FDA approvals are complicated, but some products are more complicated than others. In the case of combination products, those that utilize a device and drug together, approvals become very complicated. What’s the problem with these combination devices? They need to be auditable together and able to transfer to a clinical setting.
Roadblocks During FDA Approval
Medical device developers often make common mistakes during FDA approval. Combination drug and delivery devices are notorious for their challenges during the approvals process. Drug and delivery systems are under an even heavier level of scrutiny and have an exponentially higher cost. With these facts, it’s important to know the common challenges that these systems will face during each stage of development–and the approvals process is no different.
Problems with Device and Drug Combination Products
Perhaps the most pressing issue is that both the delivery device and the drug in your system must be auditable together. It is a common misconception that these two separate entities can be evaluated separately. This makes the approvals process an all-or-nothing game, with an extremely narrow margin of error across two products.
Additionally, developers can face other challenges during this stage like clinical verification. Successful implementation of your product is much different in a clinical setting. A lab setting allows you to control for a variety of variables that will change in a clinic. Your system must be capable of transferring to a clinical setting, or you risk needing to redesign it entirely.
Using Expert Help from Minnetronix
With so much that can go wrong during the approvals process for these combination systems, working with an expert saves you time, money, and effort. Minnetronix Medical offers unparalleled expertise in combination device and drug delivery products. To see what a partnership would look like with us, contact us to learn more.