A Chief Technology Officer writes about Spectre and Meltdown cyber threats on medical device and clinical assets. Have you been hit by this?

A group member seeks an FDA and GMP facility to fill high viscosity gel (500,000 CP) into ABL tubes. Suggestions?

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!

And visit the 10x Medical Device Conference website here for a copy of his slides. (I'll send them to you as soon as I find them! Hey, Lucia! Where did you put them?! 🙄)

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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.)

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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.

Click here to join us.

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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.

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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.

Joe Hage
Medical Devices Group Leader

P.S. The 10x agenda for May is really coming together nicely. See the agenda in progress and click here if you want to speak at the event!

MDMA, the Medical Device Manufacturers Association, created this easy-to-join outreach to contact your member of Congress to include repeal of the medical device tax in ANY legislative packages enacted by Congress this year.

Editor's note: Hey, it's Joe. The above image resulted from simply entering my name, email, address, and phone. The form routed the email, without my having to look up anything.

I wish there were a way to adequately convey what's going on right now at Singularity University's annual event Exponential Medicine.

I know. It sounds like a commercial. Like I'm being paid to say this.

I'm not. Event founder and chairperson Daniel Kraft doesn't even know I'm writing this.

His sold-out event is "an intensive four-day experience that gathers world-class faculty, innovators and organizations from across the biomedical and technology spectrum to explore and leverage the convergence of fast moving technologies in the reinvention of health and medicine.

It was live-streamed and available for you right now.

Here's the four-day agenda. Look it over and decide which presentations you want to watch.

Each video is roughly 10 hours long. You'll have to be selective.

Thank you, Singularity University!

For the inspiration, the leadership, and so much more to improve the world's healthcare.

Love,
Your biggest fan

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Jobs for Hire: Click for details.

Aerolase: Project Manager, Medical Laser Product Development

HORIBA Instruments: Regulatory Manager - Medical

Encision: Director/VP RA/QA

Instem: Senior Director of Outsourcing Services

Confidential: International Sales Manager (Medical Drug Delivery Devices)

GeneCoda: Regulatory and Quality Consultant

Hiring managers, promote your jobs for only $49 at https://medgroup.biz/jobs (promo code NOVEMBER) and candidates, search medical device jobs and sign up for job alerts!

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Discussions You May Have Missed

Emily Saba, Research and Development Intern at NCGrowth, asks for input on an "ER Vital Wristband"

Tom Bowen, President at Bowen Medical, asks if you need to "sacrifice accuracy of blood pressure cuffs to low cost disposables?"

Amy DeWinter, founder of Ascenda Medical Marketing, needs your advice on "hardware maintenance pricing," specifically, if she should bundle it in to the capital purchase.

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Thank you for being part of our Medical Devices Group community.

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Check out those Exponential Medicine videos when you have a chance.

YAY! I finally figured out how to conduct polls for you here on MedicalDevicesGroup.net!

To create your own poll for our community, ask your question here.

YAY! Let's do this thing!

I want a seat in Rob's free workshop!

Live event: October 25 at noon New York time

Among the topics:

• Changes to RTA process
• Human Factors Guidance
• Changes to eCopy process
• Small Business Qualification Changes
• Interoperability Guidance
• eSubmitter software status
• Device Modification Guidances
• Quik 510(k) Pilot
• Impact of De Novo & Fee Changes
• Cybersecurity Policies
• UDI Requirements
• New ISO 10993-1:2018 Standard

When it rains, it pours!

Yes! Sign me up for the FDA announcement!

Okay, so who needs a new medical device job?

Discussions You May Have Missed

Thank you for being part of our Medical Devices Group community!

“Let's forget about how many of you have invested in Bitcoin. How many have just heard of Bitcoin or blockchain?” began Jad Mubaslat, founder of Bitquick, and Industrial and Human Factors engineer.

“How many of you understand it?” he continued. (Not so many hands went up and – I won't lie – I had to watch his presentation more than once to "get it.")

“Blockchain is not going to completely revolutionize how you build medical devices, but it is going to revolutionize how that data flows in the background, and how effective your medical devices can be, and how they can take advantage of the data going around.”

Jad explained what a blockchain is, how it fits into healthcare, and answered the question, "Do you need one?"

If you have an interest in blockchain and how it may affect your business, give a listen.

I made the video and slides free for everyone – even had it transcribed for your download. 😊

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Next Week! 10x for ENGINEERS in San Diego

This time next week I'm boarding a plane to San Diego to spend quality time with group members eager to make new connections and keep abreast of the latest thinking in medical device design, development, manufacturing, and commercialization.

I got a lot of positive reviews on the agenda.

We can accommodate another dozen or so folks – so please reply to this email if there's even a chance you might attend. (I have to finalize food and beverage numbers with the Hyatt by Friday.)

The event is geared equally for senior and junior levels. If you're senior, you'll return with ideas the team can use. If junior, you'll return with specifics lessons, materials, and action items to do your job better.

Our keynote speaker is Lance Black, Medical Device Innovation Lead at Texas Medical Center

Dr. Black is fascinating.

He served in the U.S. Air Force, where he completed a residency in family medicine with additional training in aerospace medicine. He had the opportunity to deploy twice during his service, first as Chief of the Medical Staff at Manas Transit Base in Kyrgyzstan, and then as a Squadron Flight Surgeon in Okinawa, Japan.

During his time in Manas, Lance helped to create a mobile modular medical facility aimed to uplift the surrounding defunct healthcare system. In Japan, he responded to in-flight emergencies and orchestrated protocols ensuring the safety of F-22 pilots and their crew.

His work with wounded warrior amputees during his military career and his background in biological engineering prompted him to refocus his efforts from patient care to the design and development of medical devices.

Following the completion of his commitment to the military, Lance attended Georgia Tech’s Masters of Biomedical Innovation and Development program to include one year in their Masters of Industrial Design program.

Now as Medical Device Innovation Lead, Lance focuses on the resident companies of TMCx by supporting their efforts in developing innovative health care technologies.

His Keynote Topic:
How the world’s largest medical center invests in medical device innovation (and how you can benefit!)

Did you know Texas Medical Center is the world’s largest? And did you know they spend millions annually on medical device innovation with players ranging from industry titans to the smallest start-ups?

No?

Then come listen to Dr. Black and learn how TMC – potentially one of your biggest customers – looks at innovation and how it fosters it among companies like yours!

P.P.S. Special thanks to RTI - The Industrial Internet of Things Connectivity Company. Their 10x sponsorship made it possible for us to make some seating available for students and those in transition. Thank you!

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Featured Medical Devices Group Job Board opportunities

See something you like? Click away!

Hiring managers and recruiters, let's get these nice people some jobs! 

List your opportunities at https://medgroup.biz/jobs anytime this month for just $39 using code OCTOBER.

Candidates, make yourselves at home. You can:

• Create a profile;
• Upload your resume;
• Run searches by keyword and location (city/state or ZIP); and,
• Sign up for job alerts (available at this time only in the US, Canada, UK, and Australia).

Good luck!

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Discussions You May Have Missed

Got a question? This is a free resource for all members. Ask yours at medicaldevicesgroup.net/question/add.

Minakshi Mohanty, Bio-sensor and Design Engineer at BioTraceIT , asks, "How to Design Protocols?"

Valeria Fast Wouterlood, Training and Development Manager at Venn Life Sciences, asks for "A question about annual safety reporting medical devices (pre-marketing)."

Kasper Friis, Head of UX & Design at Technolution A/S, asks, "How do you make sure that people will love your product?"

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Thank you for being part of our Medical Devices Group community!

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. If you can't afford the time to attend the entire 10x for ENGINEERS conference – no problem! Come only for Dr. Black's talk on Wednesday night. Stay for the reception! Register now.

IS BLOOD PRESSURE READING JUST A NUMBER?

One of the most critical factors in patient assessment is the blood pressure reading. If the accuracy of the blood pressure reading is compromised then the ability for accurate assessment of the patient is also compromised.

For many years we were exposed to cross contamination due to microbe laden blood pressure cuffs. The medical industry has solved this dilemma through the use of cheap disposable blood pressure cuffs. New research questioning the accuracy of these cuffs is now available.

A major teaching hospital was concerned about the cross-contamination of their manufacturer-validated cuffs. They substituted a washable cuff. In their hypertensive unit they documented that 33% of their patients with poorly controlled hypertension were wrongly diagnosed as normotensive due to lack of accuracy of the washable cuffs. One third of the entire patients in this hypertensive unit would not be given the proper medication to control their hypertension had they not discovered the compromise in accuracy.¹

The most comprehensive research to date on accuracy of various types of cuffs compared eight different types of cuffs made of coated woven and non-woven fabrics. There were variations of up to 27mmHg for systolic readings and 17mmHg for diastolic reading.²

Using the American Heart standards for blood pressure- a person with an accurate blood pressure reading of 113 systolic that had an erroneous 27mmHg systolic cuff could be diagnosed as Stage 2 hypertensive at 140.

This lack of accuracy should alarm every health care worker. The blood pressure measurement should be focused on accuracy, not the lowest cost of a cuff.

There is remedy for the compromise of accuracy by using a reliable well-made reusable cuff such as the W.A.Baum company makes and a low cost cover to protect the cuff, like Bowen Medical Cuff-Guard to prevent cross -contamination. Cleaning of the reusable cuffs between each patient is also an option-if it is thorough and documented.

The most basic of healthcare are the accurate evaluations of vital signs. The blood pressure reading should always be the most accurate we can strive to obtain.

“Since hypertension is a major world-wide problem affecting millions of people, its accurate estimation is imperative and needs further attention. The methods of measurement, equipment and the size of the cuffs have already been standardized but the cuff fabric construction and the material of the cuffs which are the cornerstone of accurate BP measurement have been neglected.”2.

1. Unsafe health and safety: sphygmomanometer cuffs are not interchangeable. By Shaw KC, McEniery CM, Wilkinson and Brown. Published in Journal of Hypertension 2013 July,27(7):434-36 2. Variation in BP values for different cuff types by Naqvi, Potluri, Mandal and Lewis published in Journal of Industrial Textiles 2018, Vol.47(7) 1478-1495.