Blog Articles

New injection devices are being asked to deliver larger volume injections, with higher viscosity formulations, and with increasing expectations of users on device aesthetics, simplicity, and quality. All injection devices risk finding that they fail to perform adequately when challenged with components, volumes, and viscosities at the upper end of their tolerances. The risk of failure is present when developing devices for biosimilars and generics too.

With the continuing shift of healthcare from clinics to the home, more injectable therapies are moving from intravenous (IV) to subcutaneous (SC) administration, particularly in oncology and immunology. SC delivery of high-dose biologics offers clear advantages, including greater patient convenience and potential cost savings, but large-volume or high-viscosity formulations bring distinct challenges in formulation stability, device design and the route to commercialisation.

Lyophilisation, or freeze drying, is a widely used formulation strategy in drug development, particularly for biologics such as monoclonal antibodies, peptides and nucleic acids. These molecules often exhibit limited stability in liquid form, making lyophilisation an attractive solution. By removing water, the primary mediator of many degradation pathways, this process can dramatically extend shelf life, reduce storage constraints and simplify transport across diverse climates by minimising or…

Studies in neuroscience and physiology show that stress, pain, disrupted sleep, and mental fatigue are indicators of reduced flexibility in the autonomic nervous system (ANS). Under normal conditions, the ANS shifts fluidly between sympathetic “fight-or-flight” activity and parasympathetic “rest-and-repair” processes, but chronic stress can disrupt this balance.

When a device fails Electromagnetic Compatibility testing (EMC) testing, it can suddenly delay product launches and increase costs due to redesigns and retesting. Understanding and mitigating emissions are essential to creating reliable, compliant electronics. In this blog post, we will introduce the two primary types of emissions and offer practical steps for troubleshooting both conducted and radiated EMC issues.

A revolutionary cancer treatment device is currently under development by one of our clients, offering a new, more targeted mode of action than existing options on the market. By precisely focusing on affected areas, this technology has the potential to deliver improved outcomes and quality of life for patients around the world. The client intends to release the device on the European market, meaning they must comply with the MDR.

The medical device industry is larger and more innovative than ever. Clinical research is experiencing a surge of innovation in life sciences, with breakthroughs such as cell and gene therapies, personalised medicines, identification of new biomarkers and point-of-care diagnostics. These technological advances not only create exciting opportunities for innovative product development but also introduce new complexities that demand a sophisticated approach to device manufacturing.

As a full-service CDMO for medical devices, we offer a suite of services: from device development and human factors engineering, to prototyping, mould tooling, injection moulding, and device assembly.

For people living with a rare, progressive, and life-limiting disease, access to the right treatment can be transformative. Our client has developed the first and only therapeutic option for a condition like this—an important step forward in care. However, like many early-stage drugs, it must be stored in a lyophilized form, requiring careful reconstitution before injection.

Autoinjectors provide a safe, consistent, and often life-saving treatment to users outside of clinical settings. However, as the range of drugs delivered subcutaneously grows in complexity, this has a profound implications for the devices designed to deliver them. High-viscosity biologics, in particular, pose mechanical and usability challenges that off-the-shelf devices are not always equipped to handle.