Why is it important to have processing expertise from your material suppliers whenyou’re working in medical? And what is the actual definition of a medical grade plastic? Dave Gray caught up with Joanne Belshaw, business development manager healthcare at Albis to find out more.
Albis
DG: So Joanne, tell us what products in the portfolio your healthcare customers are buying at the minute?
JB: The three most important portfolios are polyolefins, polycarbonate and styrenics. Covestro’s Makrolon and Bayblend (PC/ABS) are our most popular PC brands, in styrenicswe sell Ineos’ Styrolution, with our largest sales volumes coming from Novodur HD ABS, andin terms of polyolefins, LyondellBasell’S PP and PE brand Purell continues to be popular.
Our polyolefins brands are popular because they’re such a versatile material with a great cost balance. It isn’t an engineering plastic, so it doesn’t hit the wallet too hard, but it hasgreat functionality, and can be processed easily.
Meanwhile our polycarbonates are popular as they do have engineering properties – customers don’t tend to use those for things like single use devices, but they want to use it for more durable devices, since it gives them a lot of clarity coupled with exceptional toughness.
DG: And what kind of trends are you seeing in terms of applications?
JB: The biggest trend continues to be single use applications, because obviously there’s less risk of disease transmission. But diagnostics is growing quite a lot, particularly thingslike point of care. People are really looking at their own health in a more preventative way,rather than waiting until they've got a problem.
Wearables continue to be a growth area, which creates huge demand for plastics. But now we’re also seeing pharma companies developing connected devices to help monitor things like medication adherence. This also helps with stock management in pharmacies.
DG: It's interesting that that conversion of consumer and professional healthcare, isn't it? Iguess that has an impact on the way devices are being designed?
JB: Exactly, yes. You've got to make it simple for people to use. If you’re giving diagnosticsdevices directly to the patients to administer, then you've got to have a device that's able todo that analysis with a small amount of blood, as you can’t have patients taking full blood samples when they haven’t been trained in that. And then you have to make it easy for them to dispose of it and recycle it if possible.
DG: I think everyone supplying plastics into healthcare probably felt the uptick in demanddue to Covid. Has the levelled off now?
JB: Pretty much, yes. In some cases, actually, it's probably dropped a little bit belowprevious levels because in the case of delivery devices for vaccines, some people stockpiled. So in some cases there has been an oversupply of delivery devices that still nowneed to be consumed.
DG: Do you just supply the materials based on the application? Or do you and your team provide any other type of support or guidance?
JB: Our philosophy is to try and help people through the whole supply chain. So we don't just want to talk to converters, we also want to help with their customers. It could also be that we're supporting them with getting information for regulatory bodies or preparing for an audit, or actually after an audit when there's something's not been ticked off. And we try to support them with finding the best material for the job. And then we look at whether it’s the right fit in terms of the policy of the supplier, and then processability too.
We also offer design advice using state-of-the-art injection moulding simulation tools, which can save on expensive toolmaking and re-making. With the right material and vice versa. So do the two things fit together? Try and avoid expensive tool making only to have to have it remade or changed later.
Also, we are quite heavily involved in various industry groups like MedPharmPlast Europe.That meant that when MDR (European Medical Device Regulation) was coming in, wecould understand what that would mean for the whole supply chain. And we’ve beeninvolved with the VDI, who have tried to issue a definition for the term ‘medical grade plastic’.
So, if you are manufacturing a material and you want to call it medical grade, what does thatactually mean? Each supplier has their own support package that makes it a medical gradein their eyes. And that might not necessarily fit with what a converter thinks that means, orwhat a brand owner might think that means. We try and keep abreast of all the problems that people have, whether it's regulatory, quality, technical processing or aftermarket.
DG: So what is the VDI’s definition for medical devices?
JB: It's about what kind of support package you would need. I suppose that's it in a nutshell.So what is it that the producers need to do? What is required and what isn't required of the manufacturer? Obviously there'll be some manufacturers who will need to do a huge amount of testing that is going to be repeated by the person making the medical device or the pharmaceutical packaging.
But there's other things that they could do, like notification of change periods, consistent formulation, and how they notify people of what they're doing. So it’s really to be seen asmore of an add-on too, because it's not about the quality of the product. People manufacturequality products already, but it's about what do they do externally, and how much time dothey give people to deal with it?
So the VDI I is making it clear what is and isn't included as a standard package for healthcare. It’s quite a long document, which originally came out in German and is now available in English. And I understand that they are in discussions with some other bodies that might want to take the guidelines up. Some suppliers give 36 months notification of change, while others give 18. So if you are making a medical device, 18 months is still quite a short timeframe. There might be technical reasons why you can't give a longer notification of change. It might be that one of the raw materials doesn't have a shelf life long enough.
So it's just about trying to get everybody on the same page. I mean, people understand it alot better now than they did 20 years ago when I first started working in this area. And it's also about them understanding that just because somebody says it complies with ISO 10993doesn't mean that they don't have to do their 10993 testing. It’s about making sureeverybody still knows what their responsibilities are in the supply chain.