MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

MX: Questioning the Healthcare Reform Bill

Jim Capretta

Among Capretta’s criticisms of the current bill is that of the much-ballyhooed medical device tax, which imposes a 2.3% excise tax on the sale and import of Class I, II, and III medical devices beginning in 2013. Although the bill’s backers expect to raise $20 billion over the next ten years, Capretta surmises that costs will ultimately be passed down to consumers as the prices of devices are increased to compensate for the hike. “The incidence of these things falls directly on consumption; it doesn’t fall on industry per se, but of course industry is hurt,” he adds. “There’s going to be some shrinkage associated with this tax: It’s going to cost jobs.”

Trepidation about the tax was shared by some of the presentation’s attendees, such as Isaac Erickson, vice president of manufacturing and research development at Revolutionary Science. “I’m worried about [the bill]. We’ve been in the laboratory equipment industry for 10 years and we’re just getting into medical with three products,” he says. “So, when I see a 2.3% excise tax, when you’re talking about a device that sells for $5000, that’s a heck of a lot of money.”

In addition to the controversial medical device tax, Capretta has reservations regarding the efficacy of the subsidy system proposed in the bill. The legislation forces companies that do not offer healthcare coverage to pay a penalty for employees that ultimately need subsidized insurance; however, if the employer offers qualified coverage, the employee must accept it and is ineligible for subsidized coverage, according to Capretta. “This is probably the most important provision of the entire bill—what makes the math on paper appear to work, but it really doesn’t,” he states. “This says, in effect, some small employers will have a worker who will end up in the exchanges because they don’t have to offer coverage at all and will be penalized.”

But the numbers don’t add up, Capretta says. He points to a discrepancy between the 17 million people that the congressional budget office estimates will receive subsidized coverage through the exchanges and the 127 million eligible recipients that meet the criteria according to Census data. “A firewall keeps everybody in the employer-based system and does not have them migrate into the exchanges if at all possible,” Capretta says. “[The budget office] knows if they had to subsidize coverage for 127 million people instead of 17 million people, the cost would have been sky high. So, they wrote a provision in the bill that if your employer offers you qualified coverage, you can go in the exchange, but you can’t get a subsidy.”

The rationale behind this approach is that high-wage workers will continue to accept a job-based plan while low-wage workers will receive better subsidization if they go into the exchange system. The problem with this approach, according to Capretta, is that the budget office assumes that employers will not adjust their labor structure over time.

Jim Capretta, a fellow at the Ethics and Public Policy Center, and Rich Nass, content director for Medical Device Brands, discuss the overarching influence that healthcare reform may have on insurance policies, the medical industry as a whole, and the medical device manufacturing systems.

“I think we’re heading toward a situation in the not-too-distant future where you’re going to wake up one day and read a headline that says: Healthcare bill costs lots more than people expected,” Capretta says.

He also expresses concern about the multifactor productivity adjustments to Medicare payment updates, noting that the chief actuary of the Medicare program questioned its viability as well. This provision could cause Medicare’s rates to fall below those of Medicaid by 2019, Capretta states, which, in turn, could reduce the number of willing suppliers and compromise care for seniors. Medicare coverage may further be affected by pressure exerted on physicians to give up their practices and join hospital-based accountable care organizations. This trend could result in a large number of seniors entering into a managed-care environment by default without their knowledge or consent.

Whether the public echoes Capretta’s myriad concerns about healthcare reform remains to be seen in the upcoming elections, however. “I think in three weeks after the political decisions have been made, we’re going to see a dynamic trend, if favorable [to the bill’s opponents], to perhaps push to repeal parts of [the bill],” comments audience member Mark Distin of Ortho Solutions LLC. “If not, perhaps a lot of the industry is simply going to go offshore, whether they relocate their facilities or simply try to open up new markets for their products, and that will be a very aggressive shift.”

Molecular Fingerprinter for Trace-Gas Detection Could Improve Diagnostic Devices

breathalyzer illustration
Artist's rendering of JILA's molecular fingerprinting system. A gas mixture (left) is probed by a frequency comb, a laser-based tool for identifying different colors of light. By analyzing the amounts of specific colors absorbed, the system identifies molecules and their concentrations. (Image by Baxley/JILA)

Scientists at JILA (Boulder, CO), a joint institution of the National Institute of Standards and Technology (NIST; Gaithersburg, MD) and the University of Colorado (Boulder), have demonstrated that an improved laser-based "molecular fingerprinting" technique can pick out traces of key hydrogen-containing and other molecules from a billion other particles in a gas in 30 seconds or less. This performance could render the technique suitable for breathalyzers used to diagnose diseases.

Described in Optics Express, the research extends the range of an existing NIST/JILA invention to cover the mid-infrared region of the electromagnetic spectrum, a critical range because it includes the frequencies associated with strong molecular vibrations, including various hydrogen bonds. The technology can thus identify a much wider variety of molecules than the previous-generation instrument, including virtually any containing hydrogen, and can measure lower concentration levels.

The heart of the JILA system is an optical frequency comb, a tool generated by ultrafast lasers that precisely identifies a wide range of different colors of light. Researchers identify specific molecules based on which colors of light, or comb "teeth," are absorbed by a gas, and in what amounts. The comb light usually passes through a gas mixture many times, significantly improving detection sensitivity. Concentrations are measured with the help of molecular "signatures" assembled from databases. The technique works quickly and reliably even when molecules have overlapping, continuous, or otherwise confusing absorption signatures. Because of its rapid data collection capability, the technology is suitable for surpassing or replacing conventional Fourier transform infrared spectrometers for many applications.

In the demonstration, scientists measured a dozen important molecules at parts-per-billion precision, including the greenhouse gases methane, carbon dioxide, and nitrous oxide and the pollutants isoprene and formaldehyde. In addition, the system detected molecules useful in human breath analysis: ethane (a sign of asthma) and methanol (a sign of kidney failure).

Collaborators from IMRA America Inc. (Ann Arbor, MI) developed the fiber laser used to make the frequency comb. The comb itself is based on a nonlinear optical process that shifts the light from the near-infrared to the mid-infrared. The JILA researchers now plan to extend the system further into longer wavelengths to cover a second important molecular fingerprinting region, to identify a more diverse set of complex molecules containing carbon, and to modify the instrument to make it portable. Planning is also under way for clinical trials of the breathalyzer application.

Minisensor Can Detect the Signature of a Human Heartbeat

magnetic mini sensor
About the size of a sugar cube, NIST's miniature magnetic sensor features an inner square cell containing rubidium gas. The diagonal bar is an electrical connection to the cell's heaters, which are powered by the red, black, and white electrical wires. The clear optical fiber extending from the middle bottom of the sensor connects to a control box. (Photo by S. Knappe/NIST)

Researchers at the National Institute of Standards and Technology (NIST; Gaithersburg, MD) and the National Metrology Institute of Germany (PTB; Braunschweig) have used NIST's miniature atom-based magnetic sensor to successfully track a human heartbeat, confirming that the sensor has potential biomedical applications.

Described in Applied Physics Letters, the study focusing on this sensor is the first to be performed under conditions resembling a clinical setting. The sensor--a tiny enclosure containing about 100 billion rubidium atoms in gas form, a low-power infrared laser, and optics--measured the heart's magnetic signature in picoteslas (trillionths of a tesla). The tesla is the unit that defines magnetic field strength. For comparison, the Earth's magnetic field is a million times stronger than a heartbeat, and an MRI machine uses fields several million times stronger still.

Placed 5 mm above the left chest of a person lying face up on a bed during the tests at PTB, the sensor was able to detect the weak but regular magnetic pattern of the heartbeat. The same signals were recorded using a superconducting quantum interference device (SQUID), the "gold standard" for magnetic measurements. A comparison of the signals confirmed that the NIST minisensor correctly measured the heartbeat and identified many typical signal features. While it generates more noise in the signal than SQUIDs, the sensor has the advantage of operating at room temperature, whereas SQUIDs work best at -269°C and require a more-complicated and more-expensive supporting apparatus.

A spin-off of NIST's miniature atomic clocks, these minisensors were first developed in 2004. Recently, they were packaged with fiber optics for detecting the light signals that register magnetic field strength. In addition, their control system has been reduced in size, so that the entire apparatus can be transported easily to other laboratories.

The new results suggest that the sensors could be used to make magnetocardiograms, a supplement or alternative to electrocardiograms. The study also demonstrated for the first time that atomic magnetometers can offer sensing stability lasting tens of seconds, the amount of time required for an emerging technique called magnetorelaxometry (MRX), which measures the magnetization decay of magnetic nanoparticles. MRX is used to localize, quantify, and image magnetic nanoparticles inserted into biological tissue for such medical applications as targeted drug delivery.

Oops! FDA Seeks to Rescind Knee Implant Approval

This case that has received significant attention over the past year or so, in part because the device was approved over the objections of FDA scientists.

ReGen executive Gerald Bisbee said in a statement that the company "is currently weighing its options" in light of the FDA decision.

Live from MD&M Minneapolis: Evaluating New Stent Materials

Will today's stent materials be in tomorrow's designs? What new materials should be explored for use in stents? These questions were raised today by Jochen Ulmer, director of sales for Euroflex GmbH, at MD&M Minneapolis in his presentation, "Requirements on Materials for Cardio Stents: Today and Tomorrow." And while he answered these questions, he also posed a slew of new ones that give stent designers something to think about.

As for today's stent market, Ulmer notes that stainless steel has a majority hold on the market. Cobalt chrome, however, is nipping at its heels with a 45.71% market share. A similar divide of the market, he says, can be seen with drug-eluting stents versus bare-metal versions, which have 43.24% and 56.76% of the market, respectively.

But do these materials have staying power, or is something better in the works? Ulmer thinks that a new twist on the same material groups could be the way to go for next-generation devices.  In the stainless steel group, for example, he observes that substituting nitrogen for nickel could provide nickel-free stainless-steel stents with better MRI compatibility, higher radial force, and overall better biocompatibility than traditional stainless-steel designs. Likewise, he proffers that stent designers could build on the success of cobalt chrome and attempt the use of CoCrMo, which has not yet been tried in stents.

Or a different approach altogether could be worth investigating. Ulmer points to the success of titanium alloys in orthopedics and speculates that they could possibly be optimized for stents.

And, of course, no presentation or conversation about stent materials would be complete without mention of bioresorbable materials; they are, after all, the future of stent design. But these promising materials currently represent "an open game in the market," according to Ulmer, owing to the fact that there is so much uncertainty and so many unanswered questions.

Among these pressing questions are:

-       Do you use synthetic or metal materials?

-       How long does the stent have to keep its radial force?

-       What kinds of materials are released in the body? Are they safe?

-       Are they visible by x-ray?

-       How do you test biocompatibility, fatigue, and corrosion?

-       How do you process these products?

Absorb that information and let me know in the comments section which materials show the most promise for tomorrow's stents. Do you have any responses to Ulmer's questions?

New RF Welding Technique Allows the Use of TPEs in Medical Fluid-Delivery Applications

Genesis Plastics Welding (Indianapolis) has announced what it calls a radio-frequency (RF) breakthrough in conjunction with PolyOne GLS Thermoplastic Elastomers (Cleveland), enabling thermoplastic elastomers (TPEs) to replace traditional materials in medical fluid-delivery applications, including bags, tubing, and other products. The new technology from Genesis enables nonhalogenated and nonplasticized GLS Versaflex TPEs to be RF welded into any 2-D shape or configuration, including mandrels.
Collaboration between Genesis and PolyOne expands the portfolio of Versaflex grades that can be welded using ecoGenesis technology, providing better flexibility, mechanical properties, clarity, aesthetics, and value in fluid-delivery applications, according to the companies. Prior to this development, RF-welding techniques were restricted to high-dielectric-loss materials, and TPEs could only be heat sealed, limiting configurations to straight lines.
The ecoGenesis technology enables nonphthalate, low-dielectric-loss materials to be RF welded. Applications for ecoGenesis RF-welded Versaflex TPEs include infusion kits, blood transfer and drainage bags, and urinary bags.
"Medical device trends are highlighting the many advantages of TPEs for healthcare applications," notes Rick Noller, director of global marketing at PolyOne. "Through our work with Genesis, our Versaflex TPEs can better meet the needs of the medical device industry. We have validated ecoGenesis welding for use with Versaflex CLE and Versaflex MT220 grades, providing the industry better choices for the next generation of fluid delivery products."
"With ecoGenesis, manufacturers can use materials such as PolyOne's Versaflex TPEs in RF welding just like PVC, often providing improved cost savings and a more environmentally friendly product," remarks Tom Ryder, president and chief executive officer of Genesis Plastics Welding. "Our collaboration resulted in a breakthrough solution that can help manufacturers and healthcare organizations address concerns about patient safety and environmental protection, while also delivering improved performance across the board."
Versaflex TPEs surpass traditional resins in performance, aesthetics, and cost-effectiveness, the companies say. They are more flexible than polypropylene, autoclavable unlike polyethylene, and have better tear strength than competitive materials. These products also exhibit clarity and have a fine, matte finish. In addition, thinner gauges of Versaflex TPE can provide the same feel and texture as thicker gauges of traditional materials.

Tracking Those Elusive Medical Devices

Tracking is also on the minds of Medical Tracking Solutions, which developed the iTraycer for the iPhone and iPad (Android, Pocket PC, and Blackberry versions are coming, the company says). This app uses advanced GPS technology to provide real-time tracking of medical trays, devices, and biologics, including part and lot numbers. The product debuted at the North American Spine Society meeting last week in Orlando, FL.

Medtronic doling out funds—internally

Word on the street is that Medtronic is more interesting in acquiring technology than developing it internally. After speaking to Manda, it’s obvious that this is not true. They really want to come up with their own technology, and are obviously willing to put their money where their mouth is. Manda made it clear that he’s not doling out the money willy-nilly. But he is very interested in helping to discover the next new great technology.

One of the things to keep in mind when funding such ventures is that they’re not all going to pan out. Manda understood the risks involved. “We’re not afraid of having people fail, as long as they fail for the right reasons.” To me, the “right reasons” means that the company can learn from the experience and potentially capitalize at a later time or gain a deeper understanding into a particular space.

Three key criteria that Manda uses in his evaluation process are: is the idea based on solid science; does it identify a critical unmet need; and is there a sound business rationale. That sounds like a solid strategy for any type of business.

Richard Nass

New ‘Smart Alloy’ Is Thankful for the Memories

Known for their elasticity, bendability, and biocompatiblity, shape-memory alloys (SMAs) are used to fabricate a variety of medical devices, including implants, guidewires, and stents. However, despite their utility, SMAs have traditionally been able to remember only a single shape--that is, until now. Determined to enhance SMA's functionality, researchers at the University of Waterloo (Ontario, Canada) have developed a 'smart material' that they say can remember a range of shapes, not just one.

"The memory in traditional materials is based on a certain transformation temperature," explains Ibraheem Khan, a research engineer and PhD candidate at Waterloo. "Below that temperature, the alloy can be deformed and shaped, and then once it is heated up, it returns to its original shape." This type of material is known as a single-memory alloy.

In contrast, the new technology--dubbed multiple memory material--allows virtually any memory material to be quickly and easily embedded with additional local memories. "Our smart material process enables you to invent multiple memories for an alloy," Khan says. "Thus, we can take a single sheet, single wire, or any shape-memory alloy and then form and train it to have different transformation temperatures. Effectively, we program it." The addition of multiple transformation temperatures results in multiple memories, Khan adds. "It's more of a multiple-memory material than just a memory material."

Shape-memory alloys typically have two states: a low-temperature martensite state and a high-temperature austenite state. In the low-temperature state, the material is typically very malleable; it can be bent every which way and retain its shape. But once it has been heated up and brought to the austenite state, it returns to its original shape. The point at which the low-temperature martensite state becomes the high-temperature austenite state is the material's transformation temperature.

"Multiple transformation temperatures result in multiple transition zones," Khan comments. "While one local zone has one transformation temperature, another local zone on the same piece of material has another. Those two zones have different memories." A transition zone can be as small as a few microns in width, whereby each zone has a discrete transition temperature. As the processed shape-memory material is subjected to changing temperatures, each treated zone changes shape at its respective transition temperature. Created side by side, the transition zones facilitate unique and smooth shape changes.

While the Waterloo team has received government funding to develop the new alloy for automotive applications, Khan notes that materials with multiple memories can benefit the medical device realm as well. "For example, we're hoping to control the deployment of stents using our technology," he says. "By controlling the shape of the stent's valve, our aim is to enable doctors to control how open or closed the stent is at any given time." The material could also contribute to increased microgripper control in such applications as neurosurgery and endoscopic procedures, Khan adds. "And in the area of orthopedics, we hope to enhance the pseudoelastic and shape-memory properties of bone staples to improve the treatment of bone fractures."

This Week In Brief: October 12, 2010

Edge Electronics Inc. (Bohemia, NY) has announced an agreement with LSI Computer Systems Inc. (Melville, NY) to distribute LSI's product line of standard integrated circuits. Edge Electronics will promote its partner's incremental encoder interface ICs, brush and brushless motor drives and controllers, stepper motor controller ICs, lighting control and dimming ICs, PIR sensor interface ICs, programmable digital timing ICs, programmable digital lock ICs, and counter and divider ICs.

Chroma Corp. (McHenry, IL) and Annolino & Associates LLC (Columbus, OH) have entered into an agreement whereby Annolino will become the Southwestern territory representative and sales agent for Chroma's line of compounded products. These products include concentrates; precolor; glass-filled compounds; photoluminescent, biodegradable concentrates; FDA frosted PET colors; and products designed for the rotational molding industry.

To meet increased demand for medical device parts and components, ATEK Plastics (Kerrville, TX) is investing in two new Toshiba 500-tn electric injection molding machines equipped with new robots, vision systems, and RJG eDarts. The equipment investments will enable the company to complete multiple new projects from large OEMs in the surgical and stem cell reclaim markets and to tackle new projects from existing medical customers.

Seeking to expand its ability to serve the spinal-implant market, Tecomet is opening a development center for spinal implants at its headquarters in Wilmington, MA. Housed in a 2500-sq-ft facility and equipped with high-speed CNC machining centers, the new center will assist both large existing customers and new start-up companies by developing and fabricating products for spinal-implant applications. 

The Fisher-Barton Group of Companies, including Accurate Specialties Inc. and Thermal Spray Technologies Inc., has broken ground on an 1800-sq-ft addition to its materials laboratory in Watertown, WI. The new lab will serve as a resource for all five Fisher-Barton divisions to develop materials and further processing innovations. Scheduled for completion by March 31, 2011, the expansion will assist the company in advancing materials and coating technologies.