5 years after acquiring a promising medical device, a major MedTech discontinued marketing following a Class I recall. Here are a few lessons learned for risk management.
For me, this recorded message is very frustrating. The ultimate 'best guess' in the recording was the obvious candidate with no more information than the title of the post. But the recording forced me to listen to information about the trials that was obviously carefully constructed so I wouldn't get any tip-offs to the obvious reason that might prompt me to leave the recording.
Then, when the recording advanced sufficiently to share that reasons for new causes, the recording went limp - saying the needed information wasn't there. If the recording is going to do this, then the recording needs to cite another case where the information is there.
Hello Richard - thanks for your feedback. The recording is intended to provide a broad overview and lessons learned for QA/RA and Risk professionals. Not necessarily find a conclusive root cause(s) for the main issue.
I personally spent hours compiling various resources to dig deeper into this case. I was very intrigued by it because it is unusual for a company to simply stop distributing a product after a Class I recall. They try to fix the issue and keep the business.
But unfortunately, I could not find a "smoking gun" in the publicly available literature, including company press releases.
One good thing about Google NotebookLM is that it uses only the sources you provide, not any random sources on the internet. As noted in my post, I used 16 sources for the analysis after careful review of the information.
I appreciate you taking the time to listen to the recording and providing this feedback. To the extent possible, indeed we want to get to the root cause. But here, the intent is to provide a general overview but capture key lessons that can be broadly applied in our work.
While post market surveillance is critical, it sounds like a familiar disconnect between risk management and the clinical evaluations prior to product release.
For me, this recorded message is very frustrating. The ultimate 'best guess' in the recording was the obvious candidate with no more information than the title of the post. But the recording forced me to listen to information about the trials that was obviously carefully constructed so I wouldn't get any tip-offs to the obvious reason that might prompt me to leave the recording.
Then, when the recording advanced sufficiently to share that reasons for new causes, the recording went limp - saying the needed information wasn't there. If the recording is going to do this, then the recording needs to cite another case where the information is there.
Hello Richard - thanks for your feedback. The recording is intended to provide a broad overview and lessons learned for QA/RA and Risk professionals. Not necessarily find a conclusive root cause(s) for the main issue.
I personally spent hours compiling various resources to dig deeper into this case. I was very intrigued by it because it is unusual for a company to simply stop distributing a product after a Class I recall. They try to fix the issue and keep the business.
But unfortunately, I could not find a "smoking gun" in the publicly available literature, including company press releases.
One good thing about Google NotebookLM is that it uses only the sources you provide, not any random sources on the internet. As noted in my post, I used 16 sources for the analysis after careful review of the information.
I appreciate you taking the time to listen to the recording and providing this feedback. To the extent possible, indeed we want to get to the root cause. But here, the intent is to provide a general overview but capture key lessons that can be broadly applied in our work.
While post market surveillance is critical, it sounds like a familiar disconnect between risk management and the clinical evaluations prior to product release.