HEALTHCARE REFORM

Even as healthcare reform continues to take shape, pharmaceutical manufacturers can see a trend in which patient outcomes will be a primary factor in reimbursement. More than ever, packaging will be called upon to help patients adhere to medication regimens, particularly in treatment areas such as hypertension and diabetes where non-adherence poses considerable clinical and financial costs. That was a key takeaway from the presentation, "Surviving and Thriving in a Volatile Marketplace: Strategies for Drug Companies," given by Michael Wokasch, author and pharmaceutical industry veteran at the May 26 Healthcare Packaging Conference & Workshop in Princeton, NJ.

Tags: HCP Conference & Workshop; Patient outcomes; Medication regimens; Healthcare reform

Process Analytical Technology, or PAT, refers to how to design, analyze, and control pharmaceutical manufacturing, all in the name of quality control and ultimately patient safety. PAT is "using the knowledge of the process itself to control the quality of the process," according to Dennis Brandl, who has done a lot of work with manufacturers in pharmaceuticals, packaged goods, steel, and electronics. One of his recent clients was Pfizer, where collecting and transmitting complex, multi-dimensional data quickly became an automation headache. Integrating control systems to collect the necessary data cost 10 times that of the automation components themselves—all due to interoperability issues, according to Brandl. This article discusses the OPC Foundation and certification of components, and how they can better manage costs and improve efficiency.

Tags: Pfizer; Controls; Efficiency; OPC

A May 24 InHealth Institute for Health Technology Studies report about the results of a Northwestern University survey pertaining to the FDA's 510(K) product review process quotes the study as saying: "Increasing uncertainty about the implementation of the 510(k) process-partly attributable to increases in device complexity-is posing challenges for FDA and industry that may lead the United States to experience a 'brain drain' in the medtech sector." About two-thirds of the survey's respondents believed that Europe's CE marking process is the most predictable, with predictability a key factor in determining whether or not to invest in a new product. Meanwhile, the FDA's perspective is evident on its Web site, which includes a nearly hour-long video on the subject. FDA says the Initiative could help "accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safely and based on sound science."

Tags: Medical devices; 510(k); Diagnostics; Innovation

The Assn. for Electrical, Electronic, and Information Technologies (VDE, Frankfurt am Main, Germany) surveyed 1,300 member companies and universities about medical technology, with results showing that 64% of respondents view that country as having a lead on the U.S. (30%). The dynamic and growing global health market and increasing competition between manufacturers is among the reasons behind the international interest in Compamed 2011, an international trade fair for the suppliers' market in medical manufacturing, to be held Nov. 16 to 18 in Düsseldorf, Germany, parallel to Medica 2011, Nov. 16 to 19. Medica will cover the medical technology supply chain, from materials and components to systems and intermediate products, as well as complete systems and services.

Tags: Medical devices; Compamed; Medica; Nanotechnology

In mid-June, Amgen announced that it published its first annual Environmental Sustainability Report, "which presents data on the company's overall environmental performance and describes progress made to meet its 2012 conservation targets. The report also details Amgen's long-term plan for environmental sustainability." No packaging specifics were offered yet.

Tags: Sustainability

Mirafoil eliminates off-line lamination or foil stamping, lowers carbon footprint, boosts shelf impact

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