The Boulder IQ blog provides articles and whitepapers that are related to diagnostics and medical devices. We cover topics from sterilization, regulatory, product design and development, manufacturing, methodology, and more. We are excited to share our thoughts with you and hope you find them helpful.
What the New EPA Ruling on EO Emissions Means for You – and What to Do
March 20, 2024
Last week, the U.S. Environmental Protection Agency (EPA) announced a rule that will put in place the strongest measures to date for ethylene oxide commercial sterilization facilities – a rule that has medical device manufacturers worrying about their future sterilization options.
Conversations to Connections: Delving into Enthusiasm and Sterilization Solutions at MD&M West 2024
March 14, 2024
Earlier this month, Boulder iQ exhibited at the MD&M West trade show in Anaheim, California. For three days, I was surrounded by some of the most interesting, innovative people and companies I’ve met in the medical device industry. I came away with new relationships, new ideas and new insight into the best of the medical device world.
From the Desk of Jim Kasic
Looking Back, Looking Ahead: Years of Explosive Growth
December 20, 2023
I think most businesses would agree it has been an interesting year, and here at Boulder iQ, it’s no exception.
Coming out of the COVID-19 pandemic, we’ve seen that the market has turned sharply upward. In the medical device space, companies are ramping up investment, even with inflation. For us, that has meant one word: growth.
Photo courtesy of RESI Conference.
Beyond the Booths: Enthusiasm for In-Person Events
November 29, 2023
With in-person events back in swing, I’ve had the opportunity to attend some key industry conferences over the past few months. What I’ve observed: enthusiasm, heightened interest in sterilization options and a still-in-process transition to the in-person platform.
Walking the Talk at Boulder iQ
Jeremy Anderson, Director of Business Development
September 19, 2023
Plenty of companies in industries ranging from banking to grocery claim to be one-stop shops. Medical device product development is no exception.
“Yet there are very few that actually are what they claim,” says Jeremy Anderson, Boulder iQ’s new director of business development. “And that’s why I came to Boulder iQ.”
Med Device Online: Biocompatibility Testing Tips to Speed Your Medical Device to Market
August 31, 2023
Mention biocompatibility testing to a medical device developer, and you may evoke expressions of fear and terror. In truth, biocompatibility testing can be complex, time-consuming, and expensive.
Design and Engineering Services: Bringing Medical Products to Life
August 31, 2023
At Boulder iQ, we know that every company and every product is different. What’s the same? Creating products that are commercially successful.
August 31, 2023
If you’ve ever been camping – or been to a circus – you know that the longest pole in the tent is what holds everything up. Without it, the tent becomes unstable at best and fails at worst. The concept applies directly to project management…
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.
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…
The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One
Part 2: Planning for the Meeting(s)
March 27, 2023
The FDA does not limit the number of Q-Sub meetings a company may request. Between that and the fact that there’s no FDA charge, it can be tempting to mismanage the opportunity….
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…
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…
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…
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…
2022
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…
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…
Manufacturing Strategies for Start-ups: Start Flexible
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…
4 Tips to Reduce EO Emissions Today
September 21, 2022
Boulder iQ looks at the EO issue from the product side in light of recently released EPA report.
Medical Device Packaging Labels 101
March 17, 2022
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 Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One – Part 1
March 3, 2022
Ah. The Q-Sub. The FDA loves Q-Sub meetings, manufacturers love to get FDA input and they’re free. What’s the issue? There is no issue – when product developers use the program well…
Unpacking Contracts: Fixed-Bid or Time and Materials
February 24, 2022
We have many clients who come in asking if we do fixed-bid or time and materials (T&M) for our proposals. Now the simple “consulting” answer is that it depends. Fixed bid and T&M have a time and place where they work best…
Animal Study Mishaps: How to Prevent Mistakes
February 10, 2022
Animal studies are an important aspect of any medical device product development program. Animal studies provide data and evidence needed for development and regulatory submission…
2021
Is it an Engineering, Regulatory or Business Decision?
December 13, 2021
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…
Second Sourcing EO Sterilization: From the desk of Jim Kasic
December 1, 2021
I’m a pilot. My son and I flew to the Sawtooth Mountains over Labor Day to do a 4-day backpacking trip. The air strip that we landed on is only accessible by plane…
How to survive an FDA inspection! Part 2
November 15, 2021
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…
How to survive an FDA inspection! Part 1
November 1, 2021
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…
Great is the Enemy of Good – Be Smart with your Startup!
October 18, 2021
Things are looking good! You’ve raised some money for your new medical device startup and are ready to take your idea to the next…
FDA’s Breakthrough Devices Program
September 9, 2021
To its credit, the FDA has developed a number of programs to increase, or speed, the availability of medical devices, drugs, and biologics under special circumstances…
3D Printed Models Can Be Misleading
September 2, 2021
Things are really cookin’! Your startup got some seed funding a few months ago and your product concept is taking shape. A few quick concept drawings in a 3D drawing…
Designing Packaging for Sterilization
August 19, 2021
Packaging is one of the last stages of the design and development process for a terminally sterilized medical device, despite it being at the end, it is a critical aspect of the design…
Making In-Person Connections: From the Desk of Jim Kasic
August 5, 2021
We have some very nice conference rooms here at Boulder iQ, and they’re essentially brand new. Our new headquarters building was ready for occupancy in mid-March of 2020…
Valuation Strategies for Early Stage Medical Device Companies (Part 2)
July 29, 2021
Who else has something even remotely similar to what you are doing? Did they exit in a merger or acquisition? How similar was their enterprise to yours?…
Tips to Make Your Company More Investable
June 13, 2021
I love medical device startup companies! We at Boulder iQ work with many startups and do our best to help them succeed. Acquiring adequate investment capital during the process is critical…
The New EU: IVDR (In Vitro Diagnostic Medical Devices Regulation) and Economic Operators
June 2, 2021
The EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will replace the EU In Vitro Diagnostic Medical Devices Directive 98/79 (IVDD). Compliance with the IVDR is required no later than…
7 Factors to Consider in Selecting a Medical Device Sterilization Contractor
May 28, 2021
For medical devices, sterility is one of the most important steps in development and production. In today’s world, sterilization and the decision on selecting a sterilization contractor may be more critical than ever…
Valuation Strategies for Early Stage Medical Device Companies (Part 1)
April 25, 2021
To be an entrepreneur in the medical device field, you must have a compelling vision, a goal, a dream, a passion. But a dream without a plan is just a wish…
Avoiding Failure to Launch
February 16, 2021
A venture capitalist once said that in his experience no really good idea failed due to lack of resources. In my over 25 years of experience, nothing could…
Quick Turnaround Ethylene Oxide Sterilization
February 16, 2021
Ethylene Oxide (EO) sterilization is a method routinely used for product that needs to be sterile. EO is particularly great for products that are plastic,…
The EU Medical Device Regulation: Post Market Surveillance
February 16, 2021
The EU Medical Devices Regulation (MDR) goes into effect on May 21st. The MDR takes more of a life-cycle approach than the Medical Devices Directive (MDD),…
From the Desk of Founder Jim Kasic
February 16, 2021
2020 was quite a year! Everyone was impacted by the pandemic and associated economic challenges. At Boulder iQ we were affected as well, but 2020 turned…
Think Fast! Challenging the Phase-Gate Paradigm to Improve Time to Market
February 16, 2021
Medical device development is a regulated activity, and rightfully so. The provisions of the FDA Quality System Regulation, international standard ISO…