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January 19, 2011


FDA's new postmarket surveillance system may have a farther reach than expected
By Sherrie Conroy, Director of Content

FDA’s Sentinel System, the national resource under development for medical product safety surveillance, was the topic of a workshop Jan 11 and 12. Convened by the Engelberg Center, the workshop focused on the impact of the system, which ultimately could allow access to others beyond FDA. Key stakeholders came to explore a range of issues, including recently completed FDA contracts committed to the development of the Sentinel System and ongoing pilot projects tracking medical product safety, according to the agency. Broader discussion topics focused on maintaining patient privacy while conducting medical product safety surveillance; developing the Sentinel System as a national resource for medical product safety, and developing a multipurpose distributed system to conduct not only safety surveillance work but also for comparative effectiveness research, product quality assessment, and other types of health questions. I spoke with one of those stakeholders about his impressions of the workshop and of the Sentinel System itself. Kevin Quinley, CPCU, ARM, is vice president, risk management services for Berkley Life Sciences, which provides liability insurance to life science firms.


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Articles

Scorecard: Global changes driving medical technology innovation offshore

The United States continues to lead the world in its capacity to produce the latest in medical technology innovation, but emerging markets led by China, India, and Brazil are catching up, according to a report from PricewaterhouseCoopers (PwC). Moreover, their market power is shifting innovation resources and activity overseas, according to the PwC report “Medical Technology Innovation Scorecard: The race for global leadership.” While the United States is expected to maintain its leadership for the foreseeable future, even a narrowing of the gap has implications for US jobs, exports, and Americans' access to advances in medical technology.

The report is based on the findings of the PwC Medical Technology Innovation Scorecard, a new, multifaceted assessment of the capacity of countries to adapt to the changing nature of innovation. While there has been much anecdotal evidence that the US is losing ground as the world's innovation leader, PwC analyzed the specific factors that contribute to medical technology innovation and quantified them, using 86 different metrics to evaluate how well each nation promotes the factors that advance innovation. The report is based on the findings of the PwC Medical Technology Innovation Scorecard, a new, multifaceted assessment of the capacity of countries to adapt to the changing nature of innovation. While there has been much anecdotal evidence that the US is losing ground as the world's innovation leader, PwC analyzed the specific factors that contribute to medical technology innovation and quantified them, using 86 different metrics to evaluate how well each nation promotes the factors that advance innovation.

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Value Plastics offers updates, resources for ISO 80369 standard

Value Plastics has set up an online resource to help keep medical device OEMs informed of the changes and updates to the ISO 80369 standard. The manufacturer of plastic tube fittings is one of only a few connector companies worldwide actively participating on ISO 80369 committees. According to the company, while connectors may have once been one of the most overlooked components of a medical device, the number of patient injuries associated with medical tubing misconnections has caught the attention of the International Standards Organization (ISO),” says the company. In conjunction with a number of other driving forces (AAMI, FDA, EN, JCAHO, WHO, and even states such as California), ISO has deemed it necessary to develop standards intended to reduce future tubing misconnections in healthcare/hospital environments.

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MDD: AdvaMed and EucoMed team to update EU directive

AdvaMed and EucoMed, the European medical devices association, concluded a recent meeting by with discussions on proposed Changes to the Medical Devices Directives (MDD) by the European Commission (EC). AdvaMed hosted a two-day session with EucoMed, bringing together 25 medical technology companies to consider plans by the EC to revise the directives, which regulate medical devices in Europe. During the first day, AdvaMed says that discussions focused on two major issues the EC has identified as particularly important: improved management of the regulatory system among the EC's 27 member states, and the EC’s view that there is a need for enhanced premarket review of high-risk innovative technologies.

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New Products

Silicone elastomers offer thermal management

Two thermally conductive healthcare silicone elastomers can be used as a cure-in-place adhesive or potting compound between electrical/electric components and heat sinks as part of a thermal management regime to keep medical devices operating at their optimal levels. MED-2980 and MED-2955 from NuSil Technology, LLC, Capenteria, CA, are able to wet out on a variety of substrates to ensure excellent contact between uneven surfaces. The low modulus characteristic of these elastomers ensures that, during operational thermal cycling, the bond line will not warp or break sensitive electronic components. MED-2980, a versatile 1.6 W/(mK) thermally conductive silicone, is available in a two-part configuration and is excellent for larger devices. MED-2955 is designed to have low volatility and low ionic content for more sensitive electronic devices or processes.

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Software plug-in makes simulation easier

A software plug-in provides an intuitive user-interface and common-component project templates, making it easier for partners and customers to create customized Isight applications. Isight 5.0 from Dassault, Providence, RI, provides designers, engineers, and researchers with an open system for integrating design and simulation models—created with various CAD, CAE, and other software applications—to automate the execution of hundreds or even thousands of simulations.

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Suction cups improve pick-and-place of small products

To increase efficiency in the pick-and-place of small products, Piab, Hinham, MA, has expanded its range of Duraflex BX suction cups to include three new models in small diameters. The new suction cups offer improved sealing capabilities for products with porous, uneven, or textured surfaces, such as medical products and plastic or metal parts, allowing manufacturers to increase line productivity and reduce energy consumption.

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