Activate Your Practice Podcast
Activate Your Practice Podcast
Navigating Medical Device Regulations: A Vital Conversation with Markus Gee on Chiropractic Compliance
Unlock the secrets to ensuring your chiropractic practice stands on the solid ground of regulatory compliance. As I, Dr. Arlan Fuhr, sit down with Markus Gee, Axeon Corporation's sage Director of Medical Device Division, we pull back the curtain on the often-neglected realm of medical device regulations. Our enlightening conversation promises to arm you with the knowledge to discern the risks of counterfeit devices and the profound importance of using licensed, safe, and effective equipment. Venture with us as we dissect the intricacies of the FDA's 820 quality system regulations, ISO 13485 standard, and the game-changing MedSAP certification.
Amidst this regulatory deep-dive, we pause to celebrate a historic moment for chiropractic care—Activator Methods' landmark achievement of securing the first 510K approval from the FDA. This trailblazing success not only stands as a testament to quality and innovation but also serves as a clarion call to the importance of rigorous compliance and quality assurance in our field. With Markus Gee's expert guidance, we share insights from our recent BSI audit triumph and reflect on the unwavering dedication and investment required to supply top-tier, research-backed chiropractic tools. Be inspired to hold your practice to the highest standards, ensuring the certifications of your instruments are not just a matter of legality but of patient care excellence.
Welcome to the Activate your Practice Podcast. I'm Dr Four. Take data, always win, always twist Hi. I'm Dr Arlen Four, coming to you today with a podcast Activate your Practice. Today we're going to talk about something that people do not talk about very often. That's medical regulation and why it's necessary. Today in the studio we have Marcus Guy, who is the Director of Medical Device Division of Axion Corporation, and you might wonder why do we have somebody in the area of compliance that we're interviewing today and talking about today? We want you to know that when we put out an activator, there's a lot of things that go behind just being allowed to sell it and the things that are necessary to keep all of the regulations intact. And so Marcus is an expert in that area and we've gotten to know him over the last three years and he has been so helpful to us to bring activator to the standards we're going to talk about today. So, marcus, welcome. What are the medical device regulations and what are they for?
Speaker 2:Well, thanks for having me and let me see if I can answer that question. What are the medical device regulations? Here in the United States we have what's called the FDA, and the FDA has specific regulations for medical devices. It's not just for food, but it's also for medical devices and cosmetics and they have a specific criteria in the law called 820. And 820 is the quality system regulations for good manufacturing practices for medical devices. So those companies who manufacture medical devices here in the United States or bring product in to sell in the United States, they've got to be able to manufacture and show compliance to that law. So that's the FDA. There's also similar laws in Brazil, australia, canada, europe and throughout the world. Those are what's called the law. We just can't navigate around the law, or then we're selling and distributing devices that aren't legal.
Speaker 1:Now I'm looking down here at the different types of laws, and there's a thing here that's called an ISO 13485. Is this the world recognized gold standard? It is.
Speaker 2:In fact the United States is moving towards the FDA, is moving towards combining the 21CFR 820, the law and complying also with the 13485 ISO gold standard for manufacturers. It allows us to be able to tell our device worldwide if we get certified to that 13485 certification.
Speaker 1:So if you don't have a 13485, the FDA approval will mean nothing in the distant future, or?
Speaker 2:near future. I should say that is correct.
Speaker 1:Now MedSAP. These are all terms that I had to learn and get familiar with, but what is a MedSAP certification announced to the world?
Speaker 2:Good thing you asked that one. Medsap is an acronym that stands for Medical Device Single Audit Program, and so there are five countries that have joined together so that there is one universalized auditing program or, if you're looking at FDA language investigation program to make sure that medical device manufacturers are following the law, and so that single device audit system is called MedSAP, and the countries that were involved in that were Australia, Brazil, Canada, Japan and the United.
Speaker 1:States. So why do countries have medical device regulations?
Speaker 2:The main reason why they have those medical device regulations is so that the devices that are manufactured and then distributed throughout at least the United States and throughout the rest of the world is that they meet the required medical device manufacturing quality standards. There are counterfeits out there and people piggyback and they try to sell these devices that aren't legally approved and activator methods. Devices are legally approved in the countries that they're being sold. They are actually licensed, so that following those regulations means that the devices are also safe and that we have evidence that they're safe, that they're effective and that we have evidence of their activity and that they're licensed and that they're able to be distributed in those countries. And one of the big ones is if we're following the law and the devices are licensed, it helps the countries maintain to eliminate counterfeit devices that might flow into their countries for distribution.
Speaker 1:Well, you know the thing you said here proven to be effective with evidence. We've worked about 30, some years now to have 150 plus peer reviewed papers, and all of this is necessary to be MedSAP approved and get your ability to sell throughout the world. Is that correct? That is correct. You know why has activator methods chosen to follow the regulation? I guess it's the law right.
Speaker 2:That is basically it. You're following the law, and so you can come to work and sell your devices throughout the world and know that you have a safe and effective device that is legal and licensed in the countries where you're selling it.
Speaker 1:What are the benefits of having an ISO 13485 and MedSAP?
Speaker 2:Great question. It helps to ensure consistency in the manufacturing method of the device. So the company, when we're distributing products out there, that we know that we're selling the top quality devices that are legal, their license, their safe, high quality, effective and that they're reliable.
Speaker 1:You know, we just, as a matter of fact, went into another room here and we were looking at some of the knockoffs that come off the internet and it was amazing to me the junk that's out there. And so I would say to every student of chiropractic that's just getting started and so forth, be sure that you check with the manufacturing people to see if they have an ISO 13485 or a MedSAP. You know certification and you can check us. You can call them. They'll be happy to tell you that we're certified. But I mean, just be careful of some of the things you get, because if you get sued, you know you're going to have a problem if you haven't got a piece of equipment that's certified.
Speaker 2:And that makes it a lot more challenging to show that the devices that you're using in your practice are approved devices that are going to be safe and effective.
Speaker 1:And what benefits do customers experience from having a certified quality system?
Speaker 2:Well, the devices they're going to perform, and they're going to perform as they are intended because they're built to consistent quality standards through the quality management system process. Another benefit that the customers reap is they're going to have consistently high quality devices and the devices they're legal, they're licensed and they're approved to be distributed and used in those particular areas and, ultimately, in the person's practice. And that activator methods. They were one of the first ones. They were the first ones to have a 510K for these types of devices. So that is a very powerful message that everything that's following is following what activator methods has put out originally.
Speaker 1:I remember when we got that 510K we were all celebrating and about five years later somebody came in with another 510K and they said activator one was the predicate device. In other words, we had done all the work to get it approved by the FDA and then people start following in our footsteps, which is that's a normal process. It is. But, marcus, we've come to know you and appreciate you because you have saved us through this whole period of time with the audits. As a matter of fact, we just finished an audit today from BSI. What's BSI stand for?
Speaker 2:BSI I don't know actually what the acronym stands for, but it is a worldwide recognized notified body and what they do is they come into organizations like activator methods and they audit the quality management system to make sure that we're following the law and the appropriate standards.
Speaker 1:They're the biggest in the world too? They are, yeah, and so that's why we chose them, because we wanted to sell and distribute throughout the world, and this is the way we could go through it. So I put this out today because I thought it would be interesting for students especially to know that you might complain when you pay so much for an instrument, but it takes a lot of money to keep the regulations all correct so that you have an instrument that is effective, backed by research. And so, marcus, thank you for bringing us up on all of the latest things in the regulation world.
Speaker 2:Thanks for having me.
