Over the past several years, we have had the opportunity to meet with and work with so many individuals and types of companies within the medical device industry. From the inventors, to the doctors, the nurses, and eccentric entrepreneurs who have had ideas to support life and save lives. From the large multi-nationals, to the growing regionals, the small businesses, the mom-and-pop, the supporting service providers, and the startups. It continues to be ups and downs, and we are enjoying our role within the medical device industry.
Creo Quality focuses exclusively on the medical device industry. The businesses we work with are typically either established or aspire to become established medical device entities in some form or fashion. Many are registered with FDA as such (or eventually will be). In all cases, though, the clients we work with are consciously and deliberately medical device companies.
And yet, I continue to be surprised that some of the medical device clients we have worked with over the years seem to be ill-informed about the expected behaviors of a medical device company.
Let me give you a more specific example.
FDA has specified the Quality System Regulations in 21 CFR part 820. Part 820 lists the specific regulations that medical device companies MUST follow. These are the “rules”. You might think that a medical device company would know, or at least be somewhat familiar, with these FDA regulations. In some cases, though, you would be very, very wrong. In some cases, medical device companies are very unaware of the FDA QS regulations. No quality system in place. Constant push back when advised about the regulations.
When this happens, I have been confused? Did the company not fully realize what they signed up for when they decided to be a medical device company? Did the company some how conclude that the FDA regulations were suggestions and not necessarily applicable to them and their business? To this day, I do not know.
I’ve often speculated that this line of thinking is sometimes reinforced every year the company goes without a FDA inspection. Which is dangerous and reckless! Medical device companies are all on a schedule to be inspected at some point in time by FDA. Theoretically, this is supposed to happen every few years. If you are a medical device company that is registered with FDA, you will have a FDA inspection some time in the future.
And you should ALWAYS be ready for this. It could happen tomorrow. FDA does not have to tell you when they are coming! I’m not trying to strike fear. Actually, quite the opposite. I’m giving you a heads up that now is the time to get prepared (by the way, we help companies with FDA-preparedness).
When we have gotten push back on the need to implement a FDA-compliant quality system, we do our best to demonstrate the business case behind doing so. I don’t like pulling out the “you have to because it is the law” card. No one likes to do things because they are forced to. And sometimes the companies we work with are resource tight and strapped. They don’t always have the extra manpower to put the parts and pieces in place. They often don’t have the money to spend on hiring outside resources to help either. This is a tough scenario. But consider the alternative. What would it cost you to have the FDA come in for an inspection and identify numerous non-compliances that you must address? Trust me, it is much, much more than hiring someone to come in to assist.