Medical Device Packaging - What’s New and How to Stay Ahead of the Competition
Charlie Webb is the founder of Van der Stähl Scientific, a company that provides medical device packaging systems and services. In this episode Charlie shares information on the types of packaging systems available, materials used, considerations for choosing the correct system for your device, understanding user needs, what packaging sealers do and how they have evolved, why verification and validation are equally important, and packaging sustainability.
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome! Today we're going to talk about packaging. Now packaging is a subject that many people don't even think about, or they take it for granted. But it actually can have a profound impact on your product integrity, your product sales, the potential for recall, which is something that should wake us all up, or it could be a missed opportunity to enhance your brand. Our guest today is Charlie Webb, the founder of Van der Stähl Scientific. Van der Stähl is a company that provides medical device packaging systems, and also services. In our conversation today we discuss the types of packaging systems available, the different types of materials that are used. And then we get into considerations for choosing the correct system for your device. Because it's not always always one, one stop fits all. Understanding user needs, what packaging sealers do and how they've evolved? Why verification and validation are equally important. And then we also talk about sustainability in an issue that's that's becoming more more prominent in packaging. Here's our conversation. Charlie, you're earned a BS in business administration in college. So how did you get into the medical device field? And more specifically, how did you found a company in something so specialized as medical device packaging and testing machinery
Charlie Webb 02:07
is a weird journey. So I started as a consultant helping technologist, principally physicians who had a technology they had a patent and they were looking to get it into the marketplace and started working with my identical twin brother who was a president of a microsurgical blade company. So my role there was not only sales and marketing, but I was also in the on the tech side. He and I both come from a very mechanical parent, and so engineering and tools. And those were both ham radio operators. And so we're both tech guys. And so he was a, in fact, he has 60 patents right now, one of them is the world's smallest surgical implant. So a couple of marketing guys that also were on the tech side, we're running this company. And so I got pretty good at understanding how a medical device made the journey from the ideation side, all the way into the clinical point of use. So after we sold the company, my brother did, I moved on to be a consultant helping, again, physicians principally take their device and find a home for it in the surgery centers hospital or the the clinical point of care. During this process, I was hired by a large company, Mitsui plastics, to help them with one of their partners get some packaging machinery validated. So they didn't understand the regulatory process. And so that was something that I was involved in as part of the scientific review board for the surgical blade company that worked. So I became sort of a SME in that sort of narrow space where I connect technologist to the sort of distal delivery and distribution. And this company hired me they were in the packaging business. And it was obvious to me that there was a need for higher end tech at this, this call point. At this point, I mean, basically, packaging machinery of this era was just a hot bar that melted plastic together. And I guess that it's in that still sort of that, but there was no, no logic upstream of that. So there was no sensors, the microprocessors really didn't exist on this category. You know, so how do you tell the FDA or an accredited body that you 100% For sure, have that medical device, there's going to stay sterile through this closure system, if you don't have the technology surrounding that, so that became a sort of an interest of mine later turned into a vocational hobby passion of mine too. I've several patents on this type of equipment and I've just over the years have seen where you know, we need to do a little bit better on packaging, and now through the regulatory bodies, we can see that my hunch was right. They really tightened it up. In fact, so much a medical device and its containment system through the vista of ISO and the FDA, it really see these as a single aggregate unit, right. So now a medical device and the packaging system they're in is one approved piece of your device. So it's become super important. So that's kind of where I got started in the, in the packaging space from a much more from the surgical side, which is unusual, because a lot of people, my colleagues, my competition that are in this business, they came from a general packaging, you know, closing up bags of potato chips, and those sorts of things. So mine obviously was a much more high level, and it was able to sort of leverage that knowledge that I had of regulatory processes and the tech side to be able to come up with some cool stuff.
Patrick Kothe 06:01
So Charlie, you mentioned that regulatory bodies are viewing the complete product as the product and packaging associated with it. Why why did that change? What what was the what was the impetus behind making that that change
Charlie Webb 06:16
infection? In short, you know, patients, a lot of the H AIIS. hospital acquired infections or associated infections are associated with them. Caregivers, a lot of times, you know, hands aren't being washed, and so on. But, you know, as they take a sort of a more Bird's Eye, look at these nosocomial infections, we can see that, you know, some of those can be coming directly from the the SPD departments, sterile processing departments, or hospitals and OEMs. Also, they're bringing their packages into that point of care. So the whole value system, really what turned into the zeitgeist of the entire medical device packaging industry was that we all need to do a better job at creating systems that are more reliable, that are monitored through sensors. And that we can assure that that device that we've made, is going to get to the point of care, safe and sterile. Oftentimes, I've been quoted as saying is that even the most efficacious medical device, if sterility law is lost on it, it becomes effectively poisonous. So we really need to do a good job, when we are connecting packaging with the OEM side the development of a medical device, it's great to have an incredible device. But if that device doesn't make it to the patient, in that sterile field with sterility intact, then it's an issue. And so the FDA, ISO has also sort of seen that process through those same optics. So in 2019, ISO 11 607, was sort of reworked a little bit in order to really talk about the new sort of nomenclature that's commonly used in medical device packaging the sterile barrier system. And so that sterile Barrier System encompasses the containment system, the seals that are made, obviously, the material, and even the device within that containment system is the sterile barrier system. So, you know, again, our goal is to get that device to the patient without sterility loss, I mean, it happens, people are done. And really, we have a very difficult time trying to extract reasonable metrics to understand how many people may in fact, be infected by a non non sterile medical device, and we have some ideas. But you know, we're talking about ha eyes in the, in the order of, you know, several 100,000, there's been several different numbers that have come out over the years. But, you know, several 100,000 People are dying in the hospital from hospital acquired infections are associated infections. So can you imagine if we were to use that metric that number, under the same process that we report COVID cases, for instance? So we need to look into the World Health Organization halls who was looking at these aggregate numbers to what really does it mean, but backing up? You know, I think the the obviously the responsibility for regulatory bodies like ISO and an FDA, is develop protocols and processes that medical device manufacturers can follow, to help them to assure that they get their device sterile to the point of care. And remember, their goal is to help the medical device manufacturer, this isn't an IRS punishment system. This is something hey, how can we work together as a community? How can we connect in link together all of the shareholders of this process everything from the selection of the material of that device, all the way through its journey, getting into the point of care with that device, working well? shoring, sterility and the containment system that has Balls had been sound. So that was really what brought this to play.
Patrick Kothe 10:05
So, Charlie, there's different types of packaging systems for medical devices. Can you explain a little bit about what types of packaging systems are out there. And what's most commonly used?
Charlie Webb 10:19
It's interesting, I would say, every bit of 40% of our customer base is a new medical device startup. So you know, when we're not when we have to kind of change our Look, we're not at consumer products, we're not packaging pretzels. We're talking about a medical device. And some of our customers literally, they have these very specific devices that are only using in very unusual cases, we had one customer that seals up two parts in a year. But the FDA and ISO require the same process, regardless of how many you're doing it. So basically, in short, you know, we're mostly in the business of a standard vanilla sort of Tyvek bag that the CIRCULATING NURSE or caregiver would grab, and there's a place to grab with gloved hands, and you would open that up and deliver it into the mayo stand. That's the sort of the vanilla standard pouch. And that's the business we're in, we're sealing up that final seal on that containment system. Now, in cases, if you have a bulky product, it's very difficult to put that in a flat bag because it's it pulls on the pouch, and it causes issues on the seal. So then you go into tray sealers. Now, that's something we don't get involved with. But if you have a procedure kit, for instance, tray sealers lend themselves to that process quite well. Because you can compartmentalize, you know, think Lunchables or the old cafeteria plates where everything is separated into a different cavity, Brian, now we all think of Apple as the sort of high watermark of how you open up a process. We've all even in the clinical side, we're all thinking about what is that user experience of opening up the pouch, hard to believe that we think about this in medicine. But we do not only on the aesthetic side, but we're now wired to do things a certain way. And so we have to do that on the industrial side. So it feels natural and organic to the user. But we can open up that tie back lid, we can take out each one of those components that are usually packed in the order in which they'll be used for the procedure. And it accommodates that, that deeper width. So the tray sealer in some time blister packing, those are the those are kind of common for more bulky products, we do the bulk of flat pouches. That's really our business as well as testing machinery for medical pouches. So those prints will be the ones I mean, when you have high dollar, I mean low dollar high volume products like cannulas. Those are typically done in a form and fill machine that devices are fed in, they're dropped through a very highly automated system. And they get spit out the other end, you know, 1000s of pieces per hour. So, you know, those are kind of in short, the the types of sealers that are used are packaging machinery that's used tray sealers, and then bar sealers for the flat pouches. And then the more automated form and fill type processing for high volume. That's principally what we've done.
Patrick Kothe 13:23
Do you have any idea from all the medical devices that are out there? What what percentage breakdown would be for tray sealers versus pouches?
Charlie Webb 13:32
Gosh, that's a good question. In fact, we wish we had that Intel for our marketing function here sometimes, but you know, it sort of shifts, I would say that, you know, just generically, I would say we're probably somewhere about 30 to 40%. For tray sealers. The rest of that would be probably in the flat pouches with a much smaller amount for the for the fast, you know, processing packaging, but we do see a trend right now, there's a lot of complexities and when you're talking about medical device validation, you have to validate that that lid stock that's on top your tray is going to stay in place and we're not going to lose to real name. It's very difficult you have more surface area when you put a lid this this Tyvek lid on top of it. thermoform tray right. So what a lot of our customers are doing is they're taking their their low profile trays, and they're just installing them into an already sealed on three side pouch. And then they're using our machines to make that final seal. So we actually see some of our customers been a trend a lot lately actually, that are moving away when they can from the lid tray in order to make a simpler packaging process and also to make validation way easier because validation is a very arduous, heavy process that I think blindsides a lot of medical device companies when they just get into that secondary and tertiary part of getting their device to market.
Patrick Kothe 14:59
So There are other things beyond sterility when you're talking about packaging. So if you've got a needle in there, or you've got some type of thing that could puncture from the inside out, there's considerations there as well and type of packaging that you're that you're going to use. So it's not only it's not always just putting a device inside a pouch, sometimes there's backer cards and other things that need to need to go in that packaging as well. Correct?
Charlie Webb 15:25
Oh, yeah, great observation. I mean, right now we see a lot of companies doing cool stuff, all of our packaging is, has some nice little insert cards where a sharp device that can be moved, because obviously you have a distal tip of a surgical blade, for instance. And obviously, if there was movement through shipment, that's going to go right through the pouch. And so through these capture systems using a corrugated, thin chipboard, they're able to have a low dusts, low particulate insert card, they put the device in there, and it helps to cradle them to market. And so there is other, you know, components like that. Some of the snap in type of containment systems to hold that part in place. And, you know, as you alluded to, when you're looking at your medical device, packaging, journey, or the devices journey, you have to look at, you know what's going to happen, that's why we have to do accelerated aging, we have to understand, you know, how long is this containment system going to hold is sterility by doing accelerated in real time aging. And then we have to do in what we sometimes call the shaken bake testing, where we're beating the device up, and we're trying to see what the worst case scenario, we change the atmosphere. So when it goes up into an airplane, in the hole, we understand what that's going to be. So there's a lot of that challenges that go into medical device packaging. And so the industry has responded with a lot of cool little inserts, and so on, that you can put inside your pouches to help secure because you're absolutely right, those are a big issue.
Patrick Kothe 17:02
So let's talk about the pouch themselves. You mentioned that the pouches come and many times are sealed on three sides, and the top just needs to get sealed, things get deposited inside that pouch, and the top needs to get sealed. What are the materials that are used with these pouches?
Charlie Webb 17:19
Or there's a long list we you know, I would say the the most vanilla most commonly used pouch is a 1073 b Tyvek. breathable material with a clear film. On the other side, usually it's mylar PE T, sometimes nylon, and that is the selection for that material. And there's layers of material depend on a lot of things. How peelable Do you want that pouch to be even talking about what we just spoke about on the sharp side? How abrasion resistance is this material going to be. So we have to make those now some of the other ones as we move into these, you know ko devices that are embedded with a host of Pharmacopoeia. We have all sorts of for instance, we have medicated stents that are embedded with a anti rejection drug. So we have to make sure that we're not only physically protecting that device. Now we've added chemistry into the mix. And so we only have to understand that sometimes. We also sell vacuum sealers. And with a vacuum sealers, we can extract out the ambient environment, build it with a gas flush, where you can put nitrogen in, because some of this chemistry will decay in the presence of oh two or oh two when the the containment system allows for moisture to participate precipitate inside the pouch, which will also damage the chemistry. So we have to look at those kind of components. And some of them just don't like sunlight. We have a lot of our customers that are using FOIL pouches where you're completely occluded the device to any sort of daylight that can come into the pouch in order to preserve, again, typically the chemistry and also to give it a more robust sort of protection against the outside environment. So there's a host of different peelable materials. Hank Bloom from Paksas, who was also on a board with me for the Kilmer group. Their company has a very interesting technology right now where he's cohesive materials, they can pull apart and they can reliably pull the material apart because rather than the one side of the material bonding to the other side, there's this intermediate material that bonds to itself and has a sort of cleavage that opens up very reliably. So there's a lot of cool tech that's happening on the material side. It'll be interesting to see as that unfolds to give us much more reliable peels and safer pouches because we understand how those are going to open
Patrick Kothe 20:00
So you mentioned there's different types of materials and see through Nazi through foil pouches, etc. Some of that, I assume is also due to the type of sterilization method that's being utilized as well.
Charlie Webb 20:14
You're right, yep. So depending on, you know, some of the, obviously, if you're using ethylene oxide, you need to have a breathable material to be able to have the sterilant reach the device, others that are gamma radiated, don't necessarily need that. But you know, there also was other concerns about shadowing the device and so forth. But yeah, that's absolutely right, what sterilant is going to be used, one of the pieces of medical device packaging that continues to get a growing view of, of how it's happening in the field, is the the sort of user connection to the device, how's that device actually going to be used and organizations like the American Academy of operating room nurses will put on a little show for those of us in the packaging side, or just any OEM medical device manufacturer. And they they give us a big hint on how that that device has been handled in the hospital? You know, what does it journey look what we call in the Kilmer group, the last 100 yards? It's that group when the brown truck shows up, takes it into the hospital. Where's it going? Where, where is central load holdings for that device? How was it moved through the hospital? How is it stored? Is it shoved in a bin? And then when it gets to the end user? How does the end user actually present in real life? Not the sort of theoretical things, we in these sort of forums will just throw some pouches onto a tray. And we watch as these skilled or nurses open them up as they would in a surgical procedure. So it helps us understand not only what the journey is, is what is the, what's that arc look like? What's that destination look like when that device is actually delivered? ready for surgery. And it's important, I mean, one of the challenges, just one I can think of is, in ambulances. There's a problem where the, the EMT or medic will, with his teeth, or her teeth will grab one end of the pouch, and they'll open it up. So what is that, you know, mouth Flora onto that device, you know, look like on the infection control side. And we also see on some of the narrow pouches where we open them up where I've had a patent pending design on a on a new opening system that that allows for a better grip. So because we hear so much with gloved hands, you know, you have a bunch of sales and marketing people and sometimes a manufacturing engineer in a board room, and they're all opening up pouches, but they're not doing it with, you know, their vision partly obscured, they're not there, they're obviously not using gloved hands. And they don't understand the protocol, how do those individuals actually open up those pouches. And so it's really important for us to understand exactly how these are going to be used, we have to understand, of course, the sterilant, the transportation, the end use of it, and any other sort of potential problem. And you know, now we're starting to peek into sustainability. It's opening up another door.
Patrick Kothe 23:18
And I think, you know, as you mentioned, the use case, scenario two, is it a single pouch design or a double pouch design?
Charlie Webb 23:26
That's another one. And, you know, a lot of times we find out that the packaging engineers go back to the drawing board and said, hey, you know, this seemed like it was a good idea. How can we configure this better to make that, you know, it's, again, when we talk about UX and UI, we talk about that for website experiences, user experience, you know, and that the user experience part is important. One of my pet peeves has always been when I was a consultant is an industrial medicine. They somehow feel like they're exempt from the cultural value of the day. So if we're interacting with beautiful user interfaces on your iPhone and computers and even product and going to a Trader Joe's, you can look at packaging that pulls you in by using every psychodynamic that can come into that color. We know that, you know, a red box can repel a blue box can provide a counter belief and comfort and safety. So when we're using all of these little pieces to try to, you know, build out something that matters on the consumer side. Like it or not, the individuals that are opening those medical pouches have just left the local supermarket or target. So they're pulled in by the same psychodynamics that drive them towards a product and when we come up with unattractive packaging or poor user experiences, nothing worse is seen as sticky pouch that It's been trying to be opened up, we see now and, and frankly, if you go to the hospital now and you're looking at that contraption that captures your vitals, it used to be a box that look like a 1950 Maytag washing machine. Well, it doesn't anymore. They're curvaceous, they're pretty, the lighting is subtle, the buttons are tactile and easy to use. So we're moving into this industrial design part. The interesting thing about industrial design is not only does it make the experience more pleasant, hey, you're at the hospital, we weren't pleasant, right? And so to have that, that use your experience of pretty things that we're used to, is really important, even on our design of our machinery, we think consumer product, we believe in industrial design. And we're supported by that, because industrial design metrics tell us that to an end user, not they have a more of a belief into the product. Now, it's not to say that you should have a fraudulent product, that's all pretty. But if you have a good technology, why would you not skin it with industrial design, I mean, industrial design that is on par with what consumers are expecting, because you have a consumer there, just because they're in a cold hospital, on a rainy day, and everything is, you know, not targeted Christmas Eve, they expect to have the same beautiful experience, user interface matters. It's an it's it's one of the most important things on our website for our company, we spend a great deal of time having a flow, what they talk about removing friction, and removing friction at every point. And that's what we talk about even in the Kilmer grill, we're talking about how to get a medical device to that patient who is sick and in need of this surgical procedure, or this medical device? How can we do that without friction and do it and make it pretty? Why not?
Patrick Kothe 27:00
What's curious about that, Charlie, is that medical device design has a wide range of people who get customer feedback. Sometimes there's a ton of customer feedback that goes goes into the development of the of that product, and a lot of iterations based on that feedback and other devices. Don't gather that feedback on the device itself. Now we're talking about putting another aspect on that. And getting people to say your widget is not necessarily the total product. Now packaging is also part of that part of that product. And your experience right now. How is that? How's that being embraced by industry? And that whole message of getting the more elegant packaging implemented at a time when people still haven't done that with the device that they're using? Yeah.
Charlie Webb 27:55
Well, you know, I, again, I mean, if you go into YouTube, you can query unpackaging videos, and it will come back with about 23 million returns. Because people find this weird or maybe it's not weird, it's completely normal. To me, there's a great deal of satisfaction of watching a box open up and things beautifully unfold. I mean, I just grabbed I needed another pair of my headphones for my iPhone. So I took the little container that Apple created and it beautifully pops out the earpieces and it nicely spool on this beautiful spool. But it turns out that not only is that a spool, those are other size earplugs to accommodate different holes in your ear depending on the size of the humanoid that's going to use it right so beautiful packaging that was also functioning because on the sustainability side, it uses less packaging in order to create the delivery, it actually double duty double duty everything is is everything you know that in medical devices, you were on the cost containment world, we have to worry about cost. So to have that packaging experience that told a story. It told the story of sustainability, simplicity and quality. So it is it's important and I think enough people are connected with packaging being such an integral part of what the contained system I've been pulled in so many times by ho hum underwhelming products that were skin through some beautiful packaging that used to be where a clinician feels like hey, there's no place for pretty here. This is serious business. We're at a hospital. This is a surgical procedure. Just give me your darn device and let's get busy. But that's changing because again, you cannot change the mind once they walk the double doors of the hospital. That consumer brain is still connected, their online, their computer, their phone, everything is beautifully connected and they will expect in fact, they demand nothing less than that.
Patrick Kothe 30:00
I think we also have to look at who's opening the package. Because as you said, I mean, if if the surgeon is open, if the surgeon surgeon is not opening up there, there may be somebody who's an influencer. That is. So that's one, one scenario. Another scenario is you have a physician that's opening up and the physician is making a decision on the product, that's a different level of the importance of the packaging. Regardless, the quality of your company is reflected in the packaging that it's in, and how easy it is or not easy it is to utilize your product. So that is that packaging is part of your part of your product, how important that is in the decision process is different for every product,
Charlie Webb 30:40
well, you make a really good point. So if you have somebody that has a lower educational experience, versus somebody who has gone all the way through graduate school to their internship, and now they're an MD, like it or not, there are different socio economic people, they view the world through a different optic. And you have to understand that I'm not saying that one is better than the other, I don't want to say that I'm just saying that we have to understand as marketers, that we're reaching a group of people that has biases, they have a bias, some, you know, a physician may have a bias towards a pretty boxes, whereas the other person, it may not be okay, it could be reversed. So we have to understand, you know, what is important to that individual and who the ultimate person is, as you say, is going to open up that box, it's a real important part to understand, when we try to sell something to the sterile processing department at a hospital, when we're talking to that group, we have a very different language that we use, I'm gonna say we're dumbing it down, I'm saying we're speaking to their concerns in issues that are very real, when we're when back in my day when I used to have the leather bag sitting in the waiting room to talk to a physician, so I could show him my sharp pointy things that he may want to use an eye surgery. That was a different conversation that I had, back in those days, you know, we had to be very subtle about how we spoke to the physician. And you know, now that things have changed. I mean, the the the way that I communicate with physicians now is very different than it used to be 30 years ago when I was a young man. So you're right, we have to understand who that person is, what their biases are, what's important to them. And what they see is a good extent aesthetic, because those are going to be different. A lot of people in the SPD, maybe didn't have an art history class, maybe the MD did. We need to know that. And we need to understand that it's something comfortable for them, the person is going to open it. Really important. That was a good point.
Patrick Kothe 32:40
So Charlie, let's get into the ceiling itself, because that that's what your company does. So first of all, Vander stall, you founded a company, why the name
Charlie Webb 32:51
I know every you know, it's funny, my family's Dutch. And so my, my twin brother, or family name is Van Vechten, or van vactor. And so it was already taken by a company that he owned. And so I wanted something as an homage to our Dutch gymnasts. So we really came up with a kind of a hybrid German Dutch, a named Vander style, which sort of loosely means from the steel, but really was it was a really a shout out for my my mother, Vivian van vactor, who I of course, adore. And it was, yeah, just for our, our family name. And that's where it came from.
Patrick Kothe 33:29
Interesting. So so the machines that you make are to put that last seal on right, that's it. I'm curious, because if you're buying a buying a pouch, and it's got seals on three sides, are you trying to match the same strength as those other three and and do pouches come with different seal strengths?
Charlie Webb 33:51
Yeah, you know, again, like we talked about earlier, depending on the, on the bond to the material, some bond better, some, you know, here's the big challenge we have in making that final seal. So in the name, it's called appealable pouch. And our goal is to make it not peelable. So we're making the closure with sometimes called the butt seal. So that closures seal that we're creating, we don't want it to ever open, but we're sealing on material that's designed to appeal. So it's kind of a weird oxymoron that we're we're pushing against. So yeah, your answer to your question is we're trying to match or be typically will beat what the factory or manufacturer or sometimes called converters, seals are, we beat that value to make sure that our machine isn't engendering the weakest link on that sterile barrier system, that closure system
Patrick Kothe 34:42
but you also don't want it so different in the two that you're using. As you're opening it. It's it's not a smooth opening. It's jerky because you have two different sales tricks. It
Charlie Webb 34:54
depends on how it's going to be presented, but because we're at the very end of that seal Usually they never peel down to our real estate. So it's not usually that's not an issue,
Patrick Kothe 35:06
you're not sealing the chevron 2.0 on either side, you're sealing the opposite side,
Charlie Webb 35:11
right. So those are formed by the converter. So they make that you know, the chevron the nice little part there. So they put the part in from the back into the seal on the appealable side, and then they're making that final seal. So as I say, we they rarely get to the end. Now, there's an interesting folklore in our industry, that there's a it should have one pound appeal strength against the ASTM F 88 test. And that test basically says you take a one inch strip of the mud seal material, you put it in a force, peel testing tensile testing device, we we actually make and sell those, and you pull the material part at a known rate, I believe it's between eight and 11 inches per minute. And the goal is to have it stronger than one pound of force. And this, this whole notion of the one pound is become the sort of panacea of all the answer. And every time I get into a group, I was just on a discussion yesterday about this with a packaging group. And I said, you know, it's now become an audit risk, because it basically says you're not using any science to determine what that seal string should be. So you have to determine, I mean, if you have an orthopedic, three pound, artificial knee or something, versus a two gram cannula, obviously what that seal strength needs to be is going to vary because there's environmental forces that are going to put at risk that seal. So you have to aggregate the material that you're being you that's being used the sterilant, the class device that is going to be contained in this system. And then that's where you sort of come out with this metric. Now what we do in our 17, we're an ISO 1702, five empirical lab in a calibration lab as well. And in our empirical lab, and we'll peel the factory seal, and then we try to beat it by five or 10%. And that's kind of sounds a little generic, but really, the goal is again, to not be the weakest link, because the converter provides validation information regarding those other seals. So in house, that's the one you got to be worried about, mostly, because you're doing it every day, you have to make sure that that it meets or exceeds the factory seal. So that's the goal.
Patrick Kothe 37:25
So Charlie, you're not a packaging engineer. But I imagine many of your customers are packaging engineers, and they're developing products or packaging for different products. How do you interface with packing patches and packaging engineers?
Charlie Webb 37:39
Well, you know, it's one of those things where, like in the motorcycle initiation, you go through the kicking line, and by the time you get to the other end, you're a Hells Angel. So it's kind of like that, I mean, I own multiple patents, I've designed one of the most popular medical pouch sealers in the industry. I'm a CPP, certified packaging professional through the Institute of packaging professionals, you know, I'm on the fo to board for the ASTM, I'm a killer on the kip group. And so, you know, at one point through your career, although my degree isn't in packaging, I absolutely speak the language of packaging engineers, I've always been kind of an autodidactic sort of learner. And so I, I have always been very mechanical. And I consider myself an engineer, I do a lot of high level engineering to develop the machinery, you know, I speak the the regulatory language because I haven't as a ham radio operator, I love regulations and always have even when I was young. So I like the actually enjoy the regulatory side. I'm also the quality manager. And I write the the our quality management system in our we actually got an award for our some of our home made quality systems in our laboratory that I wrote. So I guess what I'm saying is I kind of earned the chops over the years to be considered kind of a high level packaging engineer. And so you know how that works. Sometimes if it's not your formal education, people are like, I don't know about this guy. But I certainly feel very comfortable in that group. And so interfacing with them, I speak the language. In fact, it's very common that I'll be in a forum with young packaging engineers, and have the opportunity to really provide some sort of what I believe to be sagacious advice, advice about how to move forward with their career, what they need to look for. And also, you don't have, I'm probably at a better advantage in a lot of engineers in that we sell hundreds of our machines each year. And I'm in the first call when they get an ISO or an FDA audit. So I became a certified internal audit auditor for our 1702 Five. And so I speak with auditors often and so I get to hear the sort of street talk about what is the concerns by the FDA, or what's the is what's ISO concern? I'm having that discussion with that person at that mahogany desk, and everybody's sweating and nervous. And I'm very comfortable having the conversations about explaining our machinery talk about the process. And, you know, I, I dare to say that I might even have taught an auditor or to some things about Medical Packaging over the years.
Patrick Kothe 40:19
So tell tell me about the machine. So you've got different different types of machines, different models, different sizes, what are they designed to do? And what are the options associated with the different different machines that you have?
Charlie Webb 40:32
Sure. So, um, you know, our most popular machinery is our Ms. 350 is a simple medical pouch sealer that comes out ready to go and, and so with packaging machinery of this category, they really don't qualify to be validated unless they meet some machine, sort of threshold stuff. In the case with us is because we're ISO 1702. Five you see lab, we calibrate to assure that the force is within a tolerance. We also test our we have a ceramic resonator and our microprocessor we're, we're checking to make sure that it resonates the right frequencies. So we know that the timer is is good and solid. And then we can do of course, a thermal calibration. So when they when they get our equipment, it has three calibrations that show that it's within account. But what we do is we in that box, one of the greatest presidents are packaging injured and engineers ever good is that first IQ PC installation qualification that has all of those certifications allow them to move forward with the validation. So that's one of our first machines, one of the machines that we think that we're very proud of is our ms 451. The cool thing about this machine is that in the sealer itself, when you lift the lid open, it contains a ASTM F 88 Ready peel tester and an ASTM 1886 Ready visual inspection tool. So if you're a medical device startup, you got your new cleanroom, you're ready to put your device into a pouch and get it to market, you need to have a peel tester because the new value in medical device packaging is in the morning, you appeal that pouch and check it against that ASTM F Ada and see that there's no process creep, you do it again at lunch and you do it again at the end of the day. That's kind of the standard way that most medical device packaging engineers are making sure that there's no slip or creep in their packaging process. So that's, that's, you know, one thing that this thing contains all within it is a sealer appeal tester and a visual inspection tool. In fact, it's really cool. One of the problems that we're having, you know, they say some bad things happen in clean rooms at 2am. Because people want to hurry and get to the cigarette break or something and they'll run past. And so we'll go through processes, you probably heard on urine as well, the human factors are becoming huge, you can have the greatest process in the world, you can mechanize it. I'm a Six Sigma guy, if there's a fault in your process, you're through a human by lack of training, then there's a problem. So what this machine does, is it will tell you, the quality department can program and let's say a 2am have them run appeal test to make sure the sealer is working well. So it stops the process, they can't go any further. He requires that you load up a sample, you peel test. And if the values are low, he won't let the machine continue to seal until that's been rectified. The new expectation under the ISO 11 607. And this is true with devices everything is two things, patient safety and output. So these both are affected when we don't manage regularly the quality process on a medical packaging line. And so this machine actually will stop and not allow it to go forward until we can figure out exactly what went wrong. So even when the Quality Manager isn't on site is sort of watching the process to make sure that nobody is just letting pouches continue to run through the machine without there being some sort of a check in. So we have two patents on that. It's been a hugely successful device we're very proud of it makes beautiful seals, we have a price point that's been, you know, very good for the industry, surprisingly good, in fact, so that's one of the star of the show. We also have rotary sealer. So if you want to print on your pouch, the rotary sealer will allow it to go through the plate and platens and then on the other end it'll seal or it'll print on the non sterile side of the pouch, lot numbers, product coding, expiry date and so forth. So those are the other kind of things that people are looking for. We also have vacuum sealers as I mentioned earlier, if you have some chemistry on your device and you want to get the ambient environment out there, the vacuum sealer withdraws the air and so it makes your device safer. And then we also sell the testing equipment to do the ASTM F 88. Testing and then we also sell a visualization action tool. So our whole world is sort of centered around how to get somebody from having nothing at all. They're just got a medical device, they got a 510 K, they're ready to go to market. And how can we help them do everything on the packaging side, and through our Indian partnership with another company that we work with, we can get you into the machine calibrated, go through all of the testing, everything from accelerated aging, everything, the whole IQ OQ, pq process of validation. So we handle it all here. And that's kind of our, our, what we're known for.
Patrick Kothe 45:34
You mentioned earlier that the early early days, it's a heated strip, and you're melting the plastic plastic together, what are the parameters that you're managing? Were you doing? I assume there's temperature, there's time, there's pressure? Are those the main things? Or what else are you looking at when you're making that seal?
Charlie Webb 45:52
Yeah, I mean, we're through that triad, you can, you can control what the outcome of that pouch is going to be before what was happening. And again, going back to people in the clean room, just cranking things up, in order to crease the line, there's always been a cultural fight between production and quality control. Quality control wants to go out the big door onto the trucks and make some money. Quality control is saying, hey, let's slow down a little bit, here, we're getting ahead of ourselves. So when we develop a constant force, and we can control temperature, and we can manage time, and we can also do something else that the FDA is for, and that is having a password lockout, so users don't have the ability to change validation parameters. So as you suggested, those are the three most important ones, I can take those three numbers of values. And I can play around with any material, thermal form type of pouch material. And we can find that nominal setting by using things like Taguchi modeling, or using Minitab, or software application that allows you to do a design of experiment where you're manipulating all of those three numbers until you navigate into the center this virtual cube, that way, you know, you're not going to go out of sight of stasis, and you're going to get good results. In the old days, it was just turn the thing up if it doesn't look pretty, and a lot of people didn't understand what an overseas seal look like. And so we've come a long ways. And there's some pretty advanced sensors, and lockouts. We're currently working on a new app called seal stats. And on its third iteration, we're only in the first iteration of this right now. This will have the ability that if your medical pouch sealer, has entered an alarm, because for some reason, it's not feeding fast enough, or the temperature dropped outside of the range, it'll actually send a text message to a packaging engineer, just what you want it to aim in the morning, right. And it'll let you know that there was a issue with that device. So it allows that real time connectivity to the device because it's become important. I mean, nothing is more devastating to a new, particularly a new medical device company is a packaging recall. I mean, you did all the right stuff only to get in trouble on packaging. Yeah,
Patrick Kothe 48:15
that that 2am phone call is a lot less painful than than that that recall is gonna be
Charlie Webb 48:20
definitely I mean, it's good. In some companies, it's literally put them under. So you know, the the most that's why testing is becomes such a big deal. Again, using that new value system of output. I mean, we have it everywhere in our laboratory, it's like, in the problem with validation historically, has been you take three or four very bright people who are good at math. And they run statistical numbers on their design of experiment. And they say, based on all of the inputs that we have, we believe that this machine is going to create X amount of strength on the process. And then they pack their bags, and they as consultants and go to the next company, or the they go on to another project. And as a result of that, that's where those those problems come output testing, peel your pouches daily. I think that's really the the most important mission message there. Because we do need theoretical data that we've created a sound process, the expectation, just like when you're in college, the professor wants to see your work as well as the answer. So we need to have that work in place. But at the end of the day, we got to quit talking about theoretical data and theoretical output and measure it against actual real world output.
Patrick Kothe 49:39
So to speak, in a real world, Charlie, a lot of times, device companies, especially startups, they're working on their device, they want to nail their device and then at the tail end, they say oh, yeah, packaging. Is that kind of your experience and and when should people start thinking about packaging?
Charlie Webb 49:58
Yeah, that's that's a problem. Boom, you know, really now the discussions, I just heard, somebody had this conversation the other day, when you're developing a device, it's in that, you know, first iteration first pass of the device. You know, we're obviously understanding and focus in on his clinical application. I mean, that's the name of the game on a new medical device. But we also need to look at, you know, not only just creative ways, but sound ways that we're not going to get into a regulatory hurdle. We've seen several of these devices that they spent all of their money. On the developmental side, all of the regulatory attorneys have the new shiny office with a great reception room and all that sort of stuff. Now just throw a packaging machine in the cleanroom, let's get this stuff to market. Only to find out I've had several manufacturing engineers tell me that there was more regulatory girth involved in the ISO 11 607, then there wasn't developing the 510 K for the device itself. People don't realize that that home, IQ OQ PQ process of you have to spec the right equipment, the equipment has to be calibrated and gated and tested in in random, we have to run design of experiments to really show all the potential ways that this might develop a nominal number, then we have to shake and bake it and sterile. And so all of that stuff is connected with the device. And again, that's why the FDA is or ISO is really connected the two is that they're trying to draw attention to the fact that it's not a footnote to your arc to get your device into the point of care. It's an integral part of the device itself. And so I think that's where finally, we see a lot more with younger engineers that have heard this message more, or understanding that, hey, let's co develop our packaging as we go along with the device. And let's get I mean, right now, I just sold a medical pouch, Gav vacuum gas sealer, to a company that does the the device doesn't even go to really testing for another year, they already wanted packaging validation complete as a complete package as they present the process forward. Now, that makes sense. We have other companies when during COVID, particularly of course, this is an emergency situation, so we can understand this. But we had people who bought a machine. In San Diego, we're in the east of Los Angeles a little bit on our where our lab is, and we were running a same day a packaging machine to them. So they could get stuff packed up to go to market, kind of doing validation on the fly. And some people will call us and say, Hey, we need something we're ready to go and, and then they find out a month goes on and they're still in that validation process. Really, they should have done that upstream. Because it's a lot more than they, they can imagine a great deal to it. And for those of in the on the packaging side of the device. I'm still stunned at what's involved.
Patrick Kothe 52:57
You mentioned earlier about the increases in technology, and especially around the monitoring of the process, what's happening there to make packaging better, more more reproducible? What do you what's the future? What are you what are some other areas that we're gonna see some advancements in packaging,
Charlie Webb 53:18
can have this conversation without talking about sustainability. You know, during the, the 80s, when AIDS and hepatitis really came to the forefront, when we're concerned about cross contamination at hospitals, there was a paradigm shift there we went to, things that were never disposable, before became disposable. And anything that can go into that hospital, nobody wants to reuse it, we don't want to recycle medical waste, you know, unless there's good price. So there is I mean, we we do, we are able to do that. But because of that shift, we maybe went a little too far with a waste stream, inside of hospitals and clinics. So now we have, you know, a pretty girthy waste stream that we need to deal with. And so we're now looking at reusable containment systems potentially, and also how we can sort of truncate sizes and, and maybe even stopping points along the way, in order to have less waste to go into the hospital waste stream. What comes to mind is that a lot of times companies want to be part of the sustainability thing, but they use it as a corporate slogan, which I don't like, I like if you're going to do be involved in that sort of stuff, actually believe it or do something as well, because think about it if you have a medical device, and it has to go back into an autoclave, and it has to be processed with more over wraps and so on. You really haven't changed the game in terms of sustainability. The power that that energize that autoclave, you know, didn't come from heaven, right. So we have to look at the the whole path and so I think we're looking at it energy efficient packaging machinery we have in our MD 880 series, we use a very, very low voltage. And so I think, you know, we're, we're doing more in terms of how can we get to where we need to be without risking process, because we don't want to go anywhere near that. So without bumping up the edge of efficacy, how can we use more efficient systems in order to deliver that close seal? So I think we're we're moving away from too many bells and whistles, we're simplifying processes, machines are becoming more complicated. But behind the scenes, the mission for companies with technology is to have that good user experience user interface. That's easy to use. But the technology is still blooming behind the scenes. And that's what we've done, we think we've on our new nano pack system through our partnership with HAVO. We have a a beautiful way of just going through button menus, it's very intuitive. Anyone can quickly understand what it's what you need to do, almost don't need a manual going through parts of the interface. So I think that's really where we, on the medical side are we're trying to prevent these human failures that are happening from complexity. Complexity is one of those things that happens no matter what and technology, people always are asking for more. And at one point, if they're, if they need more, it's okay. But that more needs to be hidden skin behind beautiful interface. And that's where technology seems to be going with packaging machinery.
Patrick Kothe 56:36
Well, Charlie, thanks for great discussion here and getting into an area that a lot of us are familiar with packaging, but not the details of packaging. So thanks so much for guiding us through this discussion. You deal with very specialized people many, many times. But you don't always get to get to talk to the sales, marketing, business development, management people in the company. Are there some messages or is there a message that you'd like to deliver to people within the medical device industry,
Charlie Webb 57:08
packaging is becoming a bigger deal. were mesmerized by on boxing videos, we all seem to be focused in on packaging, make a pretty device that delivers beautifully through every step along the way. If it's a device that needs to be autoclaved, make that experience beautiful. I think my biggest message is to focus in on on the UX and the UI, just like you would on a website focusing on packaging, because it's going to be a bigger and bigger deal as we move forward.
Patrick Kothe 57:40
There certainly is a lot more to packaging, then just dropping your product in a pouch. A few of my takeaways from the discussion with Charlie, first customer feedback, keep hitting this customers are most important design your products and packaging to their specifications, not yours. Work with your customers to see exactly how the packaging is used, not just your product. But how is the packaging used? And it's a diff probably a different customers probably not the physician that's doing it's probably somebody else. The second goes to packaging design. And Charlie hit on this quite extensively. In that your your product is more than just what the product is. It's the whole experience that you've got. So what's it what is expected for the level of quality of your device? Is it cheap packaging? Or is it something more elegant. And also remember that every one of our customers are a consumer, just like they're going to be a consumer for the latest phone, the latest TV, they're also going to be a consumer for your product and expect good packaging there too. And finally, we discussed managing the quality process. And we talked about it from a packaging standpoint and packaging machines. And Charlie discussed how humans are a variable in there, and how do you make things reproducible? But I'd also like to say that it's not just in production, but what processes are we putting into place for surgery? What process? Are we putting it in place for sales or for marketing? Or if you're in r&d? What are your processes? And how are you going to assure that those processes are going to be followed when you've got human variation. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical device podcast as interviews like today's can help him become a more effective medical device leader. Work hard. Be kind
