Packaging Validation Best Practices

The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays?

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Jeff Barrett, CEO of J-Pac Medical, about packaging validation best practices.

Jeff has 25 years of experience in the medical device industry, specializes in getting new devices to market, and scaling your commercialization. He has extensive knowledge and understanding of ISO 11607-1 & -2, Packaging for Terminally Sterilized Medical Devices.

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Some highlights of this episode include:

• Sterilization validations/revalidations take a lot of money ($40,000-80,000) and a long time (16-20 weeks) to complete.

• Don’t underestimate labeling - 40% of FDA recalls are due to labeling. Make sure your CM has good labeling controls.

• Over a third of all package validations fail the lab test for transit. The biggest reason why companies fail packaging validation is not understanding the various shipping modes and their related testing.

• ISO’s 11607 standard has two parts: Part 1 is about designing the package; Part 2 is validating the package. Also, there is a guidance document due to the complexity of the packaging process.

• The criteria for filing a 510(k) and steps related to packaging include validating that the seals are good from a sterile barrier standpoint and the product is good and has not changed over time because of transit testing or aging.

• From a design standpoint, document how the package has been designed and meets customers’ needs. Recently, the FDA added user testing to the standard for sterile transfer.

• Feasibility testing of prototypes and samples of vibration, drops, and humidity should be conducted to prevent potential problems. Ask engineers about product changes and the risks for redesign of packaging to know if the package will fail or pass.

Links:

Jeff Barrett on LinkedIn

J-Pac Medical

Etienne Nichols on LinkedIn

ISO 11607-1

ISO 11607-2

ISO 13485

ASTM International

FDA - 510(k) Clearances

Greenlight Guru Academy

Greenlight Guru Community

MedTech Nation

Greenlight Guru MedTech Lifecycle Excellence

Greenlight Guru YouTube Channel

Memorable quotes from Jeff Barrett:

“The FDA looks at a standard called ISO 11607. That is the Bible for medical device packaging validation. There’s two parts to it, Part 1 and Part 2. Part 1 is all about designing the package and Part 2 is about validating the package.” 

“Over a third of all package validations failed at the lab for transit. It’s staggering.” 

“Less so do we see damage to the product itself. So, I’d say, 8 out of 10 times on these failures, it’s the product and the seal failing, not the product breaking.” 

“One of the biggest problems we see is, (the FDA) they don’t do any validation. They say, ‘We’re going to do it later.’ That’s obviously a problem. You can’t market the product if the package hasn’t been validated. That’s why the FDA gives you a break on that.”

“The bottom line is you’re trying to maintain the product without getting damaged and without the sterile barriers getting damaged. That is the end goal.”

Transcript

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Hey everyone, welcome back. I hope this day is treating you well so far. Today's episode is on a topic that doesn't usually make headlines until it's done wrong and that is packaging. And this is an important, but often overlooked topic, especially if you're producing a sterilized product. So today's guest that we have on today to the show is to discuss packaging. It's a little bit on sterilization. His name is Jeff Barrett, CEO of J- Pac Medical. Jeff Barrett is a 25 year veteran of the medical device industry, having operated in commercialized experience in both public and private device companies. Jeff specializes in getting new devices to market and scaling that commercialization. So Jeff was CEO of GI Supply, Optim, which was an ENT product. He was also Vice President of Operations at Haemonetics, which was blood processing, as well as Aspect Medical, a part of Medtronic. Specifically relevant for today's topic, he has extensive knowledge and understanding of ISOs 11607-1 and 2 packaging for terminally sterilized medical devices. So I hope you enjoy the episode and I wish you the best in all your packaging endeavors. Thanks for listening. Hey Jeff, it's good to be with you today. I'm excited to talk about what we have in front of us today. First of all, packaging validation, but then how we're going to relate that to preventing 510( k) delays. As we were talking about briefly, everybody wants to prevent delays, but maybe if you like, you can go ahead and give a little bit more information about you and your background there if you want.

Jeff Barrett: Sure. Well, thanks for having me. It's a timely topic. It's always a source of problems and we see it all the time. J_Pac, we're a niche contract manufacturer for medical device and diagnostic companies. We specialize in the mid market. We are very good at a turnkey solution. So from the entire package design, the assembly, establishing assembly processes, sterilization validation, packaging validation. So when a customer comes, they really get a turnkey set of data for their filing. And we also work with larger companies too, the very large ones as well. But even with those, our niche is really the introduction of new products.

Etienne Nichols: So you know what you're doing? Yeah.

Jeff Barrett: Yeah, we know what we're doing. My background, I'm the CEO. I've been here seven years. I've got a long history in medical device companies, both larger and smaller growth stage companies. So I've always been involved in the technical aspects as well as the business aspects, but I'm here with the technical aspects today, which I love, so.

Etienne Nichols: Awesome. Well, I'll tell you, I never worked directly with packaging. I was a project manager on a couple different devices, but I always made friends with those packaging guys because it did always feel like we were running just a little behind on packaging because it was on nobody's... The forefront of anybody's mind, it seemed like. But is that your experience or what has been your experience?

Jeff Barrett: It is. Well, first the standard. The FDA looks at a standard called ISO 11607. That is the Bible for medical device packaging validation. There's two parts to it. Part 1 and part 2. Part 1 is all about designing the package. And part 2 is about validating the package. It's very complicated. That standard's over 100 pages long and they put out a guidance document for it that's over 60 pages long. There's a lot of source of confusion and package design. So we've seen everything. I just had one yesterday, a company came and they just said," We're filing our 510( k) in 30 days and we need a package." They don't understand and it's saved till the end. And it's pretty simple to get it going earlier, but it's just a neglected thing.

Etienne Nichols: This might have an answer of, it depends, but when someone does come to you like that towards the end of the project, what kind of timeframe should they be expecting to have to look at when it comes to that?

Jeff Barrett: Well, it has to do with the complexity of the package and what's been validated. But if you just take, like in this case, it's a product that's fairly straightforward. It goes into a pouch, so I don't have any real concerns about it failing from a transit test, but it's just got to go through that process of going through the whole validation. Which is you got to validate your sealing, it's got to pass a transit test and then you got to age your seals. And you can use what's called accelerated aging. So just say in this case, they want to label this product for a three year life. The FDA will allow you to use what's called accelerated aging studies, but you have to back it up down the road with real time. And just a rule of thumb that we tell customers is, it's 45 days of accelerated aging for every one year of shelf life that you want to label. So just right there, three year shelf life, is 45 times three. And then add to that, the packaging, the transit piece. In a schedule we'll plan on a month. In reality, if we expedite it, could be done in two weeks. And even at a minimum, right, you're looking at whatever, 120 days for you're aging and another month for just getting your transit test and protocols done and all that.

Etienne Nichols: Yeah. Okay. And maybe I jumped ahead to, how long does it take? Because in my mind, that's what I want to know. But at the same time, what we really want to know are the criteria. So I always like to use that Steven Covey quote," Begin with the end in mind." We want to file a 510( k). What are the steps leading up to that as it relates to packaging? Are you able to lay that out a little bit?

Jeff Barrett: Oh, absolutely. I won't go through the whole 100 pages, because it's taken me seven years to understand it.

Etienne Nichols: We'll link to it. How about that?

Jeff Barrett: The very end. I think it's good to start at the end. What you're trying to do is you're validating that the seals are good, from a sterile barrier standpoint. And you're validating that the product is good, that the product hasn't changed over time, because of transit testing or just aging. So that's the end game, but how you get there, you've got to follow the two parts of the standard. So part 1 is all about the package system design. And what a lot of our customers have to be educated on, that it's a packaging system is, in this case, it could be a product in a pouch or a tray sealed with Tyvek. That then goes in a shipper box or a what's called a shelf container, that's maybe at the hospital sitting on a shelf. And then so many of those go into a carton, typically is shipped in a carton with multiple units. So that whole system needs to be validated, not just the package that holds the product. And so from a customer standpoint, they got to think as a system, because they may just haven't even thought of a shipper box or a carton container. And you've got to determine, is this going on a skid, a plane? All that comes in the play. So, that's an important point, is understanding those requirements right up front. But from a design standpoint, you have to document how you've designed this package and how it's meeting the customer needs. But one thing the FDA has recently added, that's part of the standard actually, is user testing. Because most of these sterile devices have to get from an unsterile environment over some imaginary line, into a sterile environment and they call that sterile transfer. And that is very important. How does that happen and how do you do that while maintaining the sterility of the product? So they want to see user testing on that. I would say 99 out of 100 customers don't do it. So they have to go back later and just make sure it's good. We do offer that as a service. We have access to OR staff scrub nurses, and they can give feedback on that. They're the best people to give feedback as far, because they're the ones that do that transfer. That's a pitfall we see, and the FDA is starting the push back on that. So this first standard is you've got your package designed. You've got your sterile barrier designed and you've done your user testing. But one thing we like to do, that prevents problems down the road, is what we call feasibility testing. So you make some prototypes, you're ready to go into a transit test. You've made a bunch of product, but before we do that, we like to make a small set of samples and just do some internal drop testing, vibration testing. It's not per the ASTM standards, but it's good enough to let us know that we have confidence in the package. So over a third of all package validations fail at the lab for transit. Yeah. It's staggering. So we try to do that up front to make sure we got a good shot at passing.

Etienne Nichols: So when you do that initial testing, is it just a percentage of your final sample number that you're doing?

Jeff Barrett: Yeah. It is as simple as we'll take the product that might be in a pouch, there might be 25 in a shipper box and we might just test that on its own, because that's the most aggressive way. You're not going to have a carton or anything. What we'll do is just test that. If it looks good with that being shaker table and some drop testing, then we're pretty confident once it's in a protective carton, it's going to be fine.

Etienne Nichols: So vibration and drop testing. What about humidity and things like that?

Jeff Barrett: So the second part of the standard is all about the packaging system validation. So the first part defines how you design the package and make sure and it meets the user needs. The second part is, okay, now you've got to validate the whole system of the package. And as I reviewed before, it's the product in a package, in another package, in another package. It depends on the design. So when you get into the transit testing, there's a bunch of ASTM standards that define preconditioning. That's what you're referring to. How's it going to be stored? Is it going to sit in a humid warehouse in Florida for a month before it gets shipped to the customer? So there're standards around that. There's also standards around how it's expected to be shipped. Is it a FedEx common carrier that's just going in a truck, a single box, or is it a pallet that's going to go through a distribution chain? So, that has to be determined. So basically what you're doing is you're saying," How is this product going to be shipped?" And we'll go to the packaging lab and they will select the ASTM standards that are appropriate for that. That's their expertise. We're experts in the design and verification and making sure we got a good package, but we always go to a third party lab. And quite frankly, I think that's the way to go because I don't like to be responsible, in a sense, for designing the package and doing the final testing to say it's good or bad. I just think having an independent party is a good thing to do.

Etienne Nichols: Testing your own work at that point. So one of the questions I have when I think about the validation is, if we're beginning with the end of mind and we're going to start this relatively early, some of that design process for the actual part might still be ongoing. So maybe you have to beef something up. Maybe you have to take something out so that the weight may change. So for some of those, maybe depending on the orientation of the packaging or whether it's a pouch or something different, it seems like it could potentially change that. So I'm curious, is it okay to use a dummy part? And if so, what are the exact geometrical and weight requirements there?

Jeff Barrett: That's a very interesting question. What you can do is validate a worst case scenario. We do that. So you see this a lot in orthopedic implants where they'll have, God, 30 SKUs of a certain implant, various sizes. And a lot of customers misunderstand that they've got to validate the package for each one of those. You don't. We take the worst case, the heaviest, biggest, sharpest, the one that's going to be the most aggressive on the package and we test that. And it's fine from an FDA standpoint that there's a justification to use that for all the products. Now, products that are going to change, that's interesting. We had a product that the customer wanted in a pouch, but they changed the feature on it that gave it a sharp feature. It was fairly sharp. It wouldn't cut you or anything, but from a package standpoint, it was sharp. So we told them, we either have to deal with this sharp edge with some kind of protection, additional protection, or perhaps change the package from a pouch to a thermo form tray. And they were pretty adamant, they just wanted to keep the package. And it failed, but we knew it was going to fail, but they went through three failures and they finally let us change the package design. So, that gets back to worst case. It's just a discussion around what are the risks for redesign? Usually the engineers kind of know, we might add this, we might add that. The geometry might change. And those are just questions to ask, because you can be fairly confident depending on the answers to those, whether the package is going to be okay.

Etienne Nichols: So maybe skipping to the 510( k). I had a question about that as well. So you said a third of products fail their packaging validation, which is a little mind blowing to me. What do you see companies getting into the biggest issue for those failures?

Jeff Barrett: Not understanding the shipping mode and then the test that's done for that mode. The product ends up violating the sterile barrier in some way. It pokes through for a lot, for layman terms. It just damages the seal. Less so do we see damage to the product itself. So I'd say eight out of 10 times on these failures, it's the product and the seal, failing, not the product breaking.

Etienne Nichols: So what you're saying is, they've actually maybe not fully vetted out their distribution channels or the way they're going to transit. And that is the biggest problem?

Jeff Barrett: Right. Yeah. If you think about, I mean, just at a high level, just in layman's terms. If you have a box that ships FedEx and it gets dropped and thrown around the truck, that's a lot different than dropping a pallet, 1, 000 pound pallet. Way different forces. Completely different. So they need to consider that. So we've had situations where they've reduced pallet size or reduced weight of the shipping materials, that sort of thing. But the packaging lab really helps with that. We work hand in hand with our lab and we try to get ahead of that stuff before it becomes an issue, but customers do get annoyed with those questions like," How is it going to ship? I don't know how it's going to ship." Right?" Well, what's the worst case? Is there a chance this is going to be on a pallet? Well, yes, maybe next year when we're scaling up, we're going to not ship individual boxes anymore, it's going to be pallets. Well, let's test for that." And that's the same in sterilization, by the way, just a whole other topic, but somewhat related to packaging. When you validate sterilization, you have to basically have it, you're validating in a certain volume in a chamber. So as customers grow, they sometimes get behind in the sense that they had their product validated for say a chamber that's one pallet. And then they grow, now all of a sudden they're shipping four pallets at a time. All of a sudden they got to redo the sterilization validation as well. I just wanted to throw that out there. That's another common thing we see related to packaging.

Etienne Nichols: So maybe I can just chase that for just a second with the sterilization. Is that the same with gamma versus ethylene oxide or acetylene.

Jeff Barrett: I'm going to say no, because if you look at the case of gamma, what they do is they have these kind of carriers they call them. And if you could just picture, it's a predetermined carrier size, like a basket, and you're basically putting the product in that basket and it goes through the gamma radiation. So I'd say no on that. It's more of an EO, EtO issue, where you've got a specific chamber that holds so much product. So what we'll do with customers say," Hey, let's think through this. What's the upside here? We're doing 100 units a month now, but are we going to be doing 5, 000 units a month next year?" So we'll validate a larger chamber and just use dunnage. We'll use fake parts and we'll fill that chamber up and validate it for that.

Etienne Nichols: Okay. Yeah. That makes sense. So again, going back to your worst case scenario, it sounds like. In the event that you filled it up completely, you're still validated for that.

Jeff Barrett: Yeah. A lot of customers aren't in that position to do that. You're just risking a re- validation and validations are, I'm going to say averaging right now, anywhere from 40 to$80,000 on sterilization. And they take a very long time. You're talking 16, 20 weeks. Customers are always asking why so long, and it's a very simple answer. You got to let the bugs grow before you can test it. So you've put it through a sterilizer, you've got to basically grind that product up and plate it, for lack of a better term and put it in an oven and let the bugs grow for a certain period of time and then test to see if there are bugs or not. So when you validate sterilization, you have to use different cycles, a fraction or a half, a full cycle. So every time you do that, it's another growing bug growing process and lab testing. So I guess that's a topic for another webinar. That's another interesting one for sure.

Etienne Nichols: Yeah. We'll definitely have to get into that sometime, but okay. So let's go back to packaging for a minute. We've kind of touched on several different points in the life cycle, I guess, of the development of the packaging, but one of the other things, have you ever seen customers as they go to submit their 510( k), any specific issues the FDA has with their packaging validation? Maybe they thought they were good. Issues that maybe they're facing?

Jeff Barrett: Yeah. I mean, I think a lot of it is the labeling for the shelf life and it'd be helpful to, in worst case conditions. So I'm kind of going a little bit around, but let me regroup and explain that. So before you validate this product, the package, you have to bring it through worst case conditions. This is a huge problem that is overlooked. So what is a worst case condition? It means we're going to make the product. We're going to put it in a package and seal it, but we're going to seal it so that it's on the edge. It's not our normal seal. We're going to use the lowest parameters we can. It's still an acceptable seal, but maybe we used a colder temperature or we used less time or less pressure to make that seal. That's a worse case scenario and that's what the FDA wants to see. Because once it scales up and you have normal manufacturing, you're going to have that kind of variation., Still within spec, but you're kind of on the low end. Then that product that's made under worst case scenario then has to be sterilized under worst case scenario. What we recommend is what we call a 2X sterilization cycle prior to doing your package validation testing. And people will say," Well, why so aggressive? Why two times? That's very aggressive." And it is. But what we see a lot is down the road, you go to these big contract sterilizers, they may have a malfunction in the run. And if you haven't validated that for two times, you can't do another cycle, you have to scrap the product. So we try to package that together and say," Let's use 2X as the worst case scenario, because it is worst case. And it's going to let you in the future, rerun your sterilizer if you have a problem down, the road." Happens all the time. Customers want to change labeling, or the sterilizer malfunctions. Happens all the time. Happens all the time. So the concept of worst case ceiling, worst case sterilization, and then obviously transit, that whole concept is around worst case shipping. So you're stressing this packaging system. That's what it's all about.

Etienne Nichols: And I'm going to ask a few questions just to make sure I understand. So when you could do that 2X sterilization, you could potentially be, I don't know, diminishing the strength of the adhesion of the seal. That's kind of the reason it's getting closer to the worst case. Am I understand that right?

Jeff Barrett: That is a good point. Yes. You've got heat, humidity, time and all those factors are really stressing the seal. We have our own in- house ETO sterilization, which is quite useful because the engineers will do some studies on the product itself. We'll over sterilize, just the produc,t as they're going through design. They just want to make sure that it's not impacting the product. So, that's a good point to do that. Because you don't want to get in a situation where you do a 2X sterilization, the seals are okay and now your product is... And that's especially a concern for implantables that we do. We do a lot of bioabsorbable implants. Very sensitive to heat and humidity. So you got to be very, very careful on your sterilization. That's why we brought it in- house because we can control the parameters. We do what's called a low temperature cycle. So we can really fine tune the cycle for these bioabsorbables to extend the shelf life. I mean, some of these bioabsorbables, I've seen some that have a three month shelf life. You can't commercialize it. You've got to come up with a way to extend it.

Etienne Nichols: So one of the reasons I bring that up and ask that kind of specific question, I guess, is we started out talking about the importance of doing this early, because there's a time. You don't want to have six months at the end of your product waiting, submit your 510( k), but there's a bigger reason. And that is you could potentially be impacting your product maybe. Hopefully not.

Jeff Barrett: Absolutely.

Etienne Nichols: But yeah, that's something to think about. A reason to... Yeah, go ahead.

Jeff Barrett: It's good to go, whether you used us or anybody else, it's good to go to people that have this expertise. Because if you do it on your own, you're trying to coordinate the sterilizer, you're trying to coordinate a packaging designer. You're trying to coordinate a packaging lab. And once I did a count on all the protocols and test reports, it came out to over 20 protocols and test reports that's required. So it's good to go to a company that can just do all that for you and provide everything that you need for your filing. You would ask before about what problems we see with the FDA? And I see, one of the biggest problems we see is, they don't do any validation. They say," We're going to do it later." And that's obviously a problem. You can't market the product if the package hasn't been validated. So that's why the FDA gives you a break on that, right? They'll say," Well, you can use accelerated aging. We'll take that. Clear your 510( k). We're confident in that. But you have to come back later when you actually did real time aging for the years that you want."

Etienne Nichols: And that's a reason-

Jeff Barrett: Another reason why it's so expensive. If you come up with a product and you want to label it for five years, you literally have product on the shelf waiting five years. And then after every year, it gets tested for its seal strength.

Etienne Nichols: Okay. No, that makes sense. And I don't know if you're familiar with QMSR, the new part 820, moving towards alignment with the harmonization of 1345. But one of the things that they call out that they may be beefing up, because they didn't feel like 1345 was strong enough in, was the labeling specifically. I can't remember if packaging was a part of that, but that is one of the things that they care a lot about that I've seen as well.

Jeff Barrett: Oh yeah. Well, look, 40% of FDA recalls are due to labeling. I mean, you basically have all this... The packaging is such a nightmare, but you have to make sure, I'm not an expert in that standard, but I do know that part of the validation is you got to make sure the labels don't get damaged in this whole process. You don't have runny ink and things like that. Yeah, labeling, I'm telling you, it's such an underestimated thing and it becomes an issue where you get a lot of products with high SKUs, like these orthopedic implants. It's very easy to mislabel. So just a word for the wise out there. Don't underestimate labeling, make sure your CM has really good label control because that's 40% of all recalls.

Etienne Nichols: Wow. I didn't realize that high. That's interesting. So I wonder if we can dive just one layer deeper when we talk about the actual tests that some of the packaging goes through. So you mentioned the primary packaging. This is the only time I think in my engineering career, I got to use the primary, secondary and tertiary, maybe with your bulk-

Jeff Barrett: That's correct, yep.

Etienne Nichols: So what are some of the actual tests that each one of those go through?

Jeff Barrett: The bottom line, is you're trying to maintain the product without getting damaged and without the sterile barriers getting damaged, that is the end goal. So there's basically two main tests that are used. Once all this transit testing and aging is done, you take the product and the package and you have to do what's called an integrity test. That could be injecting blue dye to make sure that you're not seeing dye go all the way through the seal. And then you do, what's called strength testing. You actually do some peel strengths. You peel the seal apart and you measure the force to do that. And the industry standard is roughly one pound, not to go into all the detail, but-

Etienne Nichols: No, and that goes back to the user testing too.

Jeff Barrett: We always tell customers, we're designing this for a one pound seal strength and the integrity. So you can use bubble testing, submerge it. But as far as the standard goes, I believe it's just requires a visual. It could require like a bubble leak test or a dye test. I think it's two out of the three, but.

Etienne Nichols: Okay.

Jeff Barrett: Don't quote me on that.

Etienne Nichols: No. And that's the sterile barrier. The things that I'm curious about are tests that every company, the majority, 90% maybe, maybe not that high, but have to go through these specific tests. So when we talk about the sterile barrier, you have the integrity and then the strength test.

Jeff Barrett: Yeah, the strength. Yep.

Etienne Nichols: But then when we get to the secondary packaging and then the tertiary in bulk. Yeah. I don't know.

Jeff Barrett: There's no standards on that other than you're looking at the seal.

Etienne Nichols: Still doing the same thing.

Jeff Barrett: Then you got to look at the product. You have to make sure the product was not damaged. So that's where that tertiary packaging comes in. It's trying to protect the product as well as the seal. So those two tests are done in parallel. You've got to look at the product as it ages and make sure it's good, but that's as simple as, we typically let the customers do that, because they're the experts in the product. So we'll return the product after the ship test to them so they can inspect the product itself and we evaluate the seals.

Etienne Nichols: Okay, cool. Yeah. I love how simple you can make it. I mean, it is a complicated process, but the concept itself-

Jeff Barrett: I'll tell you even today, there are days I'm just like... Like this guy today, he asked," Can you just use pre- validated seals?" And I'm like," You can. Let me think about that." It's complicated. But in the end it's all about maintaining a seal and not damaging the product.

Etienne Nichols: Yeah. Well, very cool. Any other advice that you can give companies or recommendations you have?

Jeff Barrett: Yeah, I think it's a nuance, but I have seen this be very helpful and that's to validate a seal, you don't have to put a product in it. So we have customers with really expensive products and they want to do this package validation with the product in it. For aging trials, to make sure that the seal's good over time, you don't have to have product in it. And you can run into problems when you're doing accelerated aging with higher temperatures and the product will fail before the package. So now you don't know what the shelf life of your package is because the product failed. So sometimes what we like to do with customers, is separate that out. We'll do the aging, the oven studies with the product, but in parallel with all that, we'll do empty packages for the seals. It's a nuance, it requires more discussion. But I think from a customer standpoint, the key takeaway is, is there a chance that the product expiration date will be shorter than what I want the package to be? Because some customers will say," Look, we want to use this package for the next generation product and that's going to be labeled for five years. This one's only going to be labeled for one." So it's good to tease that out, because if you could take the product out of the package and validate that package seal for five years, you're done.

Etienne Nichols: That's a great point. I love that. So knowing when you can use the package and not have anything in it. But then the other piece, I guess in my mind, is when can you use just dunnage versus the actual or do you actually have to have an actual part?

Jeff Barrett: Good question. I think, technically, you could use something that is worst case. So like I mentioned before, orthopedic implants use the heaviest one for the package and then you can use it for all the other pieces. We get into this, it's a whole other topic, pre- validated packaging. But yes it's possible, but I wouldn't recommend it. You want to make sure you got the package for your product. It can be helpful when you're doing worst case, when you want to validate a worst case scenario. Right.

Etienne Nichols: Okay. Yeah. That makes sense. And honestly, I don't even know if it makes sense to do that anyway, with the real time and the accelerated aging, you're going to want to test your product as well.

Jeff Barrett: Exactly. And like I said before, you can separate those. But from a package standpoint, we do that. We call it family packaging where we'll say," Okay, this tray or this pouch, we're going to validate worst case so that you can use it for other products as well." And you just need justification in your files, design files, of how you justify that. And it's typically, well, it's less weight. It's doesn't have any sharp features. It's just a less complicated part. So the FDA's fine with that.

Etienne Nichols: That's one of the reasons I like knowing people like you, Jeff, because knowing what is required and what's not, helps you figure out," Okay, these are the actual parameters I can work within." And then you start moving those levers.

Jeff Barrett: Yeah, exactly. And what are the ways? It really is, because it's such a big time sync and customers do it too late. You got to get good at it's not cutting corners, but what can we do to kind of compress the schedule? And by that, I mean, how do we take risk out, because that's schedule killer, at these 30% that fail. That's a killer.

Etienne Nichols: So I work with a lot of customers who are working through the design controls and risk early on. You just mentioned it is a time thing. It's good to do it early, but maybe one question I get asked a lot is, when do you start this specific task? Is it in that design controls? I mean, should the packaging be a part of your design controls and your user needs or?

Jeff Barrett: I believe it is. We don't design products. By the time you get to us, they might need some design for manufacturability and scale up, but the product's designed. But my understanding is that it should be considered early. And most engineers that we see, they're starting to look at sterilization methods early, because they have to look at, see if there's any EO residuals or stuff like that, that impacting the product. So at least do that. And then on the packaging side, I think your outsource partner can handle a lot of that, ask the right questions. It's like us. I see a catheter, from the customer standpoint, it's cutting edge. It is the latest and greatest, but I've seen a thousand catheters. I know how to package them. So I have a lot of confidence so we can just show them. Well, here are going to be some options that you can evaluate down the road, but we're very confident that it's not going to be a problem.

Etienne Nichols: Yeah. Awesome. 11607. I'll have to put that in the... Its 11607. Every state-

Jeff Barrett: Yeah. It's 11607, part 1 and part 2. And if you have trouble getting to sleep at night, just bring that to bed and read that in bed and you'll be out like a light.

Etienne Nichols: Oh man. Well, no, this is great. I really appreciate you kind of breaking some of these things down. I'll put in a link in the show notes of how people can find you and get a hold of you, see what you're up to. And yeah, thanks for coming on the show today.

Jeff Barrett: Yeah, no problem. Anytime.

Etienne Nichols: All right. Those of you who are listening, you've been listening to the Global Medical Device Podcast. We welcome you. Come back next time. Hope this was a good episode. We'd love to hear any feedback. If you have any feedback, send us an email at podcast@globalmedicaldevicepodcast.com and we'll see you next time.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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