Medical Design and Outsourcing Archives - Page 82 of 154

Discover where this artificial pancreas pioneer sees medtech development going

Frank Doyle — a prolific medical device inventor and Harvard engineering school leader — will discuss the future of medtech development during DeviceTalks Boston, May 10–11, 2022.

A pioneer in developing artificial pancreas technology to treat diabetes, Doyle will share his insights on the future of medical device development, including the expanding role of robotics and artificial intelligence.

(Register today!)

Doyle is the Dean of the Harvard John A. Paulson School of Engineering and Applied Sciences. His success earned him election into the National Academy of Engineering last year (and National Academies of Medicine and Inventors before that).

Doyle will hit upon several critical areas during his keynote presentation at DeviceTalks Boston including:

What lessons he learned from the many years spent developing the complicated systems and algorithms of an artificial pancreas and providing the support necessary to bring it to market. How, i…

Medtronic’s CEO would like to put the tech in medtech

Medtronic CEO Geoff Martha

Medtronic CEO Geoff Martha spoke of the company’s goal of “putting the tech in medtech” during a keynote today at the Design of Medical Devices Conference at the University of Minnesota.

The head of the world’s largest medical device company thinks that medtech could enable healthcare that is much more individualized than it is today.

“We are heading down a path of large-scale personalized healthcare and delivering it in an efficient way. And the key to that is data,” Martha said.

An algorithm on an implantable device, for example, could ping a physician that their patient’s AFib is heating up and help them catch it early. Martha said that a host of medical conditions could be better managed with AI insights from device data. In the process, a device company such as Medtronic could help a much larger swath of the population b…

FDA issues draft guidance for increasing racial and ethnic diversity in clinical trials

The FDA today issued a new draft guidance outlining plans for increased diversity in clinical trials in the U.S.

Expanding upon previous guidances for improving clinical trial diversity, this latest draft guidance — “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” — recommends that sponsors of medical products develop and submit a “Race and Ethnicity Diversity Plan” to the agency in the early stages of clinical development, based on a framework outlined in the guidance.

Get the full story at our sister site, MassDevice.

This handheld surgical robot could automate catheter placement

Researchers at the Massachusetts Institute of Technology’s Lincoln Laboratory have developed an artificial intelligence-guided ultrasound device to help physicians quickly deploy a catheter at a point of injury.

Following traumatic accidents, medical professionals often have to apply life-saving treatment to patients with severe internal bleeding. Delivering catheters into a central blood vessel to administer fluid or medication can be complex, the researchers said, and first responders like EMTs are not really trained to perform those types of procedures. Oftentimes, treatment can only be administered at the hospital.

The team of researchers, led by Laura Brattain and Brian Telfer from the Human Health and Performance Systems group, along with physicians from the Center for Ultrasound Research and Translation at Massachusetts General Hospital, developed a solution to the problem. Its AI-guided ultrasound interventions device (AI-GUIDE) is a handheld platform t…

Consolidation Innovation: Creating New Opportunities for Medical Devices

By Dan Aicher, CEO of EmbedTek, LLC

Medical device designs are complex – from the technological advancements that created them and interconnects between different functional facets, to their enclosures and regulatory requirements. When you add scalable manufacturing to the mix, medical device OEMs are faced with a complex burden to manage. Third party partners experienced in medical product design, supply chain, manufacturing, and regulatory can help OEMs streamline design without sacrificing integrity.

Consolidating multiple elements of a design into one single product can provide significant benefits to OEMs in ergonomics, regulatory, cost, and quality. Device consolidation improves the supply chain and, most importantly, the customer experience.

Ergonomics

Ergonomics go beyond the look and feel of a device and can improve the customer experience in the field. Enhancements can be made across the board, from the device itself to how it is…

Top tips and tricks for feasibility testing

Custom test setups, multi axial loading, or unique wear paths often require complex fixtures and equipment. While there are test standards available (in some but not all cases), designing the test to evaluate a critical feature of your part needs to be considered. [Photo courtesy of Element Materials Technology]

Avoid unexpected failures and keep your project on time and on budget with these best practices.

Eric Kennedy, Kaleidoscope Innovation; and Maciej Jakucki, Element Materials Technology

You’ve passed through your design freeze, parts are rolling in and everyone is excited as verification testing starts.

The first few tests are underway and — uh-oh — your device’s performance is not meeting your requirements. Scrambling to root-cause analysis and rationalizing the poor results leads to no avail. The numbers don’t lie.

You tell the leadership a redesign is needed, timeline is extended, bu…

3M launches 21-day adhesive skin tape for medical devices

3M Medical Tape 4576 [Photo courtesy of 3M]

3M (NYSE:MMM) today launched an adhesive tape that can be used to secure medical devices to a patient’s skin for up to 21 days.

Maplewood, Minnesota-based 3M said its 3M Medical Tape 4576 is flexible, conformable and offers “excellent adhesion to the skin,” making it ideal for devices that need continuous extended wear both in and out of care facilities.

“People deserve to live active lives without their condition — or a device meant to monitor it — getting in the way,” 3M Medical Solutions Division VP Marcello Napol said in a news release. “Adhesives are more than a simple material. They have the potential to unlock longer wear times, slimmer device profiles and more. We’re excited about 3M Medical Tape 4576 and what it can offer device developers and real-time, proactive health monitoring as a whole.”

The…

Wytech Industries announces new CEO

Wytech Industries CEO David Ohmann [Image from Ohmann’s LinkedIn page]

Wytech Industries, a Vance Street Capital portfolio company, announced today that it has promoted David Ohmann to the corner office.

Ohmann joined Wytech in May 2021 as president. A veteran of Heraeus and TE Connectivity’s MicroGroup, he has more than 25 years of medical device industry experience.

“Over the past eleven months Dave’s energy, dedication and compassion for the people of Wytech has preserved the entrepreneurial and employee-focused culture that the Casalino family started 50 years ago,” said Mike Janish, managing partner of Vance Street Capital.

“Wytech’s three-year growth plan now includes an expansion of manufacturing space at the Rahway [New Jersey] facility, including continuous expansion of Wytech’s FastLane Webstore. We are very happy with Wytech’s scalability and excited for Dave’s p…

SeaSpine fully launches its Reef TA interbody system

The Reef TA (TLIF articulating) interbody system [Image courtesy of SeaSpine Holdings]

SeaSpine Holdings (NASDAQ: SPNE) recently announced the full commercial launch of the Reef TA (TLIF articulating) interbody system.

SeaSpine said in an April 11 news release that it designed the Reef TA interbody system to reliably deliver an interbody to the anterior portion of the disc space. The goal is to optimize sagittal alignment and endplate support.

With an array of footprint and lordotic options, surgeons can intraoperatively address specific anatomical needs, according to SeaSpine

“Reef TA is an exciting addition to our interbody portfolio,” said Dennis Cirino, SeaSpine SVP of Global Spinal Systems. “This system combined with a comprehensive set of decompression and disc preparation instruments, provides a versatile and reproducible lumbar interbody solution while also offering efficiency gained throu…

Find out where Integer is going at MD&M West

Find out more about contract manufacturing giant Integer — including its $131 million Aran Biomedical acquisition — at MD&M West this week in Anaheim, California.

Integer is exhibiting at Booth No. 2615 at the show, which runs through April 14.

“We are truly stronger together with the addition of Oscor and Aran Biomedical to the Integer team,” said Payman Khales, president of Integer’s Cardio & Vascular business. “Our expanded capabilities not only meet our customers’ evolving needs, but additionally enable them to get to market faster. We look forward to showcasing this and more at MD&M West.”

Integer is showcasing examples of how it can expedite time to market. They include designing and developing full lead systems and sub-assemblies, vertically integrated manufacturing, and customizable services to complement customers’ existing capabilities.

Integer also has its new Xcellion Gen 3 lithium-ion fast charge rechargeable batteries. Th…

Synchron’s neuroscience director explains the brain implant technology and potential applications

The Synchron brain-computer interface system relays signals from the brain to a device in the chest, then translates the signals into action on a computer. [Image courtesy of Synchron]

Officials at Synchron, the developer of the catheter-delivered Stentrode brain-computer interface (BCI) implant, believe they’re the only BCI company tapping into blood vessels to capture signals from the brain.

They say they’ve already enabled a small group of paralyzed ALS patients to control a computer with their minds, and hope there will be more applications of their technology.

Shortly after the New York-based company released new results of a safety study for its implant, Synchron Director of Neuroscience Peter Yoo spoke with Medical Design & Outsourcing about the Stentrode implant and how catheter delivery could make BCI technology simpler, safer and more accessible than the leading alternative: ope…

Qosina announces new luer lock connectors amid nylon shortage

Qosina (Ronkonkoma, New York) announced today that it is adding to its luer lock connector product line to address a global Zytel nylon shortage.

The new selection of luer lock connectors is made of high-performance Vydyne that the company has in stock. As a result, the connectors are ready for immediate shipment. In addition, the connectors are REACH and RoHS compliant and come with regulatory documentation, CAD drawings and validation test data.

“We proactively assess the supply chain for our products for any potential issues and take steps to mitigate the risks of interruption,” Qosina CEO Scott Herskovitz said in a news release. “In the case of a resin supply issue, Qosina evaluates and sources compatible alternatives, ensuring our ongoing commitment to business continuity.”

Vydyne 21SPF is a general-purpose, lubricated PA66 resin with an enhanced crystallization temperature, according to Qosina. The product has been designed primarily for fast cycle…