July 23, 2020 Blog Post
Emerging Medical Device Companies
An FDA Compliance Roadmap – Part 1
This is a new blog series for all those emerging Medical Device Companies out there. I hope you find some good nuggets to help unravel some of the confusion and complexity in what you need to do. There will be four parts in this series. Each part will focus on one of the four hurdles that every emerging medical device company will need to clear in order to be successful.
Let’s start with the basics of understanding what a medical device is. Simply put, a Medical Device is:
Any device intended to diagnose, cure, mitigate, treat, or prevent disease
Any device intended to affect the structure or any function of the human body
Does not achieve any of its primary intended purposes through chemical action within the body
Is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
That means that “Medical Devices” not only make up a sizable portion of the FDA regulated products out there but also account for the most diversity among those products. Over the course of this blog series, we will review the four phases through which every Medical Device company will need to successfully progress in order to get their product on the market. The four phases are:
Today we will focus on the Idea Phase. The Idea Phase is the phase you enter once you have the idea for a medical device. If this is your first device, the most important thing you can do is become knowledgeable of the industry and the regulatory requirements. I have seen countless promising products never make it to the market because the inventor/company simply didn’t understand the criticality of taking some simple steps to ensure success.
Below are some actionable tasks to help you become knowledgeable.
Research the Medical Device industry – Begin to understand the FDA-defined product classifications and risk categories. Learn how the risk categories are linked to the regulatory submission pathways of Exempt / 510k / PMA / De Novo. Find out the differences between Clinical Trials, Non-Clinical studies, and Simulated Use testing. Then, take that knowledge and apply it to your product.
Find Similar Products – You may already know some of your competitors that already
have clearance or approval from the FDA. Start with them. Research your competitor’s product claims, compare the features, functions, and clinical value to your product. Are they similar? If so, look up the competitor’s product on the FDA’s website and try to find their product code. This is a code the FDA assigns to a group of products that are similar. If you are able to find “substantial equivalence” (SE) between your product and theirs, your regulatory submission process will be much easier. The FDA calls a product already on the market that is substantially equivalent to yours a predicate device. This predicate device is what you can leverage in your own submission to the FDA.
Read the Regulations – No one gets excited about reading regulations; however, skipping this step will cost you a great deal of time and money in the long run. The regulations lay out the minimum requirements for how you need to organize your company, design your products, and details what you need to do to stay in a state of control. Even if you plan to get regulatory experts to help you, nothing beats first hand understanding of the requirements.
Read Warning Letters – this may seem like an odd step but it is your opportunity to learn from other’s mistakes and also gives you an opportunity to evaluate the areas of particular focus for the FDA. If you read enough Warning Letters, you will begin to see patterns and it will help you avoid the mistakes of others.
Set Realistic Expectations & Timelines – this one is likely the biggest of them all. Far too often, small companies call us too late to meet their original commercialization date simply because they don’t understand the lengthy timelines to get through all of phases. As an example, a Traditional 510(k) submission (most common) takes approximately 176 days to complete. A PMA takes around 352 – 432 days to complete. If you haven’t started planning early and haven’t built these timelines in early, your market launch will be delayed which will cost you time to market and money. And you’ll have to explain this to your early investors.
In Part 2 of this Blog series, I will breakdown the hurdles in the Research Phase. I’ll lay out actionable steps that will propel your business forward while preparing you for operating within this highly regulated environment.
As always, thanks for reading! Stay safe and be well!
Thoughts? Please comment below …
CEO and Principal Consultant
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