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It’s time to recap what happened in the medical device industry this year and start to think about what’s expected to happen in 2019.
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
The last half of 2018 has been pretty exciting - a lot of news on the regulatory front.
(Wearable medical devices) This is the beginning of a trend, I think.
EU is going to be probably one of the most, if not the most challenging markets for medical device companies in 2019.
Part of (FDA) their mission is certainly to ensure and promote the health of patients. But they’re also very interested in innovation. They’re trying to be progressive.
Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Jon Speer: Hello and welcome to a special episode of the Global Medical Device Podcast. It's special because... Well, I wanna recap the year 2018, talk about some things that have happened, but also start to think about some of the things that I expect are going to happen in 2019. And yeah, folks, it's just gonna be me today, so I hope you enjoy this. But first, I thought I'd look back on the year 2018, and if you remember back toward the beginning of the year, we put out a post at Greenlight Guru five predictions for the medical device industry in 2018, and the first one... Let me just do a brief recap of all of those and see where we stood, what really happened on those predictions. The first prediction that I had is it's going to be harder for medical devices to get to market and stay in market in the EU. And I would say that, unfortunately, there wasn't a lot of clarity that was provided in the year 2018 on that path, the new EU MDR and IVDR path. So it's still pretty confusing, still a lot to be done, and a lot more clarity, hopefully, that will come in 2019. We'll talk more about that here in a few minutes.
Jon Speer: Number two, there's gonna be a mad dash update, ISO 13485 certification before the deadline, and yeah, I think we saw a lot of that happening, we saw auditing organizations that were being booked, and resources constrained and all that sort of thing. But I don't know that everybody's got through the queue that wanted do, but I know there's been a lot of progress on that. And yeah, there was a lot of people that came late to the party on that, but that seemed to move along pretty well. Number three, ISO 14971 will be revised for industry comment. Yeah, that happened in about September, October-ish time frame, there was a draft version of ISO 14971 that was out for comment. Everything points to this being revised in 2019. Again, I 'll talk a little bit more about that in a bit as well. But the good news, from what I saw on the draft standard, a lot of commonality from the existing version, some subtle changes, some things that will be a little bit more specific, but by and large, I believe it's gonna be, for the most part, stay the course with risk management. We still have a lot of work to do on that, as an industry anyway.
Jon Speer: 2018 prediction number four was Health Canada will back off on MDSAP deadline. I really thought that was gonna happen because of the constraints that this would provide for a lot of companies. Now, bigger companies, the MDSAP criteria didn't seem to be a real constraint. Smaller companies, I've heard a lot of anecdotes from small and mid-sized companies that this is a challenging thing for them to consider. And Health Canada has pretty much stuck to their guns on this, they didn't really back down. And the fifth prediction for 2018 was medical device companies shift from compliance-focused to quality-focused. There's been some movement there. I still think we have a long, long way to go. Case for Quality Program is a good example, but we're still at the very, very cusp of this shift because, frankly, folks, a compliance-focused approach has been sort of ingrained into us as medical device professionals for a long, long time. So we're trying to shift that. I know FDA is very, very proactive on that. But anyway, those were the predictions for 2018.
Jon Speer: And before I transition to talk about some of the predictions for 2019, I just wanna remind you all that Greenlight Guru, we're the only EQMS software solution that's designed for the medical device industry, specifically and exclusively for the medical device industry, and it's been designed by medical device professionals, so people that are going through and dealing with the same challenges and issues that you're faced with as medical device professionals. Those are the people that have designed the Greenlight Guru platform. So if you wanna see something that's refreshing, improve your quality as a medical device professional, help you shift from being compliance-focused to quality-focused, I would encourage you to go to www.greenlight.guru to learn more.
Jon Speer: Alright, so let's get on to the six predictions that I have for the medical device industry in 2019. And there is a blog post that goes into some more detail about this, but let's just say the last half of 2018 has been pretty exciting, a lot of news on the regulatory front, and I'll talk a lot about this as we go through these predictions. The first prediction is that wearable medical devices will become more common. And this happened earlier this year where we saw Apple was granted two different de novos for the Apple Watch for EKG monitoring. I think we're gonna see... This is the beginning of a trend, I think, and I would say, kinda add a twist on the wearable devices becoming more common. I think the other thing that we're gonna see are the influx of a lot of traditionally non-medical device companies, consumer good companies, start to enter the medical device market; certainly, Apple being one, there are others like, Fitbit is one that often comes to mind, especially when you start talking about Apple Watch, and things like that.
Jon Speer: But even companies like Bose, they quietly have a device that went through FDA processes on hearing aids, and I think there will be a lot more of companies that we haven't normally referred to them as med device companies, but I think they'll start to enter that. And the wearable trend is very, very hot right now. And FDA has a guidance document on general wellness devices. So there is a distinction between general wellness and medical device. Do refer to their guidance document. It does provide quite a bit of clarity. But I think we'll see a lot of companies in the wearable space start to make that shift.
Jon Speer: 2019 prediction number two: EU MDR challenges. As I mentioned in the beginning of 2018, one of my predictions is, it's gonna be more difficult to get products to market in the EU, and unfortunately, that one sticks around. It's no clearer today, in my opinion, on how this is gonna work, and who's going to be available to help get products to market in the EU. It's no clearer today than it was a year ago, quite frankly, maybe a little bit, actually, clearer, but generally speaking, it's still very confusing. We're very much into that three-year transition for EU MDR. I believe we're about a year and a half in, so about the halfway mark. IVDR has a little bit longer, but still, there's a lot of work that's gonna be done.
Jon Speer: And the interesting thing for me is, in my career, 20-plus-year career in the med device industry, I've seen sort of this flip-flop. It used to be largely perceived that going to market in the EU would be quicker and easier, not 100% across the board, but there are certain, definitely a certain device categories and segments where it would be a lot easier to get clearance in the EU versus like FDA. And I'll talk more about this here in a moment, but we're seeing basically that flip-flop. FDA is being a lot more progressive on some of the programs, some of the ways to get to market. And like I said, I'll talk about that here in a moment, but EU is gonna be probably one of the most, if not the most challenging markets from med device companies, certainly in 2019, unless something dramatically changes.
Jon Speer: Prediction number three, yes, we will see an ISO 14971 revision. I don't know the exact time frame. My gut tells me it's probably gonna be sometime in the... Around mid-year. I don't know that for certain, but we should expect to see a new revision. So be on the lookout for that. The next prediction, FDA QSR harmonizing with ISO 13485:2016; this is some of that news that we've been hearing from the FDA this year. FDA announced several times, I actually just saw something just a couple days ago, about their interest in moving away from 21 CFR Part 820, the QSRs, in favor of ISO 13485. And I know there are a lot of people out there that are like, "This probably isn't really gonna happen," but I believe it will for a lot of reasons, not the least of which are the efforts that FDA has put into MDSAP, Case for Quality, and a lot of the other initiatives. I think this is gonna happen much faster than most people might think. So I would expect in 2019, we'll start to see that transition plan be somewhat defined, and that transition period somewhat articulated as well. But folks, do start to prepare yourselves for this 'cause I actually do believe this is coming.
Jon Speer: The other thing that I think is interesting about this one is the... We all know about 13485; it was revised in 2016, and there's a three-year adoption period, so that March of 2019, if you were ISO certified, you need to have made that transition. And what I think is also interesting is that the ISO/TC 210 working group, and this is the group that's responsible for updating and maintaining the 13485 standard, has already communicated that they're gonna be meeting in early 2019 to talk about additional updates to that standard. So here we go again, there's this effort that's gonna be looking at 13485, possibly making some revision. Some of that work's probably gonna start in 2019, that coupled with FDA in moving from the QSR to 13485. And keep in mind, FDA does have representation as part of this ISO/TC 210 working group on the standards. So, I think there would be a lot more to come on that as well.
Jon Speer: 2019 prediction number five: FDA's Case for Quality is going to continue and it's gonna gain momentum. And this is an area that I've really dive pretty deep in, just try to understand a lot more about the program. As you know, if you've been participating in any of the Greenlight Guru webinars, we've partnered with the FDA on a webinar series on Case for Quality, so I definitely would encourage you to go check that out. We're coming out with an e-book on the Case for Quality Initiative; that should be coming out here pretty soon as well. It's a fantastic program. And part of the Case for Quality, there's a lot of initiatives that are involved with this; the big one for medical device companies is this Medical Device Discovery Appraisal Program, MDDAP, and it's being performed by the CMMI Institute, is the entity that's doing this. But it's sort of a refreshing look at the health of your business. I mean, historically, the way company health has been somewhat assessed is how compliant their quality system is to the regulations.
Jon Speer: I'm not saying that compliance goes away completely, but that's not necessarily the best way to measure the health of a business. So the CMMI appraisal process, very... It's well-established, it's been in process or in place now for over 20 years, been used in a lot of different industries. It's newer to the medical device industry, but I see the MDDAP initiative being a really refreshing way for companies to assess and improve true quality within their organization. So do check that out. But there's a lot of other initiatives that are part of the Case for Quality. We've been working, like I said, very closely with the FDA and we're working very closely with CMMI Institute. We're also working with MDIC, the Medical Device Innovation Consortium. They're all working together in some of these Case for Quality initiative. So, a lot of exciting things happening there.
Jon Speer: And then my last prediction for 2019 is that we should expect the FDA to continue to shake up regulatory submission processes, and do so in a good way. We've for roughly about a year-ish or so, certainly, the last six to nine months, there have been pretty frequent announcements from the FDA about abbreviated 510Ks, and special 510Ks, and alternative 510Ks, and guidance on de novo and so on. And sort of the big news that came out from FDA on submission process happened toward the end of September, and this is when the FDA announced that they were going to modernize the 510K process, and that they were gonna refer to this new pathway as the safety and performance-based pathway. It's so big, and again, there's more details to come and you can listen to previous episodes of the Global Medical Device Podcast where Mike Drues from Vascular Sciences and I spoke or talked a little bit about what this means and how big of a deal it is. But some have called this, including Dr. Gottlieb, the FDA Commissioner, the most significant modernization of the medical device review process in a generation.
Jon Speer: So, I would expect that we will see a lot more to come on this new safety and performance-based pathway, a lot more details to be provided on this, as well as other announcements from FDA. The FDA, part of their mission is certainly to ensure and promote the health of patients, but they're also very interested in innovation, and they want to be thought of as one of the leading markets to bring devices to market as soon as possible. So I do applaud what FDA is doing. They're trying to be progressive. They're trying to be, I'll say creative and innovative in the ways that which device companies can get their technologies to the market in the least burdensome way possible.
Jon Speer: So, I think there will be a lot more to come on this, but stay tuned. But I just wanted to share with you some of the predictions from 2018, review those, and then also what I expect we should see in the industry in 2019. And for all of you, please continue to listen to the Global Medical Device Podcast. Share the news with your friends. I also wanted to let you know that we got a new podcast that's gonna be coming out in 2019, so be on the lookout for that. We're gonna be sharing some true quality stories from customers and partners and other medical device companies and resources. So be sure to stay tuned and be ready to check out that new podcast that we'll be rolling out in 2019. So, happy holidays, happy New Year, and look forward to talking to you all very soon.
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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...