Packaging, supply & logistics
systems and catheters. “Without the ability to coil devices of this type the packaging design must allow for a straight device, typically requiring larger packaging than would be necessary if the device could be coiled,” Burgess explains. “If this need is not considered during development of the device, it may result in material or design choices that will not permit the use of smaller packaging without damage.” Burgess adds that it’s important to decide whether a product is to be sterilised at the sterile pack level or the final pack level; both approaches have their pros and cons. “For example, in ethylene oxide sterilisation, if you sterilise at the sterile pack level, you can fit more units in a chamber, which is a big benefit,” he explains. “On the other hand, if you sterilise everything in the final pack, it is ready to go as soon as it’s sterilised.”
Understanding device sensitivities Material compatibility is also crucially important, and sponsors must ask whether the material they are considering for the device has any environmental sensitivities – whether that be heat, cold, humidity, pressure or oxygen – that will require specific protection or mechanisms of assessment for the user, such as temperature indicator labels. “Since there are many different modalities of sterilisation, including steam sterilisation, radiation sterilisation and ethylene oxide sterilisation, it’s important for a development team to understand the characteristics of each material,” Burgess explains. “They must also take into consideration not only what materials may be used on the device, but also the packaging.” Nylon, for example, is a common material in both medical devices and packaging due to its strength and durability compared to other polymers, but it may have difficulty achieving the desired performance during radiation sterilisation. This is because ionising radiation can break the polymer chains and cause cross-linking, leading to a reduction in mechanical properties, like its strength and flexibility. This can compromise the integrity of the packaging material and increase the risk of packaging failure during storage or transportation. However, if steam sterilisation is the method under consideration, a different set of materials would be excluded. “In this case, high heat will be used, and many polymers in common use for packaging could be impacted since their glass transition temperatures are near temperatures employed for this method of sterilisation,” Burgess notes. DuPont Tyvek, for example, should not exceed 127°C or there may be an impact to part dimensions and porosity. The implications of not asking these questions could be severe project delays due to the substantial redesign work needed to resolve any issues. “In some cases, this could mean months or years of rework, resulting in a long delay to bringing new life saving technologies to the market,” Burgess says.
Medical Device Developments /
www.nsmedicaldevices.com Logistical challenges
Beyond the functional, companies must also consider the logistical implications of their packaging choices. What will the annual volume be for this product? How important to the company is this device likely to be? This leads into how much effort will be needed to develop packaging for the various elements of a medical device’s ecosystem. For example, the primary device might be a pacemaker, which will be implanted into the patient. This product would also come with several accessories that facilitate implantation of the device, but are not themselves responsible for delivering therapy to the patient. “Because of the risk and importance of the pacemaker itself, it’s vital to understand that more time and energy will be required to develop packaging for the device, rather than the accessories – not from a safety standpoint, but in terms of appearance or marketing,” Burgess notes. “Manufacturers must also consider the risk associated with what they are packaging; if it’s a device that is going to live in a person for a long time, there’s a lot more risk involved; if it’s not going into the body, it’s a much lower risk product. This risk is managed by regulations medical device manufacturers must follow, including the type of regulatory submission required for low (Class I) versus high-risk (Class III) products. Just like the device itself, these regulations dictate how much scrutiny and time you are going to spend developing the packaging for that product.” These considerations will also impact supplier selection – a far greater issue for medical device manufacturers today than it was before the pandemic. “Three years ago, there was never a concern about making sure we had enough parts to make a product; supply wasn’t really an issue,” Burgess says. “Now we’ve recognised that if you have a really important product, you should have at least one alternative source for materials, so that if your primary supplier fails, you have a back-up plan.” This process brings up a whole new set of questions. How stable is the back-up supplier’s manufacturing process? Can they maintain the same level of quality in two years’ time, or three? “Unfortunately, these are things that tend to show themselves over time that you might not notice right away,” Burgess says. “But these kinds of discussions are certainly taking place more frequently.”
The future of sterile packaging With net-zero targets drawing closer, medical device manufacturers are also under increasing regulatory pressure to reduce their emissions and the amount of energy used during the packaging process. This is leading to the development of new sterilisation methods, as well as the adaptation of existing ones. For example, ethylene oxide sterilisation is one of the most common medical device sterilisation methods.
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