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 […]
Maximize Your Purpose September 21, 2022 Ask Joanne Rupprecht why she decided to take the next step of her career at Boulder iQ, and you’ll get a response you may not be expecting. “It’s all about helping people maximize their purpose,” she says. “I’m all about breaking down obstacles, eliminating fear, and paving a […]
4 Tips to Reduce EO Emissions Today Boulder iQ looks at the EO issue from the product side in light of recently released EPA report September 21, 2022 Peggy Fasano, COO, Boulder iQ The U.S. Environmental Protection Agency (EPA) recently published a list of ethylene oxide (EO) sterilization plants around the country that may be linked […]
Medical Device Packaging Labels 101 Originally published on Med Device Online, March 16, 2022 Peggy Fasano, COO, Boulder iQ Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet of human factors design, and even the rigor of testing. […]
How to survive an FDA inspection! Part 2. Larry Blankenship, Director, Boulder iQ Surviving an FDA Inspection Part 2 In Part 1 we discussed the key logistics involved with the FDA visiting your facility and the types of inspections they might wish to perform. Initial inspections, routine inspections and Quality System Surveillance Inspections are the […]
How to survive an FDA inspection! Part 1. Larry Blankenship, Director, Boulder iQ It’s a Friday, late morning or early afternoon. You’re in the conference room with a few other executives of your medical device company. Also in the room is an inspector from the US Food and Drug Administration, the FDA. The inspector showed […]
Is it a Business, Engineering, or Regulatory Decision? Larry Blankenship, Director, Boulder iQ Is it an Engineering, Regulatory or Business Decision? After being in the medical device industry for over 30 years and consulting for hundreds of clients over the last 10 years it’s amazing how often medical device developers get confused about what kind […]
