The Path to Sustainable Practices in Medical Device Design and Combination Product Manufacturing
Memorable Quotes:
"It's not the same shoe that fits everyone. So there will be differences between different organizations and there are tens of thousands of different medical devices, but there are some overall principles which do work. For example, what does sustainability mean? Well, in the context of a manufacturer, sustainability is preventing your used product from going to landfill.
Okay, we can all get behind that. Even if it's a multi million pound MRI scanner, or it's a 50 cents pMDI inhaler. Okay, so if we have to get our products back again, now what do we do? Okay, here are some options." - Cormac O’Prey
"Many people who work in medical, myself included, who've been there for a while, ask the question, why are we doing this? Our mission is to design devices that provide medicines or deliver drugs or provide therapy to make sick people better or to prevent people getting sick in the first place, or to generally improve people's health and welfare… Some research came to light a few years ago which showed what the actual impact is of our industry on the world…. If we were ranked beside them, healthcare would be number 5 on the list of who are the worst producers, who are the worst polluters. How bad is the pollution? And if you look at the stats, pollution is responsible for 9 million premature deaths every single year." - Cormac O’Prey
"What supports the business case? What supports the risk profile? What hasn't been thought of from a theoretical point of view, but we find doesn't work. A good example of that as well, What's the typical recovery rate you can expect? Most people 1%. Okay. Now we know what we need to fix. So together we're hoping that, standardization helps everyone who's underneath that standard umbrella.
Medical device manufacturers are international. So if we have best practice guidelines in terms of what's expected but also how to achieve them, they'll go across national boundaries through the ISO organization and with ASTM as well. We'll have a solution that works for everyone, and that's what we're aiming to achieve.” - Cormac O’Prey
Cormac O’Prey Bio:
Cormac O'Prey, a veteran in product development consultancy with over two decades of experience, is the founder and director of Kestrel Technology Consulting. Known for developing deeply integrated client relationships, Cormac excels in leading innovative technology and product development projects across diverse industries. His expertise spans medical (encompassing drug delivery, surgical, patient care, home healthcare, ophthalmic, and biotechnology), consumer, light industrial, smart grid, power distribution, and Smart Home sectors. Cormac's commitment to excellence is evident in his contributions to international standards, notably BS8887, and his active role in sustainable design and manufacturing. Beyond entrepreneurship, he enriches academia as a lecturer in Engineering Design and Global Business Environment. With a career rooted in the Cambridge area since 2000, Cormac continues to be a prominent figure in medical, healthcare, and sustainable product development.
Transcript:
Voiceover - 00:00:03: Welcome to The Factor, a global medical device podcast series powered by Agilis by Kymanox. Today's episode is hosted by Shannon Hoste, Vice President of Human Factors Engineering at Agilis, and our guest is Cormac O’Prey, Principal and Director at the Kestrel Consultancy Group. Kestrel Consultancy Group provides expertise in sustainable design, medical communications, business development, and innovation to the medical, smart energy, consumer, and light industrial sectors. Shannon and Cormac met at the recent PDA conference in Sweden, where they struck up a conversation on sustainability in the medical world. Sustainability isn't a buzzword. It's a crucial aspect of the mission within medical device and combination product design and manufacturing. But it's not always easy to figure out all the design considerations. For Cormac, despite the challenges, it took a walk on the beach to realize he had to do something.
Cormac O'Prey -00:01:00: A few years ago, I was taking a walk in the Northeast of England on a beach, and I spotted the picture you can see on your screen now. It's a pretty bog-standard pMDI, pressurized metered dose inhaler, the type of which are produced in the many millions every year, and the type of which, as a device engineer, I've had a direct involvement in. It's not supposed to be there. I didn't design this device to wash up on a beach, contributing to a global pollution problem, and making the situation for people and the environment on the planet worse. So this is a wake-up call to me that, actually, it's not enough just to say that we need to do something. When I see something I've worked on on a beach, I need to do something. So that's when we started looking at, well, what can we do? What are companies trying to do? What are the pressures for change? What are the barriers? What are the risks? Everything in medical device is about risk, especially when it comes to patient welfare. So how can we reduce our environmental impact as an industry? How can I reduce my environmental impact as a medical device designer and manufacturing engineer? But in a way that actually can be as sustainable as the environmental targets that we're aiming for. And that's what we've been working on since about 2017.
Shannon Hoste - 00:02:12: How have you been engaging in that? So I know there's... But, you know, the regulations vary depending on country. And I know there's a lot more happening in the EU and the UK than necessarily in the US, at least from a regulatory standpoint. But, what have you seen? How have you seen that landscape evolve between regulations and other factors that drive industry.
Cormac O'Prey - 00:02:35: Okay. If I cast my mind back to right about 2007, 2008, I had an opportunity to do some training with British standards. They run training courses as part of their organisation. One of those training courses was in design for manufacture and assembly. When I was doing that training course, I met some passionate engineers and technologists who were putting together a new standard to allow people like me to design devices across multiple industries with a reduced environmental impact. It was named BS 8887, and the description was designed for manufacturer assembly, which we know how to do, but also disassembly and end of life, essentially asking the question, what happens to the products that we design and manufacture once our customers have finished with them? The idea had been promoted by the Ellen MacArthur Foundations that there is no such thing as a way. We don't throw things away when we're finished with them. They always go somewhere. Well, if they always go somewhere, then surely as designers and manufacturers, it's part of our responsibility to make sure when that happens that they don't cause any damage. So that really got me interested in the whole, how do you do this? How do you design products where the environmental impact that they have and the impact on me and my children and my children's children, is no worse than what the planet or the ecosystem can actually absorb. So we're not talking about zero waste, we're talking about controlling waste to a sustainable level. That's the question we've been working on since then. In 2021, because of some research which came out, and we can come to that later, in terms of the impact that healthcare has on the environment, we realized this isn't a problem that somebody else has to deal with. This is actually our problem within healthcare, and we need to do it. But again, we don't know how. So we put together a committee, a subcommittee within British Standards of people in the industry, people in academia, people in standards, customers, user groups, and people like myself, whose job it is to solve these problems from a design point of view. To figure out what the answers are. We all know what the challenges are. They keep on being repeated. Yeah, we get that. What we don't know is what we do about it. If we go into work tomorrow and say, we want to start making our designs more sustainable, where do we start? What do we do? So that's where we're currently at.
Shannon Hoste - 00:04:50: So this is a huge topic. I'm thinking of some questions, but there's so much to cover here. I just want to make sure we're drilling down into the healthcare sector. So you've shared some statistics with me. Can you go over some of that data? It was, it was quite, very essential.
Cormac O'Prey - 00:05:07: It is that many people who work in medical, myself included, who've been there for a while, ask the question, why are we doing this? Our mission is to design devices that provide medicines or deliver drugs or provide therapy to make sick people better or to prevent people getting sick in the first place or to generally improve people's health and welfare. We're still doing that. That's our mission. So the question is, if that's our mission, why are we bothered by the environmental consideration? Isn't that for the likes of tree huggers or people who are involved with Greenpeace or people in the recycling industry? The answer to that is really no. And the reason why the answer is no is because research came to light a few years ago, which showed what the actual impact is of our industry on the world. And it's a big one. For example, if we were ranked beside the major European nations of the world, not other industries, but actual entire countries, if we were ranked beside them, healthcare would be number five on the list of who are the worst producers, who are the worst polluters. Then you look at, well, if we're number five on the polluter list, how bad is the pollution? And if you look at the stats, pollution is responsible for 9 million premature deaths every single year. So there's a problem with people dying prematurely because of pollution and the healthcare industry is a contributor, a major contributor towards that pollution. So if our mission is to make sick people better, we're getting it wrong. And that has really shifted the emphasis from the healthcare industry of one will, will we just try and minimize the risks to patients to actually know we need to do something as well to minimize our impact on the environment because that directly affects the health of our patients. It's something we cannot afford to ignore.
Shannon Hoste - 00:06:49: Absolutely. So, Cormac, I've been in this industry about the same, we've had a parallel path, I think. I started in the late 90s. What I enjoy about what I do and that's in developing medical products is bringing together the pieces of, what does this product need to do and be? And what are the, what is the, ecosystem that it lives in. So, you know, what are all of the considerations and requirements that I need to pull together and find a solution to create a solution that addresses the patient’s needs. And meets all of the requirements around it. And what I've noticed over this journey, I guess we're about 25 years now, is that things come up that we like blind spots that we see and realize, Oh, hey, that, that we need to consider that. And for me and my career, human factors was one of those blind spots that I felt in the late 90s and early 2000s. We're not thinking about, how are we making these products so that people can use them safely? And there was a lot of work that happened, both on the regulations and the expectations of the regulatory authorities, that shifted that focus and really brought that puzzle piece to affirm if this is something we need to think about. I know sustainability, it's been, you know, obviously, on our minds and we're seeing it every day in our climate. The impact of that, but that puzzle piece as it fits into medical devices hasn't necessarily been something that's always considered. It's like sustainability. So I find this discussion and the work that you're doing with BSI, very enlightening. To exactly what you're saying, how do we tactically go about addressing this in the industry that we work in? And so, you've identified you know, the impact and the impact is huge. Hopefully this opens up open eyes and we see that blind spot, but what can we do about it, I guess?
Cormac O'Prey - 00:08:49: That's a very good question. And there are other questions behind that. What should we do about it? What can we do about it? How do we do that in the context of a successful business, which if you take on board some environmental policies in your business that actually cost the business more money than they return, they're going to struggle for support long term, even if it's a policy which is supported by the very top levels of management. At some stage, it's somebody's job to put those into practice. And if putting them into practice hurts the company's share value, it starts to cost the company money, those practices aren't sustainable. And worst case is the business starts to struggle financially, it goes out of business, and it's replaced by other companies who have not adopted that environmental practice, and we're no better off. So it's really important that companies who adopt sustainable practices, particularly in design and manufacturing, do so in such a way that actually improves their bottom line. And there are ways of doing it. The trick is, and this is where a lot of companies have started and are struggling to get a kind of foothold in this whole thought process, is that easy wins, for example, switching your packaging to cardboard or biodegradable materials, or recycling some of your materials, some of your products, if you can recover them, that's a big if. Doesn't really return any value to the company. And the Ellen MacArthur Foundations, who are international thought leaders in this area, recognize this. And looking at all the different options which are available to companies in terms of how can they reduce the environmental footprint. Those low-hanging fruit of sustainable materials and even how you recycle, recover and recycle some of your products, because they don't really return any value to the business, those materials are used to create low-value products, everything from child's playground equipment to secondary packaging. It's not really funding itself. It's not paying for itself. So then you say, okay, well, what other options do we have that may not be as immediately obvious, but if we spend the time analyzing how we could integrate them into our business, they could actually start to pay us back. The next logical question is, well, if that's such a good idea, why is nobody doing it? And the answer to that is, well, they are, you just don't know about it yet. So companies, for example, that have been manufacturing very high value but low volume capital equipment like medical imaging equipment, MRI scanners, that kind of thing, they've actually been doing this as business as usual for many years. They design their products that once they reach the end of their design life and service, they are recovered and all the useful parts are stripped and reused. They realize there's really not very good business to be throwing away most of a $3 million scanner. If you can recover $2 million worth of parts from it, put those into another machine and then sell it again. So that's the models that we're looking to establish. It's called remanufacture in the UK. In the US, remanufacture is a very, very different meaning. So we need to be careful about terminology here. But the principle of don't see your equipment that still has some residual value in it going to landfill when you could be recovering it and using it, that's a principle which can go a long way down the future. But the question is, how do we do that? How do we design and manufacture, recover and reprocess these products so we can use them again and reuse them in such a way that it doesn't cost our business more to do that than they're worth?
Shannon Hoste - 00:12:17: So there are considerations for the business, the operations side. But there's considerations also on the device design side as well.
Cormac O'Prey - 00:12:28: Absolutely.
Shannon Hoste - 00:12:29: Considering this. You mentioned capital equipment, and then that reminds me back of working in that space and designed for. And that had to be a very deliberate activity.
Cormac O'Prey - 00:12:54: Yeah.
Shannon Hoste - 00:12:55: What parts are going to fail. And where and when so that you can properly segment your architecture of your system. For that servicing.
Cormac O'Prey - 00:13:07: I think you make an excellent point. An awful lot of the thought processes that we're looking to adopt here for sustainable design, the design for remanufacture or reuse or recovery, are already familiar. For those of us who have worked in products there where the manufacturer needs to have access to them to either carry out service operations or to replace certain components or just to keep a piece of high-value equipment running in service. There's lots of analogies in other industries. For example, you wouldn't buy a car and then dispose of the car when the tires were off. You know, that would be, that's not economic. So you design the car for those tires to be removed and replaced economically. Likewise, if you need to change some of your oils and fluids, you design it so standard equipment is available at different distributed work centers where that can be carried out without needing to go and buy a new car. We can use those principles, which are already familiar, and we kind of instinctively know that these work, to keep existing equipment that can be working for longer to keep it working for longer. The trick with medical devices is, and as a designer, you'll know this as well as I do, particularly from a human factors point of view, is that you need to differentiate between allowing your patient's access to use a device but not allowing your patients access to dismantle them. So you need to put some extra levels of security in here. And there are challenges about how if you decide that your policy, your strategy for your company is to recover, let's say, a relatively complex medical device and you want to recover and reuse 60% of it, that's fine. To do that, you need to remove the other 40%. So how do you do that in such a way where you can do it at your facility, at your factory or a refurbishment plant, but your customers can't, your patients can't. We all know patients fiddle with devices. That cannot put patients in a position where they cannot use their devices when they need them. So there are challenges for the designers. And from a point of view, that kind of makes the job a bit more interesting, makes it fun. There are ways to do it. We've done it before. Even devices where you need to have cartridges replaced or need to have them refilled. Yeah, you don't want the patient doing that. So there are lockout mechanisms. There are certain features that can be provided at the refurbishment facility that aren't available to customers or to patients. Now, it's a case of where do you do it? Do you allow a pharmacist to do it? Do you allow general practitioners or hospitals to do it? Okay, provide them with the facilities. So how you do it and how you reflect that in how the design functions is really part of the overall environment where you're operating. And this is why you need holistic thinking. There's no such thing as designing a medical device for sustainability without thinking about how that sustainability will work in the rest of your business. I mentioned earlier about the need to recover these devices, and that's where quite a lot of companies who try to do this, just to test the water to see what they can do and whether it works or not, where they fail, and fail quite spectacularly. As an example, a major inhaler manufacturer in the world had a 10-year scheme for recovering and recycling the material in their asthma inhalers. After 10 years, they gave up when they had a 0.4% recovery rate. It doesn't matter how good your refurbishment or repurposing or your manufacturing facilities are. If you've got nothing to work with, it's not going to work. So one of the more unexpected but fundamental problems associated with any kind of sustainable circular design and medical is how you get your devices back.
Shannon Hoste - 00:16:35: You know what excites me about this is, again, having been in this industry for a while. And what I've seen is, brilliant engineers, brilliant designers facing challenges and facing them head on and addressing them. And just making sure that this consideration, particularly from the business I hesitate to say business sustainability, meaning economical
Cormac O'Prey - 00:17:02: We've got to be realistic about expectations here. And the business, the commercial sustainability of what we're doing here has to be thought through as thoroughly as the environmental sustainability. Otherwise, somebody will find a way to get around it or to dump it completely. And we've already seen that. It's quite disappointing. I've known some European pharma companies who've taken this on boards across the entire operation. And when they come to crunch the numbers, because of the way they're analyzing it, they're just realizing it's going to cost them too much money. And they dump it. We need to find ways to be more creative and actually get the value out of these devices which are being thrown away in such a way that it doesn't cost us more to do it. But it's got to play to the bottom line or fundamentally it will not work. And speaking to companies that have done this in the past and other industries too. And trying to draw a picture around what success looks like, what good looks like, where it works. Again, we're hearing the consistent response that unless it contributes to the bottom line, it will not work.
Shannon Hoste - 00:18:02: And just to draw another analogy, I saw very similar things in the human factor space. Particularly around physical ergonomics. I know there were some companies early on in the 2000s that developed some more ergonomic surgical tools and the like. However, they cost more. And they had a really difficult time and they really, we're almost non-thirters with hospital systems and the like. And so it kind of took a rethinking of how do you design for that user in a way that is still maintaining by the way. So in a similar vein, create the business structure around this and then the design and the product design challenges are something I have complete confidence that the engineers and designers that are working in this space can take on and tackle needs to be presented as a product requirement as a, you know, as a framework in their design considerations.
Cormac O'Prey - 00:19:09: You're exactly right. We've noticed this as well. And again, when you're sitting down to design a new medical device or redesigning an existing medical device, you have a set of criteria. It's a requirement specification, a piece of paper that says, this is what you're going to do today. This is what success looks like. These are the metrics. This is how we're going to test your design. This is what our design verification testing will look for. And if you pass design verification testing, it's a good design. It can go to the next stage into early stage transfer to manufacture. If it's not on that list, it's not going to happen. It doesn't matter if it's ergonomics. It doesn't matter if it's serviceability, design for manufacturer. If it's not on that list, it will never get onto that engineered worksheet for any particular day. So looking at how we integrate any kind of sustainable design thinking into a sustainable design operation within a medical design manufacturer, it's really important that the requirements reflect the need for this product to be sustainable. How you do it, we don't know yet, because for any requirement specification, it doesn't answer the question how you do it. It just says what you need to do, which is great because it gives the designers the freedom to be creative, to think of, well, how do I design this so if we can get it back again, it can be reused multiple times. Quite a lot of instinctive designers think, I'm really glad we're doing this because I don't like seeing my designs being thrown away when I know they're still perfectly good. Most of them are still perfectly good to be used multiple times. I don't like waste. We spend a huge amount of effort in designing medical devices to minimize waste because we've always got one eye on the bottom line, minimizing the amount of plastic, minimizing the amount of assembly operations, maximizing the amount of consistency between different platforms. It's all about being as efficient as possible. All of that effort to then see the device simply discarded in the trash, no, it just feels wrong. So how can we turn that around to devices which are designed for more than one use? And then how do we say, okay, if they're going to be used more than once, does that then offer this the opportunity to build in more quality? They've got to last for longer. Generally, they've got to be more robust. You mentioned about customization for individual users. Well, you know, if it's a disposable item, nobody's going to worry about that too much. But if it's something which has a particularly bespoke handle to it and all you do is change the attachments but go on to it, you can spend a bit more money on that because that may stay with that surgeon for the rest of their life. So he or she will spend more money on it to get it right in the first place. As a byproduct, you've now reduced the amount of material that you're getting sent to landfill almost without a second thought. It's a secondary objective to something which is actually something you're trying to achieve to make your customers happier. And there's a lot of connectivity between what we're trying to do here and some of the advancements that we're looking to achieve in other areas of medical device design. For example, the whole compliance monitoring, the whole patients usage assurance monitoring, even post-market surveillance. One of the big black holes we have as designers is we don't know really what happens to those devices once they go into service. We do our due-diligence. We try and make the designs as easy for people to use, as foolproof as possible, and we test them with drop tests and heat tests and manipulation tests to make sure that they won't fall apart in patients' hands. But we don't really know. One of the side advantages of being able to recover those devices is you can see for yourself exactly what people have done to them. That tells you in some cases where, you know what, maybe we should reinforce this design. I can see where somebody's taken it apart and put it back together again. It's not supposed to do that. So, okay, that's a trigger that that's something we need to do to improve the overall quality of the device. But it also tells you how much of that device can be reused. If somebody has an inhaler and has chewed the end of it, which most people do, is it designed for that? Not really. But if it happens and you can see it happens because you get the device back again, you know that to reuse that device, you need to do something with that end cap. Okay, what options do you have? Do you make it a separate component? So the chewed bit can be separated and discarded. Is the rest of the inhaler, okay? Maybe. Look at it, examine it, see what's gone wrong with it, see where mechanisms it's had to deal with. Find reasons why you cannot reuse it, and then you will find triggers to design it so you can. And that's where it starts to get really interesting.
Shannon Hoste - 00:23:40: Absolutely. I’m just thinking about that and thinking of the information that can be gained, both, as you mentioned, in the product and understanding the, maybe the weaknesses in the product as, as you go through and learn learning. But also one of the things I've seen a lot is sometimes I'll go out in the field and you see, workarounds is the term you use in the quality world. Or modifications that people make to products. I've seen in hospital systems where they color tag equipment based on what floor it's going to. You know, how does that affect then cleanability of that product, right? And questions like that. So when you have those products back, you can start to look for and identify those kind of-
Cormac O'Prey - 00:24:26: Thanks. Exactly. If somebody wants to reuse a drug delivery device many times, but they don't want to return it back to you, they just want to kind of clean it, look after it themselves, you then need to say, well, what are they going to do to do this? Are they going to put it in the dishwasher? Why not? Can you design it so they can put it in the dishwasher? Well, actually the materials we use at the moment won't survive that. Fine, find some materials that will. This is the next phase of the design. If you can anticipate what people will do with your products, you then have the information you need to make those products work better. And that includes allowing them to survive multiple lifetimes. So just looking at what we've got on the screen at the moment, I'd like to take you through a couple of slides that show where the thinking currently is. Most product manufacturers, not just medical device manufacturers, but most product manufacturers employ what we would refer to as a linear model. You start with some materials, some components, you put them together, you fill it with the drug, put it inside some packaging, you give it to your distributors, it gets sent to your warehouse. It then makes its way through hospitals or clinicians to patients. Patient use it and they throw it away. There is no return loop. When companies say, well, if we want to be more sustainable, we want to recover and extract some value or even just prevent the material in these products going to landfill. What are our options? And that's when it gets complicated. Now, a lot of people see this slide and throw their hands up and go, whoa, we don't understand any of that. And that's probably very true because they've never had to do it. What the stars present is a list of options. Options for the designer, options for the manufacturer, options for the distributor, and, of course, options for everyone else. People say, what's the impact of sustainability on my business or on my customers? It's difficult to quantify that because it really affects almost everything. As a business, how you recover and reuse used devices will affect everything from distribution to logistics to quality control, manufacturing. It'll affect your purchases. If they then need to talk to their suppliers about some changes you may ask them to make to the components they give to you. You may need to change some of the materials. You may need to ask them to actually take some of the components back that you've recovered and do their magic on them so that they can be resold back to you, but with less of an overall impact on landfill, less material getting thrown away. This is the overall objective we're aiming for here is to have less stuff thrown away in landfill. In some cases, the designer may struggle with that idea because, well, they say, well, that means we need to add more plastic into our products. Yes, you do. You add more plastic in, so they will last for longer, but a single device that has now been designed to last six times will replace a device that will be replaced six times and thrown away for five of them. That's overall an improvement. And again, we're not looking for perfection here. We're looking for incremental change. We're looking to reduce, not stop, all the stuff we have going to landfill. So it's a manageable volume. At the moment, it isn't. So these options on the screen show that some of the things that manufacturers can do, they can at the top of the chain. Ask the users to refill them. Life extension programs, if you have an inhaler that instead of throwing the whole device away and getting a new one, you can simply replace the canister. Well, if it's your inhaler, do you really matter? Does it really matter to you if the mouthpiece is chewed? If you don't care, that's fine. If you do, well, here's another one where you could replace the mouthpiece. Within a PMDI, the nozzle at the bottom of where the canister goes is a very, very tightly tolerance little nozzle. It's 0.5 millimeters. That wears out after three months. Okay, well, that's a reason why most of the inhaler can't continue to be used after three months. But what if you take that nozzle and put it on the canister? So the canister and the nozzle are replaced every time the drug runs out. The rest of it isn't. That saves you about 90% of that plastic and that device going to landfill. And there are millions and millions of these devices. That all adds up to reasonable improvement in the performance of the manufacturer in achieving their sustainability goals. Very small change. But the impact can be huge. So we go from that, which is life extension, on down through the list to, well, if we do need to recover and reprocess our devices, that could be a liability for us. But it's also an opportunity because if we can reuse and sell this device again without buying the components that go into it, doesn't that make us money? And some companies have already adopted that. Instead of buying whole new components to go into their devices, a proportion of their devices have components which have already been through one life cycle. They didn't have to pay for them to get them back from hospitals or from patients, but they don't have to pay for them to come from their suppliers either. So overall, the bill of materials cost, the build cost of that device has gone down. The trick comes to how you cut the costs to the business of recovering and returning those components of those devices back to a usable state. And at the moment, that's where a lot of companies are struggling because these devices have never been designed to be dismantled, to be recovered mostly. So it's expensive to do. It's labor intensive. It's not scalable. And when you factor in the cost of taking lots of inhalers apart or lots of insulin injector pens apart, it's really not worth it. So we need to think about this with the same sort of mindset that we use to approach design for manufacture and assembly. We need to automate it. It needs to be scalable. We need to embrace the fact that we have millions of these devices to deal with. Therefore, asking people to do it in their thousands by hand will not work. We know how to do this for manufacture and assembly. We need to know how to do it the other way round, working that process in reverse, but using the same kind of automation we use in the first place for the same reasons to reduce our costs.
Shannon Hoste - 00:30:26: It's such an eye opener to think about. And there's so many opportunities, actually in the space, I think. Just needing to focus on it. Focus the lens on it and think about the options and it's going to like this diagram here, there's lots of different ways to navigate this depending on the product type. Depending on the product complexity or technology. There's lots of different strategies that could be applied to various all the way from capital equipment down to a single user.
Cormac O'Prey - 00:31:01: Yeah. And quite often in an individual product, if you look at what the optimal path would be, you actually work it through and say, well, this bit will be damaged, this bit will be contaminated, this bit we can protect, and that's where most of the value is, or this bit has a battery that needs to be replaced. Or let's say this bit has some corporate branding on it, which were due to change in three years' time, so we can't reuse that. So you start to separate out those bits which you can reuse from those that you can't or you don't want to. And that's where you start to open all the other options. Well, the stuff that we can't reuse, what do we do with that? The next level down is recycling the material. Well, they're all made out of a common material, and again, this is one of the design guidelines, that if you're designing something for recycling, add as little color as you can. In fact, try not to add any color at all, and try and commonize your materials as much as possible. So everything that you recover from that device, once it's washed, that's really the same bulk material that you used in the first place. So if you know what it is, you've got some traceability behind it. Maybe that then starts the conversation about can we actually use this material to make some of the components that go into our product in the first place. At the moment, recycled material in most medical devices isn't really considered seriously because of the risk of contamination. If you can manage that contamination and keep all the material the same because you know what these components are and where they came from, then you can reduce the risk to an acceptable level. That's okay. If you can't do that, then that heads you down another path. If you need to dispose of these components, well, can we make them out of a material which will minimize the environmental impact? It'll either biodegrade, or it has a secondary use. Why not? It's a cascade effect, not unlike the waterfall diagram used to design things in the first place by the FDA. It's a case of what do we do now? And if that works, we can go that path. Otherwise, we go this path. And then what do we do with this? So the overall solution can be a mixture of most of the techniques you see on the screen at the moment. And that's great. Because it means you have the flexibility to use the best solution for your business, for your patients, and actually for the environment. And we're not being wishy-washy about this. By meeting your environmental targets can mean the difference between you succeeding or failing as a business if you're supplying into some market.
Shannon Hoste - 00:33:17: And that, yeah, that gets me to another point I want to segue into is, the drivers for this. So we can identify ways to think about this and ways to think about it from a business value standpoint, but also, you mentioned, and I know regulations are different in different locations, but this can impact the viability of your product in various locations. So if you could talk a little bit about some of the initiatives and discussions that have been percolatoring.
Cormac O'Prey - 00:33:51: Sure. It probably wouldn't come as a surprise to say it's complicated. In the UK, it's perhaps less complicated than it is in the US. We have one major customer in the National Health Service, the NHS over here. If you're a supplier into the medical industry in the UK, you kind of have to deal with the NHS unless you go to a private industry. But even then, the whole regulatory framework is based around NHS approvals and that kind of thing. It's very tightly knit together. Compliance with the NHS's sustainability policies is mandatory. It's a big stick, and they're waving it at the industry in the UK right now. And the clear message from the NHS is if you do not demonstrate not say you agree with, not say you understand, not say you're going to do it, but actually demonstrate compliance with their sustainability goals after 2030, they will not use you. It's very clear. It's very simple.
Shannon Hoste - 00:34:49: I can imagine, so they're receiving all of these products they're purchasing of these products. But then they're left to deal with.
Cormac O'Prey - 00:34:58: Exactly. So if you put yourself in the position of a typical NHS hospital, they have mandatory requirements placed upon them by the NHS itself. Now, NHS hospitals in the UK run as almost private businesses, they're NHS trusts, but they're paid by the NHS itself, by the National Health Service. Therefore, the National Health Service puts mandatory targets on them that they must achieve or they will lose their status. Those targets include their sustainability targets, which, as you can see in the screen from bottom left, from 2030, all suppliers will be required to demonstrate progress. It means you have to have done it by then, not say you have it planned, but you actually have to have some evidence that you've done this. In line with the NHS’s net zero targets through published progress reports and continued carbon emissions report. This is not something they're being wishy-washy about. This is something which they're saying, if you don't do this, we will not use you. So that's the situation in the UK. Now to achieve those, one of the first things that companies say is, well, how do I know if I'm actually okay at the moment? How do I know what I need to do? And if I do change something, how do I measure it? What are you looking for? What are you going to measure from me as a supplier into your organization that shows you whether I'm meeting these hard requirements or not? So then we get into metrics and the whole lifecycle analysis issue. And you did ask the question before this meeting about, well, how do we navigate the LCA landscape? And it is a landscape. It's a number of different techniques which are used in different territories in different ways by different companies. There was a report came out about a year ago by The Lancet in the UK. Very influential medical publication. One of the conclusions from that is that there is still a huge amount of discontinuity and inconsistency in what companies are being asked to do. If you want to say, I need to demonstrate improvement in my sustainability, which means I need to measure it now, I then need to change something, and I need to measure it later. What am I measuring? How do I measure it? How do I know what I'm measuring is the same as what my competitors are measuring? And more importantly, how do I know it meets the criteria the NHS are looking for in terms of, is it good enough? Changing all the straws in the canteen from plastic to paper will not cut it. Greenwashing will not cut it. Okay, so what are your expectations? How do I demonstrate that I'm meeting them? And at the moment, there isn't really the consistency that I've seen in the industry that gives companies what they need in terms of guidelines as to what they have to do. How far do they have to go? And how do they measure in? It's a tricky situation. Companies are waking up to this and they are starting to push back saying, look, you need to tell us what you're looking for. Otherwise, how do we know if we're going to give it to you? And they're working this from both sides. The NHS are looking at it. The regulators are looking at it. We're looking at it. And the manufacturers are looking at it as well.
Shannon Hoste - 00:38:03: I want to get into standards in a minute and a lot of the work that's happening there, but on the regulatory side or even agency policy level. Are there any harmonization efforts that you're hearing at all across EU, UK, Canada, US?
Cormac O'Prey - 00:38:23: That's really a mixed picture. In terms of the regulatory side, there is in the UK and EU medical device regulations, MDR. And that was noticed as a big change a few years ago where MDR 17 came in. Previously, as I said, the whole idea of, can we reuse components or materials in medical devices were considered toxic. That's no longer the case. That's actually surprised a lot of designers and manufacturers, that even the regulators are considering that if you can do this in a safe enough way, then not only will we allow it, but we're actively supporting it because they know, based on this research I mentioned earlier, that to do nothing is simply not acceptable. We have to do something. We still have to continue to supply into the medical industry, but we need to do it in such a way that we don't contribute towards the problem. Okay, so if we are looking at, let's say, reusing or reprocessing some medical devices, what are the guidelines for how we can do that where we don't compromise patient safety? And let's be clear, there is no compromise. There's no possible acceptance of any kind of compromise to patient safety at all. It is down to the manufacturers and the designers to prove that if they want to instigate any kind of reprocessing and reuse, recycling, remanufacturing, whatever, with however deep you want to go, that you must demonstrate that there is no residual effect on patient safety. Now that's not necessarily as bad as it sounds, because if you're designing a single use device with a three month lifespan, three months is as far as you've got to go to prove it's safe. If you're designing something with a three year lifespan that will be used multiple times, well you can do it, but actually does that then mean that that device is now safer for the user? Probably. Because it's got to be designed to be more robust. It's not as fragile. It's not as disposable as it was. Therefore, you can invest more in it as a manufacturer and also as a healthcare provider. So in principle, these objectives are kind of aligned. We're looking at designing and manufacturing higher quality devices that will last longer. By default, you get more reliable devices because you've proven that they are. Design verification trials will need to be more extensive. You'll be looking into areas like extended life testing or even accelerated life testing or even highly accelerated life testing. You'll be looking much more thoroughly into the risk profile. A lot of people are likely to do these over an extended lifetime. There's a lot more things can go wrong if you're looking at something for three years. But that means there's a lot more you can do to mitigate that. So the overall risk profile to the patients can actually come down. And that's what we're looking to achieve. So that's Clause 17 in MDR. There is also the MHRA guidelines in the UK. The FDA has its own set of guidelines, but because of some pretty fundamental differences in terminology, they can be quite difficult to navigate, but the intention is still there. It's how to make the quality of the devices that we provide to our patients at least as good as what we currently do, but over a longer time frame.
Shannon Hoste - 00:41:25: I like that. The improvement, making an improvement. We need to move. We don’t need to have the perfect answer.
Cormac O'Prey - 00:41:37: This is not something that's going to be on a turnkey. That's something we can do in the next six months. Even understanding what you need to do to a design to make it more sustainable, most designers don't know. Where do you start? What do you consider? And there's some terminology that we can adopt from other industries who've been here before. So, again, if you've been blinkered in the medical device industry for the past 20 years and you don't know what's going on in the automotive industry or the IT industry or the recycling, even the aluminum drinks can or plastic water bottle industry, what do they do about those? They've already dealt with these issues many times over. So, yeah, we don't know what the answers are, but maybe to some of these questions, the answers are out there. We just need to find what works and see if we can somehow transplant that into our industry so it works for us too. For example, the whole identification of used devices. You can't really reprocess something if you don't know what it is. There has been technology designed that developed and is currently being tested in the recycling waste management industry that can identify up to 64 different types of waste plastic bottle or aluminum drinks can. They will find them, they will pick them up and they will put them into individual boxes based on who the manufacturer is. Okay, and it will do that at full processing speed of a waste stream in a recycling centre. That's the kind of technology that we need to be looking at, but we don't need to develop it ourselves. We just need to find it.
Shannon Hoste - 00:43:03: Exciting. So, again, I’m trying to bring more clarity to the faith. If there's work that's happening on the standards So, and I know you're involved with ESI and I believe you've also been engaging with the ASTM community to do a presentation at least, we had a chance to meet with some of those folks over in Sweden at PDA. So what's happening on that front?
Cormac O'Prey - 00:43:32: Perhaps before I go into this, I should give some perspective. Where are our standards across the world? Where is the state of the art in terms of sustainable design and manufacturing and understanding what is needed, how it can be achieved and how you do this? It seems to be the case that because British Standards, through the BS 8887 Standard that we've been working on since 2007, we seem to be a little bit ahead of the game. We've been certainly asking the questions in this space for a long time. We don't have all the answers yet, but there are some territories where they're right now really just starting to ask the questions. So we've got a little bit of a headway on it, which is why most of the ISO standards in this area tend to come from the BSI stable. We're getting involved in this one because of the questions that we've got on screen. BSI has to respond to what industry wants. That's its functions. And it's hearing from industry questions like these. We want to reduce our environmental impact, but we're risk averse. We don't want to be first. Second mind most gets the cheese. We need guidance. How will we differentiate ourselves from companies who are merely greenwashing? That's front of mind for a lot of organisations. But which is better for organisation, for our business to lead or to be led? Companies need support to do this. They need to know that if they're going down this particular route, that the result they get will be acceptable to industry. And that's really what standards are all about. It's about telling people what good looks like. But we can't do that unless we find out for ourselves what good looks like and then work with industry to say, here's what we're expecting you to do. Now let's work with us. Let's work together to figure out how you actually achieve it. So the committee that we put together within BSI is specifically looking at doing that. It's looking at gathering the best practice from inside and outside medical device manufacturing. Putting that together in some guidelines that explain to businesses why they should be doing this and then how they should be doing this. It's not the same shoe that fits everyone, so there will be differences between different organizations and there are tens of thousands of different medical devices. But there are some overall principles which do work. For example, what does sustainability mean? Well, in the context of a manufacturer, sustainability is preventing your used product from going to landfill. Okay, we can all get behind that. Even if it's a multimillion pound MRI scanner, it's a 50 cents PMDI in here. Okay, so if we have to get our products back again, now what do we do? Okay, here are some options. Here's a diagram that shows you certain paths that you can choose. And it's up to you to choose which paths you take based on what your business interests are, what your priorities are, and what you're aiming to achieve. We're not going to tell you what to do, but if you decide you want to do this, we'll help you figure out paths which are more likely to be successful than not. Okay, so that's really what the standards involved are. Recently, we tried to catch up with the ASTM organization and what they're doing. And they're, we're happy to say, seem to be approaching this iNow,n a similar way. But they will be the first to say that they got some catching up to them. this is a slide which there's a lot on here, but this kind of captures where they're at. And they have done a huge amount of research and homework on the background for how this could be done. For example, they've looked at 750 publications in circular product design. They've adopted over 400 principles in sustainable design used by NIST, the National Institute of Standards and Technology. So they're really trying to look at this very much from an analytical point of view and how you could do this, what the guidelines are for device manufacturers and device designers that will allow them to achieve this. Our approach has been slightly different. We're looking at what industry currently actually does and what works outside our industry and then try and capture that experience. So I'm really hopeful that the future will be pulling what ASTM is doing together with their huge amount of analytical work that they've got behind this and the practical experience that we've got of what companies have actually done and what works, what supports the business case. What supports the risk growth model. What hasn't been thought of from a theoretical point of view, what we find doesn't work. A good example of that is, well, what's the typical recovery rate you can expect? Most people aren't expecting it to be under 1%. Now we know what we need to fix. So together we're hoping that again standardization helps everyone who's underneath that standardized, that standard umbrella. Medical device manufacturers are international. So if we have best practice guidelines in terms of what's expected, but also how to achieve them, they'll go across national boundaries through the ISO organization and with ASTM as well. We'll have a solution that works for everyone. And that's what we're aiming to achieve.
Shannon Hoste - 00:48:11: Excellent. Excellent work. And so for anybody listening that isn't engaged with this or is thinking about how do you start to conceptualize this for your organization? One encouragement I would have is to get involved with standards organizations or paying attention to the work that's happening in these organizations. And identify potential town hall meetings, different opportunities to engage and start to have some of that collaboration and crosstalk, where you can start looking at what's happening in our industry. What are other people doing? What's best practice? What are other industries doing? There's conferences and other opportunities.
Cormac O'Prey - 00:48:50: Absolutely. A lot of what we're doing here, a lot of what we're aiming to do, isn't actually new. Sustainability has this perception of being this new 21st century, even 2020s initiative that people in medical are taking. If you go back to the 1980s and the 1970s, we used to do this anyway. If you were a surgeon in the 1970s, you didn't throw your instruments away after an operation. They were designed for multiple use and they were taken away and cleaned. Why don't we do that anymore? Some people say because the device is more complicated. They've got electronics in them, and that's all true. But there's no reason why those electronics can't also be designed for multiple use. If it's a cost issue, well, okay, we get that cheap plastic disposable devices are a lot cheaper to manufacture than expensive metal ones. But if you're now looking at, as a supplier, being told by your customer that, yeah, but if you do that, we're not going to use you, that's going to have a pretty fundamental effect on your profitability as an organization. So you need to think again. You need to say, well, okay, if we're going to go more towards, what we used to do, but with 21st century technology behind us, what's the hybrid of that look like? What does good look like today based on those old practices, but with modern technology to help? So we may go back to metal surgical instruments, which are reused, or we may go back to instruments which have some expensive reusable metal components, as well as some components which have to be disposed of after one use, or even some components which need to go back to the factory to be reprocessed. And can then make their way back to the surgeon's operating theater and be reused again. These are the different routes that are available, but we're just really at the start of navigating how they work.
Shannon Hoste - 00:50:34: I'm thinking of, you mention the '70s and 80s, I was thinking of the bottles, soda bottles.
Cormac O'Prey - 00:50:41: Yeah, as an example, One of the case studies I've used is the humble milk bottle. Soda bottles, milk bottles, it's, we still get milk delivered to our front door in a glass bottle. It's delivered on an electric vehicle, rechargeable. It contains a biological product. Has to comply with regulatory guidelines in terms of cleanliness. And that container, which is more expensive than a cheap, disposable plastic bottle is used, rinsed out, returned via the same supply route, whereby which it came to us in the first place, makes its way back to the manufacturing facility, is reprocessed and reused again, multiple times. Why can't we do that with surgical equipment? Why can't we use that model? It is so familiar and makes such obvious sense, as opposed to throwing out devices, which thousands of devices, which could be recovered and reused. It's very instinctively true for anyone who thinks about it, who's involved in the design and manufacture of medical devices industry. It's something we instinctively know we should be doing. We lack the mechanisms to how to actually make it happen. That's what we're working on is to show how that mechanism can be work and what the arguments are for making that mechanism work. And the arguments that need to be made inside a commercial organization need to be commercial or need to be commercial arguments.
Shannon Hoste - 00:52:06: Cormac, I wanted to thank you so much for joining me today. And talking through this with me and sharing your knowledge on sustainability. Hopefully we put out some information that folks can dig into a little bit more. Sink their teeth into and start to consider an engagement.
Cormac O'Prey - 00:52:24: Thank you, Shannon. It's a bit of a passion project for us, but it's one of those things that once there's enough momentum in the industry to start doing this, it'll become easier for everyone.
Voiceover – 00:53:01: That was Shannon Hoste and Cormac O’ Prey. For more information on the Kestrel Consultancy Group, visit kestrelconsultancygroup.co.uk. Thank you so much for listening to or watching this episode. Please subscribe or follow this podcast in whatever app you're using right now, or follow Agilis by Kymanox on LinkedIn for all updates. This episode was edited and produced by Earfluence. We'll see you again soon on The Factor.
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