We continue our IVD study primer by examining sponsor and investigator responsibilities with regard to protocols and planning. This post is the second in a two-part series that aims to provide medical device companies with an introduction to the most important aspects of managing an IVD study. In addition to meeting the labeling requirements mentioned … 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
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 … 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
The path being taken by several medical device companies towards the development of a viable artificial pancreas became a little smoother this past June with the release of a Draft Guidance document by the FDA concerning IDE and pre-market applications for Low Glucose Suspend (LGS) Device systems. Artificial pancreas research has been a challenge to the medical … continue reading
Medical device startup companies in the state of Massachusetts have access to an important resource in the form of the Medical Device Development Center (M2D2). Managed by UMass Lowell and UMass Worcester, this business incubator is specifically geared towards providing those making their first forays into the medical device field with the support that they … continue reading
Innovation is one of the key buzzwords at the FDA, due in large part to pressure from the White House to help streamline the medical device approval process so as to encourage the development of cutting edge, high tech treatments that could lead to more effective and ultimately less expensive medical treatments. At MDCI, we … continue reading
Kristine Bello, MDCI’s Acting Director of Clinical Services, will be presenting at the MTLI Workshop, Operational Issues in Medical Device Clinical Trials, scheduled for May 24 and 25 in Washington, DC. The objective of the workshop is to provide information on ways to develop more efficient and effective medical device clinical trials. At the workshop, FDA … continue reading
Learning from the failures of others is one of the building blocks of scientific discourse, and medical device companies may soon gain access to an important resource from the FDA that could offer substantial insight when it comes to device development. The Administration is considering making public files that describe failed medical devices and drugs … continue reading
