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.

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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.

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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.

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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.”

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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.

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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.

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

The Longest Pole

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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.

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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….

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Hubly Surgical

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…

2022

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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.

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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?…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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,…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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),…

Boulder iQ, Boulder Sterilization, Jim Kasic, Ethylene oxide, chlorine dioxide sterilization, life science products, regulatory services, product design, medical device

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…

Challenging the Phase-Gate Paradigm to Improve Time to Market

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…