User-Critical Packaging: 7 Decisions That Make or Break Your MedTech Launch

Hello and welcome, everyone. Thank you for joining us today. We're gonna give people a minute or two to join. With that, I'm gonna start with a few housekeeping announcements. My name is Sean Smith from MedTech Leading Voice. The housekeeping announcements are, number one, the recording and slides will be emailed to all registrants within 24 hours via Zoom. 2. Please use the chat function to communicate with me during the session. If you have a question for the speakers, please, please use the Q&A function. Feel free to add questions to the Q&A function as we go. We're going to try to get to all of them at the end. If we don't get to them, we'll try to follow up with you. Let's see…

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newsletter comes once a week. It's also a good place to monitor for upcoming events. We've announced the winners of the MLVX AI MLV100. Thanks for the 4,000 votes. Now, I'm done with my advertising. So, today's session I'm excited about is user-critical packaging, 7 Decisions That Make or Break Your MedTech Launch. Today, we're joined by Jenny Collinson, Director of Human Factors, Strategy, and Advisory at ClareMed, and Connor Francheck, a packaging and sterilization Engineer at Canyon Labs. I also want to thank Claramid and Canyon Labs for partnering with us.

And our monitors, our, moderators, Sarah and Kelly, In case you're not aware, Claramet is a human factors and usability consultancy that helps medical device in combination product teams design, test, and validate for real-world use and prove it to regulators. Canyon Labs is a global testing and consultancy partner, serving the medical device and pharmaceutical industries with expertise across laboratory testing, consulting, packaging, and sterilization. Today is a practical topic because packaging sits at the intersection of design, usability, risk, sterilization, labeling, handling, and real clinical use. Today's conversation is built around 7 decisions that can affect

whether packaging supports the launch or creates avoidable problems late in the process. With that, I'm going to turn it over to the speakers, and thank you for your attention.

Thank you, Sean. Okay, let's get going. So, whether you've been in med tech packaging for 20 years, or whether you're completely new to the field, I'm hoping that you'll identify something in this presentation, that resonates with you. And that you've not really been thinking about. We're not going to recap or lead you through ISO 11607, but we are going to, as Sean mentioned, walk you through 7 specific areas that we see med tech teams struggle with. And where decisions can, either quietly kill a project launch, or create a packaging Problem that surfaces in the operating room, or in use, and not in the lab.

So we're going to put those real decisions in front of you, the ones that get made in program reviews, in supplier conversations, in risk file reviews, and show you what most teams know versus what most teams miss. And it would be great, at this point, if you could just drop one word into the chat that describes your biggest current packaging challenge. Without overthinking it. And we'll come back to those words throughout the session, so if you… if yours comes up, we'll try and call it out. I just want to point out here, I can't actually see the chat, so one of my co-presenters will… will shout out if they need to highlight anything to me, or Connor throughout the presentation.

Okay.

Alright. So let's start with a number. 13%. 13% of FDA medical device recalls over nearly a decade-long study trace back to packaging and labeling failures. This isn't the device itself, not electronics or the mechanism, not the chemistry, but the packaging. The source of this stat is from FDA's own medical device recall report from 2003 to 2012, and this isn't a vendor commission stat, it's from FDA's data. And here's the thing about that 13%. Yes, this data's from an older study, but that number is almost certainly a floor, not a ceiling. It's likely

Much higher now. And Jenny, you have a perspective on why that number might actually be understating the problem, right?

Yeah, so I think similar to… to most, sort of, data collection from complaints. It only really captures what's reported, so the reality is, when a package is hard to open, or peel initiates in the wrong direction, or the label's confusing, users infrequently file a complaint. They adapt, they improvise. And they bloom themselves. If a clinician is wrestling with that sterile pouch, and when they finally get it open, they don't reach for an adverse event form or a complaint form, they just move on to the next patient, because that's the priority. And the manufacturer probably doesn't hear about it.

So that 13% is… It's what surfaces, it's what, you know, is probably problematic enough for them to complain about, or frustrating enough, but the full picture of usability failures probably aren't being identified. I'm… So, again, in the chat, if you could type, yes or no, relating to whether your team's received a formal packaging-related complaint in the last 12 months. And if someone could, you know, shout out what that's looking like, that'd be great.

Hey, Jenny, if they're not… if we're not seeing it in adverse events, where do you think, It is being felt, or seen, with… If they're experiencing challenges or confusion in packaging or, unboxing.

In fact, he's just been seen in just general frustration and dissatisfaction, with that, you know, with that product.

Probably felt in commercial.

ultimately make it commercially unsuccessful. I think we talk a little bit about that later, but I think, you know, ultimately that's where these unreported frustrations go, is it damages your brand reputation. Yeah, no. Okay.

It's worth noting, I was kind of working with Connor on some of the stats here, you know, the stat… data set is technically from 2003 to 2012, but Connor and I were talking of, do you think, you know, that is a while ago, but do you think that that's greater or less than it was between 2023 and 2012? I… my first inclination was it's… it's likely a lot higher than that now. Some of the data that we looked through suggests it's… it's about the same, but I think it's actually… and Jenny, I'm curious to get your opinion on this, but I think it's actually more that you have… what I have seen within usability is you have more regulation, significantly more, since 2012 to 2026, and now you're even able to categorize those FDA recalls, you know, more intently than maybe in the past that was more broadly, like, a labeling error, or a…

you know, point of use of opening a package was not, intuitive enough. So, I guess, what's your take on it? Do you think it's gotten higher, lower?

In terms of the stats, I don't really know. I think what I do know is that, as human factors has become more embedded in the design and development of products, packaging hopefully will have been included in that, although I think it's sometimes not. You know, hence the reason we're talking about it. So the identification of issues pre-launch hopefully will have increased, which should result in a lower incidence post-launch. I think what I've seen in terms of reporting of issues in general is that it's just… it's just not very good. And in particular, clinicians don't like reporting on things that are frustrating that they think might have caused themselves, so if it's packaging, I just think falls into that. It just falls nicely into that category of, this is really annoying.

But it's not worth… worth wasting my time putting in a complaint.

Yeah, it's a good point. I mean, it's… there's a big difference also between a complaint and a compliance issue. You know, there's, this works better for me versus this is violating the, you know, necessity of packaging and its performance in the marketplace.

Yeah. Okay, let's…

the chat a little bit, Jenny, just to keep you in the loop. There are a lot of yeses, there's… decent amount of no's. I think within the yeses, you're getting some feedback on barcoding and labeling and compliance testing for bad barcodes. You're also getting some comments around… Distributors who think you need to redesign a package, but, you know, the customer is complaining about it and not sending devices back in the original packaging, so some reprocessing pieces to it as well.

Yeah, interesting. And some of… some of those are use-related, some of them sound like they're design, like barcoding, incorrect barcoding sounds like it's, you know, design-related as well, so… Yeah. Okay, let's walk through a scenario, So, a surgical team is preparing for a vascular case, and in the sterile field, there's a stent, and it's a $15,000 stent. It's in a sterile pouch, as you expect, and the circulating nurse goes to open it, and she's done this hundreds of times with other projects, but this peel sealer requires more force than expected. And with her gloved hands, she can't get hold of it cleanly. So she adjusts her grip, she pulls harder, the seal gives, and when it does, it snaps open fast, and the stent ends up on the floor.

The result is the case is delayed for 40 minutes, the stent has to be replaced, the sterile field has to be re-established. And critically. It's highly likely that no formal complaint will be filed, and the manufacturer might not find out, and if it is, it might not give the detail that drives the correct action. within the organization. And interestingly, the engineering team that validated that product probably felt it was ready for clinical use, and they had the seal strength data, the peel force measurements, everything generated in the lab, but they didn't maybe include that Packaging as part of a study.

They didn't watch it in real use with a real clinician opening it in the correct environment. So I think that what that shows us is there's a huge gap between what gets validated in a lab, with peel strengths and peel force and seal strength data. And then what actually happens in real use, and what we're trying to do is close the gap, and that's really what the next next 45 minutes is about. It's 7 decisions And 7 places where that gap can open wider, or we can close it.

And I just want to comment that not only is that what the next You know, part of this conversation is really about… it's really… why, Sarah and I came together to address this problem, because clearly Canyon Labs would provide all of that lab data, right, and help to validate it that way. But we saw a gap and a need that really takes this much further. Not only driven from the regulation, or the standards, that's one piece of it, but where really… We're seeing friction in the industry, and that gap could be closed through this partnership, where we're not just looking at, you know, the lab data, but we're really understanding

The challenges in use, and… the friction and the risk. But also, what I always like to highlight is we talk a lot about risk. But where the opportunity lies. Because it is the commercial team that's hearing about this. Really, it comes down to, you know, are people going to buy your products the next time? You know, is there gonna be a different, you know, game-time decision to use a different product if the, you know. the nurse or the technician knows that there's, you know, a problem, and they don't want to have that same experience be repeated. And so this is, yes, important that we're able to get, through the barriers or over the regulatory hurdles.

But ultimately, this is about how do we build the right products for what's the need in the market, and that we can help You, maximize your opportunity in, you know, post-launch, not just get to launch.

Yeah, I think the biggest eye-opening thing, you know, Kelly, when we first met and starting to talk to Jenny and understanding, you know, where ClaryMed fits and where Canyon fits, you know, I've spent a lot of my career in the packaging engineering world, and it's… I know it's no taboo topic to know that a lot of packaging engineers just design packages in a… in a box. You know, they're… they're only looking at the design requirements they have, such as Jenny's case here. You know, they're looking to pass a… an F88 test, appeal strength test. They're not looking at the nurse that's struggling to open that… that package, and I think that

you know, through talking through a lot of this webinar and some of the, you know, articles we've done together, I've realized on the packaging engineering side, and we've always had regulations that are pretty big, or standards that are pretty big, which we'll go into that later in the talk today. But then you look at the device side, and hearing Jenny talk about, you know, all the requirements and all of the available resource to the engineer that is looking to meet compliance standards, and it's vast compared to packaging. And… you know, looking at it from a… how does this industry advance together, it's… it is that harmony between those, you know, the packaging and the device side, and the closer that those get, I think the higher level of information, guidance.

compliance readiness that, you know, a packaging engineer will have by potentially utilizing and learning more about some of the usability guidance that is available, more on the device side of things. So, I think packaging has a… a long way to catch up, necessarily, on the guidance side of things, and packaging is trying. Like, there's a lot… I'll go into it later, but there's a lot on the regulation side that's coming to try to catch up, but the device side is just so much farther ahead than maybe where packaging is or was in the past.

And if I can interrupt for a second, Claramed and Canyon Labs have collaborated on a new white paper. The new white paper is Designing for Safety. If you want a copy of the white paper, just put WP or white paper in the chat. We'll make sure that you get a copy of it. After this call. Thanks.

Thanks, Sean.

I think with all that in mind, we'll just quickly skip through, these 7 decisions, or 7 areas that, we're going to walk through today. And I think if you can just, we'll just read them out one by one, and if you could just, tell us which one of those resonates with you the most strongly right now, and we'll maybe discuss that later. So, the decision one is, do you test with the real packaging, or with a placeholder, or nothing at all, as many people do?

Decision 2, how do you balance seal strength against gloved hand opening force?

And then Decision 3, how do you prioritize Things on the labeling, and what's… what gets sacrificed.

Decision 4 is, how do you handle color, symbols, and language when one package ships to multiple markets?

Number 5, when does packaging need to enter and be considered in your risk file?

Decision 6 is how do you monitor packaging post-market when complaints under-report by design?

Okay, and 7 is, how do you handle packaging changes, during manufacturing transfer, or even just design transfers? Or changes. So that's 7 decisions, or 7 areas. Just please just drop a number in the chat so we can have an idea what you're interested in, and make sure we… we explore those areas fully as we go through.

You got a lot of fives and threes and ones. A lot of fives, though. 5 is definitely a popular one.

Yeah, five… I nearly said it, but in danger, I didn't want to bias the outcome, but my favourite would be the risk file, because I think it drives everything else. But anyway, we'll go into that more as we go along. So, let's move on. Okay, so the first one, do you run formative HF testing with the real packaging, or representative packaging, or with a placeholder? I think what everyone knows is that formative, usability evaluation is… is something that is… is required, really. As is… most people try and include it in their submissions. And it should be with representative users under simulated use conditions, and really what it's doing is de-risking.

Your summative evaluation and making sure you've optimized the design. But I think what most teams Don't do, or see, is that a lot of formative studies are done with either no packaging. It's quite often that packaging doesn't even get included, you just put a prototype of products on the table, packaging is not considered. Or using in packaging that's nothing like what will actually be tested. In the summative, or what will go into the market. And this is usually because the real packaging's not ready, tooling's not committed, final materials aren't locked. And the schedule just keeps moving, and formative testing just gets run with whatever's available, you know, whatever can present that product for someone to look at. And of course, looking at the rest of the design's important, but the packaging gets omitted.

So, what you can end up with is a summative evaluation. That has got an entirely new packaging user interface. Included, and that can cause issues, you know, unidentified use errors and problems with that summative study. So, I'd be interested to know, In your last formative studies, Did you have final packaging or representative packaging? Or even if you have given packaging a chance to be optimized during development.

We're getting a lot of emails.

I'm a… A lot of yeses. That's great to hear. So, Connor, from a packaging engineering standpoint, why… why do you think people might not include Final or representative packaging.

Yeah, I think the reason is sequencing, right? So, in most… Med device, med tech programs. Tooling commitments happen after the formative testing on the development timeline. That's tooling for pouches or trays or whichever your primary packaging may be. packaging engineers are often still evaluating materials, geometry, configurations, when the human factor team needs those actual samples for a study, so… the human factor team gets what's available, what exists. That's maybe a pouch that's roughly the right size. A tray that's approximately the final geometry, maybe a label that somewhat mimics the content.

And everyone's, you know, saying that's close enough, and… the problem in that is that close enough is not the same as represented, so… You know, peel force is a function of the actual seal geometry. The opening dynamics depend on the actual materials utilized. Those characteristics are not close enough. They are either correct or they're not. In placeholder packaging. Cannot give you that right answer. So… I guess, Jenny, What does doing this right actually require from the program schedule?

I think it's just really getting people involved earlier, so getting the packaging team involved earlier, and having a really good idea of what you want that packaging to look like. Because actually, involving… packaging… well, just involving packaging as part of the overall system design, it just… you put it into the risk file, we'll discuss that in a minute, but… And you… you have chance to optimize that design and minimize any risks, and it's not just… I mean, the other thing that we didn't talk about, really, on this slide, actually, is there's also labelling to consider here. You know, so what does that labeling design look like? Often there's labelling on there that's controlling… controlling risk.

So that also gets time to be optimized. So I think it's just about getting packaging Artworks as early as possible, knowing what needs to go on that packaging, knowing how it needs to be designed to present that product in a safe way. Sir… it sounds simple, I know it's not, because everyone's focused on what's inside the packaging. Let's get that right, and then we'll deal with that packaging later, but, you know, you don't want to be that to be the place where Your… your product fails at the last… at the last minute.

Jenny, I'm curious where you guys get customers in their launch cycle, and I'll explain the impetus of my question, but I think especially on the packaging side, like, if you're trying to meet ISO 11607, Section 7, ranks. On the packaging engineering piece. for all intents and purposes, I see most of our clients designing their package, and then they're doing, you know, the assessment at the end, just to check the box of, like. I have my perfect package, maybe it's not perfect for my user, but it's… it's perfect for me. And I'm just sending it through this usability testing, thinking it's gonna pass, and I'm gonna move on. And…

You know, you mentioned something very important, the vital shift that is needed in this… in the design and marketplace is The ability to iterate based on, you know, usability data. Connor mentioned some of the roadblocks to that, being tooling, and packaging's very expensive, it's very hard to get prototyped at times, there's… there's a lot of roadblocks, so I… I get why you might see more no's than yeses at times, but I'm curious, I guess, from your guys' perspective, where you Typically speaking, where in the lifecycle are you getting people? Are you seeing more people thinking about it more upstream, especially given that, you know, you guys have some of the device side too, or are you

Are you noticing some of the same, maybe, bad trend that we see in the packaging side, where it's a, I did my thing, check my box, here you go.

Yeah, I think… it's difficult to say, because obviously all companies are different, but I think what we do see It's a lot of people not having quite finalised packaging earlier in the development process, so they've not even got an idea of it sometimes. They're bringing us a prototype, but it's not… we don't even start the… start looking at the tasks until it's out of the box.

Yeah.

Of course, when we come to, you know, doing someone's formal summative evaluation, that all… we would consider everything. But at that point, we don't know what work's been done with that packaging beforehand, if we haven't had the projects from… from the start, so…

Yeah.

it just depends, you know, when we receive… when we receive, or when we start working on that… that project, and I think if we were aware of projects early in their development, then we would probably highlight it, because I always, you know, the first thing I say is. have you got a use-related risk vial? And if it doesn't start from the beginning, it hasn't got the packaging in there, then that would be something that we would flag. But we don't always have, you know, we don't always see the products that early in their development.

Yeah.

Yeah, I was gonna jump in there too, Sarah. I think, you know, just like what you guys see, we see a lot of, okay, we need to do this, check the box, whether that's packaging or the device. And what we continue to try to educate on is that this is an… this should be an iterative process. This isn't a one-time thing if you want to optimize it, and you want to, you know, first de-risk your regulatory, success, but really optimize that experience for the user and balance that innovation curve with risk management. So… we do see a lot of clients come in at the last minute, and what we continue to encourage is involving us earlier, which I realize can be challenging, both from a project management as well as from a cost standpoint, but involving us earlier can actually

save time and money, and help you develop a better product, and I think that applies to packaging and… and the device itself.

wrote a comment in that I just… it resonates, and she said, I often find that no one cares about packaging until everyone cares, which is usually after a failure. And that, catherine, that hits home.

Thank you. Okay.

Alright, so the next decision, decision 2, this one's one of my favorite, I know Genie, like, 5, but this one's good on a packaging engineer standpoint. How do you balance seal strength against gloved hand opening force? So, what most teens know, seal strength is validated against different standards, ASTM, and you have a minimum seal strength requirement based on your, you know, your sealing process characterization work, you have a test method, you have data. You know, good to go, green light, we're set. What most teams don't see… A package can pass every seal strength test in the lab and still produce contamination, device damage, or improvised opening techniques in clinical use.

And the competing constraint, you know, the force that gloved hands can reliably generate is real. And the lab is not the place where that constraint gets resolved. You know, the problem there is that ASTM test methods use controlled equipment to grip and separate that seal. And that's not how a clinician opens a package, right? A clinician is in surgical gloves, often in a time-pressured environment. Uses friction, finger dexterity, and body mechanics, even, that are completely different from the test apparatus that we're testing in the lab. The peel force your package requires in the lab and the peel force a glove user can generate

Are two different numbers. And most teams, You know, are not considering that gap. So I guess, Jenny, from your perspective, what do you actually see clinicians doing when… when that seal strength, you know, is hard, or that seal is resisting?

Yeah, whatever they can to get in the package, whatever comes to hands. I think I've obs… I've observed, Just ripping the package, you know, not using the opening method, just ripping it in whatever way possible, which of course risks damage to the product inside. Scissors are an obvious one. You could end up cutting something internally. I've even heard of people using their teeth, which is frightening from a wrist point of view. And like we just mentioned on the stent example, that if you have to use a lot of force, you run the risk of losing the product inside, you know, if you don't have controlled opening.

So I think, you know. back to my favourite number 5 that we'll deal with soon. I think if you've identified those as risks in your risk file, then it helps you design that product correctly, and you know what to look for, and how to design tests. And of course, you know, for me, a lab test is more around Having a specification and controlling to that specification with materials, once you understand what's the right Force that meets the user's requirements. So I think you should know. Don't just consider what the equipment's telling you. Like Commer said, you have to look at what people do as well.

I know we have a lot to cover, but the only other thing I'd mention was some seal strength and just gloved hand opening. The other thing that a lot of people don't consider is maybe the opening, the aseptic technique that someone will likely use for the opening of their package. Like, you have your controlled and dump, you have your open and present, you, you know, you have all these different opening methods, and… I'm doing some work in the industry right now with the Kilmer Group that is trying to tie packaging types to aseptic opening techniques, and so you're looking at, truly, from a ideal sense of not having hospital-inquired infection, so you're trying to minimize the opportunity for bacterial transfer. What is the ideal opening technique for, say, a pouch or a tray, and depending on the size and length in different parts of that tray? So I think in addition to glove handling.

Also, try to think about and consider how an end user is going to open it from a septic Presentation technique perspective.

Yeah, perfect, and that is definitely one of the things that, you know, is problematic in usability studies, is keeping things sterile.

Yeah.

Okay, so… label hierarchy. It's a very interesting one. So, I think what we all know is there's lots of things need to go on labels. So, product name, size, expiration, dose, sterility status, new MDR requirements, UDIs. And then other relevant regulatory symbols. There's just some things that just have to go on there. But I think what is difficult is… prioritizing those symbols, especially of the things that need to be communicated that… that are critical. So how do you make something stand out? If it's, if it's really important. in amongst all that other information that has to go on.

I'm just interested to know how many distinct pieces of information appear on the front of people's primary packaging. I think it's probably difficult for you to determine when you're on a call, but a guest would be fine, or even just, you know, comments around Around how… how cluttered packaging looks. Connor… You probably know a little bit more around what's creating this labelling crowding from a regulatory point of view.

Yeah, several things are converging here. You have… EUMDR, requirements expanding, those labeling requirements significantly, UDI mandates. The multilingual requirements for global packages add language blocks. There's, you know, the symbols need to be present and correctly sized. So, each of these requirements comes from a legitimate regulatory rationale, but they all land on the same square couple of inches of label real estate, and no single requirement is the villain, per se. It's, you know, the collection of all of them.

And the only way to manage that is through that deliberate hierarchy design, and… Not through trying to fit everything in the same font, you know, at the same size, so… That's the solution there.

Yeah, I think… I think the key is to… is how do you prioritize, and… and back to my favourite subject again, which is… is… look at the risk file early. What's the important pieces of information that need to be prominent and visually prominent on that labeling, and how do you communicate those effectively and get those in front of the end users to check that that labeling resonates with them? I think that's the only way to do it, and I think, you know, leaving packaging and labelling till very late. in the… in the development process doesn't allow you to do that, and puts… puts launch at risk. And then, you know, if you… if you happen to get through the summertime evaluation with that, then obviously it's putting… it's putting users at risk as well, if it's not clear.

Okay, and then on a similar note, really, The decision for is about handling color, symbols, and language when one package ships to multiple markets. I think we all know that international labelling requires translation and compliance symbols. But what we… what some people probably don't know is that core semantics aren't universal, so red is a color that signifies danger in the US, and could signal good fortune in parts of China, so you can see how that might be problematic. And then if you test symbols in one. cultural context, it might not be recognized in another. So there's, you know, there's multiple examples of where

Of where symbols just don't have the same meaning in one location as they do in another. And then, you know, back to things being legible, if you have multiple languages on packaging, which you need to for MDR, certainly. It can become practically illegible. On the labelling, for… especially for very small packages. I mean, I don't know that people know how many languages they're currently putting on their packaging, I imagine it's quite a wide range, depending on target markets, but it'd be really good to know. I'm… But, Connor, from a packaging engineering standpoint, what does this mean for the physical design of the packaging?

Yeah, it means geometry matters and normalicity, so a package with 8 required languages in a fixed label area is gonna make trade-offs, right? So sometimes that trade-off is font size, sometimes it's the size of the symbols. sometimes it's removing the product illustration that actually helped clinicians orient the device. And the way to avoid this being a last-minute compromise is to design early and design for the most constrained market first, so… if your labeling requirements for the EU plus your language requirements for Asia Pacific fit cleanly on the label, the US version is easy. And if you design for the U.S. and then retrofit everything else, you'll essentially run out of room. So…

like I said, early in those constrained markets first.

Okay, great. Do we have any feedback, Sarah, on how many languages?

I… I mean, I'm more on the symbols side of things. I, I mean, I remember when… everyone was working on redoing the symbol usage behind sterile packaging, and it was… there was this huge debate. This had to be 2016 now. But this huge debate on, like, if you have a dotted line, or, like, a dashed line, or a solid line, and how that fits into dual or single barrier symbols, and their whole schtick of having this argument was trying to make it universally understood, regardless of language, country, wherever. And so, I don't know, I think about it more from a symbol perspective. To me, it's… I don't know, I'm curious how labeling will evolve over the next 10, 20 years. I mean, I see, you know, IFUs are already going away, it's all e-IFUs, pretty much going forward. I think the next piece is you're gonna have some AI thing that teaches you how to do it in real time, and it'll, you know, you'll have some cool little video camera thing.

I think the same with labeling, like, it… I'm curious when it'll just become, like, a scanned barcode or something that tells you exactly what you need to know in whatever language you need, and it's not this, you know. legibility problem, or, you know, a thing that you're looking at square footage on your package that you have room for this label. I think… I think the conversation will change a lot in the next 10 years with just the way tech.

I think it needs to, because I think… I think there's just a bit of a direct conflict between human factors engineering, making those… those products safe. Yeah. For the end user, and getting the information on that the regulations, you know, currently require. So something needs to… to move, doesn't it? It's just… it's very hard at the minute.

Yeah, I mean, IFUs scare the heck out of me if my doctor's reading the IFU before he sticks this thing in me, like, I'm out. I don't want anything to do with that, so…

Begot.

I've evolved.

Okay, my favourite. When does packaging usability enter the RISC file? Well, as early as possible, really. So we all know that use risk analysis is part of the HF process. It's, you know, it's required through 4971, it's referenced in FDA guidance. There's no choice in doing it. But I think what often happens, as we mentioned earlier, is that packaging risks are identified very late and without a lot of granularity. So often, when I review, a risk file. there'll be nothing related to packaging, the tasks will start with Using the actual product that's inside the packaging. Or if it's there, it'll be something very, very generic, like, package difficult to open.

Which doesn't really, you know, doesn't really help, so… It doesn't really include the specificity that a regulator reviewing an HF file would expect to see. So I think what needs to be included as early as possible are some real packaging hazards, such as sterile field breach, selection error. I think that's super important for, you know, dosing dose, you know, doses of drugs and things. Device damage, contamination due to packaging debris, you know, all sorts of packaging things that need to be… need to be captured in the file. And then some realistic severity and probability assessments to ensure that they're driven as a priority as part of design decisions.

And like we mentioned earlier, it's usually timing-related why they're not there. No one's really thinking about the packaging. when they're developing the product at the early stages, it's sort of… you need to have a product on the table to design a package for, and it's… so there is a bit of a timing conflict, but I think… The use risk analysis needs to incorporate as early as possible, you know, even at a basic level, at the beginning of the project, and then it develops as the packaging becomes realised. I think sometimes it just gets put in as placeholder, a single line, and then never gets filled out, because

It's a last-minute… it's a last-minute thing. And I think it's likely to start generating more and more Questions from regulators as they become more educated in what can cause the risk to the end user as well, from the product, because it's not just the product, it's the whole system around. Around that product development. So, Connor, do you have any thoughts on what could be done different.

Yeah, yeah.

I'll close the gap.

I think just, you know, having a packaging engineer in the room when that Use-related risk analysis as being written would be huge. Not just… contributing a test report after the fact. Obviously, that's important, but, you know, the hazards that come from, say. Material properties, from seal geometry, from dimensional tolerances, those require packaging expertise to identify correctly, and if the risk analysis is written without that expertise in the room, then the packaging risks will be incomplete, essentially.

And you guys received a question in the chat that said, don't the RMF lines roll automatically out of the customer requirements and the system requirements of which most projects start?

Yes? But not everyone has that level of… of… control in their product development. You know, people… we, you know, we're considering here people who start, you know, very small companies. They don't have these… very formalized development processes in the same way that a large company would. So, yes, some companies will have this completely controlled. They'll develop the documents in the right order, and they'll have, you know, they'll have automated or manual ways of linking things together. Other companies don't have that. It's much more ad hoc than that.

Jenny and Connor, I'm seeing a few questions around, you know, small companies. A lot of companies don't have a specific packaging engineer, and, you know, what to do in those cases. It's either following on the main project engineer, or not Getting adequately addressed, and maybe both.

Yeah, I mean, I think… I think, really, the key… like I mentioned, about… it's just… it's getting the risk management right, because actually. if you identify what the risks relating to packaging could be, then when you go to design the packaging, you know what you're looking for. And I think, you know, there's certain key things that need to be included in that risk file. I appreciate not everyone has a packaging person. But there will probably be a packaging person at the person… at the place that you're getting the packaging designed, so maybe involve them early, you know, to get that To get that feedback.

Yeah, I was thinking the same thing, Jenny, is speaking with your suppliers, if you don't have a packaging engineer of your own, That's a great way to start. They obviously have knowledge of the materials. They, like, if it's a tray that's being sealed, they'll understand sealing as well, so that's someone you can discuss that with.

I would say we have a whole packaging consulting team at Canyon Labs who could give us a call if you need one on a temporary basis. I think, you know, when you look at packaging consultancy in general, I think the… it is a newer trend for companies to have full-time packaging engineers, and newer meaning last 10 years. Prior to that. to everyone's point here, you know, the fickle need for a packaging engineer is peaks and valleys, you know, it's really high at certain points, and then it's non-existent in others, so I think that's really been the… the birth point of packaging consulting and packaging engineering degrees has been, you know, fulfilling that void, if it's only temporary, so…

And I think that's the same that falls within usability and HF. Do believe it should be integrated, but it is iterative in certain points in time, and I think, you know, this earlier stage, where you're… leaning on packaging engineering, like, that's a good time for us to come in and do kind of an expert review, and provide some input to what the user might experience and how that might… play into your… your risk file. And so, you know, it's about… what does the effort look like, at what point in time, and how robust does it need to be? But not getting the information, and going ahead and designing and developing with that early input is where you increase your risk.

Okay.

Alright, so decision 6. How do you monitor packaging post-market when complaints under-report by design? So what most teams know, you know, complaint trending is the primary post-market signal. You track complaints, you trend them, and you act on those spikes. What maybe most teams don't see is if packaging complaints under-report. systemically, and they do, as Jenny described earlier, then complaint training is measuring just a fraction of the actual Packaging failures. And you can have a packaging problem that is costing you clinical accounts that, you know, never registers as a complaint.

In practice, the first Signal that packaging is failing clinicians is often a… maybe a business signal. That could be a drop in sales, in a specific account, a lost Contract renewal, maybe a field sales rep hearing the… We're looking for alternatives. Those are packaging usability signals that will never show up in your Complaint database, so… I guess in the chat, maybe you can put, has your team ever surveyed clinicians specifically about packaging performance? Yes or no?

One yes and two no's thus far. Three no's.

Yeah, I would think mostly no is across the board, is what I would guess, and this means most of us are monitoring a signal that, by design, misses most of what's actually happening, so… what does… proactive monitoring look like? This could be structured in-service observations, clinician interviews at field sites, and not just asking, was the packaging okay, but asking specific questions, you know, about opening force, or label clarity, and how often they Are improvising during that process. They are, you know, the minimum viable surveillance for a use-related risk.

So I guess, Jenny, from your perspective, from a human factor standpoint, what does… A good clinician feedback mechanism look like?

Well, I think… I think what it's not, you know, is… is a generic satisfaction survey. Clinicians often will say, oh, it's fine, because they've adapted to it, and they've developed a workaround. I think you actually just need to go and ask or observe specific tasks. Such as peel initiation, label readability, you know, look at how it's been utilized in its actual clinical environment. And then ask… you know, what they do, if it doesn't work as they expect, or, you know, and get that, and get that feedback. I think you're really looking at behavioral, questions and not opinion. So that's really what you're trying to get to for improvements.

I'm just gonna…

skip forward really quickly, because I'm aware we're running out of time, actually. So, let's go on to… So, Decision 7.

7… How do you handle packaging changes during manufacturing transfer? So, you know, what most teams know, manufacturing transfer requires revalidation against design specifications. There's gates, documentation, sign-offs. The process exists. And what most teams don't see is… appeal characteristics. Seal geometry and dimensional tolerances can drift. within engineering specifications, while the user experience changes dramatically. And this is the, I guess, silent degradation problem. And here is what that looks like in practice. So, your original site uses a specific ceiling bar geometry in a specific film lot.

Your new site uses equipment that is within spec. You know, peel force numbers are in range. Seal width is in spec, the dimensions pass, but the opening dynamics are different. Peel initiates differently, the way the package Presents the device changes. And if you have not done a usability comparison with representative users, You will never know. The clinical performance of a package can degrade across a manufacturing transfer. That passes every gate, you know, mentioned earlier. And the thing about that is. no complaint will be filed. You know, no recall will be triggered.

the users will adapt. You know, that word's come up a number of times in this presentation. And your market share will erode in ways you won't immediately be able to attribute to packaging. The right answer is either a retest with users at a… at the transferred configuration. Just being a simulated use evaluation, not just physical testing. Or in the explicit documented judgment that the packaging user experience is unchanged. And most teams do neither. They do physical testing and sign the transfer package off. And… I guess, Jenny, is there a regulatory expectation here, that teams may not be aware of?

Well, I think, in reality, most teams will be aware that, you know, the process of change control requires them to consider whether they're making Like, an impact to their validated products. And what you're really looking for here is… is changes that could affect use-related risk, and of course, a manufacturing transfer could, or any sort of change to Change to the product design, so you need to assess whether the usability data that you've generated is still applicable to that new design. I'm not sure many change control processes actually ask that question. And they'll ask whether the physical performance characteristics are impacted.

But like we mentioned earlier, they're physical performance characteristics, so maybe if you've gone from the top end of a spec to the bottom end of a spec, or, you know, all the slight geometry change. Then… It might really impact the way someone interacts with the product, and that just needs to be considered.

Alright, so we wanted to look… I said earlier, we'd look at some of the, you know, rules and regulations that go, and guidances around packaging. So, some of the kind of evolution of usability, it originally got introduced to packaging standards. The, you know, holy bible of sterile packaging is ISO 11607. In 2019, they added Section 7, which brought usability into the mix for the first time ever. You know, 11.607, you had transit, aging. seal integrity testing, you never before had considered the end user. You had everything considering the manufacturing process and the, you know, validation process of ensuring it gets to the end user safely. So this was the first time you took it beyond getting to the end user and actually being in that end user's hands.

In 2023, an amendment was added to 11607 for Section 7 to just add more direction. And then the Amy TIR, 16775, came out alongside the Section 7 piece, but it has been reiterated recently to add more risk assessment language in there, so you can really work and use that as a guidance on how to assess the usability of your package. And again, the added element of your risk assessment. And then some new things happening in 2026. There's actually two working groups within ASTM right now that are working on… one is working on an actual method that is trying to help you have a test to do in R&D as a quick down and dirty to get some, you know, user feedback, within the design process, very early on in the design process.

And then the other group, that's mentioned here was trying to add more of guidance around how to test specifically for packaging. And that, ASTM was actually just put out to ballot, so, that will hopefully be coming out in the, in the coming months, which is great. So I think one of the questions we had was, has your team had Section 7 question come back on a submission in the last 18 months? I will say, when Section 7 came out in 2019, I feel like it was this kind of, like, light suggestion. It was, like, the should, shall, you know, argument that you get in standards a lot, and I've seen it, you know, much more prevalent in FDA feedback within the last, you know, 3 to 4 years.

So as we're…

Sorry, Sean, I'm calling.

So as we're, wrapping things up, I do want to call attention to a very special offer, from Clarimed and Canyon Labs, with, Jenny and Connor as an opportunity for you to speak to them about what you're working on. No obligation, but we are looking for up to 15 companies that want to take advantage of, this, packaging vulnerability Review. If you could advance a couple slides, I think that we have a slide about this, and… Yeah, you're also gonna get a packaging program. self-assessment, if you write self-assessment in the chat, we'll send that. But type PVR, for a chat with them, and,

Yes, so I wanted to make sure that I got that in before the end. Now you can go back to talking, because, I wanted to interrupt.

Okay, thanks.

No strings attached 30-minute conversation. If you don't have a human factors expert or a packaging engineering expert, here's your… your 30 minutes to get some opinions from some.

Yep. And I think, I mean, we are approaching… approaching the end of the session, but I think, you know, it'd be nice just to go over the next couple of slides, just because it sort of… Talks about why and what good looks like, and then, you know, we'll go through them as quickly as possible, but… And this slide just really… it shows this curve, which is the same for most design issues, you know. I think what makes packaging uniquely vulnerable to costing a lot of money at the end of programmes is it gets addressed latest. So, often after the device design's locked, and after the risk file's written, and the formative studies are complete.

So by the time you find the packaging problem, you're always on the expensive end of this Curve. But looking at it and iterating it at concept stage costs virtually nothing. Cost of iteration during early development is… is… is relatively, you know, good value. Once you get into tooling commitment. Then you're, you're into, you know, a hugely expensive, cost if you want to then change Packaging design, you know, tooling for a thermoform tray, or a die-cut pouch. It's just much more expensive as you move up the curve. Connor, do you want to add anything to that?

Yeah, not too many extra details, I'll just add some numbers, so… With tooling, that can be 3 to 6 months, you know, timeline there, so… The cost of a formative study with real packaging at the right stage of development is a rounding error compared to that 6-month launch delay.

Yeah, and that just leads directly onto, just what does… what does doing it right look like across the product lifecycle? And of course, you know, phase one is concept and early development, so… do some contextual inquiry, get onto clinical environments, and watch how packaging actually gets used. Don't ask clinicians what they want, watch what they do, and design products that work with that. Watch where they're hesitate, improvise, adapt. And this is where you can write, packaging usability requirements and ensure you design that packaging right. And if you're referencing clinical observations as part of your, packaging requirements document, then I think that reflects that you're… that you're doing things right.

And then Phase 2 is design iteration, so… Make sure that you are testing… are evaluated with real packaging. looking how people interact with that packaging, make sure you run that in parallel with performance testing so that you can align them. Like I mentioned earlier, you know, the spec is how you control The… the good performance in… with a, with a user. And make sure that you are comfortable with the design, and the design in the hands of the end user before you Close that design iteration loop, and before you commit to tooling. So, you know you're doing it right when formative study results influence your packaging design, and that you're including packaging as part of that human factors process.

Tana, do you want to quickly skip through 3 and 4?

Sure, yeah. Phase 3 is verification and validation, and this is where summative usability evaluation happens, you know, coordinated with packet need validation, not sequenced after it. So, you know you're doing phase three right when your summative protocol was written with input from both. human factors and packaging engineering. On the other hand, you know you're doing it wrong when the packaging gets tacked on to an, you know, an existing device study as an afterthought, another common theme. Phase 4 is transfer, launch, and post-market. This is where proactive monitoring happens. Structured clinician feedback, field observations.

If something changes in your packaging, whether that's materials, manufacturing site, the question does usability data still apply? That needs to be asked and answered with evidence. And you know you're doing this phase. Right, when you're post-market surveillance. Has a packaging-specific section, and With specific monitoring activities, and you know you're doing it kind of wrong when your only post-market signal is… is complaint trending.

Nope. That's a very, very… I mean, again, that's common for all, all All post-market data monitoring, you know, looking at things proactively is always… is always an improvement. So I think Sean just presented these two slides, so I don't think we need to go over them again. And I actually don't think… Really have time for any questions.

No, we're a little bit over, but I want to thank the four of you for your time today, and sharing this information with us. Everyone looking forward to the white paper in your inboxes. Designing for Safety. It's a fantastic white paper, I just read it. And I want to thank the audience for giving up an hour of your time, an hour and five minutes at this point. So thank you very much. If your, panelists would like to say goodbye. We're gonna sign off, thanks.

Thank you, everyone.

Thank you all. Appreciate your time.

Thank you.