Packaging departments for medical device manufacturers can now help save months of development time and up to a million dollars in development costs with a new pre-validated package and process.

Pre-validated packaging solutions typically use empty, generic packages for testing, says Jody Birks, regulatory/new product introduction manager at Eagle Medical. But once the actual device is introduced, it might not be compatible with the package during distribution testing, resulting in a potential package failure and a frustrating return to the drawing board.

During a Design Alley presentation on February 8 at the advanced manufacturing event co-located with WestPack, Birks explained that PATH, which stands for Packaging Accelerated Timeline Help, is addressing this issue by providing the missing component to reduce the risk of failure during packaging distribution testing: The device inside the package.

Dubbed Frankenstein, or Frankie, this device is an engineer’s worst nightmare. According to Roy Morgan, PE, PMP, president/CEO of Eagle Medical, it contains all the worst packaging components of a surgical device that vex packaging engineers, which can then be used to write an adopted worst-case device rationale within the company’s family of products.

But PATH is more than just a package: It includes complete data sets based on actual distribution testing after sterilization.

To further support its PATH offering, Eagle Medical has partnered with Greenlight Guru, a QMS software company for the medical device industry. The alliance gives OEMs the tools necessary to accelerate medical device development timelines.  

Learn more about PATH in this podcast, recorded during the WestPack show, where Packaging Digest Executive Editor Lisa McTigue Pierce talked with Eagle Medical President/CEO Roy Morgan.

PACKAGING POSSIBILITIES - Season 3: Episode 3

If you have a topic you’d like to propose for a future PACKAGING POSSIBILITIES episode, please email Lisa Pierce at [email protected].

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Lisa McTigue Pierce

Hi, this is Lisa Pierce, Executive Editor with Packaging Digest, with another episode of Packaging Possibilities, a podcast that reveals what’s new and what’s next for packaging executives and engineers, designers, and developers.

Today we are interviewing here at the WestPack 2023 event here in Anaheim, CA, and I have the pleasure of talking with Roy Morgan, the president and CEO of Eagle Medical. He’s got a new program cited … You know, I can’t even define… It’s not a product, it’s not a program, it’s not a process. It’s like everything all rolled into one, and we’re going to learn about that.

But this is the Packaging Accelerated Timeline Help for medical device manufacturers. I said that slowly so you could understand that that is going to be an acronym: P – Packaging, A – Accelerated, T – Timeline, H – Help, and that spells PATH. So, Roy, hello. Thank you for joining us, by the way.

Roy Morgan (guest)

Hi. Thanks, Lisa. Thanks for having us.

Lisa McTigue Pierce

Tell us as succinctly as possible, what is PATH.

Roy Morgan (guest)

So, PATH represents a revolutionary change in pre-validated packaging for the medical device space. Previous to this, pre-validated packaging came with really only a partial solution for medical device manufacturers. It’s key lacking point was not having a real challenge device inside the packaging that is being provided. PATH changes all of that. We give you a package that actually had a real challenge device inside of it undergoing all of the consensus standards tests to achieve that validation. So that really is a game changer.

Lisa McTigue Pierce

OK. And we’re going to hear a little bit more about your Frankenstein product — your Frankenstein device, worst-case scenario, lovingly called Frankie — in just a second. But how long has this been in development?

Roy Morgan (guest)

So PATH has been under development for the last two-and-a-half years at Eagle. We perceived the need for the change in the industry because we’ve been watching so many companies with real life-changing technology attempt to enter the industrial space here in medical only to be thwarted by things like excessively long development times, a big part of which is packaging. And so if a company doesn’t get it all right, right up front, right at the very beginning, just tremendous amount of life-changing technology is at risk toward the end. Our solution for that was to bring PATH to the fore that would make that time compression, that cost savings, that ability to get to market much more real for smaller companies, mid-box companies, even big-box companies that have need of overflow within their development product pipelines.

Lisa McTigue Pierce

OK, and tell me, I’m not all that familiar with the process here. So, how often is packaging validation slowing down a device launch? Does that happen a lot?

Roy Morgan (guest)

You know it happens more … more commonly than people would think. Just in my own career, and I’ll use those examples that I have experienced personally.

In my younger years as a device engineer trying to bring new products to market it was not uncommon for us to have initial packaging failures with prototype testing of prototype devices. And the reason for that is when you’re cycling through designs early on, as any device engineer will be able to tell you, you don’t really understand every little feature or nuance that has to go into a device. Sometimes you might underestimate the power source that’s needed to drive a specific drill. Or, you know, a shaver or deburring system or an RF tool or a sensor. You might underestimate the sensitivity of the onboard electronics or the lack of robustness in a fastening technology, whether it’s adhesives, screws, snaps, ultrasonic welding, or what have you, and you’re cycling through all these different options and alternatives, trying to get a prototype to work. You finally seize on something that does work, and then the nightmare unfolds where you forget about packaging and advance that much farther along because you cracked the nut. You got the design to work, but you forgot to bring the packaging with it. You go into that first round of testing, and either one of two things happens: You get lucky or you don’t. And if you don’t, you either break your device, you break the packaging, or you break both, and that’s what PATH addresses in totality.

Lisa McTigue Pierce

OK, so the typical validation process for packaging is months, correct?

Roy Morgan (guest)

That’s right. It typically will take between six to nine months for a design team that has thought about their packaging to get a product all the way through. If you’re on the unlucky side, it can stretch out to a year. And I’ve seen even, you know, 16-, 18-month programs go on. So that’s not unheard of. But six to nine is about the typical time that it takes.

Lisa McTigue Pierce

OK. And with PATH then the packaging validation process would be?

Roy Morgan (guest)

It shortens dramatically. What we tell people is possible — and this is really for companies that are truly prepared; design teams that have every “I” dotted and every “T” crossed in preparation to make a submission — it is possible to achieve within three to six weeks. This sounds impossible from most perspectives, but if you have everything ready and the only things left are your packaging validation and your sterilization validation, and you line up the right laboratory and get everything done just right, it can be achieved.

Lisa McTigue Pierce

OK. One of the other benefits that … Roy had the opportunity to speak here at … this is a co-located show, so he was speaking at Design Alley, which is part of the bigger Anaheim event that WestPack co-locates with. And during that presentation, one of the things that I saw on the signage that was there was that PATH can save medical device manufacturers up to one million dollars in development costs. Did I read that right? 1MM? Is that a million?

Roy Morgan (guest)

That’s a million. And yes, you read that right.

Lisa McTigue Pierce

OK, so it didn’t specify packaging development or device development, but either way tell us how can the device manufacturers save a million, up to a million dollars in development costs with, through PATH?

Roy Morgan (guest)

Sure. So this is a regional-specific type of savings. So let me talk about how that works. Anybody who’s been in a startup or any CEO that’s run a startup appreciates that every company, whether it’s a big box, mid box, or startup has a burn rate per month. How many dollars is that company spending every month to keep the lights on, employ the engineers, keep the cleaning staff coming, put coffee on the table out in the break room, and all of that. If it’s a Northeastern company, you’re probably burning between 30 to maybe 40,000 a month. If you’re a Midwest company, maybe a little bit less. If you’re a West Coast company, it’s probably closer to $50,000 a month to do that.

All of that has to go on whether the product is launched and making revenue or not. And if you’re into a packaging development cycle that has an error issue or some other problem and you exceed the planned … and typically the plan, I’ve seen most startups do is packaging will take three months, and we’re done. The reality is it’s six to nine months. So that’s three months longer than you probably have in your plan. And if you have a problem, it’s probably another three or four months at $50,000 a month in burn rate. It’s pretty easy to see how that rapidly adds up to half a million or more, or potentially as much as a million.

Lisa McTigue Pierce

OK, excellent. Thank you for explaining that to a word person, because you explained it so clearly that even I got that without a calculator in front of me. So yes, all good. That’s kind of the big picture kind of thing that I wanted to frame the conversation with. Let’s get into some of the nitty-gritty here.

So how does PATH help the medical device manufacturers complete their device-specific packaging validation in less than three weeks, and maybe this is the time for you to introduce us to Frankenstein. Frankie?

Roy Morgan (guest)

Yeah, this would be a great time to talk about that. So, Frankie, as he’s lovingly referred to inside of our company, is really just a beast of a device, a monster as people call it. That’s how it got its nickname. What we did was try to envision the worst aspect of every potential device feature that we have seen in our 30-plus years of packaging, everything from medical instrumentation to orthopedic implants that includes radial fracture repair systems with maxillofacial screws, pedicle screws, vinyl cages, and so forth. By virtue of having seen so much we were able to put so many quote, unquote “terrible features” into a single device, and hence that monster became known as Frankie. That is the challenge device that goes into the PATH packaging system, and that’s what makes it so special because we know by virtue of being able to validate that, that it is robust for so many different types of medical products.

Lisa McTigue Pierce

OK. And so, again, getting into some of the details here, Eagle Packaging is selling the pre-validated pouch system, the sterile barrier system package that is pre-validated using the data from testing with Frankie. Is that correct?

Roy Morgan (guest)

That’s absolutely correct, and it’s so much more than that. The PATH system is not just the package itself. Of course you get that when you buy the PATH system. But in addition to that comes an entire digital library package that’s part of an IP transaction that gives the purchasing company the ability to use that in their digital submission to the FDA or other regulatory body, wherever you might be filing. So in there are all the validation reports, the signed data sheets, the reviewed protocols, all of the things that you would expect to find for a submission filing preconfigured and ready for upload.

In addition to that, we also have a rationale adoption template because that’s what you’re going to do to bring in your device, or the OEM’s device, into the PATH packaging configuration. You have to choose the feature set that’s on Frankie and determine that’s the feature set that applies most to your device, and establish Frankie as the worst-case device for that family of product. You then write that adoption rationale, and put that into your filing, and you’re done.

Lisa McTigue Pierce

OK, so it’s a … it’s a mix of a stock. You’re starting with some stock stuff, and you’re customizing it for the particular product that you’re — you being the MDM, medical device manufacturer — is putting on the market.

Roy Morgan (guest)

Well, let me be clear about that. We’re not really customizing. There are some limits. Yes, the OEM has custom products, but we, Eagle, have a fixed packaging configuration that if the custom OEM device fits into then it can adopt and ship under that paradigm of configuration. So that’s, that’s the clarity that needs to be understood.

Lisa McTigue Pierce

OK. And is the pre-validated pouch system that Eagle sells available in multiple sizes? I know at the presentation we saw one particular size. Talk about the flexibility there in a package configuration.

Roy Morgan (guest)

So right now PATH is available in only one size [see photo at top of page]. That isn’t to say that more aren’t coming, but we have it available in one size right now, and that’s for a small- to medium-size product.

Lisa McTigue Pierce

OK. And I’m assuming since this is all one system, and you are in business to make money, that the process that you’ve come up with to help with speeding up the validation for the medical device manufacturer, that this is all part of … like they couldn’t do that with somebody else’s…they couldn’t do that kind of pre-validation testing with somebody else’s package. Or are you offering the PATH system, the PATH process, as a service without selling the package? It doesn’t sound like you are.

Roy Morgan (guest)

No, no we’re not. We have very specific constraints on the packaging materials because in order for us to validate the ceiling capabilities of those materials and the integrity of the factory seals that come on them, we want to have clear traceability through that supply chain so that we know the quality of that product remains consistent. So we’ve taken the trouble to scour through our vast supply chains of various packaging materials to select those that have the best track record over that 30-year history with solid package integrity, and that’s where we’ve moved to use the most heavy-duty pouching system out there that we have custom spec’d for this program.

Lisa McTigue Pierce

OK, and it’s a two-pouch sterile barrier system. Can you tell me which pouch is the sterile barrier?

Roy Morgan (guest)

Yes, it’s the inner pouch that’s the sterile barrier, of course. The outer pouch acts as protection through the transit system all the way up to the point where circulating tends to transit it to scrub in to the sterile field. So that’s how we’ve structured it. And again, it’s going to be quite a game changer for the industry.

Lisa McTigue Pierce

OK, excellent. So the medical device manufacturer is still going to have to validate the packaging though for their particular device, correct?

Roy Morgan (guest)

They … No, they will be able to use an adoption rationale using the challenge device that we’ve included inside the PATH system, and by virtue of that adoption rationale, state that it is the worst-case device that they would see for their familial line of products, and then use that packaging system for those product lines.

Lisa McTigue Pierce

OK, thank you for clarifying that. One of the other things that you mentioned in your earlier presentation today was about the shelf life of the device. And I thought that was quite interesting and just wanted to mention it here and give you an opportunity to talk a little bit more about it. So, the pre-validated pouch that you have comes with a five-year expiry date. Can you explain why that’s such a benefit to the device manufacturers?

Roy Morgan (guest)

Yes, but let me be clear. Up front, we’re starting with a single year, and we expect to have the five-year data probably between now and summertime. Anyone who subscribes to the PATH program early will receive the benefit free of charge once the five-year expiry is achieved. So, it’ll be sort of grandfathered in to any PATH participants down the road. But right now we’re launching with one-year accelerated aging. The importance of that five year however is really manifold for smaller companies that have limited availability to produce build-to-stock programs such that if stock should sit on the shelf for, you know, more than a period of say three months, six months, there’s a real potential danger that it could not or would not make it into product circulation fast enough that they wouldn’t have to re-sterilize. So having a longer expiration period could be meaningful.

Lisa McTigue Pierce

And I know it’s not quite the same comparison, but the folks in the food and beverage packaging industry, they’re always looking for more shelf life for their products because of the flexibility it gives them on the business side. So, it’s always good to have that flexibility built in there, whether you use it or not, you know, it’s one of those things that’s better to have it and not need it than need it and not have it.

Roy Morgan (guest)

Yes.

Lisa McTigue Pierce

OK. So just a couple of final questions here, Roy, thank you so much for your time. Where does PATH stand with the FDA?

Roy Morgan (guest)

We have taken the time to have a Q-Sub meeting with FDA in advance of our launch of this product. So, FDA is aware of the PATH system and its technology. We plan to have follow-up meetings with the FDA in the very near future, and the intent of that is to solidify our master file, which will remain on file with FDA. That number will be made available to PATH participants wherein proprietary information is contained but made transparent to the FDA. And so all of that really lets people evaluate PATH on a very open source level, if you will, to appreciate what’s in it, how it works, how it can accelerate their submission filing and shorten their overall product development time line.

Lisa McTigue Pierce

And if I have this right the debut of PATH was here at the show, so this is available for sale now?

Roy Morgan (guest)

Well, we expect to have it right about May 1st.

Lisa McTigue Pierce

OK, that’s right around the corner. So, great.

Lastly, is there anything that I haven’t asked you about that you feel compelled to tell us because it’s uber important?

Roy Morgan (guest)

Well, I think it’s really just that in our industry thinking of packaging a whole lot sooner and actually thinking about it as integral to the development of the device itself is crucial. The sooner that’s done, the sooner you’ll get past that hurdle.

Lisa McTigue Pierce

OK. Thank you. I know there’s a lot of people in packaging that would second that very strongly. Wonderful, Roy, thank you so much for joining us here.

Roy Morgan (guest)

Thanks for having us.