November 02, 2015
Overheard at GMM HQ
“It’s not official until it’s Facebook Official.” - Valerie awaits that final step in her relationship. Learn how device companies can cope while their product awaits FDA approval.
WHAT THE INDUSTRY IS BUZZING ABOUT
NOW PLAYING: MICE MICE BABY
After a University Edinburgh study suggested that researchers are not doing enough to remove potential bias from animal testing, the FDA has publisheda draft guidance on the topic.
It turns out, some researchers might have confused proper study protocol with your kid’s classroom pet guidelines. The lead researcher on the UE study raised concerns about randomization, conclusion assessments, and record keeping relating to animals that require removal from studies. Now we’re questioning everything we learned from If You Give A Mouse A Cookie.
UNTIL THEN, PETA
Although scientists are working on a number of alternatives to animal testing, until then, the FDA is accepting public comment on their latest draft guidance. Once finalized, it will replace “Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices,” published in July 2010.
Protocols for animal testing are about to get more official. In the meantime, manufacturers can request a pre-submission meeting, where the FDA will review their research design and let them know if they’re likely to get swiped right or not.
MATCH.COM FOR MEDICAL DEVICES?
Not exactly, but Phillips has just announced a partnership with Amazon Web Services (AWS) and the so-called Internet of Things, creating a cloud-based platform to streamline the acquisition and utilization of data from heterogeneous devices in real-time. Through the AWS, Phillips HealthSuite will collect, aggregate and analyze data from apps, medical device systems, and electronic medical records (EMRs).
THEY COULDN'T JUST MEET EACH OTHER AT A BAR?
It’s not easy (or cheap) to make sure that disparate devices interact smoothly and securely with each other. The Phillips/Amazon partnership aims to make devices “smarter and more personalized over time.”
When devices–and the data they generate–work together efficiently, everyone wins. But let’s be honest, it will still be hard to get past a bad profile pic.
Theranos, a much-hyped startup that claims to have developed breakthrough blood testing technology earning them a $9 billion valuation, is in the hot seat after a recent WSJ article raised concerns about the merits of their claims. Don’t worry, Theranos, just squeeze this ball and look away, it will all be over soon.
NOW WE GOT BAD BLOOD
While the WSJ is scratching their heads over the makeup of the board (heavy on the politicians, light on the scientists), amongst other things, Theranos CEO Elizabeth Holmes is like; They just hate us ‘cause they ain’t us.
Theranos is now in a “pause period.” Kind of like waiting for test results. Brutal.
GOOD TO KNOW
Argentina is literally sending in the clowns. Your move, Patch Adams.