In an effort to control overall risk in medical devices, the FDA has looked to Human Factors Engineering (HFE) as part of the design controls process to reduce or eliminate use-related hazards. Central to that process is the development of a risk analysis, which takes into account potential hazards that can occur through the use [...]
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Venture Capitalists Pressure FDA About Medical Device Approval Process
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 [...]
U.S. Military Investment A Viable Source of Medical Device Funding
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 [...]
Pulse of the Industry Report Offers Insight For Medical Device Manufacturers
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 [...]
Make Plans to attend MDCI’s complimentary seminar addressing Adaptive Clinical Trials and Conduct of Medical Device Clinical Trials
MDCI, an Aptiv Solutions company is hosting a seminar November, 9, 2011 that tackles two subject areas that are important for life science and device companies. The complimentary, no-fee seminar is scheduled to take place the afternoon of Wednesday, November 9, 2011 at the Boston Marriott Cambridge Hotel in Boston Massachusetts, and it will offer [...]
Smaller Medical Device Companies Facing Extended 510(k) Review Periods
Smaller medical device companies aren’t imagining things – it really does take longer to receive 510(k) approval for medical device developers with fewer than 100 employees than it does for larger industry players. This startling information comes from a study published this summer by researchers at Northwestern University, which took a hard look at how [...]
New ISO 14155 Standard Focuses on Medical Device Safety
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 – [...]
AdvaMed Releases Competitiveness Agenda to Preserve Medical Device Innovation
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 [...]
FDA Update: Administration Announces Initiative to Improve Reusable Medical Device Reprocessing and Conducts Two Day Workshop
Health care providers routinely reuse medical devices for the diagnosis and treatment of multiple patients. The process for preparing a reusable medical device for use on or by a patient is referred to as “reprocessing.” It is critical that the processes, procedures, and materials used for reprocessing be adequate to ensure that the reprocessed device [...]
