How to survive an FDA inspection! Part 2.

How to survive an FDA inspection! Part 2. Larry Blankenship, Director, Boulder iQ Surviving an FDA Inspection Part 2 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 Surveillance Inspections are the […]

How to survive an FDA inspection! Part 1.

How to survive an FDA inspection! Part 1. Larry Blankenship, Director, Boulder iQ 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, the FDA. The inspector showed […]

Is it a Business, Engineering, or Regulatory Decision?

Is it a Business, Engineering, or Regulatory Decision? Larry Blankenship, Director, Boulder iQ 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 […]

Second Sourcing EO Sterilization: From the desk of Jim Kasic

Second Sourcing EO Sterilization: From the desk of Jim Kasic Jim Kasic, CEO & Chairman, Boulder iQ 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 […]

Great is the Enemy of Good – Be Smart with your Startup!

Great is the Enemy of Good – Be Smart with your Startup! Larry Blankenship, Director, Boulder iQ 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. […]

FDA’s Breakthrough Devices Program

FDA’s Breakthrough Devices Program Mike Andrews, Ph.D., Vice President, Regulatory and Quality, Boulder iQ 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 […]

3D Printed Models Can be Misleading

3D Printed Models Can be Misleading Peggy Fasano, COO, Boulder iQ 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) […]

Designing Packaging for Sterilization

Designing Packaging for Sterilization Peggy Fasano, COO, Boulder iQ 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 […]

From the Desk of Jim Kasic

From the Desk of Jim Kasic

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)

Valuation Strategies for Early Stage Medical Device Companies (Part 2) Larry O. Blankenship, ©2021 Blankenship Research, LLC, published with permission 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 […]