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Balancing Risk Key to Development

Depending on the device, there will be different levels of risk management. When thinking about risk and quality, companies should ask themselves, "Do we have effective controls?" The quality of the device must be absolute, and the processes must ensure that quality. For speed-to-market considerations, companies want to be aggressive, but they must also be realistic. When thinking about product performance, companies must make sure that their products deliver real benefits, and end-users need to be able to see the value of the product. Finally, cost must be considered. Companies must evaluate whether they can consistently produce products that meet specifications, and whether they can make that process profitable for them. "The real question to ask," said Wrobel, "is how much risk you are willing to take for each item. Then plan your process with those decisions in mind."

Treat FDA as Your Customer

This was the advice of Michael Barile of Barile & Associates in his talk, "Anticipating and Avoiding Regulatory and Compliance Hurdles," at the conference session, "Manufacturing for Innovation," at MD&M West. Barile stressed the importance of approaching premarket approvals or 510(k)s by anticipating the reviewers needs and identifying with their point of view.  He also reiterated the need to use checklists and cover sheets provided by FDA. The most important thing, he said, is to organize the information and make it as easy to understand. FDA rewards organization and it is critical to jumping hurdles to gain market access. "FDA may not be paying you for your product like a regular customer," he said. "But you need them to become part of the market."

Industry Pioneer Retires

Marotta was one of the most respected people in the medical device packaging industry and was a fixture at the MD&M shows and in the pages of MD&DI, to which he contributed from almost the beginning, and who named him an Industry Pioneer in its 25th anniversary issue. He will be missed. Tolas will retain its focus in medical packaging, however: Its relationship with Oracle, a substrate supplier, goes back more than 20 years.

Simplexes Simplify Designs of Experiments

It takes running conditions at three different verticies made up of two or more variables (for example, time, temperature, and pressure.) Taking those results and doing some calculations from there will take an engineer toward the direction of a more optimal response. The engineer then derives the reduction from the initial results, throws out the lowest result from the reduction and the first three vertices, and repeats the experiment. This continues until results start getting worse instead of better -- that's when the engineer knows he has reached the optimal performance point. And it can be realized in days or even hours instead of weeks or months.

MD&M West Kicks Off with Conference Sessions

Consultant Mark Crossley offered insights on how to account for measurement errors and how to use the Evolutionary Simplex method to make the Design of Experiment process more efficient. And validation expert Brian Callahan shared tools to be used in medical device process validation. Tuesday marks the opening of the MD&M West exhibit hall, and the conference sessions will continue, with presentations on CAPA, manufacturing innovation, and polymer engineering, among other topics. Stay tuned to hear about the latest developments at the show from the MD&DI staff.

Offshore Manufacturing a Valid Option

UK-based Gyrus Group PLC announced its confidence in outsourcing by signing a 10-year agreement with The Offshore Group, a company that provides manufacturing support services in Mexico. If you're interested in learning more about outsourcing strategies and will be in the Anaheim, CA area next week, check out MD&M West. There will be two full days of conference sessions that discuss collaborative outsourcing.

FDA Approves Breast Cancer Genetic Test

Questions are already being raised about the performance of the test. Steven Gutman, MD, director of CDRH's Office of In Vitro Diagnostic Device Evaluation and Safety, notes that the test's computer analysis is less accurate when it predicts that the cancer runs a high risk of returning. Len Lichtenfeld, MD, the deputy chief medical officer of the American Cancer Society, says that the test might not be accurate enough to be used in determining treatment. According to the Washington Post, FDA is developing regulations for this kind of genetic testing. The agency plans on establishing a policy within the next two months that details the required data to support claims for genetic profiling for breast-cancer prognosis, says Gutman. FDA is holding a public hearing tomorrow to discuss its proposals for requiring approval for certain complex home brew tests.

CMS Sends Mixed Messages on Stenting

At the same time, CMS has proposed an expansion of coverage for carotid artery stenting. The center would now cover carotid stenting for Medicare patients who have not yet experienced a stroke or a transient ischemic attack. The change came after Abbott asked the center to reconsider its coverage policy, which had applied to only patients whose risk was too high for surgery.

Transforming FDA

Transforming FDA LogoThis year should be a significant one for FDA and CDRH. The agency has a new commissioner. Congress is in the hands of the Democrats for the first time in 12 years. The Medical Device User Fee and Modernization Act is up for reauthorization. Significant reforms pertaining to postmarket surveillance are being implemented. MD&DI will be doing its best to cover these issues comprehensively, and in a way that shows how these changes might impact the jobs of everyone in a device firm. To that end, we are identifying these pieces with a Transforming FDA logo (right) that calls attention to them, so you'll know that the item is of potential significance. We have also created a Web page that brings all of these stories together from this blog, other online sources, and our print edition. You can also find all of the blog entries related to this effort by searching in the Transforming FDA category. We hope you find it helpful, and if you have any coverage suggestions, please contact us at

Manufacturer in Hot Water After Dog Death

According to the Washington Post, the procedure, which induced a brain aneurysm on a dog to demonstrate a medical device that was supposed to help stop bleeding, wasn't authorized, and the hospital "bans such use of animals." A statement from PETA also noted that a high-tech silicone model could have been used instead of the dog.