Medical Design and Outsourcing Archives - Page 22 of 154

Medtech Big 100: These companies just missed the list

Each year, it takes more and more revenue to make our Medtech Big 100 ranking of the world’s largest medical device companies.

This year’s No. 100 — Artivion (formerly CryoLife) — secured the final spot in our ranking with revenue of $313.8 million.

Last year, $236.2 million was enough to get Cardiovascular Systems (now part of Abbott) onto the Medtech Big 100 company ranking at No. 100.

Companies on the bubble in recent years have made their way onto the Medtech Big 100. For example, Inspire Medical Systems missed the list by a single spot last year, but made No. 94 in our new ranking.

With that in mind, here are the companies that would have ranked Nos. 101 to 105 on this year’s list. Watch out for them in future versions of the Medtech Big 100.

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Tiny sensors implanted in the brain could interpret speech for people with ALS

Frank Willett operates software that translates Pat Bennett’s attempts at speech — recorded by sensors in her brain — into words on a screen. [Image courtesy of Steve Fisch/Stanford]

Researchers at Stanford used baby aspirin-sized sensors implanted in the brain to guide speech from a person’s mind to a computer.

The devices transmit signals from speech-related regions in the brain to state-of-the-art software. That software decodes brain activity and converts it to text displayed on a computer screen.

Pat Bennett, 68, received a diagnosis of amyotrophic lateral sclerosis (ALS) in 2012. The progressive neurodegenerative disease attacks neurons controlling movement, causing physical weakness and eventual paralysis. Bennett’s condition led to the loss of the ability to speak intelligibly as the condition’s deterioration began in the brain stem. However, she was able to use the sensor…

Private equity-backed adhesion group buys another brand

Adherex Group today announced its acquisition of Stretchtape, a supplier of converted polyethylene and polypropylene films and custom printing solutions for biaxially oriented polypropylene packaging films.

Private equity firm Akoya Capital launched Adherex Group in March with the brands Primetac (purchased in 2019), Concord, Cutting Edge and SpecBond. The group now serves original equipment manufacturers the medical, aerospace, transportation, electronics, industrial and appliance industries.

“This acquisition demonstrates our commitment to being a growth catalyst for today’s packaging distributors,” Adherex Group CEO Bob Marquette said in a news release announcing the Stretchtape purchase. “The integration of Stretchtape gives distributors wider and quicker access to expansive and innovative film converting and printing capabilities, and decades of expertise across markets and applications.”

Before joining Akoya Capital in 2021 and becoming CEO o…

Medtech supplier CEO steps down after 50 years

Jonathan Fain is the majority owner and chair of Teknor Apex. [Photo courtesy of Teknor Apex]

Teknor Apex CEO Jonathan Fain is stepping down after leading the company for 51 years, the custom plastics compounder said today.

Fain will retain a majority stake and continue serving as board chair of the company that his grandfather Alfred Fain founded as Apex Tire and Rubber Co. in 1924.

Teknor Apex said it has grown sales by more than 650%, expanded beyond North America and completed 11 acquisitions under Fain’s leadership.

Replacing Fain as CEO is Donald Wiseman, the former CEO of Ravenswood, West Virginia-based Star Plastics.

“I have had the privilege and honor to lead a great company for over 50 years, and while I am not retiring, I do want to hand over the day-to-day responsibility to someone who can drive to keep the company strong, growing and build upon our culture,” Fain said in …

How Noah Medical’s robotic Galaxy system goes deep into the lungs

Noah Medical’s Galaxy system for lung biopsy uses a robotic bronchoscope to reach and sample for suspected cancers deep in a patient’s lungs.

But the brightest star in the Galaxy system isn’t that disposable, robotic scope, but rather Noah Medical’s tool-in-lesion tomosynthesis (TiLT) technology, designed to help surgeons retrieve samples that will provide a definitive answer from the pathology lab.

Medical Design & Outsourcing spoke with Noah Medical VP of Engineering John Shen to learn more about how the system works, how it was developed, and potential applications of the technology.

Noah Medical VP of Engineering John Shen [Photo courtesy of Noah Medical]

“Robotic systems are hellishly complex,” Shen said. “There are many, many, many systems or components that in their own right are complex devices, and they all need to be working together …

Researchers develop bacteria that can detect tumor DNA

As seen in a dish, Acinetobacter baylyi (green) bacteria surround clumps of colorectal cancer cells. Credit: Josephine Wright/UC San Diego

Scientists at the University of California San Diego, along with colleagues in Australia, engineered bacteria capable of detecting the presence of tumor DNA in a live organism.

Previously, bacteria could perform diagnostic and therapeutic functions, according to the UC San Diego website. However, they lacked the ability to identify specific DNA sequences and mutations outside of cells.

The researchers say this innovation could create a pathway to new biosensors capable of identifying various infections, cancers and diseases. This “Cellular Assay for Targeted CRISPR-discriminated Horizontal gene transfer,” or “CATCH,” demonstrated success in detecting cancer in the colons of mice.

“As we started on this project four years ago, we weren’t even sure if using b…

Two technologies that will be huge for robotic surgery, per Intuitive’s Dave Rosa

Intuitive President Dave Rosa [Photo courtesy of Intuitive]

Intuitive Surgical President Dave Rosa says he doesn’t get too excited by the idea of better robotic surgery graspers or more flexible wrists.

Instead, Rosa identified two technological opportunities that are going to advance surgical robotics and minimally invasive surgery in a major way: improved visualization for surgeons and focal therapy.

“How can we help surgeons see more about what they’re doing? … That, to me, is a huge piece of the puzzle going forward that I’m really excited about,” Rosa said in an interview with DeviceTalks Editorial Director Tom Salemi for our Intuitive Talks podcast.

DeviceTalks West: Intuitive President Dave Rosa will give a keynote interview in Santa Clara, California on Oct. 19

Improving visualization

The difference between the best and worst surgeons isn’t…

Three steps for traceability in medical device software development quality and compliance

Many medical devices contain complex software and interdependencies with other software and hardware systems that weren’t designed to operate in a safety-critical environment. [Illustration via Adobe Stock]

A former FDA reviewer offers his perspective on building confidence in medical software validation.

By Paul Jones, Ketryx

When reviewing the software in software-as-a-medical-device (SaMD), software-in-medical-devices (SiMD) and systems-of-systems-of-medical-devices (SosMD) at the FDA, I was always looking for sufficient evidence to justify the sponsor’s claim that the device performs as intended — safely and effectively.

The arguments to support this claim are derived from the manufacturers’ quality management system (QMS) quality assurance, design controls, and corrective and preventative action (CAPA) process artifacts, which includes device distribution, post-market monitoring, and updates. Read more

Unlock your medical device’s potential by choosing the right silicone adhesive

From implantable medical devices to external insulin pumps, medical device engineers can choose from a wide range of off-the-shelf and customized silicone adhesives for many applications. [Photo courtesy of NuSil Avantor]

The right high-purity silicone adhesive can optimize medical device manufacturing and have a life-changing impact on patients.

By James Darlucio, NuSil Technology — part of Avantor

From next-generation prostheses to cutting-edge diabetes care, medical device manufacturers are at the forefront of developing innovative technologies that have the potential to change and save patients’ lives.

Various materials and components come together to form the device. For many manufacturers, silicone is an ideal adhesive to use in device assembly due to its proven biocompatibility, ability to bond to various substrates, and stability over a wide range of conditions.

Choosing the right sili…

ProMed plans open house of new facility near Minneapolis

Medtech contract manufacturer ProMed Molded Products has opened its new development facility in Plymouth, Minnesota. [Photo courtesy of ProMed Molded Products]

ProMed Molded Products has scheduled an open house of its new development facility in Plymouth, Minnesota, from 1-4 p.m. on Oct. 9

The contract manufacturer — which supports applications in medical devices and drug-releasing combination devices — will let registrants tour the facility, meet the executive team and plan projects.

The ProMed Development Center is at 15255 23rd Ave. In Plymouth, less than a mile from the company’s headquarters. ProMed opened the 28,000 ft² facility earlier this year as a “dedicated space for early-stage programs.”

“Within this center, ProMed fosters cross-functional collaboration between prototyping, tooling and development teams to reduce the time required to launch a new product,”…

Researchers use machine learning to boost cancer diagnosis, treatment

DNA rendering. [Image from Warren Umoh on Unsplash]

A new analysis technique developed by researchers at the University of Wisconsin-Madison uses machine learning to improve cancer diagnosis and treatment.

Using short pieces of DNA floating in the bloodstream of cancer patients, doctors could diagnose specific cancer types and choose effective treatments. The new method developed at UW has compatibility with liquid biopsy testing equipment already approved in the U.S. Researchers say this could accelerate the method’s pathway to helping patients.

“Liquid biopsies are much less invasive than a tissue biopsy — which may even be impossible to do in some cases, depending on where a patient’s tumor is,” said Marina Sharifi, a professor of medicine and oncologist in UW–Madison’s School of Medicine and Public Health. “It’s much easier to do them multiple times over the course of a patient’s disease to mon…

Fast Prototyping for Medical Devices with Laser Processing

By Eduard Dobre, Senior Program Manager

When it comes to medical devices, time to market is critical, not only is it a competitive advantage, but it can sooner help patients in need. While the process can be lengthy, from proof of concept all the way to commercialization, laser processing capabilities can shorten the development stage.

Weiss-Aug Group’s Laser Lab Technology Center, part of Weiss-Aug’s Surgical Products division, is located in Fairfield, NJ. It’s array of laser processing technologies expand on Weiss-Aug’s existing capabilities to better support the demanding developmental requirements of today’s fast moving medical device market.

Precision laser cutting is faster, requires shorter setup, can process a vast array of raw materials and material tempers compared to that of traditional CNC technologies, all without sacrificing precision. This leads to quicker turnaround times for prototyping, putting parts in the hands of customers in…