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.
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…
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…
