It’s without question that medical devices are becoming more and more advanced. These technological increases only continue to provide data, and lots of it! An article which asks, “Is The Medical Device Industry Ready for Big Data”- caught our attention and we’d like to know your thoughts, are medical device companies ready for what could be ahead?

AdvaMed, the medical device trade group has never been shy about sharing its opinion with the FDA.  According to a recent article in Medical Device and Diagnostic Industry (MD+DI), AdvaMed has voiced its opinions on what priorities the medtech industry believes the FDA should prioritize.

In a report from the Institute of Medicine (IOM) was based on a workshop held with this focus: “Public Engagement and Clinical Trials.” In this report, IOM draws attention to the fact that many clinical trials are slow to enroll patients, and some studies never reach their recruitment number goal.

Your site is weeks past study initiation and all the candidates that you expected to be screening for the study have not materialized.  Would trial-related advertising or recruitment materials enhance your sites enrollment efforts?

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

It has always been my goal to make clinical research education more widely available to professionals, raising standards across the industry. This vision was the foundation for IMARC more than 16 years ago, and now, we’re taking another major step toward realizing that vision. Starting today, clinical research professionals will have easier access to affordable training through IMARC University, our new series of online training courses.

Please take time to review Emily Haglund’s article “Risk Management in Clinical Research Process and Application” that was recently posted on GxP Lifeline.  The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial, and is the focus of this article.

The FDA’s device center (CDRH) has established time based performance standards to help ensure draft guidance documents do not remain in an unresolved state for too long.  The following draft performance goals have been outlined:

On Friday, May 23, 2014 the Federal Register announced a notice that in an effort to increase the quality and efficiency of clinical trials, the Food and Drug Administration (FDA) was planning to grant a one-year, $7,500,000 grant to Duke University’s Translational Medicine Institute (DTMI) (renewable up to a total of five years, $37,500,000). This grant would primarily go to fund the public-private partnership Clinical Trials Transformation Initiative (CTTI).  CTTI  was originally created as a partnership between the FDA and Duke University in 2008, but now includes more than 60 organizations with representatives from government agencies, industry, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.

Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something.  Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.