He found that the rule constituted a "substantive" change to patent law, and the law "does not vest the USPTO with any general substantive rulemaking power." Lifesciences firms, including device companies, and inventors had opposed the rules because they could have diminished the value of patents, which account for much of the value of lifesciences firms, especially startup device companies. High-tech firms had supported them because they were intended to speed up the PTO's decision-making process and stop abuses of the system. Glaxo argued that the PTO already has other means by which to stop abuses. UPDATE: The PTO is considering whether to appeal to the Supreme Court.

Specifically, FDA cited the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component, and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor's component was used. The failure was first noted at a 2001 inspection.

The judge, Sarah Evans Barker, had earlier dismissed consolidated securities class action proceedings against Guidant and several of its former officers and directors. It is not yet known if the plaintiffs will appeal.

ENGINEERING SOLUTIONS

Arthroscopy is a minimally invasive surgical procedure that allows the interior of a joint to be examined or repaired. A primary purpose of arthroscopic surgery, as compared with more invasive procedures, is to reduce the stress on recovering patients. In the process, however, a great deal of stress is placed on the sutures used to hold soft tissues together. Aware of dissatisfaction among some surgeons with the performance of braided-polyester sutures in arthroscopic settings, DePuy Mitek Inc. (Raynham, MA; www.jnjgateway.com) sought to develop a suture possessing better strength than braided polyester and minimal thickness.

Dyneema Purity is the first UHMWPE fiber produced specifically for medical devices.

High-strength sutures play a critical role in arthroscopic procedures. In contrast to open surgery, the sutures used in arthroscopy must allow for a series of knots to slide down the suture, through the small incision, and around difficult angles without the suture fracturing or breaking. Therefore, the suture needs to be easy to handle, to have excellent tensile and breaking strength, and to allow for pinpoint placement of tight knots in confined joint spaces. Given the space restrictions, particularly inside the joint capsule, the bulk of a suture’s knots must not abrade the repaired soft tissues.

For DePuy Mitek, a recently developed material from DSM Dyneema (Heerlen, Netherlands; www.dsm.com) was the right fit for its suture project. In response to requests from customers, DSM Dyneema had developed an ultrahigh molecular weight polyethylene (UHMWPE) fiber suitable for a variety of medical applications. The result, called Dyneema Purity, is the first UHMWPE fiber produced specifically for medical devices, according to the company.

“We found that Dyneema Purity was the best choice for increasing the tensile strength of our new sutures,” says Chuck Pearlman, director of marketing at DePuy Mitek. “When we combined it with our proprietary technology, we were able to develop a product that features both high strength and excellent handling characteristics.”

From conception to product launch, the companies collaborated in product development, quality control, and regulatory compliance. The resulting sutures can provide more strength than polyester at the same diameter. “This is critical to the success of arthroscopic procedures,” says Carina Snijder, medical business manager at DSM Dyneema. “The tensile strength is important not only during the surgery when a break can be frustrating for the surgeon, but also afterwards when it could affect a patient’s recovery.”

An orthopedic suture made with the Purity material can be about half the thickness of a polyester suture of equal strength. The thinner suture diameter leads to smaller knots and the potential reduction of abrasion of adjoining tissues, thereby maximizing patient comfort.

The sutures are currently available and have been adopted by some surgeons. Their reactions have been as positive as that of Rick Angelo, orthopedic surgeon at the University of Washington, according to the companies.

“The strength of these sutures is great and the material seems a bit more flexible,” Angelo says. “Knots tie easier and compress more readily. They are also softer and less stiff.”

Of that group, four survived to be released from the hospital. This could be a blow to Phillips, the only firm approved to sell AEDs directly to patients without a prescription. The study does not question the value of AEDs in public places like hospitals, schools, and emergency vehicles. Those settings usually have a number of people who are trained to use AEDs. But many of the incidents that beset the patients in the study occurred when no one else was home, meaning the AED could not be used. And in some cases, the AED was not used despite someone else being present. For these reasons, the study's authors concluded that spending money for a home AED is not a wise use of resources. The patients in the study had previously suffered heart attacks but were not considered at-risk enough to warrant having an implantable cardioverter-defibrillator. They had spouses or caregivers trained to use AEDs. When the AEDs were appropriately used, there was a 33% survival rate, but the sample size was so small that the numbers were not statistically significant. Rather than a springboard to mass marketing of home-use AEDs, the study may lead to other things, such as better alert systems for when patients who are alone collapse, and better training in AED use and CPR for caregivers and companions. UPDATE: WebMD's spin emphasizes that the devices do work -- but other, less expensive options work just as well.

Of the 300 patients in the trial, 6.6% of Xience patients suffered an adverse event, while 11% of Taxus patients did. Boston Scientific, which under a licensing agreement will distribute a version of Xience called Promus, said the results were not statistically significant.

SPECIAL FEATURE: DRUG DELIVERY

Return to Article: Injecting New Ideas into Drug-Delivery Systems

Despite the slew of developments in active drug delivery, passive technologies remain effective for many treatments. But in order for any drug-delivery method to be successful, selecting the right material for the application and then the right approach is paramount.

Silicones, in particular, lend themselves to use as excipients in passive drug-delivery applications ranging from transdermal to implanted technologies. They enable drug delivery through their incorporation into either a matrix system or reservoir design. In the case of a matrix, the drug is mixed directly into the silicone elastomer material and is then cured; the therapy then elutes out of the system over time, according to Stephen Bruner, marketing director of NuSil Technology (Carpinteria, CA; www.nusil.com), a supplier of silicone-based materials.

Silicone is commonly used as an excipient in passive drug delivery.

“Sometimes, the chemistry of the drug interferes so much with the curing chemistry of the elastomer system, you may have to go to a reservoir system,” he explains. “The drug is concentrated in a cavity within the device and then sealed to prevent leaking. These systems take advantage of the release-rate properties of the silicone [because] the drug migrates from the cavity through the silicone.”

Frequently employed in patch technologies for nicotine addiction, birth control, and hormone replacement therapy, silicone is used for drug delivery because of its permeability to a range of small-molecule hydrophobic drugs. However, permeability of active agents is contingent on solubility and diffusivity.

“Drug-delivery companies must consider compatibility between the drug and the silicone to address the issue of solubility,” Bruner says. “A drug won’t deliver through a silicone unless it is chemically compatible; insoluble active ingredients or those that react with silicones are unable to move effectively. Movement of the drug is also affected by the physical size of the molecule and must be considered, as large molecules get trapped in the cured silicone.”

To broaden potential for silicone use in drug delivery, NuSil offers custom hydrophilic silicone formulations. The company can modify the siloxane backbone to enhance compatibility—thus improving solubility—with hydrophilic active agents and biomolecules for integration into a polymer matrix. Naturally hydrophobic, silicone’s properties can be altered. Polyethylene oxide–modified silicone features both hydrophobic and hydrophilic characteristics, thus extending the material’s possible applications in drug-delivery devices.

NEWS TRENDS

Mandatory Skills Professional appearance and behavior (143) Good technical skills (163) Good verbal skills (166) Good writing skills (180) Sufficient experience for job level (124) Desirable Skills Leadership potential (161) Sense of humor (118) Knowledge of product under development (121) Knowledge of FDA requirements (119) Knowledge of ISO requirements (128) Positive track record at other firms (122) No unexplained gaps in employment history (109) Presently located in the area (119) Industry certifications (RAPS, ASQ) (125) Optional Skills Knowledge of a foreign language (110) Graduate degrees (116)

Technical skills, writing skills, and verbal skills are among the most important characteristics that medical device firms look for when hiring entry-level quality and regulatory personnel, according to a survey. Yet, according to the same survey, the majority of interview candidates lack good writing skills and knowledge of FDA and ISO requirements.

Compliance-Alliance LLC (Arlington, VA) conducted a survey of 395 individuals looking to hire medical device quality and regulatory personnel. The skills that at least a plurality of them deemed as mandatory for entry-level applicants were:

• Good writing skills.
• Good verbal skills.
• Good technical skills.
• Professional appearance and behavior.
• Sufficient experience for job level.

A plurality of them deemed most of the other characteristics listed as desirable but not mandatory. These included leadership potential, knowledge of ISO and FDA requirements, knowledge of the hiring firm's products under development, industry certifications, and positive track records at previous employers.

Most respondents did not deem knowledge of a foreign language or possession of graduate degrees to be all that important for entry-level candidates.

When asked which characteristics are lacking in the majority of applicants seen, respondents most commonly said:

• Knowledge of firm's products under development.
• Sufficient experience for job level.
• Leadership potential.
• Knowledge of ISO and FDA requirements.
• Possession of industry certifications.
• Good writing skills.

Although a number of entry-level candidates don't have some of the skills that device employers most demand, neither do employers tend to have internship programs that can help develop those skills. Only 13.4% of respondents said their firms had formal internship programs. On the positive side, 70.6% said their firms have a tuition reimbursement program for graduate education.

When asked to list what skills can make a candidate competitive, quite a few respondents named adaptability and creativity—but within the boundaries of compliance, not to an extreme extent.

NEWS TRENDS

MD&DI is pleased to announce the addition of its new publisher, Lisa Perrin. She brings more than 20 years of experience in business-to-business print and online publishing. “I've come from the marketing sector to the medical sector, and I'm very proud to be associated with this well respected magazine,” she says.

Perrin has previously held management and leadership positions at Primedia Business Magazines and Media, as well as Miramar Communications and Morgan-Gramipian Publishing Co.

In 2006 she was recognized for her 20 years of leadership in special events by the Steve Kemble Leadership Foundation.

FROM THE EDITORS

The alleged heartlessness of the medical device industry was decried by its critics in late February when Medtronic won a U.S. Supreme Court case over federal preemption of premarket approval (PMA) products that are not in violation of FDA requirements. The decision means that patients injured by PMA devices cannot sue manufacturers in state courts if the devices are not adulterated or misbranded.

But this is not the stripping-of-legal-rights scenario that the industry's critics, including some prominent congressional Democrats, make it out to be.

The high court ruled 8–1 that because FDA has already made a determination about the safety and effectiveness of a PMA product, state lawsuits are barred when they would impose different requirements. The ruling pertained to a case brought by the family of Charles Riegel, who was injured in 1996 by a Medtronic catheter.

The Medical Device Amendments of 1976 explicitly say that states cannot impose standards of safety and effectiveness on medical devices that are inconsistent with federal regulations. Sen. Edward Kennedy (D–MA) and Rep. Henry Waxman (D–CA) said that Congress did not intend for that provision to limit lawsuits against manufacturers.

Ignored by these critics is the fact that the decision does not apply to the majority of medical device product-liability cases. In most cases, patients can still sue manufacturers. The Riegel case was a rare exception—and the problem was that his family sued the wrong party.

“The notion that this means patients are being stripped of their right to sue is a bunch of hogwash,” says Kevin Quinley, senior vice president of Medmarc Insurance Group (Chantilly, VA). Medmarc insures life sciences companies against product liability claims.

A substantial majority of devices come to market via the 510(k) process. The decision does not apply to them. This makes sense because CDRH does not review them as rigorously as PMA devices, and thus 510(k) clearance does not carry the same level of confidence in safety and effectiveness as premarket approval does.

Critics might be making a big deal nonetheless, says Quinley, because cases involving PMA products “often involve devices whose use can determine life or death, and those cases come with high legal costs and high potential awards. But the financial impact is disproportionate to the frequency.”

Also, manufacturers of PMA devices can still be sued by patients in state courts if the device is proven to be adulterated or misbranded as per FDA regulations.

Neither of these factors pertained to Riegel's case. His doctor used Medtronic's catheter in a way that was not approved by FDA, nor encouraged by the company. There was no evidence of a manufacturing defect or any other adulteration. It was not Medtronic's fault that the procedure failed and Riegel was injured; it was his doctor's. His family should have sued the doctor, not Medtronic. But it didn't. Quinley believes that was because the family thought it could get a bigger settlement out of the deeper-pocketed Medtronic. Charles Riegel's injury was a terrible thing. Holding the wrong party liable would also have been a terrible thing.

The case is a victory not only for Medtronic, but for FDA and the device industry as a whole. A loss would have meant that state courts could have made their own determinations as to what constituted safety and effectiveness. This would have undermined FDA's authority, exposed device companies to increased liability, and potentially thrown the whole medical device regulatory system into chaos. Could you imagine having to navigate 50 different interpretations of safety and effectiveness?

Erik Swain for The Editors