Medical Design and Outsourcing Archives - Page 2 of 155

EPA starts the clock on new EtO sterilization emissions rule

Commercial sterilization facilities will have two to three years to comply with a new ethylene oxide (also referred to as EtO or EO) sterilization emission rule announced by the EPA today.

However, the EPA said it will not require commercial sterilizers to use lower concentrations of EtO or to limit the use of packaging and pallet material, citing industry feedback.

Addressing the potential for medical device shortages if sterilizers are unable or unwilling to comply, the agency’s final rule also includes presidential authority for two-year exemptions for stationary sterilizers if the commander-in-chief “determines that the technology to implement such standard is not available and that it is in the national security interests of the United States to do so.”

The EPA’s previous proposal would have only allowed 18 months for compliance.

The EPA said the new EtO sterilization limits and air pollution control requirements will …

Injectable hydrogel could save lives of kids with deadly heart defects

Jervaughn Hunter, the paper’s first author, left, with his Ph.D. adviser, UC San Diego bioengineering professor Karen Christman, in the lab. They took part in the research establishing a hydrogel as a potential mitigation for right ventricle damage. [Image courtesy of UCSD]

Researchers say an injectable hydrogel could mitigate damage to the right ventricle of the heart with chronic pressure overload.

The research came out of the University of California San Diego, Georgia Institute of Technology and Emory University. Investigators published their work in Journals of the American College of Cardiology: Basic to Translational Science.

For this study, they used rodents, but a 2019 FDA-approved Phase 1 trial demonstrated the hydrogel’s safety in humans who suffered a heart attack. As a result of the new preclinical study, the FDA approved an investigational new drug application (NDA). The teams …

Zeus hires new CEO from Becton Dickinson

Paddy O’Brien will become CEO of Zeus on April 1, 2024. [Photo courtesy of Zeus]

Zeus has hired Padraic “Paddy” O’Brien as CEO from Becton, Dickinson and Co. effective April 1, the medical tubing supplier said today.

O’Brien is worldwide president of BD Peripheral Intervention, where he “developed an extensive and consistent track record of delivering durable, sustainable growth while creating a winning culture,” Zeus said in a news release.

O’Brien held management positions at Bard from 2001, rising to the position of global marketing VP by the time of the company’s December 2017 acquisition by BD.

He’ll replace Steve Peterson, who joined Zeus as SVP of global sales and marketing in 2017 and was promoted to president in 2018 and CEO in 2020.

Zeus recently closed its sale to private equity firm EQT, which said it hired O’Brien after an extensi…

Emuge expands thread mill line for manufacturers

NEWS RELEASE: EMUGE Expands Thread Mill Line with a Range of New, Innovative Tools

Complimentary Product Guide Details Extensive, Expanded Line of Thread Mills

Emuge’s expanded thread mill line [Image courtesy of Emuge]

WEST BOYLSTON, MA – EMUGE-FRANKEN USA, a leading manufacturer of high-performance taps, thread mills, end mills, drills, and other rotary tools, has introduced a significantly expanded line of Thread Mills, including innovative solutions for challenging threading applications and materials such as nickel alloys, titanium, high tensile strength steels, hardened high alloy steels, cast iron, cast aluminum and more. EMUGE-FRANKEN offers manufacturers a wide breadth of tooling options and industry-leading designs with five distinct thread mill tool families to address a range of machining requirements.

“To improve productivity and profitability in the most challenging threading applicat…

PTI Engineered Plastics wins industry honors

Medtech supplier PTI Engineered Plastics has been named processor of the year by Plastics News.

The awards are sponsored by the Washington, D.C.-based Plastics Industry Association. Plastics News said the processor of the year award “is the most prestigious honor in the North American plastics processing sector.”

PTI Engineered Plastics is a provider of custom injection molding and contract manufacturing of medical device components and assemblies, with a specialty in low-volume production.

Plastics News said PTI won high marks in all criteria for the award, including financial performance, quality, customer relations, employee relations, environmental performance, industry and public service, and technological innovation.

“This year the company also excelled in technological innovation,” Plastics News said while announcing the award. “Thanks to its in-house expertise with automation and Industry 4.0, PTI is automatin…

DeviceTalks and our team are finalists in the Software & Information Industry Association’s Neal Awards

DeviceTalks Editorial Director Tom Salemi (left) interviews BD Chair, CEO and President Tom Polen at DeviceTalks Boston 2023. [Photo by Jeff Pinette for Medical Design & Outsourcing]

DeviceTalks and the WTWH Media Life Sciences team — which includes editorial staff from DeviceTalks, Medical Design & Outsourcing and MassDevice — are finalists in the Software & Information Industry Association’s (SIIA) 70th Annual Jesse H. Neal Awards competition.

SIIA calls the Neal Awards “the most prestigious editorial honors in the field of business-to-business journalism.”

DeviceTalks is a finalist in the category of best range of work by a media brand for our DeviceTalks podcasts, live events in Boston and California, and print and online coverage through MassDevice and Medical Design & Outsourcing.

DeviceTalks Boston 2023: Registration is now open for our life event on May 1-…

Scientists develop new bonding method for biomedical hydrogels

This illustration highlights how two hydrogels (shown in blue) can be bonded in different ways by thin chitosan films (shown in orange). The bonds that form are extraordinarily strong and can resist high tensions. [Image courtesy of Peter Allen, Ryan Allen, and James C. Weaver]

Researchers say they created a method to bond layers made of the same or different types of hydrogels and other polymeric materials.

A team at the Wyss Institute for Biologically Inspired Engineering at Harvard University and Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) conducted this research. They created a simple, versatile method to instantly and effectively bond those layers using a thin film of chitosan. Chitosan, a fibrous, sugar-based material comes from the processed outer skeletons of shellfish.

The team successfully applied their new approach to a number of unsolved medical problems. They us…

SMC expands with end-to-end fill/finish facility in Charlotte, N.C.

NEWS RELEASE: SMC Ltd. Announces Expansion of Sterile Fill Finish Capabilities, Unveiling State-of-the-Art Facility in North Carolina.

SMC’s Charlotte, N.C. facility [Photo courtesy of SMC]

Somerset, Wisconsin — SMC Ltd., the worldwide contract manufacturer of single use and disposable medical devices, has today announced the acquisition of an end-to-end fill/finish facility in Charlotte, North Carolina. The facility enables SMC to offer a wider portfolio of services to its pharma clients including lab-to-market development, analytical services, device manufacture, fill/finish, final assembly, and secondary packaging.

The state-of-the-art facility compliments SMC’s footprint of global manufacturing capabilities and illustrates SMC’s commitment to the pharma services industry by offering high-speed, sterile fill finish lines with onsite formulation, compounding, and packaging capabilities.

VP and Ge…

Accumold plans upcoming micro molding innovation showcase

NEWS RELEASE: Accumold showcases innovation through micro molding at OFC 2024

An Accumold micro molded silicone lens with a matchstick head for scale [Photo courtesy of Accumold]

Ankeny, IA — For 35 years, Accumold has led the way in the industrial use of micro molding for industries in need of cost-effective, prompt delivery of miniaturized components. As the need for intricately shaped geometries grows, alongside the use of diverse and challenging-to-process thermoplastics, and increasingly stringent precision requirements, Accumold has consistently risen to meet these evolving demands.

At the Optical Networking & Communication (OFC) Conference and Exhibition, San Diego, CA, USA, Accumold is delighted to be displaying an array of parts and components showcasing the versatility, precision, and accuracy of its micro molding service, and the variety of materials and applications that it has experience in man…

AI-powered smartphone app diagnoses ear infections

An image of the tympanic membrane. [Image courtesy of UPMC]

Physician-scientists at UPMC and the University of Pittsburgh found a way to use AI to accurately diagnose ear infections.

The AI-powered smartphone app that diagnoses acute otitis media (AOM) could help decrease unnecessary antibiotic use in young children. Researchers published their outcomes in JAMA Pediatrics.

AOM commonly has antibiotics prescribed to treat it, but can prove difficult to discern from other ear conditions without intensive training. This AI tool makes a diagnosis by assessing a short video of the eardrum captured by an otoscope connected to a smartphone camera. The researchers say this offers a simple and effective solution with potentially more accuracy than trained clinicians’ diagnoses.

“Acute otitis media is often incorrectly diagnosed,” said senior author Dr. Alejandro Hoberma, pro…

MDO wins ASBPE awards for medtech coverage, data journalism and DEI

Medical Design & Outsourcing won regional Azbee awards for these 2023 cover stories.

Medical Design & Outsourcing and members of our team have once again won honors in the annual American Society of Business Publication Editors (ASBPE) Awards of Excellence competition.

The ASBPE Awards of Excellence, also called the Azbee Awards, recognize the highest quality reporting, editing and design in business-to-business, trade, association and professional publications.

Medical Design & Outsourcing won four regional awards in the Heartland region, which covers the Cleveland, Ohio headquarters of our owner. ASBPE will reveal whether they are gold, silver or bronze awards in April or May.

Additionally, ASBPE will name national gold, silver, bronze and Overall Excellence finalists on April 18. Medical Design & Outsourcing won four national and Overall Excellence honors from ASBPE in 2023.…

SGS wins ISO/IEC 17025 certification for Fairfield, N.J., lab facility

NEWS RELEASE: SGS Laboratory in Fairfield, NJ, USA Demonstrates Its Commitment to Testing and Calibration Excellence with New ISO/IEC 17025:2017 Certification

The SGS lab facility in Fairfield, New Jersey. [Photo courtesy of SGS]

The world’s leading testing, inspection and certification company announced today that its Fairfield laboratory has earned its ISO/IEC 17025:2017 certification.

The globally recognized accreditation, together with Fairfield’s extensive experience as a GMP FDA approved laboratory, allows SGS to clearly demonstrate the reliability of its drug development testing results, as well as the integrity, competence and overall quality of the Fairfield laboratory’s practices.

A highly respected quality certification

ISO/IEC 17025:2017 is a globally recognized quality management standard for testing and calibration laboratories. ISO 17025 certifies technical competence in lab testing and ca…