The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One Part 1: Timing considerations Jim Kasic, Founder & Chairman, Boulder iQ Ah. The Q-Sub. The FDA loves Q-Sub meetings, manufacturers love to get FDA input and they’re free. What’s the issue? There is no issue – when product developers use […]
Unpacking Contracts: Fixed-Bid or Time and Materials We have many clients who come in asking if we do fixed-bid or time and materials (T&M) for our proposals. Now the simple “consulting” answer is that it depends. Fixed bid and T&M have a time and place where they work best. Fixed-bid contracts are exactly like they […]
Animal Study Mishaps: How to Prevent Mistakes Introduction Animal studies are an important aspect of any medical device product development program. Animal studies provide data and evidence needed for development and regulatory submission. It can illustrate the performance and efficacy of the device in a live biological system. The study can also provide evidence on […]
How to survive an FDA inspection! Part 2 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 most common. The FDA publishes […]
How to survive an FDA inspection! Part 1 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 up the previous Monday for […]
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 […]
