The "V" edition - Viral outbreaks, Venostent, "Vaping" and Valentines Day
On Jan. 23rd, the largest-known quarantine began in Wuhan, China.
It appears to have been effective in containing the pneumonia-causing 2019-nCoV virus, or Coronavirus (COVID-19) as it’s more commonly known. However, global health authorities are not calling it yet. Experts estimate that it may affect as many as 500,000 people before it peaks, and today’s count is estimated to be about 1/10th that.
Last week, China began a clinical trial with Gilead’s yet-to-be-approved antiviral remdesivir. The data on remdesivir indicates that it appears to be safe. It did not work well against Ebola in previous tests, but Ebola and Coronavirus are very different. The trial will enroll 500 patients and may be the fastest-enrolling trial testing a vaccine ever. Could A.I. help?
While we’re on the subject of clinical trials in China, Eric Topol, MD, notes that, despite all the talk about the impact of artificial intelligence on healthcare, only six randomized, controlled trials of decision support systems have been done—all in China.
Dr. Topol, who is one of the most forward-thinking physicians in the world, reveals that we as potential patients demand to know how the algorithms work but points out common sense stuff like the fact that we’re fine with getting on a 747 despite the fact that scientists have yet to agree on how planes stay in the air.
That got me wondering if this was truly an unanswerable question for now, or if there was an issue with the software companies, the standards we are setting for these companies, or the tricky reporting of clinical trials in the US site www.clinicaltrials.gov. I don’t know the answer, I’m just good for questions. Let me know what you think.
BTW--it could be user error. Maybe he just searched neural networks which may not capture all decision support systems with machine based learning. Don’t tell him I said that!
To look at a slightly less drastic method than quarantines for preventing the spread of disease, sterilization with ethylene oxide (EtO) is the most widely used technique in the industry, sterilizing around 50% of all medical devices. On November 25, 2019, the FDA announced updates on its campaign to improve medical device sterilization techniques. If you’re a medical device company and want to understand the implications, check out our recent blog post.
Also, for you medical device innovators - if you’re looking for some feedback on how to manage consultants and advisors (people like us!) check out Isabella’s Schmitt’s latest podcast. Great tips in there. Particularly around 15:20!
Not a day goes by that someone doesn’t remind me of what Brad Pitt and I have in common. If you caught the end of his Oscar speech and read my last newsletter it’s just one more thing.
We love innovators and especially those with interesting devices. Catch Dr. Tim Boire, PhD, founder of Venostent, as Alec Santiago interviews Tim about one of the most exciting vascular products in the neighborhood.
Many of us also love Valentine’s Day. Why, just seeing that picture of Dr. Tim in front of that stallion is enough to get your pheromones going and send you straight to Walgreen’s to buy everything heart-shaped in the store.
However, some of us who’ve been at the game longer dread Valentine’s Day, although not for the reasons you may think. I’m saying, “some of us”, because I’m still taking a beating on Newsletter #1 and my disdain for holidays.
Not true, I say!
For those of you that need a little boost in your V-Day attitude, all you have to do is give a little more. Just like sir Paul McCartney said, the love you take is equal to the love you make... and now there’s a scientific explanation.
Happy Valentine’s Day!
Very truly yours,
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