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Ethical Breaches Hurt Device Industry’s Reputation

MOVERS AND SHAKERS 2006

Analysts think Crawford's conduct hurt the agency and that he should have known better.
Although the vast majority of people in the device industry try to stay within the lines when it comes to ethical business practices, some seem intent to cross the line. Last year, executives from AbTox Inc. (Mundelein, IL) were convicted for selling unapproved devices, former FDA commissioner Lester Crawford pled guilty to conflict of interest charges regarding stocks of FDA regulated companies, and two Cyberonics executives resigned following a stock options scandal. These actions might not be typical, but they generate bad publicity for the device industry and can blemish its reputation.

Fraudulence committed by AbTox executives led to damage and blindness in one eye in 18 patients, with the problems starting more than a decade ago. FDA approved a small gas sterilizer for stainless-steel surgical instruments without tubes or hinges. Company executives instead claimed they had approval for a larger device that sterilizes a range of non-stainless-steel instruments. In 1998, AbTox issued a voluntary recall on the device, and FDA sent out an alert for the Plazlyte sterilization system, stating it never approved the product. FDA also warned hospitals and doctors to stop using the product, as it caused serious eye injuries. AbTox filed for bankruptcy in 1998.

A judge found Caputo responsible for sterilization devices that harmed 18 patients.

In 2006, following a nine-week trial, Ross Caputo, president and CEO, was sentenced to 10 years in prison, and Robert Riley, vice president of regulatory affairs, received a six-year sentence. They were also ordered to reimburse hospitals $17 million for the devices. Mark Schmitt, former director of marketing, and Marilyn Lynch, former director of clinical services were also indicted and pled guilty in the case. The company sold 168 devices, worth more than $18 million in sales.

Margaret O'K. Glavin, associate commissioner for regulatory affairs at FDA, called the convictions proof that FDA is committed to ensuring devices are safe and effective. “Our criminal investigations aggressively pursue those that endanger the public health by manufacturing and selling unsafe products,” she said.

In another incident, former FDA commissioner Crawford got into trouble for owning certain stocks. About a year after his sudden resignation, Crawford pled guilty to conflict of interest charges and falsely reporting information about stocks he owned in companies regulated by FDA, including at least one medical device company. Senior FDA employees are restricted from owning shares in companies regulated by the agency.

Given Crawford's past experience in the agency, some people can't understand how he could have fallen victim to such a scandal. “With all his years of service at FDA as deputy commissioner and acting commissioner, it's a terrible shame for a man with his talents and experience to go out in that fashion,” says Jonathan Kahan, partner at Hogan & Hartson (Washington, DC). “I believe it hurt the agency for that to occur.”

Larry Pilot, partner at McKenna, Long & Aldridge LLP (Washington, DC), shares the same sentiment and notes that Crawford was involved in the agency in the 1970s, when pressure regarding public disclosure was intense. “It was such a major issue, so he should have recognized the importance of full disclosure.”

Each misdemeanor charge that Crawford faces carries a maximum penalty of up to one year in prison. At press time, Crawford was scheduled to face sentencing in January.

Pilot speculates that ethical problems in the device industry could be part of a larger issue facing the country. “If there are ethical breaches in the agency or within the community that are subject to regulation, it probably has more to do with deterioration in society and a willingness to tolerate or accept what used to be unacceptable,” says Pilot.

The corporate world is also seeing more attention given to bad practices, but enforcement isn't far behind. “There's been increased scrutiny over the past six to 12 months, and companies that did violate are being called out on it,” says William Plovanic, managing director and equity research analyst at First Albany Capital (Chicago).

Despite overcoming adversity and gaining FDA approval for a controversial vagus nerve stimulator, Cyberonics Inc. (Houston) faced problems that shook the company's executive structure. Last November, following an audit committee that found problems in the way the company reported certain stock option grants, Robert “Skip” Cummins, president and CEO, and Pamela Westbrook, vice president and CFO resigned. The company's cofounder and former CEO, Reese Terry, was named interim CEO.

“I think the company has been under a microscope for a long time and not just because of the options, but also because of the behavior of Skip Cummins himself,” says Jan Wald, medical device analyst at A. G. Edwards & Sons Inc. (St. Louis). He notes that Cummins had a very aggressive approach to handling FDA and CMS issues regarding the company's vagus nerve stimulator. (At press time, A.G. Edwards or its officers owned stock in Cyberonics, and the firm was looking into doing investment-banking business with Cyberonics.)

An investor advisory had called attention to the timing of the company's June 2004 option grants. It was reported that after receiving positive regulatory news about its stimulator, Cyberonics approved stock option grants for company executives. The following day, the company's shares soared, along with the options' value.

As a result of the audit committee's investigation, Cyberonics stated it would adopt a policy that limits the granting of options to certain time periods. In addition, it will require approval of all option grants, and institute a policy that states that all internal approvals of award grants must be in writing before the award is granted. Cyberonics must also restate its financial statements for fiscal years 2000 to 2005, along with fiscal periods ending July 29, 2005; October 28, 2005; and January 28, 2006.

Although ethical problems within Cyberonics have done their damage, the situation may also provide new opportunities. New management could be beneficial to Cyberonics, and Wald suggests the possibility that the company could be acquired within the next year due to the attractiveness of the fast-growing and underpenetrated neurological market.

Copyright ©2007 Medical Device & Diagnostic Industry

Integra LifeSciences Founder Named Entrepreneur of the Year

NEWS TRENDS

Richard Caruso, founder and chairman of Integra LifeSciences Corp. (Plainsboro, NJ), considered one of the pioneers of regenerative medicine, has been named the Ernst & Young Entrepreneur of the Year.

Caruso was named both the overall winner and the health sciences national winner in November 2006 at a ceremony in Palm Springs, CA.

After a 20-year career in finance, Caruso decided to pursue something that would benefit mankind. He partnered with two medical researchers who were working on an extracellular matrix technology, financing laboratory and manufacturing facilities and hiring a sales team. The result, Integra Artificial Skin, allowed burn victims to regenerate new skin and was one of the first tissue-engineering products approved by FDA. Integra has taken its regenerative technology into other fields, developing the DuraGen, which allows the protective covering of the brain to regenerate itself after surgery, and NeuroGen, which allows severed peripheral nerves to be regenerated.

Integra now sells products in more than 100 countries. It has annual revenues of almost $400 million and boasts a market capitalization of $1.2 billion.

Copyright ©2007 Medical Device & Diagnostic Industry

Siemens Makes Deals to Diversify in Diagnostics

MOVERS AND SHAKERS 2006

The acquisitions of DCP and Bayer open new diagnostic markets for Siemens.
Siemens has made major moves to position itself at the forefront of the future of diagnostics. The company's goal of combining in vivo and in vitro diagnostics with a broad range of imaging, laboratory, and IT applications came nearer to fruition with the multi-billion-dollar acquisitions of Diagnostic Products Corp. (DPC) and Bayer Diagnostics.

In late April of 2006, Siemens announced that it was acquiring DPC for just under $2 billion. DPC, a leader in immunodiagnostics, specializes in the development and manufacture of automated body fluid analyzers and tests for heart disease, cancer, and hormone and allergy conditions.

Siemens is well known for its computed-tomography imaging devices, such as the Biograph 64.

“DPC is an ideal fit, as it has a similar philosophy to Siemens, with a dedication to trendsetting innovation, customer partnership, and efficiency in healthcare,” said Siemens Medical Solutions CEO Erich Reinhardt.

After the deal closed in July, DPC became a wholly owned subsidiary of Siemens Medical Solutions USA Inc. The deal extends Siemens' reach significantly, given DPC's presence in more than 100 countries.

One month before completing the DPC deal, Siemens announced its acquisition of Bayer's diagnostics division for approximately $5.3 billion. While the DPC purchase gave Siemens access to laboratory diagnostics, the Bayer Diagnostics deal can get Siemens involved in molecular medicine.

Because advances in molecular medicine allow medical treatment to be increasingly tailored to individual patients, Siemens seems to be following through with “rigorously focusing its portfolio on promising growth fields.” Molecular medicine can be used to help fight diseases using genetic profiles, detect diseases earlier, and determine the effects of medication before it is prescribed. The Bayer acquisition should be completed in early 2007. Bayer Diagnostics and DPC will be merged and will operate as Siemens Medical Solutions Diagnostics.

Copyright ©2007 Medical Device & Diagnostic Industry

Nanomaterials Hold Promise for Tissue-Engineering Applications

NEWS TRENDS

Certain nanomaterials show strong promise in tissue engineering and orthopedic applications because they appear to promote better tissue regeneration than other methods, according to an engineering and orthopedics expert.

Thomas Webster, PhD, associate professor of engineering and orthopedics at Brown University (Providence, RI), said that nanomaterials might promote tissue regrowth because human tissue is itself nanostructured. Because of that, he said, cells are accustomed to interacting with surfaces that vary on the nanoscale level. Thus, they respond to certain nanomaterials quite well.

He made his remarks in October 2006 at the materials, medicine, and nanotechnology summit sponsored by the Cleveland Clinic and ASM, the materials information society.

“Nanostructured materials possess higher percentages of atoms at the surface, increased portions of surface defects, and greater numbers of material boundaries at the surface that may be influencing protein interactions important for cell function,” Webster explained.

Webster has conducted research showing that nanoscale versions of titania, alumina, and ceramics all attached to bone cells better than their conventional versions. “We are extremely encouraged by how versatile [nanoscale materials are],” he said. “We are also seeing this in animal studies, in multiple labs that have no connection to each other. It raises the question that if you have a material with good properties, can you make it nano?”

There is also evidence, he said, that nanomaterials can reduce bacteria functions while increasing bone cell functions.

Although the conventional definition of nanotechnology is a particle size of 100 nm or smaller, for bone-cell-adhesion purposes, the nanomaterials need to be between 49 and 67 nm, Webster said.

The best manufacturing method for orthopedic implants may be making them out of nanofiber ceramics, because bone is a nanofibered material, Webster said. Nanofibers could also be added to polymers to make coatings for orthopedic implants, he said.

Copyright ©2007 Medical Device & Diagnostic Industry

Alaris, Baxter Run Afoul of FDA with Infusion Pumps

MOVERS AND SHAKERS 2006

The Syndeo pump could be reintroduced after Baxter fixes its design problems.
CDRH has historically been suspicious about the reliability of infusion pumps. Incidents with two pump makers in 2006 have reinforced that suspicion and mistrust. Both companies have had repeated run-ins with FDA over various infusion pump issues. However, in 2006, the problems came to a head.

In June, Baxter Healthcare Corp. (Round Lake, IL) signed a consent decree with FDA to stop making and distributing the Colleague Volumetric Infusion Pump and the Syndeo Patient-Controlled Analgesic Syringe Pump. An inspection a year earlier found inadequate management controls over quality system operations and corrective and preventive action procedures, as well as design defects. Then, in September, FDA and Baxter entered into a penalty-free consent decree to resolve GMP problems involving the pumps. Rather than seeking a disgorgement provision, FDA allowed the company to post a $20 million letter of credit, which will be canceled once Baxter reconditions or destroys previously seized devices. Baxter decided to take a $70 million charge for remediation costs associated with the decree, indicating the company's commitment to a resolution.

In mid-December, however, it looked like things might be turning around for Baxter. FDA issued the company conditional approval to fix the pumps, which could clear the way for them to return to market. Although there has been no speculation from Baxter about when the pumps might return, FDA will review the company's regulatory filings. At press time, the agency was expected to reply to Baxter shortly.

Meanwhile, in August, four models of Alaris Signature Edition Gold infusion pumps were seized by U.S. marshals at FDA's request. The pumps have a defect called a key bounce, in which a number pressed once on a keypad may appear twice, leading to possible overinfusion. Warning letters citing this problem had been issued to Alaris in August 1998 and again 14 months later. The company was also “given opportunities to correct the violations, but failed to take appropriate actions,” according to an FDA statement. Alaris issued a product recall letter in August that provided users with ways to minimize key-entry errors until the problem could be corrected, and it suspended the pump's production, sales, repairs, and installations. Alaris is a division of Cardinal Health.

Copyright ©2007 Medical Device & Diagnostic Industry

Von Eschenbach Appoints Woodcock, Dyer to Top Positions at FDA

NEWS TRENDS

Andrew von Eschenbach has named two people, one of whom should be very familiar to FDA observers, to top positions in the agency. Janet Woodcock, MD, takes a new position, chief medical officer. She will oversee scientific and planning operations. Woodcock has previously been deputy commissioner for operations and director of the agency's drugs and biologics centers. John Dyer, MPH, has been named deputy commissioner for operations and chief operating officer. He will focus on issues concerning management, business processes, and information technology. He was previously COO at CMS, where he helped implement the vast reforms at that agency.

Copyright ©2007 Medical Device & Diagnostic Industry

Laser-Micromachined Marks Track Small Surgical Implants

MACHINING

Manufacturers of medical devices and implants are increasingly marking their products. They do so for a number of reasons: to enhance traceability for economic reasons, for long-term quality control, and in anticipation of inevitable future government regulations. Many are also trying to prevent counterfeiting and unregulated distribution. But one- and two-dimensional bar codes have several limitations for some medical device applications. They can be easily read and counterfeited and are usually difficult to miniaturize for placement on small devices. In addition, any defacement can result in information being lost.

One type of coded mark based on encryption theory circumvents these limitations with a marking system that is unique to each manufacturer. These marks could have a large effect on the device industry and its bar coding of devices (see the section “The Future of Bar Codes”). Moreover, this two-dimensional marker identification can withstand significant defacement without information loss. It can also be miniaturized and permanently created on metal and plastic products by use of laser micromachining.

Laser Micromachining Enables Permanent Miniature Marks

Sidebar:

As with legacy bar codes, there are several ways a two-dimensional marker identification code can be applied to a product or product packaging. These include direct ink printing, printed labels, and surface marking of products. Rigorous implementation of unique device identification (UDI) for medical devices will require direct marking of the product itself. (See the sidebar, “Why Mark Devices and Implants?”) Moreover, the mark must be permanent and inert, which rules out the use of ink in most cases. Therefore, the tool of choice for applying a two-dimensional marker identification is laser marking.

Figure 1. (click to enlarge) Laser micromachining can create marks by using either a direct-write or a mask-based process. Because of its flexibility, the direct-write process is preferable for creating medical device bar codes.

The two basic methods by which a laser can mark a surface are photomasking and direct writing, as shown in Figure 1. In the photomask method, the laser beam is expanded to fill a mask that often consists of a pattern of reflective chromium on quartz. The pattern created by this mask is then reimaged using lenses onto the surface of the product. This method works well for high-speed applications, but it is only useful if the mark stays the same for each product; any change in the mark requires creating a different mask. Because each identification mark must be different, photomasking will probably not see much use for UDI in the device industry because of its inflexibility.

In the direct-write method, the laser beam is focused to a small spot on the work surface. The spot is rastered across the surface by two mirrors, which are mounted on galvanometer coils to deliver fast computer-controlled angular deflection. The laser power is modulated on and off as the beam is scanned to create virtually any type of mark, from simple alphanumerics to intricate product logos and other patterns. The main benefit of this method, as opposed to a photomask, is its flexibility. The mark can be easily modified in software for each individual product, which makes direct-writing the likely method of choice for most medical devices.

Laser selection is very important. As with other micromachining applications, there are numerous types of lasers, each with its own set of output characteristics and unique advantages. For marking small medical devices and implants, the Q-switched solid-state laser is a good choice. It is often called a diode-pumped solid-state (DPSS) laser, and it produces rapidly pulsed output. DPSS lasers are available with an output wavelength of 1064 nm (near infrared), 532 nm (green), or 355 nm (ultraviolet). The first advantage of this type of laser is that it produces a clean, cylindrically shaped beam that can be focused to a small spot, making it well suited to direct writing. The ability to choose a wavelength also enables users to efficiently mark any material. Most laser manufacturers offer all three wavelengths, and device manufacturers should evaluate a laser manufacturer's process in its applications lab before choosing a particular laser system.

For highly miniaturized marks on metals and plastics, theory and experience indicate that the best results are achieved with an ultraviolet DPSS laser. Infrared and visible lasers micromachine surfaces by acting as an intense local heat source that essentially boils off material. This can result in significant thermal damage in adjacent material, the so-called heat affected zone (HAZ), which can range from an unattractive charred appearance to functional impairment of the product. Moreover, the boiling produces rough edges and recast debris, which may need careful cleaning postmarking. An ultraviolet DPSS laser, however, removes material by breaking interatomic bonds in a relatively cold process called photoablation. This process creates clean edges, and there is almost no recast debris and minimal HAZ. Thermal effects are further minimized by the laser's very short pulse duration (a few tens of a nanosecond). Any peripheral heating that might be created by one pulse dissipates before the next pulse arrives.

Another advantage of an ultraviolet laser is the ability to produce highly miniaturized marks. Specifically, a phenomenon called diffraction determines the smallest spot to which any laser beam can be focused. The size of the spot scales with wavelength, so a laser at 355 nm can be focused to a much smaller spot (e.g., less than 10 µm). For an infrared laser with a wavelength of 1064 nm, a typical spot size can't be much less than 100 µm. Mark miniaturization allows a UDI mark to be created unobtrusively and, importantly, allows marking of tiny devices such as catheters and small surgical screws.

An ultraviolet laser can mark most common device materials, from plastics to tough metals such as titanium alloys. In the case of plastics, a mark can be in the form of a color change or a physically engraved surface mark, depending on the particular plastic and the laser power setting. With metals, the mark can be engraved.

Titanium Medical Implants

Pilot studies are currently under way that examine two-dimensional marker identification of small screws and plates using a marking system that incorporates a solid-state ultraviolet laser. Titanium parts such as screws and plates are used to repair fractures of the mid-face, mandible, and hand, for both neurological and reconstructive purposes. For this reason, screws are generally very small (e.g., 3.2 × 42 mm). In addition, some are as small as 1 mm in diameter with a 1.8-mm-diam head and 2-mm length.

Figure 2. (click to enlarge) A UV laser marking system can produce miniaturized two-dimensional marker identification as shown on this titanium screwhead. Photo courtesy of Stryker Micro Implants (Freiburg, Germany).

These studies demonstrated that tiny screws can be marked with up to 15 bits of information onto a mark that is between 250 and 350 µm square (see Figure 2). These screws and plates are classified as nonsterilized products during transshipments, or shipments that pass through multiple hands (e.g., manufacturers, distributors, hospitals, etc.). They are sterilized at each hospital just prior to use. Hospitals often do not keep records of their use of nonsterilized devices, unlike the case of sterilized products. This can lead to uneconomical use of such products. For example, a distribution center may assemble a manufacturer's products into sets that contain as many 20 individual screws and parts. In many cases, a surgeon will not use all these parts in any given procedure. Without UDI marking, there is no safe way to return these parts to inventory.

The long-term goal is to be able to read the miniaturized marks at every stage of the supply chain using handheld retail-style scanners. This is not a trivial task when the entire mark is only a fraction of a millimeter in total size. Existing conventional scanners don't provide sufficient speed and readability for such small marks. However, there are some prototype scanners designed specifically for this application that are showing promising preliminary results.

Two-dimensional marker identification could allow device companies and their customers to identify counterfeit products. At first glance, devices like screws and plates may seem to be unlikely choices for counterfeiting. However, these are high-value products. Clearly, it is not in the interest of the patient or a device company for unregulated copies to make their way into critical surgeries.

The Future of Bar Codes

In many industries, one of the most commonly accepted methods of applying UDI is to use bar codes that are either linear or two-dimensional. In a conventional linear bar code, the information is coded as alternating dark and light lines of varying thickness and spacing. In a two-dimensional bar code, the information is coded in an array of dark and light square pixels.

Figure 3. (click to enlarge) The two-dimensional marking identification system consists of multiple intersecting straight lines within a square or rectangle.

In a two-dimensional marker identification code, a computer algorithm converts the binary or alphanumeric information into a rectangular or square pattern of intersecting straight lines that the laser will cut into a device. Typical examples are shown in Figure 3. The position, angle, and thickness of these lines determine the coded information that is carried.

Figure 4. (click to enlarge) Two-dimensional marker identification can be significantly defaced, as in this example, without losing any information content.

There are several significant advantages to the two-dimensional marker identification approach. First, it is relatively immune to information loss through damage. For example, if part of a traditional bar code is obliterated, then that segment of the coded information is permanently lost. But with two-dimensional marker identification, as long as the reader can scan some part of every line, then the system software can readily reconstruct the entire image and thereby decode all the original information. In fact, an entire corner or most of a side of a two-dimensional marker identification mark can be obliterated without any loss of information (see Figure 4). This is particularly useful in multiple-use and high-wear products.

But for medical device manufacturers, a more important advantage of two-dimensional marker identification is that it enables proprietary coding. The coding of conventional bar codes is standardized, so they can be read and duplicated by anyone to re-create them on counterfeit products. With two-dimensional marker identification, complex proprietary encryption algorithms generate and decode the marks. Moreover, these algorithms support almost infinite combinations of coding.

There is also the issue of miniaturization, which can be very important for manufacturers of small devices and implants. There is a limit to how small conventional bar codes can be generated and read. The pixels and lines are close together and need to maintain certain sizes. But a laser micromachined two-dimensional marker identification is a relatively open mark with well-spaced lines. Therefore, it does not require the resolution or contrast of a conventional mark. This allows a two-dimensional marker identification mark to be used in a much smaller format; the mark can be a fraction of a millimeter in size and thus can be completely unobtrusive. In addition, high-quality lasers are capable of machining very small marks onto the devices.

Conclusion

The benefits of having a coded marking system are significant. Advances in laser micromachining have made such systems possible, particularly for small devices that need small bar codes. Lasers used today can machine such marks without being plagued by thermal damage and debris concerns. In addition, lasers that leverage low-heat techniques can be used to machine plastics as well as metals. As the medical device industry faces the possibility of mandated UDI, these types of machining systems will play an important role in the future of medical devices.

Acknowledgment

The authors would like to thank Dieter Franki, director of Stryker Micro Implants and Resorbable Solutions (Freiburg, Germany) for his input and assistance.

Sri Venkat is director of marketing for Coherent Inc. He can be reached at sri.venkat@coherent.com. Kevin T. Simmons is vice president and managing director of global sales for ORBID ( San Francisco). His e-mail is ksimmons@orbidcorp.com.

Copyright ©2007 Medical Device & Diagnostic Industry

Device Pumps Faster Test Results

R&D DIGEST

The gas permeation micropumping mechanism moves miniature drops of fluid to specific locations in a microfluidic lab-on-a-chip device.
(click to enlarge)

A micropump that pushes lab samples through a credit-card-sized lab-on-a-chip is keeping up with the race to develop smaller, faster, and cheaper diagnostics. The tiny three-
layered pump could accelerate the time it takes for patients to receive test results. Instead of waiting for weeks, the patient might be able to get results almost immediately.

“The general motivation for our work is the development of lab-on-a-chip devices that can replace large, cumbersome laboratory equipment with a small portable benchtop and point-of-care instrumentation,” says Mark Eddings, a bioengineering graduate student at the University of Utah (Salt Lake City).

A micropump is a necessary component that manipulates the samples and reagents required for a medical test. Although some researchers have developed pumps that require sophisticated manufacturing and materials, others have designed low-cost silicone-rubber-based pumps, which are on the path to commercialization, according to Eddings. “Our micropump uses similar manufacturing and materials as these groups,” he says. “However, we exploit the permeable properties of the silicone rubber, polydimethylsiloxane (PDMS), to push and pull fluid to specific locations within our lab-on-a-chip.”

The pump is made of three layers of PDMS. The top fluid layer contains both the wells where the sample is placed and microchannels through which the sample flows. The thin middle layer allows only the passage of gas, not liquid. The bottom layer has inlets and channels through which air pressure or a vacuum is applied. The air pressure or vacuum respectively pushes or pulls air through channels and transmits pressure or suction through the middle layer. This pushes or draws fluids through the upper-layer channels. After flowing through the channels, the liquid is pushed into test chambers where the sample is mixed with the chemicals or antibodies needed for the test.

The PDMS-based gas-permeation pump isn't a stand-alone device; it must be incorporated into a system. About the size of a wallet, an outside device that has air pressure or a vacuum to run the micropumps would operate the lab-on-a-chip. The chip is like a credit card that fits into the wallet.

Eddings notes that practical applications of the micropump are mainly in point-of-care diagnostics and biochemical testing. The researchers at Utah have demonstrated the micropump's ability to generate controlled flows. That could lead to future drug-delivery applications.

“We're also looking at integrating the micropump into some of our own lab-on-a-chip applications for genotyping and mutation scanning of DNA,” adds Eddings. “A number of microfluidics research groups expressed interest in possible collaborations when the work was presented at a recent conference in Japan, but we are continuously looking for industry and academic partnerships.”

A paper on the work by Eddings and Bruce Gale, assistant professor of mechanical engineering at Utah, can be found in the November issue of the Journal of Micromechanics and Microengineering. Funding was provided by the university's Center for Biomedical Fluidics and the National Science Foundation.

Copyright ©2007 Medical Device & Diagnostic Industry

Why Mark Devices and Implants?

MACHINING

Currently, the regulations regarding tracking and traceability of medical devices stipulate that products should be marked with unique device identification (UDI) “where appropriate,” which clearly is a subjective term. But this situation will not remain for much longer. FDA is expected to require device manufacturers to adopt UDI, and industry must work with the agency to come up with a feasible system.1 FDA mandated bar codes for drugs and biologics back in 2004 but did not extend the provision to devices after industry convinced FDA that implementing a standardized identification system for devices would be too difficult. However, that conclusion was reached before the uproar over safety issues involving implantable cardioverter-defibrillators and other devices. In the coming years, FDA is not likely to retreat from any idea that it believes will improve patient safety, so mandated UDI is inevitable. Similar conclusions are being drawn within the European Union.

But UDI should not be seen just as another negative bureaucratic burden. A properly implemented UDI system can actually benefit device manufacturers, hospitals, patients, and everyone along the supply chain. Ideally, with each device permanently marked with a UDI code, even nonsterilized products such as screws and plates could be fully tracked by some type of reader from fabrication through surgical insertion. This would simplify inventory, reduce waste, enable back stocking, and allow manufacturers to rapidly identify and isolate lot numbers in the case of suspected early failure and defects. It also could prevent the use of counterfeit or reject products.


Reference

1. Erik Swain, “Identifying What Will Work,” Medical Device & Diagnostic Industry 28, no. 9 (2006): 16.

Copyright ©2007 Medical Device & Diagnostic Industry

Shattered Bones Get a Boost from Glass

R&D DIGEST

Within the glass scaffold, macropores and nanopores are interconnected.

Glass that has interconnected pores and could assist in bone vascularization. The glass has potential as a biocompatible material for implants in orthopedic procedures.

According to Himanshu Jain, director of the International Materials Institute for New Functionalities in Glass at Lehigh University (Bethlehem, PA), the glass's porosity is the key to its use. He says it can be used to treat broken bones or osteoporosis. “The ideal treatment for diseased or damaged bone is to coax the body's natural bone tissue,” he says.

“Doctors do this by taking a bone graft from one part of a person's body and using it as a scaffold to stimulate bone tissue elsewhere to regrow.”

Likewise, he says, biocompatible glasses have been used as bone transplants. The glass is unique because it is porous at two scales. It contains nanopores that measure up to 20 nm in diameter, and macropores measuring 100 µm or wider. The nanopores facilitate cell adhesion and crystallization of bone's structural components, Jain says. The macropores allow bone cells to grow inside the glass and to form new blood vessels and tissue.

Director Himanshu Jain leads the international research project that has created dually-porous glass for use in orthopedic implants.

The research team includes members from Lehigh, Princeton University, the University of Alexandria in Egypt, and the Instituto Superior Tecnico in Portugal. So far, the international team has been able to create glass that features both nanopores that have diameters of 5–20 nm and macropores.

To get there, the traditional melt-quench glass-making technique had to be refined. Members at the Alexandria facility developed a recipe for the powders that make up the glass. The materials are a mixture of silicon, calcium, phosphorus, and boron oxides. A chemical treatment then etches the glass to induce the desired porosity. They also used a sol-gel technique for glass-making that encourages the development of nano-sized pores. Then the team added a polymer to the solution.

The polymer caused a phase separation to occur parallel to the sol-to-gel transition, which helped overcome a significant obstacle, explains Jain. “Thermodynamically, the coexistence of nanopores and macropores is unstable in that the larger pores should absorb the smaller pores,” Jain says. “We have developed a material that defeats that expectation.”

Jain's Lehigh group is in the process of refining the fabrication process and investigating the mechanical properties and bioactivity of the materials.

In addition, another team at Lehigh is also measuring cells' interactions to the glass. The researchers have found that when the glass is attached to the damaged bone, a layer forms on the surface of the glass that has the same chemical composition as the natural bone.

The new material has been successfully tested in laboratory experiments, and the researchers are currently conducting in vivo tests at the University of Alexandria.

The researchers are also collaborating through the U.S.–Africa Materials Institute, which is headquartered at Princeton. The project is funded by the National Science Foundation.

Copyright ©2007 Medical Device & Diagnostic Industry