Connectivity has been a common trend for the medical device industry for some years now, particularly in the drug delivery sector. While medical device connectivity offers a number of potential benefits, from improving the patient experience to providing important use data for device manufacturers, it also introduces environmental impacts that need to be considered.
There are many tools to help understand the environmental impact of medical device development, all of which can be applied within sustainability engineering to help create a less carbon-costly product. These tools may be used to focus on the entire life cycle of a product, or to focus on areas such as packaging and disposal.
One tool that can be used to gain valuable insights into the sustainability of different design choices, including the carbon footprint of adding device connectivity, is Life Cycle Analysis (LCA).
Life Cycle Analysis is a methodology for calculating the carbon footprint of a product
or process. It is based on the LCA framework as described in ISO 14040:2006. Typically, there are three scopes that may be used to focus the analysis:
An LCA involves gathering product characteristics for each stage of the product life cycle, such as materials, processes and supply chain routes. A life cycle inventory (a database of environmental impact data, readily found within LCA tools such as SimaPro) is then used to convert the characteristics into carbon footprint, or Global Warming Potential (GWP), measured in grams of emissions, equivalent to carbon dioxide (gCO2e).
To help understand how the carbon footprint of a connected device compares to a non-connected equivalent device, Team Consulting conducted an LCA on two fictional devices: an autoinjector with a 1ml pre-filled syringe, and an identical device with a connectivity module. Using our expertise within the drug delivery sector, we generated a bill of materials for the two devices, with components and supply chain routes that are typical of such devices. The scope of this exercise was limited to a cradle-to-gate, focusing on just the steps for producing the device.
It is important to note that the use case was not included in the analysis, including any consumables that may be required. The devices were instead based on a generic use case so that we could make a reasonable assessment of the impact of an added connectivity module. The manufacture of the drug formulation was also excluded from the assessment, though it was included in the supply chain analysis.
Our analysis was broken down into four areas:
Materials and manufacturing were combined for the device components and transit packaging. Sterilisation processes were also included in the analysis, but were found to be negligible, so this has been excluded in the results.
The analysis involved exploring the supply chain routes and methods in detail, assigning reasonable locations for each step. Above is a diagram to represent how the components are manufactured, assembled and transported around the globe to the final assembly site, for which we selected Dublin. Regular transit packaging elements for each sub-assembly have been selected, such as trays for the front and rear body assemblies, and robust tubs for the syringes.
As shown in figures 1 and 2, the device components of the non-connected autoinjector have a carbon footprint of 204gCO2e. Adding the components required for connectivity increases the carbon footprint by just under 200%, despite the fact the mass of the connected module is about a third of the rest of the device. This increase in carbon footprint from such a small mass is mostly driven by the materials involved in electronics and their complicated manufacturing processes.
The majority of the transit packaging is from the trays for the mechanical sub-assemblies and the syringes, as they are relatively delicate and require sturdy packaging to ensure quality during the supply chain. The additional transit packaging from the electronic elements presents an increase of only 17gCO2e, due to simple boxes and bags moving the electronics from Singapore to the final assembly site in Dublin. Overall, packaging accounts for 20% of the standard autoinjector’s carbon footprint, and 14% of the connected variant.
The core of the analysis for this area is based on the energy required for maintaining a clean room during assembly. The carbon footprint from assembling the standard autoinjector is 86gCO2e, and the additional processes for the electronics in the connected autoinjector increases the carbon footprint by 65%.
While this analysis focused on generalised device examples, further assessments could be conducted on the energy usage of assembly machinery and any consumables or waste products, to provide a more accurate picture of the impact of assembly.
In this example, all of the components in the connected module are sourced from Singapore. It is assumed that the components are sourced locally and assembled at one site, before being transported by air to the final assembly site in Dublin. For the connected device, the supply chain carbon footprint for just the connected module makes up 18% of the complete supply chain. Although the mass of the connected module is lower than the mechanical module, the carbon footprint is still high due to the air travel involved. In an ideal scenario, the electronics should be sourced more locally to help reduce this impact – in this case local to Dublin.
In this analysis, adding a connectivity module produced an additional 577gCO2e compared to the non-connected device. It is worth noting that around 32% of this is related to transit packaging, supply chain and assembly. As device developers, we need to consider all the factors that contribute to the carbon footprint of the products we create, exploring methods for reducing the impact of not only the components themselves, but the wider supply chain impacts as well.
While this LCA clearly highlights the carbon costs of adding device connectivity, this is of course only part of the picture. There are indeed multiple other considerations around environmental impact that are harder to define, some of which may not all necessarily be negative, either.
This example LCA highlights the difference between the carbon footprint of two devices that may be marketed and used in different ways. When conducting sustainability analysis for a specific product, it is important to consider the various use scenarios (known as a ‘functional unit’ in LCA terms), to help generate fair comparisons between designs and competitive products.
For example, it is very unlikely that a single use connected autoinjector would be marketed, due to the increase in complexity and cost per dose. Meanwhile, a connected device, like the one used in this LCA, may have some reusable element, such as a replaceable primary container, as this may be cheaper and result in a lower carbon footprint.
By analysing different use scenarios, we can better understand how the carbon footprint of a product compares with other devices over a defined therapy. For example, in the case of a drug delivery device, the ‘functional unit’ may describe the number of devices used by a patient to complete a month’s therapy. In this case, the number of devices will depend on what is a reasonable target for performance. Once this use scenario has been defined, it can be used to compare the carbon footprint of devices with the same performance requirements, such as competing single use autoinjectors, reusable devices with disposable primary containers, and alternative therapies. This comparison can be done by calculating the carbon footprint for a patient to complete a month’s therapy for each of the devices or therapies, each of which will involve the use of varying numbers of devices and disposable elements.
Overall, conducting LCAs based on use scenarios can provide a fairer comparison to similar, competitive products.
It’s easy to assume that adding connectivity to a product is negative from a medical device sustainability perspective, but this isn’t necessarily the case when looking at a whole patient treatment scenario. While connectivity does lead to a higher carbon footprint during development (owing to the resource-intensive processes needed to manufacture the required electronic components), this does not take into account the potential secondary benefits that device connectivity can bring.
It can be argued that the carbon footprint of device connectivity may in fact be offset to some degree by less quantifiable sustainability benefits from the device’s use, including improved adherence to medication and support for at-home treatment. The following are some of the potential ways that connectivity could work to improve sustainability in medical devices:
The potential benefits of even simple factors such as reduced hospital visits should not be understated. In 2019 it was estimated the NHS produced 25 mega tonnes of CO2 equivalent, 24% of which came from the direct delivery of care. Even patient travel to and from hospital can have a significant carbon footprint, within scope 3 emissions (indirect emissions from other businesses and activities outside your company’s control).
Some studies have already shown a significant reduction in environmental impacts due to improvements in patient management via the use of a connected device. New guidance has also been emerging recently to highlight the various sustainability factors that need to be considered around device use, including guidance from the Sustainable Healthcare Coalition.
While these secondary benefits seem promising at face value, it is important to note that more research is still needed to effectively quantify their impacts in terms of carbon footprint reduction. Either way, it’s important for device manufacturers to consider the potential sustainability benefits of device connectivity to understand the wider picture, even if the potential advantages are only estimates at best.
It’s easy to state that everything must be 100% sustainable, and of course that would be wonderful if it was possible. However, we must also weigh up the health benefits that might be lost should a medical device fail to meet this challenging requirement. For example, what if a start-up company’s new, innovative connected device is blocked because it can’t be truly sustainable in the short term, for technical or commercial reasons? Perhaps the start-up simply doesn’t have sufficient funding to build in sustainability during its race to market, however the product still has potential to bring great benefit to patients.
In this case, there may be a sliding balance to make with regards to the sustainability costs versus patient benefits. While we should always aim for a fully sustainable medical device, if there are significant technical, logistic or commercial hurdles to achieve this and the clinical benefit of the device is likely to be very high, it might be acceptable, in the short term, to launch the device onto the market with less-than-perfect sustainability credentials. This should of course then be followed up with continued sustainability improvements, or the development of a second generation, more sustainable device.
Such a scenario is likely to apply more to start-up companies who need to get their first innovative product on the market as soon as possible with minimal development time and cost, however the principle behind it is an important one to consider.
On the other hand, if adding connectivity has only a small clinical benefit, but may provide a significant marketing advantage, then sustainability should be evaluated very carefully, with the aim to produce a truly sustainable medical device. Indeed, companies may even find that reducing the environmental impact of the product could in turn have additional commercial benefits itself.
Ideally, adding device connectivity should offer both a significant clinical advantage and be implemented sustainably. In reality, a more pragmatic approach may initially be required.
Ultimately, the question of whether device connectivity is sustainable is not a simple matter. Tools such as LCA allow medical device developers to delve down and collate data from any point within the development process, providing information that can support key discussions and decisions. In order to enact real change, however, the key will be in how device manufacturers translate these results into action.
In a market that’s increasingly conscious about sustainability, it’s important to sanity check your concept and establish the clinical benefits of adding device connectivity, before committing to this in your development. If the clinical benefit of connectivity is high, it may be acceptable to launch a new device that is not as sustainable as we would wish, provided goals are set to subsequently improve medical device sustainability.
It is also important to establish if there are any potential sustainability benefits of adding connectivity, such as reduced waste, or fewer patient trips to hospital. Whilst these may be hard to quantify, they have the potential to help offset the impact of adding electronics. As more work is done to understand and quantify the secondary sustainability benefits of device connectivity and patient adherence, we can hope to gain a better picture of what adding device connectivity really means for sustainability.
This article was taken from Team Consulting’s Insight magazine. Sign up for your own copy here.
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