In the medical device industry, we are hypersensitive to complaints. Here, we examine complaints from a business satisfaction perspective, rather than the FDA definition, and discuss how to evaluate your customer base.
The American Burn Association reported approximately 486,000 fire or burn injuries were seen at emergency departments between 2011 and 2015. AVITA Medical has developed their ReCell skin regeneration platform (currently under FDA PMA review) to improve outcomes for burn victims.
Existing electrophysiology systems don’t have the fidelity, or noise floors in the hardware and software, to allow doctors to see subtle abnormalities. Doctors believe the ability to see these subtle abnormalities may enable them to provide better, more accurate treatment for arrhythmia.
He sat there in the room, looked the FDA reviewers in the eye, and told them there were 10 people who died at his site during the trial, and if he had been allowed to use the data from the new diagnostic, he could have saved at least five of them.