Informed consent checklists, just like the informed consent, are more than just a document, but rather can be a process. To begin, what is an informed consent checklist and how do you use one?

Recently, a team of IMARC monitors traveled to a sponsor’s clinical research headquarters to meet face-to-face, study team to study team, to kick off a new medical device study. The two teams joined together with a heavy agenda to get the study’s ducks in a row prior to our monitors hitting the road for the on-site initiation visits scheduled in the upcoming weeks. While this is not always the case at study start-up, with tight timelines and limited budgets, there are many advantages to getting the teams together at the beginning of the study to help prepare for a successful study. Additionally, the teams can process through potential study challenges before they become potentially larger issues. Read on to learn five reasons why the sponsor should meet with and include the CRO in study start up!

A MassMEDIC commissioned survey, one-third of device firms queried expect the Affordable Care Act to increase their customer base.  In addition, one-third of the companies feel the new business will be enough to cover the medical device tax.

In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.

The FDA recently hosted a meeting that included industry, government and medical society experts.  The goal of this meeting was to establish a resource for real world data on transcatheter valve replacement technology and also serve as a model for future international cardiovascular device registry collaborations.

IMARC clinical monitors are constantly on the go monitoring in the field, from California to Connecticut, Vancouver to Miami.  The monitors are no strangers to airport security lanes and the Transportation Security Administration agents (TSA).  Some may even creatively compare monitors to TSA agents. Both groups of people are required to be familiar with federal regulations. The regulations exist to allow for monitors and TSA agents to execute their primary role; ensuring safety. Monitors ensure the safety of subjects in clinical trials and ensure compliance to 21 CFR 812 (device) or 21 CFR 312 (drug). TSA agents ensure safety of travelers and flight staff as well as ensure compliance with FAA regulations.

Being a CRO that specializes in helping companies gain FDA and world-wide approval through monitoring, auditing, training and consulting services- it’s fair to say we’ve come across a wide range of fellow CROs, investigative sites, research teams, and hospital systems. It’s amazing how much innovation exists- not just with the investigative products- but with technological advances to platforms used the healthcare industry.

Many sponsors in the medical device research industry are challenged with the decision between having a remote or on-site initiation visit. An initiation visit is imperative to the overall success of a study as many tasks are accomplished during these visits.

We have written many blogs on the medical device tax and thought we have covered almost angle on this issue.  However, we thought this article in FierceMedicalDevices brought a new strategic twist to the discussion. There has been a concerted effort by the industry to repeal the 2.3% medical device revenue since it was introduced in the Affordable Care Act.

There are only four days left for the medical device industry to provide comment, as requested by the FDA, on the topic of extreme weather conditions and medical device safety and quality. Hurricanes, floods, earthquakes, and tornados can pose potential interference with the manufacturing, shipping, storage, or use of marketed devices which is a cause for concern for the safety and effectiveness of devices.