Lets not react too quickly to market research based on sales figures that primarily encompass only two market leaders, who are also the two main market participants. Eventually the FDA will wade into CGM and change their review standards so that CGM is at least as accurate (forget precision) as test strip technology. In 2015 ISO tried to bring the two technologies (test strips and then primarily for Dexcom) into the modern "at-home" chemistry accuracy world. This attempt was halted by industry hue and cry after 12 months and now in the ISO CGM has their standard and test strip technology has their accuracy standard. CGM operates at the, believe it or not, ISO 2003 standard, what is known in the industry as 15/20.
The FDA has yet to wade in, currently allowing the main participants, Abbott and Dexcom, unfettered access to a moderately growing market at relatively low accuracy standards. But FDA will, unless their kill industry/kill innovation mind-set has changed (and it hasn't), set standards in typical knee-jerk fashion, that make it impossible for worthy aspirants to meet, leaving the industry in an FDA caused depression. My personal belief is that CGM will finally emerge in 2022 or 2023. Of the many good things that Trump has done, and IMO he has not done enough at the FDA, has been to lower the level of political appointee to the 4th tier in the FDA center, one tier lower than Obama, and two tiers lower than Bush and Clinton. The latest 4th tier Trump appointees come from industry, which raises the question, why would someone from industry want to work for government.
Nonetheless, market research and publications aside, FDA has yet to cause a technology shake-out --- but they will.
Full confession. I left retirement four months ago and now work for an American arm of a Japanese at-home test strip manufacturer and work full time with my team on CGM. We buy the best market research money can buy and don't believe a word of it.
The FDA has yet to wade in, currently allowing the main participants, Abbott and Dexcom, unfettered access to a moderately growing market at relatively low accuracy standards. But FDA will, unless their kill industry/kill innovation mind-set has changed (and it hasn't), set standards in typical knee-jerk fashion, that make it impossible for worthy aspirants to meet, leaving the industry in an FDA caused depression. My personal belief is that CGM will finally emerge in 2022 or 2023. Of the many good things that Trump has done, and IMO he has not done enough at the FDA, has been to lower the level of political appointee to the 4th tier in the FDA center, one tier lower than Obama, and two tiers lower than Bush and Clinton. The latest 4th tier Trump appointees come from industry, which raises the question, why would someone from industry want to work for government.
Nonetheless, market research and publications aside, FDA has yet to cause a technology shake-out --- but they will.
Full confession. I left retirement four months ago and now work for an American arm of a Japanese at-home test strip manufacturer and work full time with my team on CGM. We buy the best market research money can buy and don't believe a word of it.
