Boulder Sterilization Offers Ethylene Oxide, Chlorine Dioxide Service More choices. More options. Better results. May 30, 2023 Boulder Sterilization is introducing chlorine dioxide (CD) service this summer, making it the sole contract sterilizer to offer CD and ethylene oxide (EO) technologies for the sterilization of medical devices and in-vitro diagnostic products. Our CD sterilizer is […]
Team Member Spotlight: Steve Seyer, Chief Operating Officer March 27, 2023 With decades of experience in the medical device industry, working at companies ranging from start-ups to larger manufacturers, the one area Steve had never explored was the consulting side of the business. That curiosity and interest led him to Boulder iQ. “I was intrigued […]
What Does the End of the COVID Public Health Emergency Mean for Emergency Use Authorizations? February 27, 2023 I remember listening to many predictions after the Department of Health and Human Services (HHS) issued the COVID-19 public health emergency Jan. 31, 2020. None of them included that it would last for more than three years! […]
What is the Product’s Intended Use?…a Simple Question With a Big Impact on the Success of Your Regulatory Strategy February 27, 2023 You’ve no doubt heard the old adage, “measure twice and cut once.” It applies to many things, including the creation of a regulatory strategy. After 35 years in the industry, including teaching regulatory […]
Success Story: Boulder iQ Helps Hubly Surgical Assemble, Package and Sterilize Advanced Cranial Drill January 29, 2023 Cranial drilling, a widely used technique in neurosurgery, calls for precision of the highest degree in both the process and the equipment. Hubly Surgical, based in Lisle, Illinois, is the developer and manufacturer of the first and only […]
Rapid Prototyping Materials: Are They Compatible With EO Sterilization? January 29, 2023 Rapid prototyping (RP) is, yes, we’ll say it, rapidly becoming mainstream in medical device development. Defined as the technique used to quickly fabricate a physical part or assembly, RP generally relies on an additive manufacturing process – commonly known as 3D printing – […]
From the Desk of Jim Kasic December 6, 2022 December 2022…It’s hard to believe it’s been almost three years since the onset of the COVID-19 pandemic. To say the medical device industry – let alone the world – has gone through upheaval is an understatement. But as we close out the year and toward 2023, […]
Team Member Spotlight: Mike Olichney, Lead Engineer December 6, 2022 Boulder iQ’s new lead engineer is a man of principles. “I’m a first principles guy,” says Mike of his approach to engineering. Referring to the reasoned thinking that requires breaking down a problem into its fundamentals, he operates on the basis that things should work […]
Manufacturing Strategies for Start-ups: Start Flexible. By Jim Kasic, Founder & Chairman, Boulder iQ December 5, 2022 Your medical device may have the potential to be groundbreaking, life-saving and marketable. But it won’t be any of those things unless you can manufacture it in a way that gets it to the market as quickly as […]
Melinda Sogo, Directory of Quality October 20, 2022 Think of quality management as a logic problem. That’s the key to Melinda Sogo’s approach. Much of quality management is about taking apart a regulation and figuring out how to meet its requirements in the most cost-effective way, she says. “It’s a logic problem: finding the intersection […]
