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FDA in talks to regulate 3D printed medical devices to ensure correct care

(TECHNOLOGY) The FDA wants discussion about medical devices that are 3D printed at the point of care to maintain safety for patients.

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medical 3d printing

3D printing is changing manufacturing in many different industries. The medical industry discovered the value of 3D printing in the 1990s, using the technology to create dental implants and custom prosthetics. Today, 3D printing is being used in cancer research, to print surgical tools, and to create organs and skin for transplant. The FDA regulates medical devices, including those printed through 3D technology.

Traditionally, healthcare providers who need 3D printed devices would send the information to a manufacturer and wait for the device to be made and sent back. With 3D printing technology becoming more available, more healthcare facilities (HCFs) have the capability to print devices at the point of care. The FDA recognizes that this is a significant development for the medical industry. To that end, the FDA is engaging in a discussion to establish the framework for regulations to print medical devices at the point of care.

Key points of discussion for medical 3D printing

The FDA published a discussion paper to drive the conversation on regulatory oversight. The 19-page document includes information about the history of 3D printing in medical devices and the regulations by the FDA to date.  It also gives examples of regulatory oversight, but this document is not meant to provide regulations, just to start the conversation. The concerns:

  • Make sure 3D printed devices printed at the point of care are safe and effective. Many HCFs entering 3D printing may not be aware of the regulations about manufacturing medical devices.
  • Assuring that product specs are met. The regulations for 3D devices are less defined than for those made with traditional manufacturing.
  • Clarifying responsibility. A medical device can go through many hands before it gets to the patient, from design to quality control and adverse events. There are concerns about who is responsible for each of these activities.
  • Knowledge and training. The FDA wants to ensure that the entity printing medical devices have the understanding and expertise to handle the process.

Submit comments on the discussion paper

The discussion paper goes on to ask specific questions from the industry, manufacturers, healthcare providers, and other stakeholders to address the challenges and concerns of 3D printed medical devices. Comments are open until February 8, 2022.

Dawn Brotherton is a Staff Writer at The American Genius, and has an MFA in Creative Writing from the University of Central Oklahoma. Before earning her degree, she spent over 20 years homeschooling her two daughters, who are now out changing the world. She lives in Oklahoma and loves to golf. She hopes to publish a novel in the future.

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Tech News

Want to save snippets of a Zoom meeting? Listener makes it possible!

(TECHNOLOGY) Listener lets you screenshot or bookmark important sections of live meetings, as well as curate a playlist of snippets, to share or playback.

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Listener for Zoom tool landing page on laptop.

We live in a very computer-mediated world where the bulk of communication is done virtually. Many of us spend a great deal of time – whether for work or pleasure – on video calls connecting with people that we’re unable to meet with in person.

Zoom became the unofficial mascot for the pandemic and has shown no signs of going anywhere. So naturally, people are looking for ways to put this to even more of an advantage – like by creating messaging extensions to utilize in lieu of live meetings.

Now the folks behind Listener are getting in on the action by creating Listener for Zoom.

The new tool allows users to bookmark important moments of Zoom calls in real-time and easily turn long recordings into bite-sized video clips.

As founder Nishith Shah puts it, “Zoom meetings just got more productive!”

Listener allows users to do a myriad of things, including live bookmarking to create short video clips; ability to transcribe your entire meeting; edit video clips by using transcripts instead of struggling with video editing tools; share video highlights with your team; create playlists from video highlights across different Zoom meetings to tell powerful stories; use projects to organize your meetings and playlists.

Founders say that Listener is designed for pretty much anyone who uses Zoom. In early testing, the founders found that it is especially helpful for product managers and UX researchers who do customer interviews.

They also reported that early-stage founders have been using Listener to add powerful customer videos to their investor pitch decks. It is also helpful for recruiters and hiring managers who search transcripts across hundreds of hiring interviews to remember who said what and to pass on important clips to other people in the interview process.

The tool is also beneficial for teams and hiring, as customer success and sales teams create a knowledge base with Listener to train and onboard new employees. They also use it to pass on customer feedback to the product teams.

This could also be great for clipping video elements that are appropriate for social media use.

On January 11, 2022, Listener was awarded #3 Product of the Day on Product Hunt.

Listener for Zoom is free while in Beta. The tool works only with licensed (paid) Zoom accounts.

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Opinion Editorials

Job listings are popping up left and right, so what exactly *is* UX writing?

(EDITORIAL) While UX writing is not technically new, it is seemingly becoming more and more prevalent. The job titles are everywhere, so what is it?

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UX writing

The work of a UX writer is something you come across every day. Whether you’re hailing an Uber or browsing Spotify for that one Drake song, your overall user experience is affected by the words you read at each touchpoint.

A UX writer facilitates a smooth interaction between user and product at each of these touchpoints through carefully chosen words.

Some of the most common touchpoints these writers work on are interface copy, emails, and notifications. It doesn’t sound like the most thrilling stuff, but imagine using your favorite apps without all the thoughtful confirmation messages we take for granted. Take Eat24’s food delivery app, instead of a boring loading visual, users get a witty message like “smoking salmon” or “slurping noodles.”

Eat24’s app has UX writing that works because it’s engaging.

Xfinity’s mobile app provides a pleasant user experience by being intuitive. Shows that are available on your phone are clearly labeled under “Available Out of Home.” I’m bummed that Law & Order: SVU isn’t available, but thanks to thoughtful UX writing at least I knew that sad fact ahead of time.

Regardless of where you find these writer’s work, there are three traits an effective UX writer must-have. Excellent communication skills are a must. The ability to empathize with the user is on almost every job post. But from my own experience working with UX teams, I’d argue for the ability to advocate as the most important skill.

UX writers may have a very specialized mission, but they typically work within a greater user experience design team. In larger companies, some UX writers even work with a smaller team of fellow writers. Decisions aren’t made in isolation. You can be the wittiest writer, with a design decision based on obsessive user research, but if you can’t advocate for those decisions then what’s the point?

I mentioned several soft skills, but that doesn’t mean aspiring UX writers can’t benefit from developing a few specific tech skills. While the field doesn’t require a background in web development, UX writers often collaborate with engineering teams. Learning some basic web development principles such as responsive design can help writers create a better user experience across all devices. In a world of rapid prototyping, I’d also suggest learning a few prototyping apps. Several are free to try and super intuitive.

Now that the UX in front of the writer no longer intimidates you, go check out ADJ, The American Genius’ Facebook Group for Austin digital job seekers and employers. User-centric design isn’t going anywhere and with everyone getting into the automation game, you can expect even more opportunities in UX writing.

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Tech News

How Apple is trying to combat the AirTag backlash (hint – its not working)

(TECHNOLOGY) Apple’s weak-kneed attempts at fixing their AirTags issues aren’t working. They can be placed on anything (or anyone), and it is detrimental.

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Apple airtag being held between two fingers.

A few weeks ago, I wrote up an article on how the Apple AirTag can be used to stalk and track people, and now it’s happening. Unfortunately, not all stalkers have the same glamour as Joe from the hit series You.

Engadget reported that model, Brooks Nader, says someone used an AirTag to track her. Per her account, she didn’t receive the notification until she was walking home, alone, at night. If that’s not scary enough, now imagine she was an android user. The only way for her to know someone was tracking her would be if she had installed the Tracker Detect app.

As stated by TechCrunch, “Apple has made its own post-launch efforts to tighten up how AirTags that don’t belong to a certain user can be detected, but these notifications have proven buggy and have often waited far too long to alert users. Add in the fact that Apple has seemed to treat Android integration as an afterthought, not a necessary partnership in order to ship a device like this, and Apple’s incompetence looks a bit more severe.”

The app itself, which was released on December 11, 2021, is getting a lot of negative feedback. One issue is that to see if you’re being tracked you have to manually scan to find the AirTag. How often and when you do that is up to the user. Whereas with the Apple Find My app, it alerts you automatically without the user having to scan anything. It’s not perfect, however. It’s buggy and can take hours to notify the user that an AirTag is tracking them. However, it’s still better than the android app.

Another dreadful scenario that hasn’t been factored in this equation is children. Not all kids have devices, much less Apple devices, nor should they necessarily, but if someone was going to track them, they would be easy targets.

Apple, for the love of all that’s decent, pull AirTags and reconsider how they function. Examine the ways an AirTag could be used without using the mesh network of all iPhone users so that it doesn’t continue to emit a location or, I don’t know, give up. If it doesn’t mean anything to you to risk other’s lives with this product then consider the possible dangerous consequences as a reflection on Apple.

Contrary to popular belief, not all publicity is good publicity.

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