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Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast.

We take a look at a few tools to help in the process and liability as it relates to on-label vs off-label use (Some really interesting points on this topic). 

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We suggest following the ISO 14971 standard which provides manufacturers with a framework to manage the risks associated with the use of medical devices. 

Another helpful guidance document is TR 24971 (Yea it’s not free, but probably worth the couple hundred dollar investments). If your product will be released in Europe, then it’s good to know the European version as well. 

FMEA is another popular risk management project tool and there are others available.

We then discuss the on-label use versus the off-label use of a product, and admittedly the whole thing is a dilemma.

From a product liability perspective, if legal counsel can show a manufacturer knew a risk associated with a product that they did not mitigate, then the manufacturer can be held to a higher level of liability.

We dive deeper into the topic as we discuss:

  • Setting a strategy regarding limiting discussion on use
  • The difference between intentional and unintentional off-label use
  • The meaning of unintentional misuse
  • Staying focused on the intended use of the product
  • When to push back with regulators

Risk management can be overwhelming if you let it.  Approach it from a process point of view and understand the documentation suggested. 

greenlight.guru is about to make following risk management so much easier, featuring a module that allows you to conduct risk management activities and integrate with design control activities all in one, cloud-based solution.

Your hosts today for the Global Medical Device Podcast,  Jon Speer and Michael Drues Ph.D thank you for listening as they continue to share how you can implement their proven strategies at your organization.


About Our Guests:

Michael Drues, Ph.D., is a prolific speaker and consultant to the medical device industry as well as being the President of Vascular Sciences.

Jon Speer is co-founder and resident “Guru” at greenlight.guru, making waves with his innovative approach to QMS software being built exclusively for the medical device community.


Transcription:

Jon Speer:

Welcome, this is Jon Speer. I'm the Co-Founder and I guess resident guru of greenlight.guru. Just a little bit about greenlight.guru; we're a software company and we're really changing the way that companies are changing their quality system. We've been doing the Global Medical Device Podcast now for a while. Today we're going to shift gears a little bit and try to make our content a little bit more conversational and a little bit more informational for you the listener.

 

 

Today I do have with me a familiar guest in our podcasts. I have Mike Drues. Mike is a prolific speakers and a consultant to the medical device industry, as well as being the President of Vascular Sciences. Mike, how are you doing today?

 

MIke Drues:

I'm well, Jon. Thank you. Nice to be with you and the audience again today.

 

Jon Speer:

Well, Mike you know you and I were talking a few minutes ago and we decided to bring this conversation that you and I were having into this podcast. The topic, loosely, today is risk management and as you and I both know people talk for days about risk management. We're going to try to narrow that down a little bit, maybe do a little bit of an introduction in to the topic and look at it from a perspective of maybe a regulatory affairs side of view, but also from a product developer's point of view as well and try to make some sense of this topic risk. Does that sound good?

 

MIke Drues:

I think that sounds great and for the benefit of the audience, I think there's two things that we wanted to highlight in this short podcast. One is just a couple quick examples of some of the tools that people use for risk management and the second is how sometimes things like risk management is diametrically opposed to what we want to do from a product viability perspective. Especially when it comes to risk associated with on versus off-labeled use of a medical device. So, Jon why don't you start us off by talking a little bit about some of the different tools that people can use and then we'll talk about the on versus off-label use liabilities.

 

Jon Speer:

Sure, I mean I think it's probably no secret today if you're in the med device industry you probably, if you haven't heard of this I'll be real surprised, but there's standard that we should all be very familiar with and that standard is ISO 14971. So, first of all this needs to become your framework for your risk management process.

 

 

There are a couple of versions out there of course. There's the 2007 version, which for the most part is the way the world is ... The medical device world is aligned from a risk management standpoint. There is a 2012 version, which is accepted in Europe and theoretically the only differences are there's a couple of annexes in the 2012 version that historically have been informative, but from a European standpoint are now supposedly not required. But, you should be familiar with those, especially if you have products going into both the US, Canada, Europe and abroad.

 

 

But, aside from that there are a couple of other tools, documents or information that you should be aware of. In addition to the 14971 there is a guidance document for that standard it's called ISO/TR 24971. It's not free, but it's probably worth the couple hundred dollars investment. Aside from that there are other tools, like FMEA, Fault Tree, Hazard Analysis and so on. It can be very, very confusing. So, hopefully today we start to shed a little bit of light on the pros and cons of some of these different approaches and some of the tools that you can use to capture your risk management activity.

 

MIke Drues:

Well, Jon that was a great overview of some of the general tools. Let me share with you a scenario that I was involved with recently, and you can talk about how these are addressed in any of those documents, if at all.

 

 

Recently, I was invited to facilitate a brainstorming session in a large medical device company where we were essential ticking off all of the risks associated with this new medical device that the company was developing. So, we were doing essentially an engineering brainstorming session and people were listing off all the risks that they could think of associated with the on-label use of this particular medical device.

 

 

Then the topic of risk associated with off-label use of the device came up and as soon as that happen, the ranking person in the room, a senior VP said, this meeting is over. Don't the door hit you in the you-know-what on the way out. I'm wondering, I'm going to leave this as a rhetorical question for you Jon, but for the audience; why do you think he said that? Then Jon, the question to you would be; what in the documents just referred to distinguishes risk from an on versus off-label use, if anything.

 

Jon Speer:

Mike, you always ask these loaded questions. I'm going to do my best and this conversation that you and I have today to not give the cliché answer of "it depends". Hopefully we can provide some tidbits and some useful information. Your story is interesting to me because it reminds me back to a prior life where we were involved with a stint product. Mike, you're familiar with stints, am I right?

 

MIke Drues:

Yup.

 

Jon Speer:

Once upon a time, well as you know getting a stint for a vascular or a coronary indication is a little bit more difficult than getting a stint for a biliary indication. But, once upon a time, every stint company in the world would release their product as a biliary stint first, knowing that anybody who is going to buy that product was going to use it for coronary or some sort of vascular indication. I'm sure that you probably were involved in scenarios or aware of that situation. It was probably about ... Gosh, probably about 15 years ago. Do you remember when that craze was in the market?

 

MIke Drues:

I have no knowledge of any conversations along those lines.

 

Jon Speer:

So, yeah, but thanks for the tongue in cheek. That was a scenario a lot of companies were faced with, especially engineers. They know that they're designing this product for an indication that's different than the clearance that they were going to get on this particular product. So, what do you do? Do you ... Do they focus FMEA or risk management activities only on the biliary indication or do they also think, huh I bet a doctor could use this for a coronary case and stinting a patient that's got clogged arteries. Should I also think about the risks associated with that use, even though it's not how I'm labeling my product.

 

 

So, you know I've kind of been a part of this a time or two from a risk management standpoint as an engineer, you know it's kind of this moral dilemma. What do you do? What don't you do? The powers that be want your product to be labeled as a biliary device, but everybody knows ... It's the elephant in the room that you don't talk about. Everybody knows it's going to be used for coronary case.

 

MIke Drues:

Well, Jon for the benefit of the audience, for those that are not quite as ... Have not been playing this game quite as long as you and I have, let me just briefly explain the reason why my friend the senior VP ended the meeting when the topic of off-label use came up. It is simply because from a product liability perspective if an opposing council can show, and I've been involved in a couple of expert testimony cases like this, if the opposing council can show that the manufacturer knew or should have known or as my attorney friends like to say, was thinking about a risk associate with a particular product that they did not adequately mitigate then you can actually be held to a higher level of liability than if you cannot. So, this is why i often say from a regulatory perspective we want to document everything, but as soon as we do from a product reliability, we want to shred everything.

 

Jon Speer:

Yeah.

 

MIke Drues:

It does sound a bit humorous to a lot of people, but that is the unfortunate reality. So, my pragmatic advice and Jon, I'd be curious to share your ... The audience what your advice would be, but my advice when I go into companies to help them with their risk management strategy, which I spend a fair amount of my time doing. At the beginning of the meeting we will agree as a group that we will limit our discussion to the risks associated with the on-label use of the product. We will not mention or talk about risks associated with the off-label use.

 

 

Of course, we will not write that down in the meeting notes. We will not make any documentation of that whatsoever. But it's a ... Not to be sexist here, but it's sort of a gentleman's agreement at the beginning of the meeting to avoid that. Believe me, from a humanitarian perspective, I wish we did not have to do that. I wish we could be honest, opened, candid and talk about this. But, Jon in a similar situation; how would you advise the audience to handle a situation like that?

 

Jon Speer:

Well, I mean it's one of those delicate topics and it's one of those things where hopefully ... I'm not naïve to think that there won't be another product case where the product that we're designing is really intended for a much more stringent, regulatory classification and type of indication for use and that somehow or another I'm going to try to find a quote "loop hole" to bring the products to marker with a lesser indication to use that I know physicians are going to use off-label. I mean, I suspect that that's probably happening in a number of other areas as well.

 

 

You raise a really good point. I think regardless what you do or do not cover during your risk management discussions in your teams, you need to define what that scope is of that discussion. You need to try to stick to that scope. A good way to start is defining here are the indications for use for this particular product. This is what we're going to stay focused on. I mean, it's an interesting way to do about it.

 

 

I think one thing that we should probably highlight too Mike, is that there's a difference between off-label use ... Intentional off-label use and unintentional off-label use. For me, I don't want the audience to be confused. If you're going through a risk management activity, failure mode, defect analysis, hazard analysis, what have you; it's my opinion that you do consider the unintentional off-label use of your product. Because people are going to use your device incorrectly, you need to be thinking about that from a risk management standpoint. Do you agree or disagree about that?

 

MIke Drues:

Yeah, absolutely Jon. Obviously the topic of off-label use is a hot topic in the medical industry, not just in the medical device industry, but in the drug side of the world as well. But, from a strict reading of the regulation versus the intent of the regulation; Jon do you think that the regulation asks people to differentiate between the two?

 

Jon Speer:

You know ... You're jogging a memory here and I don't have the document right in front, but my memory of 14971 for example, I kind of use that for my risk management. It's just ... It's my encyclopedia, I guess. Wikipedia is probably more apropos reference today. It is my go to. When I have a question about risk, I'm going to go to 14971 and I'm going to try to find a specific clause within that standard it tends to support. But, my memory says that 14971 does talk about unintentional misuse as something that you should consider as part of your risk management process. I believe they do use the term misuse. But, I don't remember if it does specify intention misuse of your product as part of 14971.

 

MIke Drues:

Well, Jon it's an interesting topic. We could probably have another discussion about trying to equate misuse versus off-label use. I have many physician friends who would probably argue very strongly that the off-label use of a product is not necessarily misuse. On the contrary, often times the off-label use of a product, again this is not limited to medical devices, the same thing happens in drugs all the time. The off-label use of a product is actually standard of care. It's actually what we teach in medical school.

 

Jon Speer:

Yeah, but from a product developer standpoint, that's ... Boy, that's loaded. If I'm an engineer designing a product, how could I possibly this about all the ways that a doctor may conceive of using my product? I can't.

 

MIke Drues:

You can't, you're right. You can't. But, just to kind of get this close to the end because we're almost out of time in this particular session. I'd just like to share one other real quick story that was shared with me not long ago.

 

 

That is one of the companies that I work with, their CEO was doing a presentation at a conference talking about their new medical device and off script he started talking about some of the off-label uses of their new medical device. Long story short, there were a couple of FDAers in the audience. Talk about getting your hand caught in the cookie jar. But, the irony there is that every single person in the room, including the two FDAers, knew that that is exactly how that particular medical device was being used in the real world.

 

 

So, really it gets to the age old philosophical question that is; we have all of this regulation, design controls, risk management, and so on, but is it realistic? One thing that everybody in the audience should keep in mind is that the FDA does not regulate the practice of medicine. That is, the FDA cannot tell physicians what to do, the only thing they can do is tell us in the industry what to do. The simple reality is that we can put anything we want to on our label; only use our product this way, never use our product that way. Once our product leaves our door, we have no control over how it's going to be used. That's something that all of us should keep in mind.

 

Jon Speer:

Absolutely, and it's just as a product developer my job is to make sure my device is safe. What does safe mean is sometimes a difficult thing to answer. You certainly have to consider how the product is going to be used and how you intend for it to be use and make sure the product is safe. Risk plays a big part of that. To think that a device you're going to develop is somehow absolved from risk is ludicrous.

 

 

Everything we do every day carries some risk. My short example is; most of us get in a car and we drive to places every day. We don't think bout it, we just do it. We accept that risk. Then, we all know somebody who's afraid of flying. The person who's afraid of flying somehow equates that getting on an airplane is riskier than getting in a car. They drove to the airport chances are. You know, we all know if you look at the statistics involved that flying is much safer than driving. There's a much greater likelihood that we're going to have some sort of accident in a car than we will in an airplane.

 

 

When we think about risk in that context it's very important to consider that everything that you do, including your medical device, it is going to have some risk involved. So, having a practical, pragmatic approach of identifying those hazards, the harm, assessing the severity and the likelihood of risk and so on and so forth. It can be overwhelming, but if you stay focused on the intended use of your product and keep safety in mind, then I think at the end of the day, you're on the right track.

 

MIke Drues:

Well, that's a good point Jon. I'll just wrap up my section of this discussion by offering two pieces of advice for the audience then Jon I'll let you have the last word. First, as I said earlier, when it comes to risk management in the design control sense of the word, my recommendation is to limit your discussion. Not just what you talk about verbally, but certainly in writing as well, to the on-label risks ... Sorry, the risks associated with the on-label use of your device. That's number one.

 

 

The other piece of pragmatic advice that I would like to offer the audience is more from a regulatory submission perspective because I spend a lot of my time developing regulatory strategies and presenting and defending regulatory submissions. I've been in situations with FDA many times, where we'll present a particular medical device or drug and somebody says, well that's all well and good, but what happens when somebody starts using your product for this, which is not part of our labeling. I will simply reply, well that is not currently indicated under our labeling and therefore, we don't have any information on that.

 

 

Usually that's enough to make the reviewer's question go away. If they persist, and occasionally it's happened, I will be a little more resistance, a little more forceful. I will say, look that is not on our labeling and useless and until we as an industry and as well as FDA are willing to sit down and have an intelligent conversation as to whether or how FDA should regulator the off-label use ... Sorry, regulate the practice to medicine, something that I personally do not advocate. It is not fair for FDA to hold me, a manufacturer, to a higher level of scrutiny than any other medical device company or for that matter any other company in this industry in general.

 

 

Bottom line, there is no more of a fan of communication, there's no bigger advocate of communication with FDA than I am, but on the other hand I will offer the appropriate resistance when I think it's necessarily. So, those are the two things that I think I wanted to leave the audience with. Jon, I'll give you the last word, then we'll wrap it up.

 

Jon Speer:

Alright, sounds great. You know, I just want everyone to realize that risk management can be overwhelming if you let it ... Approach it from a process point of view. I don't mean to sound like a broken record, but ISO 14971 as far as standards are concerned, it's one of the better ones that you're going to come across in the med device industry, in my humble opinion. There is steps that are outlined, it gives you kind of a breakdown of a step by step process from a risk management standpoint. So, use that as a guide. I can't emphasize that enough.

 

 

One of the things ... My final word is, we've been doing these podcasts as a way to inform you and you know it's powered by greenlight.guru. Greenlight.guru is about to change the way that you do risk management. We've got a new module that's available that allows you to easy conduct risk management activities. That is going to comply with 14971 and it's also going to integrate with your design control activities and it's going to allow you to keep your risk management file alive throughout your entire product life cycle.

 

 

Be sure to check us out. Our website is greenlight.guru. You can also visit Mike, he's available at LinkedIn. You can check him out on a number of other industry publications. He's ... Search for Mike Drues. That's D-R-U-E-S and you'll come across some wonderful content, podcasts and other information from Mike. Without further ado, thank you for listening in to the Global Medical Device Podcast. Thank you Mike for being the guest today. I will look forward to having a conversation about risk or design control or some other pertinent topic to the medical device industry in the not to distant future.

 

MIke Drues:

Thanks Jon. It was a pleasure to be with you and your audience as well. I look forward to speaking again soon.

 


About The Global Medical Device Podcast:
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 The Global Medical Device Podcast powered by greenlight.guru is 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.

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Read the Definitive Guide to ISO 14971