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Filtration Expert Inducted into National Inventors Hall of Fame

The company he founded in 1946 developed a number of fluid management systems used in the manufacturing and administering of medical devices and pharmaceuticals. The leukocyte reduction filter was introduced in the early 1990s. Pall was one of 18 new inductees announced today.

Radiologist Beats Boston Scientific in Patent Case

The company says it will appeal, first in post-trial motions in the Texas court, then, if necessary, at the United States Court of Appeals for the Federal Circuit in Washington. It says it expects to win on appeal and has not set any money aside in case it loses. Saffran's patent had mainly to do with a method to heal fractures, based on controlling the flow of molecules, but it also described how the invention could be used in stents. The suit charged that Boston Scientific's Taxus and Liberte stents are the "sheet" described in Saffran's patent, wrapped around a stent.

Nominate a Notable Person

(The nominee need not work for a medical device company, so long as they are involved in some way with the industry as a whole.) Third, the person need not be an executive. We hope to honor all levels of contributors to the industry, regardless of job title. To submit a nomination, fill out the form on the 100 Notables Web page.

Patents May Hold the Key for Acquisitions

Lloyd, a patent attorney and project analyst with Nerac Inc., spoke at the MD&M West conference. A key aspect of developing a robust patent portfolio is analyzing competition in the market, Lloyd said. For example, does a product geared toward physicians give them a unique advantage. Firms need to make sure their product is part of a procedure that is better than the one already in use. Yet they also need to be mindful that some physicians don't want to disturb their relationships with their current vendors, who may be competitors. Firms should make sure that a technology's patent covers the commercial lifespan of the product, he said. Otherwise, the patent portfolio's value could be weakened. Some weakness can be overcome if a firm: * Properly defines the relevant product and geographic markets. * Quickly secures patent protection. * Substantiates the validity of patent claims. Acquiring companies may be looking to exploit any weaknesses in a target's patent portfolio, Lloyd said. So potential weaknesses must be identified and analyzed before negotiations begin. Also keep in mind that the Federal Trade Commission will also be taking a close look at the patent portfolio. -- Lawrence Lloyd

The Da Vinci Is Recession-Proof

A good part of the reason why is that the robots used to be used almost exclusively for prostate-cancer surgery, but now their application has expanded into procedures such as hysterectomies and kidney surgery. This kind of promise is why MD&DI named Intuitive Surgical one of its Medical Manufacturers of the Year in 2007. Intuitive's success has also paved the way for other companies with robotic-surgery technology, including Accuray, Hansen Medical, and Stereotaxis. Accuray is a direct competitor with Intuitive, while Hansen and Stereotaxis focus on catheter-based applications.

Materials Manufacturers Answer the Call

These ceramics provide superior dielectric strength, thermal stability, hardness, and insulating capabilities as compared to nonceramic materials. The company says its new product development is being driven by an aging population that nonetheless demands an active lifestyle. D-M-E Co. announced new elastomer processing equipment for the device industry. Demand for elastomer-based products is expected to rise 6% annually through 2011, but many device companies don't have the proper equipment to run them, the firm says. So D-M-E has brought its LSR Cold Runner System to the United States. It is designed for molding elastomers such as liquid silicone rubber and high-temperature vulcanizing silicone rubber. The system makes elastomers by injecting the material at lower temperatures and curing them by heating the mold. These and other new introductions show just how much materials suppliers can contribute to a device company's reaching its potential. -- Julia Ford-Carther

Leadership Coaching Key to Achieving Company Goals

Louis Mazzarese, a regulatory, clinical, and quality consultant, tried to change this notion as he spoke to conference attendees at MD&M West. "I'd like to hope we can start instilling in senior RQC [regulatory, quality, and clinical affairs] professionals a sense of urgency and can-do positive thinking in their attitudes with respect to project team development and accelerated product registration timelines," Mazzarese told MD&DI before the conference. "Too often [RQC] professionals grow up in a situation where they approach the task as policemen." Mazzarese, a certified professional coach, discussed his three-pronged approach to coaching regulatory, quality, and clinical professionals with the magazine. 1. Think positive thinking and change the perception of being seen as a hurdle rather than a key asset in a team by peers and the management team. This perception can come from how the professionals conduct themselves daily. "Coaching is a tool that can be used to explain to them how they can be perceived when they say 'no,'" said Mazzarese. "It's okay to say 'no', but sometimes the way it is said leads to the negative perception that the regulatory process is what's causing the company to slow down and otherwise getting in the way." 2. Coaching aids RQC affairs personnel during the product development process. It helps them continue to refine their skills, develop leadership profiles, and work on self awareness related to how they're coming across to their team. This can convert the negative perception of RQC people to a positive one. 3. Focus on self awareness, leadership, and how they relate to their peers. "When they do these things, all of a sudden they have a feeling of who they are as professionals and what they're contributing to the process," said Mazzarese. "As part of that, there's much more value added as they conduct themselves in their current job." -Maria Fontanazza

Health Hazard Evaluation Essential to Recall Decisions

Could existing conditions contribute to a clinical situation that could expose humans or animals to a health hazard? How will the hazard impact various population segements? That is, it is more serious for geriatric patients? Neonates?" Garvey spoke at an MD&M West conference session. The evaluation must address the degree of seriousness to which at-risk populations would be exposed, the likelihood that the hazard will occur, and the assessment of consequences (both short-term and long-term) if the hazard of occurs. "The assessment must be done in the context of broader safety knowledge," he said. It is particularly important that financial considerations not enter in to the evaluation, Garvey emphasized. "Business determinations should not be in your recall determinations. Period." But what should be in a health-hazard-evaluation system are links to a firm's CAPA system, and perhaps even process validation records. "Well-versed investigatiors will look for a `holistic' view on product safety/CAPA/health hazard evaluation systems integration," he said. At the same MD&M West session, Michael Barile, managing partner of Barile & Associates, presented a model health-hazard evaluation form. It assigns a factor of 1 to 5 for the probability of the fault's occurrence (1 being remote, 5 being continuous). It does the same for the probability of illness or injury should the fault occur (1 being extremely unlikely, 5 being extremely likely). And also for the severity of the protential illness or injury (1 being none, 5 being life threatening.) These three numbers are then multiplied together and compared to pre-set criteria for "risk to health." These criteria should be documented in the firm's standard operating procedures on recalls. A score of 1-4 means the risk is negligible. A score of 5-9 means it is low, 10-24 means it is moderate, and 25-125 means it is high. These scores can help determine the level of the recall (Class I is the most serious, Class III the least serious), if one is necessary. -- Erik Swain

Chemical Characterization of Materials Is Now Expected

Albert, PhD, senior scientist and chief chemist for NAMSA. "Chemicals cause the reactions that we're testing for." Albert spoke recently at the MD&M West conference in Anaheim, CA. Chemical characterization establishes baseline testing that will serve as a benchmark. This is especially important because sometimes material suppliers change their formulations without telling their clients, he said. And when used properly, it will eliminate the need to repeat expensive and time-consuming biological testing to qualify new lots or vendors. He explained that the goals of chemical characterization testing are to identify the general constituents of the material, to identify any additives or processing aids, and, most importantly, to identify bioavailable chemicals. That is, the ones that stand the best chance to migrate or extract from the material into the human body. The degree of characterization should depend on the nature of how the body will be exposed to the device, he said. Devices that will be implanted for at least 30 days should have their materials be subject to stringent testing. Devices that will only impact the surface of the body can have their materials be tested more leniently. Testing on materials for devices that will contact blood or tissue but are not implants falls somewhere in the middle. -- Erik Swain

Document Management Systems Should Be Based on Company Needs

98% of your system will already be compliant if you do it right." She spoke at an MD&M West conference session in late January. Also important, she said, is to understand how changes will affect the system. That means understanding what is the intended use of each document, and who is impacted by it. It means understanding the potential cost of any change. And it means understanding the change's impact on all stages of the relevant product, the personnel involved with it, the processes it goes through, and the equipment used for those processes. It is also crucial that a system be set up to prevent the unintended use of obsolete documents, Reilly said. Initially, it will be a "babysitting function," she said. "But you must get to the point where the document owners know to get rid of the old ones. That will still require spot checks, if you have a paper system. You should have repercussions for those who fail to do this, and you need management support for that." -- Erik Swain