This article is taken from The future of pharmaceuticals is green, pages 6-9. © Regulatory Rapporteur

1. FOCUS GREEN PHARMA
6 | REGULATORY RAPPORTEUR | Vol. 19, No. 4, April 2022 www.topra.org
Background
Over the last hundred years, there have been immeasurable changes
in how diseases are treated and how medicines are delivered. Many of
these have been driven by changes in our understanding of science and
physiology. However, many have also been driven by regulations, which
have been implemented to make treatments safer to both patients and
the environment. By exploring these regulations, we can identify how
future regulations may impact medical devices.
A prominent example of the impact of regulations on medical devices
was the changes to the use of refrigerants as propellants in the medical
inhaler marketplace. Pressurised metered dose inhalers (pMDIs) have been
around since the 1950s. By the 1980s, they were commonly pressurised
using Chlorofluorocarbons (CFCs). When CFCs were identified as a major
source of damage to the ozone layer, they were banned from use, as part of
the Montreal Protocol in 1987.1
While other industries could simply switch to
replacement propellants, such as hydrofluoroalkane (HFAs), such changes
were significantly slowed down in the medical industry. In pMDIs, CFCs not
only had a functional purpose, they also had an interaction with the drug
and the crucial metering components. This meant that exemptions were
granted, to allow pharmaceutical and device manufacturers time to identify
and make the changes necessary to provide stable, effective medication
with the new propellants. As it happens, these HFAs are now in turn being
phased out, as the Global Warming Potential (GWP) of some of them is
many times higher than that of CO2
.
With a growing awareness and concern for the environment among
all industries, medical device developers should begin considering how
to move towards an increasingly sustainable future. Some sustainability
decisions may be driven by trickle-down effects from other industries,
such as the drive towards plastics made from sustainable feedstocks or
improvementsinreprocessingandrecycling.Otherchangesmaybedriven
by corporate strategy, such as moving towards low-impact business or
utilising a lower impact product as a marketing tool. The increasing push
for lower impact treatments, as has been requested by the UK National
Health Service (NHS) and some insurance providers, could also increase
themarketformoresustainabledevices.Insuchcases,amoresustainable
generic device may be desirable for its reduced environmental impact,
as well as potentially lower costs. In addition to these drivers, there is a
strong belief that changes towards more sustainable practices will also
be driven by future regulatory requirements; so companies should begin
looking at how to start implementing these now.
Existing guidance for sustainable business practices
Although there is currently no industry standard specific to medical
devices, there are other business practices and guidance which companies
can utilise. As its title (Guidance on Social Responsibility) suggests, BS EN
ISO 26000:20202 offers guidance on the principles of social responsibility.2
It is compatible with the 17 UN Sustainable Development Goals (SDGs).3
These goals were adopted in 2015 by member states of the United
Nations, with the aim of “ending all forms of poverty, fighting inequalities
and tackling climate change while ensuring that no one is left behind”
by 2030. These are an ideal guide for environmental social governance
(ESG) programmes for all organisations worldwide. ISO 26000:20202
aims to help an organisation maximise its contribution to sustainable
development, although it’s important to note it is a voluntary standard only
and does not offer any certification or accreditation.
Before an organisation can decide where it wants to be, it should
start by taking stock of its current practices and measures and assess
where it is on this journey. Independent assessment houses will audit
files and generate sustainability ratings based on ISO 26000 and the
global reporting initiative (GRI).4
The GRI itself was the first of many ESG
reporting frameworks and it can be used separately as a framework to
prepare sustainability reports based on its standards. These reports
will provide an organisation, as well as its board and clients, if they
wish to share it, with clear and concise results and metrics, alongside
Planning for the future:
sustainable medical devices
AUTHOR
Alastair Willoughby, Head of Mechanical Engineering, Team Consulting, Cambridge, UK
KEYWORDS
Medical devices, sustainability, life cycle assessment, ISO 14040, medical device connectivity, carbon footprint
ABSTRACT
Pharmaceutical and medical device companies are increasingly looking at new ways to incorporate sustainability into their strategies in a bid to
help the environment. While existing medical device standards do not address sustainability explicitly, ISO working groups and others are now
considering sustainability as an important component of medical device development. The heavily regulated world of medical devices will likely
see sustainability standards emerging in the next decade.
To ease compliance with sustainability regulations introduced in the future, medical device developers should start building sustainability
into their device designs and change business practices today. Achieving this will involve evidence-based sustainable decision making, as well
as incorporating sustainability engineering as an integral part of the product development process.
This article will consider some of the tools pharmaceutical and medical device companies can utilise today to start planning for more
sustainable outcomes. It will explore the use of Life Cycle Assessment (LCA) as a method for understanding the carbon footprint of drug delivery
systems, considering how to weigh the environmental impact of added complexity against the potential benefits this can bring. It will also
consider how sustainability needs to be addressed at all levels, from device design through to business practices and more.

2. GREEN PHARMA FOCUS
www.topra.org Vol. 19, No. 4, April 2022 | REGULATORY RAPPORTEUR | 7
measurable evidence of innovation, impact and scalability. They can also
assist organisations to assess the performance of their suppliers and
provide performance improvement tools for supply chains.
Sustainability tools businesses can use today
We don’t know what changes will be mandated in the future, which raises
the question of what device developers can do in the short-term to best
position themselves and their products. Device developers should engage
with the regulators and keep a careful eye on what is being discussed in
industry knowledge- sharing forums, while also moving their own processes
and products towards a more sustainable future.
There are many tools that companies can employ to support this, such
as a green file to document sustainability metrics and decisions, as well
as life cycle assessments (LCAs) to understand the impact of products
and where improvements can be made.
Creating a “green file”
As both regulations and company policies begin moving towards green
initiatives, it will become crucial for device developers to demonstrate
the steps taken to minimise their environmental impact. This is already a
common practice when documenting risk management in medical device
development. Companies should focus on developing internal processes
and standard data formats for recording sustainability considerations.
These are likely to be relatively open and based on initial assumptions
Figure 1 LCA of a simple pre-filled syringe needle safety system (1mL)
Figure 2 LCA of an autoinjector (1mL)

3. FOCUS GREEN PHARMA
8 | REGULATORY RAPPORTEUR | Vol. 19, No. 4, April 2022 www.topra.org
but will help engage internal stakeholders with the continual evaluation
needed during the development process.
Implementing a green file will allow medical device developers to make
informed decisions and gather the background data needed to realign their
development process with sustainability, as well as business goals.
Using life cycle assessment
The LCA methodology is an effective tool for systematically evaluating the
carbon footprint of device technologies, which may contain many different
materials and use various manufacturing methods. It is a relatively simple
process that can be effectively implemented into a development process,
to help drive environmentally sustainable decision-making and strategies.
By using an LCA, medical device developers can effectively compare the
sustainability of different parts and suppliers, allowing them to opt for the
option with the least environmental impact where possible. In particular,
LCA can offer valuable insights into the carbon footprint of add-on features,
such as device connectivity, which are typically not essential for the device
to perform its core function. This can enable device developers to compare
the carbon costs of such features, against the benefits they bring.
The ISO 14040 standards set out a methodology for performing an
LCA, following four main phases5
: goal and scope definition; inventory
analysis; impact assessment and the interpretation phase. An LCA can
be deployed at various stages of a device development or the selection
process, allowing key decisions to be made at important milestones and
phase exit points. A cradle-to-grave LCA, also known as a full LCA, will
consider the development stages of each component, from raw materials
extraction to materials manufacture, product manufacture, transport and
usage, and disposal/waste.
The results of an LCA, amongst other outputs, can be used to provide
an estimate of the carbon footprint of each device component. Carbon
footprint is defined here as the measure of carbon dioxide (CO2
) and other
gases that accumulate in the atmosphere and impact the earth’s average
temperature. The results can be provided in grams of CO2
equivalent (g
CO2
-eq), which is determined by analysing the sum of each greenhouse
gas (GHG) emission in the process.
How LCA results can be used
To help understand how LCA results can be used, figures 1, 2 and 3 show an
example of an LCA with a limited scope implemented by Team Consulting
on three parenteral devices of varying complexity. The devices covered
in the analysis included a simple pre-filled syringe (1mL), an autoinjector
(1mL) and a connected autoinjector (1mL). Although this analysis has
been conducted on theoretical models, the components included in
the assessment are based closely on existing devices of their nature. To
determine the environmental impact of producing a medical device on its
own, the analysis focuses on the manufacturing of the various mechanical,
primary pack and electrical components of the different devices, while
excluding the drug formulation.
The pre-filled syringe in figure 1 is made up of eight components
(including the primary container and needle). It is made from a mixture
of polymers such as polypropylene (PP) and polycarbonate (PC), as well
as a spring, glass, needle and plunger materials, with a total weight of
8g. The LCA results show a total carbon footprint of 47.9 g CO2
-eq. Here,
the mechanical parts comprise most of the carbon footprint of the device
(87%), while the primary pack and needle make up the remainder (13%).
Moving on to an autoinjector, as depicted in figure 2, the overall carbon
footprint increases to 127.4 g CO2
-eq, which is ~2.5 times greater than
the simple pre-filled syringe. The autoinjector is made of 14 components,
including the primary container and needle, at a total mass of 35g. Once
again, the mechanical parts comprise most of the carbon footprint (95%),
compared to the primary syringe pack (5%).
When adding a connectivity module to the same autoinjector, in figure
3 we can see the total carbon footprint more than triples for the device
components, reaching 410.3 g CO2
-eq. Of the ten added components
in the connected module, the bare printed circuit board (PCB) has the
greatest carbon footprint at 151 g CO2
-eq.
Clearly, adding connectivity to a drug delivery device can greatly
increase its carbon footprint. Adding even a relatively small PCB in this
example has increased the carbon footprint by more than all the basic
autoinjector components combined. Although this offers a useful insight
for device developers wishing to understand the environmental costs of
Figure 3 LCA of connected autoinjector (1mL)

4. GREEN PHARMA FOCUS
www.topra.org Vol. 19, No. 4, April 2022 | REGULATORY RAPPORTEUR | 9
varying device complexity, it is important to note this only comprises part
of the sustainability question.
Sustainability trade-offs
Though it is clear that adding complex components, such as connectivity,
can increase the carbon footprint of a medical device development, this
needs to be weighed against the potential benefits these features can
bring. Device connectivity and companion apps offer several benefits,
both for users and device developers. They can gather a wealth of data
on device usage to understand patient behaviours, while also supporting
users in onboarding and tracking their medication. Connected devices also
have the potential to help improve patient adherence, something which
can have a direct impact on the environment itself.
The World Health Organization (WHO) has estimated that only 50% of
patients successfully take their medication as prescribed.6
This can have
a direct impact on the environment, due to the overuse of both medicines
and devices, as well as an indirect impact, if conditions are poorly
managed and patients end up in hospital. In 2019, it was estimated that
the NHS in England produced 25 megatonnes of CO2
-eq, 24% of which
came from the direct delivery of care.7
Some studies have already shown
a significant reduction in environmental impacts, due to improvements in
patient management via the use of a connected device.8
Conclusions
More research is certainly needed in this area to help pharmaceutical and
device developers make sustainable decisions in their device development.
By using the LCA methodology, they can determine the direct carbon
footprint of their own development and weigh this against other factors.
Preparing for upcoming standards will involve evaluating,
implementing, measuring, auditing, reporting on and improving
sustainability practices. Although this will take time and effort, the drive
to achieve a more sustainable future will ultimately give a competitive
advantage and help pharmaceutical companies and device developers
to remain compliant in the long-term. The key now is for companies to
use the tools available to them, to determine what their sustainability
priorities are and the roadmap to get there.
References
1. United Nations Montreal Protocol on Substances that Deplete the Ozone Layer
Montreal, 16 September 1987. Available at: https://treaties.un.org/Pages/ViewDetails.
aspx?src=IND&mtdsg_no=XXVII-2-a&chapter=27&clang=_en (accessed 21 February
2022).
2. Guidance on social responsibility. BS EN ISO 26000:2020. Available at: https://www.
en-standard.eu/bs-en-iso-26000-2020-guidance-on-social-responsibility/ (accessed
21 February 2022).
3. United Nations Sustainable Development Goals: Department of Economic and Social
Affairs. Available at: https://sdgs.un.org/goals (accessed 28 January 2022).
4. The global standards for sustainability reporting. Available at: https://www.
globalreporting.org/standards/ (accessed 28 January 2022).
5. International Organization for Standardization. ISO 14040: 206: Environmental
management – Life cycle assessment – Principles and framework. Available at:
https://www.iso.org/standard/37456.html (accessed 28 January 2022).
6. World Health Organization: Adherence to long-term therapies: Evidence for action
2003. Available at: https://www.who.int/chp/knowledge/publications/adherence_
report/en/ (accessed 28 January 2022).
7. Tennison I, Roschnik S, Ashby B et al. Health care's response to climate change: a
carbon footprint assessment of the NHS in England. The Lancet Planetary Health.
2021 Volume 5, Issue 2. https://doi.org/10.1016/S2542-5196(20)30271-0
8. Digital Adherence Monitoring in Poorly Controlled Paediatric Asthma, AstraZeneca,
Adherium. Available at: https://shcoalition.org/wp-content/uploads/2021/02/
SmartInhaler-AZ-Case-Study.pdf (accessed 28 January 2022).