Inclusive Design Is Reshaping Medical Device Packaging: Healthcare Packaging

How does a transition from a disposable, prefilled autoinjector to a reusable pen change user experience?

Editor-in-Chief, Liz Cuneo, sits down with Lucy Baldwin, Head of Research and Design at Ensera Design. They discuss why when it comes to medical devices, safe isn’t the same as usable, and usable isn’t the same as equitable.

Read the full featured article on Healthcare Packaging.

Transcript

SPEAKER_01 0:03

Welcome to Through the Line, a podcast exploring innovations and information across the packaging and processing landscape. From topics impacting consumer packaged goods and healthcare packaging to the latest technologies in food processing operations.

SPEAKER_02 0:22

Hi, Liz Cunio here, editor-in-chief of healthcare packaging. What follows is an interview I did with Lucy Baldwin from Insera Design. We talk about how inclusive design is reshaping medical device packaging. She even shared a specific example about a disposable pre-filled auto injector and making the move to reusable pen and how that meant redesigning for an even better experience. Thank you, Lucy, for joining me today. So we met last month at PharmaPak, as you remember, and you gave a presentation on inclusive design in device packaging. And you gave an interesting example, which I know we'll talk about in a minute, but I thought we'd kick off the interview. Actually, you can introduce yourself first and then we'll dive in.

SPEAKER_00 0:59

Of course. Thanks, Liz. Thanks for having me back after ThermaPack, and it's good to meet you there. I am Lucy Baldwin. I work for a product design consultancy called NSERA Design, and we're part of a wider manufacturing group called NSERA. And I head up our search and design strategy team. And really our role is to make sure that when we're designing products and services, particularly that are going to be used in healthcare, that they meet the needs of the users that are intended for.

SPEAKER_02 1:24

Awesome. Going back to your presentation and kind of what you do, why the strong focus on inclusive design? And is this a new thing? I've been hearing about this a lot and I'm just wondering why the strong focus.

SPEAKER_00 1:36

I think historically, inclusive design has not got the attention it deserves. And what we essentially mean by all we mean by inclusive design is designing something that is usable and a good user experience for the broadest possible spectrum of people living in our society. And I think it's quite interesting contract, it's quite an interesting construct to think about people being disabled by society in the way it's designed, rather than disabled because of anything to do with them as an individual and their physical cognitive characteristics. So just trying to think about what are those different physical and cognitive, situational and circumstantial characteristics that make a person who they are as an individual, what does that mean for what they need? And how do we design to support that? In terms of the shift, certainly medical device design, a lot of regulation is built upon this idea of a predicate predicate medical device. So if there's something substantially equivalent already on the market, you just have to prove that your device is equivalent to it and forms. But that doesn't mean that device that was originally put on the market was designed inclusively. It doesn't, it means that it was tested on a population of people. It doesn't mean that that population of people represented the needs of the people that actually use the device. So we just try to, when we're designing inclusively, think with the conditions we're looking at, let's say it's diabetes, as it was in this case. What are some typical or cognitive characteristics that someone with diabetes might also have an experience, such as sight loss? And how do we design to make their experience just as great as someone who's got 2020 vision?

SPEAKER_02 3:11

Yeah, sure. In fact, going to your presentation talking about a diabetes device, you mentioned a reusable auto injector project. So I thought maybe we could talk a little bit about why that project, why it was so important, why the change from a disposable preloaded to reusable auto injector product.

SPEAKER_00 3:29

So the change from a disposable to a reusable product was really the reason for that was driven by AstraZeneca and it was around a sustainability decision to move to that reusable product. So that wasn't actually the reason for that wasn't from an inclusivity standpoint, but there was a really important recognition that through changing that protocol where people had got used to a disposable device and then had to move to a reusable one. That was quite a significant change. And how could we, through inclusive design approaches, redesign packaging to make that transition more user-friendly for people?

SPEAKER_02 4:04

Yeah, and that's great. And I was going to ask too about balancing sustainability and user friendliness, right? And there's a lot of things to consider when creating a device. I guess how do you balance everything that you have to with regulations, sustainability goals, obviously user experience and safety?

SPEAKER_00 4:20

It's a great, it's a great question. And there are so many different dimensions to think about when it comes to sustainability. And I guess one thing we always think about for some people, sustainability is a meaningful driver. But in healthcare, in medical devices, someone's not, someone doesn't choose to use an insulin pen. They don't choose to take insulin every day. They have to as part of their condition. So if we're gonna make something more sustainable, it better be just as good as what they're using already, or a better experience for them. And ideally needs to give them some other advantage. So when we design sustainably, we try and think about what that advantage is. It's giving from a user perspective as well. Some people, yes, sustainability is a drive for them, but not for everyone, and not when it's something that you have to use day in, day out. So that as a consideration, I think another really interesting lens to put on it is if something isn't user-friendly for the population that need to use it for a diverse population, it in a way it isn't sustainable because they're not going to use it in the way that it's designed to be used, they're not gonna maintain it, and it might go to waste. So there's that also flip side to think about, which is quite nuanced, but often I thought you said something interesting in PharmaPak.

SPEAKER_02 5:32

You said that deep research is necessary into the user's experience and their pain points. So, how did you research that for this device?

SPEAKER_00 5:40

Yeah, exactly. And by deep research, a really traditional route to approval would be to do a formative study, and it would be in quite a research environment. So it might be in a room a bit like the one I'm in now, which is the backside of a viewing facility, and there might be a one-way mirror, you might have people watching in the background, and you've got some devices there, and you're getting to compare them. So it's quite an artificial environment. It's really important because you're getting someone to go through task-based steps of how to use a device and making sure that they can do that safely, effectively. What it doesn't give you is any context into that person's life beyond what you see they've come into for the day. And so what gives really large value in what we did on this study was get contextual research. The way we did it on this study is via remote diary studies. So we used a platform called Inkling. People can add an app to their phone, to their tablet, to their laptop, enables them to answer questions remotely and supply video diaries to show you where they store their medication, how their emotions have messy, messy, maybe you wouldn't say messy, but refrigerators, right?

SPEAKER_02 6:48

Like a real life on the counter at dinner, like very real life use cases instead of a sterile environment that you maybe want them to be using. It's that's not the real life case.

SPEAKER_00 7:00

It's not. And it's super easy, I think. In if you're working in a big medical device company, uh pharmaceutical company, it's really, I think, hard to it's easy to be quite removed from the NE user in real life. But yeah, it doesn't exist in a sterile vacuum. It exists, it does exist in a kitchen where there's food prep going on. We saw people who had their chopping boards out with dirty knife and some onions being chopped, and right next to it is the insulin bile about to be loaded. And so we've got to think about those constraints. We've got cupboards filled with not just one medication, lots of people have got lots of different conditions, yeah. Some vitamins, supplements as well, everything mixed in. And so usability in terms of finding the right medication, getting that out, putting it away again, etc.

SPEAKER_02 7:48

Sure, yeah, of course. So you mentioned moving from the disposable to reusable. How did secondary packaging help transition that change for end users? Or did it? Did it play a part in that?

SPEAKER_00 7:59

It did, yeah, it did. It was really around, in terms of aiding the transition, it was around having a overlapping design language, mechanisms people were used to, like how to the type of tamper seal, how to open and close, where the vars would be stored, where the pen would be stored, mimicking as far as possible what was happening. So obviously, with the the disposable pens, they'd be multi, multi-dose, but one disposable pen. And then with the new device, it'd be a single device and lots of different bars of insulin to be loaded. So there were more items actually in terms of opening, closing mechanisms, the shape of the box, colour to aim and guide just following that identity system is really was really key.

SPEAKER_02 8:51

And now we didn't talk about this, and hopefully you have some insights on it. But do you were the end users given any kind of reason as to why, as a far as hey, it's more sustainable to do it this way? Just wondering if do you see that buy-in from the end user? Are they excited to have something more sustainable? Or do you think it's really not on their mind? They're too preoccupied with with their care and with their medicine.

SPEAKER_00 9:13

I think it it totally depends. I think that story is often shared. I can't guarantee it was shared with every patient for this particular product, is often motivating and exciting to people and they do want to do something more sustainably. I remember is it okay to talk about another project? Yeah, of course. This we did a really interesting project with a company called Ekin looking at stamina bags. And with stamina bags, often people are changing those multiple times a day, and they're not at the moment, in the vast majority of cases, they're not recyclable, they're not reusable. And there were lots of people talking about the waste and how conscious they were of that and how they wanted impact. So people are hungry and excited for that change, but also I think we can't under we can't underestimate how much of a change for some people that is. It's already, I think, for lots of people like a big adjustment to live with a medical condition, perhaps especially if they're recently diagnosed or they've got cognitive characteristics that impact them day to day. We've got to think about balancing that user experience with sustainability in terms of how we design. We can't ever be putting something out there that is a subpar experience or worse than the current experience. Yes, in order to be more sustainable. It's I feel that is not justified in in healthcare.

SPEAKER_02 10:34

Yes, I agree. I think maybe with some other industries, you almost can, and it's okay, especially if it's a very limited use product that maybe doesn't have as much importance. But of course, in the medical healthcare field, it's very different. I just I have family that receives shipments of biologics and they're always talking about wanting to be able to reuse or send back. Just I only ask that because it is top of mind for some patients, which is neat to see. I'm just wondering how much more of that will change, change the industry from a sustainability standpoint.

SPEAKER_00 11:06

I think my view is, and I've heard this from a lot of pharmacy, pharmaceutical leaders, is there's lots of appetite in the industry to do things like take back schemes for things like auto injectors and design for disassembly so something can be disassembled and the parts recycled or used afterwards. And the challenge comes with the fact that you're dealing with bodily substances is one challenge. And two, yeah. So there are regulations around what can and can't be done and what you can reconstitute something into. So it's not like a situation where you've got a P bottle and you can recycle that into a new PET bottle. You could never we can't really do that with an auto injector because of the fact that it's a medical device because it is going to interact with the body. However, there are ways that things can be reconstituted and recycled into different types of products and materials. But as I was saying, lots of our clients have said it it really needs lots of different pharmaceutical organizations coming together to agree on a take back scheme that everyone sponsors. Because it's no good if just one platform does it and but they only accept certain types of water injectors. So unless you're on that one as a patient, you can't use it because then it's just not we go back to the same thing, it's really makes it really challenging for the end user, for the patient in terms of actually recycling.

SPEAKER_02 12:29

Yeah, of course. So you mentioned risk in your presentation when talking about developing devices. So what type of risk are you talking about? Failed, a failed project, a user error, risking the end experience or safety for the patient, or is there more? Or am I way off?

SPEAKER_00 12:46

You are absolutely in the right, ballpark. I guess there's there are there are lots of elements or aspects or dimensions of risk. One is about the user, so that we'll start with the user. There's making sure something is safe for the user, that they understand how to use it. And then there's also making sure something's a good user experience for it. And they can be two different things. So something can be safe for someone to use, but they don't enjoy using it or they still find it challenging to use. So that's one aspect to it. And we find that a lot of at the moment, a lot of devices reach the market having gone through regulatory approval, and they still get recalled because they fail, because they have, and that means that they fail because they've been dangerous, they've endangered someone's life as a result of using them. So at the moment, things still unfortunately get through aren't safe. So a lot of it is about doing diligent research and really understanding your population to try to eliminate eliminate that. On top of that, you want it to be in a good user experience. So I give quite a nice example of a project uh that RIB did. They developed this concept. Someone asked them the question of a pregnancy test. A blind person can use a standard pregnancy test, but to use a standard pregnancy test, they need somebody else to read the result to them. So they can use the pregnancy test. It's safe for them to use it, but can they use it with dignity in the way they want to? Is it a good user experience? Yeah. No. So RIB developed this concept so that a blind person could independently use it a pregnancy test. So that's that thing of like safe user experience, but a good user experience that's equal for different people with different needs. That's another layer.

SPEAKER_02 14:29

Wow, that's so interesting. I haven't thought about that from that type of product. Yes, they can use it, but right. But is it can they do it within the privacy that they want? Maybe not.

SPEAKER_00 14:39

Yeah, and it's a really interesting thing to think about, Liz. There are lots of other medical devices. Like an auto injector is a great example of if you think about someone who's blind, can they use it? I don't know. That would be challenging. And I think asking ourselves more challenging questions as an industry and as an industry of designers and creators about who we're designed for and what they need, and can they use it safely? One question. Can they use it in the way they want to? The delivery experience, different question.

SPEAKER_02 15:06

Yeah, and independently, I think that's a huge factor.

SPEAKER_00 15:10

Yeah, absolutely. Um and I think if you layer on things like we are as a society an aging population and the birth rate is declining, as we get older, a lot of us will have developed characteristics that make us less independent. And so we probably do need to rethink the way we're designing lots of things to promote independence for as long as possible in people's lives.

SPEAKER_02 15:33

Yeah. Um I was gonna switch gears, but if you have something else, go ahead.

SPEAKER_00 15:39

I was just gonna talk about the other risk that was important to us in this, which was which impacts the way we did things, which was not so much around the end user experience, but was around will this design behave in the ways we think it will when it's actually manufactured? And so for that, we created physical prototypes, but we also did finite element analysis. So what that essentially means is we took we were using or proposing a new material for packaging, and we didn't know how that would behave. So we prototyped it, modelled it, simulated that model in the digital reality, and that enabled us to put it through more complex and difficult tests to mimic what would be happening in real in real life in like transportation and so on and so forth, or storage, and to make sure it performs under those pressures. So it was also around like design, like reducing risk and design to manufacture, given we had a tight turnaround and making sure that what we spec'd out actually performed and there weren't going to be some problems once we got into manufacture.

SPEAKER_02 16:50

Yeah, I imagine that's a huge, a huge issue if we do run into problems once you start manufacturing large volumes of a device that a lot more to make.

SPEAKER_01 17:01

Thank you for listening to Through the Line Packaging and Processing. You can listen to more episodes on all streaming platforms. Be sure to visit us at packworld.com, profoodworld.com, and healthcarepackaging.com for more packaging and processing news. This podcast was edited by Brady Guns.