Designing and analyzing clinical studies for pediatric devices and for medical devices that treat or diagnose a rare disease or condition brings unique challenges for clinical researchers. For pediatric devices, sponsors need to consider patient size and body structure, level of activity, duration of use, device longevity, and long-term exposure to implanted materials. For rare … continue reading
The Ernst & Young “Pulse of the Industry: Medical Technology Report 2011” was released last month, bringing with it a host of data, recommendations, and insight applicable to medical device manufacturers of all sizes. The report, which was presented at the Advamed 2011 conference, aims to offer a global analysis of the entire medical device … continue reading
Medical device companies have become increasingly concerned with the potential for new FDA regulations to negatively impact their ability to remain competitive in the global market. Earlier this summer, the Advanced Medical Technology Association (AdvaMed) put together a series of recommendations on how to shape regulatory policy in order to deal with this particular problem … continue reading
