Medical Design and Outsourcing Archives - Page 20 of 154

How LimFlow’s foot-saving system prevents amputations in patients with no other options

LimFlow’s crossing stent diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ischemic foot. [Illustration courtesy of LimFlow]

LimFlow’s breakthrough system for treating chronic limb-threatening ischemia (CLTI) is the first of its kind approved by the FDA for this severe form of peripheral artery disease (PAD).

The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is now the only option other than amputation for ceratin CLTI patients who have lost blood flow below their knee. LimFlow’s TADV system won breakthrough device designation in October 2017 and secured FDA premarket approval (PMA) in September 2023.

“A lot of technologies come out of people fiddling with technologies that already exist, and then developing unique proprietary solutions after that,” LimFlow CEO Dan Rose said in an interview with Medica…

Device strategies to prevent healthcare-associated infections

[Image courtesy of the National Institute of Allergy and Infectious Diseases]

Device design, sterilization before use and proper cleaning of reusable equipment can prevent infections and save lives.

By Ted Eveleth, AvantGuard

Nosocomial infections, also commonly known as healthcare-associated infections (HAIs), are a multibillion-dollar problem and a leading cause of morbidity and mortality around the world. On any given day, about 1 in 31 hospital patients has at least one HAI, according to the Centers for Disease Control and Prevention.

A significant cause for many of these HAIs are medical devices that touch or are implanted in the body, such as surgical implants, catheters and endoscopy devices.

For example, 75% of urinary tract infections in healthcare settings are associated with urinary catheters. Central line-associated bloodstream infection (CLABSI), another category of HAIs associate…

MGS breaks ground on innovation and tech center

MGS breaking ground on its new Innovation Center in Germantown, Wisconsin [Photo courtesy of MGS]

MGS has started construction of its new innovation center at its headquarters campus in Germantown, Wisconsin.

The medtech contract manufacturer said the 120,000 ft² facility is scheduled to open by the end of 2024.

The MGS expansion will have collaborative workspaces dedicated to ideation and product development, tooling development, automation, and part and process validation, the plastics manufacturer said. Class 7 and 8 cleanrooms will offer space for part and process validation without disruption to production environments, while an on-site dedicated quality lab with enhanced tactile-, optical- and CT-measuring capabilities will ensure optical, dimensional and functional product quality throughout the product development process.

“The MGS Innovation Center represents an important milestone in our…

Two-armed surgical robot prototype targets pediatric brain tumors

The endoscopic brain robot’s arms are each 2.8 mm in diameter and 35 mm long when fully extended. Together, they offer a 43 mm diameter workspace. [Image courtesy of Boston Children’s Hospital]

Researchers say they’ve developed a surgical robot for removing brain tumors in children, and that it could also offer a less invasive, safer option for adult neurosurgery and other procedures.

The trick is using hollow, nitinol robot arms to allow neurosurgeons to swap tools during a tumor resection procedure, said Pierre DuPont. He’s the chief of pediatric cardiac bioengineering at Boston Children’s Hospital, and the corresponding author of a new research paper detailing the potential advantages of a two-armed neuroendoscopic robot.

In an interview with Medical Design & Outsourcing, DuPont traced the project back to conversations with Dr. Jim Drake, chief of neurosurgery at Sick…

S3 Connected Health joins DiMe’s International Regulatory Pathways project

NEWS RELEASE: S3 Connected Health joins DiMe’s team of digital health experts in their new project ‘International Regulatory Pathways’

DUBLIN, September 19, 2023 – Building on the success of the Digital Health US Regulatory Pathways, DiMe has assembled a global team of digital health experts, including S3 Connected Health, to support digital health product developers in pursuing and optimizing their regulatory, evidence generation, and business strategies across multiple global markets and regulatory regions.

Their new project ‘International Regulatory Pathways’ will combine the expertise and experience of the project team, with current global digital health product regulations, regulatory science, and industry pathways, to support life science companies looking to achieve accelerated access through multi-market evidence plans for digital health initiatives.

S3 Connected Health is strategically placed to bring its 20+ years of experience in bo…

Four steps medtech startups can’t put off

Greenberg Traurig shareholder Ginger Pigott [Photo courtesy of Greenberg Traurig]

Developing and commercializing a new medical device is a success worth toasting for medtech startups — but that success also makes it more likely that litigation is in their future.

There are steps medtech startups can take to protect themselves down the road, said Greenberg Traurig shareholder Ginger Pigott, a litigator who defends major medical device manufacturers in court. She also advises medtech startups on early decisions and strategies that could have major ramifications down the road.

Pigott and two other women — Greenberg Traurig lawyer Miki Kolton and Fogarty Innovation Chief Innovation Officer Denise Zarins — will offer their expertise at our DeviceTalks West show in an Oct. 18 panel, “Going the Distance: Building Startups to Last.”

Pigott offered a preview of the panel for Medical Design &…

How Biosense Webster aims to expand access to AFib care

Biosense Webster U.S. President Nikki Sidi [Image courtesy of Biosense Webster]

Electrophysiology is “an incredibly vibrant space,” said Nikki Sidi, but access remains a challenge.

Nikki Sidi, the U.S. president of Johnson & Johnson’s Biosense Webster, can look at her own company as one of those paving the way in electrophysiology (EP). Its recent milestones include multiple atrial fibrillation (AFib) mapping catheters, including ablation and mapping devices.

Sidi has worked across a number of businesses at J&J, including leading U.S. marketing for Biosense Webster. She took on the post of U.S. president at Biosense Webster in December 2022 after a stint with J&J Vision.

Her return to Biosense Webster — and her return to AFib treatments — has been nothing short of “amazing,“ she said in an interview. Biosense Webster competes in a market that also includes …

Tessy Plastics announces CEO and president transitions

Tessy Plastics President Stafford Frearson [Photo courtesy of Tessy Plastics]

Tessy Plastics today named Stafford Frearson as the medtech supplier’s new president with former President Roland Beck becoming CEO.

Frearson joined the contract manufacturer in 1997 and was promoted to his most recent role, VP of engineering, in 2018. He’s now responsible for day-to-day business operations across the plastics company’s 13 locations in the U.S. and China.

Beck is the owner of Skaneateles, New York-based Tessy. His father, Henry Beck, was one of the family business’s co-founders in 1973.

The younger Beck became president in 2002, and under his leadership annual revenue has grown to more than $500 million and expanded its footprint to eight facilities in Central New York; one in Erie, Pennsylvania, one in Meadville, Pennsylvania; and two in Shanghai, China.

Accumold details injection molding of thin wall cannulas

NEWS RELEASE: Injection molding of thin wall cannulas — a lesson in expertise and persistence

After 5 years of painstaking work, leading micro molding innovator Accumold has developed a way to micro injection mold thin wall cannulas in very high volumes. Previous to this innovative approach to production, cannulas were typically produced via an extrusion process, which is at the same time expensive, prone to high fall out rates, and which does not lend itself to the high volumes required by medical device OEMs for some applications.

It took Accumold 5 years to perfect the micro injection molding of thin wall cannulas at volume, and this article describes how it was done, the issues at play when micro injection molding such intricate devices, the advantages of the micro injection molding process, and what this means for medical device applications moving forward.

THE CASE FOR MICRO MOLDING

Micro injection molding is a precision manufacturing process that involve…

How exposed are Medtronic, Intuitive and other Medtech Big 100 device makers to China?

China promises risk and upside for Medtronic, Intuitive and other major medical device manufacturers. [Photo via Adobe Stock]

As economic concerns shift from the U.S. to China, medical device manufacturers such as Medtronic and Intuitive are monitoring how procedure volumes and new policies affect their businesses.

In a new note, William Blair analyst Brandon Vazquez details the exposure of those companies and four more on Medical Design & Outsourcing‘s Medtech Big 100 ranking of the world’s largest device makers.

“The bottom line for our coverage universe is that exposure seems manageable with all companies at 10% or less of revenues/procedures coming from China, though we admit materially worsening macro conditions, if materialized, have the potential to move the needle on results — something we have already heard from some intra-quarter updates this month,” Vazquez wrote. Read more

Bluetooth Deployment in Hospital Settings

Introduction

Because the security aspect of Bluetooth is greatly improved and newer technologies counter the RF interference often caused by wireless overcrowding, Bluetooth is becoming a much more trustworthy connectivity solution even in hospitals and other healthcare facilities.

Hospital Settings And Its Effect on Connectivity

Hospital settings are both hectic and fast-paced. The evolution of connectivity technologies greatly enhances a hospital’s ability to successfully deliver vital services, but there are a multitude of RF obstacles inherent to a hospital or other medical settings. The following are just a few of these obstacles.

Challenging Physical Environment: Walls, electronic equipment, and people are obstacles to efficient and reliable wireless communication. With so much inherent water, human body can both reflect and absorb RF energy which means that, the busier the hospital, the more likely the disruption of radio signals. Unpredictable Cap…

Siemens Embedded Software for Medical Devices

Siemens Embedded Solutions address the challenge of developing medical devices through an integrated suite of software that includes:

Proven operating systems and middleware Quick, easy, and secure cloud connectivity Comprehensive built-in security Best-in-class security vulnerability monitoring Pre-certified software components and quality artifacts that enable safety certification Professional services

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