“Wait a minute, what did you just say?” More than once we’ve paused a conversation with clients to ask that question because hints about potential study-impacting changes were hidden within routine conversations or off-handed remarks. The trickle-down effects of...
Swift IDE approval is possible when your submission convinces FDA that you know your investigational device well and you have robust bench and pre-clinical data to demonstrate the device is ready for further evaluation in humans. This calls for clear technical, not...
The randomized controlled trial (RCT) is the gold standard of clinical research, providing the highest level of scientific data for evidence-based medicine, and is often referred to as “Level I” in literature reviews and meta-analyses. RCTs are usually the most...
Most leadership teams would agree that it is better to meet the timeline of a well-thought-out clinical study schedule than repeatedly miss the mark on an over-zealous one, even if the timeline is longer. No matter what your advisors told you, do not commit to your...
You are developing a medical device that addresses a clinical need, but how do you get it into the hands of physicians to improve the lives of patients? In this article, we discuss the most common FDA pathways to market clearance...
The voluntary FDA Q-Submission Program, specifically the pre-sub meeting process, can serve as a powerful tool to streamline and optimize your medical device product development strategies, timelines, and budget, especially if you need to conduct a clinical study. In...
The medical device product development cycle can take several years and cost millions of dollars, especially when a clinical study is required. With an investment that large, it’s smart strategy to ensure your study design is locked-in well before you submit an...