All Plastics Are Not Equal - Choosing the Right One For Your Device
Lucas Piandegonda is Managing Director of Gradical, which provides specialized expertise to companies that need help with plastic evaluation, material compliance and testing, and training. In this episode he shares the challenge and opportunity of becoming a consultant, considerations in choosing a plastic, how additives and manufacturing processes changes plastics, the importance of supplier choice and management, and options for making our devices more sustainable.
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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! Many of our devices use some type of plastic enough. Choosing the right plastic is not as easy as you may think. There are many different types and depending on the formulation, and the attitudes you choose, they have vastly different properties. material choice is crucial that ended and you need to get it right the first time, because wrong choices can lead to longer development time, and very costly changes once a product is already in the market. Our guest today is Lucas Piandegonda, a plastics expert who recently formed his own consulting company in Switzerland Gradical, which provides specialized expertise to companies that need help with plastic evaluation, material compliance and testing as well as training. In our conversation, we discuss the challenge and opportunity of becoming a consultant, considerations and choosing a plastic how additives and manufacturing processes change plastics, the importance of supplier choice and management, and options for making our devices more sustainable. Here's our conversation. Lucas, you've recently moved out of a large company. And now you have your own consulting firm, tell me about moving out a large company and moving in and do things yourself.
Lucas Piandegonda 02:03
That was a very scary step to take, to be honest. So I did this, I did this writing exercise. And really, it came to my mind, you really have to do that. Or you will regret it all your life. And I thought, let's do this. And and if I if I fail, I fail, but I will I'd rather fail than having the regrets. And then I basically did the analysis of my skills, what what do I really do? Well, and what I do well is I'm an expert for medical grade plastics. And I thought I can build a business on that. And it turns out, I really can, because I am doing, I'm doing good. I set a goal. And then I go off and do all the things necessary and learn all the things necessary that you have to learn. And that's all the exciting part about doing your own business. Because if you're in a big company, it's the stay in your lane, you have your responsibilities. In a small company, you're everything. You're not only the engineer, the consultants, where you have the productive work where you help your customers, choose the right plastics, your district administrator, you're you're basically the office secretary, you're you're the CFO, CEO, everything in one. And you've never done that. And that's so that's the that's the exciting part. First, you get the imposter syndrome, I am never, I'm never going to get this done. I am never going to learn this. And then you remind yourself that this is basically your dream. And let's say the food of your children depends on it, and then you do it. What I've learned, that is the most useful advice I could give everybody. It's if you ask, you will receive so basically you go you go and ask people can can you support me on this? Sir? Can you give me advice on this? And sometimes you need to pay people. I mean, the the accountants or advisers, sometimes you have to pay them but most of the time people will will will give you advice for free. Because actually it turns out people love giving advice. The only thing I really would say in a big company you have to resources, you have to do politics, you have to fight for your resources. But in the end it's a big company and there's money and people that that are very skilled and in if you need to get something done, you can actually and in in a one man show you have to work on on, on, on what do you have,
Patrick Kothe 05:03
you know, when you're describing that, when you move out and you're doing something yourself, and you're an expert in one field, but in your case, I'm sure you didn't know how to put a website up, you didn't know how to how to get customers, you didn't know how to network within, within your space, you didn't know, as you said, the finance part of it, you didn't know, you know, how you build people what pricing was appropriate. So all of those things are things that you need to learn. But the other thing that you just mentioned, and the old saying, you'll keep the main thing, the main thing is, what are you going to prioritize? How are you going to make sure that your business is moving forward, and as you said, you're you're putting food in your children's mouths, because that's your responsibility, you've got two young children, you know, what you say, you've got a six week old and a two year old at this point. So so you've got you've got responsibilities, and that's a major move, when you're moving out of, you know, the steady paycheck, the resources, the benefits that you've got, and then moving off and doing it, doing it by yourself. So the entrepreneurial journey is always interesting, fulfilling, sometimes successful, sometimes not. That depends on a lot of different things. But starting off with, as you said, an inventory of yourself and what you do well, and what the market is looking for, if you've got a good good value proposition, that's the way to start. And then you've got to put all this other stuff and learn as you go. To make sure that you're you're building building that business,
Lucas Piandegonda 06:52
about networking. I knew networking in in the in the real world world in 2021, was pretty difficult. I got on LinkedIn, and basically decided that it would take that seriously. And therefore, I started to reaching out to people and and try to introduce myself to them. So first, I would I would contact I would send them an invite. And if they would accept, I would send them a message and say, Hey, can we chat for a half an hour. And that was kind of a habit already, when I started my business, and that was a habit that helped me tremendously. Because if you get people in front of you for half an hour, and you can introduce yourself and tell them what you're doing, that is the best marketing, you can get one on one. And you have to see if there's a demand for what you're offering, you do that by just listening to them in the in the, in the conversation what, what do they think is their biggest challenge? Or what do they complain about? That's a big part, our or what they think the future will will look like. So if they are in, in a certain space, and they tell you Yeah, I think this is the future. Or they complain about something. This is where their mouth demand lies. It's either a benefit for them, or it's a painkiller for them. This is basically my customer acquisition. It's talking to people.
Patrick Kothe 08:32
Well, I couldn't agree with you more on talking to people and understanding what the needs are. The other thing that you mentioned was ask for help. People are always willing to give help my experience as well. If you ask for help, and you're not asking for something in return, you're just saying, hey, I need some help on this. Can you help me? Most people are gonna say yes, most people want to help you be successful. And if you're humble and asking, they'll agree to have those conversations. Yeah, couldn't agree more. You started talking about being an expert within medical plastics. And that's what our conversation is about is about today is medical plastics. We've got all kinds of different plastics that are out there all kinds of use cases for, for plastics within medicine. So I want to start off with kind of talking about the considerations people have when they're choosing choosing a plastics. So they've got a project that's going, they've got a plastic component for it. How does somebody go about the process? And what are some of the key key things that that they're looking at when they're considering different types of plastics?
Lucas Piandegonda 09:47
The whole process I'm going to describe this is what I would call a material evaluation or a plastic evaluation. And what you would start off with is you We would look at what your final device should do. So your product requirements. So what should it do in terms of mechanical properties? What should it do in terms of lifespan? And what risk class does it have? Where do we do want to? Put it on the market? Is it only for a year? Is it for Europe is is for the US? Where does it have to be on the market and to all the technical and regulatory requirements of your product?
Patrick Kothe 10:39
So this is this is after you've done user needs, you've gone out to the marketplace, you find out what the needs are now you're, you're designing your product, you're putting down the the specifications?
Lucas Piandegonda 10:50
Yes. So you're in the design faith, you design your product, and use you you will list all your product requirements. And if you have the product requirements you derive from them, your material requirements, and this is basically what you would work with to find the material. So what strength does the material need to have? What What kind of stiffness do you have to have?
Patrick Kothe 11:23
The end is and this goes back to the user requirements, though, or somebody has told you it's it's a it's a tube, and it has to be supple enough so that it doesn't cause skin necrosis or it has to bend around a certain way. So these are these are user requirements generated specifications.
Lucas Piandegonda 11:44
Yes. And then yeah, so you derive all the technical requirements that your material has to have, which are mechanical, physical properties, chemical properties, and then of course, you need to consider biocompatibility. And then what what is to add these to the regulatory requirements, so you your hazardous substances that you might use, the regulations that you are, that you need to comply with, or that you want to comply with. Another point that is getting more and more important is also your sustainability requirements. So So you want the least environmental impact for for your technical performance, the least bang at the most bang for your buck, basically. And then what is also important, of course, is the economical requirements, what can it cost? Where does it have to be available? Where do you want to manufacture your parts of the medical device or your medical device. So those are all considerations that you have to have to list in your material requirements. And this is basically that stage. So you will have a list of all your requirements. And then you go off and do a broad search. So which class of plastic could could fulfill all these requirements, then you search for a group, then you pick out candidates of this group of of the group and and go and search for specific grades. And then you have a bunch of them? Maybe it's it's three, maybe it's 30. And then you can compare all the requirements. So the technical that you get from the technical datasheet and the regulatory requirements that you get from from the certificates. And you will have to have some inquiries to your material suppliers. Where is this available? And what does it cost? And then you put that all together, you compare it, and then you make a weighted judgment of your candidates for for material selection. Then you go back to your stakeholders and tell them this is basically the choice we have we have these materials for our medical device. And then you do a pre selection, take a few of those grades, and then you go into sampling and testing. So you would manufacture the devices, test them and see how the performance is. And based on these tests, you would then go with with one or two candidates, which which you would then go into biocompatibility testing and then regulatory clearance.
Patrick Kothe 14:50
A couple of tips that you didn't mention, as you kind of go in high level, but there's a couple more that are in there. One is is whether you need to attach that to another component. Another so it could be a could be a plastic could be a metal component, and you know kind of how that works. And then the other one is what sterilization method. And sometimes that goes into cost decisions as well. So are those also kind of in the, at the front end when you're when you're putting those, those original specs together,
Lucas Piandegonda 15:28
of course, sterilization, processing and processes that follow are all in the material requirements. And what I mean by that is, do you have to laser mark your material, for example, you want to put a UTI on it. And you want to do that with the laser, your laser and your material have to be basically compatible, that you will get a marking that is readable and reproducible, of course, sterilization. Can you sterilize it with gamma, or do you have to use eto, that is a very important consideration. I mean, I'm an expert. But as you said, as you already saw, I forgot one point. And it's very important that you get all the points correctly. And therefore, what I use is a is a structured interview form, where it's basically a checklist or a list of requirements. And then what I would do is I would invite a customer for this structured interview, and we will go through all the points and if the point is not applicable, or it doesn't matter that much we can put in Yeah, no requirements there. But it would make sure that we don't forget such things as sterilization and processing, and post processes such as assembling welding, or anything like that. The point is, it's, it's not always clear how this how it is that you would test this. So you can ask your supplier, can I weld it to this type of plastic, and they sometimes say, yes, you can, or no, you would have to test it. So many of these requirements, you you cannot test on on a paper basis, there's some that you can like strength, they will most always give you a a indication of the strength of the material. But for let's say the more specific requirements like welding to a certain type of other plastic, you would have to test this. And this is so where are your basically your verification plan comes into into play. So the sampling and testing has to be planned. Accordingly,
Patrick Kothe 17:52
you may get some real good indications for these different things strength or ability to weld together, you could get into indications for that. But the final submission that you're going to make to regulatory bodies that's different. So even though you're using a plastic that everybody else uses, you still have to do the testing on your particular particular product. And what I mean by that is it could be used in a indwelling catheter that's in for your 30 minutes. And then there's another indwelling catheter that's in for 30 days, completely different use case scenarios. So the testing needs to be different because it's a different use case. So each each one of these products need to be tested according to their their own particular indications for use.
Lucas Piandegonda 18:45
Yes, I mean, plastic is not always equal equal to plastic. So the whole magic with the plastic is is always in the additives. So it's 99%, let's say polypropylene. But it's a it's destabilize stabilizers and crystallization agents and all the all the let's say, seasoning that you add to your plastic that is making or breaking your performance. And to say that it is it is just polypropylene. And it's the same material that everybody uses is that's not accurate.
Patrick Kothe 19:22
So when you say polypropylene, and I'm getting polypropylene from one manufacturer, and it's it's 100% polypropylene, here's here's the formula for it and then you move to another manufacturer is that the same polypropylene is that different polypropylene.
Lucas Piandegonda 19:39
So processability is going to be different. There's a thing that's called the melt flow rate. So how how well your plastic flows. So that's gonna be if it's, if it's the same, you may be able to process it. So that's one thing. Then 100% of polypropylene is basically unusable. So you will need to have some additives. And then they're going to use different sources for their additives, and they may have different impurities in there. So your buyer comp is out the door. So you will have to retest, if you switch a supplier, you have to retest. If you switch from a polypropylene from the same supplier, same manufacturer, to another one with the same specification, so they changed the name, for example, that is a minor change, you will get around it, if you would change from polypropylene from one manufacturing site to another manufacturing site from the same supplier that could have an impact, because they're maybe using a different processing or manufacturing methods that would impact your your technical performance, and maybe also your your biocompatibility. So changes in your supply chain are very, are to be evaluated very critically.
Patrick Kothe 21:12
How do you locked down so you've you've chosen one, you've gone through the manufacturing, you've gone through and you've taken it back out to the marketplace, it's hit hits all of the specifications that you want to hit. And now you say okay, that's the material we're going to use, how do you lock that down, so that you make sure that it doesn't change,
Lucas Piandegonda 21:31
you would have a quality agreement with your manufacturer with your plastic manufacturer or supplier, so that they would agree to inform you if they have any changes. And they will agree to a so called notification period. So that if they wanted to implement the change, they would need to notify you ahead of time. And ideally, something like two years ahead of time, in the ideal case, then they would say, okay, hey, guys, the great you're using there, we're gonna have to make a change due to reasons. And we will give you two years that we are still manufacturing this. And then you will have last order chance to put three years of supply on stock. And after these two years, plus three, five years, you would need to do this change. And, of course, we as a medical device manufacturer wouldn't be happy about the change. But we will still have time, we have time to do two biocompatibility testing to do the verification of the product to have the regulatory clearance in place. So that we don't have to pull the device from market. And in an ideal case, you would use something that is called a medical grade plastic. This is not a protected name, so to say. But there is a guideline from the German engineering Association follow the E which is called medical grade plastics guideline, it's the 3217. And they're basically all the requirements what what I just described with the quality agreement, the notification period, the change control, this is all written down there. And if you would fulfill this guideline, you you your medical grade plastic according to the fall day 217. And in an ideal case, your supplier is committed to that. So there are suppliers that have a dedicated medical great concept that incorporates all these things. And they're of course, committed to no change. Sometimes life happens, I mean, if your plant burns down or if you have severe supply chain disruptions, sometimes even these companies cannot fulfill their, their commitments. If you're manufacturing medical grade plastics and other plastics, for example, food grades or or industrial grade, something like that, if you have to allocate your resources, what all the plastic manufacturers are going to do with that can they will allocate it to the medical grades were to have commitments. And they know people's life depends on it. So nobody wants to be responsible if people die because they couldn't supply the material. So if they can they will allocate it towards the medical grades, medical grades will cost more because of these commitments that you have. And this is an advantage of medical grade plastic, because your manufacturer is committed to, to the medical technology and change control and the supply security.
Patrick Kothe 25:24
When you think about it, you know, like, like a baker, you know, the old analogy, you're baking a cake, and you've got, you know, different ingredients that you put together and they've got to be baked at a certain time, in a certain temperature, each of these things that with a plastic as well, it's are the ingredients that are going into that plastic quality ingredients, are they the same ingredients. So each of those ingredients needs to be needs to be controlled, but then also the manufacturing how they're manufacturing that also needs to be controlled because a cake baked that 300 degrees for 40 minutes is a different cake than when it's been baked at 400 degrees at 20 minutes. So So each one of those components needs needs to be locked down in order to assure that you've got the right type of plastic. So let's let's talk about said medical grade plastics, what are the most commonly used plastics right now for medical products,
Lucas Piandegonda 26:22
I would say polyolefins which is polypropylene and polyethylene, both high density and low density polyethylene and then probably PVC.
Patrick Kothe 26:35
And you mentioned that there are additives that go into these, what does the additives do?
Lucas Piandegonda 26:41
I mean, they help with processing they help with stabilization. So, for example, stabilization against gamma radiation then they help crystallization So, the mechanical properties the microstructure of a plastic is influenced by its semi crystalline or amorphous structure, if you have a semi crystalline material influencing how that crystallizes can help with mechanical properties, then you would want to have color pigments and are a very common additive. And then, in lack of a better word special effects such as laser laser additives, so, they would absorb light at the exact laser frequency in order to help with laser engraving. And then there are other like special masterbatches, where you you would have additives so, they could lubricate your lubrication, for example. So, you would have a more slippy plastic, for example, for syringes, you would want to have a low friction. And there you can do that with additives.
Patrick Kothe 28:05
And sometimes these additives have unintended consequences, for example, have one additive and a plastic and then you go to do your, your sterilization. And sometimes that will discolor the plastic or sometimes it'll it'll make it more brittle. depending on you know what temperature again, you're doing that sterilization at or what type of sterilization methods so these unintended consequences, are they predictable? Or are they always kind of a surprise?
Lucas Piandegonda 28:43
I wouldn't say that I was never surprised that a material did what it did under testing. But some of them are predictable. For example, gamma radiation and yellowing actually, what is yellowing is the stabilizer that you have in there. And if it reacts, if it does its purpose, its it turns yellow. So, that is basically very predictable that you have the the yellowing and other effects are, are not known to you or not known yet that that they occur. And this is why you need testing with all the expertise in the world. I'm only human. So, I cannot know everything. And plastics is a very large field that you you can no I mean you can spend all your life on plastic science. And this is why you test your requirements.
Patrick Kothe 29:49
So it is one of the other things that commonly occurs with plastics is it attaches to something else. And that attachment method could be a glue could be crimping could be melting together, you know, all of these different attachment mechanisms? How do you deal with that that subject when you try to choose one, one plastic, and there's another plastic or another material that's going to be involved? And you've got some type of mechanism how you're going to attach those to how do you deal with that when, when you don't exactly know what your material is yet, and you don't know what the attachment mechanism is going to be
Lucas Piandegonda 30:36
one very easy solution to this. You go to your design engineer and say, yeah, it's gonna be something mechanical like clamping mechanism, that's a very reliable solution. Then the second solution is you take it up into your material requirements, for example, in material requirements could be has to be laser valuable or ultrasonic valuable to said material. And then it is a requirement and must have requirements for your material, and then you're not going to select it, if it doesn't fulfill the requirements. This brings me to one point, you may end off with a list of zero materials, there's no such thing as a material that can do everything and doesn't cost cost anything. And then you have to go back to your requirements and critically evaluate what do I really need. And then you climb up your plastic hierarchy, there's such a thing as a plastic pyramid. And on the top is the high performance, plastics. And then the bottom is the commodities. And this is performance. And price is basically very nicely correlated. So you climb up this pyramid. And if you're at the top and peak doesn't do it, then you have to switch to something else, such as metals, or ceramics. So there's also cases where plastics are at their physical limits, and you have to use something else.
Patrick Kothe 32:20
You mentioned earlier about sustainability. And I want to talk about that for a couple of minutes. Because it's something that is a is a topic that we all hear about. In different parts of the world, sustainability is more well embraced than others. You know, when we're making medical devices, the top consideration is the product has to be safe and effective. And sustainability is more or less a secondary concern, it has to work first, then you know that you have to go through door number one before you can get the door number two, in some countries, sustainability as well down the list, price may be up further. Ease of use may be up further. But in another country, sustainability makes its way, way up up towards the top. So let's talk about sustainability. And what we mean about sustainability? Is it the sustainability of the manufacturing process? Or is it just how you how you dispose of the product? Talk to me about about how sustainability is working its way through plastics at this point,
Lucas Piandegonda 33:35
as you already mentioned, sustainability is a big trend, around 60% of my customer requests that I get are in some point or the other, touched by sustainable aspects.
Patrick Kothe 33:52
So are these customers that have existing devices or want to change to a new plastic or that is this new design new device development?
Lucas Piandegonda 34:01
I mean, it's it's both it's both. Most of the people want to learn about sustainability, what what are the possibilities that I have? How easy would it be to switch to such a material? Do we want to incorporate this in our development process? Do we want to have a good design guidelines in our development process? So it's it's both? It's both I would say, it is certainly a trend, sustainable materials and sustainability in general, I'd say in in Europe, it's making its way up there. To price and and patient safety. In medical devices, what we often have is, in the end, we we end up with a device so in the end of life, we end up with a device that is contaminated and potentially biohazardous. So if you're in the operating you room, you most likely will end up in incineration. So, recycling of your device is basically out the door. Although we produce a lot of plastic waste in the medical industry, but it's, it's also because this this plastic is, it's cheap. And it's actually not the most unsustainable choice that you can do. So imagine everything would be made out of, let's say, gold, or, or platinum, something like that some precious metal, that would be very unsustainable to throw that away. Because you put in a lot of energy. And a in the end, you would throw throw that away plastic is actually very, it's a very sustainable material. So what you can do, you can reduce the impact of your plastics to a minimum, you could either use bio based plastics, or chemically recycled plastics, or something with less hazardous substances in there, then you could also try to reduce components. So you use just less plastics less components, you could try to reduce the weight of your device with design optimizations. So maybe you could optimize your design in such a way that you would use less material. And what I'm investigating at the time, is, if you actually could also use recycled material, but I have no final conclusion on that. And maybe you will hear of that later. Let's say,
Patrick Kothe 36:56
let's talk about the manufacturing of the plastics itself to reduce the carbon footprint of of this product.
Lucas Piandegonda 37:05
So one input is, of course, the plastic that you use, and then there's the processing. So in the in the processing, you could use more energy efficient machines, you could switch to a manufacturing method that is less energy intensive. For example, if you are drilling or carving your device out of a solid block, and you would use injection molding, instead, the injection molding is probably not going to produce as much waste, and is not as as energy intensive, I'd say. But if you really want to know and compare two processes or two materials in for that matter, you would do a thing that is called a lifecycle analysis or lifecycle assessment, or also sometimes called lifecycle impact assessment. So you would go through all the manufacturing steps to produce your device, starting from the material, then your manufacturing process, or processes that you have, and then see what energy use, which is this energy, this energy is most certainly linked to certain co2 footprint, or to other emissions that go into the environment, such as wastewater, during this analysis, you would then get out an environmental footprint of your product. And then you can compare, for example, two manufacturing processes or two materials against each other, and then decide which you deem more sustainable. So basically, what you're going to tell your customer is, we've looked at this, we've looked at our manufacturing process, and we've looked at what the competitive competition does or what we did before. And we deem that this is more sustainable. And and this is basically how much we reduce, for example, co2 footprint, or what do you sir, or anything like that. So that's the lifecycle assessment. And this is the best tool you have to see what is more sustainable or not.
Patrick Kothe 39:32
In Europe, are there regulations that require something to be more green than it is today and how is that measured?
Lucas Piandegonda 39:43
In the medical field? At the moment? Nothing that I know of. There is the thing called European Green Deal. So the European Union makes its member states pay a certain amount of plastic tax For the plastic waste that is produced in this state, and then it's up to the states. How they would distribute this to their companies or, or citizens if and how they're going to regulate that. But at the moment, it's not for for pharmaceutical packaging for medical device for medical devices in which regen diagnostics, I do not know if anything that is requiring this. It's much more of a, I'd say, requirements from an ESG perspective. So this is what drives the sustainability, I think.
Patrick Kothe 40:42
So is this all self reported? Or are there there things that you can do to test for it, to give you an example, somebody is using a certain plastic, a certain manufacturing methodology, and they say, Okay, we want to be more green. And we're going to change a new to a new formulation, we're going to change processing, and we're going to reduce our carbon footprint by x x percent. Is that something that the manufacturer just says, A Natan, and they can stamp it on their box? Hey, you know, we increased our sustainability or is there something is the regulatory and financial it's a benefit to them to do this?
Lucas Piandegonda 41:25
There's a lot of greenwashing if you if that is your question. There's certainly some of this. But there is a a bunch of ISO standards that lay out how your lifecycle assessment is going to be, or else it's not complying to this standard. And then there's such thing as third party certification. So either someone does a lifecycle assessment in your own company, and then you give it to a it's not a regulatory body, but it's basically someone who is qualified in in certifying your LCA. And then they're going to check if if this is all according to standard, and then they certify it. So that is third party certified LCA. And that is the best we can do in terms of verifying that this is correct. What do you also have to know is sometimes there are a lot of assumptions going into this lifecycle assessment, you cannot know everything, and sometimes you need to leave out some some aspects. So you, you caught off some some aspects, or you have to do an estimation for something because either your supplier cannot tell you cannot give you data on this. Or you do not know it better, and you use industry benchmarks. So what I want to say with that, with that is lifecycle assessment is in, in my opinion, no. exact science is the best we can do. Because it's a very complex system. And we were trying to understand the very complex system.
Patrick Kothe 43:17
I guess what I want to try to get to is if sustainability is is a driver of product adoption, if somebody is, is interested in sustainability, and let's say you've got two syringe manufacturers, and one is manufacturing in one particular way, and another one is, let's say it's greener, better materials better. Better manufacturing, better disposal, however, that is, the claims are are interesting, you can make a claim about something but within medical device that has to be backed up with facts. How would the second manufacturer who's more green be able to say we're more green than the first manufacturer and that becomes a driver for product adoption in those in those areas where green is really important?
Lucas Piandegonda 44:12
I'd say third party certified according to ISO 14, zero 40.
Patrick Kothe 44:19
Because you'd have that green claim, and you'd be able to verify for your product, but you wouldn't necessarily need to be able to verify for somebody else's product because it's proprietary information.
Lucas Piandegonda 44:32
There's a very that's a very good question. Because lifecycle assessment is it's basically according to what you your body, what you lay down, it's basically a logical flow. And if one of your assumption is is wrong, the standard doesn't, doesn't doesn't check for validity of your assumptions is basically is the process according to the right flow.
Patrick Kothe 44:56
Right. And the other thing is, sometimes we lay out her own standard down, and we say this, this is how we're doing it. This is a, this is a project that we did to increase sustainability. This is how you know how we're approaching this. And then it's up to the up to your competitor to say, hey, we did the same thing, or we didn't. So, so you're laying a standard down, and your customers may go to your competitors and say, Are you doing the same thing, now, we're not doing the same thing. Okay, now, now, it's kind of validated that one is more green than the other,
Lucas Piandegonda 45:28
what you could always do is with, with the changing material, so you do a new development, and you have product A that you always had on the market, you do product B, which is basically the same in a sustainable material. And then you can say it's bio based, or it's maybe chemically recycled. And to verify that this is the case, you can do that you can show them, hey, or manufacturer does this, you can audit him if you want to. And then the competitor is most likely not having that. He's probably working on something like that. Maybe it's going off into the different direction, maybe it's biodegradable, or something. But this is something that you can certainly most certainly do.
Patrick Kothe 46:18
And this is a trade off too. Because if you're going to if if one of the one of these projects to make your product greener, and you're going to switch materials and manufacturing process, let's say let's say it costs a million dollars to do that, you got to make that million dollars up in sales price of your product, or take a hit on your profitability. But if you pass it on to your customers in Europe, that may be acceptable in other markets, it may not be acceptable to say, Wait a second, you know, you're telling me that you did something green do I really believe you. And secondly, you know, you're charging me more, and I can't afford that more. It's, it's not something that I want to do. The issue that we've got is products or global products, you're not going to have one formulation, you typically will not have one formulation of a plastic and your product and have it for one market and a different formulation and have it for another market is going to be your one product, that's that's going to go go across. And if you can gain more average selling price in one market, because it's green, but it's costing you sales and the other market because the price is higher. That's a trade off that we got to we've got to make as well.
Lucas Piandegonda 47:32
That is absolutely correct. But what you have to think about is what portion of your manufacturing costs are coming from the material. If you have very bulky and product, you can have up to 50 60% of your product manufacturing cost is the material. But if you have a complex assembly, this is very labor intensive. And this makes you makes your manufacturing costs so the material in in in the whole device make up a smaller portion of your of your manufacturing cost. And if you increase the material price by a bit, which at the moment the sustainable materials, biopic based and chemically recycled are more expensive than the let's say fossil based virgin materials. So and then he you increase your material price by a bit, it's it depends on which case you have to you have bulky parts that is mostly material driven in cost, or you have something that is more assembly labor intensive. This will marginally increase the price of your product. So it's basically a strategy decision of your company. If you're going down the sustainability route. If you decide against it, you may end up being the chaser because everybody now expects that the product is more sustainable at the same cost. I think this is where it's going. Or you commit to it and say, Let's do this. And we're going sustainable and this is will this will help you help us grow.
Patrick Kothe 49:18
It's a fascinating topic. Its sustainability is something we've got going in all aspects of our life medical being no different. If all things being equal, people were I'm sure would be choosing the sustainable product. It's when all things are not equal is how do you make the decisions on that, you know, obviously with medical device safety and effectiveness is always number one and then we've got other aspects that that become important. So all things being equal, the sustainable one should be the one want to go but how what is the cost of that sustainability? Is is kind of the question and costs both ways. Out of pocket cost is one thing, but the cost if you don't adopt sustainability, what's the what's the market like, a few years from now, 510 years from now, when your device is still out in the marketplace, and the expectations for sustainability are different than what they are today, are you making the right choice today, when you're when you're choosing that, that that plastic that that's the that's going into your device, because that device is got a long life. And any choice that you make today is is impactful, because changing to a new plastic is a big project and a lot of a lot of expense there too. So really, as you're looking at the lifecycle of your device, and looking at, you know, how you assess sustainability, I think that that's going to be an interesting conversation inside companies.
Lucas Piandegonda 50:53
Couldn't agree more. You're perfect summary.
Patrick Kothe 50:57
Lucas, thank you so much for enlightening us on a lot of different things, a lot of different topics, relative to choosing different plastics, if you're someone who's got a new device, you're designing a new device, and you suspect that that plastics are going to be part of it, what are some of the big things that you would tell somebody to do when they're doing this evaluation of different different types of plastics.
Lucas Piandegonda 51:29
So I would say, the number one thing is as get your material requirements, right, because if you fail to list all the material requirements, adding something in the end, this is going to be very, very costly in terms and in terms of time and, and money. Take some time to derive your material requirements. critically assess them Do we really need this is this a must have is this a nice to have. And then get in contact with with an with an expert, if you don't have a plastic expert to review your your material choices, it's always worth talking to an expert. What you also can do is usually your contract manufacturer that is dealing with plastics, they can also help you on help you on this. So don't don't just go ahead and say it's going to be this material. But But half the discussion with with the stakeholders, get a few samples out to customers and tell them a which works, which works better. Sometimes it's even, it's even something like like feel, do you want the soft touch? Or do you want something more harder? For handheld devices, it's, it's it's very important. So get your material requirements, right, involve the stakeholders. And if you're you don't have an expertise in plastics, talk to an expert, either your contract manufacturer, or someone like me.
Patrick Kothe 53:02
We all know that medical device is a specialized field. And some areas are more specialized than others. If you don't have in house expertise, make sure you get help, as Clint Eastwood said, and Magnum Force man's got to know his limitations. material selection has wide reaching and long term implications. A few of my takeaways, I really enjoyed the way we started out talking about founding a company. And the way that he said that he did it is you know, starting off with the self assessment, you know, what does he do? Well, what, what what interests him. So doing doing that self assessment really helps to focus on on what your business is gonna be all about. The other thing that struck me was when he said, I'd rather fail than live with regrets. Sometimes we have to take that step, the one that we're not comfortable with, in order to make sure that we're moving forward and not being just standing still. The way that he did it is he talked with others to validate the need, but also ask them for the challenges. And what it turns out to be is, you know, those are potential customers of his. So you're talking to talking to customers, potential customers is always the best way to validate the need, and also to establish those relationships. And as he said, asking for help is something that is easy, something we should all do more of. The second thing that we discussed was experts can provide insights, but not everything is predictable. And as much as we think that we know a lot of things and we go to experts for their expertise, they are not going to know everything. So how do we mitigate that risk? Well, we can risk by talking to them, but we also need to put time in our schedule to allow for these unplanned results and and the changes that we have to make as a result of them. Finally, the discussion on sustainability and the desire for for sustainability. And it's different worldwide. So we have a common product. So we have to make sure that we understand what the needs are of the marketplace in general. So we need to meet user requirements for effectiveness and safety first, and then look at other considerations and where they stand. But it's not only where they stand today, but where, where they're gonna stand tomorrow. 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 you become a more effective medical device leader. Work hard. Be kind
