tag:blogger.com,1999:blog-9076190155284676524.post970271817312959236..comments2024-03-18T17:54:37.827-04:00Comments on Your Diabetes May Vary: The FDA Comment that Got Away... or Maybe NotUnknownnoreply@blogger.comBlogger6125tag:blogger.com,1999:blog-9076190155284676524.post-11538301248671211452012-09-09T15:24:36.729-04:002012-09-09T15:24:36.729-04:00Thanks Kevin. Appreciate the insight. Thanks Kevin. Appreciate the insight. Bennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-17272594371120049652012-09-09T15:15:44.430-04:002012-09-09T15:15:44.430-04:00In my experience in diabetes technology and as a f...In my experience in diabetes technology and as a former member of the CDMA Steering Committee, standards have a funny way of slowing innovation and driving the industry toward sub-optimal implementations. Can standards be helpful? Yes. But beware of an FDA that regulates based on a published standard vs. an approach that encourages innovation by those who drive forward ahead of the herd albeit with safety mitigation practices squarely in place (ie IRB oversight and adherence to methods published in peer reviewed clinical research).kevinlmcmahonhttp://type1techventures.com/clinical-trialsnoreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-26043754423123782952012-09-05T19:25:52.066-04:002012-09-05T19:25:52.066-04:00Your are welcome Bernard.
It strikes me as totall...Your are welcome Bernard.<br /><br />It strikes me as totally illogical that easily killing yourself by confusion between devices, misreading them or setting them up wrong is not seen as a valid concern.<br /><br />I suggest that part of the issues is to see that data from multiple devices is all part of care of one individual. That standardizing information has the potential reduce confusion and misreading and so improve safety. In addition standardized data should reduce the effort needed by each firm to create their own data protocols and speed up development in the long run. <br /><br />Bennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-28026902587975086142012-09-05T17:45:58.232-04:002012-09-05T17:45:58.232-04:00Thanks Bennet for a well thought out comment. This...Thanks Bennet for a well thought out comment. This is such a challenging issue. As folks living with diabetes we know that insulin pumps and glucose meters are regulated, but it's still way too easy to kill yourself by accidentally misunderstanding the information presented, or having incorrect settings. In a private email to someone at the FDA I proposed that lack of unified access to data could be seen as a danger, unfortunately that currently isn't taken as a valid argument. We do need well thought out applications, so how do we balance safety with timeliness?Bernardhttps://www.blogger.com/profile/14936264471078732019noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-59945220432031788262012-08-30T12:16:48.707-04:002012-08-30T12:16:48.707-04:00Nice call for action Scott.
I added two draft for...Nice call for action Scott.<br /><br />I added two draft form letters. People who are competent at spelling, punctuation and the niceties of the written language are more than welcome to point out my mistakes. I am sure there are a lot of them. <br /><br />BDBennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-434910691051021172012-08-30T11:08:49.997-04:002012-08-30T11:08:49.997-04:00You know what my thoughts are: it's our legal ...You know what my thoughts are: it's our legal right as American Citizens to comment on any guidance (or draft guidance) and anything the FDA puts out at any time, legally. So we can still do this, but I've been overwhelmed with work and other stuff that I didn't have time to put into this, but I concur. Now, how do we want to handle this? A Citizen's Petition, a formal comment on closed guidance documents? A number of possibilities remain open to us for this!Scott Shttps://www.blogger.com/profile/03286529314567223617noreply@blogger.com