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May 19, 2023

FDA Human Factors Regulatory Roundup - Safe and Effective

FDA Human Factors Regulatory Roundup - Safe and Effective
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In the premiere episode of Safe and Effective we bring you an exciting blend of regulatory insights and live interviews from this years HFES Healthcare Symposium in Orlando, Florida.

In our first regulatory roundup segment ever we talk to Janet Creaser about the FDA’s newest human factors draft guidance released in December 2022, Content of Human Factors Information in Medical Device Marketing Submissions. We discuss its content, goal, and use, while pointing out some of its advantages, as well as weak spots.

Additionally in this episode we share some insights from this year’s HFES International Healthcare Symposium in Orlando, Florida, from our field correspond indent interviewing some of its organizers.

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[00:00:00] Heidi Mehrzad: Hello and welcome to Safe and Effective, the Medical Human Factors Podcast and the latest cast in the Human Factors cast family. For the first show, I've brought on a familiar face. Welcome to the show, Nick Rome.

[00:00:15] Nick Roome: Hi. Thanks for having me. I'm really happy to be here with the kickoff of Safe and Effective.

So exciting.

[00:00:20] Heidi Mehrzad: All right. Bringing the energy there. All right. Nick is joining us today to lend us a helping hand and kickoff our show and of course to ensure that we bring the same level of production, quality, and care to the table that the Human Factors Cast Network is known for. So Nick will be co-producing .

Right Nick? Yeah, that's

[00:00:41] Nick Roome: right. So I wanted to come on the show because we're really just aiming to have high standards across all of our podcasts. We wanna make sure that the same level of care, same level of detail same level of that continuous improvement, if you've been following Human Factors cast for a while, you know that we're dedicated to making sure that the show is always improving and that we're always investing in communication of human factors concepts.

So I'm really excited to be here to talk about this and from the main show. I call it the main show cuz that's where I'm at. But this is gonna be its own main show, so that's fun. The the main Human Factors cast, we talk about weekly topics, a different topic every week where it's more of a discussion panel.

Heidi I'm really interested to have the conversation with you, what makes Safe and Effective different.

[00:01:28] Heidi Mehrzad: So safe and effective is going to be purely focused on medical, human factors, medical, healthcare, anything and everything that has to do with that space. That can be medical device development, that can be medical influence, that can be hospitals, that can be health organizations, that can be healthcare.

It can be patient care, it can be anything and everything in the medical human factors space. And we will be focusing on that space specifically.

[00:01:57] Nick Roome: And that's great because it's not like we have to stay away from medical human factors on human factors cast, but this is just a dedicated space for human factors, professionals in medical, human factors.

And that's really exciting to me. This is something that we've been talking about for a long time. This has been in development for a long time and really excited to see what this actually becomes. So, What is the show?

[00:02:23] Heidi Mehrzad: I have to go a little back for that. A few years back, I started to realize that every year at our annual conferences, whether it was the Healthcare Symposium or the annual H F E S, or for a matter of fact, other conferences in the medical space where human factors comes up, human factors, engineering, research, design, anything and everything, right?

We would have such great conversations and exchanges, but then they would be paused until the next conference, right? , as there was no existing forum or platform where we could continue the conversation with a lot of, downfall because then conversations wouldn't continue, they would stall.

Or worst case scenario, which happened a lot, is they would just be repeated at the next. Conference and we would never really get anywhere. And then often we all struggle with the same challenges, especially in the medical device development world. But as we all suffer from the confidentiality burden and often organizational culture restrictions, individual companies, it almost seemed as if there was no open exchange happening. And that kind of bothered me.

It bothered me because I knew my peers were struggling with the same thing and everybody was trying to figure it out on their own in silos. Therefore, I really wanted to create something, a safe space where we could continue our conversations, hash out whatever ongoing hot topics we had, and, find a forum on which we can ask each other for advice and insight.

Maybe not even so often, to problems. Also share the latest discoveries and learnings. It's a space where we can just, Talk openly. Of course, I'd like to invite experts, leaders known and up and coming from all medical spaces in the human factors world, including regulatory and clinical experts.

We often leave those out, but they do affect us, right? And to facilitate an open exchange on all things medical and healthcare human factors. You know, Have a collaborative place for professionals to come together to discuss relevant topics in the industry without having this connotation that it has to be X, y, z.

It has to be a webinar, it has to be this, it has to be that, You know,, it can just be an open conversation. I really wanted to focus on that because I can tell you right now what it is not. It is not a giant advertisement for x, y, z consulting agency.

It is not a giant billboard for x, y, z, medical device, company manufacturer, pharmaceutical company, whatever. It is not going to be one of those driven things that just produces content for the sake of producing content. It is supposed to be a safe space where we openly get to actually talk about the topics that bother us that excite us and share without that connotation in the back.

So that's really what I wanted to create and I hope we're gonna be successful with that.

[00:05:17] Nick Roome: I, for one, am really excited about this and I am. So I genuinely, Heidi, I am really happy to pass off like the host reins onto somebody else to make this your own. With that, bye.

[00:05:34] Heidi Mehrzad: All right thanks Nick for coming on today.

Always lovely to talk to you. On today's show, we will have our first regulatory roundup with my dear friend and Pier and a seasoned expert in the human factors medical device development world, Janet Kreer. And then later on we will hear from our field correspondent Elise as she sat down with some familiar voices at this year's H F E S International Healthcare Symposium in Orlando, Florida.

All right, welcome to the regulatory roundup. First segment ever on safe and effective. And today, Janet is joining me, my dear friend and peer. Janet has a PhD in human factors and ergonomics. She has been working in the medical device industry for eight years and has 23 years of experience in human factors , including many years in transportation safety, and some time in aerospace.

Janet's passion is designing systems to minimize risk and make life easier. Oh, isn't that lovely? Hi Janet.

[00:06:36] Janet Creaser: Hello. Thank you for having me here today.

[00:06:38] Heidi Mehrzad: Thank you so much for doing this with me. It's so nice to do this with a friend on the first episode, and especially with somebody who I share so many passions with when it comes to regulatory guidance, right?

[00:06:53] Janet Creaser: Yes, definitely.

[00:06:56] Heidi Mehrzad: So today we picked something interesting for our regulatory roundup, and that is the new draft guidance on the content of human factors information and medical device marketing submissions, which is a draft guidance issued from the F D A , on December 9th, 2022. , it's not a final. Okay. So what we're saying is all in relation to a draft guidance. .

. So first and foremost, this document is supplemental to the C D R H'S 2016 guidance . This guidance is not a supplement for how to conduct human factors, . Okay.

all right,

janet, you wanna get into it with

[00:07:41] Janet Creaser: me? Yeah, I do wanna get into this. , It was interesting to see this guidance come out ,, , one thing that we really do wanna focus on today is that this is, Draft guidance, again, not finalized.

, It is ready to be commented on. If you have thoughts and feelings , and perspectives on this guidance, I highly recommend you go and make your comments. , And one of the things we wanna be clear is that PERTs intention, and I'm gonna make a direct quote , from section two of this draft, is to help submitters and F D A staff determine what human factors evaluation information should be included in marketing submission for medical devices.

So this applies to five 10 de novo applications and pre-market approvals and supplements, as well as humanitarian device exemption applications. , But what it is not doing is telling you how to do your human factors process. It is really talking about the content of your marketing submission based on the deliverables you've already produced for your process based on that 2016 guidance.

[00:08:40] Heidi Mehrzad: . that's a good point it is not on how to do human factors. It is what to submit in your submission. All right, let's get to the basics here. In it's very simplistic form, the guidance consists of 23 pages, not including the title page, given this is not intended to be a document on how to conduct a process, it is half the size of the original guidance, which contains 46 pages total and 10 sections.

So Janet, do you wanna give us a little intro?

[00:09:11] Janet Creaser: Yeah. The first section in this guidance is actually their introduction to why they are creating this guidance in the first place and why they think it's needed , based on what's coming out of industry. So I think any of us who have been in human factors in the medical space for a long time, Know that people are often a little bit confused about what it means to scope a human factors process.

So basically in the introduction this section introduces the intent of the guidance document and reviews that similar to how the human factors process should be scoped, as I already mentioned, per the original 2016 guidance, the submission materials can also be scoped based on what level of risk and work was required for the product in the first place.

It also gives an overview of, , that human factors is risk-based process, and yes, that is very true. , And I think it serves as a, its a reminder. Yeah, it serves as a reminder. It really is a risk-based process, but we can do so much with it

, And it will replace, , what. Previous draft guidance, which was known as the list of highest priority devices, which was a list of medical devices that had a high enough level of risk or had enough issues that the F D A required that you had to submit your full human factors summary report and ensure that you had a robust design history file in place for that product.

, and , what it's going to do is actually add more , than that prior draft guidance had, which is really tell you how to handle your lower risk devices or maybe like where you had to make some minor changes to your user interface , but you're not overhauling your entire product or creating a new one.

[00:10:41] Heidi Mehrzad: , it's. More detailed information on what you're submitting. It's not so much more detail on how you're doing . your activities or how your document is supposed to be compiled or how a program is supposed to be structured. It's just basically saying, look, we understand in our original guidance there's section nine, appendix eight, it gives an outline of the H F E report and that's what we expect to see in the report.

, And a robust human factors engineering program will cover all those sections. , What this guidance is more is saying, We understand, we've listened to you and we understand that there are various different pathways, various different formats you're submitting in various different devices in situations where it's not always just a new device, it's not always just this, it's not always just that.

So it's giving this , like a plug and play. If this is the case, then you submit this material. Now what we should be very clear on is that when we say robust human factors engineering process, you should always have a robust human factors engineering process.

However, you might not need to submit every single section in your report depending on what type of program you did . Doesn't again mean that you're not doing certain things in human factors engineering, it just means they're not applicable to the device you're developing. So I think , there's a little bit of a disconnect in the guidance that it gives a little bit of a misconception of, here's an example.

In this example, you should do X, Y, Z. Even though it doesn't say do it, just, it implies it with the examples, which are great examples. But again, reading this, you could get that kind of misconception that this is just reducing your program to these items when it really isn't reducing your program.

It's just saying, we wanna see the results of that in these sections. And X, y, Z section might not be applicable to you because of A, B, C. And I think that's what's really critical , on that part as well. , The other thing that I , wanted to mention that leads us into section five, which I would love for you to talk a little bit more about , is that .

. This is written for human factors professionals. . This is not is not a , No pun intended. User manual for how to do human factors . , And I think , , that alone takes a lot of questioning out of the guidance because as a human factors professional who's experienced in this, who knows why they're saying certain things, why the FDA's putting in a certain terminology, that alone gives you kind of the hint, oh, okay, I got it.

That means I don't have any new critical tasks and I have X, Y, Z, then they don't need me to fill out at length section X, Y, Z in the H I V report, right? , Or they just want a high level summary of X, Y, Z, because. We did not find any new critical tasks, and it doesn't have any changes to the user interface, but that doesn't mean that you oit certain tasks and activities that led you to that conclusion.

So Janet , with that being said, yeah, do you wanna give us a little bit more on section

[00:14:17] Janet Creaser: five? Yeah I like what you said there, Heidi, about, still needing the robust process and you need all your deliverables and this is really just about what you're gonna put in your submission. But I think one of the most interesting things about the table in there is that it is really short and sweet.

We already have a human factors summary report outlined in the 2016 guidance. It's already a scoped , process where you do your risk evaluation of your device and you decide how much work human factors work that you actually need to do. And the manufacturer is responsible for making that determination by following the process and making sure that those deliverables exist.

One of the surprising things I find about this guidance is , how actually the core of it is really summarized in this table one. , In section five where if you just take the human factor summary report and you do the risk category, describe your risk categories.

You could just do the check boxes and say, just submit these things out of your Human Factors summary report. It would simplify the guidance. You could just still have 2016 as your main go-to document and a nice handy little table for your regulatory folks to say, Hey, we know our device is this risk level.

we know that we did this scope of work and these are the deliverables we have. And the f FDA is saying, just submit X, Y, and Z from the Human Factors Summary report. And you could really go about it that way. , Because I think in a lot of people's minds, including my own, is the Human Factor summary report is already a summary of all the work that you've done.

You have other documents, right? You have a use specification, , You have a use error analysis. You have , Formative reports most likely maybe not. . I think what I'm saying is that the process is modular.

You have to understand 2016 takes into account the fact that human factors should be conducted by people who are experienced and knowledgeable in why we do human factors processes, right? How we evaluate human performance and how we design for human performance , when interacting with the system in its environment.

And so if you understand that, you can scope that process correctly. And really what you just need to be able to tell your regulatory folks is, okay, we've done all this work. This is why we've done it. We have all these deliverables. We now have this H F E summary. And the F d A would like you to submit, these sections of the summary report, or they want you to submit the whole report.

And I think , the biggest difference between this and the prior guidance, which was the highest priority list of. Devices for HF submission , is that document was really short. I think it was one and a half pages. It just gave you a list of products that required a submission.

[00:16:45] Heidi Mehrzad: And I think that's a good point to bring up and so critical to us that we keep reiterating the fact that these guidances are not written for somebody who doesn't understand this in the first place.

It's written for us human factors professionals to just have more guidance. It's just taking a little bit of the ambiguity out of certain things. , , And I think what's valuable in here, speaks to the fact that, f d A also intends this to concurrently revise to human factors guidance by replacing Section nine in the original guidance documentation and Appendix A for the H F E report of the guidance with cross references to this section five.

And by making any other revisions obviously. But what it really is saying is, yeah, we gave you the full guidance and we gave you an outline of what we want to see in a submission. And in that submission, we would like you to follow X, Y, Z outline, which was Appendix A, still is Appendix A.

Remember, this is a draft. We're not changing what we're doing until this is finalized, but what the FDA is saying is here, Hey, here's a little bit more guidance based on some of the comments we've gotten.

And what they're saying is if, and that brings us to this , beautiful chart

[00:18:09] Janet Creaser: I know where you're going with this, by the way, cuz I think I'm there as well.

[00:18:13] Heidi Mehrzad: Which brings us to chart figure one on page seven where they say, look, here's the deal. Is it a new device? Is it a modification to an existing device? Yes. No. All right, move on. Is there a change to any of the following?

X, Y, Z User interface? Intended device uses intended use environments, training or labeling? Yes or no? Then go on, move to decision point C based on the use related risk analysis. Are there any critical tasks? And for modified devices? Are there any new critical tasks?

And here's something interesting, . It's a little bit hidden in the guidance, but. in this chart it says, modified devices only. New critical tasks introduced or are critical tasks impacted. When they say impacted, they also mean whether you eliminate it, whether you change the number of critical tasks, whether you change the sequence of tasks.

It is not purely directed at do you just have no critical tasks, or are the ones impacted and have X, Y, Z changed. It actually also means have you changed the sequence, eliminated anything? It could be as simple as you had four before, now you have three, and now number three is on number two, and number two is parallel to number three.

From the outside looking in, it would look as if there are no new critical tasks. But when you really evaluate it does impact them. And this was a very critical point for me in the guidance. I don't know if you feel the same way, Janet, but this is where I went. And this is why it is not a replacement.

It is not telling you how to do it because this exact point makes you remember that you can only get to this decision point C if you've done the activity of a use related risk analysis or comparative task analysis or a known use problem analysis. You can't get there by just going yes, no, yes, no, yes, no.

You have to do the activity to get to that decision point. And that is what I think is honestly a little weak in this guidance. Yeah, because that chart. Makes it seem a little different.

[00:20:45] Janet Creaser: Yeah, Heidi, and I think one of the things to clarify in what we're talking about is that, earlier I was referencing table one, which is the list of information from the H F E summary report that you should submit.

Whereas figure one, which you were just talking about, is the decision tree, which seems to be more of a decision tree, not about. Your , human factors submission category, although that's how it's laid out, but it seems to imply this is how you should also do your work. You exactly. That. If you're category one, you can stop, but that's not necessarily true.

You may still have formative studies and validation that you need to do to complete your process to make sure that you feel confident that your device is safe and effective. I use the podcast title in the real world. You want that thing to be safe and effective, so you're not just always gonna stop.

And I think you and I aligned on this really early that the concern between the figure one when paired with Table one implies that to some people who are not familiar with the process, that you may just be able to not even do these things. And that's not necessarily, that's not true or true at all depending on what situation and device you have.

I think it's great. I, we need clearer guidance. I think we need to help our quality and regulatory folks, and even our hfe peers, , understand. What submission processes look like and how the FDA operates with their submission processes so they can make good decisions about what should go out for approval or certification.

And so I think this guidance will be very useful with some modifications and , I think it just needs to be really clear that this is not telling you how to do your work, but I do worry having seen how things have gone in the past and misinterpretations even of the existing guidance that you can stop your work at certain points or that you don't need to be doing certain things.

, Or in some cases where people decide they don't need human factors at all, even when they are modifying user interfaces, for example. We love those. It does happen. It's unfortunate and it does happen. And, , depending on your risk category, you may or may not be successful depending on. Where that goes.

And we want our manufacturers to be successful. We want them to be able to put their products on the market and have their , patients, their healthcare providers, or whoever their users are, have a good experience with it. And so I think it's valuable that this guidance be very

[00:23:02] Heidi Mehrzad: clear. And let's , remind ourselves for a second.

What this table is actually really telling you is, Hey, in your submission, the parts we wanna see the most highlighted is if you fall into category one, we wanna have a real tight conclusion and high level summary of what you did and why you came to this conclusion.

Category two. We wanna see that and we wanna see a description of everything because X, Y, Z, category three, we just wanna see the full report right now.

What this is just saying is those are the parts we wanna see in the submission. Documented and highlighted and emphasized. In order to get to conclusion, high level summary, you need to do the activity. You can't just get somewhere by just stating it. You have to do some kind of activity to get there.

At a minimum, you had to do some kind of risk related work, known use problems . You had to do a , use related risk analysis. You did your U F M E A to show X, Y, Z, that it's same, that there's no risks or whatever. And let's be very clear if it's modifications, you had to do comparative task analysis.

And at a minimum, , you started with a task analysis because you had to have an idea of , how it works and how you got there.

And they gave, they gave us a nice little table example and said, at a minimum we'd really like to see this information. , And this is where I love to say this, the f d a loves tables as a tip, as a friendly reminder, just make your life easy and put it in a table.

Stop writing it in long word documents. Just put it in a table. It's just the way they love it. And when you look at this again, this chart and then you continue reading, there are actually in section five where it speaks to these examples, right? There are actually. Real detailed call outs that speak to the fact that you are still doing the process, right?

So as we were just saying about comparative task analysis, right on page 13, for example, in the section three, right above the table four, it actually speaks to description of device user interface when applicable, this section should include. And then on the bottom it says four modified devices consider providing information, comparing the subject and existing devices, right?

And again, , in a , so how do you get that table? You have to do the comparative task analysis, right? So I think , sometimes I feel like in this guidance it's a little hidden, , What the premise of it is. But , that was a big takeaway for me.

And Janet, I know that you feel the same way

[00:26:07] Janet Creaser: I do. Again, I agree with you a hundred percent. I think a guidance like this, or even if this could be shortened and put into the original guidance as an appendix to keep it all together. , Yes, my comments are probably coming , at some point to the open comment period, but , It, it is really valuable , to have this information, to understand that the process has to be followed, the details have to be adhered to.

You really have to understand what you're doing , and that the documentation portion of it can be modified for submission only. , You still have to retain, , whether it's human factors or not, you must retain all of your deliverables in your design history file, whether or not you submit them for submission.

So you do have to have evidence that process was done beyond your submission documents. , And so one of the things that I would really like to see, and I think why we're talking about this guidance today, is because we're fans of things that clarify. Guidance for people. We're fans of it and we wanna be part of the solution, not part of the problem.

And what I would really like to see is to just see this be shorter, more succinct, and more closely linked to the 2016 guidance in a way that helps people understand. First I have to scope my process, then I have to do all my things. And then at the end I can check something like a table or, and some examples maybe of different product risk categories to understand where I am.

, And know what I need to submit for my submission very easily, because we do have a range of submissions. My experience , in a couple of different medical areas has been, sometimes it's as small as a paragraph in your overall regulatory submission for human factors. And sometimes I did two products that were on that highest priority list, your whole Human Factors summary reports going in, and then sometimes they're asking for more after that.

[00:27:47] Heidi Mehrzad: . But let's also be clear. I love that you just brought that up, right?

Because you said Human Factors Engineering report and we had to do the full, the whole shebang,


[00:27:56] Janet Creaser: You always have to do the full shebang. Yeah.

[00:27:58] Heidi Mehrzad: Yeah. But let's remind ourselves, this is always the fun part for me. , if you did your document proper , your h f E report is just a copy paste most of the time from the documents you already produced.

Yes. Because every document you produced already at the top of it should have a summary of what the document is and the activity that was conducted in. I love when you do that , for the people who can't see, we're touching our noses.

[00:28:31] Janet Creaser: Ding. Yeah, we're touching

our noses. You got it. You're right

[00:28:33] Heidi Mehrzad: on the nose.

You got it. . , if you did your document in your activity right, you already have the summary, which then goes into your h I v report because your H F E report, guess what is , as you said, a summary of the summary. So it's more of Hey people, let's remind ourselves what we're doing here, and then here's a way for you to condense it in a sense that this is what we exactly wanna see highlighted for x, y, z situations.

And, before we wrap it up a little bit here today. I also wanted to point out two things , that left an impression on me on this guidance.

I actually enjoyed reading the definitions in this guidance because what really struck me is, And , I texted Janet earlier already today about this. , so many texts. , When you look on page five, right? , The definition of use, error use safety and user interface use related risk and use related risk analysis.

What really struck me, oh, let's also go back. Page four. Page four, sorry. People hazard and harm and hazardous situation, right? When you do your U F M E A, the different columns you have in it, right?

And the sequence of them and what they're supposed to be titled and what's supposed to be in them. And I get that in this guidance they give us a minimum what should be in it. But There's always this discussion of is harm the same as risk? Is hazard the same as hazard a situation?

Is it hazard equal risk? Is it, what is it? And honestly, I liked that it highlighted this a little bit and changed a little bit, tiny wording of it. Because what you get out of these definitions finally is to understand that, harm is the injury, right? Or damage to the health of people or damage to property or environment.

Hazard is the potential source of the harm. The hazardous situation is the circumstances in which people property or the environment are exposed to one or more hazards, right? And then when it goes to the use related risk, it is the combined probability, occurrence and severity of a harm for a given aspect of device use or for the overall use of a device.

And so that kind of was like, all right, can we finally all agree to not have a hundred columns in your U R A or in your U F M B A?

[00:30:59] Janet Creaser: I agree with you. Sometimes we have too many co I have minimal columns in my use risk analysis, just fyi.

Of course you do. Yeah, of course. Do. And if you wanna do a detailed podcast on probabilities of occurrences someday, I can totally wing that too. Oh,

[00:31:14] Heidi Mehrzad: we're for sure doing that. A hundred percent. So one thing before we close up today's session,

, Is we really wanted to have a casual conversation about this between human factors professionals who actually are gonna use this and apply it ,

I really wanted to make sure that we all understand that this is not a how to do your human factors. This is actually, I love to frame it this way. This is actually an open conversation, the FDA we are having together human factors, professionals and fda, , they listened to our comments, our feedback, and they said, based on that, here's what we're gonna give you.

So we can take a little bit of the ambiguity and the confusion out of what your submission should entail. They are very clearly saying in this does not mean you get away with not doing the process. It just means, hey, we get it. It'll is little confusing maybe in the beginning or maybe it's a little much, or maybe everything doesn't apply to you.

So let's take the question, the confusion out of it, and here's what we think and based on your comments and feedbacks what we really would like to see. That's it. That's all This is, it's a supplement. Let's leave it at that. , it's like your vitamin B pill in the morning.

It gives the boost to the original guidance. It makes you be a little bit more well informed about what your submission should look like, what it should entail. It does not replace anything, yeah, it supersedes the list of devices

but it's not superseding the human factors engineering process. So I think that gives it a nice little wrap up and. And at this point, I think I should just thank you so much, Janet, for coming on and having this conversation with me. Always lovely to talk to you , I think the audience gets it by now that we are friends and yes, this is the life of a human factors professional. When you are friends with another human factors professional, most of your conversations center on human factors, funnily we don't tire of it.

We still find it exciting, interesting.

[00:33:15] Janet Creaser: We just really wanna help clarify this.

We wanted to be very clear that. This is a great intent and it's a good start. And I think that if people who are knowledgeable and thoughtful come out and comment on this guidance, it'll get to a place and maybe positioned in a place that it is easy to use and that it's really helpful for everybody.

[00:33:34] Heidi Mehrzad: Lovely, lovely end words. Thank you so much, Janet. I can't wait to have you back on . As always, thank you everybody for listening and I hope you enjoyed our conversation today on the new guidance. And I hope you had some insightful moments.

Maybe some learnings, maybe some disagreements. Hey, share it all. We're open for feedback. Share it all in the comments section. Let us know what you think. And Janet, thank you again and I hope you all have a nice day. Thanks

[00:34:00] Janet Creaser: Heidi. This was fun.

[00:34:02] Heidi Mehrzad: And now we will take a quick break and come back with Elise's interviews from this year's annual H F E S, human Factors in Ergonomics International Healthcare Symposium in Orlando, Florida.

Stay tuned.

[00:54:13] Heidi Mehrzad: All right, folks. That's it for today. Great discussion. Please do share your thoughts with us and comment wherever you're listening to today's discussion. And please do support the show, of course, only if you like what you hear, or maybe if you don't like what you hear and you just wanna throw us a pity bone, leave us a five star review, tell all your friends about us and consider supporting the Human Factors Cast network on Patreon.

Links to all of our socials and our websites are in the description of this episode. Thank you again, Janet and Nick for being on the show today. Much appreciate it. You can find Nick at Human Factors Cast and Nick Rome on all socials. As for Janet, you can find her on LinkedIn under Janet CreER. As for me, I've been your host, Heidi Meza, and you can find me across all social media at H F U X research.

Thanks again for tuning in. Until next time, stay safe and effective.