December 2011 Posts

SOPs: What You Need to Know

SOPs: What You Need to Know

Mark Crawford

According to the FDA, the problem cited in 60 percent of all warning letters is SOP—standard operating procedures.

That’s actually a good thing because it is relatively straightforward (but not always easy) to fix SOPs. Identifying them is one thing—they also need to be concise, clearly written, well-communicated, monitored, and enforced. Taking the time to meet or exceed FDA SOP expectations will not only bring you into compliance but also improve operations and productivity in every department—leading to higher quality, improved profits, lower costs, faster delivery to market, and improved customer satisfaction. (more…)

Supply Chain Management Is a Big Target for the FDA

Supply Chain Management Is a Big Target for the FDA

Mark Crawford

According to Alan Schwartz of mdi Consultants Inc., a former supervisor of field operations for the FDA, supply chain oversight is the FDA’s next big area of concern.

About a year ago the FDA indicated plans to expand its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to assume a bigger role in managing their supply chains. An FDA spokesperson, compliance officer Carmelo Rosa, further stated that “currently the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations, but is looking at other options.” (more…)

Medical Technology Is Hot in Germany

Medical Technology Is Hot in Germany

Mark Crawford

There is no question that Germany is one of the most prosperous countries in the EU—especially when it comes to medical technology products. According to Germany Trade and Invest, Germany ranks third in the world for medical technology behind the U.S. and Japan; in terms of new patents, Germany is second only to the U.S. About one-third of Germany’s medical technology output consists of products that are less than three years old—especially imaging systems, implants, operational and interventional devices and systems, and in-vitro diagnostics.

Innovation is driven by the Medical Technology Action Plan, which pools various federal funding sources to focus on three main categories: medical technology in rehabilitation and care (intelligent implants), molecular imaging, and medical technology for regenerative medicine. (more…)

Pre-IDE Meetings Can Be Helpful in Understanding FDA Expectations

Pre-IDE Meetings Can Be Helpful in Understanding FDA Expectations

Mark Crawford

There are many pressures on medical device companies today—reduced venture capital investment, changing health-care reform, smaller and more complex devices, advanced materials, and the ever-present push from OEMs to keep costs down but get products to market faster, to name a few—all while increasingly managing their supply chains and meeting FDA regulations. (more…)