Preparing for the future of device contract manufacturing
At Bespak, we provide contract manufacturing services for drug delivery devices at any scale under one roof, specialising in inhalers. Our services are fully integrated, from analytics, device design and development, and rapid prototyping through to clinical and commercial supply. The needs of the industry are not static, however. That’s why we keep a close eye on the latest developments in device contract manufacturing. As the industry evolves, we aim to apply our outstanding track record, strong New Product Introduction (NPI) process and industry-leading capabilities to support the supply of innovative, life-saving devices now and into the future.
How device contract manufacturing is evolving
Industry 4.0 is a huge trend across all areas of manufacturing, encompassing connectivity, advanced analytics, automation, and advanced manufacturing technology. In the pharmaceutical industry, including in device manufacturing, there is a push towards digitalisation that can enable traceability throughout the whole value chain, enhancing regulatory compliance. In addition, digitalisation will also enable AI-driven data analytics and operational improvements that can ultimately increase efficiency, enhance quality and reduce costs.
Beyond this, new manufacturing technologies are extending what is possible in device manufacturing. As a result, we are seeing increasing performance requirements for complex devices. For example, with the introduction of more complex materials, additive manufacturing and advances in injection moulding, there are many more considerations in the manufacturing process than ever before.
Supply chain resilience is also coming into increasing focus. ‘Nearshoring’ is a key aspect of this, reducing the size of supply chains and bringing them closer to point of use. This is driven both by geo-political concerns and recent experience of natural disasters impacting supply chains. Efforts to mitigate risk can extend to the selection of materials based on the resilience of their supply chains. In addition, sustainability initiatives drive us towards minimising emissions by reducing transportation and the resultant packaging, simplifying the supply chain as much as possible.
Finally, environmental sustainability is an almost universal trend that creates new pressures and opportunities for device manufacturers. We have implemented ESG (Environmental, Social and Governance) initiatives across Bespak, and we are starting to build these strategic principles into our NPI process. Going forward, we anticipate that sustainability of materials will be as much a consideration for selection as performance.
Challenges in DPI manufacturing
Dry Powder Inhalers (DPIs) are one of the key platforms for which we offer contract manufacturing services, and for which we are very well known and respected. It’s a well-established device format, but there are still challenges associated with the manufacture of DPIs. In response, there is a need for innovation to continue improving these inhalation devices.
Some of the challenges arise due to the powder formulation – for example, achieving the right consistency, uniformity and moisture levels to enable drug delivery performance. The device itself can also be complex, requiring mechanisms that will deliver the correct dose whilst maintaining the integrity of the formulation. DPIs also need to be functional for a broad range of users. Factors including age, strength and dexterity, combined with lung conditions such as COPD, impact the patient’s coordination and therefore ability to use the device. Beyond patient-centricity, the device and formulation must be stable across the lifetime of the product – which can consist of up to 60 doses over a one-month period – even when exposed to changing storage and usage conditions, such as moisture and temperature. Finally, regulatory compliance is a key pressure when manufacturing DPIs, as requirements for reliability and demonstration of performance are evolving.
Beyond these challenges, patient considerations can require a more modern take on design and therefore updated manufacturing processes. There has historically been stigma associated with using inhalers in some cultures, so increasingly compact and easily portable devices are in demand, which must be factored in during both design and manufacturing. Similarly, increasing ease of use and tailoring devices to best meet patient needs is an ongoing process. Smart devices that can improve patient adherence are also an area of interest – however, additional functionality must always be balanced with cost. Finally, sustainability pressures are becoming stronger for DPIs in accordance with the wider industry trend towards ESG drivers, but so far this has not translated into direct changes for DPIs. Whilst there aren’t any major movements towards reducing the DPI environmental footprint yet, CDMOs that have built sustainability into their supply chains will be well placed to adapt to future needs.
Key considerations for contract manufacturing
Evolving trends and advancing technologies will open up new possibilities for the contract manufacturing of DPIs and other inhalation devices, but there will always be typical, long-standing considerations that drive decision-making.
As discussed, sustainability is an additional benefit rather than a firm requirement for most drug product developers in this space currently. Cost and time-to-market are fundamental drivers of commercial success, so customers will look for a partner that has all the capabilities they need in-house to shorten timelines, with a track record of meeting unit and project costs. Quality and reliability are also core necessities in the DPI contact manufacturing space.
Regulatory challenges are also a concern when bringing a new device to market. This leads developers to look for an experienced partner that can provide support with submitting the appropriate documentation and securing approval from the relevant authorities.
Bespak is well positioned to address all of these factors, with a long track record in the contract manufacture of billions of commercial inhaler devices, and expert capabilities in DPIs, SMIs and more. Additionally, a core principle at Bespak is that we are a partner for every small step and every giant leap — meaning we partner with our customers for the long term. Using our specialist industry understanding, we can align with customers’ needs, and act as a strategic partner that focuses on helping our partners achieve their goals.
Looking ahead
There are a variety of trends and challenges shaping the device manufacturing landscape, but what does that mean in practice for the next 5-10 years? It seems clear that, when looking at the future of the industry, we can expect changes to both the devices themselves and to wider manufacturing practices.
The trend for connected technologies will likely continue. As more connected devices are produced, more complex data management and integration of the connected aspects in devices will be required, driving further development. These advances won’t be prioritised over cost unless in applications with a clear health economic case, so it will be interesting to see how the balance evolves. Additionally, more complex formulations will be needed to better address specific diseases, which in turn will require more complex devices and innovative delivery methods to be developed in tandem.
In terms of broader attitudes and approaches, sustainability will likely gain weight in decision-making. This might lead to measures such as more careful choice of materials used, reduction in device size, reusability, recycling, and deeper consideration around sourcing and supply chain strategies.
In the context of a more connected world better adapted to patient needs and sustainability initiatives, contract manufacturing has an exciting future ahead. At Bespak, we are aiming to channel our capabilities towards meeting the evolving needs of the industry in a single offering. We have the track record and current expertise in the production of inhalation devices that allows us to adopt new approaches and incorporate new technologies. And beyond this, our wider sustainability initiatives mean that we are already considering the environmental footprint of our processes and supply chains, so that we – and our partners – can help to minimise our impact.
Get in touch to discover how we can help you reach your device manufacturing goals now and into the future.
