Our Blog
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.
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…
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…
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…
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…
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?…
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…
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 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…
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…
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…
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…
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 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…
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…
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,…
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…