Is Metal Additive Manufacturing for You?
Are you interested in high-volume-production metal additive manufacturing (AM)? If so, first and foremost you must develop a deep understanding of the total cost per part and how it breaks down. Without this understanding, it will be impossible to develop winning business cases that set up you for success. Rather, unexpected costs and surprises run the risk of disappointing you months or years down the road. By understanding this up front, you can develop lasting applications that can outcompete traditional manufacturing. The three main types of costs can be found in pre-printing, printing, and post-processing/post-printin...
Source: MDDI - March 9, 2020 Category: Medical Devices Authors: Matt Sand Tags: 3-D Printing Source Type: news

Skin-Like Sensors Bring Human Touch to Wearables
Researchers have been working to improve wearable technology so that it’s more comfortable for those using it while still offering optimal performance to monitor health- and wellness-related signals from the body. Researchers Xinyu Liu and Binbin Ying from the University of Toronto developed a stretchy, transparent, and self-powering network of sensors called AISkin that they said can be used in wearable electronics, personal health care, and robotics. (Image source: Daria Perevezentsev) Scientists at the University of Toronto have gone one step further with this endeavor and developed a flexible, tran...
Source: MDDI - March 9, 2020 Category: Medical Devices Tags: Design News Source Type: news

Handheld 3D Printer Could Be Game Changer in Burn and Trauma Care
A new handheld 3D printer that looks sort of like a packing tape dispenser can apply sheets of skin to cover large burn wounds, and its “bio ink” can accelerate the healing process, according to researchers from University of Toronto Engineering and Sunnybrook Health Sciences Centre in Toronto. The handheld 3D printer can apply sheets of skin to cover large burn wounds. It could be seen in a clinical setting within the next five years, according to researchers. Image courtesy Daria Perevezentsev/University of Toronto Engineering News. The device covers wounds with a uniform sheet of bio...
Source: MDDI - March 8, 2020 Category: Medical Devices Tags: Plastics Today Source Type: news

SXSW is Latest to Be Canceled Because of Coronavirus Fears
South by Southwest (SXSW) joins the list of conferences canceled due to concerns of the coronavirus pandemic. The event, which is a music, tech and film festival was slated to be held in Austin, TX from March 13 to March 22. In a statement on its website SXSW organizers said, “We are devastated to share this news with you. “The show must go on” is in our DNA, and this is the first time in 34 years that the March event will not take place. We are now working through the ramifications of this unprecedented situation.” Organizers said they were exploring ...
Source: MDDI - March 7, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Eastman Launches Next-Gen Copolyesters for Medical Device Housing
Eastman has launched a new portfolio of next-gen Tritan MXF copolyesters that offer chemical resistance, higher impact strength, and easier processability for the housing and hardware of electronic medical devices. The company unveiled the new copolyesters at MD&M West 2020. “Most electronic medical devices have an enclosure that meets a UL 94 V-2 flame resistant rating, and customers came to us asking for higher impact strength,” Ellen Turner, Eastman’s global market development manager, medical devices, told MD+DI. “If you look at failure modes, ...
Source: MDDI - March 6, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Materials Source Type: news

Medtech in a Minute: SweynTooth Bugs, Thermo Fisher Makes a Move for Qiagen, and More
Bluetooth-Related Cybersecurity Vulnerabilities Put Medical Devices at Risk A family of 12 cybersecurity bugs associated with Bluetooth Low Energy (BLE) may introduce risks for some medical devices. The SweynTooth bugs can't be exploited over the Internet, but a hacker within radio range could launch attacks to crash targeted devices, disable their BLE connection until a restart, or in some cases even bypass BLE's secure pairing mode to take them over. Medical devices like pacemakers and blood glucose monitors are among those most at risk.   Thermo Fisher Makes Its Move to Acquire Qiagen After month...
Source: MDDI - March 6, 2020 Category: Medical Devices Tags: Business Source Type: news

Realizing the Promise of Artificial Intelligence in Pathology
Digital pathology specialist Proscia has been working hard to change the current pathology narrative. The Philadelphia, PA-based company has made several moves to accomplish this goal and its most recent move is a collaboration with the University of California, San Francisco (UCSF). Proscia builds software and has a platform for imaging workflow management that allows a pathologist in the lab to take digitized images of the glass slides the tissue biopsy sites on and move these images through workflows. The company uses its computational AI-based applications to find patterns in the imaging and transform that information ...
Source: MDDI - March 6, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Business Source Type: news

A Few New Challenges with EU MDR
The upcoming EU Medical Device Regulation (MDR) was a popular topic at MD&M West, as the industry is working to understand specific requirements as well as any emerging implications. A few specific requirements were examined in the Feb. 11 panel discussion, “Strategies for Implementing the New EU MDR Requirements.” Read on for insights that may surprise you. Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP) “We just became comfortable dealing with post-market surveillance and post-market clinical follow up . . . a...
Source: MDDI - March 6, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news

An Update on ISO 11607 and EU MDR
One of the objectives of the most recent revision of ISO 11607, "Packaging for Terminally Sterilized Medical Devices," published in February 2019, was to meet all packaging-related expectations outlined in the EU Medical Device Regulation, according to Thierry Wagner, global director, regulatory & standards – healthcare at DuPont Safety and convenor of the ISO TC198 Working Group 7. He spoke during the MD&M West 2020 presentation, “Global Medical Packaging Consensus Standards Development to Meet Regulatory Requirements.” The standard seeks to support...
Source: MDDI - March 6, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news

Quest Joins COVID-19 Detection Fight with New Assay
Quest Diagnostics joins the growing number of firms that have developed tests for the coronavirus (COVID-19) in recent weeks. The Secaucus, NJ-based company said it was launching its COVID-19 test service that aids in the presumptive detection of nucleic acid in respiratory specimens of patients meeting Centers for Disease Control and Prevention clinical criteria. The diagnostics firm said its test is a molecular-based assay that detects viral RNA in respiratory specimens. Quest said it will be in a position to receive specimens for testing and begin to provide testing Monday, March 9. The company said the new test service...
Source: MDDI - March 5, 2020 Category: Medical Devices Tags: IVD Source Type: news

Major Healthcare Conference Cancelled for First Time in 58 Years
Cancelling a major industry event like the annual Healthcare Information and Management Systems Society (HIMSS) meeting could not have been an easy decision, but event organizers said Monday that it was "unavoidable" at this point. So far, attendees and vendors seem to be understanding of the news. “It is for sure a better case scenario of canceling instead of spreading and creating an epicenter for an epidemic across the U.S.," Ryan Basschief operations officer at TrackMy Solutions, told MD+DI shortly after he received word that the event was cancelled. "Hard to cancel a show of s...
Source: MDDI - March 5, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Supplier Stories for the Week of March 1
(Source: MDDI)
Source: MDDI - March 5, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Packaging Source Type: news

Changing How the Medical Device Industry Looks at Robotics
When it comes to the term “robot,” those in the medical device industry might typically think of robotic-assisted surgical systems such as Intuitive’s daVinci robotic system. But Barry Cohen, chairman and CEO of AVRA Medical Robotics, disagrees. Instead he thinks of these devices as primarily mechanical manipulators. “AVRA’s robot has seven degrees of freedom, so that's like your arm having seven different wrists,” Cohen said, in an interview with MD+DI. He likened it to a snake seeing something and rearranging its e...
Source: MDDI - March 5, 2020 Category: Medical Devices Authors: Susan Shepard Tags: Assembly and Automation Source Type: news

Livongo is Still Blowing Minds with Its Success
Livongo, a digital health specialist that raised more than $350 million in an initial public offering last year, continues to blow investors away. The Mountain View, CA-based company said its 4Q19 revenue was $50.2 million a significant increase over its 4Q18 revenue of $21.2 million. Despite beating Wall Street expectations, Livongo has yet to make a profit. The company lost about $6 million for the quarter and about $55 million for 2019. However, that will come, said Lee Shapiro, Livongo’s CFO. "I also feel confident reaffirming our commitment to profitability in 2021 on an adjusted EBITDA basis,â...
Source: MDDI - March 4, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

This Robot Gives Birth and We Can & #039;t Stop Watching
She bleeds, breathes, and births a baby that is as eerily lifelike as she is. But most importantly, Victoria takes labor-and-delivery training to the next level. Victoria, first introduced in 2014, was developed by Miami, FL-based Gaumard Scientific, and is considered the most advanced childbirth simulation system on the market. In the latest version, Victoria's eyes can focus and interact with her caregivers, enabling users to conduct a neurological-assessment that evaluates impaired eye motion for warning signs of a stroke, head trauma, drug use, cranial nerve ...
Source: MDDI - March 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Design Source Type: news