Global Human Factors Strategy for MedTech: U.S., EU & UK Requirements Explained

started. Hello and welcome, everybody. My name is Sean Smith from MedTech Leading Voice. I'd like to welcome today's speakers, Jessica and Jenny. They're going to be leading us today in Global Human Factors Strategy for MedTech. Testing, de-risking, and planning for global success in the US, the EU, the UK, and China. A couple of housekeeping announcements before we get started. I'm gonna put all this in the chat. Let's see. A certificate of attendance will be provided upon request. If you would like a certificate of attendance, please put your name and your email address as you would like it to appear, the name as you would like it to appear on the certificate, and we will provide that to you in a

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Thank you.

Thank you, Sean.

So we're going to talk a little bit today about, planning a global human factors strategy for MedTech, And… and we just want to just really guide, guide people through how to think about… about a global strategy, and how you might implement that in the development of, of products moving forwards. Jess, can you just move on a slide? Thank you. So, looking at this slide, it's easy to understand why human factors requirements can be confusing and very onerous for companies developing medical products. There are lots of standards and guidances, all quite similar in their requirements, but with some key differences, which we will talk about a little bit later on.

So how do you, know which ones to take notice of? Which ones to tackle first? It's a difficult question. Most people in the industry will know that the FDA guidance is non-negotiable for US submissions, but we're seeing increasing requests from regulators outside of the US. For further justifications, and data. And there's an increase in the country-specific standards and guidances that reflect that, and just some key, you know, key things that have come into effect recently. Obviously, there's the EU MDR, That has… that has suddenly, brought into, effect more compliance to 62366, so there's more pointers towards human-factored engineering within that.

The MHRA in the UK, have issued guidance around human factors engineering. Most people probably know that China have issued, their own requirements, and their new… their own HFE guidance in 2024. And there's also, a specific Japan requirements. So… As you can see, the requirements are increasing and becoming more country-specific. Jess, why do you think the requirements are increasing globally?

I would just say that this growing interest from various markets with following suit to the FTA and 62366 is really encouraging. I mean, it's daunting, as you mentioned, Jenny, but it's really encouraging to see that everyone is starting to put particular focus on the usability requirements for their devices. Now, it's more so encouraging because most of our clients tend, or most manufacturers tend to only consider human factors at the end when they need to get a product on the market and tick a regulatory box. But really, what these guidance documents and regulations are trying to drive is to ensure that we're developing products that are a good fit for our end users. We want to ensure that, you know, when you're putting out your global strategy.

you're designing those products for those various markets that you're getting into, the different individuals that would be coming into contact and using your product in those various markets. And essentially, that's what these guidance documents and regulations are really and truly driving. They're ensuring that you are developing a product that is the right fit for those users in those intended markets. I wouldn't be surprised to see if we have more of these standards and guidance documents coming out, as time goes on. So yeah. that's why I believe that they're there, and I know we've had lengthy discussions about why we're seeing an increase in these regulations and standards.

Yeah, and I think all that means it's just really important to be able to build a global strategy up front, because if you've got all these differences in the different markets. And we'll talk a little bit around some of those differences later, but you need to build that strategy to ensure that you consider all those differences, minimize your cost, and maximize the efficiency of gaining global approval, and of course, commercial success.

That's so true, and I think… You know, if we look at the different regulations and standards documents that we've currently got that are specifically calling out human factors. The one key thing that differentiates some of them is, if we look at the FDA, for example, they require validation testing to include US-only residents. Now, we're seeing something very similar in China, where they're requiring Chinese individuals, to be included within the testing, not to mention the testing has to be done in Mandarin as well. But, you know, Jenny, I'd love to know whether you've heard of any situations where

when you've generated human factors data with non-US residents, have you ever been successful, with using that data for FDA submissions?

Unfortunately, the answer is I have not, but I've also never tried it, or heard of anyone that's tried it. I wouldn't recommend that approach either, just because the FDA is so… are so specific around wanting US residents as participants in human factors studies, so they're really… they really push Understanding the US users and how they might interact with the products. I think if you wanted to attempt that, you would want to have a very detailed prior discussion with the FDA before even starting on that approach. And I think… you would require substantial justification and evidence of how participants from outside the US represent those US residents.

I think it's… I do still think it's highly unlikely that they would accept it, though, and I have no evidence that they would, but maybe with an excellent justification and a lot of evidence to back that argument up, they would. I think the situation's very different, though, for… in Europe and for UK submissions. So, Jess, I just wonder if you could tell us a little bit about what might happen for companies that have already carried out work in the US? How might that work for Europe?

Yeah, so for companies that have already done the legwork in terms of usability testing in the US, it's important to note that while the FDA and IEC 62366 are broadly compatible within their intent. They do differ somewhat in the terminology used, the documentation structure, and also what constitutes as sufficient evidence. So… sometimes there'll be a bit of a mismatch, but it's really and truly understanding exactly what the requirements are for your submission for EU, UK regulations, and then where the gaps lie from your US-based evidence that you've already captured. So, for example, the FDA

calls for an HFE report, which does detail, you know, a summary of all of your human factors activities that you've undertaken throughout your product development lifecycle, but there is an extensive focus on the human factors validation, or summative results. Whilst when you're looking at UK, EU under 62366, they're looking more at the usability engineering file and the process that you followed throughout your design and development. So, from ensuring that you've got your intended use, user groups, use specification, user interface specification, task analysis, and all of those, if I can list them, going on and on. So…

sometimes… companies that have done formative evaluations and summative evaluations in the US, they tend to just have that summative report that they're then trying to submit to the FDA without really understanding, if you're wanting to create that global compliance, so that you can get your product on the market in the UK and EU, that there's a little bit more that may be needed. So… to reiterate, the FDA, they create that snapshot of everything, and yes, the ATFE report or summary report that you're submitting is giving them an idea of all the human factors activities that you've done, but when the UK and European notified bodies look at

the evidence, they're looking for how was usability built into the design, and not necessarily just bolted on at the end. So this, again, comes to a point I raised earlier about some manufacturers just waiting until the end to do usability testing without integrating it into their, product development lifecycle.

Sorry, Vess.

Yeah, go ahead.

The interesting thing about, about the, expectations of notified bodies, again, 62366, is they, they tend to go through a checklist. So, they'll be specifically looking for the items out of… out of 62366, and check compliance. So, if they… if you write a use specification. And they have… CAU specification in the checklist, they'll put a check against that, and I think that's, you know, it's important to know that they are looking for that exact terminology, and that's how they will assess whether you've met the, human factors engineering requirements.

Yeah.

Did you just…

No, that's absolutely fine. I was just going to add to the fact that, you know, even though there's the usability-specific documentation, so all of the documents that you are completing to compliant to either FDA or 62366, or MHRA, there's the… accessory documentation, if you want to call it that, and that's, like, your IFU, your user manuals that accompany the product. There are some fundamental differences between what the FDA expects in those documents and what the EU and UK expect, and I think we touched on this a little bit later, but that can impact the usability of the IFU in terms of can they find critical information for safety, can they locate it, and can they comprehend it? Now.

If you're tested in the, in the, US, and you haven't made modifications to your IFU, you'll likely make some modifications to comply with, EUMDR. And consequently, that can kind of change where things are located in your IFU. It might make the text smaller, because you don't want to use bigger pieces of paper now, all of a sudden. And that impacts the usability, so really understanding You know, creating that global strategy, knowing which markets you're going into, can impact not just the specific usability activities, but it's also the Ancillary activities and the accessories to the product that we need to consider.

As well.

And I think the other thing I think that's the key… that's key to note is that Whilst it's preferable to use data generated in the country that you're intending to launch into… for your summative validation, it's important to note that in the EU and in the UK, it is possible to use data generated elsewhere with appropriate justification. And again, we'll talk about that a little more later, but that is a… that is a real key differentiator. I don't know whether you want to just mention China here, Jess, and just, you know, what what implications… just having… looking at China as a large market have?

Yeah, so China is a little bit more different, in comparison to EU, UK, and the FDA. And I mentioned earlier that for China, they do expect individuals representative of the Chinese population to be involved in their studies, so very similar to the FDA wanting U.S. residents China wants exactly the same with their testing. China also specifically wants, their testing to be done in Mandarin, so particularly summative evaluations, and that's just to ensure that testing reflects the Chinese users in the context of use, representative of their healthcare environment that your product would be used in.

you know, there… there may be instances where, for lower-risk products, you could potentially leverage some of the usability testing that you've done in English-speaking countries, so whether that's been in the US or UK, or… in Europe, where English was the primary language spoken by those users involved. But… it is very unlikely in the instance that… it depends on who those users are, it depends on the product, and it depends on the context of use. Is it going to be a home use environment? Is it going to be a hospital? And what type of hospital is that going to be as well? So sometimes leveraging data from one country into China

is really sometimes more of a headache than it would be just to be able to test there. There are differences in clinical workflows, there are differences in hospital infrastructure, the training levels, the cultural approaches, to device interaction, and If you don't understand what those are in the context of your product, creating a justification for leveraging US-based validation data, or just leveraging any data from Western countries may be difficult. So, it's imperative within the China context to really understand who your users are going to be, where they're going to be using it, as well as

is there a possibility that you can do some formative testing to ensure that the Chinese population was considered during your development, not as an afterthought, you're then deciding, okay, we're launching in China, and now I'm going to do some formative testing to confirm that the UI that we've designed is appropriate for those users. In some instances, it may be, but in most cases, you'll probably find you'll have to make some modifications to suit those needs. So, there are… there are some significant differences, which rarely do… kind of inhibit or prohibit the use of Western data to help leverage that for China submissions.

Excellent. And I suppose the big question is, how do you build a strategy around all this regulatory landscape, I suppose, of various different… various different requirements and… and different user characteristics. Should we just move forward the slide, please?

Yeah. They didn't click on the right foot there.

So there is a… there is a way that, you know, you can sequence your human factors project, to try and gain global success in multiple markets and make sure that product's as successful as possible. Jess, I'm just wondering if you've got, if you can talk through, how you could structure some global activities to, say, project budget and just optimise that project design.

Yeah, so one way that one can certainly ensure that you're creating more of a globalization to your human factors activities, and importantly, to the user interface design process. And when I say user interface design, I'm not speaking about a graphical user interface. I'm talking about all of the elements of the product that a user needs to interact with in order to use your product. So, whether that is The physical design itself, the graphical user interface, some accessories that go with the product that you're designing in as well, as well as any of the, user manuals, the labeling, the packaging that comes with it. So all of that is considered the user interface. And in order to really ensure that you're testing for, or you're designing for the right people, one way to do that is start doing formative testing in UK or Europe.

They tend to be slightly lower costs involved with that, and considering also if you're wanting to create that globalization in terms of your design and your strategy. having at least one formative in the… if you're a US-based company outside of your primary location is always a good idea. it enables you to somewhat take the blinkers off when you're designing a product. It opens your eyes, it gets you to think a little bit more outside of the box to ensure that you are designing for all the potential users in additional markets and not just the US. So, one way to kind of plan that sequence is do a UK or EU formative, and then build your file as you go along. So.

don't wait until the end of your development, when all of a sudden now you've got this final product, and you're needing to put something in front of users. Start early, start making sure that you are including the users and human factors at the forefront of the design process. you know, this optimizes the design, and that's really the key focus here. First and foremost, you're optimizing the design, you're fitting it to the end user, rather than fitting the user to the product. It, as Jenny mentioned, it really helps with commercialization. You're really taking that feedback in from those end users.

And then, obviously, the big one that everyone tends to look at is that you're ticking all of those compliance regulations. So building that file iteratively, starting small at the beginning. But doing so continuously and iteratively throughout the design and development lifecycle of that product. And then, if you do have the option of potentially running a formative in the US, do that prior to going into your validation. That then helps confirm everything, it gives you confidence going into your validation as well. If that's not necessarily an option, running a pilot before you go into a summative would be advised.

But you then run your summative in the US, and you gather that data to then be able to help with your submission for UK, Europe, if that's a secondary market for you. And then also ensuring that you're assessing China's requirements. Now, we've got that as step 4 here. But I want to make sure that it's clear, you're not only assessing that once you've done your validation, you would know at the start of your project and the start of your development, which markets you're intending on launching this product in. If China is one of those markets, and even if it is 10 years down the line. start considering it at the beginning, because then you can build that into your strategy. Waiting until the end means, you know, you've done your validation, yay, you get to launch in the US, yay, you get to launch in Europe and UK, yay! You get to launch in China.

Maybe not. You don't want to get to that maybe not stage where you're then having to fundamentally change the design of the product. Because that change in design is not only potentially going to impact, all of the technical file documentation and testing that you've done, it also affects the cost of getting that product onto the market in an additional market, so… while I like to say human factors is, you know, the bearer of bad news, and most times they are. We do try to ensure that, you know, yes, users are at the forefront of everything we do, but… there's so many other fish in the pond that we need to look after as well when you're on a project. So don't just wait until after your validation to look at China's requirements.

Really, really interesting point, Jess, because I think you just touched on it then. You don't really want to be making specific products for specific locations, or specific user interfaces for specific locations, so… Actually, doing some early work in China, if that is one of the intended launch markets, is so important, and doing that in parallel. with working in other locations. It's much easier, actually, to use UK-EU, work to inform the US, even though there are differences between those two markets. there is a huge cultural difference between, Europe and… or the US and China, so some of those user interface design

Characteristics, you may only… realize, once… once that product's been in front of end users in China. In addition to that, I just wanted to go back and mention that, you know, carrying out some formatives outside of the US could reduce costs on projects anyway. And it generates great data to inform the user interface design. It also helps build the data to ensure that you can robustly use that data that's been generated in the US in the summative, and you have some rationale and justification in place to say why those participants in the US are representative of those outside the US. And the other thing that you can do as part of this sequence as well is to… is to look further into, user interface requirements through additional market research, so not formal usability work, but more

you know, will that product work in that location? Is it going to be commercially acceptable? So market research can be incorporated into some of these early-stage formatives as well. So you're not just generating usability data, it's part of an entire package of user research, let's call it.

So, I would like to interrupt for one moment, bearer of good news. We're gonna start the poll right now, hopefully. and launch, and while the poll question is running, I want to remind people of some important things, and I want to share some good news. Claramed has put together a global strategy kit, which is a… document, which, has a 25-point checklist, it has a country-by-country comparison, and it has some general, guidelines. If you would like a copy of the strategy kit, just write KIT in the, chat right now, and we will make sure that you get a copy of it, in the next, 24 to 48 hours. We're just, doing some final edits on the thing, so please, be patient, but I will make sure, personally, that everyone who requests a copy gets a copy.

Fantastic. And then the other point was, if you want a certificate of attendance, please put your name and email address into the chat as well, and say Certificate of Attendance, because that will be really helpful. To us. We have a number of questions, coming into the Q&A. Remember to use the Q&A function, not the chat, for your questions. Sorry, I cannot copy them over for you, otherwise I would. And yeah, I'm gonna turn it back over to our speakers. You can just minimize this on your screen. the poll, I'm gonna let it run for a couple more minutes, but it won't be in your way.

Thank you.

Guy, Jean.

Thank you. Okay, do you want to… should we… have you… do we move slides, Jess? Next slide. Yeah.

Good segue.

Yeah, okay. So, so really, this is just a summary of what each region looks at, so just some key points, and you can see there's some differences, and I think we've touched on quite a lot of this already, about which, you know, how you summarize the data, you know, the different pathways that you can take. Jess, I think you… we were talking about, labelling compliance to MDR and how all that can be problematic. I just thought that might be an interesting thing to touch on, just as a focus for the EUMDR section. Can you give us some more detail on that?

Yeah, so we've noticed… obviously, since EU MDR came into effect, that… there's certain things within an IFU that… UMDR requires that are just slightly different, somewhat… quite different to what the FDA expects in an IVU. One of those differences is, in terms of the intended purpose and then the intended use. Now. The FDA talks about intended purpose, which is, what does your product do? While EUMDR talks about intended use, and this goes beyond just what does your product do. It talks about what the patient population is, what the clinical conditions are that you're planning on treating or managing or monitoring with your product talks about the user profile to an extent, the use environment, and also encompasses the contraindications as well. So, as you can see, it's a lot broader, there's a lot more information that needs to be included there.

And if you've already covered, kind of, what your product does, and then now you need to expand on it, if you imagine a tiny little paragraph in your IFU that now becomes a slightly bigger paragraph. Again, to my point that I raised earlier, if you are in a sticky situation where you are unable to change the size of the pages that your IFU is meant to be in, you know, those specifications have already been set. you may be in a position where you now all of a sudden have significantly smaller font. I've certainly had that in the past, where we had to reduce the font size because of the additional EU MDR requirements for labeling.

And consequently, we ended up with participants using a mobile phone camera to enlarge what the text was in the eye view, and that was a very clear indicator that This would not pass, the requirements. at the end of the day, if someone needs to use a magnifying glass to read something that's quite critical to the use of your product, that's a big no-no. We then need to revisit the font size. So the intended purpose and intended use distinction is quite clear between the two. There are some symbols and language requirements that are different for FDA and EUMDR. And the EU MDR has specific kind of restrictions as to which symbols can replace text, and which text can replace symbols. So it's very important that you're aware of those differences there as well. There is additional information that needs to go into the IFU.

So, EUMDR is, very prescriptive in terms of the IFU requirements, while FDA-style labeling tends to be a little bit more conservative and marketing-aware. So, a very big distinguishing factor there is that EUMDR labeling is Demanding a little bit more of a clinical, transparent disclosure of limitations, rather than being a nice little marketing… an additional form of marketing that manufacturers can use. Now, the gaps are not necessarily what's in the labeling, but rather the supporting documents that help support the labeling. And this is also just looking at the claims and tracing back through your risk management file, your clinical evaluations.

And really and truly, the EUMDR is extremely specific about what they require there. It's not to say that the FDA is lax in that. I think, if anything, EUMDR has taken FDA bases, and then added onto that because they're wanting additional information. Another thing to factor in is EUMDR requires the IFU and labeling to be in the different languages as well. So, what you might just have had as a one-pager English for, US market, or maybe English and Spanish for US market, has now turned into a 26. language document. So that then also means when you are looking at your labeling and the way the information that you're putting in there and how you're describing things, you're probably wanting to be as concise and clear as possible, so that when you're doing those translations, it doesn't become lost in translation for any better

Way of describing it. So, labeling is not just a communication document either. It's a regulated output of the quality system. It's rooted on the technical files, it's rooted on your risk documentation, and really and truly, those are the primary drivers. Certainly, when we're looking at a global strategy, our labeling that we're creating is really being driven by what's in that risk file, first and foremost, and then, obviously, what's in the technical files as well. So, exactly how a global strategy helps with this is really ensuring that your labeling conforms to those different markets, and you're… you're hitting all of those points. But while you're conforming, you're also considering, does this

change impact the usability of the product? You know, when EUMDR came into effect, and all the IFUs had to be changed. We've had to do a lot of retesting of those IViews, not necessarily invalidations, but at least formatives to confirm that no significant changes were being made, to the way that users would be able to find and comprehend information within the IView. So, Jenny, I know I've spoken about EU MDR a little bit there, but I know you've been involved in the MHRA FDA HF guidance. Sorry, apologies, FDA, I've got that on my mind. Mhra FA guidance document. Could you tell us a little bit more about what that means for submissions?

Yeah, so essentially, the MHRA issued a guidance, and it is just that. It's a guidance, so there's no expectation to comply word-for-word with that guidance. It's meant to be a practical, document which helps Helps Compliance 62366, and make sure that human factors engineering is incorporated in the design and development of products. So, it's not intended to provide a different set of requirements, But it is a good guidance document, you know, it's something that… something that helps, you know, helps understanding and will aid somebody who's trying to… to comply. But it, yeah, it is essentially aligned with 62366, and to some extent, the FDA guidance.

I just wanted to touch on China again, Jess, because, you know, you're our resident expert on… on China. I just wondered if there's anything additional on this slide that you wanted to point out, because I know you went into some detail on it earlier. But if there's anything additional.

Yeah, I think… I think two things really stand out to me on this slide in terms of China, the one being the second bullet point there. So, external evaluators are required. So, unlike the FDA, where it's implied that individuals, Should not be part of the manufacturer that are conducting the summative testing. China is extremely explicit. They state it full out there for everyone to see that It needs to be an external party that performs that validation. And… if you think about it, it makes sense. They're wanting to ensure that there's no bias held within the conduct of that validation. You're not manipulating data to be able to get the correct outcome for your submission to be able to be successful. So.

that… that to me is something that's very important to point out, that if you are looking at China, you may need… well, you're not… that you may need to… you will need to be looking at partnering with an external partner to be able to conduct the validation in that region. The second thing that stands out, and while it may not necessarily stand out as a bullet point here, but it alludes to something that should really be at the forefront of, considering usability requirements for China is the 15 participants per user group. Now, I mentioned earlier that there are differences in training, there's differences in healthcare, there's different… and Jenny, you alluded to differences in culture.

One thing that, in MPA, we're very clear on is when you are doing your usability testing, you need to ensure that if your users are going to include healthcare professionals from different tiered hospitals, and they're not just going to be in urban areas, they may be in rural areas, that you rarely and truly encompass that within those user groups. Now, where it does become tricky is when your product is going to be a home use product, or something that a patient may potentially get exposed to in the hospital, but then take home with them. Them going home may not just be down the road from the hospital in an urban area, it could be over the mountains in the valley.

which is extremely rural, and so culturally, there's going to be so many considerations there. If you don't understand what that means in the Chinese context. the design of your product may fall to the wayside. So, one thing I always like to pinpoint is red in Western culture is danger, it's stop, it's don't push that red button. In the Chinese culture, red is a happy color, it's a positive color, so… Yes, while your healthcare professionals may not necessarily be concerned about colors, because they are very influenced by Western culture within the healthcare settings. You've got to consider if your product is a home use device. How does that fare for someone who doesn't really interact that much with Western culture, who isn't significantly influenced by that?

Another thing to consider with those individuals is, you know, How they view information. if anyone's ever seen instructions, in Chinese, I can't speak Mandarin at all, and I can't speak Chinese at all, nor can I read it. But it's very interesting, because it's very infographic-orientated. Our IFUs that we're seeing in Western culture Currently, are not very graphic incorporated. Yes, we are doing more of that, because we're seeing more people being inclined to review images and find those more helpful for using products. But certainly in the Chinese culture, culturally speaking, they're very far ahead with the way that information is presented and processed. So that may be something that you need to consider as well.

I say two points, but I suppose the final point is, obviously, you've got to consider, your testing has to be done in Mandarin, your report also needs to be done in Chinese. Now, what you could do is, if you did do your validation in Mandarin to comply to that requirement, so that it is representative of, the Chinese users. You could write your report in English, but you will have to have that translated. appropriately, not just Google Translate, unfortunately, appropriately translated for your submission. So it's something to bear in mind as well, because that, while it may seem something simple, can add time and money into your validation costs that you're putting forward for NPM.

So…

Thanks, Jess. Shall we move… move on?

Yeah! So, looking at demographics recruitment and participant selection, I wanted to ask Jenny if you have ever seen significant differences in participants that have impacted the use of study data.

Yes, so… so not so much the use of study data, because I think as we… as we've, explained previously, you know, you need to make sure those participants are representative. But it's… it's more around, whether they've, you know, whether it's impacted the actual Like, the study data itself? because obviously… and it's more around, you know, I've seen various different use characteristics that You know, that might, you know, you've done a study in… say, for example, you've done a study in the UK, and then you transfer and do your summative in the US, and it's an absolute disaster. Because even between the UK and the US, there are significant differences which could impact the use of a product.

And just to give you a few examples of where users can differ, even though you might not expect them to, and they speak the same language. So they can use different units of measurement. This has happened to me, unfortunately. So, Europeans tend to use centimeters and meters. In the US, inches and feet. Projects get developed, you forget about these minor things, and then you go to somebody study and no one knows what you're talking about. And then there are, you know, different words are used to describe things, there's different clinical terms. Jess just mentioned there's difference in what colours mean. The red's the obvious one, but I've had it with amber and yellow before as well, between UK and US, so that's… that's caused confusion.

And the other thing that I think is quite key is quite often people have the same job title, but different responsibilities between… in particular, between Europe and the US, so… in the US, people may be performing tasks that a different type of clinician or different type of healthcare professional might perform. in Europe, So it's really important to… understand all that. And there are lots more examples as well. But they… they can… they probably won't impact… if you get a successful study, they probably… those details probably won't impact your regulatory submission. You know, you can probably use your US data

for Europe. Because you will have had a good… a good pass in the US, but the minute you put that project into market in Europe. And people actually start interacting with the product, then some of those differences in user characteristics Could cause problems, and could really… could result in, increased use-related issues in market. Jess, do you have any other examples?

I'm just trying to think, I know I've recently had a study where, We… as part of the use specification. we had included physicians as a user group in the US. Not really… so this client themselves didn't really understand the difference in physician in Europe versus physician in the US. Physician in the US is like a general practitioner, whereas in Europe it's a general surgeon. those are two different roles, they're two different responsibilities. They also operate in different use environments. So we… we had made some adjustments, but it's something as simple as that. Very similar terminology, or similar titles, but as you alluded to, Jenny, very different roles and responsibilities. It's important to kind of create

an understanding of those. Now, you de-risk it by doing formative, so that you can gather that info. Sometimes one doesn't have the ability to do that, whether it's time or money, that are the limiting factors that varies from one manufacturer to another. But I think it's very important to be able to test that out, to make sure that you are testing the right people, and you're recruiting the right people to begin with. One thing that I have done in the past, when I've worked on documentation that has been leading up towards formatives and summitives. is within the use specification to come… because we're doing a global strategy, we've developed a use specification to comply with 6366. I've actually separated the users and the user groups according to the region. So, when we've done testing in the UK,

You may have a tissue viability nurse, who is the name of the nurse that would be using that product, but in the US, they're not known as tissue viability nurses, they're known as certified wound ostomy Care Nurses, and so… a sea walk-in and a TBN, they do very much the same thing, but their titles are very different. So in order to capture those differences, I have separated them into US and rest of world, or US and EU, UK markets. And that's really okay, but it's… I think understanding what those differences are is so important, to making sure that you're firstly de-risking your product development and design, but also de-risking any studies that you're going to be conducting in those markets.

Thanks.

Right, so, looking at what this all means in terms of cost, You know, we talk about cost quite regularly, advising individuals on what's the best strategy for their… their products and their projects. But Jenny, it often looks like skipping formative seems to be a really good idea to save budget, but what really and truly is the real cost or benefit of conducting formative studies?

Well, I hope we've already covered quite a lot of that today, with all the, you know, the examples, but, I mean, there are a number of reasons why formatives are important. And I think the most obvious is that they de-risk the summative. So, knowing what might occur and iterating the product design, it prevents summative failure, it prevents you losing all of that study budget, it prevents a delayed project launch, and potentially the redesign of a user interface and repeat testing And that whole process of going around that loop again when you've got… think you've got to the end, that can cost hundreds of thousands in product design.

And… delays of years rather than months, usually. But in addition to that, if you do multi-market formatives, you also optimize the design for commercial success in more of your intended markets. So they ensure that that product design is a good fit, for different markets. And it will fit cultures, healthcare systems, and clinical practices, amongst many, many other things. And that minimizes potential for, post-launch use-related issues in those untested markets, so I think I think formatives, you know, they just… they do… they do a great thing, not just for regulatory submissions, you know, making sure that that is… is… is a safe, you know, you're following a safe path, and you're going to get where you need to go on the time and budget that you're expecting.

But also that your product will be commercially successful and a really good fit for the end user. And I think planning that global strategy can be relatively cost-effective. Jess, do you have an idea of what it might cost?

The actual planning strategy is extremely affordable. It's minimal cost, it's looking at how you're going to design the right product for your intended users. And it's also looking at how are you going to justify any information should you need to. So. You know, if you have a substantially equivalent product on the market, do you really need to be doing all of that human factors testing, or you know, maybe you've done a validation in the predicate device. Okay, so let's evaluate what changes have been made from that predicate device to this new iterative device that you're bringing out. Because really understanding those changes then gives you a clearer path of exactly what is going to be needed from a human factors and usability standpoint.

Now… That's quite cost-effective. But the execution of said plan will… Probably be a little bit more than what you might expect, perhaps, but… The benefit of implementing a global strategy outweighs the risk of potential customer complaints that you get once that product is on the market. The potential recall if things really go badly, and whether it's a voluntary recall, or it's a forced recall by a notified body, or by… a regulatory authority. You don't want to have a recall against your name. But also, more complaints, potential recalls, that all impact your brand loyalty. And I know we've spoken mostly, Jenny, you've mentioned, you know, the commercial viability of products, you've mentioned the commercialization, and really how that features.

At the end of the day, you're creating a product that is going to enhance the business that you're creating that product for, and that business most likely is built on brand loyalty. I know I keep using the same type of products over and over again, and I'm quite sure there are a number of people on this webinar that do exactly the same thing. And even when you do have an issue with it, you'll probably try something else. And then… you might come back, but depending on what that issue is, it just takes something significant for you to change your mindset, and you won't use that again. You're going to go back to find an alternative, or, you know, you'll look at Google reviews to see what the best alternative is out there, or in this day and age, you'll either use

ChatGBT or Claude or any other AI format to find out what the alternative is. But that brand loyalty is so valuable, and if you think about a medical device, it's trying to enhance the life of individuals, it's trying to get them to live their lives to their fullest. Depending on what the condition it is that they've got, the, problem that your product is trying to solve, manage, support. monitor. Whatever it is that your product is trying to do, you're enhancing the life of either the individual that is using it, or ultimately, the patient. And so, you know, if they lose that brand loyalty, they keep getting complaints, your products get pulled from the market, it's not that great.

So, yes, the execution of a global strategy Because you might want to add in you know, not just one UK formative, you've got a UK formative, you've got a US formative, then you've got the validation. You may also have built in a formative for China and a validation in China, just because you know that that's what you're going to need. And those can add up, but the risk of not doing them, or not knowing exactly what you're testing, how you're testing it, when you're testing it. and factors that feature into that can really end up being way more costly. I know, Jenny, you mentioned earlier about making design changes.

You know. those design changes don't just impact the usability testing, it's all of the validation and verification testing that you've had to do. It's going back to the drawing board and those tests, having those redone. So it's the cost of those tests, both in time and finances, and then also having to communicate to your stakeholders that no one wants to do, communicate to your stakeholders, oh, by the way, you know you want to to launch in about 6 months' time. It's not gonna happen. Let's add a year and a half onto that because of all the testing that we need to do now.

So.

It's the cost of lost business as well, isn't it? You know, like, that's a huge cost.

I think we just need… just so we can get on to Q&A, Jess, I think we should just move on to the… onto the next slide, and I'm just going to very quickly tell you… what my biggest recommendation would be to avoid pitfalls, and then maybe, Jess, if you can do it, and then we'll move on to Q&A.

Yes.

So, I think my biggest recommendation would be, understanding where you want to launch up front. So you can understand the regulatory requirements, and plan how to meet them, and understand the users through research informatives, and plan how you're going to generate the data to support that global strategy, just so you don't get caught out later on. Jess, what's yours?

Mine would be integrating human factors, early in the design and development lifecycle of the product. The earlier you do it, the quicker you can catch any issues, the more influence you have on the design to ensure that you're designing it for the right… you're designing the right device or product. for the intended users, rather than waiting until you get to the end, and then you're like, oh, we need to make all of these changes. So implementing it early is always going to be my biggest recommendation for avoiding any of these pitfalls.

Right?

Oh, lovely. So I'll stop sharing. Sean, do you want me to stop sharing my screen, or… Just go to the last slide, think through one more. So, right.

We're gonna, start with some questions from the audience. There was one here, so for minimum participants, it identifies 15 per user group, is this a must, or is it possible to leverage or rationalize, for example, an OBGYN versus a GP, etc? Does that question make sense?

I think so. Typically it is 15 per, unit user group, so… I… I think that there are, you know, and this is… and this is for the FDA we're talking. I'm assuming this was for the FDA. So there is… there is a little bit of… of leeway if you've got a user group where, you know, you've got… you've got a very rare type of user, where there aren't that many that you can recruit from. I've not come across that many, but there are, you know, as with everything, if you can build a rationale about having A much lower… a lower number. then you might be able to have that conversation with the FTA. For Europe, it's not quite so set in stone. It is possible.

to use less users per user. We probably wouldn't recommend it. Again, you know, 16366-2, just talk about using the same The same number of users per group. But yes, in general, 15 is the… is the golden number per group.

Fantastic. The next question is, considering that risk assessment output is an input for usability testing, what would be the global strategy for integrating risk management? Does that make sense?

make friends with them early on. I think this really speaks to why I feel that number 5 on the previous slide is, what resonates more with me, is You have to start early, so starting that risk file early, but the basis… particularly for usability, so when you're looking at your UFMEA or your URRA, you are… Starting it off looking at the tasks that individuals perform, the steps that they may need to perform to use your product, and then really working out what could they potentially do wrong, because that then spits out the hazardous situations, the hazards, and the associated harms. Now, I know saying start that early is all well and good, me saying that when you only have, kind of, a concept on a piece of paper, but that's really still a very good place to start. It's getting into the habit of integrating human factors activities early on into the risk management process. And I'm really and truly not joking when I say, make your risk management team your best friend.

Because if you don't have them on your side, and you're wanting to try and communicate something through the RIST files. they're going to push back on everything you want to do. I mean, as they should. They should be challenging you while you're doing it, but you also want to make sure that you've got a very transparent relationship with them so that you can have open and honest conversations about what you're wanting to include, what you feel is feasible, what is not feasible, and really hashing that out. I don't know if you have anything to add to that, Jenny, but…

I mean, it's such a good question, this, because risk management is such a key part of human factors engineering. You know, we can't do our jobs properly, as per the regulations, without having a very robust risk file. But part of that robust risk file from a human factors point of view is about understanding the precise tasks that someone undertakes, and the actual severity of harm that could occur. So it's not just about documenting the risk, it's about having an accurate clinical, determination of what could happen as well, because being very… overzealous with the, with assigning severity could mean that you have a lot of critical tasks, that you have to put a lot more onus into controlling those risks within the user interface design, or being, like, underzealous, I'm not sure that's a word, is,

It means that you probably won't have an appropriately designed user interface to control risks properly, so if you see the risk file as being the thing that guides the development of the user interface. then what Jeff said is true, you know? Be friends with, input into the risk file, make sure that it's a two-way… a two-way street between… between those two systems and documents.

Thank you very much. We are really pretty much out of time. I would like to take this last minute to remind everyone, if you're interested. In a private workshop, please reach out to me, on, human factors and, for your team, and we'll see if we can arrange that. Then, if you would like the kit, please write kit in the chat, and we'll make sure you get a copy of the kit, or email me. And lastly, I would like to say there were nearly 30 questions in total. Obviously, we didn't get to all of them, so we'll follow up with you individually and try to answer your questions, as best as possible.

Finally, a favor, if you've requested a certificate of attendance, remember name and email, in the chat, please share it on LinkedIn. It could really, you know, do a lot for us. And, I think today's session was extremely valuable. I'd like to thank our speakers, first of all, Jess and Jenny. sponsor, Claramed, and, all of you for your time and attention today. Thank you so much for coming. Jess and Jenny, would you like to say goodbye to everyone?

Yeah, I'm loving all of the little things that are popping up on my screen. I can't see them on the big screen, but I see them, and I'm loving them, so thank you all so much for attending, and I really hope you found it insightful. Jenny and I love having a conversation about HF, so always happy to continue the conversation.

Keep the questions coming, share the love, complete the feedback survey, and thank you so much for your time, everyone, today.

Thank you all.

Bye.

One thing.

Thank you.