Medical Design and Outsourcing Archives - Page 18 of 154

MasterControl announces Validation on Demand in Manufacturing Excellence

NEWS RELEASE: MasterControl Announces Validation on Demand Is Now Available in Manufacturing Excellence

Users can configure their production records and validate in one simple step.

Salt Lake City, Utah, Oct 4, 2023: Today, MasterControl, a leading provider of quality management and next generation manufacturing execution software, announced Validation on Demand is now available for its Manufacturing Excellence solution users, allowing them to test their custom workflows in their unique environment and ensure compliance.

MasterControl continues to innovate and build on its validation strategy. As a leader in quality management and manufacturing execution software, they have provided validation documentation to customers for over 15 years. With configurable, no-code software, as customers build production records unique to their processes, additional validation may be necess…

Medasense’s finger probe makes pain management easier for anesthesiologists

Medasense Biometrics founder and CEO Galit Zuckerman-Stark [Image courtesy of Medasense Biometrics]

Pain management is vital to patient comfort and treatment success in medical care. Effective pain management alleviates suffering and optimizes medical outcomes, particularly surgical procedures. However, existing methods for gauging and addressing pain have significant limitations.

Medasense Biometrics is a commercial-stage pain management technology company that develops AI-powered patient monitoring solutions to help clinicians manage physiological pain. The company’s mission is to personalize and optimize pain treatment to reduce patient suffering from pain and its side effects.

Galit Zuckerman-Stark, an engineer with a background in high tech and a love for science and technology, founded Medasense almost 15 years ago. With her expertise in AI, she saw an opportunity to provide better objective tools …

Cardinal Health CEO becomes one of medtech’s top-paid executives

Cardinal Health disclosed pay and perks for other leaders and its median employee, as well as severance payouts for two former top executives.

Cardinal Health CEO Jason Hollar [Photo courtesy of Cardinal Health]

Cardinal Health paid CEO Jason Hollar nearly $18.8 million in his first year on the job, the device manufacturer and pharmaceutical distrbutor said in a new executive pay disclosure.

That makes Hollar — who was Cardinal Health’s chief financial officer until his promotion in September 2022 — the second-highest-paid CEO among the world’s largest medical device manufacturers.

Abbott CEO Robert Ford is the top-paid CEO of all medical device manufacturers at $21.7 million in total compensation. Like Cardinal Health, Abbott also has a major pharmaceutical business, but Abbott does not disclose pay for Medical Devices EVP Lisa Earnhardt.

Hollar’s total compensation for fiscal 2…

Biomerics completes expansion in Minnesota

Biomerics’ Brooklyn Park facility outside Minneapolis. [Image courtesy of Biomerics]

NEWS RELEASE: Biomerics announces completion of 100,000 ft² expansion of Brooklyn Park, Minnesota, facility

Salt Lake City (Sept. 22, 2023 ) – Biomerics , the leading vertically integrated medical device contract manufacturer in the interventional device market, announced the completion of a 100,000 ft² expansion of its operations in Brooklyn Park, Minnesota, bringing the facility to a total size of 170,000 ft². Driven by increased demand, this investment benefits customers by consolidating multiple facilities under one roof and expanding Biomerics’ engineering Centers of Excellence for Complex Extrusions, Laser Processing and Advanced Catheters & Steerables, as well as final assembly operations.

Biomerics’ main facility in Brooklyn Park specializes in designing, developing and manufacturing complex, highly specia…

Cadence acquires ARC Group Worldwide’s Florida location

NEWS RELEASE: Cadence acquires ARC Group Worldwide’s Florida location

Staunton, Virginia (October 3, 2023) – Cadence, Inc., a leading provider of design, development, and contract manufacturing services to the medical device, drug delivery, and diagnostics markets, announced today that it has acquired the Florida location of ARC Group Worldwide (arcw.com), a precision manufacturer specializing in metal injection molding (MIM) and cleanroom plastic injection molding. ARC Florida is located in DeLand, Florida.

“Acquiring ARC Florida is another major step in our strategy to be a leading medtech manufacturing partner to our customers, providing complete solutions from early-stage development to scaled manufacturing. By adding MIM to the Cadence portfolio, we further expand our vertical manufacturing platform with another cost-effective method to increase volume production as products reach scale,” stated Rob Werge, Cadence’s president and CEO. “We look forward to lever…

MGS acquires medical toolmaker Winther Mould Technology

NEWS RELEASE: MGS acquires experienced medical toolmaker Winther Mould Technology

Integrated healthcare manufacturer expands tooling capacity while strengthening global position.

GERMANTOWN, Wis. (October 2, 2023) – MGS, a global leader in end-to-end manufacturing solutions for healthcare innovators, announced today the acquisition of healthcare tooling manufacturer, Winther Mould Technology A/S (“Winther Mould”). The investment in additional tooling capacity and expertise reinforces MGS’ offer of best-in-class speed-to-market and continues the company’s strategic growth as a leading provider of high-precision plastic solutions for Pharma, Diagnostic and MedTech applications.

Located in Demark, Winther Mould brings 56 years of experience in design for manufacturing (DFM), mold design and manufacturing, and testing and validation to supplement MGS’ proven track record in launching and maintaining large-scale healthcare programs. …

NAMSA opens expanded preclinical lab near Minneapolis

North American Science Associates (NAMSA) recently opened its expanded preclinical lab near Minneapolis.

It is “the biggest worldwide preclinical facility dedicated to medical medtech services,” NAMSA CEO Christophe Berthoux said in a promotional video by Medical Alley.

The facility — at 8945 Evergreen Boulevard in Coon Rapids, Minnesota — now has six cath labs and three operating rooms. The company said it added one more of each in the expansion to reduce wait times for procedures.

“We can do all sorts of different development studies for medical device manufacturers, all the way from very basic interventional procedures such as stent placement to highly complex studies” such as extracorporeal membrane oxygenation (ECMO), NAMSA SVP of Global Laboratory Operations Lisa Olson said in the video.

Toledo, Ohio-based NAMSA also expanded the facility’s lobby, break room, and locker space.

NAMSA announced the expansio…

Resonetics closes $900M nitinol deal and rebrands Memry and Smart Materials

Nitinol is used for a variety of medtech applications. [Photo via Adobe Stock]

Resonetics has closed on its $900 million acquisition of the SAES Getters medical nitinol business.

Nashua, New Hampshire-based Resonetics said it will rebrand Memry Corporation and SAES Smart Materials as Resonetics.

The Smart Materials business creates raw nitinol alloy from nickel and titanium and produces nitinol wires, bars, ribbons and sheets. The Memry business offers electric discharge machining, laser processing, centerless grinding, and nitinol tubing, sheet, and wire fabrication.

Those two companies have around 600 employees at facilities in Bethel, Connecticut, New Hartford, New York, and Menlo Park, California.

Nitinol has superelastic and shape memory properties that make it uniquely useful for a variety of medical applications. Medical device developers are finding new and improved ways to use nit…

Engineering Medical Devices with Biocompatibility in Mind

By Michael Alabran, President of PSN Labs

Characterizing the risks of medical devices has always been a challenge. Materials are at the core of this challenge, especially as supply chain disruptions have led to the need to alter materials to continue production of critical devices. The understanding of toxicology and the effect of chemistry on the human body is evolving in real-time. When you combine all these factors into an industry that is classically slow to alter the charted course, it leads to a perfect storm. This article will explore what this means to the industry based on the belief that engineering, material selection, and biocompatibility must be considered in concert and effectively balanced throughout the entire development process.

Biological response and safety is a complicated subject, but at its core requires adherence to basic engineering and scientific principles with material selection ultimately driving the impact of the de…

Ananya Health wants to bring battery-powered cryoablation to the global fight against cancer

Anu Parvatiyar, cofounder of Ananya Health [Image courtesy of Ananya Health]

Cervical cancer is the fourth most common cancer among women and has a high mortality rate globally, according to the World Health Organization. Screening and effective interventions can reduce cervical cancer deaths, but that access is limited in emerging markets and developing countries.

Ananya Health, co-founded by Anu Parvatiyar, is at the forefront of tackling this global health disparity. The company is developing a cryoablation device that can freeze abnormal cells in the cervix at the point of care, all on a battery-powered system designed to bridge the accessibility gap in regions that typically lack these resources.

Typically, when a Pap smear comes back as abnormal in places like the U.S., doctors refer patients to a specialist at a hospital or larger specialty clinic with the tools and operating space to treat the le…

“Maybe we’re overthinking it” — A tough call was the right call for this medtech developer

LimFlow’s ARC arterial catheter (pictured with needle extended) and the mesh V-Ceiver venous catheter [Image courtesy of LimFlow]

The challenges of developing the LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) went beyond engineering and anatomical obstacles.

One of the biggest hurdles was downright emotional, Limflow leaders said in an interview with Medical Design & Outsourcing.

Vein-to-artery crossing is key to LimFlow’s unique FDA-approved system for chronic limb-threatening ischemia (CLTI) patients who have no other option than lower limb amputation.

To restore blood flow to an ischemic foot, the TADV system uses LimFlow’s ARC arterial catheter’s needle inside the tibial artery to puncture the adjacent tibal vein at the precise location of Limflow’s V-Ceiver venous catheter. A guidewire between the two catheters allows a physician to insert a self-…

FDA proposes boosted regulations of lab-developed tests

The FDA today announced a proposed rule that would make it explicit that in vitro diagnostics are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.

The agency is publishing the full rule proposal in the Federal Register.

“A growing number of clinical diagnostic tests are being offered as laboratory-developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” FDA Commissioner Dr. Robert M. Califf said in a news release. “According to the Centers for Disease Control and Prevention, 70% of today’s medical decisions depend on laboratory test results. Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health.”

The move marks a break from decades of more hands-off regulation. Historically, FDA offic…