In 2016, the Kigali Amendment to the Montreal Protocol set a clear global ambition to phase down the use of hydrofluorocarbons (HFCs) and reduce their environmental impact. For the inhalation industry, this marked the beginning of a major transition towards low Global Warming Potential (GWP) propellants; a shift that continues to demand new manufacturing capabilities, reformulation strategies and significant long-term investment.
A decade on from the amendment, expectations placed on the pharmaceutical sector has intensified. Time-to-market pressures are increasing, regulatory frameworks are evolving, and sustainability is no longer viewed as a future objective. Instead, it has become a defining factor in how drug-device combination products are designed, developed, manufactured, supplied and used.
Against this backdrop, innovation can no longer happen in isolation. Device design and development increasingly require the intelligent application of digital technologies, such as AI-enabled modelling and simulation, combined with meaningful collaboration across industries facing similar engineering, manufacturing and sustainability challenges.
Sustainability as an industry imperative
As the inhalation industry’s green transition drives on, sustainability is no longer a ‘nice to have’. For developers of drug-device combination products, sustainability is now an expectation from regulators, customers, investors and patients alike; its influence extends well beyond environmental considerations alone. Sustainability is intrinsically linked to supply chain resilience, helping to ensure continuity of access to essential medicines even in the face of disruption. It also encompasses patient usability and adherence, as well-designed devices reduce wasted doses and support better clinical outcomes. In parallel, sustainability is closely tied to regulatory readiness, particularly as expectations around environmental impact continue to grow. Finally, it influences scalability and cost, since inefficient designs tend to amplify waste, risk and expense as products move to higher-volume manufacture.
Ideally, embedding sustainability into drug delivery device design means making better decisions earlier. Choices around materials, component tolerances, ergonomics, manufacturing processes and logistics all have downstream consequences. Retrofitting sustainability late in development is costly and inefficient, whereas designing it in from the outset is far more effective.
However, modern inhaled and nasal drug-device combination products are highly complex systems. Small design changes can have disproportionate effects on performance and manufacturability. Historically, generating the evidence needed to support confident decision-making has relied on extensive physical prototyping and testing, bringing cost, time and material waste. This is where AI-driven modelling, simulation and collaborative innovation are proving transformative.
Reducing physical testing and material waste through simulation
AI does not replace scientific expertise or engineering judgement. Its value lies in how it is applied, enabling teams to explore broader design spaces, understand complex interactions and make better-informed decisions faster and with fewer physical resources. Human expertise remains essential to define the right questions, build credible models, validate outputs and ensure results are meaningful, compliant and aligned with patient needs.
From a sustainability perspective, the impact of modelling and simulation is significant. Digital optimisation reduces reliance on physical prototypes and repeated experimental testing, lowering material and energy consumption while shortening development timelines and reducing cost.
This is particularly important as the inhalation industry transitions to low carbon solutions. Reformulation and device or componentry redesign introduce uncertainty. AI-enabled simulation allows risks to be explored and mitigated digitally, optimising aerosol generation, plume characteristics, deposition behaviour and device durability before physical trials begin. It also supports the development of refillable or multi-dose systems that reduce single-use components and packaging.
Beyond optimisation, modelling and simulation unlock new routes to innovation. Emerging delivery approaches, such as nose-to-brain administration or nasal vaccines, demand exceptional control over aerosol characteristics and deposition. These challenges are well-suited to in silico exploration, enabling higher dosing efficiency, reduced waste and improved patient outcomes.
Case study: pMDI valve optimisation
Bespak has extensive experience applying advanced modelling and simulation to respiratory devices and components, and few areas illustrate the connection of sustainability and manufacturing variability more clearly than the pressurised metered dose inhaler (pMDI) valve. These valves must deliver accurate, consistent doses while protecting formulations from moisture, yet they are highly complex assemblies with many interacting elements. Each design involves a large number of interdependent inputs; all subject to manufacturing variability and collectively influencing multiple performance outputs. Exploring this complexity through physical testing alone would be time-consuming and resource-intensive.
To address this, Bespak adopted a simulation-driven approach that combines finite element analysis with statistical learning to build a detailed understanding of valve behaviour and sensitivities across the full design space. This methodology enabled the team to identify the parameters that most strongly influence performance, assess the impact of manufacturing tolerances and adapt designs to meet new customer requirements, without extensive physical testing. Once the design space was established, the workflow became highly automated, allowing digital adjustments to be made and their impact on performance assessed rapidly.
The outcome was a more efficient development process, reducing time, cost and reliance on human resources while maintaining quality. Manufacturing waste was reduced by identifying where tolerance limits could be refined safely, without compromising device performance. More targeted design of experiments further reduced the need for manual testing and physical prototypes.
By virtual exploration replacing physical exploration, the use of up to five tonnes of plastic was avoided, and validation against real manufacturing data showed strong alignment, providing confidence in the models’ predictive capability. This work was shared at the Ansys Leaders in Simulation Summit, where Bespak engineers exchanged insights with peers from sectors including aerospace, motorsport and heavy machinery.
The role of design houses and cross-industry thinking
Sustainability is a collective challenge, and no single organisation can address it alone. While digital technologies are powerful, they are most effective when combined with diverse perspectives. Design houses play a valuable role in this ecosystem. Drawing on experience from varied sectors, design houses bring multidisciplinary expertise, lateral thinking and a strong design-for-manufacture mindset. Fostering diversity of thought and fuelling creativity, design houses facilitate idea generation that pushes beyond traditional approaches and explores new solutions for patients and the environment alike.
Bespak collaborates closely with various design houses, where there are exceptional engineering depth and world-class facilities. Many have academic origins and operate at the intersection of research and industry, with capabilities spanning innovation labs, pilot plants, human factors testing and market research. By combining their early-stage concept generation with Bespak’s modelling, simulation and manufacturing expertise, a truly synergistic approach to innovation can be explored. For example, design house concepts for sustainable inhaler materials can be rapidly assessed and optimised using Bespak’s in silico modelling expertise, creating a pathway from innovative idea to scalable, patient-ready product.
Beyond helping to refine component or device design, design houses bring sustainability approaches from consumer industries that pharma has not traditionally adopted, such as lightweighting, modular design, improved material choice, recyclability or design-for-disassembly. For example, a design house may assist in improving product sustainability by suggesting design modifications that enable recycling or reduce mass to lower the carbon cost of transportation. They may also provide logistical insight into the use of different materials. By pooling cross-industry knowledge and diverse perspectives to tackle these complex challenges effectively, sustainable practices can become a reality.
Regulatory evolution and in silico evidence
Strengthening existing partnerships and building new networks is a strategic priority for Bespak, and these collaborations help the organisation stay ahead of emerging technologies and trends. Additionally, regulatory frameworks are evolving alongside technology. Authorities are increasingly exploring how validated in silico evidence can support submissions for complex drug-device combination products. Bespak contributes to this evolution through its involvement in the UK Centre of Excellence in In Silico Regulatory Science and Innovation (UKCEiRSI), helping to shape best practice for the use of modelling and AI in regulated product development.
Greater acceptance of digital evidence has profound sustainability implications: reducing physical testing, accelerating timelines and lowering the environmental impact of bringing new medicines to market.
Designing the future together
As sustainability expectations rise and patient needs evolve, the drug delivery industry must continue to rethink how products are designed, developed and delivered. AI-enabled modelling and simulation will play an increasingly central role, embedding sustainability from conception while optimising existing offerings to remain viable, compliant and accessible. But technology alone is not enough. Meaningful progress depends on collaboration between CDMOs, pharmaceutical companies, design houses, regulators and academia.
At Bespak, sustainability by design underpins our approach to innovation. By combining digital engineering with human expertise and cross-industry partnerships, we are helping our customers to navigate complexity, reduce environmental impact and deliver better patient outcomes worldwide.
Sustainability is no longer optional. It is how the future of inhaled and nasal drug delivery will be built.
Author bio
Alan Harris, CTO Bespak, is a seasoned technical leader with over 25 years of experience in respiratory product development and manufacturing across innovator and generic pharmaceutical organisations. He most recently served as Senior Director of Global Technical Services for Respiratory at Viatris, where he led global technical oversight for externally manufactured respiratory products. Alan has held senior leadership roles at Respirent Pharmaceuticals, Cipla, Mylan, and GSK, bringing deep expertise in product development, technology transfer, and regulatory compliance.
