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 […]
7 Factors to Consider in Selecting a Medical Device Sterilization Contractor Medical device companies benefit by evaluating additional services, scalability, green operations 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) 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. You are probably working hard at building your company, perfecting your product […]
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), which focused on the pre-approval stage of medical device manufacturing.
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 be further from the truth!
