Pharmaceutical drug delivery
Are you looking for a design partner with a proven track record and a thorough understanding of how to deliver robust and clinically effective devices, that patients really value?
Our device design experience spans all major drug delivery routes, including:
Connected drug delivery
As diagnostic and monitoring techniques advance, healthcare professionals gain insights into their patient’s condition and how this is trending. But since most medicines are self-administered and compliance is often sub-optimal, it is important to understand how reliably an existing regimen is being followed before determining the direction of ongoing therapy. This is one important driver for connected drug delivery, and there are many others.
Connectivity can encourage patients to track their own medicine usage and so improve confidence and compliance. It should also increase the competitiveness and flexibility of the pharmaceutical industry.
What should you consider?
The technological eco-system now exists to monitor drug delivery devices reliably and unobtrusively. Low-power communication technologies such as BLE and NFC can provide ideal routes to transfer data, but there are many considerations and some pitfalls to avoid when determining how to connect a device.
Economics is a fundamental consideration, since any impact on device cost must always be justifiable against the value being added. This, in turn, leads to a complex matrix of considerations that must be carefully weighed when identifying the optimum connectivity solution. Of course, any solution must be assessed within the context of an increasingly complex IP landscape.
Considerable multi-disciplinary skills and knowledge are needed to successfully navigate these issues.
How we deliver connected devices
Our procedures are certified to ISO13485 and aligned with IEC62304, ISO14971, IEC62366 and 21CFR820. We operate a strong matrix structure, which delivers real expertise across each of our disciplines and provides the flexibility and focus needed within all our project teams. Each project is led by a dedicated sector specialist, bringing breadth of experience in medical device development.
This approach allows us to tackle the development of even the most complex and innovative engineering systems with confidence and capability. As experts in the development of physical artefacts for digital eco-systems, we are the multi-disciplinary partners that can help deliver your next connected product.
How sophisticated should your system be?
Many medicines can be self-administered easily and effectively without excessive risk or significant training, but there are always exceptions and these are increasing.
The reasons for this are complex, but they include factors such as:
• Increasing life-spans leading to more complex comorbidities.
• Healthcare providers seeking to improve outcomes, or save money by encouraging treatment at home.
• Intensive therapeutic regimens targeting improved outcomes.
• Access to better information from diagnostics and environment monitors.
For some patients this will create challenges, where the delivery of a therapy is at the limits of their capability and significant risks may result. In this context it can be predicted that we are poised to see an increase in the development of new generations of smarter drug delivery systems.
Mapping your future product portfolio
We anticipate that passive monitoring and communication functions will become augmented with more interactive, ‘smart’ features, capable of recognising patterns and responding to inputs from patients or monitoring devices. These new features may be targeted at improving compliance or technique, assisting in emergency situations or simplifying the management of complex conditions.
Creating a new breakthrough technology is challenging and often requires a series of innovative steps. As technology, strategy and development experts, at DCA we see further ahead than many. This enables us to identify and map out realistic future product scenarios. Our specialist teams work every day to create and inform exciting new development opportunities for our clients over both short and longer timeframes.
Our design and development work in the field of parenteral drug delivery devices is significant.
As one of world’s leading injection device development teams, we bring deep and broad experience to every project we undertake in this area.
(Lyxumia® is a registered brand of Sanofi Aventis).
Our broad experience
DCA’s design and development experience covers almost all injection device types.
With work spanning ultra high-volume disposable pens, reusable pens, connected devices, electro-mechanical systems, autoinjectors, fixed and variable dose delivery, infusion pumps, patch injectors, needle-based and needle free devices, we are proud of our achievements in this area.
(Lyxumia® is a registered brand of Sanofi Aventis).
Globally recognised design
Notable in our portfolio is SoloStar®, a leading disposable pen-injector for insulin.
We partnered Sanofi throughout the development of SoloStar®, applying our rigorous evidence-based approach to all aspects of the design. The result is a device that delivers leading performance in almost every respect. With superior levels of safety and comfort, the pen is sophisticated, yet simple to use.
Since its launch in 2007, SoloStar® has achieved global recognition and huge commercial success.
(Lantus® SoloStar® and Apidra® SoloStar® are
registered brands of Sanofi Aventis).
Where large doses or viscous medications are needed, automating and power-assisting key device functions can improve the injection experience.
The ‘3D’ pen injector was developed by DCA and Sanofi to enable precise delivery of user selectable doses of medicine in single-unit increments, up to a class-leading maximum of 120U. Unlike traditional pen injectors, the ‘3D’ device contains a spring-powered mechanism, meaning that the button does not wind out of the housing when selecting a dose.
With this pen, very large doses can be delivered automatically at the touch of a button. There is no need to adjust hand grip during injection, allowing a high degree of control to be maintained over the device for comfort, convenience and confidence.
A new digital reality
Connectivity is driving important developments in drug delivery, and nowhere more than for injection devices.
As the number of new drugs that are administered by injection increases, the ability to capture dose events, see use data in real time and detect day-to-day changes brings new opportunities. Connected injection devices target improved adherence and outcomes for different patient groups and especially those that may otherwise struggle with compliance.
Together with our clients, we are seeking to close the loop between diagnosis, monitoring and treatment, in order to make lives better every day.
Augmenting an injection device with connected features takes significant multi-disciplinary skills and expertise. Great care is needed to ensure that dose events are captured reliably and that product size, usability, cost, robustness and lifecycle are appropriately balanced. Navigating these issues and selecting the right communications technology are key to success.
At DCA, we are experts at integrating the electronics and software needed to make devices work effectively and efficiently within growing digital eco-systems. We are the multi-disciplinary partner that can help deliver your connected injection device with confidence.
We have a significant track record in identifying, road-mapping and creating new opportunities for drug delivery platforms. Thousands of granted patents and applications are testament to our underlying creativity, which is core to this success.
The picco range of mechanical autoinjectors is one such platform that targets key unmet needs in this increasingly important sector.
Designed as a best in class device with very few components, picco is a simple, robust and fully featured autoinjector. With an exceptionally compact form factor, it is customisable to address the needs of a wide range of applications, dose volume sizes, drug viscosities and user populations.
Wearable injectors offer great potential to deliver new drugs and to improve lifestyles and outcomes for patients.
BD Libertas™ is a pre-filled wearable injector for self-administration of large volume and high viscosity drugs that cannot be delivered with autoinjectors.
Developed with support from DCA, BD LibertasTM is intended to administer high-value biologic medicines in the comfort of an in-home environment. The device combines usability, safety and performance with high levels of manufacturing efficiency.
BD Libertas™ has won two of the world’s most prestigious design awards: the Good Design Award and the iF Award, affirming the quality of its design.
Improving the environmental impact of the products we use every day is a core responsibility of everyone. Robust, reliable, reusable products can offer sustainability benefits over their usage life and is an area receiving increased focus.
AllStar® Pro is a reusable pen injector intended to help people living with diabetes. The pen uses replaceable cartridges, providing a convenient and sustainable option for patients who inject regular doses of insulin.
DCA partnered Sanofi throughout the development of AllStar® Pro, achieving a product that delivers superior levels of quality and performance, with efficient use of materials. The AllStar® Pro was recognised with a prestigious Red Dot design award and a Good Design award.
(AllStar® is a registered brand of Sanofi Aventis).
The AllStar® reusable pen injector shares it’s basic architecture with AllStar® Pro, but has been created especially for the needs of developing markets.
Produced originally for diabetes patients in India, AllStar® provides state-of-the-art features and class-leading performance with a cost efficient design. AllStar® was selected as a finalist in the Medical Device Excellence Awards and won a Good Design award.
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, connected devices, mechanical dose counters, and regimen assurance devices.
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 is a challenge. This challenge is magnified by the need to manufacture economically in very high volumes.
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.
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.
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. This information can be used, 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 multi-disciplinary 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. At DCA, we are experts at integrating the electronics and software needed to make devices work effectively and efficiently within growing digital ecosystems. We are the multi-disciplinary partner that can help deliver your connected inhaler with confidence.
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.
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.
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 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 device testing. We also work with external laboratories to execute specialist tests and comprehensive evaluation programmes.
Design for automated manufacture
Creating devices that can be manufactured efficiently in high volume is complex. It brings design constraints that require significant know-how and detailed focus to navigate successfully. 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.
Our work with leading pharmaceutical and drug delivery device companies has helped to create devices that provide benefits in comfort and ease of use over conventional nasal spray devices.
We have worked on the development of novel products for regular intranasal self-administration of liquids and gases, as well as devices for vaccine delivery by healthcare professionals.
With our rigorous approach to development, we can provide the strong engineering skills and experience necessary to ensure that your intranasal device can be produced reliably and will perform consistently when it reaches market. When coupled with our deep understanding of user needs and expectations, we can offer an outstanding multi-disciplinary development service to pharmaceutical companies and device manufacturers in this area.
Topical Drug Delivery
Topical medicines come in a huge variety of forms; from gels, lotions and creams to liquids and powders. They are applied in different ways to many regions of the body, creating a diverse range of usability considerations.
Yet all too often, the packaging and application aids that topical medicines are supplied with are basic, generic and uninspiring. They take little account of the specific challenges of the patient population or the condition that is being treated.
Opportunities to win
There are significant opportunities in the area of topical drug delivery to differentiate and achieve great outcomes for patients.
We can help build understanding of patients needs and the challenges they will face applying your medicine. Leveraging these insights, our engineering and design teams have a proven track record of developing effective device solutions that deliver topical medicines and other personal care products more cost effectively, with better control, more comfort and less mess.
Digital medicine platforms
At DCA, we are experts at integrating the electronics and software needed to make devices work effectively and efficiently within growing digital eco-systems.
Part of a range of connected drug delivery devices, the Aptar cDermal (pictured) is able to monitor and connect a number of Aptar’s popular dermal pump systems to a smart app for processing and displaying usage data.
This information enables a range of app based features, which can provide valuable insights to healthcare professionals and support the user in their treatment. This is intended to encourage engagement and better compliance, ultimately focussed on improving patient outcomes.
DCA worked with Aptar to develop a connected platform, here embodied in cDermal, a device that is discrete, reliable and simple to use.
Creating devices that can be manufactured efficiently in high volume is complex. It brings a vast array of design constraints that require significant know-how and an intense focus on detail to navigate successfully. This is an area where we bring a wealth of experience, gained across multiple successful drug delivery platforms and fast-moving consumer goods (FMCG).
A great example is our detailed engineering design for LYNX / AXE body spray. Few complex FMCG products are made in higher volumes, yet this one also pushes boundaries to provide a unique, sophisticated user experience.
To conceive a pack intended to create a sense of magic and delight for the consumer is one thing. To engineer this sensory experience for the user in an ultra-high volume, low cost product is where the ‘magic’ is delivered.
The world is looking for more innovative solutions that help us lower our carbon footprint, whilst delivering on our needs.
APS MiniMist is an innovative alternative to traditional aerosols and other spray dispensers. It produces a continuous fine spray without any chemical propellants, resulting in a significantly lower carbon footprint than aerosol products, whilst remaining cost competitive. DCA created the detailed design and developed fully functional pre-production demonstrators of this ground-breaking new product for APS.
MiniMist’s spray characteristics and visual design are easily customisable to suit different brands and product categories.
We are experts at developing refined devices for controlled delivery of drugs, as well as healthcare and beauty products. Our world-class engineering and design teams work together to create complete product designs, or independently on standalone aspects.
Veet Easywax (pictured) is an innovative, precision electrical roll on wax applicator for hair removal. DCA worked with RB to develop 3D brand language for Veet. Our work in support of the detailed execution of this design language has helped to create a range of highly commercially successful products.
We have helped to create visual brand language (VBL) strategies for some of the world’s leading companies in healthcare and FMCG.
Products and their packaging are often the most important way in which brand values are communicated to consumers, so it is essential that the messages are clear and consistent.
When creating a VBL, we translate a brand’s unique values and personality into tangible elements that can be embodied in product design, such as form, detail, material and colour. We create VBL guidelines to equip brand managers with powerful tools to brief their design projects, to inspire, and to evaluate the success of a design in expressing core attributes and ideas.
Pharmaceutical packaging and instructions
The design of pharmaceutical packaging and labelling is too often focused more on the constraints of manufacture and regulation than on the needs of the user.
(Lyxumia® is a registered brand of Sanofi Aventis).
There are powerful reasons for this; not least the need to maintain production flexibility within a heavily regulated environment. But the pack and the patient instruction leaflet are the first important touch points many patients have with their medication.
Our experience indicates that good packaging and instructional design can help significantly to allay patient concerns and improve compliance with a treatment regimen. We believe that investment in good design not only helps patients, it also communicates eloquently that a company cares about its customers.