Beyond Human Factors: Identifying the Barriers to Real-World Use

Hello and welcome, everybody. Sorry we're a minute late. Technical… last minute technical difficulties. I am very excited about, today's webinar, Beyond Human Factors, Identifying Barriers to Real-World Use. Real World Use is a recently coined term, that, Alper and I came up with together to describe the junction of market research, market insights, and human factors. Today, Before we get started, I have a few housekeeping announcements to make, and a couple of upcoming events, so I'm just going to run through that really quickly. There will be a recording of today's session, and slides will be made available to all registrants.

They'll be sent, tomorrow. Certificates of attendance will be available upon request. Please write your name as you would like it to appear on your certificate and your email, in the chat function below. There'll be a brief poll during the call and a post-webinar survey. Please share your feedback. Your feedback is very, very important. Alper, you want to mute? please use the Q&A function to add speaker questions. So, questions go in the QA, chat, for me, goes in the chat function. Alternatively, you can email me at sean at virtuebtob.com.

The upcoming events, tomorrow, Charles Rolais from TraceX is going to be presenting the QMS conversation your clients are having without you. This is especially important for consultants on the call, if you want to join this session. Then, let's see, Friday, May 22nd. Oh, this is new, the 7 Deadly Sins of Test Method Validation. So, if you're interested in test method validation, this is… this is the, webinar for you on Friday the 26th at 11 a.m. And then, the last… Two more. Register now for… from observation to action, what to expect after a 483. So, how to respond to a 483 from the FDA with the shallot.

Benson from LeanRIQA, that will be on the Thursday, May 28th. And last but not least, InSilico, Evidence and the Future of Clinical Evaluation with Suresh Suresh from, Tuvsud, will be on Friday, June 12th. There'll also be an event on, June the 5th to be announced shortly. shortly. That's it for my announcements. Again, if you have any questions for me, please put them in the chat. And, without further ado, I am going to, turn it over to you, Albert, and you tell me when to advance the slides.

Awesome. Great stuff. Well, firstly, thanks so much, Sean, for… for the introduction, and thank you, everyone, for those of you who have been able to join… for joining. It's an absolute delight to be able to walk you through, the series of slides I've prepared. I know we originally suggested it would take maybe an hour. It's likely to fall slightly short of an hour, which I don't think anyone will necessarily grumble about. But before… yeah, I mean, I guess before I introduce myself, thought it'd be useful just to take a step back and just really touch upon the purpose of the next half an hour to 60 minutes in terms of what we'll be covering. As the title states, Beyond Human Factors, Identifying the barriers to real-world use.

And here, what we'll essentially be focusing on is what lies behind, both before and after human factors. So when we think about human factors, we're talking about and thinking about that program of work that focuses on the safety and usability considerations for medical devices. And what we're thinking here, in terms of what lies beyond and before and after, are, I guess, those rumblings, those factors, circumstances, considerations. that can quite heavily impact, Tom. Hinder or equally facilitate product preference? And ultimately, product adoption and continued use. And that really will be the focus, looking at when we should be focusing our attention to understanding these considerations, and at what stage in the product development lifecycle, and also why, why it's important.

So, in terms of my experience, and I won't bore you, with my bio, but essentially, I've been in the med device space 13, plus years. Previously, I spent, pretty much all of my life pre-med devices in a more gritty social policy space, including health. Understanding the needs of some of the most disadvantaged, challenged, sometimes challenging populations, and equally some of the most privileged, people you can imagine in their own environment. So we're talking about homes, prisons. Police chiefs, politicians, young people, the list… the list does go… go on. So, just moving across to the next slide, Sean, please.

Super. So, as the title identifies, human factors gets devices through validation. That's all clear, we understand that's the principal focus. Now. A device can shine in a usability study. It can be handled perfectly, seamlessly. clear comprehension of the instructions for use. No use errors, no significant handling challenges. But does that necessarily mean it will shine, it will be adopted, it will be preferred, prescribed, purchased over competitor devices? And I guess the simple answer there is no, not at all.

But knowing this, sadly, what we see, what often happens is that Is that that reality is often discovered a little bit too late, either at launch, post-launch, years later, when the device maybe isn't prescribed, not used as much, when users switch away. And it's often too late that the groups and teams realize this. And that's largely due to the fact that a key, a vital part of the jigsaw is not having been put in place, and that piece is what Sean referred to earlier as real-world user research, or real-world research. So if we move on, just in terms of what we'll be covering for the next 60 minutes, so we'll kick off just to think about maybe adoption barriers and why they sometimes go unseen.

We'll then move on to think about the four real-world user research moments in development, and just provide a whistle-stop tour of those, and also highlighting what's at stake. When those big barriers maybe aren't explored and don't become visible. And then we'll provide some examples of real-world user research in the field, so we'll focus on three programs. And then, maybe just take a step back to think about how does real-world user research sit alongside human factors? What are the… what are the pros? What are the strengths there? And then provide, reward user research diagnostic, really a take-home for you guys when it comes to assessing your own, program, and where it stands.

And then finally, and arguably the most exciting, part of today's session, will be a quick run-through of what we'll be offering, some of you who have kindly been able to attend today's session in terms of a complimentary service. And I'll tell you more about that at the end. It's a really exciting. Really, really exciting opportunity. So let's move on to the first of the many areas we'll be covering. So, as it states, where adoption barriers form, and why they often go unseen. Now… there are essentially four main factors, or I guess you could call them approaches, that can cause challenges. And blockers, to materialize, and also go unnoticed, which real-world user research is specifically designed

to address and overcome. And we've listed some of them here, and these are really the key from our perspective, but there may well be others. It'd be interesting to hear your views. So initially, if we think about that reliance on internal expertise. Now, drawing upon internal expertise in product ideation, product design, is incredibly valuable. It's invaluable when it comes to shaping the focus, the design of product. But the reliance on that expertise, especially when there's only a reliance on that expertise, does come with significant risk. In the internal expertise, or even the views of friendly KOLs, friendly surgeons.

presents a view that's filtered through a particular lens, and with that, potentially comes bias. As you're drawing views from quite a unique pool that doesn't necessarily reflect the views of those who will ultimately be using… using the product. And this is where real-world user research adds that truth, that color, that depth. That grounded evidence, which is critically important when it comes to product design and adaptation. We also think about human factors. As I mentioned before, it validates use. Real-world user research investigates adoption. Now, together, that combo is incredibly powerful. It's an immensely powerful partnership, each which essentially answers mutually complementary questions, and as a tag team, it is invaluable.

We also have the buyers, the users, the prescribers, three audiences, often there are many more. And… and in all device categories. there are multiple perspectives, as I mentioned, beyond buyers, users, prescribers. There are many other audiences, and what's critically important is that each of those need to be not only identified. but understood, once again. And what real-world user research does is focus heavily and places the spotlight on all relevant parties. Early on, so product designs Develop in the… in the interests, of a much broader, much wider audience.

The other gap that we often see is when… well, I guess it's more of a question that we hear is, when is the right time for real-world user research? And I guess in a nutshell, it's never too early, and we'll talk more about this in a moment. And it's never too early, even before concept ideation. It's critically important to identify those needs and barriers and ill-met needs before they become a problem. So the earlier, the better is… is the take-home there. So why is it that adoption barriers stay invisible for so, so long? And there are a number of issues, or what we've coined as, I guess, problems here that I'd like to run through, the first of which we're calling the delay problem.

Now, where the delay problem's concerned. the true impact of barriers that are suspected very early on don't always resonate with teams early on, so they don't necessarily resonate with sales teams, R&D, Largely because they're not felt at that moment in time. And the cost of skipping real-world user research isn't wholly appreciated in that moment, and it's not realized also at that point in time. And I get it, we get it. Budgets are tight. And a focus, purposeful, focus on real-world user research is often just seen as a luxury, and either conducted tokenistically, or sometimes just pushed to one side. But an initial investment in that type of research

Would have been a far, far cheaper option. I want to make sure that.

On the right slide. What slide are we on? Section 1?

Why adoption… why adoption barriers stay invisible? 7.

Sorry. You need to condense the slide.

So then, thinking about the confidence. problem. As it says, the concept's well understood, adoption drivers and user needs sometimes aren't. So, what we see here is that at the concept level, it works, it works well, but confidence is sometimes based on a very partial view, and it misses that full picture. Essentially, not knowing whether it'll work for users, and you only really get that by talking to all audiences. concerned, whether it's the person living with a condition, sales team, procurement professionals, carers, or teachers. and others in loco parentis. So, it's about having that confidence and understanding beyond the concept, and ensuring that things work beyond that concept.

And we also have the timing problem here. in terms of when real-world research is conducted. Now, Noah touched upon this earlier, but really, I think the… If in doubt. I think the safest thing to think is, if real-world user research feels a bit premature to you. That's often the best time to conduct it. As early on as you can. To establish, design, preempt, and fundamentally mitigate any issues, any blockers raising their head down the line as early as possible is most likely to pave A smoother path. And… and journey.

Moving on to the next slideshow. So the four moments of real-world user research in development, and what I'd like to do is just really provide a flavor Some examples of real-world user research in development, and also some of the considerations, concerning… concerning these. So there are a number of focus points here, just worth, Just worth focusing on. See, if we think about the early stage, early stage exploration, and firstly, the early stage Is there a need? appetite for the product. This is really what we're seeking to understand. Questions such as, how could it be used? When, where?

How might it impact? How might it add value and benefits? And here, the drive is the need to dig a lot deeper, and to learn a lot more. I think a prime example here is the ADA, American Diabetes Association, in 23, clearly stated there's an inadequate understanding of the experiences And the emotions associated with real life. emergency use for people living with diabetes, and that stems largely from an inadequate and maybe inappropriate type of research having been carried out or not being carried out. And this is an area of re… an area… a therapy area, a condition area, where a huge amount of attention

and funds are thrown out. But yet, according to the ADA, still an inadequate understanding of those lived experiences. So there lies the critical importance of carrying out that early-stage research. We then move on to two, thinking about the design stage. And here, what we're asking, to a great extent, is do we really understand the true use environment? And a number of issues spring to mind, really, here. One of them is, it's all well and good conducting sessions, research sessions, in beautifully plush, swanky viewing facilities, and there's a time and place for that. But a lot more needs to be done. We need to get out there. We need to experience, understand.

Appreciate the true use environment. for example, noisy children, a frantic lifestyle. Also, the emotional, the physical, tension and burden associated with living with a condition, and these don't… impact… operate in isolation from using a medical device. These all often shape how someone not only perceives and relates to their own condition, but also shapes how someone feels about and uses their medical device. And it's critically important that we have a thorough insight and understanding of that. Both at the early stage and throughout the design stage, touching base time after time with the intended user, just to make sure that different iterations of the product still align with their realistic needs and their use environment.

We then move on to pre-launch. We've established there's a need, through stages 1 and 2, but will the product be prescribed? Will it be… will it be purchased? Will it be used? Will it continue to be used? What does the launch, the marketing plan need to look like? What does it need to feel like? What does it need to do to resonate and spark adoption? And this is where the type of research I'm referring to really, really comes into play to understand what needs to be done in order to tickle those boxes with the user, the buyer, the prescriber. And… and beyond. And then finally, post-launch. The product's out there. But is it ticking all the boxes you hoped and aimed for it to tick?

We need to be talking both to current users, those who are not using for whatever reason, also those who have switched away from your product, just to understand what's motivating Continued use, what's resulting in people not being aware of your product, or choosing not to use it, and equally choosing to switch away from it. And here again lies the importance of real-world user research. Moving on to the next slide.

I'm gonna go ahead and run the poll, feel free to talk over the poll, but.

Yeah, sure. Everybody could.

Just… Take the poll, and then…

Super. Okay. So, if we think here about… almost taking a step back. So, what we're hopefully realizing at this stage is that Human factors and real-world research. not only answer different questions and have a slightly different focus, but they're a beautifully powerful combination. They work from the same brief, but they provide different perspectives and necessary benefits for products to fundamentally succeed. So if we move on to the next slide, Sean. So we're… what I'd like to do is just give you an insight, just briefly, into three programs, and the risks associated, with barriers that aren't… barriers that aren't really addressed.

So, a number of examples here, initially thinking about real-world user research, where neuromodulation is concerned. So, thinking maybe here about an implantable neurostimulation device for people living with chronic conditions. Now, potentially, more or less, there are 3 audiences here that we're relying on saying yes to a product. And these audiences need to be one over time. So we have the implanting specialist who maybe recommends the device, we have the referring clinician who screens candidates, and the person with the chronic condition who decides whether they want to use the system. And what real-world user research and real-world research does is understand

Those different perspectives. critically important for a product to succeed. So programs that win the implanter and lose the referring clinicians spend launch budgets on the wrong audience. And equally, contented users drive long-term economic success. So it's critically important to ensure that those individual and often quite distinctive. In contrasting views are fully understood and incorporated into not only product design, but also the marketing campaigns that underpin those. We think about maybe the diabetes space, maybe about continuous glucose monitoring, insulin pumps for people with type 1. Now, product adoption relies on products meeting very, especially with diabetes, very complex

deeply entwined needs, environments, and thinking about pump and CGM use, there are so, so many complex variables. The needs, the needs, demands, the challenges, that ones face, the ones face in terms of data management, using a device, tiredness. stress, how to manage food, and exercise. And don't forget the consultants, the caregivers, the parents, the schools that care for children during the day. All of these play a key role in impacting a person's diabetes. and management. And there's so much difference there that, again, real-world research really drills into. As you can imagine, the needs, the demands, maybe the challenges faced by

On one hand, a teenager managing exam stress or a game of soccer whilst living with diabetes and handling an insulin pump or an injection pen aren't the same as those of a corporate exec crossing time zones to present to the board, again, having to factor in the times programmed into their insulin pump. And again, adoption relies on a product meeting those complex, versatile needs, conditions, those unmet needs that often exist. And again, that's where real-world research really comes into its element, dridging deep, often qualitatively. And then finally, if we think about stroke rehab, maybe recovery, rehabilitation.

devices for people post-stroke, in some instances, living with communication impairment. And again, so, so many needs and differences that need to be teased out. You may be talking to people living with aphasia or motor impairment. caregivers managing daily routines that ties them in emotionally challenging nature of those circumstances. Rehab commission clinicians. prescribing across acute and community settings. And what real-world user research does. that enables us to tap into those is use a whole host of different approaches and methods that I'll touch upon in a moment.

And it's these that enable us to ensure that these unique perspectives are fully exposed, firstly, and probed and explored to ensure that we have as thorough a possible understanding of them. To feed into product design. Moving on to the next slide, please. So we've covered why real-world user research matters, and to what end. But also, how we go about doing real-world user research matters just as much. And I dug up a quote by a chap called Alfred Adler. Some of you may be aware of him, he's the founder of the School of Individual Psychology.

And I think his perspective and his suggestion, resonates beautifully here. And what Alfred suggested we need to do is to be seeing through… with the eyes of another, listening with the ears of another. And feeling with the heart of another. And in my mind, that philosophy rings absolutely true across every real-world user research study, regardless of who the research is conducted with. So, with surgeons, just understanding their lived experience, they're understanding their protocols, experiences, the pressures, the pain points, the anxieties as well, seeing through their eyes.

When we think about, for example, people with diabetes, understanding how insulin pump and CGM use is shaped by the daily routine, understanding the interrelationship between device use, work, home, social life. Intimacy, what that looks like, feels like, and how the two are entwined and interrelate. It's critically important, again, seeing with the eyes of another, listening with the ears of another. Even with hospital procurement folk, again, understanding their lived experience when at work, the priorities, their needs, their motivations, the pressures Understanding what resonates. And why?

So it's very much about essentially putting ourselves in another's shoes and digging deep to understand what's going on, and feeding at every stage those insights into product design. So if we move on to the next slide, please. Sure. So, thinking here about where your real-world user research, actually, I've skipped a few here, bear with me for a moment. There we go, apologies. Had a slight glitch. There we go. Apologies. So, we've again spoken about real-world user research and what needs to be done, and earlier I alluded to how we go about doing this. And there are, as you'll all likely know, a plethora of tools that allow us to do what Alfred Adler suggests we do, so seeing through the eyes

Of others. And what I'd like to do is just focus in on some of the more commonly recognized used approaches, which, I guess, arguably form the backbone of many of the approaches and skills that we apply when we carry out real-world user research. Now, these many methods in many ways differ from the types of approaches and methodologies we utilize when we conduct human factors research, in quite important and distinctive ways, but there are also shared commonalities. Between the two. So if we think about in-depth interviews, these can be carried out in many, many different ways. Both in person, online, etc. But what's often the ideal here is to really get out there, so to move beyond the viewing facility. Nothing beats seeing someone handle a device in their own environment with distractions

taking place, that would always take place, whether it's a child running around a television, being on, sat on their own sofa. And in-depth interviews of this nature, especially in situ, are fantastic for understanding an individual's unique experiences. Their motivations, their needs, the device interactions. And especially where real-world user research is concerned, they're especially dynamic, they're very probing, sensitive, responsive. sometimes involve constructively challenging views, again, in order to gain further insight. So what's important is we get to the bottom of what it's like using a device, which these types of methods are fantastic for.

We also have focus groups, which generally get a mixed reception, very widely used in all spaces, maybe less so in the med device Arena, but it makes sense for them to be used far more, especially where real-world user research is concerned. Really, because there's a strong need, in my view, to capitalize on human nature. We're social beings, and a lot comes out of that dynamic, and we need to utilize it. And the way it can be utilized beautifully, for example, is when generating marketing collateral, we're exploring… When exploring blue sky concept ideas and encouraging groups To share their experiences with current devices, encouraging them to

Share challenges, and on that basis, working together, facilitating them to work together, to identify concept ideas, or identify solutions to currently ill-met or unmet needs. And sometimes there's that age-old concern around dominant voices overshadowing others, and I push that to one side largely because it's easily dealt with. Effective experience moderation will nip that concern in the bud. We also have observational methods, and again, so many variations here, and beautifully placed to provide contextually rich, grounded insights, whether researching people with a condition. healthcare professionals, in any context, really, because it's important to understand how context shapes behaviour, which it fundamentally does. And these methods, again, can be conducted as a participant approach, where you're involved in the mix of what's going on, or non-participant, where you stand back.

Purely and utterly, and observe. What's… what's going on there?

I'd love to interrupt for a moment and just ask the audience to put 1, 2, or 3, or any combination of them, 1, 2, and 3, you know, to say which kinds of qualitative research, or real-world use research you've participated in or done, feel free to explain in the chat, but give you an opportunity to To, participate a little bit in this. And a reminder, if you would like a, certificate of attendance, please put your name and email in the chat. As well. Moving on.

Great stuff. Thanks, Sean. So, moving on to one brief, two complimentary… lenses.

We're good.

Super. So what we see, and what we have seen here, is that both disciplines produce, when they work together, something really, really powerful. Almost invaluable, in that when you have the two disciplines, human factors and real-world user research. running alongside, in tandem, hand in hand. You end up with this far more grounded, almost 360 insights. of what needs to be developed, who it needs to be developed for, and I guess the fundamental reason why. You get that in-depth understanding of the population's unique and shared views, covering all the different perspectives, again, ensuring that your product covers as broad a possible

customer base. It provides insights that allows teams to design, I guess, in a truly inclusive manner. Fundamentally helping to mitigate barriers from the get-go, identifying those barriers and mitigating them, which not only paves the path for a smoother product design journey, but also fundamentally saves time and saves money in the long run. Also, risk management documentation, just ensuring that it's built on comprehensive, inclusive, real-world insights. And hybrid insights, again, combining the two, that combines safety and a usability lens. Also with a preference and adoption lens, once again, providing this

this beautifully… powerful combination. And together, what we see with real-world user research and human factors, giving R&D, clinical and commercial teams a complete view Of not only how, but also why their device should be developed, for whom, and also how it should perform, and maybe how it's likely to be used, and likely to be performed. So where does your real-world user research program stand? Just moving on, sure. So… Fundamentally, to successfully apply those four movements, four moments of real-world user research to your device program.

Ideally, you should be asking yourself four key questions that I guess we've been going back and forth. From as we've been running through the slides. Firstly, thinking super early stage, is the problem that you're solving the problem that your users actually have? Is there a need, fundamentally, for what you're developing? Secondly, thinking about the design phase, does your solution link to how your user actually operates, works in real-world conditions? Just ensuring that the design observed in actual settings is observed realistically, just to ensure that the variability of use environments is fully, fully understood.

When we then move on to pre-launch, will buyers, prescribers, users each have reason to choose your product? And again, ensuring that those different perspectives are fully understood, because they're so varied and differing, comparing a buyer, a user, a prescriber. These are all decision makers. Understanding that purchase, that procurement process, the budget lifestyle, who are the gatekeepers, who are the blockers, positioning the product, the pricing. Also, the marketing collateral to ensure it has as high an impact as possible. And then, as we mentioned earlier, post-launch. Is actual usage matching projected usage?

And what explains that gap? Where… where it exists? What's going on? What are the blockers? What are the motivators? Why are maybe a proportion of users jumping ship to… to competitor… competitor products? And these really are those critical four Key questions that should be asked. When you're applying real-world user research at those different moments in time. So I mentioned earlier that, we're really, really excited to be able to extend an offering here, and what we're… Referring to is a real-world user research review. And really, the intention here is to offer something that will help

help the cause. We'll be offering this review, and it's really intended to help companies get on the right path, where the development of their products in concern, by providing an expert perspective On where maybe adoption barriers might raise their ugly head, where they might form and what they might look like. And participation here, obviously, would be subject to qualification, but fundamentally what would be offered would be a 60-minute review, a real-world user research review, for qualifying teams with active device programs. Following that, there would be a written, real-world user research summary delivered post-session.

And the way this is operating is by priority scheduling for requests that come through within 2 weeks after this webinar, and you can click on the link that will be shared with you in this slide to register an interest. And really, it's open to all, really, if we think about it. So, it could be open, including medical device teams at any stage in the product development lifecycle, whether it's early-stage exploration through to pre-launch positioning. This could include clinical teams, human factors teams, commercial teams, all All welcome, but all with active device programs, essentially at any stage.

And obviously, once an expression of interest has been displayed, we'll jump on the phone, have a chat, and really confirm your fit, and maybe what you're likely to get out of the review. And that's…

minor point is you can just drop review into the chat, to, you know, not wait for the link. The other thing is, if you'd like the self-diagnostic tool, please just write diagnostic in the chat, and we'll send you that, Following… following the call. So yeah, write review in the chat if that's of interest, and diagnostic if that's of interest, or both, you know? I think that's the easiest way to do this. I always like easy.

Well, that kind of brings us to the end, well, the end of everything else I was hoping to cover, slightly ahead of time. I know we said an hour, but yeah, 40-odd minutes, which is not necessarily a bad thing. I haven't actually seen any questions or the questions coming through, Sean, so I don't know… Where do we stand as far as questions are concerned?

Let's see, I haven't seen, any questions come through. I encourage you, if you have questions, to please, put them in the chat. I wanted to ask, your colleague, Jessica, if she can join, for a moment on screen. to, give her insight. Hi, Jessica!

Hi, we do have some questions. So, we do have someone who's asked, do you see a difference in post-market real-world evidence versus user experience and procedure development as part of clinical studies, as a guide for adoption or identification of barriers?

Sorry, Jess, can you… you glitched a bit. Can you repeat that?

Yeah, so do you see a difference in post-market real-world evidence versus user experience and procedure development as part of clinical studies as a guide for adoption or identification of barriers?

Well, I think… I don't know what your thoughts are, Jess. I mean, they're quite… each of those have quite a distinct… focus. So, one, I guess, is more about understanding Interactions, again, during that product development. process, that product development cycle, where kind of tweaks to product iterations can take place. And the other, really, is looking at maybe what's gone well in terms of the product being out there, and what might need to change, whether that's in marketing or product design post-launch.

Yeah, I think you're quite right, Alpa. when I first read that question, it overwhelmed me with all of the different components of it, if I'm completely honest. But they're… they're definitely… I think what's important is that post-market evidence that we do get is very much dependent on someone self-reporting, whilst when we're doing that user research. we are the motivators to get that information from those individuals. Yes, there are a select few, but there is a slight difference in what we see there.

I'll say that.

Sorry, go ahead.

So, just going to say, Jess, and I know we've had the conversation before, but when it comes to post-market surveillance, real-world user research is a critically important element of that. Thinking about different methods, we've discussed just sitting down, understanding what's… how things are working, what's going wrong, what the niggles are, what the issues are, what's happened as a result of those. That's a… An important piece, that needs to take place alongside all of the other approaches that enable post-market surveillance.

Yeah That's a very valid point. Sorry, we do have some more questions, Someone has asked, what challenges do you face conducting observation studies regarding access to care settings, settings, privacy, etc?

Yeah, it's a good question. There are challenges, again, so that they may… they sometimes vary depending on the markets you're… you're operating in. Sometimes there's a requirement to go down the simulation route. Other times, if we have friendly settings. That we're able to access. That makes life a lot easier, but on the whole, there are lots of… hoops that need to be jumped through. Ethics, ethics approvals as well. I mean, fortunately, we have our own IRB in the US, which speeds things up, but for certain markets, like the UK, gaining those approvals You can add on weeks and months, or generally months, onto any project when you're thinking about accessing a clinical setting to conduct observations.

Yeah. It certainly is one of the biggest barriers, but understandably so. We want our participants to be safe. We want that to be completely at the forefront of the research that we're doing, but it definitely is one of the biggest challenges. Someone had asked, how do you determine the best way to move forward if the treater perspective and the patient perspective of unmet needs differs? So how do you decide how to proceed?

That's a juicy question. I like it. map. I guess it depends on the… the nature of the perspectives, and what type of research that's… that's arisen from. I think if that's… and it sometimes does happen, I think it depends on the condition, depends on the device. sometimes there's a need to… it sounds like a cop-out response to carry out… to carry out more… to carry out more research. Maybe more extreme in the past, I've most definitely carried out research workshops where we've brought the two together.

to throw.

it out, but just to understand those differences in opinions. These workshops are run over several days and weeks, where you bring the two together, have smaller breakout groups, and it's about addressing those needs and working through them, really, to understand what's going on, what's bubbling away. That's driving that difference in opinion. Because there are lots of different approaches there, some of which are maybe more exciting than others.

Definitely. I think one has to start with why is there a difference, and really understanding that. It could also be down to the healthcare setting for that treater. It might be specific to their healthcare environment, and consequently, their unmet needs are very… unique for them, but might not necessarily be generalized. And then also for the patient, sometimes they battle to verbalize those unmet needs in the most appropriate manner, so it comes down to, are they really different, or have they just been… Worded in very different manners as well.

It also quite often boils down to whose voice, in this instance, does it make more sense to listen to, if we're oversimplifying it, but if we're thinking about product development, as we often do, and maybe… very much oversimplifying it, but if we're thinking about Whether a product needs to beep, or click, or whether a product needs to be white, blue, or black, a healthcare professional will have potentially lots of different views and opinions. and feel that they're able to justify why they're saying X, Y, and Z, but fundamentally, for someone using the product, whether it's an inhaler, injection device, insulin pump.

It makes more sense, when we're thinking about real-world use to tap into and maybe run with what the end users a saying. I know that's quite a simplified, example, but, yeah.

Yeah. I think, I know we… we had a recent discussion about it in terms of, like, the, emotional attachment that.

patients.

and caregivers have towards their products, and that can also then sway your unmet need, but that is going to be very different to the treater's perspective, because they don't.

Absolutely.

to have that emotional attachment to that device. If you're thinking about inhalers or injectables. Patients that are using them on a daily basis, they don't want to be or they don't want that device to be their identifier. They don't want to be defined by that device, so the less… medical device-y looking, it could be the better it is for them. But then, for a healthcare professional, they want it to look medical. So it's really finding that.

You're about.

between the two.

And also, I mean, very much just to underline what you're saying there, often it's the patients, it's the people living with conditions that are the experts. It's their voice that fundamentally should count more in certain instances. They're living, breathing. deciding, in some instances, on a daily basis, so as experts, their view is critically important. That doesn't mean that we push to one side the view of anyone else, but in certain situations, depending on what the consideration is. We need to think about where that weight needs to be.

Yeah, exactly. We have one additional question, and that is. What tangible methods do you use to determine prescribers? So how do you identify those prescribers?

how do we identify prescribers to decide who should be involved in research, I'm assuming?

I believe that is.

Yeah, I mean, as we all know, the role of the prescriber and strength of influence will vary quite significantly between and across regions and markets globally. And really, the best way there, beyond literature searches, is to have boots on the ground, so we have some fantastic associates. and colleagues within these different markets who offer, an insider view, a real clear understanding of what's going on in each market. Obviously, we need to get that right. There's quite a big difference between, A prescriber, if we're thinking about procurement, a procurement decision maker on the one hand, or a procurement influencer, maybe, on the other hand.

So it's about having a very thorough insight and understanding of what's going on in each unique market.

Yeah. I suppose… kind of going away a little bit from the prescribers, but I suppose in a way, the prescribers are part of that adoption process. So one of the questions that we do have is, is the adoption strategy or the identification of adoption barriers different based on different levels of intervention? So surgery versus office procedure versus home use, or different user groups, so your surgeon, nurse, layperson?

Absolutely.

Nope.

Who would have thought? I would say. Most definitely. Such quite significant differences.

Yeah, I suppose it comes down to the use of those products, what the environment looks like, what other factors Bay, as well. You know, some patients don't have a choice because they've got a condition that they require that product for, and that's the adoption. They get told what to do. I think sometimes the adoption to barrier Or the barrier to the adoption is more within the surgeon or, you know, the nurse that is prescribing that product, that is advocating for the use of that product to begin with. And so your strategy there is going to be very different compared to what you'd have if it was a layperson for a home use product.

Yeah, mostly funding.

Yeah, I think…

insurance.

Over the counter, it might also be a… another conversation. But that, again, also then determines a different adoption strategy. And then the adoption goes into the adherence. Once you adhere to that.

I mean, even, I know I've kind of defaulted to diabetes as a particular area of interest for me, but if you think about the UK, and when it comes to insulin pump, or even insulin pen selection, it's almost, being it's a restaurant scenario, where you'll be sat with a diabetes specialist nurse, and you'll have an array of insulin pumps that you can essentially pick from. Sometimes it might be two, three, other times it could be up to 5, and you have an absolute free reign. Which is incredibly fortunate, but that contrasts with many other markets where that most definitely isn't… isn't the case.

Yeah. Good morning. Stratton. So what would be effective methods for performing real-world user research with existing customers to enable engagement with them, in spending time for answering questions, etc? So what would… what method would you employ for existing customers or individuals to engage with?

There are so, so many methods that we can and do employ, and there are so many factors that will impact on which… in which direction you go, how… how small or large that population is? Are there sensitivities in terms of the discussions that will be had? Are we looking at obesity? Is it respiratory conditions? Does it have something to do with sexual health? So with that in mind, that will make the difference between maybe whether you're going into people's homes, which is the… which is ideal, especially when it comes to real-world research, it could make the difference between doing that or bringing them in. It will make the difference in terms of those sensitivities between whether it's a one-to-one.

Are there sensitivities that someone may not want to air? Subjects they might not want to discuss around others? Or is it a great opportunity to get people together to share their views, views and opinions? So, in some instances, individual interviews. focus groups could be workshops. If you're looking for a far larger pool, then yes, you can achieve that through a qualitative approach, but sometimes it makes more sense to run a An online survey, so you're really tapping into not only a larger pool, but if you're looking at a global pool of participants, then that can sometimes make it A lot easier. But that, I guess, there are many exciting, different, exciting stages of product, project design, but for… for me, that's probably one of the most exciting, just understanding what's going to be the best

The best approach to tap into people's views and experiences and needs.

And what if that user is a healthcare professional rather than a patient? Would there be a difference there?

Yeah, again, I mean, we've carried out many, many, many focus groups with healthcare professionals, so it's less around sensitivity, although there are some sensitivities in markets such as China and Japan, most definitely. Often carrying out focus groups with HCPs in those markets is a big no-no. You've got to think about the most basic level of scheduling busy lifestyles for some healthcare professionals. Often, it's easier to run sessions online, one-to-ones online. Far easier for them to schedule in between clinics, or during their lunch break, or even during the evening. Having said that, with surgeons, we've carried out sessions at 7am in the morning, or 10 o'clock at night, where they've squeezed us in.

After hours, so it's about adapting to the… to the needs, whether we're talking about sensitivities or scheduling needs of the participants. So similar rules apply whether some… whether you're researching someone with a condition or a healthcare… healthcare professional.

Great, thank you.

I would love to know about head-to-head competition, you know, two products. Do you ever do that? Give people two, five products, and have them do one of them?

Yeah, absolutely. We spend a… in fact, just recently completed a… device comparison study. They're some of the most juicy studies. There are lots of different approaches. Generally, you want people to be handling products, unless you're comparing More vague concepts, but we get people to handle products, to work through different use scenarios, give them the opportunity to get a real feel for what they're handling, and then drill down into all aspects of their interaction, not just the physical, but the emotional. Importantly, looking at beyond handling, whether they can use them, really drilling down to understand how would this fit into their

life, their lifestyle. It's all well and good someone being able to use a product as intended, but if they're not likely to use it in a busy cafe in a costa because it's too large, or it beeps too loudly. Or they can't simply travel with it because it's too large, doesn't fit into their bag. That creates a barrier. So device comparison studies are fantastic, and they cover so, so many different variables and factors that will lead one participant to prefer product A over B, and vice versa.

Fantastic. Well, I'd like to thank both of you, for your time today and your insight. This has been a very rewarding session for me, and I hope it has been for all of the audience members who gave up an hour of their time today. to join us, I appreciate that. I know it's a holiday in Europe, and so, thank you for… for coming, and I look forward to seeing everybody tomorrow, for, the QMS TraceX, talk, and in 2 weeks for the 483. presentation. Also, just a little preview for all you HF people on the phone, we're planning a really, really cool packaging, webinar coming up.

So, look for that. And, thank you both.

Thank you so much.

Pleasure.

Thank you, Alpam.

Thank you.

SMJ to get. I think so.