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 […]
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 […]
