006 – Are You Skipping This Essential Medical Product Development Step? Find Out From Karen Greene

In this episode I sit down with Karen Greene from Life Pack Labs to talk about an often overlooked step in development, medical device packaging.  We talk about steps that can save you time and money to market, and why you should consider your packaging from the very beginning of your project.

  • Why packaging should be considered right at the onset of your product development.
  • Why the primary packaging is important for sterile medical devices and how this saves time and money if done early
  • The purpose of the secondary packaging for your product.
  • Things to consider when designing the tertiary packaging.
  • How Karen’s team uses temperature chambers to simulate “aging” and test your product.

Take Action:  Download your 7 Essentials For Successful Medical Package Design Here

Quote:

“Your packaging is really a part of the product itself.” – Karen Greene

Links to Things Mentioned in This Episode:
Instron
Mocon
Life Packaging Technology

Guest:
Karen Greene has 30+ years of professional experience in package engineering, 22 of which have been spent in medical device and pharmaceutical package engineering and engineering services.

Company:
Life Pack Labs brings together MOCON®’s packaging permeation, integrity equipment and testing with Life Packaging Technology’s expertise in design, testing and validation of packaging systems for sterile and non-sterile medical devices, biotechnology and pharmaceutical products.

Quote:
“Your packaging is really a part of the product itself.” – Karen Greene

Guest: Karen Greene
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Guest Company: Life Pack Labs
Email: info@lifepacklabs.com
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Host: Meghan Alonso
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Host Company: Imua Services
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All Podcasts:
iTunes: bitly.com/InspiredbyIMUA  

Podcast Transcription:

– [Announcer] Are you ready to master the waves of medical device product development? Well, wax up your surfboard, because you are listening to Inspired By IMUA and here is your medical device product development expert, that Hawaiian-hearted hostess who will help you hang ten, Meghan Alonso.

– [Meghan] E Komo Mai and Aloha. Welcome to another episode of inspiredbyimua.com and I hope you guys are ready. I have a great guest lined up for us today. She is the president of Life Pack Labs, which is a contract testing laboratory and offers technology services. It’s a jointly owned business operated by Life Packaging Technology and MOCON, which is involved in laboratory instrumentation. So they do not only testing services for packaging of medical devices, but they offer services where they do packaging engineering as well. So help me in joining Karen Green to the show. Karen, are you ready to hang ten?

– [Karen] I’m ready, Meghan. Let’s go.

– [Meghan] Alright. So I think what you do is really interesting and a lot of people don’t think about this when they’re developing a medical device, so just give us a few tips and insight into what they need to be thinking about when they start their engineering process.

– [Karen] Yeah, thanks Meghan. Yeah, packaging is frequently the last thing that people think about because they’re so focused on designing the medical device in regulatory compliance, just getting it to be functional, there’s just so many technology and design hurdles that packaging is something that, it’s just kinda last on their lists. So, it’s gotten a lot better, I’d say, over the years because packaging engineers are usually an integral part of the teams and they try to educate the product development team on the value of packing and how integrating packaging, design, and development up front, it’s really part of the design control process. It should be thought of right at the outset and in parallel with the design control process and the product development process because many, as medical devices become more and more sophisticated and we get more accommodation products, drug device, drug biologic, device electronics are incorporated, that the packaging is really part of the product itself. So there’s a lot a value that packaging can add and they need to treat it kind of with the same design control rigor that they would the package. So we try to get engaged early and product development folks should be thinking about that too, engaging early.

– [Meghan] So one thing that I was thinking about today, so the term packaging engineering can be confusing sometimes. Some people think it’s the package that the device goes inside of, which is rightfully so, and that’s part of it, like, if you were to have this shipped to you, it comes inside of an Amazon box for instance, I’m just using this as an example. So, comes in its Amazon brown box, but then, once you open that brown box, there’s the air pellet or the air pockets that they have around that and then there’s the actual package. So maybe you open a box and there’s some foam inside of there securing the device, or maybe it’s in a plastic bag and then you finally get to the device. So there’s that aspect of it, but then there’s also the aspect of maybe the device is housing some reagents or, like you mentioned, some drugs. So that is a package in of itself. So give us some more details on both sides of that.

– [Karen] Yeah, so packaging has multiple levels, Meghan, as you kind of indicated and the terms that we usually use are primary, secondary, tertiary, and I think fourth level might be quaternary. So a packaging engineer, sometimes the business of developing packaging is broken out into what they call primary packaging, which is the package that’s most intimate with the drug or the device. So that type of package is really very closely allied with the product itself, so there usually has to be quite a bit of testing, very long term testing, a lot of shelf life evaluation usually goes in, is involved with the primary package. So that’s one level of packaging design, and for a sterile medical device, that package has to be the sterile barrier, so that’s kind of a big focus of that primary package is to provide sterile barrier integrity over the life of the product. Then you move out farther away from the product, the device or the drug, and they’ll call that secondary packaging, that might be more like a shelf carton, and the purpose of that is probably more like a dust cover, you know to convey important information about the product, labeling, expiration dates. So that package, when people design that kind of a package, they’re thinking about, at least for medical devices, how storage issues, you know how it sits on the shelf, how the clinician can access the product quickly, identify the product quickly. So there’s a little less interaction and testing that might go on with the secondary packaging, but then you’re focused a lot around design and storage and dimension and ease of identification. Then depending on the type of product that you have and its requirements, you get into the tertiary packaging, there’s all kinds of issues with that too, there’s physical protection, your product can be temperature sensitive so you kinda get into this whole realm of thermal packaging, like if you have a drug that has to be kept at refrigerated temperatures. So now you’re designing what we might call a shipper that perhaps has insulation, and that we can demonstrate it maintains the required temperature for a certain period of time, you have to evaluate that, test that and validate that, as well as if it’s kind of a high volume product, and it’s shipped in large quantities on a pallet, so you’re cubing out a big pallet and you want the most efficient dimension to fit on the pallet, so you’re getting the most number of units on a pallet. You know, that’s another area you can, a packaging engineer would get involved in. So packaging engineers get involved in an enormous range of activity from how that primary package interacts with a device and protects it and provides all the requirements up to how it moves through the supply chain throughout the world. Then you almost start to deal with the FedEx’s and the UPS’s of the world as well as something they call like, third party logistics. Companies that just help you move your product around the world. So a big skill for a packaging engineer.

– [Meghan] So Karen, I’ve been to your facility and you’ve got many exciting things going on over there, and it’s quite the experience to walk in your acceleration oven. So walk our guests through, since they can’t, since we can’t physically walk them through the oven, kind of walk them through the equipment that you have there and the layout and how your equipment can help them.

– [Karen] Sure, Meghan. So we’re a relatively small laboratory, but we have big aspirations.

– [Meghan] Oh and for those of you listening, this is in Vista, California which is just north of San Diego about 30 miles.

– [Karen] Yes, lovely Vista. So our facility is, as I mentioned, is relatively small, but we have certainly space to grow and sufficient space for the instrumentation that we have. Maybe just a quick little bit of background. So our focus is primarily in providing testing services around package integrity, I’ll kind of use that very broadly and what do I mean by that? So we have, as Meghan indicated, we have a number of environmental chambers, and those chambers are capable of generating cold, hot and humidity, and they’re all programmable with controllers, so we can develop custom temperature and humidity profiles for whatever the customer is trying to do. In medical devices, and really in many products, food requires this as well. Something called shelf life, and shelf life kinda is a generic term, and what we mean by that is how long does my widget, my thing, my product stay good, if you will, just to use simple language and good is usually meeting your specifications for whatever that is. So we use the chambers, the environmental chambers, for example, to do something called accelerated aging, which allows us to, using temperature, it’s kinda temperature heats like a catalyst, to accelerate chemical reactions to create a real-time equivalent. So there are some ASTM which is standardized test method, it’s a society that creates standardized test methods for anyone to utilize. So ASTM has a test method around accelerated aging it’s widely used in medical device for packaging, you can apply it, it’s a thermodynamic principle, you can apply it really to anything where you want to accelerate time basically. And what it allows you to do is gather data in a shorter amount of time because people don’t want to wait two years necessarily to do a shelf life test and then release their product, because time is money, you wanna get your product on the market.

– [Meghan] Exactly.

– [Karen] So we have chambers and we have something called the Universal Test System, which, the brand is Instron, and I only say that because it’s a common instrument that people in the industry are aware of, and it’s basically a unit that can provide tensile, measurement in the tensile direction, and compression, so we can basically pull things apart and we can crush them, and so some standardized tests in that arena, for packaging and for products, for medical devices sometimes, companies will wanna quantify like a bond strength, that they have tubing that’s bonded together, we can quantify them out of the strength of that bond, just as an example. We have some other MOCON instrumentation in our laboratory, MOCON is a manufacturer of instrumentation that can measure package strength through burst testing, through pressure decay testing, we have an oxygen headspace analyzer, we can accurately, if your product’s oxygen sensitive, we can accurately measure the amount of oxygen inside your package. We can do other tests for leakage, dye ingress testing, bubble leak testing, for leakage, dye penetrations, Many, I won’t rattle off the ASTM standards, put everybody to sleep. We can do a whole host of standardized test methods and then customize, we can customize methods too if a customer is interested in discovering more about their package or their system.

– [Meghan] Okay, so walk us through, the classic example that comes to my mind, is someone that will be shipping their product, and you mention FedEx and UPS, so their product, they take it or they have someone pick it up, and then it is trucked somewhere and then loaded on a plane, so some of the testing that would be involved in that is, you know how does the product react when you take it up to 30,000 feet and what, not only the product, but the packaging around it? So I can think of that example, walk us through some other real life examples that people really need to be concerned about and how your services can really help avoid future problems and identify them early on?

– [Karen] Yep, good question, Meghan. So, I forgot to mention we have a vacuum oven, or we could also use it like an altitude chamber. So we can create the pressure equivalent, you know there’s a conversion chart, so if you’re at 30,000 feet, or actually most, I think, air cargo they pressurize the cargo hold to about 8,000 feet.

– [Meghan] Oh, I never knew that.

– [Karen] Yeah yeah, so when we’re inside the plane, when we’re flying Southwest from point A to point B, the atmospheric pressure inside that airplane is about at about what you would feel at 8,000 feet, like if you went to Mammoth Mountain here in California.

– [Meghan] And I know even on the plane as a person, you have your little lotion bottle, or your hand sanitizer, and it expands.

– [Karen] Yep, and ’cause here in lovely San Diego, we’re basically at sea level, right? So if you go to Denver at 5,000 feet you might see your hand lotion or your potato chip bag puff up a little bit, that’s because there’s less pressure at 5,000 feet than at sea level, and it’s a little bit more about 8,000 feet in a plane, so that said if, just you said as an example, if a client has a pouch, some type of pouch or bag system, or if they have a container closure system, again I’m in the business of leakage, so the customer, they don’t want their seals to pop open and sometimes if the package is constrained in the shipper box and it kinda expands, you could blow a seal. And now you’re compromising your product, right? Anytime your seal’s open that’s an undesirable situation. So we can simulate the altitude and see if we’re getting that phenomenon of seals popping open. And that’s useful information for the customer, maybe they have to go back and change their sealing parameters or change the material to not have that happen. Or if they have like a reagent in a container closure system, a screw top jar, the plastic will kinda contract or expand, based on the negative pressure, and if they have liquid it could leak, or if they have a powder it could leak, so we can help them understand that type of environmental hazard, that’s what they call it.

– [Meghan] Yeah.

– [Karen] And with the environmental chambers, temperature and humidity they do kinda nasty things to most things right? As your product moves through the supply chain it’s not sitting really in general for extended periods of time, because in general you want the freight gets moved. But it can, it’s very hot, and very cold in many different parts of the world, so products sitting on a tarmac, it’s waiting to get loaded on a plane, so we can help them through some standard environmental profiles that are out there. We can simulate how, what their product will see through the supply chain, for temperature, for humidity, and evaluate that and that data’s useful for the customer to see whether their product is behaving appropriately, meaning their specs, or whether there’s some negative consequences of that heat and humidity and cold on their product. We don’t have the transit testing equipment, so we might work with another laboratory, to do things like execute a drop test or a vibration test.

– [Meghan] So explain the drop and vibration test. What is that simulating?

– [Karen] Yeah, so that’s a good question, and a lot of people spend a lot of time on this, it seems like a pretty boring subject, but it gets exciting when you can expose your product to these, I’ll call them environmental hazards, and stuff starts breaking or breaking down. There’s been research by a few standard setting organizations, where they’ve actually taken, I’ll call it a black box, it’s like a data logger that, it might have an accelerometer inside of it, and temperature loggers, where it can track if you put it in a box with your product and you ship it, you can get data out of that data logger that says these are the kind of vibrational inputs that your product experienced. So companies have done that, and they’ve used that data to create profiles, and then they make machines like a vibration tester, primarily that can simulate say a truck shipment, or an airplane shipment. ‘Cause it’s kinda all about the profile, and what they call transit testing, profiles, it’s a very common word, and what does that mean? It means that you take data that you just, raw data that you measure from the field, and you have to turn it into a representative profile, because you can’t possibly just take the raw data and expose your package to that, you have to condense it down basically into something that is repeatable. So, organizations have done that, and people like me can deploy those profiles to, with instrumentation and companies that make the instrumentation they take that and build it into their software, the profiles, so that you can utilize those profiles.

– [Meghan] So that’s everything from, the driver picked it up and then he accidentally dropped it and then it goes back on the truck and it’s the normal road bumps or maybe uphill, downhill, slamming on the brakes, that type of thing?

– [Karen] It is, and think of it this way is that, so it’s what your product sees. So your product maybe it’s going like Roadway Express, the truck transportation company you might see on the highway or freeway. So the products sitting in the back, not up with the driver right?

– [Meghan] Mmhmm, yeah.

– [Karen] Yes, they’ve created profiles that have experienced all that, Meghan. And through the, if you’ve never done this, maybe it’s exciting to a packaging engineer, and not so exciting to the average person, but if you go into like a UPS hub or a FedEx hub, a sorting hub facility, where they sort. It’s like amazing, ’cause boxes are flying through that thing like spaceships, right? It’s just moving at lightning speed getting sorted. Especially around Christmas time, it’s probably like mayhem, and your product gets bumped and banged in that situation, too. So like, ASTM has standards that kind of incorporate that sorting, what happens at a sorting facility. So believe it or not, as boring as it may seem, people involved in packaging and logistics have spent a lot of time characterizing shipping.

– [Meghan] Well, I mean it’s important if you think about that, if you don’t design it right, and then it gets, it either bursts because of altitude, or if you don’t pack it right in the box, and it breaks open, then that’s lost revenue. So it really is important especially if that’s gonna happen. It’s not just one, if that’s happening to all of your products then you’ve got a big problem on your hands.

– [Karen] You’re right, Meghan. Damage loss through shipping can be huge. And companies, usually it doesn’t take them too long, once they start experiencing damage, they’re gonna try to rectify it quickly, ’cause it’s a revenue killer, it’s just money out the door, you’re burning time fixing it, you may have to stop shipping your product, because it’s unacceptable level of damage. So when you look at a medical device or a drug, think about this, is that our job as packaging engineers, is to help manufacturers deliver safe and effective drugs, because, or medical devices. So if you’ve compromised the safety and efficacy, those are two buzzwords in our field, you could almost, you could kill somebody. So the stakes are really high. That’s why packaging engineering is so important, because the very dark side of designing a poor package, could be harm to a patient.

– [Meghan] Yeah, okay. Yeah, that’s really important and it kinda hits home. So that’s on the, now let me circle back, ’cause I think that in terms of later on once you have your product designed and then you focus on that particular part of the package, but let’s move back a step, if you’re just designing your product, in terms of packaging engineering, what are some key things that our listeners can take away that they need to start from day one?

– [Karen] Yeah, I’d say maybe I’ll outline even like a little, a mini-little process, Meghan. ‘Cause I find that if you have a process–

– [Meghan] Sure and if you want to I can, if you want to share this process, I can put it on our show notes page, so our listeners can access it.

– [Karen] Okay good yeah, I have a little two page document on that, but absolutely. So it’s probably best explained in terms of a process. So really start out much like you would designing a medical device or a drug with kinda design requirements. What does this package need to do? And obviously it needs to protect the product. That’s intuitive. But how? So you drill down a little bit deeper. So it starts with the design requirements, and that’s why there’s kind of a big partnership with the product development folks, right? ‘Cause they’re gonna dictate largely what the design requirements are for the package. So you start out with the design requirements, and then things like user needs might be kind of a subset of that. Something that I’m seeing, that’s kind of part, in my mind, again, sort of design requirements and user needs, and I’m not an expert in this area, is human factors, where many device companies are spending more time on insuring that, okay we designed this particular package, but is it really user friendly? Are we really designing it for optimum use by the clinician?

– [Meghan] Yeah.

– [Karen] Human factors gets involved in that. And then you kind of move into a prototyping phase, where you probably also want to incorporate some good clinical, you wanna get good clinical feedback, so you can start prototyping your package, so you’re making samples. Okay, we think it’s going to look like this, and using things like 3D printing, that’s kinda helped in some areas, it’s helped packaging develop prototypes and samples, and there are other rapid prototyping tools, I won’t get into it too much in detail. But our consulting part of the business does a lot in prototyping, where, let’s go out and create some packages and see how they interact with the device. And once you start prototyping, kind of an area why I kind of opened this lab, or had this idea for this testing laboratory is, it’s so important to start gathering testing data, you know performance data. We’ve got the materials we think identify the design, given how all these environmental hazards and other things, how is this package gonna work? So you might take some of the prototypes out to the field and get clinician feedback, right how do they think it works? And then in a testing laboratory, how does this package perform when you put it through some hazards and stresses? Temperature, humidity, vibration, shock, drop, so that’s probably the next phase of kinda moving through a package development process. And then that can be iterative, right? You design it once, it’s not quite right, and you kinda keep going back and refining it.

– [Meghan] Yeah, and what I’m, what immediately is coming to my mind, if someone waits ’til the product is fully designed, or almost fully designed and ready for manufacturing, they’ve already wasted a lot of time. Because, then they’re gonna have to hook up with you and go through the iterations, and if they could’ve started that process earlier, then they save that time to market. So again, it’s just lost revenue.

– [Karen] The one thing that you’re right on, Meghan. So that’s the downside of starting too late, is that you just, you can delay all your timelines. Another thing too that, it doesn’t happen probably as often as it should but, some might see it as the tail wagging the dog but, if product development teams partner early on with somebody with some packaging experience, we may actually try to influence the product design, you’re thinking well why should the package influence the product design but, but it can to the point where it could actually make a better product and definitely save some money, because what I find, what I found a lot in my career, is we end up band-aiding, the package becomes the band-aid, because the product is not very package friendly.

– [Meghan] Okay.

– [Karen] Things like, I dunno, even changing the radii on a molded part, a radius on a molded part, so it’s not so abrasive on a pouch, say a film, right? Most packaging is, are thin right? They’re not putting them in titanium cases, because that wouldn’t be cost effective. So if we can look at the product and say you know if you could modify this design slightly, we could get a less expensive package, and not have to spend a lot of time, band-aiding the packaging system to make it work, to have a high performing package. So that’s another area where packaging can add value, we can help actually take costs out of the packaging.

– [Meghan] Good. Well, thank you for being on the show today, I think you really brought some value in terms of, again, I have this up on my website as a tip, you have to start with end in mind, and start things earlier than you think you need to, and that was just proven again here today. So thanks for hitting that home for us.

– [Karen] You know, I agree, Meghan. And I think you got some great things going on here, and hopefully we brought, shed a little bit of light on a field that may not be terribly sexy, but there’s a lot of fun, there’s a lot of innovation in packaging going on. A lot of people, packaging folks are pretty passionate about it because we’re not usually the stars of the team, but we’re key players, and we’re all motivated to make, make the product shine. So that’s our goal.

– [Meghan] Alright, good.

– [Karen] Thanks, Meghan.

– [Meghan] Thank you. Thanks for tuning in today for another episode of inspiredbyimua.com and good things happen when we all come together and collaborate and we bounce ideas off of each other. So, if you haven’t already, go to facebook.com yes, we’re doing business on Facebook. So, search Inspired by IMUA o Facebook, there’s a Facebook group that we can all be a part of, and talk about this while off the air, but still online. So I’d love to see you in there, check it out, and ’til next time, IMUA!

– [Announcer] Mahalo for joining us. If you’re new to riding the waves of medical device product development, or if you’ve been in development for awhile already, Inspired By IMUA is here to surf with you. Wanna be a master of the waves? Text hang ten, that’s H-A-N-G-T-E-N, to 4-4-2-2-2, we’ll send you the most common wipeouts companies make in product development, so you can avoid them and reach master wave status. Again that’s hang ten to 4-4-2-2-2. We publish a new episode every Tuesday, so catch us at isnpiredbyimua.com IMUA!

About the Author

Meghan M. Alonso
Meghan M. Alonso, referred to by Shark Tank’s Kevin Harrington as a medical device development expert, is known for her award winning medical device podcast, Inspired by Imua, the chapter she wrote in best selling book “Put a Shark in Your Tank, and her valuable connections in the medical industry. According to the Huffington Post, she helps clients navigate the complicated process of bringing their ideas to the marketplace. She’s a patriotic military wife, pet parent, founder and co-founder of 4 successful companies who thrives on guiding medical device and IVD companies through development and manufacturing. When she isn’t helping others, Meghan is hard at work on her MBA she is pursuing from Auburn University, staying active with her adorable husky Abby, crossfitting, enjoying great restaurants and fine wine with her husband, and soaking up the sun the nearest beach.

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