If you read this entire article entirely, what a mess. Every device is different and there’s a limited number of processes that every device needs to meet before individualization begins to creep in, just like in genomics, same thing, looking for more predictable methods in science when they just don’t exist yet. If they don’t exist, transparency I believe is the better avenue though, rather than to develop a flurry of special interests and lobby groups, as it appears some of that existed with this product, a long story.
I can also see the pressure from the manufacturer of the device, either it gets approved or they hang up their hats, lay people off and potentially close down, so one hates to see the latter happen, but on one side of the coin at least, someone has made a decision. If the device doesn’t work and is approved, you can still get sued. 
This product falls into an area called regenerative medicine, something most are perhaps not real familiar with and I’ll have more on that topic later with a couple interviews done recently. In the meantime you can view this video from the TED convention this year and see what regenerative medicine is all about.
Speaking from a total outsider’s viewpoint and with only the information contained in this post, it sounds like technology could have been a real asset here with some Share Point Servers and perhaps a dashboard that would keep all informed at the same time as it sounds like there was one heck of a lot of wasted time running around here. I would guess there’s some type of software in place somewhere along the line like Microsoft Project or something else along that line to do the general follow up and story on the entire process, but is is shared? The article here just doesn’t seem to allude to that fact, but again speaking only from what I have read.
Last year I found some articles that stated some studies were still being written in longhand at the FDA. Perhaps the new Sentential Program will aid in this process as well as I’m not sure how the business intelligence is structured as it relates to medical devices, but any new and upgraded technology to filter and get the needed information shared and in front of those who need it is certainly a step in the right direction. BD
WASHINGTON -- The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.
The FDA's internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions.
Political Lobbying Drove FDA Process - WSJ.com
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