The top 5 complications of FDA medical device trials

This post is sponsored by IMARC Research, Inc.

“You do a really good job with complex trials.”

We’re lucky to say that we’ve heard this from several clients over the years. But, while we’re glad for the recognition, it made us ask ourselves a key question. What is it that makes a trial complex?

With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.

For pharmaceuticals, trials can be relatively simple. A company makes the drug, the drug is administered to the trial patients and the effects are monitored. There are very few moving parts involved. Medical devices, which can be complex machines in and of themselves, will require training and retraining of all parties that are involved with implementation and monitoring of the device — there are numerous moving parts and numerous opportunities to fall out of FDA compliance.

To help shed some light on common device trial complexities, we’ve written “Is Your Trial Complex? The Top 5 Trial Complications”.

We’ve taken a look at the complications that many device makers run into during trials. Here’s the Top 5:

Inexperience with medical device trials
A high number of people/entities involved in the trial
Dual roles acting as both sponsor and clinical investigator
Highly complex devices
Conducting a study outside the U.S.

If any or all of those sound familiar, please read the white paper. We’ve addressed these topics and provided some insight into how best to overcome trial complications. We’d also love to hear from you about other complications you’ve seen. Let us know about your unique challenges in a comment here or on our Facebook page.