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What Matters: November's MedTech News You Need to Know

Overheard at GMM HQ

"I used to think vanilla creamer was a treat, but that was before Starbucks' seasonal latte flavors changed everything. Pumpkin Spice Lattes for life! #PSL"– Lauren Kirmil, on how Starbucks created a new category of coffee drinkers to increase their market share.

WHAT THE INDUSTRY IS BUZZING ABOUT

THAT FEELING WHEN...

...You can feel again. That's what paralyzed patients are experiencing when using a robotic arm paired with a brain-computer interface currently being studied at University of Pittsburg.

GUESS WHICH FINGER?

After a surgical procedure implanted a microelectrode array in the sensory cortex of the patient's brain, they reported having sensation as detailed as differentiating between each finger of the robotic arm. This came in especially handy (pun intended) when asked how they felt about the current election cycle and were able to indicate a response with just one finger.

THE 411

These outcomes represent progress in understanding the stimulation patterns needed to help paralyzed patients achieve effective movement. Unfortunately, they do not offer any significant movement in getting us through the election.

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DON'T HACK MY HEART, MY ACHY BREAKY HEART

After Johnson & Johnson's recent admission that their insulin pumps could potentially be hacked, everyone wants to reevaluate the cybersecurity of, well, everything.

MO' DEVICES, MO' PROBLEMS

The scary truth? Any device that is connected to a network could potentially be hacked, from CT imaging machines to implanted devices like pacemakers. While current FDA guidelines surrounding cybersecurity are only voluntary, concerns mount about the possibility of device cybercrime ranging from identity theft to functionality interference to ransomwear (e.g. "I'll disable this pacemaker unless you pay me [insert Dr. Evil voice] one million dollars.").

THE 411

J&J maintains that the actual risk is "extremely, extremely low," which has been anecdotally supported so far. The real news is simply the signaling shift that manufacturers—and hospitals—have to start considering cybersecurity with every device they create to ensure that Dr. Evil is kept at bay.

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HOW TO PRACTICE SAFE TESTS

After being available in draft form for over three years, the FDA recently finalized the "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,'" which provides a strategic approach to manufacturing and evaluating a medical device through a risk management process. Hey, no one ever accused the FDA of sexy guidance titles.

IN OTHER FDA NEWS

The agency is also fine-tuning a guidance addressing the clinical evaluation of software as a medical device (SaMD), opening it up for public consultation a few weeks ago. In case you're wondering, the puppy memes you view from your smart phone do not count as SaMD, regardless of their powerful antidepressant properties.

THE 411

The FDA continues its dance with medical device manufactures, waltzing into the high-tech future one guidance at a time.

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GOOD TO KNOW

Minnesota Congressman Erik Paulsen has been proudly wearing half of a heart-shaped 'Best Friends Forever' necklace with the medical device industry for years (he delayed the ACA's tax on medical device companies for two years, amongst other pro-device reforms). With his Congress seat threatened in the upcoming election, MN-based device companies like Medtronic and Boston Scientific are donating heavily to his campaign and hoping to keep their BFF in power for one more term.



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