Miles Kottman, head of commercial, Bespak shares key considerations for patient-centric inhalation device manufacture.
Bespak
Developing inhalation devices means maintaining a delicate balance between innovation, cost, complexity, and time to market. Against that backdrop, patient-centricity is an important consideration. Shortfalls in comfort and convenience, and the need for training on complex devices all contribute to poor adherence. For patients, the impacts can be concerning, potentially leading to reduced symptom control, more hospitalisations, and increased costs.
As a result, patient-centricity is more than just a checkbox. It should be woven holistically into the entire development and manufacturing process, with the aim to improve the lives of patients.
A personalised approach to device design
A more personalised approach to device design and manufacture is in demand. This is driven by several factors. Firstly, patients and caregivers are increasingly in control of treatments, especially in home care settings –– making usability non-negotiable. Digital health and data capture are also on the rise, illuminating more personalised care pathways and placing greater demand on devices to provide the support needed.
The first step is understanding that there is no one-size-fits-all solution for patient challenges. Patient-centricity should consider diverse patient backgrounds, capabilities, and routines. For example, elderly patients or those with limited dexterity, weaker inspiratory flow rates, or cognitive disabilities each require device designs that remain effective in their specific situations. Looking beyond ease-of-use, there is also in certain cases some historic stigma attached to inhalation device use. This leads patients to search for more discreet options that pack the same therapeutic efficacy into smaller, sleeker device designs.
Designing a patient-centric device
A common question is: when should patient-centricity be brought into inhaler development and manufacturing? The answer is simple. Patient-centricity should be considered from the very start of the design process. Early incorporation reduces costs and avoids reactive problem-solving and late-stage changes further in development. How to proceed will depend on device type – whether the project is a pressurised Metered Dose Inhaler (pMDI), dry powder inhaler (DPI), or a soft mist inhaler (SMI).
Each device type has characteristics that make them better suited to different patient demographics. For example, classic press-and-breathe pMDIs require coordination between actuation and inhalation, which could make them less suited for patients with cognitive disabilities. DPIs require less coordination but, to be effective, patients must have the required inspiratory flow rate, as the efficacy of DPI delivery depends on how effectively medication can be inhaled. In addition, the loading and priming of some DPIs, particularly capsule-based systems, can prove challenging for some patients, leading to incorrect use. SMIs lie somewhere between pMDIs and DPIs but are typically more complex to prime for use – this can be a multistep process, again posing challenges for patients with cognitive disabilities or dexterity challenges.
From a manufacturing perspective, there are also different considerations depending on device type. For pMDIs, ensuring reliable valve performance and actuation force is critical. DPIs, on the other hand, require consistent powder dispersion across varying inhalation profiles, and typically also need an intuitive open, inhale, shut mechanism to prepare the next dose. SMIs, meanwhile, involve intricate mechanisms to control spray/mist generation.
Whichever device is chosen, it must accommodate a wide range of user behaviours without compromising on dose delivery or accuracy. Human factors engineering, which takes into consideration the intended patient populations, their challenges and limitations, is helpful to set the scene from the outset. When this data has been gathered, virtual simulations can be helpful in the initial stages of device design to streamline effective prototypes. Further down the line, precision moulding and assembly capabilities can ensure complex devices are manufactured to high standards within the required tolerances. No matter what, across the board, the goal is for technically complex devices to feel effortless to the user.
Beyond ergonomics: sustainable device design
Another key consideration is sustainability. A truly patient-centric device should be developed with a holistic approach to enhancing patient health and wellbeing. Pollution is a major contributor to respiratory disorders, such as asthma and chronic obstructive pulmonary disease (COPD). Added to that, patients increasingly care not just about whether a product works, but how it is made and the impact it has on the world they live in. From a design and manufacturing perspective, reducing carbon footprint, selecting recyclable materials, and minimising waste all align with the broader goal of enhancing health –– for individuals and for the planet.
More efficient manufacturing and reduced waste are key, but most importantly, by ensuring suitability and usability, a patient-centric approach will facilitate greater patient adherence to treatment regimens. This ultimately leads to fewer hospitalisations, and that too has a positive effect on the environment, with reduced travel to and from hospitals and less use of carbon-intensive hospital resources.
Support by a CDMO partner
Outsourcing allows pharma companies to tap into specialist expertise. The ideal partner should offer simulation and modelling for device optimisation, clean room manufacturing facilities, and a track record in high-precision moulding and automated assembly. Beyond that, a CDMO with experience in user-centred design development, materials science, concept development and regulatory pathways will accelerate product development while de-risking critical stages on the way to market.
Beyond in-house capabilities and expertise, a shared vision and values are also vital. The right partner should be proactive in challenging assumptions, advocate for the end-user, and bring integrated capabilities — from early-stage design through to scale-up for manufacturing. Experience across different platforms, a strong quality culture, and genuine collaboration all contribute to an enhanced device design.
A specialist CDMO, such as Bespak, will combine experience in human factors engineering, sustainability, and combination product compliance — all of which are crucial for patient-centricity. For instance, Bespak proactively conducted human factors studies for a proprietary unit dose nasal spray device. The research supported the design of a spray nozzle that was comfortable for the target user groups, confirming that two different nozzle designs should be considered to meet adult and paediatric user requirements. By leveraging expertise across patient-centric device design and incorporating insights from human factors engineering, experienced CDMOs can help to more effectively tailor devices to meet patient needs and enhance outcomes.
Charting a course for success
While usability is often the first feature that springs to mind, a truly patient-centric design should go further by ensuring precise, sustainable design and manufacture. A specialist CDMO partner with end-to-end expertise can prove instrumental in designing a device that falls within project manufacturing constraints while ensuring the best possible outcome for patients and for the planet.