At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it?

In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software and FDA’s Clinical Decision Support Software guidance, which was released in draft form in 2019 and is at the top of the FDA’s list of priorities to be finalized in 2022. 

 

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Some highlights of this episode include:

  • According to the FDA, CDS software “provides healthcare professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”

  • As with most regulations and guidances, the verbiage used for CDS software is ambiguous and makes room for interpretation or manipulation.

  • There are a few reasons why the FDA is making CDS software important and its #1 priority. More companies and customers are or want to work and produce products in this space.

  • For now, CDS software is not regulated by the FDA due to limited resources. However, that will change when companies’ products provide wrong or inaccurate information. Nobody or not too many people have been harmed, yet.

  • According to Mike, CDS software provides clinicians as well as patients with information to enhance health and health care. Examples of CDS software include telehealth and AI platforms that ask patients questions about their health.

  • FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person - not by a device or software.

  • Make sure that CDS software properly provides accurate information because there can be major product liability implications if not regulatory ones.

  • Regulated or not, usability testing is a must. What if your software tells patients they don’t have a problem, but actually do, and wait to take care of it?

 

Links:

Clinical decision support guidance tops FDA’s agenda for 2022 (Med City News) (Oct. 29, 2021)

FDA's 2022 A-list guidance plan hits on software, post-pandemic future

CDRH Guidance: Clinical Decision Support Software (September 2019)

FDA - Medical Devices

Software as a Medical Device (SaMD)

Combination Products Webinar

https://www.greenlight.guru/webinar/combination-products

General Wellness Device and Wearable Exemption Webinar

WebMD

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable quotes from MiKE DRUES:

“I’ve got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space.”

“Right now, much of this is not being regulated by the FDA. The FDA - they’re using their enforcement discretion to not regulate.”

“FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person.”

“As soon as the practice of medicine is being practiced by a device or in this particular case, software, now all bets are off.”

 

TRANSCRIPTION

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 in companies.

Jon Speer: On this episode of the Global Medical Device podcast, catch up with familiar face and voice on the podcast, Mike Drues, with Vascular Sciences. And we talk about a topic that, frankly, I thought I knew a little bit about, which I guess is probably true, but I learned a whole heck of a lot more. And I think it's a topic that's pretty important for our industry. And based on some of the feedback and comments from FDA on this topic, I think its something that's going to become more and more important to us in the Med Device and other life science spaces. And that topic is Clinical Decision Support Software. What is it? Why should we care? Well, I encourage you to listen to this episode of the Global Medical Device podcast to learn more. Hello and welcome to the Global Medical Device podcast. This is your host and founder and Greenlight Guru, Jon Speer and joining me today is Mike Drues with Vascular Sciences. Mike, welcome.

Mike Drues: Thank you, Jon. Always a pleasure to speak with you and your audience and to see you today.

Jon Speer: Yeah, I know. It's a video. It's become an all too common thing in recent, well, almost years now. But yeah, it is great to see you. Certainly, would prefer the face- to- face alternative, but you're in Southern California and I'm in Indiana. It's nice and warm where you are and its getting toward winter where I am. We'll deal with it. Anyway, today, topic that thought we could discuss is Clinical Decision Support Software, and maybe the little bit bigger topic, Clinical Decision Support. These are probably great places to start. What is this all about? And then we'll get into some of the nuances and some of the details. But maybe a great place to start. What is Clinical Decision Support and software, I guess, as part of that?

Mike Drues: Well, sure Jon. As always, I appreciate the opportunity to have this discussion with you and your audience about a very important and a confusing topic to some people. So, what is Clinical Decision Support Software? Well, Jon, why don't we start out with what FDA thinks it is.

Jon Speer: Okay.

Mike Drues: And then you and I can talk about whether we agree with them or not. So, according to FDA's guidance, and by the way, just setting the stage here for our audience, Jon, the Clinical Decision Support Software guidance, which came out in draft form just about a year and a half ago is on FDA's number one priority for finalizing in 2022. So, this is a high priority area for the agency. And we can talk about that in a moment as to why at least I think it's a high priority. But anyway, starting out with the definition. FDA says that Clinical Decision Support Software provides healthcare professionals and patients with knowledge and person specific information intelligently filtered, I love that inaudible, intelligently filtered or presented at appropriate times to enhance health or healthcare. I'll read that one more time. It's software that provides healthcare professionals or patients with knowledge and person specific information, intelligently filtered or presented at appropriate times to enhance health and healthcare. And maybe we can talk about what you think that definition means, and is it a good definition? We can unpack it as we go.

Jon Speer: As with most things regulatory and some of the guidances and the verbiage, there's a lot of ambiguity and I'm quite sure that's oftentimes on purpose.

Mike Drues: Well, I would call that Jon, rather than ambiguity, I would say room for interpretation.

Jon Speer: There we go. Yeah.

Mike Drues: Or some people might call it room for manipulation. But I agree with you. There's an awful lot of room, whatever you want to call it. It's an awful big room to move around in.

Jon Speer: Yeah. I guess as you read that definition, what does that mean and that sort of thing. As we oftentimes talk about guidances and regulations and so on, another question that I suppose we'll get into probably today is, why now? Why is this suddenly now important and why is this a priority? And maybe that is a good place to start. Why do you feel like this is suddenly now elevated to the top of FDA's priorities for 2022?

Mike Drues: Well, that's a great question, Jon. And I think there's a couple of reasons. First of all, there are a growing number of companies that are working in this area. In fact, a number of companies have put out products, online tools-

Jon Speer: Yeah.

Mike Drues: For example, in this area, perhaps you've seen some of them. In addition, I've got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space. So, I think it's coming higher and higher on people's radar. And as a result, it's coming higher on FDA's radar.

Jon Speer: Mm- hmm( affirmative).

Mike Drues: And so to FDA's credit, they want to get ahead of the story a little bit, because as we'll talk about, I'm sure over the next several minutes, Jon, right now much of this is not being regulated by the FDA.

Jon Speer: Yeah.

Mike Drues: FDA says they're using their enforcement discretion to not regulate. But I'll tell you exactly when that will change, Jon. That will change when companies put out products that suffice it to say, provide the wrong kinds of information or inaccurate information. And as a result, people start to get harmed and companies get sued. And that's when that will change. But for right now, what do they say, no news is good news.

Jon Speer: Yeah.

Mike Drues: It's still a relatively new area. And let's be honest, nobody or not too many people have really been harmed.

Jon Speer: Yeah.

Mike Drues: But anyway, that I think is why it's a priority. Do you think you would add anything to that list, Jon?

Jon Speer: Well, hearing that is a little encouraging that FDA sees this as something that's starting to become more in vogue or have more utility in our industry and is trying to get ahead of it and stay on top of it. So, I suppose that's a good thing.

Mike Drues: One other thing that I would add, Jon, pragmatically, again, as we'll talk about, I don't want to get too far ahead of our sales here. But some of the functions that some of these software products conduct, they definitely fit the Code of Federal Regulation's definition of a medical device.

Jon Speer: Yeah.

Mike Drues: In other words, they definitely will provide a diagnosis or something, which according to the CFR is a regulated medical device. But what FDA is saying is they're using their enforcement discretion not to regulate these things at this time, even though they do fit the definition of a regulated medical device.

Jon Speer: Sort of. And I suppose in those cases where the Clinical Decision Support Software does meet that definition of a medical device, are there existing regulatory codes and classifications for this or is it kind of depend on the application?

Mike Drues: Sometimes there are. But not usually. And the other reason why I think, not a criticism, but just merely an observation, the FDA is taking this stand at this time with this kind of software is because we don't live in a world with infinite resources.

Jon Speer: Right.

Mike Drues: In the ideal world, if FDA had infinite resources, they would recommend these kinds of products. I don't think there's any if, ands or buts about it. But unfortunately, FDA, just like companies, we have to decide where we apply our resources and where we don't. And FDA is taking this risk based approach. And thus far they have determined that this is a low risk area. And therefore, it's more appropriate to apply resources to other areas that might not be so low risk. But as I said before, Jon, this will change when people start doing, as I like to say, stupid things. But anyway, we'll continue.

Jon Speer: Right. One other curious thing for me anyway is, you do a lot of work, not just in device, but also in biologics and pharmaceutical.

Mike Drues: Mm- hmm( affirmative).

Jon Speer: I have to believe that there are the equivalents of Clinical Decision Support Software not just device, but also in biologic and pharma. Is that what you're seeing in practice?

Mike Drues: Yeah. As a matter of fact, I think, Jon, is actually more fuzzy than you just make it out. Its not like we have software in the device world and different software in the drug world.

Jon Speer: Yeah.

Mike Drues: On the contrary, there's a huge overlap because many of the software programs that are available now, indeed some of the examples that FDA sites in their own guidance is software packages that, based on the information that the patient provides, make specific recommendations about the drugs that the patient should consider-

Jon Speer: Right.

Mike Drues: Or go talk to your doctor or that type of thing. So, this stuff is already integrated together.

Jon Speer: Right. Which then begs a different question. Which branch of FDA has jurisdiction on products like this?

Mike Drues: Well.

Jon Speer: Is it CDRH, CBER, other?

Mike Drues: Not only that Jon, but one could argue if a piece of software, Clinical Decision Support Software, which is a type of SaMD, a type of Software as a Medical Device, if it's now pointing to a particular drug, does that now constitute a combination product?

Jon Speer: Right.

Mike Drues: This would be a cross- labeled combination product, a so- called E3 combination product. I don't think, as far as I've seen anyway, nobody, at least at FDA has suggested that these be regulated as a combination product. But from a regulatory perspective, one could easily make that argument. But to be fair, also from a regulatory perspective, one could argue that because FDA is not regulating these things under their enforcement discretion, it might be a combination product, but it would be a unregulated combination product.

Jon Speer: I want to get into that more here in a moment. To help me and maybe to help the audience a little bit, do you have an example of what a Clinical Decision Support Software does? I know you will be generic. You'll leave specificity as far as the products and companies and things like that, but can you maybe provide an example that might help illustrate what a Clinical Decision Software does and maybe what it does not do?

Mike Drues: Yeah. Great question, Jon. So, just coming back to the definition that we started at the beginning. If we were to boil that down, it's basically providing both clinicians as well as patients information to enhance health and healthcare. As we talked about a moment ago, Jon, we can interpret that in many, many different ways. So in essence, what these software programs do, they're essentially Telehealth platform.

Jon Speer: Mm-hmm(affirmative).

Mike Drues: And what they do is they usually ask the patient a series of questions. Sometimes the software will be kind of dumb, in the sense that it asks everybody exactly the same set of questions, or sometimes the software will incorporate artificial intelligence. And depending on what answer that the patient gives to one question, then the software will direct them to another question, a different area, something like that. So there's all kinds of different perturbations. Anyway. The software will typically ask the patients questions, collect information about their health status, what kinds of symptoms they might be having? Are they having any pain? Are they on any medications? Do they have any previous conditions? All that kind of stuff. And then they will advise the patient, based on the information that they provide, that they should go and make an appointment with their doctor. Sometimes, make the appointment with their doctor sooner, rather than later. I have no problem with that much, Jon. As a matter of fact, as you know, I come from a medical background, I used to teach pathophysiology in medical school. Occasionally, I'll have people come up to me and they'll describe their symptoms to me. And I'm pretty confident I know what the problem is.

Jon Speer: Right.

Mike Drues: But I won't tell it to them. Instead, I'll say, well, you should go and see your doctor. Or in some cases I'll say you should probably go and see your doctor sooner rather than later.

Jon Speer: Right.

Mike Drues: So, I have no problem with the software doing that much, Jon. But when you take it that step further, when the software is actually making a diagnosis based on the information that the patient has provided, you have XYZ disease, that's where it starts to get more challenging, if you will.

Jon Speer: Okay, that's helpful. I was going to say, it reminds me, and maybe this is an example, quite a few years ago, a friend had some health thing. I don't remember the specifics and it's sort of irrelevant to what I'm going to describe. Of course, in the days of the internet and oftentimes that's where we go to search for things. And I remember this friend of mine, she went to, did a search and one of the search results led her to WebMD. And I'm just mentioning WebMD not because I think it's good or bad, it's just that's where it went to. And she entered in her symptoms and that sort of thing, and it produced a list of search results that it could be this, it could be that, it could be this, and that sort of thing. And I'm pretty sure they had the disclaimer that said consult your healthcare professional, yada, so on and so forth. But is WebMD an example of a Clinical Decision Support Software?

Mike Drues: It's an interesting question, Jon. The short answer to every question in regulatory affairs-

Jon Speer: Depends.

Mike Drues: Is it depends. So, if WebMD is acting like a textbook, in other words, you type in the diagnosis-

Jon Speer: Right.

Mike Drues: Or a treatment, and it gives you information about it then probably not-

Jon Speer: Right.

Mike Drues: Because that's essentially a textbook.

Jon Speer: Right.

Mike Drues: In the olden days, when you went to the library and you opened up a book and this is what you would find. But if the software, as I described a moment ago, goes a little bit beyond that, collects your information and you don't go to it with a predetermined diagnosis, it collects your information, and then it says you have a particular disease or injury or condition. This is exactly what a physician would do.

Jon Speer: Right.

Mike Drues: And this is one of the areas, Jon, from a regulatory perspective, where it is kind of gray area. Why? Because as you know, and as we've talked about many times, FDA does not regulate the practice of medicine. That is FDA conditioned what to do. The only thing FDA can do is tell us, meaning industry, what to do. And that's what every regulatory textbook says. That's what every regulatory consultant says. But there's a big caveat to that statement that most people do not say, but I do, Jon. And that is, FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person, by a physician, a surgeon, a nurse, a pharmacist. But as soon as the practice of medicine is being practiced by a device or in this particular case, a software, now all bets are off. I had one of my recent customers ask me this question, Jon. If a patient goes to the emergency room and they're seen by a doctor and that they say, I have the following symptoms and the doctor says, okay, your diagnosis is X. Your treatment is Y. And so on. Does FDA have anything to do with that? Absolutely not. Because that's the practice of medicine being practiced by a person. But imagine this, not so hypothetical scenario, Jon. So, at the entrance to the emergency room, you have a little kiosk.

Jon Speer: Mm-hmm(affirmative).

Mike Drues: And before the patient goes into the ER, they sit down at the kiosk and they're asked a series of questions from Clinical Decision Support Software. And even if they ask exactly the same questions that the physician would ask inside the ER, does FDA regulate that? Well, at least theoretically, yes. Why? Because it's not being practiced by a person anymore.

Jon Speer: Right.

Mike Drues: It's being practiced by a device or in this case, a piece of software. Does that make sense?

Jon Speer: It does. It presents an interesting caveat that, well, we can dive into that. But I think curiously, as we've talked today, you and I have talked about general wellness devices in the past, and in some respect, what I'm hearing, if I'm interpreting correctly is, there's aspects of a Clinical Decision Support Software that sounds very similar to a Wellness Device. So, how do these things compare? Are they the same? Are they completely different? Or some similarities, some differences?

Mike Drues: Great question, Jon. And there are a lot of similarities. One of the biggest similarities is that neither one of them are regulated by the FDA. You and I have talked about the wellness exemption before. In fact, I did an entire webinar for a Greenlight-

Jon Speer: Right.

Mike Drues: The wellness device exemption. And basically, what the wellness device exemption means is if you have a medical device that fits under the wellness exemption, it would not be regulated by the FDA in any way, shape or form. In other words, no 510( k), no De Novo, no PMA.

Jon Speer: Right.

Mike Drues: No quality management system, no design controls, no FDA registration, no nothing. If we had a medical device that fit under the wellness exemption right now, we could start selling it here in the US this afternoon.

Jon Speer: Correct.

Mike Drues: The difference with Clinical Decision Support Software is that some of these functions, and FDA comes out and says, that some of these functions do fit the CFR definition of a medical device. But that for whatever reasons, be they low risk or what have you, we're not going to regulate them anyway. We choose, at least for this time, not to regulate them anyway. So, at the end of the day, neither one is being regulated, but for different reasons. And here's another thing to keep in mind, Jon. As long as your device fits under the wellness exemption, it will stay that way forever. But for companies that are working in this Clinical Decision Support Software have to realize. And I've said this to many of the companies that I've worked with at this space, you have to be prepared for that to change at some point in the future. In other words, FDA is saying that we are not regulate these products for now. And so yeah, you can go ahead and put out one of these software programs. But be prepared. I'm not saying that it will happen, but it might happen. And I'm not saying that when it will happen, but it could happen that FDA changes their mind and says, we are now going to regulate these things. And you might need maybe even a 510( k) or De Novo-

Jon Speer: Right.

Mike Drues: To be able to continue.

Jon Speer: Well, on that point, and you and I have talked both on the Global Medical Device Podcast and just when we've chatted before, I think a lot of times people or companies hear, oh, this is not regulated, therefore, I have carte blanche or free reigned to do whatever. That's a little bit of an exaggeration. But just because in this case, technically speaking, there might be enforcement discretion applied to Clinical Decision Support Software, it is I think, companies that are developing these products, at least in my opinion, I hope that they're doing prudent engineering to borrow a term you've used before and good development practices and documentation and that sort of thing because it still is an important aspect or piece of the healthcare equation that's being applied. So, I hope these folks are developing these platforms and these software in a way that takes into account best practices and defining requirements and proper V&V, and all these sorts of things. I would hope.

Mike Drues: I would hope so too, Jon. But unfortunately, I don't live in the theoretical world. I live in the real world.

Jon Speer: Yeah.

Mike Drues: I didn't fall off the turnip truck yesterday. And here's the downside of FDA not regulating wellness devices or this particular case, not regulating some, not all, but some of this Clinical Decision Support Software. Who is going to make sure that these companies are doing those validations that you are just alluding to? One of the very first questions that I ask companies that come to me in this area is, okay, your software is providing this information, making this potential diagnosis or recommendation, or what have you, well, show me your testing, show me-

Jon Speer: Right.

Mike Drues: Your evidence to say that it's actually giving the patient the right information. In the absence of some kind of an oversight, basically what you're leaving people do, you're allowing them to do the right thing. And I don't want to suggest that everybody out there is a bad person or anything like that. That's not my intent here. But the simple reality is that not everybody is going to do that.

Jon Speer: Yeah.

Mike Drues: I'll give you a perfect example, Jon. One of the companies that I'm working with now, when they originally came to me, they wanted very badly to bring their product onto the market under the wellness exemption. And I had some concerns about that. And they kept telling me about, oh, how safe this is and so on. I said, I don't have doubts about the safety of your device because you've gone to great pains to make sure that, I don't want to give too much away about the technology.

Jon Speer: Right.

Mike Drues: What you're doing to the patient is well below the threshold of safety and so on. But the problem is if you bring that onto the market as a wellness device and FDA allows it, it's going to open the door to other people doing similar things that might not take the same approach. And so sometimes when FDA says to a company, we have to regulate your device, it's not because they're concerned about that particular device. It's because of the Pandora's box that they might be opening that might allow other companies to be able to do things without that kind of regulatory oversight. Does that make sense, Jon?

Jon Speer: Yeah.

Mike Drues: To use another regulatory metaphor, it's the difference between Class I devices that are only subject to general controls versus Class II devices that have special or what I call specific controls. The general controls apply to devices across the board. But the Class II devices, sometimes, and in my webinar that I did for Greenlight on what is a medical device, Jon, I think I talked about this or maybe it was the classification webinar or both. I gave examples where we had devices like blood refrigerators, for example, that were Class II devices. They were 510( k) exempt but they were still Class II. Why? For one simple reason, because the general controls under Class I were not sufficient and we needed to be able to impose special controls or what I call specific controls on them. So, it was sort of a compromise. FDA said, all right, it's not necessary to have a 510( k) for a refrigerator, but it also, it has to be a Class II to impose those special controls. I think the regulatory logic that we're talking about here around wellness devices and around Clinical Decision Support Software is very much the same. Does that make sense, Jon?

Jon Speer: It does. As we've been thinking about this through our conversation, just the kiosk at the ER was an interesting metaphor, if that's the right example. There we go. Because it's reality. It's not hypothetically. But I go to a kiosk and an ER, and I answer some questions, I enter some PHI, Personal Health Information, whatever the case may be. The curious question that pops in my head is, what happens to that data? Who gets it? Where does it go?

Mike Drues: That's a good question, Jon. There's all kinds of patient confidentiality issues, HIPAA issues, and so on. I had a conversation just earlier today with one of my customers about this. I'll be honest, I'm not an expert when it comes to the details of HIPAA requirements. But you're right. There are confidentiality issues that we need to be aware of as well.

Jon Speer: But even if it's de- identified PHI or information, is the manufacturer, the developer of the Clinical Decision Support Software, what are they doing with that data? And I know that's not necessarily a rhetorical question, but not necessarily in the scope of today's conversation. But it is kind of interesting to think about where does-

Mike Drues: Well.

Jon Speer: Yeah.

Mike Drues: It's a good question. Sometimes you can, to use your word, de- identify this data. But other times you can't. Some information is being transmitted, for example to a doctor's office, with the patient name or identification number on it for all the obvious reasons. As a matter of fact, some of these web- based clinical decision support programs that are available right now, they often don't charge the patient until they sign up for a consult with a doctor. So clearly, there's got to be a linkage there-

Jon Speer: Right.

Mike Drues: In order to do the billing.

Jon Speer: Right.

Mike Drues: But how they control that information? That I'm not sure.

Jon Speer: Interesting.

Mike Drues: But FDA does put some boundaries on this, Jon. I do think-

Jon Speer: Yeah.

Mike Drues: That we need to make sure that this is not opening up a floodgate here. FDA does put out some boundaries. And if you think it would be of interest, Jon, maybe we should just tick through some of the limitations-

Jon Speer: Yeah. For sure.

Mike Drues: That FDA puts on.

Jon Speer: I don't think it would hurt. Yeah. Absolutely.

Mike Drues: Okay. So, in a nutshell, FDA says that if you do any of the following things, that this is probably not going to be Clinical Decision Support Software that is exempt under FDA's discretionary or enforcement discretion. The first one is, it can't be intended to acquire a process or analyze a medical image or a signal from an in- vitro diagnostic.

Jon Speer: That's clearly Software as a Med Device.

Mike Drues: Yes.

Jon Speer: Yeah.

Mike Drues: Yes, absolutely. So, that's a good thing. The second thing, it's intended for the purposes of displaying, analyzing or printing medical information about a patient or other medical information such as peer- reviewed clinical studies and so on and so on.

Jon Speer: Yeah.

Mike Drues: That one is another boundary.

Jon Speer: Yeah.

Mike Drues: The third of the four, it's intended for the purposes of supporting or providing recommendations to a healthcare professional about prevention, diagnosis or treatment of a disease or a condition. And notice that they're parsing their words very carefully, Jon. They're saying for supporting or providing recommendation.

Jon Speer: Right.

Mike Drues: That's door of the CFR definition of a medical device.

Jon Speer: Right.

Mike Drues: They're not saying that they're diagnosing. They're saying that they're supporting or providing recommendation.

Jon Speer: Mm-hmm(affirmative).

Mike Drues: And then finally the fourth boundary is that it's intended for the purposes of enabling such healthcare professionals to independently review the basis of these recommendations that the software presents, so that there's no intent that such information can rely primarily on these recommendations. In other words, what it's saying, Jon, is that if the clinician wants to, they can sort of fact check it. They can see, okay, how is the software coming to this determination? But of course, that's going to assume, Jon, that the physician wants to do that.

Jon Speer: Right.

Mike Drues: There's no obligation for the physician. Some physicians might just take what the software is telling them, it's gospel and not question it.

Jon Speer: Yeah.

Mike Drues: I would like to think that physicians won't do that, but some might.

Jon Speer: All right. Well, this has been enlightening or helpful for me to better understand Clinical Decision Support Software. Before we wrap up, anything else that you think is important on this topic? Or maybe some key takeaways that you'd like to leave our listeners with?

Mike Drues: Yeah. I think this is an interesting area, both from a technology perspective, as well as from a regulatory perspective. I think it's just sort of the tip of the iceberg. I think some companies now are starting to stick their toe in this water. As I said at the beginning, I'm getting more and more pings from customers about wanting to work in this space. I think we have to be careful. I think there's basic concepts that we have to keep in mind. One of them is that no matter what our software does, we need to make sure that it's doing it properly, that it's doing it accurately. We need to make sure that we have to do some sort of V& V testing and so on. Even if FDA's not going to be regulating them right now, because remember Jon, although there might not be regulatory implications here, there are potentially huge, huge product liability implications here. And this is another thing I warn my customers about in this space. If your software tells a patient that they don't have a problem, when in fact they really do have a problem and they don't go to see their doctor or they wait six months to see their doctor and something really bad happens or they're not diagnosed deserves as it could. It doesn't take a JDF from Harvard law to appreciate.

Jon Speer: Yeah.

Mike Drues: So we have that obligation.

Jon Speer: And I chime in there too. With respect to V& V, I would also say this is hopefully an obvious use case for usability. Hopefully, it's obvious. But in the risk that it's not, folks, if you're working on products like this usability, this is a prime candidate. I think everything that device is, but this is a definite candidate.

Mike Drues: I could not agree with you more, Jon. But again, here's the problem. Like with wellness devices, they're not being regulated by the FDA.

Jon Speer: I know.

Mike Drues: So, there's nobody looking over the company's shoulder so to speak, to just say, hey, did you do usability testing?

Jon Speer: Yeah.

Mike Drues: So, theoretically, the company could put a product out there without doing any of that. You and I are very much in the same belief that company shouldn't do it. And I think most companies probably wouldn't do it. But maybe there are some. Either because of naivete or ignorance, I'm not sure, but some people might just not do that.

Jon Speer: Yeah.

Mike Drues: The other thing to keep in mind, Jon, as I mentioned earlier, is that this is a very dynamic area in regulatory. I see this FDA using its enforcement discretion for right now, but this can change in a nanosecond in the future. And there's tremendous precedent for this. If you look at the areas of laboratory developed test-

Jon Speer: Yeah.

Mike Drues: FDA used their enforcement discretion. They did not regulate lab developed tests until when? Until Theranos came along.

Jon Speer: Yeah.

Mike Drues: Right. There's a lot of areas. I could give you a number of examples where FDA used its enforcement discretion for a while and then somebody did something that they probably shouldn't have done and boom, everything changed. What I'm saying to companies now is, go ahead and develop your products and put it out there on the market, but make sure you do all that other stuff, like the V& V, like the usability testing and so on. So that, if and when it does change, and FDA says, oh no, no, no, you need now a 510( k) to do what you're doing, it's just a matter of taking all that information that you've already done, putting it into a package, stamping 510( k) in the front and sending it to the FDA and you're done, no problem.

Jon Speer: Right. The other piece of that, I don't know if it's handwriting on the wall per se, but as we mentioned it at the beginning of this conversation, this topic is a top priority for FDA in 2022. So, is that your sign that FDA is focusing on this, so it may be enforcement discretion for now, but for how long? And again, that shouldn't be the decision or the thing that influences your decision on what you do and don't do.

Mike Drues: Well, to be clear, Jon, literally, it's a top guidance priority for FDA.

Jon Speer: Okay.

Mike Drues: Finalize the guidance.

Jon Speer: inaudible.

Mike Drues: However, what I would read into it a little bit further is, and this is just my opinion, but I'm pretty sure I'm pretty right on this, FDA recognizes the potential for problems in this area, just as well as I do. And therefore, they're keeping an eye on.

Jon Speer: Yeah.

Mike Drues: And I would argue that that's a good thing. That part of-

Jon Speer: Yeah.

Mike Drues: FDA's job goes back to taking this risk- based approach. For now, FDA sees this as a relatively low risk area. And with their limited resources, they feel that those resources are better applied in other places-

Jon Speer: Yeah.

Mike Drues: For now. But when people start getting harmed or if the bodies start lining up on the side of the road, that's when things will change.

Jon Speer: Yeah.

Mike Drues: Or so it seems to me.

Jon Speer: Mike, I appreciate your insights on this topic. And I think this is our opportunity to try to get ahead of this and try to help share some key points and hopefully some tips for the industry.

Mike Drues: To their credit, Jon, just one very last point. This is an example, albeit a small one of the infrequent examples. But this is an example of FDA being proactive rather than reactive.

Jon Speer: Right.

Mike Drues: In other words, putting out guidance in an area where the technology is just starting to emerge and become popular as opposed to, let's be honest, Jon, and so many times regulation is created after-

Jon Speer: I know.

Mike Drues: Something bad-

Jon Speer: I know.

Mike Drues: In order to try to prevent it from happening in the future. So, I give FDA credit. It's an area that we have to keep our eye on to see what happens. As I've said before, Jon, there's no better way to ensure that we will have more regulation in the future than if companies and the people in them continue to do stupid things. But that street runs in two directions. There's no better way to ensure that we have less regulation in the future than if companies and the people in them continue to do smart things.

Jon Speer: Yeah.

Mike Drues: So, I don't blame FDA on the amount of regulation that we have or don't have, Jon. I blame us.

Jon Speer: Yeah.

Mike Drues: We want more regulation, do stupid things. If we want less regulation, do the right things. Maybe that's naive, Jon, I don't know. But that's my kind of naive view of the universe.

Jon Speer: I like it. That feels like that should go on a t- shirt somewhere. Mike, I appreciate it. Thank you so much for sharing your insights on Clinical Decision Support Software. Folks, as you probably have picked up by now, if you've been listening to the Global Medical Device podcast for any period of time, Mike Drues, with Vascular Sciences, is the best when it comes to regulatory strategy, advice and insights and wisdom. So, if you have questions about Clinical Decision Support Software, wellness devices or just plain old medical devices, he's your guy. So, reach out to him and I know he is happy to help provide some guidance and direction for you on the best options and path forward. So, Mike Drues, Vascular Sciences. And of course, folks, I hope you know, anyway, that Greenlight Guru, we're here to help as well. We have the only medical device success platform on the market today. What is a medical device success platform you might ask? Well, we have incorporated workflows to help you manage just about everything you need to worry about with respect to your quality management system, with respect to design controls, risk management document, and record management. It's all workflows that are incorporated within a single software platform, a single source group. So, if you'd like to learn more about Greenlight Guru and our products and services, then I would encourage you to go to www. greenlight. guru to learn more. And if you'd like to have a conversation, we'd love to chat with you. We'd love to learn about your needs and requirements and see if we have solutions that might be able to help you. So again, that's www. greenlight. guru. As always, thank you for listening to the Global Medical Device podcast. It's because of listeners like you, that we remain as the number one, the top podcast in the medical device industry. So, thank you for that. As always, this is your host and founder and Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device podcast.

 


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