Drug Delivery
The rapid technological and human focused advances in drug delivery are unlocking possibilities for treating complex and previously untreatable diseases, creating a future where drugs are not only more effective but also more surgeon & patient-friendly.
At the same time, the complexity and number of disciplines needed to realize these new and remarkable surgical and diagnostic devices can seem overwhelming at first glance - but well orchestrated cross-disciplinary collaborations including experts in materials, digital/AI, mechanical, electrical, fluidics, and more can bring solutions to life. Regulatory guidelines and communication with regulatory officials help set the proper parameters along the innovation path.
Innovative Drug Delivery: Precision and Patient Impact
We thrive on ground breaking drug delivery challenges that address complex technical and user requirements.
Our team is engaged in complex, high-risk development programs across drug delivery, surgical, and diagnostic fields, partnering with pioneering start-ups and global leaders in the industry.
As an ISO 13485-certified organisation, we uphold rigorous design control systems to ensure safety, efficacy and regulatory compliance at every stage of development.
Rising Demand for Targeted Drug Delivery Solutions
Targeted drug delivery strengthens treatment effectiveness while reducing side effects, improving patient outcomes, and providing personalised care for complex conditions like cancer, autoimmune diseases, and neurological disorders. The medical industry faces challenges in identifying targets, designing drugs, developing delivery methods, and overcoming costs and regulations. Overcoming these hurdles is essential for advancing precision medicine and improving patient care.
Enhancing Treatment Success Through Patient Compliance
Engaged patients have better health outcomes. Techniques such as clear communication, simplifying treatment regimens, and using convenient delivery methods like extended-release or less invasive options improve patient compliance. Digital tools, like reminders and dose trackers, further support adherence. Working with patients and clinicians before new drug delivery solutions are designed and during the development process helps build solutions that are more likely to be used properly.
The Advancement of Gene & Cell Therapies
Advances in delivery methods, such as improved viral and nanoparticle-based vectors, have increased the feasibility of delivering genetic material safely, however handling gene therapies is challenging due to their complex nature and the conditions required for their stability and efficacy. Delivery to specific cells or tissues requires precision-engineered delivery systems. Safe and effective delivery of gene therapies poses unique challenges.
Human Centered Design
High Stress Environments
Designing surgical products and equipment for high stress situations requires an in depth understanding for the roles and workflows of each individual in the surgical theatre. The overall performance goals for the team drives the balance of many factors including usability, ergonomics, durability, safety, integration with surgical techniques, aesthetics that contribute to less stress and more.
Researching And Testing With Clinicians
First hand, practical feedback from the people who will use the product - especially when designing for doctors - ensures that the product usability, ergonomics, and effectiveness are tuned to real-world workflows and conditions. Testing with clinicians allows designers & engineers to make iterative improvements based on the key expert insights- accelerating the development of a tool that truly meets the demands of surgery.
Researching And Testing With Patients
Patient testing is critical in developing procedures that are both safe and effective, ensuring that they meet the highest standards for patient care before they are widely adopted. This provides important feedback on procedural steps, timing, and techniques, which can be refined to optimize performance and integrate smoothly into clinical practices.
End To End Technology Development And Engineering
End-to-end technology development and engineering are essential in medical device design because they provide a comprehensive, integrated approach from initial concept through development and hand off to manufacturing.
Holistic Design Perspective: Our end-to-end development ensures that each stage of the design process aligns with the final goals of the device, from functionality to user experience and regulatory compliance.
Enhanced Safety and Risk Management: Medical devices must meet strict safety standards, as any failure can have serious implications for patient health. By incorporating risk management practices across the entire development lifecycle, end-to-end engineering can identify and address potential risks early, ensuring the device is safe and effective by design.
Throughout this process we help our clients pave the way for safer, smarter, and more personalized medical devices that enhance the quality of care and align closely with the needs of both patients and healthcare professionals.
Working Closely with Suppliers
Supplier engagement involves early collaboration to align on material specifications, quality, and capabilities, enabling the incorporation of the latest material innovations and refined designs for performance and cost-effectiveness.
Supplier selection emphasizes technical expertise, quality standards, regulatory compliance, and scalability, prioritising reliable partners in precision manufacturing to meet the high standards required for high-risk medical devices.
Complete System Development
We specialize in developing complete systems, handling every aspect from design to validation and deployment.
Our team integrates multiple elements—such as fluidics, electronics, and software—into fully functional systems.
Consistent Technical and Use Environment Testing
We prioritise real-world testing with end users throughout the development process to ensure system reliability, performance, and safety.
Early testing identifies potential issues, allowing for prompt adjustments and minimising risks. This approach verifies component functionality, maintains quality and functionality under various conditions, and meets regulatory standards.
Fluid Delivery Systems
Designing microfluidic systems for precise therapeutic delivery is central to our work. We focus on minimising residual volume and reducing waste of high-value drugs and biologics by developing designs that use ultra-pure, inert materials and optimizing surface finishes, treatments, and coatings. These choices help prevent drug-device compatibility issues, like API concentration loss due to adsorption or particulate formation.
With expertise in fluid seal design we can develop fully customised fluidic systems. Whether it’s an ultrasonically welded hermetic seal or a specialized piston-barrel interface to control break-loose and glide forces, we build robust systems that enable stable, repeatable delivery.
With comprehensive in-house fluidic testing, we can precisely measure system pressure and flow using microfluidic sensors. We also develop tailored test methods to verify system performance and ensure it meets regulatory standards.
Design Assurance
Our development teams play a crucial role in our programs regulatory design assurance by ensuring that medical devices meet stringent regulatory standards and comply with industry requirements.
We bridge the gap between design innovation and regulatory compliance, ensuring that medical devices are not only effective and user-friendly but also safe, compliant, and ready for market success.
We can either assist or take the lead in developing detailed documentation, which is critical for regulatory submissions. This includes design inputs and outputs, risk management files, validation protocols, and traceability matrices that demonstrate a structured approach to meeting requirements.
For instance - In the early stages, we conduct risk analyses (such as Failure Modes and Effects Analysis, or FMEA) to identify and address potential risks. They help design and implement control measures to ensure safety and effectiveness, documenting this in ways that comply with regulatory expectations.
Regulatory bodies increasingly focus on usability and human factors. We work with our clients to conduct user studies to ensure devices are safe and easy to use, identifying and mitigating use-related risks. This documentation can be vital for regulatory submissions, as it demonstrates that human factors have been appropriately addressed.
