Liz Cuneo: All right, thank you, Jen, for joining me today. I’m here with Jen Goff, Chief Commercial Officer at Packaging Compliance Labs, which offers packaging testing, contract packaging and packaging engineering services for the health care industry. And today we're talking about startups and what startups do wrong with packaging.
Goff: Awesome. Yeah. And I will say that I am a huge fan of the startup culture. I've not worked in, well, I'll caveat that with, I've worked in kind of what felt like a startup culture to me. My first job out of school at Edwards Life Sciences. It was very innovative. It was wild and exciting and thrilling and, speed to market was the name of the game. But I just kind of commend those folks that can work in that space and do just amazing work and just grind every day. It's really cool.
Cuneo: Yeah, startups are cool. I'm a big Shark Tank person, so I feel like it's exciting to see ideas come to fruition. And, I mean, talk about grind. People work so hard to get stuff off the ground, that is awesome. So, diving into startups in packaging in the healthcare space. What are some gaps you see or why is packaging an afterthought? Because I know that it can be, right? We're very focused on the product, the device and maybe not thinking about the packaging…why is that?
Goff: Yeah. So, I mean; to be honest, it's not just startups that have this problem of considering packaging as the afterthought. So, if anyone's part of a startup that's listening to this, don't feel alone. You just tend to have, you know, maybe less resources to recover as quickly as maybe a global MDM that sometimes thinks of packaging at the last minute, too. So, you're not alone. But honestly, you know, early-stage companies are thinking about the device. They're thinking about fundraising, they're thinking about the clinical environment. They're not necessarily thinking about packaging. So, it's not intentional. It's just that there are multiple different functions and different expertise that it takes to launch a medical device that, packaging or packaging sterilization, labeling, is not typically on the top of their list to identify and solve those problems right away. So, I mean, at the end of the day, it's just the fact that packaging is more of an ancillary piece of the puzzle. And so, it's just not top of mind.
Cuneo: Before I started writing about packaging, I didn't think about it either; unless you're more intimate with the real purpose of packaging or how it can enhance your product, it’s one of those things that I think could be easy to fall to the wayside.
Goff: And it's such a niche. So, it's not like every college or university you go to has a packaging program. Most of them have engineering programs. So, it makes sense for people to not be aware that packaging is even a thing or, you know, I can't tell you how many times I've heard, well, we just need to put it in a box and ship it. It's like, oh, yeah, yes, we do, and there's more to do than just that.
Cuneo: Absolutely. So, I guess then what are some common mistakes besides just throwing it in a box?
Goff: The most common mistakes I see specifically in early-stage companies are with regard to timeline and budget. So those are the things that get those companies into trouble more often than not, I would say, because they don't know what to expect with sterile packaging and what that could cost, how long it will take, how that bolts on to the rest of the testing during verification and validation, even feasibility testing. So, during the development cycle, how packaging plays into that is also something that's often an oversight. And so, it's really important for folks to think about, you know, how do we get packaging involved early ultimately. Those are probably the biggest oversights, I would say.
Cuneo: Is it timeline because everything takes longer than you think it's going to?
Goff: Yeah, it has a lot to do with the specific requirements. So, whether it's shelf life, whether it's feasibility, whether it's, you know, transit or integrity testing, all of those things tend to take some time. And when you see that if you get to the end of the cycle and you're like, our device is ready, it's awesome. We've proven the shelf life. It's great. And then you say, okay, now it's time to put it in the package and ship it, while you also have to age the packaging and do the, the transit testing for the packaging and the packaging functionality. So, it really goes hand in hand with the device development timeline as well.
Cuneo: So, you know, there's probably technical requirements for the packaging and you mentioned testing. What about regulatory issues? Are there business priorities? Like what are some of the gaps that people maybe don't think about?
Goff: You know, it’s kind of like a mix of a bunch of different things. When it comes to regulatory business priorities, you know, different types of requirements, whether it's the actual design requirements, all of those gaps exist because packaging is probably not discussed early on. We'll probably talk at some point what kind of recommendations I would make. But it's really important to have packaging part of the entire design history file up front. So, getting into the user needs, packaging user needs, getting into the design requirements is important up front and all of that. To say if you have packaging considered up front, you’re kind of constantly thinking about it as you're going through iterations of those documents.
Cuneo: Okay, yeah. And I'm sure that will help so streamline because, you know, the product and the packaging really do work hand in hand, correct?
Goff: Yes, yes, yes.
Cuneo: Are you able to share a real-world example where overlooking packaging early cause major problems later?
Goff: I have many. I've been a packaging engineer my entire career and in the medical device space, my entire career. So I have had many sleepless nights where we were brought in very late into the project and it was up to us to speed things up, get things going quickly. A couple of big things I've seen in the startup space are, you know, there's a lot of budget and timeline considerations that need to be discussed. And when those conversations start to happen and if it's later in the game, they can start to maybe make some decisions that can hurt them down the road.
For instance, if you're considering, if you have a big bulky device, which is a real-world example I've personally been involved with bulky device needs to get to market. We evaluate it as a packaging engineer and I say, hey, it needs to go into a tray, this is the best solution. This is the way that it is going to be de risk failing during design verification. And it really needs to go into a thermoformed tray. And then, you know, there's a lot of pushback because the timeline to develop a tray can be lengthy. The cost of a tray can be more than say maybe a pouch or some other packaging. And so it was in my history, I've had both scenarios where people are like, yep, great, moving forward, got a tray. It's in the timeline, it's built, budget's going. I've had other scenarios where it's like, nope, we're not doing a tray. We don't have the timeline, we don't have the budget, we don't have the margin within our product. And so therefore we're going to, we have to figure out how to get it into a pouch. And there have been those situations where it's just test after test, failure after failure, tweak after tweak. You know, you can go with the most robust material but if you have something really heavy and sharp, the chances of it passing are not great. So, all in all, that increases the timeline, that increases the spend at the end, it increases all of the expectations and communication back to your investors. I mean, it just turns into a huge mess. So that's probably the most real-life example I can give other than also, you know, there's always the regulatory component too. So, it’s a game of risk. I mean, at the end of the day, we all, anyone that's in this field is considering patient safety and that's our number one priority.
And then there's this, this compliance piece too. Where you have to check every box, dot every I, cross every T. And when you have to do that, there might be some ability to make some decisions based on risk around compliance. And when you do that, you take risk. And when you do that submission that your regulatory body may ask additional questions, may not agree with your strategy, may ask you to retest. So, there's that piece as well, that if you don't understand the risk or what is probably the norm within industry, you, you can get into a bit of trouble and delay your submission or your approvals as well.
Cuneo: Okay. And delays are not a good thing.
Goff: No, not at all. They're not.
Cuneo: Especially in the startup culture of launching and getting out there.
Goff: Yeah.
Cuneo: So, what are maybe some early warning signs that a startup's packaging process might derail their timeline?
Goff: So, the one that I've always looked out for is we'll figure out packaging later. If I hear someone at a very high level saying we'll figure out packaging later, it doesn't mean they're wrong. It's very dependent on where they are in the process. But if we start to get too late into the process and I'm still hearing it, it's a red flag.
Another one is the decisions being left to contract manufacturers who are very cap talented with the device creation or manufacturing but have no experience whatsoever in contract packaging. That can be a space where companies can get into a bit of trouble because they don't know the sealer requirements, they don't know the packaging requirements, but they're really great at the device and they're going to get into sterile packaging. That can tend to be challenging for folks. And I've seen it go well, it can happen, but I've also seen it go pretty poorly. So that's another one. And then anytime that they say we don't have budget, that's a red flag. We don't have budget for packaging or there's no budget line item for packaging, that's always a red flag because it needs testing. There's definitely outsourcing that happens there.
And the last one, but probably the most important one is no feasibility testing. So when a device is getting ready to go to market, you're doing development cycles, you're doing development testing, you're iterating, you're making a change, seeing if it works. Maybe it needs a little bit more tweaking. So you make that change, you go back, see if it works. It's the same for packaging. So not all packaging is going to fit with the device. At the end of the day, you make a change on the package, you have to test it to see, okay, do we think it's going to pass? And if you get a lot of confidence that it's going to pass, then you can go right into design verification. But if not, you may want to make some additional tweaks and redo that. But startups typically don't have that built into their timeline. They don't have that built into their budget. But it can cause major issues down the road.
Cuneo: It sounds like the whole company kind of needs to buy into the packaging, from a sales and marketing perspective. Why should commercial leaders be in the packaging conversation early? Because I'm assuming it's not just the packaging engineers. that are talking about it or the engineers of the device. I kind of feel like everyone needs to be on board.
Goff: Yeah. I mean, if you think about in other industries, it's a little easier because the package sells the product. So, if you go to like a Target, or if you go to a different store that has different products on the shelf, the packaging is part of selling the product. So, a lot of vested interest in the packaging. When it comes to medical devices, it's harder to get that vested interest because it's really functional. But what people tend to maybe forget or something that is really important for commercial folks to understand is those user needs, that clinical feedback upfront in how the packaging is being transferred into the field, how the packaging is being stored, how the packaging should be labeled for their users, can help create brand awareness, it can help create brand credibility. It can give you a competitive advantage in some point or in some ways.
My favorite packages are ones that part of a tray or a card are part of the actual procedure prep. Those are really cool. They're being used as maybe storage of the procedure. I've seen cards or discs that. Or tubing where the device is used and then it's put back in the coil to be stored there until it's needed to be used again. I've seen trays that have like swivel components and washing stations on them. I mean, there are some really cool things that commercial folks would be interested in had they, you know, if they know that that exists and that process exists, and they can solve a problem through packaging. So, all in all, it helps with brand. It helps with a positive experience with your end user. So, it's not just the device. I always like to say that. One of my favorite equations, and you kind of have already said it, but in so many words, it's the device plus the packaging equals the product. So all in all, we want a good experience with the product. Not just the device, not just the packaging. But the interaction of those two things together and labeling plays into that as well.
Cuneo: Yeah, of course. I love that. I'm going to give you credit for that, not me. The device plus the package equals the product. That's cool. So, let’s talk about the ROI in investing in packaging expertise early versus kind of fixing it later. And I think, I think the answer generally is an obvious one of doing anything early on, right? You get a better price. The timeline is not rushed. So therefore, you're not paying for maybe rush fees or just pushing back your launch. So, is there anything else from an ROI standpoint there?
Goff: It could be maybe thousands of dollars, tens of thousands of dollars if you have multiple iterations all the way to potential millions of dollars lost due to push timelines and lost revenue. Cost avoidance. Recalls cost companies millions of dollars if it's not done right the first time. So, there's definitely a lot of cost avoidance that you can consider during packaging verifications. And then the return on investment is really just making sure that you're getting to market on time and within the right amount of time and meeting the timeline.
Cuneo: So, moment of truth. If you had to give startup companies three must-do packaging steps in their first year, what would they be?
Goff: I would say the first one is, so startups don't typically have packaging engineers on staff. If they do like bow down, amazing. I don't know how you got that, but great. But they typically don't. So the important piece is for them to find a trusted partner. Find people like
packaging compliance labs that has the experience, has the understanding of what the industry is doing, can meet you where you're at. I can't tell you how many times I tell people, just, you know, pick up the phone, text me, call me, I want to help you. Because sometimes you get stuck and you don't have time to set up a meeting that's like three days later. You need to know an answer now. I think it's really important to find a trusted partner. So that's number one.
Number two is really to understand the packaging requirements and build them into your design inputs and user needs. I mentioned that earlier, that it's critical to the success of your overall timeline, budget and project. And then third is to just get your partners, the people that you work with, that are going to be the packaging experts, get them involved early, bring them into a meeting, introduce them to the team, invite them to the table. It doesn't have to be every single week, but it needs to be early and it needs to be good conversation where you can take some of the information, whether it's feasibility testing, whether it's package design, whether it's design verification, whether it's process validation. All of that information is important to have upfront so you can build an appropriate timeline and meet expectations of your, of your investors.
Cuneo: Kind of ending on that, do you have a piece of advice that you can leave behind for startups and maybe what they should know before starting to design their packaging?
Goff: When it comes to advice, I would say everyone is trying to get devices to market. Everyone cares about the success of advancing the medical field, and everybody cares about patient safety. So the biggest piece of advice I could give is to assume good intentions. I actually have heard that from multiple people in my career, and it's helped me a lot. But no one is trying to bypass packaging. No one's trying to bypass labeling, no one's trying to bypass sterilization. What we're trying to do is just get a device to market and learn as we go. So the biggest advice, I would say, is get that partner early. You know, find a trusted someone that you trust that has the expertise. Ask around, who, who's everyone using? I hope that you hear PCL a lot, but, you know, if not, just make sure you find that trusted partner. And, and at the end of the day, you know, everyone's in it to win it. So just keep grinding.
Cuneo: Yeah, that's awesome. Well, thank you, Jen, so much for your time.
Goff: Yeah, absolutely. Thank you, Liz. I appreciate the time.
