Viant Medical has signed a consent order to stop sterilizing medical devices using ethylene oxide (EtO) at its plant in Grand Rapids, Mich. by Dec. 31, 2020, according to the Michigan Department of Environment, Great Lakes, and Energy (EGLE). Viant also agreed to stop using ethylene oxide (EtO) at the plant by Jan. 31, to conduct monthly air […]
Lean Product Launch: 3 Ways 3P Events can Boost Efficiency and Speed to Market
By Todd Clark, Program Manager, Viant Get a diverse group of smart people in a room and present them with a challenge. Add brainstorming and collaboration. At the end of the day, the best ideas rise to the top and breakthrough concepts emerge. That’s the magic of a Lean Production Preparation Process (3P) event. For […]
A ‘rolling effect’ on medtech sterilization plants?
The types of regulatory hurdles that contributed to the permanent closure this week of the Sterigenics medtech sterilization plant in Willowbrook, Ill., have created a “rolling effect” on ethylene oxide (EO) plants around the country, according to an industry official. The state of Illinois temporarily shut down the Willowbrook plant in February over emissions of EO, a […]
Viant acquires Meraqi Medical
Viant announced today that it has acquired Meraqi Medical marking the medical device contract manufacturer’s fourth acquisition in two years. Viant said the acquisition of Fremont, Calif.-based Meraqi will expand its range of interventional technologies, bioelectronics and minimally invasive surgical devices. It will also offer a West Coast design and development hub to compliment Viant’s […]
Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives
The FDA will continue its efforts to find alternative medical device sterilization methods to ethylene oxide (EO), even though a major EO plant is slated to reopen. Yesterday, medtech sterilization company Sterigenics and the state of Illinois announced they had reached a proposed consent agreement to reopen a plant in Willowbrook, Ill., which the state shut down in […]
Life in the Fast Lane: 3 Lean Tools to Speed Products to Market
By Don Welling, Sr. Director of Technical Solutions, Viant The average driver can change a tire in about 20 minutes. A NASCAR pit crew can change all four tires in less than 20 seconds, thanks to the right tools and processes. Of all the tools used in NASCAR racing, the air wrench has saved the […]
EO plant shutdown leads to pediatric breathing tube shortage
The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to […]
Another medtech sterilization plant will close in 2019
A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements. The FDA warned on March 1 about a potential medical device shortage due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. […]
Dynatronics taps ex-NinePoint CEO von Jako as chief exec | Personnel Moves – July 11, 2018
Dynatronics said late last month it tapped former NinePoint Medical CEO Christopher von Jako as its new chief executive officer and board member, succeeding Kelvyn Cullimore Jr. who will stay on the company’s board of directors. Prior to joining Dynatronics, von Jako acted as prez & CEO of NinePoint Medical. Before joining Nine Point, von Jako also […]
