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.

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.

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 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.

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….

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…

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

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…

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…

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…

Team Member Spotlight: 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…

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.

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…

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…

From the desk of Peggy – 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…

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…

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…