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Within the past couple of years, we have experienced significant changes in the medical device industry.
ISO 13485 was revised in 2016 and in full effect by March 2019. EU medical device regulations and IVD regulations were revised in 2017.
Medical Device Single Audit Program moved out of the pilot phase and became more common in 2018, with Health Canada requiring ISO 13485:2016 and MDSAP by January 1, 2019.
Yes, there has been a lot going on in the medical device industry as of late, and I think we’re only going to see more activities on the regulatory front as we move into 2019.
There are a number of programs and regulatory changes on the horizon, as well as technological shifts and trends. How will these impact your medical device company?
There are some things that we know are on the horizon, and being prepared early will be your best strategy. Here are some of my predictions for 2019...
#1. Wearable medical devices will become more common
A wearable is often referred to generically by the FDA as a “general wellness” device. A common example would be a Fitbit or similar fitness tracker that tells you about your step count or heart rate (yet not limited to). Apps that assess your sleep quality may also fall under this umbrella.
I recently spoke with The Verge about how Apple’s series 4 of its Apple Watch has been granted De Novo status by the FDA as a Class II medical device. This event sets a bit of a precedent for wearables here in the United States. While the Apple Watch has always had “general wellness” apps, the de novo allows this product to cross the line to be classified as a regulated medical device.
I predict that this is something that will become more common. I know of other companies that are developing wearable medical devices, and now that Apple has been cleared by the FDA, there is a visible pathway. These device contenders are often the types of products that people will buy on Amazon or through a chain store to personally monitor their health.
With Apple as the poster child, I think we’ll start to see many more of these health-related products going through similar regulatory paths to market and be sold as medical devices, creating a movement across the world.
It makes sense in a world where consumers want to be more empowered to manage and monitor their own health, that wearables could assist with those efforts. This follows a broad trend for more personalized medicine and having the ability to take health and wellness into the hands of its rightful owner--you..
Companies that decide to go the extra step to have their product be classified as a medical device understand that they will be seen in a new respectable light by consumers, who will recognize the diligence that has been taken by the manufacturer to adhere to stricter regulations.
NOTE: The FDA makes a clear distinction between “general wellness” devices and medical devices. It’s all about what you claim is the intended use for the product. The Apple Watch was considered a general wellness device, but when they added EKG and heart monitoring functionality, it changed the indications for use so that it was able to cross over as a medical device.
#2. EU MDR Challenges
I predict that 2019 is going to be a difficult year for medical devices in Europe.
Part of the challenge is that the resources - third-party notified bodies and regulatory experts - are still learning about the changes to the European Union Medical Device Regulation (EU MDR). We’re a year and a half into those changes, at the time of writing this, and still no one fully comprehends all of the specific details.
This is concerning because with only a select few notified bodies who are up to speed and have the availability, it will be challenging for medical device companies to be compliant with the new regulations.
If we look at indicators from the introduction of ISO 13485:2016, we’ve seen a huge increase in the demand for contracting services of auditing organizations for a number of reasons. By the same token, there’s been a reduction of notified bodies who have the availability to contract their services. This will create big challenges heading into 2019 for those not already certified to the 2016 version of the standard.
It’s not even 2019 yet and these valuable resources are more limited now than they have ever been before. A key factor that contributes to the challenge is that notified bodies have to go through a lengthy, formal process to be certified by the EU for MDR. At this point, very few have been through that process, compounding the scarcity of resources.
This makes it difficult for medical device companies who are trying to be proactive about meeting MDR requirements for the upcoming calendar year. There’s only so much they can do when the necessary resources are not available.
Changes to In Vitro Diagnostic Regulation (IVDR) will have an interesting impact on the industry too. As you might be aware, the transition period for EU IVDR was stated as 5 years (or by 2022) versus 3 years for EU MDR. And I know what you might be thinking: there is plenty of time to make the transition to IVDR. However, I believe this line of thinking is very flawed.
One big change causing a stir has to do with products that were previously unregulated (lab-developed tests, research-only applications etc.), now being regulated as part of IVDR. The interesting thing about a lot of these companies or products is that they weren’t initially developed using a formal QMS or design controls. Companies that fall in this category can help themselves out by making sure they have clear documentation, especially during this transition period.
Companies that realize there is a traffic jam in the EU system and work to get ahead of it now will be in a better position later on. If you’re just getting started in the first quarter of 2019, you only have a year to be compliant.
My advice is to start now if you haven’t already.
Additionally, I highly recommend you contact your auditing organization and notified bodies to better understand where they stand with the process of being accredited and recognized as a viable resource to conduct the auditing services.
#3. ISO 14971 Revision
There is a draft version of a new standard for ISO 14971 that was available for comment a couple months ago. I have been reviewing it myself to provide insight on the subject. I predict that we will see a finalized version of this risk management standard published sometime during the first half of 2019.
The good news is that I don’t expect there will be any significant changes in the verbiage or the process described within the standard. The new standard is slated to address bringing in more around connected devices, cyber security and wearables.
Surprisingly though, even though ISO 14971 has been around since the early 2000s, there are still a number of companies that have not adopted the principles of the standard. This may be a challenge for those non-adopters moving forward.
Many companies haven’t really adopted this idea of using risk management as a tool for the safety and efficacy of devices throughout the entire product lifecycle - they are still doing risk as a checkbox activity. No, a new revision of ISO 14971 in itself will not change this. Perhaps the newest version of ISO 13485 will help.
A great deal of work went into ISO 13485:2016 to include risk management, including several references to ISO 14971 and the notion of risk-based QMS. It’s important that the standards are in-sync, and fortunately, the groups that write these regulations do communicate well with one another.
#4. FDA QSR Harmonizing with ISO 13485:2016
Yes, FDA will be moving towards adopting ISO 13485 in lieu of the QSR; this has been communicated several times over the past few months by FDA Commissioner Gottlieb, CDRH Director Shuren, and others within FDA. I would expect that in 2019 the FDA will either change regulations or issue guidelines on the changeover process from 21 CFR 820 to ISO 13485.
The good news is ISO 13485 is very much in sync with the FDA’s Quality System Regulation (QSR) already. The whole idea behind this is because 13485 is constantly being reviewed in order to be the globally harmonized standard for medical devices, so it makes sense for the FDA to align with it. ISO 13485 is a little more progressive and dynamic due to the frequent updates.
The FDA has a voice in shaping the 13485 standard, with representatives in the working group. There are a number of foundational pieces that the FDA has worked on to lead the charge here as well, such as the MDSAP. With this vehicle in place, it will help to enable a likely transition.
This prediction, if it turns out to be true, will be a big shift to traditional FDA thinking. The QSR has made no updates to 21 CFR Part 820 in a quarter century, so this change would also highlight how the regulatory agency is evolving, as well.
Also related and of interest is the ISO/TC210 working group responsible for updating and maintaining ISO 13485 has also announced they will also meet in early 2019 to consider another possible update to the standard.
#5. The FDA’s Case for Quality
If you consider the things we’ve just talked about, the FDA has been exhibiting the appreciation and acceptance of new and innovative technologies, methodologies and processes.
In 2018, Greenlight Guru partnered with the FDA to help promote their focus on quality with the Case for Quality initiative. Since we launched our 4-part webinar series, we’ve seen a lot of momentum with a large number of companies joining and participating in the pilot program.
The FDA has concluded that emphasizing compliance-only for the device companies they work alongside had an inverse effect, driving bad practices which has the potential to negatively affect product safety and efficacy for device makers.
This program has been instrumental in allowing companies to put a stronger focus on the quality of the devices their developing for patients.
Expect the Case for Quality movement to increase in magnitude and importance in 2019. I predict the Case for Quality will also start to embrace more regulatory incentives and programs for Class II / 510(k) device companies.
#6. Expect FDA to Continue to Shake Up Regulatory Submission Processes (In a Good Way)
In 2018, we’ve seen quite a few updates from FDA regarding product regulatory submission processes. Throughout the year, FDA shared updates regarding an alternative to 510(k), put more emphasis on abbreviated 510(k), updated guidance on the special 510(k), and enabled breakthrough device pathway.
And the granddaddy of all was announced by FDA in late November: FDA is going to modernize the 510(k) process. This “new” approach is being dubbed the “Safety and Performance Based Pathway.”
I predict that we will learn a great deal more about “Safety and Performance Based Pathway” in 2019. The press release in November included a few nuggets of information and hints of things to come. Apparently FDA Commissioner Gottlieb stated this announcement is "the most significant modernization" of the medical device review process in a generation.
In addition to changes to 510(k) pathways, FDA is in the process of making changes to De Novo. It’s very clear that the agency is very keenly focused on facilitating ways to streamline the regulatory clearance processes. I predict 2019 will be a very exciting and interesting year for medical device companies launching products in the U.S.
Final Thoughts
The FDA has been quite clear that they’re moving from 21 CFR Part 820 to ISO 13485. There’s no strict timetable, but there are indications that we may see this shift begin in 2019. We may see some draft guidances put out by the FDA as a precursor to this, or additional pilot programs, as well. It won’t happen overnight, but I think a complete transition will have taken hold by 2020.
People may be quick to think this regulatory shift won’t move fast because of the historic, slow-moving nature of FDA, but keep in mind there are a couple of programs that already exist which would help expedite this process.
The Medical Device Single Audit Program (MDSAP) is one of the better known programs I’m talking about and has been around for a while. In fact, many companies voluntarily participate in this program and it’s even going to be the principle standard for Health Canada starting in 2019.
MDSAP is conducted by auditing organizations, the same regulators who conduct ISO audits, setting the stage for a perfect mechanism already in place to help facilitate this transition.
The FDA’s Case for Quality program is another potential vehicle for this change. The pilot has been very successful and gained a lot of momentum. This is key because, in order to qualify or participate in the program, you have to demonstrate compliance through FDA inspection.
Moving forward, I think we will see ISO 13485, MDSAP and Case for Quality all being very connected.
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