4 days ago
Did you know Texas Medical Center in Houston is the largest medical center in the world?
And they spend millions annually with medical device startups and innovators?
Do you know how to qualify for some of it?
No? Well, read on, my good friend!
Meet Dr. Lance Black, our 10x keynote speaker
Meet or watch him, your choice.
As Medical Device Innovation Lead, Lance focuses on the resident companies of TMCx by supporting their efforts in developing innovative health care technologies.
His video begins, "So, because we don't take equity, we don't charge, we've had companies come through who are your typical accelerator companies all the way to companies who are 30, 50 strong, who've raised their Series A, Series B, who want to use Houston as either their US launching pad or a new sales channel, or just a new market they can evaluate.
When you have 10 million patient visits per year, [we're our] own market!
Which of five TMCx programs is right for you?
From Dr. Black: "We have five different programs, and you can think of these programs really just at from a stage of supporting start-up companies at different stages within their life cycle. So, we focus primarily on medical device and digital health. Our partners focus on therapeutics, and diagnostics, and we'll walk you through what each of these programs mean, and how they affect innovation."
If that's relevant for you, listen to Lance's presentation. He is very engaging!
Next up: Our May 2019 keynote speaker will be...
Former Proove Biosciences' CEO Brian Meskin, and I applaud him for his brave keynote topic: What the F**k Happened at Proove Biosciences?!
"Proove Biosciences, which sold dubious DNA tests to predict addiction risk, sells off assets as CEO departs amid criminal probe" read the August 31, 2017 headline in Stat News.
The article was filled with false allegations, says our keynote speaker, but the damage was done.
According to a website called The Truth About Proove Biosciences, disgruntled ex-employees created false allegations against Proove in 2015 and filed a whistle-blower lawsuit in 2015 (which was rejected by the government in 2016).
Brian explains, "The former employees STAT News to publish the misinformation, grouping Proove in a governmental inquiry involving giants Myriad Genetics, Genomic Health, Natera, and Invitae.
In June 2017, the FBI delivered a subpoena for documents, and by August 2017, Proove Biosciences was placed into court-ordered receivership."
As our May 14 keynote in San Diego (details), Brian will answer publicly the question he gets so often, "What the F**k happened at Proove Biosciences?"
He's committed to setting the record straight and helping others not fall victim to "post-truth," "fake news," and "misinformation." If you're a business executive, business owner, or entrepreneur, you'll value this riveting keynote presentation, followed immediately by our two-hour food and drink reception. (Two drink tickets included with your registration.)
Hey, what are you doing today?
This 2012 throwback photo with Beth, Lucas (center), and Zachary might give you a smile.
Not playing basketball?
Then, if you have time and you ever reference FDA's databases, have I got a 🎁 for you!
I'm sitting with Rachel Benway today (Tuesday, December 11 at 2 p.m. EDT) for a live demo of the Navigator platform from Reed Tech. It's the first time I've shared a live demo with you. I believe it's going to be very interesting and relevant for many of you.
Joining is as easy as clicking the button below. If you miss the live event, the button will *magically* take you to the replay and slides.
Hey, throw us a frickin' bone here!
If you know the answers to any of these questions, would you help your medical device neighbors?
- Cheryl is looking for a PLM system. She said she's already looked at Arena Solutions, Propel, Oracle Agile, and Upchain.
- General Surgeon Ikenna Brown asks, "What factors, if any, increase your likelihood of getting something reimbursed?" Ikenna, see Beth Brooks' workshop for a 2016 for a start.
- Whitney Lewis got a few answers about investigational use labels. Learn from the replies.
- Kevin reminds you to write Congress about the medical device tax. It's not dead yet.
- What do you think about genetic DNA manipulation? I think it's inevitable.
- Danny needs to know about regulatory requirements for selling first aid kits in the US.
Thank you for being part of our Medical Devices Group community!
If you're looking for work, check out the newly posted jobs here!
Make it a great week.
Medical Devices Group Leader
5 days ago
As a General Surgeon, I'm passionate about medical device development, particularly as it relates to health economics and healthcare delivery in general. I would like to gain a better understanding of the reimbursement structure in the US (I'm at Berkeley now; will practice in Canada) so I can offer expert advice to companies who approach me for advice within the field of surgery.
3 weeks ago
Quality Assurance Specialist at Blackrock Microsystems
Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?
The devices are not cleared and some may or may not be on a path to be cleared, and the studies being done are not to prove the safety or effectiveness of the device but to aid in research only, but on humans.
Does this labeling requirement only apply when the device itself is under evaluation? or always when using a un-cleared device in human testing?