Inhalation Devices
We have a strong track record in the field of inhalation device development. Our work has helped to create innovative inhalers and delivered significant success for our clients in this device area.
Our design, analysis and development experience with global pharmaceutical and device companies includes dry powder inhalers for asthma, COPD and inhaled insulin, pressurised metered dose inhalers, breath actuated inhalers, soft mist inhalers, connected devices, mechanical dose counters, and regimen assurance devices.
Our work has helped to create innovative inhalers and delivered significant success for our clients in this area
Delivering DPIs
Dry Powder Inhalers are amongst the most complex of drug delivery devices to develop and industrialise successfully. Achieving a device that performs consistently across real-world operating environments, copes with widely variable patient capabilities and functions correctly in all component tolerance combinations requires significant expertise. This requirement is magnified by the need to manufacture economically in very high volumes.
DCA has significant design and development experience in the this area. Our approach is to understand and demonstrate the performance of foundational design elements as early as possible in development. We use a broad range of tools including mathematical and computational modelling, rig and prototype manufacture, testing, tolerance analysis, risk analysis and user research to inform and guide design decisions.
Our DPI design and analysis work with global pharmaceutical companies include devices for asthma, COPD and inhaled insulin.
Dual-drug inhalers
Combining two or more drugs that are delivered simultaneously from a single device can bring benefits.
As well as new therapeutic opportunities; delivering two or more drugs together from a single device may create advantages for user compliance and cost effectiveness.
Work undertaken at DCA helped to provide foundational concepts and technical evidence that underpin the first commercially available combination drug dry powder inhaler. This work included the development of a mathematical model and early design verification to understand the lid foil compensation mechanism for this device.
pMDIs that count
In the generic world of pressurised Metered Dose Inhalers, commercial advantage can be found in the details.
Features such as a simple, reliable dose counters that are easy to read, removable mouthpieces that makes the device easy to clean, or breath actuation mechanisms that improve inhalation technique, can provide important advantages in a crowded market place.
Our technical creativity and broad experience in developing robust, high-volume drug delivery devices gives us the perfect blend of skills to support the development of devices that create advantages in cost constrained markets.
In the generic world of pressurised Metered Dose Inhalers, commercial advantage can be found in the details
Competing in generics
Creating a competitive generic inhaler is not simply about the reference product. Whilst the format, performance and user interface must match the reference as closely as possible, there is typically an array of technical challenges that come with this. For example, unexpired patents may need to be avoided, or the reference product may have been designed in a way that brings functional and manufacturing issues to address.
Designing devices that can be industrialised swiftly and manufactured efficiently and very economically is particularly important for generic markets. We bring exceptionally broad development experience and deep knowledge of design for manufacture and assembly to help improve the probability of success in generic device projects.
Computational modelling
Intelligent use of mathematical and computational modelling techniques helps us to iterate towards better designs, faster.
Our design work is informed by theoretical analysis and we typically start by assessing ideas and concepts using first-principle mathematical models. This helps to rapidly screen out potential problems and identify the concepts that have inherent advantages.
As design details develop, we turn to class-leading software tools to help predict performance and improve our understanding. Whilst tools such as FEA and CFD have become invaluable, the insights they provide are only as good as the assumptions they build from. We therefore deploy a carefully balanced combination of prototyping, physical testing and computational analysis to validate assumptions and work efficiently towards optimised designs.
Connected inhalers
As sensor technology and connected infrastructure has developed, the opportunities to improve the real world performance of inhalers have become more compelling.
Today we have the potential to cost effectively monitor not just dose delivery and timing, but also parameters such as: air flow rate, device orientation and impact forces. We can also manage dose availability and access, as may be relevant to controlled drugs. Such device information can be used, together with other available supporting data, via an App, to help coach and encourage patients towards better practice, ultimately aimed at improving therapeutic outcomes.
Integrating connected features with an inhaler takes significant multidisciplinary skills and expertise. Care is needed to ensure that events are captured reliably and that product size, usability, cost, robustness and lifecycle are appropriately balanced. We are the multidisciplinary partner that can help deliver your connected inhaler with confidence.
We are experts at integrating the electronics and software needed to make devices work effectively and efficiently within growing digital ecosystems
Connected ecosystems
The digital revolution is rapidly changing what is possible in healthcare. New connected devices and companion apps create opportunities for patients to participate more profoundly in managing their own health, and to interact with healthcare providers more effectively.
But these opportunities will only be realised where patient engagement is encouraged and maintained by smart devices and apps that are relevant, intuitive to use and do not place additional barriers in the way.
We have a deep understanding of the connections between drug delivery devices, instructions for use, companion apps, websites and packaging. We are experts at embedding human factors into device ecosystems, following the principles of IEC62366 and drawing from a diverse toolset and skills base to ensure insights are captured early and leveraged efficiently.
Testing and development
The ability to execute tests in a repeatable way is fundamental to successful inhalation device development.
Through years of experience, we have become expert at developing methods for evaluating the performance of new drug delivery devices. Throughout our device development programmes we use statistical methods to help define sample sizes and analyse test results. This approach helps to ensure that no surprises arise during Design Verification.
Our in-house test laboratory is well equipped with qualified and calibrated equipment for performing a wide range of inhaler and spray performance evaluation. We also work with external laboratories to execute specialist tests and comprehensive evaluation programmes.
Design for automated manufacture
We have a wealth of experience in this area, gained across multiple drug delivery platforms and fast-moving consumer products.
Many of the devices we have designed are manufactured using very high-cavity moulding tools and high-speed automated assembly cells. Designing components that can be efficiently produced in this way requires detailed knowledge of process requirements and equipment limitations. This understanding needs to be accommodated within device designs at a conceptual level, so that appropriate balance is achieved with other requirements.
Our approach is to prototype key manufacturing and assembly process steps as early as possible during development. This typically involves us in designing, manufacturing and evaluating the performance of prototype assembly nests, feeding systems and controlled assembly stations.
Creating devices that can be manufactured efficiently in high volume brings design constraints that require significant know-how to navigate successfully
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