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

Overheard at GMM HQ

"Who needs doctors when you have the Internet? Doctors are for second opinions. Google already diagnosed me." – Holley Malia, commenting on the role of the Internet for today's informed patient.

WHAT THE INDUSTRY IS BUZZING ABOUT

A HARD AND EXCITING BREAKTHROUGH

Penises are in the news again, but we’re glad it’s not about Trump referencing the size of his this time. A surgical team at Massachusetts General Hospital has performed the first penis transplant in the U.S. and is “cautiously optimistic” about the long-term results. The patient, a 64-year-old cancer survivor, is speaking out publicly about the procedure to help dispel the stigma surrounding genital injuries. He also said it is “starting to take shape,” stating that he won’t “hide behind a rock.” [Insert ‘rock and a hard place’ joke here.]

TURNS OUT IT IS A MAN'S LIFESOURCE

Penis transplant research stems primarily from a hope to treat combat veterans who suffer genital injuries, resulting in "exceptionally high" suicide rates. "A penis transplant can be lifesaving," says MGH surgeon, Dr. Certulo. Men everywhere nodded awkwardly.

THE 411

The penis transplant, which involved 12 surgeons and 30 additional healthcare workers, is a promising development for men who have suffered genitourinary injuries. The surgery begins "a new chapter filled with hope," says the patient.

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BEAM
PRINT ME UP SCOTTY.

With 85 3D printed devices cleared by the FDA, the agency has just released a new draft guidance that addresses considerations for design and manufacturing, as well as device testing including characterization, validation and verification. Does not address how to handle a paper jam.

ADDITIVE GUIDANCE FOR ADDITIVE MANUFACTURING

The FDA says it wrote the draft guidance on the basis of feedback it received from a 2014 public workshop on challenges related to 3D printing and says the guidance is not intended to address 3D printed products containing biologics, cells or human tissues. They say it's also not meant to be comprehensive. Shocker. 

THE 411

3D printing is here to stay in the device world. The FDA says it holds a number of advantages over traditional manufacturing processes for certain device applications and has issued this latest guidance to share its initial thinking about some of the technical considerations. 

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YOU'VE GOT MAIL

MedData Point recently collected data from 157 physicians in the U.S. to determine their habits and preferences surrounding work-related email. The biggest non-surprise? Doctors under the age of 45 were more likely to read email on a mobile device than their older colleagues, who may or may not be more likely to print emails out and read them, if they're anything like our dads. [PSA: Don't forget Father's Day is June 19th.]

BUSINESS OR PLEASURE?

Eighty percent of survey respondents reported that emails containing medical news account for their most-read professional emails, although 56% said that they either have no preference or would actually prefer to receive these emails at their personal email address. No one asked to bring the fax back.

THE 411

As electronic medical records become the gold standard, email is quickly becoming a standard channel for doctor/patient communication, as well as marketing information from medical companies. We recommend against chain letters, though.

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GOOD TO KNOW

And speaking of nuts in the news . . . The nuts that you’d find in the snack aisle at the grocery store might soon be able to tout themselves as “healthy,” a labeling claim that the FDA currently reserves for food containing fewer than 3g of fats but is reconsidering.





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