Originally Published EMDM January 2006
Medtec 2006 Preview
Sessions Focus on Challenges and Rewards of Entering World’s Largest Device Market
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With healthcare spending forecast to reach US$2.1 trillion in the United States in 2006—more than half of the global total—it goes without saying that the US medical device market is the holy grail of device manufacturers worldwide. But this lucrative market has a stern gatekeeper: US FDA. One of the opening conference sessions at MEDTEC 2006 in Stuttgart, Germany, will provide attendees with a comprehensive overview of how to successfully bring a medical device to market in the United States.
US FDA staff will lead the daylong session scheduled for Tuesday, 7 March, which begins with the agency’s definition of a medical device and a summary of minimum device requirements. A discussion of the finer points of a premarket notification, commonly referred to as a 510(k), versus a premarket approval (PMA) will follow. Attendees will have a chance to digest this information over lunch before reconvening for a paper on nonapproved medical devices. The day will come to a close with a discussion of quality systems, postmarket surveillance, and other duties that manufacturers must follow in order to keep their products on the market.
Companies marketing products in the United States are not out of the woods once their devices have been approved. Some companies will be subjected to an on-site US FDA inspection. According to consultants Nancy Singer and Sue Jacobs, respectively from Compliance Alliance (Arlington, VA, USA) and QMS Consulting (Hoffman Estates, IL, USA), the best thing a company facing an inspection can do is not to panic. How? By being prepared. Precisely how to go about this is the topic of their session scheduled for Thursday, 9 March.
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The copresenters explain how US FDA decides which firms to inspect, as well as the measures companies should take leading up to the visit. Common mistakes to avoid, how to handle requests for confidential documents, and what to do if a warning letter is issued are among the topics that will be discussed.
Product development and, in particular, the application of novel technologies in medical devices are addressed on 7 March in a wide-ranging session. Leading-edge techniques in optical imaging, microelectronics, surface treatment, and smart implant materials are among the topics that will be addressed by experts in the various fields.
Other sessions scheduled during the two days will focus on the use of failure mode and effects analysis on medical devices, materials characterization and the importance of toxicological risk assessment, the value of designed experiments in the establishment of a robust validation programme, and the benefits of applying six-sigma principles during new product design.
The MEDTEC exposition and conference is scheduled for 7–9 March at the fairgrounds in Stuttgart, Germany. The exhibition welcomes several hundred suppliers of materials, components, products, and services for the global medical technology industry. For up-to-the-minute information about the entire event, go to www.medtecshow.com.
Copyright ©2006 European Medical Device Manufacturer
