks to bionics, babies born deaf can hear, people who have lost their sight can see, people living with paralysis can walk, lower-limb amputees can run, and upper-limb amputees can type on a keyboard. Bionic medical devices make occurrences once considered miracles happen every day.

The Ekso bionic suit enables people with lower-limb paralysis to stand and walk.

Driven by Moore’s Law, bionic medical devices have made huge strides over the past half-century, says Maysam Ghovanloo, associate professor in the school of electrical and computer engineering at the Georgia Institute of Technology and founding director of the school’s GT-Bionics Lab. Miniaturization has led to lower power consumption, and combined with the rise of wireless technology these factors have bred the smart prostheses we see today—devices that can sense muscle contractions and send electrical signals to nerves. “Today, new medical applications are possible that nobody could even have imagined 20 or 30 years ago, Ghovanloo says.

Still, bionic prosthetic devices have a ways to go. FDA’s granting of a humanitarian device exemption (HDE) this past February to Second Sight Medical Products’ Argus II Retinal Prosthesis System, hailed as the world’s first bionic eye, was met with much excitement. But although the device can bring people diagnosed with blindness caused by retinitis pigmentosa (RP) back to low vision, it’s nowhere near the level of sight people with healthy eyes experience.

As Second Sight and other makers of bionic prostheses work to close the gap between biological organs and limbs and their prosthetic counterparts, they’re forced to clear not only technical hurdles, but financial ones as well. The Argus II is the culmination of more than two decades of research that Second Sight CEO Robert Greenberg started as a graduate student at Johns Hopkins University. The product is one of the lucky few to make it out of the lab.

“For every 10 of these great new progresses, maybe one actually becomes commercially available,” Ghovanloo says. The rest stall out in the so-called valley of death—the period between a technology’s genesis and when it becomes commercially available.

The Argus II Retinal Prosthesis System consists of an electronic device implanted in and around the eye, a video camera attached to a pair of glasses, and a video processing unit.

Part of the problem is the dearth of venture capital (VC) flowing to medtech. According to Ernst & Young’s 2012 Pulse of the Industry report, VC investment in U.S. medtech firms last year was 10–15% lower than in the six years prior, and makers of bionic devices have felt the pinch. Only one VC firm, Versant Ventures, contributed to the more than $100 million dollars in private investment raised by Second Sight, says Brian Mech, vice president of business development.

Ekso Bionics, maker of Ekso, a bionic suit that enables people with lower-extremity paralysis to walk, hasn’t received backing from any traditional VC funds, says CEO Nathan Harding. He says the company prefers not to use VC but nonetheless pitched to a few VC firms, which didn’t bite.

“There’s still money available for IT ventures in the healthcare space, but hardware is having a tougher time,” Harding says, adding that access to capital is the No. 1 factor hampering innovation in bionics. “The going would be a lot faster if it was easier to prove to people that they need a bionics [investment] strategy,” he says.

Many medtech firms—especially those in the early stages—are feeling the VC drought, but makers of bionic devices face particular challenges in attracting investment.

“When it takes more than 10 years to get [the technology] to market and $125 million, most investors are going to say no,” Mech says. “No one has that kind of time horizon.” Second Sight, he adds, received a lot of its backing from medtech entrepreneur Alfred Mann, who also founded cochlear implant developer Advanced Bionics, and his friend Sam Williams, who was motivated to find a technological cure for blindness because he suffers from RP.

Under the HDE, Second Sight’s Argus II can only be implanted in up to 4000 patients per year. RP affects only around 100,000 people in the United States, and the Argus II targets only those who have reached the end stage of the disease, a population of 8000–12,000, Mech estimates. “We’ll never do 4000 in the U.S. per year,” he says.

Other bionic prostheses are aimed at relatively small patient populations as well. Amputees account for less than 1% of the population, says Karen Lundquist, director of corporate communications for Ottobock, a maker of bionic products including the C-Leg, the first fully microprocessor-controlled prosthetic knee. “The studies are really challenging when numbers are that limited,” she says, adding that there’s also no way to do a double blind clinical trial with an amputee.

Bionic prostheses such as Ottobock’s X3 have enabled users to continue the activities they enjoyed before amputation.

Makers of bionic prostheses also face challenges once they get their products to market. Some products might need a new reimbursement code, and obtaining one is time consuming. The process takes at least two years and can drag on for up to five years if the claim is refuted. Even products that manage to get a new code aren’t out of the woods.

“Just because you get coding doesn’t mean you get adequate payment or coverage, says Kimberly Hanson, regional director of reimbursement for Ottobock. “We got a great code for our new hip joint, yet when payment came, it was half of what the cost of the device is.”

In addition, providers don’t know before they order a prosthesis that the device will be covered by insurance or Medicare.

“Manufacturers don’t provide directly to patients; they provide to prosthetists, who are responsible for the billing,” says Joe McTernan, director of coding and reimbursement services for the American Orthotic & Prosthetic Association, a trade group that represents orthotics and prosthetics professionals. The prosthetists buy the technology and must then convince the payors to reimburse them.

“It’s kind of a crapshoot,” Hanson says. “Even if they get authorization in advance, they may or may not get enough to cover the cost of goods or to cover the cost of the service.”

Obtaining reimbursement can be particularly tough when it comes to bionic prosthetics. “There are still insurance companies—major insurance companies—that have policies in place that say these microprocessors are experimental,” McTernan says. “Fifteen years of being classed as experimental technology, that’s a bit of a stretch.”

Össur’s Symbionic Leg combines a powered ankle with an adaptive microprocessor knee joint.

Couple that with the fact that bionic prosthetics can be three or four times the cost of traditional body-powered prostheses, and you can see why providers might be wary of bringing these advanced devices to patients. “There’s definitely fear of risk, especially in small practices,” Hanson says. “I don’t know anyone personally who does it, but in this industry, they definitely do downgrade the technology for fear of not getting paid.”

While makers of bionic prosthetic devices face a number of challenges in getting their products to patients, they’re also finding innovative ways to overcome them. This past June, Össur, whose bionic prostheses include the Symbionic Leg and Power Knee products, announced an agreement with consulting firm Harrington Management Group (HMG) to provide customers the option of having pending Medicare claims evaluated prior to submission.

“HMG does quite a bit of this kind of work in the durable medical equipment area, but this was their first agreement in the prosthetics space, and the services apply specifically to claims for Össur's bionic products,” says Össur spokesperson Laura Min Jackson.

Ottobock and other companies have also achieved economies of scale by adopting a platform approach to product development. “Instead of building a new foot from the ground up, so to speak, we create variations by putting together our products,” Lundquist says. She cites the Triton Harmony, a combination of Ottobock’s Triton carbon fiber foot and Harmony volume management system, as one example.

Ekso Bionics has found success in diversifying the industries it targets. Harding says medical still accounts for about two-thirds of the company’s business, but the rest comes from defense applications of its exoskeleton technology. The company licensed its Human Universal Load Carrier exoskeleton to Lockheed Martin for military development in 2009, and Harding says the military business has “absolutely” helped Ekso Bionics weather the softness in the U.S. healthcare market. It has also helped the company expand the medical applications for the Ekso exoskeleton. A version of the product that combines elements from both the medical and military software packages can now be used by patients rehabilitating from stroke.

There are also signs that the funding climate is improving. VC investment in medical devices and equipment reached its highest level in nearly two years last quarter, according to the MoneyTree Report by PricewaterhouseCoopers and the National Venture Capital Association based on data from Thomson Reuters. Harding says he has also heard talk of VC firms forming funds dedicated to investing in bionics. “They’re coming, just not yet,” he says.

The looming question is whether they’ll come fast enough for the early-stage companies developing these innovative technologies—and the patients who desperately need them.

 —by Jamie Hartford, managing editor, MD+DI
jamie.hartford@ubm.com
 

Medtech Firm Treating Sudden Cardiac Arrest Raises $2M

Medtech Firm Treating Sudden Cardiac Arrest Raises $2M

Advanced Circulatory makes the ResQPOD and ResQGARD Impedance Threshold Devices for patients needing cardio pulmonary resuscitation during sudden cardiac arrest. The American Heart Association estimates that nearly 383,000 out-of-hospital sudden cardiac arrests occur annually, and 88 percent of cardiac arrests occur at home. These devices delivering Perfusion On Demand are meant to decrease chest pressure during CPR, increase blod circulation, protect the heart, brain and other vital organs at a time when blood flow is compromised. 

Advanced Circulatory will use the money raised will be used to further the commercialization of these two devices worldwide as well as to launch the ResQCPR device, which is being reviewed by the FDA. It combines the company's ResQPOD ITD technology with the ResQPUMP® active compression/decompression CPR (ACD-CPR) device to optimize performance of CPR.

“Our Perfusion on Demand therapy has the potential to have a global impact on patient care, and this financing round will help us push education and adoption of our life-saving therapies," said Mike Black, Advanced Circulatory's Director and CEO, in prepared remarks.

Currently, Advanced Circulatory sells the ResQPOD and the ResQGARD devices in more than 25 countries. 

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com