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.


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…

Valuation Strategies for Early Stage Medical Device Companies (Part 1)
April 25, 2021


Hopes and Dreams

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…

 

 

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…

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,…

 

 

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…