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).
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).
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).
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 and communicate dose events brings new opportunities to monitor and improve adherence for patient groups that may otherwise struggle with compliance.
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.
The picco range of mechanical autoinjectors targets key unmet needs in this increasingly important sector.
Designed as a platform 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.
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 Libertas™ 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.
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.
It can be deceptively complex to successfully design and industrialise an inhaler.
Achieving a design that performs consistently across the range of operating environments, copes with all foreseeable use and misuse scenarios 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 seek to understand and prove the basic design principles as early as possible. We use a broad range of tools including mathematical and computational modelling, rig manufacture and testing, tolerance analysis, risk analysis and user research to inform and guide design decisions and concept selection.
Our design and analysis work with global pharmaceutical and device companies includes dry powder inhalers for asthma, COPD and inhaled insulin, pressurised metered dose inhalers, breath actuated inhalers, dose counters and regimen assistance / assurance devices.
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 to different parts of the body in different quantities, with differing treatment regimens. Yet all too often, the packaging and application aids they 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.
There are great opportunities to improve in the often neglected area of topical drug delivery; to differentiate and to improve patient outcomes. We can help build understanding of your patient 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 more effective device solutions that deliver medicines with better control, more comfort and less mess.
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.