The FDA’s search for a more efficient medical device approval process continues full steam ahead with the latest announcement that the Administration is looking to leverage partnerships within the industry in order to achieve this particular goal. Although the relationship is being described as ‘informal,’ the FDA will be working together with Biocom in order … continue reading
December’s publication of the proposed rule for the Physician Payment Sunshine Act has raised numerous questions and concerns across the entire medical device industry. The Act, which is part of the Affordable Care Act, is intended to increase transparency regarding payments made from medical device manufacturers and drug companies to physicians during the course of … continue reading
R&D production in the pharmaceutical industry has fallen more than 70% over the last 15 years, according to a recently published report, “Beyond the Shadow of a Drought: The need for a new mindset in pharma R&D,” by a group of analysts at the Oliver Wyman consulting firm. According to this insightful analysis, the underlying … continue reading
It’s a refrain that is becoming familiar in the medical device industry: over-regulation is strangling innovation. Recently, however, this particular topic isn’t being championed by special interest groups representing medical device companies, but rather by a growing number of concerned outsiders from the venture capital industry who are becoming increasingly convinced that FDA regulations are … continue reading
When investigating potential funding sources for medical device development, few companies consider exploring the opportunities offered by the military. Even in times of economic hardship when other classes of investors are reluctant to part with capital and most federal agencies cut back on spending, military funding is rarely affected. This is particularly true in the … 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
A revised ISO standard designed to help medical device companies conducting clinical trials keep a handle on product safety and performance, as well as define good clinical practice, was introduced this past spring, and its adoption has been spreading through the medical device industry. ISO 14155:2011 represents an update of the original ISO standard – … 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
