How to use Life Cycle Assessment in medical device development

What is a Life Cycle Assessment?

LCA (Life Cycle Assessment or Analysis) is a methodology that can be used throughout the development of new products and even throughout the lifespan of existing products to help you get a sense of its carbon impact, where this impact comes from and most importantly, how we can reduce it.

What are the different phases of a Life Cycle Assessment?

The Life Cycle Framework can be broken down into four phases. These are:

Phase one: goal and scope definition

This defines what is to be covered, why we are doing it and what is to be achieved.

Phase two: inventory analysis

This step ensures you have a full understanding of the product involved.

Phase three: impact assessment

This is where discussion and assessment of the overall environmental impact of the product takes place.

Phase four: interpretation

This is the interpretation phase where you define what you should be looking at and decide what should be done about it.

The LCA framework has been developed and codified as part of ISO 14040:2006. It gives us an insight-driven, data-based understanding of where we can make changes as medical device developers.

Now let’s delve deeper into each section.

Phase one: defining scope and goals in your LCA

As the first step in your overall Life Cycle Impact Assessment, you’ll first work out the boundary of the life cycle that will apply to what you’re looking at.

This is often defined using the following terms on a flow model:

• Cradle to gate looks at everything from raw material all the way through to the manufactured product, when it is ready for distribution and transport.
• Cradle to grave examines the distribution of the product, how it’s used, the impact of product usage and then the disposal process.
• Cradle to cradle looks at all of the above before adding the potential for re-use or recycling to bring it back to the beginning of the process.

It’s important to remember that in the medical industry, there are plenty of additional complexities including specialist processes and requirements in terms of assembly.

Phase two and three: what happens during LCA?

Phases two and three are at the ‘heart’ of the Life Cycle Assessment ’. First, we look at the foreground data, which consists of product-specific characteristics. For many products, this concerns the total mass of parts used to create it, including the materials and processes taken to get there. All of that information is used alongside a Life Cycle Inventory database (LCI).

Using a Life Cycle Inventory database to find the carbon footprint of products

This dataset allows you to take a closer look at the device’s material and process, giving you the opportunity to ask questions around the potential impacts of gas emissions, water usage, energy usage and more.

From this, you can combine both sets of data (product-specific and LCI) to determine the output or carbon footprint of the product in question. This is in grams of CO2 equivalent, which is a simple number that allows everything to be compared against it.

That output data can be rolled up into one high level single number or, you can also split this figure down and attribute it to certain elements. This will help you pinpoint ‘hotspots’ for those elements.

From here, we can find areas for improvement – or phase four…

Phase four: how to interpret the environmental implication of the LCA and make active improvements

Of course, the LCA approach is valuable for systematically evaluating the carbon footprint of drug delivery devices at all stages of engineering and development. Through this, we can map the entire development process all the way from requirements through to industrialisation and beyond that into manufacturing and overall life cycle management.

When defining your requirements, it will likely be quite difficult for a medical device developer to get down to the exact mass of a certain polymer or the raw materials you’re thinking of using. But you can still use some of the concepts and tools within the LCA to help you understand the likely impacts of the different approaches you might take. We like to integrate this through the entire development process.

Requirements and concept generation

In these early stages, this might be a rough discussion based on outline numbers, but it will help to point you and the project in different directions. It also allows you to put tangible numbers behind it, which can let you judge the sustainability of a device on a numerical basis – putting it in the same field as some of the standard commercial factors.

Proof of concept and detailed design

As we move through the development, namely proof of concept and detailed design, more and more data is gathered. This helps us identify hotspots, such as discovering a particular material, process or sub-assembly. This is an especially impactful area that can be worked on to reduce the carbon footprint.

Balancing sustainability requirements with commercial factors

One of the main things developers need to keep in mind throughout their cycle analysis, is balancing requirements with the aim of creating a sustainable product, alongside engineering and commercial factors. While we’d all love to have entirely sustainable, zero-carbon medical devices, we also need to understand how it fits into other business needs and how much value is placed on those decisions.

As we move through the development process, one of the tools to use is a ‘sustainability file’ or ‘green file’. This is where information on why a decision was reached or made is documented and recorded. This can be referred to later on in the development program. It works similarly to a design history file but is focused on sustainability as part of your Life Cycle Assessment.

Going digital, getting connected: utilising LCA early in your processes

By using a case study, we’ll see how you can use LCAs from the beginning of your development process, especially when used to examine the impact of various feature sets. This also gives an indication of the challenges associated with comparing different products that all respond to different patient needs and varying value propositions.

With a Life Cycle Assessment, you’ll be able to come up with some numbers that give you an idea of the impact of these different products. However, to make a decision, you’ll first need to look at some of the wider aspects of this.

For example, you have to consider the impact of having a connected or digital device on overall healthcare costs and how it can help avoid taking a trip to the emergency room.

As digital and connected devices become more and more prevalent, we can see the immediate improvements that these products bring to users, allowing them to work better with their doctors and identify and manage their symptoms. This is because you can have so much information captured within a device that patients carry with them all the time compared to a system where patients have to wait until they go to see the doctor.

The data produced by digital devices can be especially helpful in terms of driving analytics for, patients, doctors and pharmaceutical companies coming up with better products, better dosing regimes etc…. Digital devices can also provide extra data monitoring, such as discerning where the has device been taken, if the device has been dropped and other queries.

So, what’s the major conundrum?

In cases like this, poor adherence, poor understanding of the patient is a major clinical and environmental concern. If patients do not adhere to their regimes, it can lead to increased hospital admissions, inadequate disease control and higher mortality rates.

But while digital devices can be a solution, they also add complexity. This is down to adding more functions or even plastic components that can increase the carbon footprints of these products. It is a balance between adding functionality that is beneficial to patients but also looking at the sustainability of the product.

Life Cycle Analysis can tell us what the impact of connected devices are, but it can’t do the opposite, which is to determine patient adherence and the benefits that come from that, This is a wider sustainability and healthcare economics question.

Case study exploration: looking at parenteral devices and their carbon footprint

By looking at three injector products (a pre-filled syringe, a generic autoinjector device and an autoinjector with a connectivity module) each with different levels of complexity and user needs, we can see the difference between their carbon usage.

A Life Cycle Assessment doesn’t answer the question of: which one is the ‘best solution’, but rather: what is the impact of choosing each of these medical devices.

At the early stage of your medical device development process, your team can carry out an environmental assessment like this one to give you an idea as to what the overall impact is likely to be and then balance that against the wider picture.

The systems we’ll be looking at are:

1. Low complexity system – A pre-filled syringe with a needle safety shield, with 8 components (including the primary container and needle) and a total mass of 8g.

2. Complex – This is a generic auto-injector device, spring powered for intramuscular or subcutaneous injection (not for emergency use) with 14 components (including the primary container and needle) and a total mass of 35g.

3. Advanced – Finally, we have an autoinjector with an added connectivity module with sensing capabilities to monitor and record a range of important use-related information. Data can be relayed in real time to the user via Bluetooth wireless technology to a supporting mobile app.

1. Low complexity prefilled syringe

By estimating the components that might go into the device and running them through the Life Cycle Assessment database, we can get an indication of its carbon footprint. This is very much looking at the manufacturing process, examining each component by the material it’s created from.

From these results, we can determine that there is a carbon footprint of just under 50 grams of carbon dioxide equivalent compared to a mass of around 8 grams – making it a simple device with a low total mass and low carbon footprint.

2. More complex auto-injectors

Amore complex autoinjector with a spring inside of the device, a primary package and a larger mass in terms of the plastic and metal surrounding will ultimately have a higher carbon footprint.

We’ve moved from a low complexity device of about 8 grams to one of about 35 grams, but our carbon footprint has increased to almost 130 grams. However, given the fact it is an auto-injector rather than a safety system, there is a lot of extra functionality that many users will find helpful.

3. Connected auto-injector

Finally, let’s move on to the potential impact of a connected auto-injector. In this example, the autoinjector has a connectivity module added to it, which can be incredibly beneficial to users. Connectivity might help patients manage their conditions, potentially reducing mortality and hospital admissions.

However, 70% of the carbon footprint of this device comes from the electronics module, jumping up from 130 grams of C02 to over 400 grams for this product.

Just by adding this functionality, we can see that it increases the carbon footprint by three times.

Overall findings

Comparing the findings sourced by the Life Cycle Assessments, it’s easy to understand that the connected auto-injector has a significantly larger impact than the simple syringe and the standard auto-injector. However, the connected auto-injector also adds significant additional functionality, which must be taken into account.

In this case study, Life Cycle Assessments have been done for single-use devices. However, it is possible that, for a connected device, the connected module could be reusable. In this case, the carbon footprint of the overall product could be amortised over the lifetime of its use.

This is one of the areas that could be looked at in the early stages of development. You might see that the carbon produced by your device is not ideal but you can brainstorm ideas to make certain pieces more sustainable, such as introducing a reusable element. This means that you will still get all of the benefits of a connected product without the massive environmental impact each time it is manufactured.

The impact of adding connectivity

Adding electronics and connective capability to medical devices can be huge on your carbon footprint. However, this is one of the factors that should be considered as part of your LCA.

Understanding the effects of improved usability and adherence can also make a huge difference to the overall sustainability picture. This is a reminder that, while the LCA is a useful tool, it is one of many in your sustainability toolkit.

It’s also important to consider the patient journey, as people navigate their treatment life cycle, from a naive user to one that may be more experienced. Understanding when functions like medical device connectivity will actively benefit people can help you determine where you can make changes. For example, a new user might benefit from a connected medical device to understand and get instructions on how to use a product, but a patient with a chronic condition who has been using a device for many years, probably doesn’t need as much support.

Why the medical device industry should be using Life Cycle Assessments and how it can create sustainable action

To summarise, the LCA is a very useful tool that helps us understand current and proposed products and the environmental implications that might arise. It allows medical device developers to delve down and collate data from any point within the medical development process, giving information that can support key discussions and decisions.

However, the key thing is translating these results into action. This can be done by integrating these tools throughout your development, from looking at requirements and different concepts to the final stages of development.

You should also be adding more data to your LCA and use this to push your development towards the creation of a more sustainable and higher-performing product.