Wake Me Up When Covid Ends
Couple of things really caught my eye this past week…
I really liked Tom Eisenmann’s article on Why Startups Fail. Enjoyed his insight on the main drivers of company disintegration, including inept personnel (from the top down) and companies jumping the gun and releasing their product too soon or ill prepared and with limited or misinterpreted research. Can’t say I disagree. Speaking of failures…
We’ll have to wait until later this week for the Elizabeth Holmes criminal trial to start back up due to potential juror COVID exposure, but keep your eye on it. This trial has something for everyone, investors, entrepreneurs, healthcare stakeholders and the general public as consumers. With my experience as a former government attorney, I know folks in Silicon Valley don’t often end up in orange. I wouldn’t start searching for her trademark black turtlenecks on ThredUP just yet.
You know who's not a failure? Our very own Isabella Schmitt. Isabella’s been honored by the Houston Business Journal as one of the prestigious 2021 “Women Who Mean Business.” I'm fortunate to know her and have her on our team. She's a key part of our success.
Here’s the latest in Medtech and Biotech.
In the last issue, we covered the topic of employee mandated vaccinations. This is still a hot topic as the post-Labor Day return-to-office has been pushed back for many companies.
Thanks for reaching out and sharing your employers’ plans and your perspectives on whether companies should mandate vaccines. It was nice hearing from everyone.
Bloomberg shared some insight from Fortunate 500 companies and their plans for employee mandated vaccinations. Companies are using incentives such as gift cards, lottery payouts, and bonus wages to convince stragglers to get the jab.
The following companies will require vaccinations and terminate employees who fail to comply unless for religious and health-related circumstances: CVS, Johnson & Johnson, Walmart, Kraft Heinz, among others.
Some bigtime companies calling for shots here. Check out the article and see how some other companies are handling vaccine mandates.
If you didn't get a chance to respond last time around, we're still interested! What's your employer's stance on mandatory vaccines? What's yours?
Reach out and let us know.
FDA Execs Fed Up
Director of the FDA Office of Vaccines Research and Review, Marion Gruber Ph.D., and her deputy, Philip Krause, are stepping down from their positions in November following concerns over the Government’s push for vaccine boosters without FDA approval.
Gruber has been with the FDA for more than 30 years and had a significant role in the development of the Covid-19 vaccine effort in the US.
Gruber’s temporary replacement will be Peter Marks, M.D., Ph.D., the director of the Center for Biologics Evaluation and Research, who will serve as acting director until a permanent replacement is found. Here’s what he had to say about Gruber’s departure:
"[Gruber's] contributions throughout her career have been immeasurable, but never more so than during the COVID-19 pandemic… Her leadership in the center’s efforts to authorize three COVID-19 vaccines, and more recently to approve one of those vaccines, ensured that the vaccines met the high standards the public has come to expect from FDA, and has positively impacted the public health in the U.S. and across the globe."
Here's to continuity and the shared interest of putting Covid behind us. We can't afford any setbacks now.
China’s Clarification on Combo Products
Some big news coming out of China— in attempt to cut down on confusion among drug and medical device manufacturers, China’s regulatory body released new guidelines for the registration of combination products.
The Guidelines for the Registration Review of Device-based Combination Products, set by The National Medical Products Administration (NMPA), state that some products defined as combination products in the US and other countries, might not be labeled as such in China.
In the guidelines, if the product’s major therapeutic effect (or primary mode of action as we refer to here it in the US) is related to the drug component of the product, then it will be regulated as a combination product; however, if the product’s therapeutic effect is related to the device component, then it will be regulated as a medical device instead.
Here at Proxima, we deal with a lot of issues with regards to combination products. Some very simple products may end up becoming combination products simply by the way they are administered.
China is increasingly becoming a destination market for medical devices due to continuing advancements in healthcare delivery and coverage. Noting this recent change, companies might find China as an attractive market for their products.
Tracking Amazon's Next Delivery: Healthcare Service
First launched two years back– Amazon piloted its healthcare service program, dubbed Amazon Care, with its own employees in the Washington area. Already set-up in Washington state, D.C., and Baltimore, Amazon will now branch out to an additional 20 cities this year and in 2022. Some of the new locations include the cities of Houston, Chicago, L.A., Dallas, NYC, and Boston.
As of this past summer, Amazon’s virtual service is now available nationwide.
The whole line up of services will include video care, mobile care visits, prescription delivery, and even the scheduling of in-home visits with medical professionals to performs services, such as drawing blood.
Ahh...There's nothing quite like hitting reload on the Amazon app a couple dozen times to find out when the medical professional you ordered will arrive.
On the Up & Up
Proxima’s very own Isabella Schmitt was recognized by the Houston Business Journal as one of Houston’s Women to Watch. The Houston Business Journal recognizes some of the most important women in leadership roles in the greater Houston area. We're excited for this news!
When Isabella joined us as a project manager three years ago, we recognized that she had talent. Now everyone knows.
We know this is just the beginning for Isabella. We can’t wait to see what 2022 brings!
Bionic Arm Offers New Sensations
Researchers from the Cleveland Clinic led the charge in the development of a prosthetic that’s got a good grasp on the needs and wants of prosthetic users.
Most brain-computer systems run in only one direction— either by picking up brain activity and sending out responses or by firing electric impulses to help fix any issues in the brain’s connections throughout the body.
This prosthetic does both.
It uses neurological signals to operate the bionic arm’s movement, then sends those responses to the brain to be interpreted as feelings or sensations. The prosthetic arm is connected to the limb nerves, where it uses neuron impulses to activate motion and movement of the bionic arm. While that’s happening, sensory receptors in the skin and muscles above the amputation site are activated, and then transform those nerve signals into feelings and sensations felt by the user.
“We modified a standard-of-care prosthetic with this complex bionic system which enables wearers to move their prosthetic arm more intuitively and feel sensations of touch and movement at the same time… These findings are an important step towards providing people with amputation with complete restoration of natural arm function,” said lead investigator Paul Marasco, Ph.D., associate professor in Cleveland Clinic Lerner Research Institute’s Department of Biomedical Engineering.
Hold on tight to your dreams with this major innovation in prosthetics.
Take a Bite Out of Time with InBrace’s AI-operated Smart Braces
InBrace has clamped onto a $102 million in Series D funding for their AI-powered orthodontics, which eliminates visits to the dentist and in-office adjustments— all while offering the comfort of teeth straightening without traditional braces or clear aligner trays.
Using InBrace’s 3D modeling and AI software, the Smartwire device is customized to a patient’s teeth and programmed by their orthodontist to fit their specific needs. Brackets are installed to the back of each tooth and wire is organized in loops while a continuous, delicate pressure is applied to move teeth to specified locations in the mouth. InBrace has named this frictionless, non-sliding mechanism Gentleforce.
The Smartwire works autonomously for months on end, eliminating periodic adjustments and painful tightening at the dentist office while still allowing the ability to floss and brush without difficulty.
“InBrace taps into the recent Zoom culture that has caused a surge of interest among consumers who want to improve their smiles with a more predictable and less disruptive process to their daily lives…InBrace is offering an entirely new option for orthodontists to meet the needs of the 178 million consumers who could benefit from orthodontic treatment but who are currently not walking into their practices,” said CEO John Pham, D.D.S.
Much respect to those before us who braved the combination of wire, rubber bands, and painful adjustments and tightening for years at a time.
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