What Matters October: MedTech News You Need to Know

written by

October 07, 2017

Overheard at GMM HQ

"The label on this cookie was green, so it's basically health food." – Lauren Kirmil on the importance of color in brand design.


WHAT THE INDUSTRY IS BUZZING ABOUT

CAN'T WE ALL JUST GET ALONG?

We sure can, according to a new FDA guidance on interoperable medical devices. The guidance outlines design considerations manufacturers should consider when developing devices that will communicate with other devices.

THE KEYS TO HEALTHY COMMUNICATION

The guidance outlines three key recommendations: Defining the interface's function and purpose, identifying the needs of users, and anticipating how things could go awry. Shockingly, the last recommendation was not authored by Dr. Phil.

THE 411

Relationships can be hard. And the relationship between interoperable medical devices are no exception. Keeping interoperability in mind at the outset of design and keeping the new FDA recommendations in mind can help. Smart, safe, and secure interactions are the new sexy.

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WHEN PHONE ADDICTION IS A GOOD THING

An app available only by prescription just received FDA approval as an adjuvant to standard outpatient therapy to treat patients with substance use disorder for stimulants, cannabis, cocaine, and alcohol. The app does not, however, treat addiction to Instagram, Twitter, or Candy Crush. You're on your own for that.

CAN AN APP REALLY DO THAT?

The reSET digital therapeutic provides patients with 12 weeks of digital neurobehavioral therapy based on the Community Reinforcement Approach, a protocol that demonstrated a statistically significant increase in adherence to substance abstinence combined with a reduced amount of in-person counseling, compared to patients who received only the standard amount of in-person counseling.

THE 411

This is the first FDA-cleared mobile medical application system for treating patients with substance use disorders, and comes as the agency is reshaping its role in regulating digital health devices. The times they are a changing, friends.

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HOT OFF THE PRESS

A new bio-ink developed by researchers at the University of British Columbia (UBC) in Canada shows promise as a critical building block for manufacturing replacement tissues and organs using 3D printing. We're guessing that ink cartridge won't be available at Office Depot anytime soon.

SOUNDS FISHY BUT IT'S NOT

The new bio-ink was derived in part from cold water fish skin and is made of gelatin methacrylate (GelMA), a hydrogel laden with living cells that survive the printing process and withstand temperature changes.

THE 411

The development of this new bio-ink is a significant advancement in the quest to heal a great deal of conditions and diseases by implanting perfectly healthy body parts in place of faulty ones. We're just one step closer to the Bionic Man.

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GOOD TO KNOW

You've heard about microchipping your dog. Now you can microchip yourself in case you have too much to drink and can't find your way home.

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