Is it a Business, Engineering, or Regulatory Decision? Is it an Engineering, Regulatory or Business Decision? 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 get confused about what kind of decisions they must make; […]
Second Sourcing EO Sterilization: From the desk of Jim Kasic 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, foot or horse. If anything went wrong, we were going to be […]
Great is the Enemy of Good – Be Smart With Your Startup! 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 level – from a back-of-the-envelope notion into real product development. You know the process. You have a Quality System […]
FDA’s Breakthrough Devices Program 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. The Orphan Product Designation grants special status to a drug or biological product to treat a rare disease or condition. Emergency Use Authorizations during Covid […]
3D Printed Models Can be Misleading 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 package, send the file to a 3D print shop (or your own 3D printer) and voila! You take your […]
Designing Packaging for Sterilization INTRODUCTION 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. Packaging keeps the product sterile and safe prior to use. A terminally sterilized medical device is a […]
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 out to be a significant year of growth for us in the services we are able to offer our clients.
Valuation Strategies for Early-Stage Medical Device Companies (Part 2) Step 4: Find Comparables – Learn From Them and Use Them 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? What comparisons can you make? I was part […]
Tips to Make Your Company More Investable 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. In order to reach that wonderful day when you are revenue positive and self-sustaining, you have to […]
The New EU: IVDR (In Vitro Diagnostic Medical Devices Regulation) and Economic Operators Mike Andrews, Ph.D., Vice President, Regulatory and Quality, Boulder iQ Introduction 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 May […]
