Diagnostic device next to smartphone

Diagnostic device design and development

We work on a wide range of exciting diagnostics projects, from novel, low-cost, high-volume cartridges to next generation connected diagnostics systems. Our multi-disciplinary team of designers, engineers and scientists has decades of technical expertise including point of care diagnostics and laboratory instruments.

We help our clients develop commercially successful, world-leading diagnostic devices from concept generation to transfer to manufacture. How can we help you?

LumiraDx diagnostics platform

Concept to manufacture support

Our diagnostic experts have helped our clients deliver leading diagnostic platforms to the market, including the LumiraDx, which was acquired by Roche for $295M. Whether you need help with a specific challenge or are looking for a development partner to take your idea from concept to manufacture, our in-house team can take you all the way.

Diagnostic instrument and packaging

Full diagnostic device integration

We support you across the full diagnostics workflow, translating complex laboratory benchtop assays into robust, user‑ready products. Our in-house diagnostics experts work across design and usability, sample handling, cartridge development and assay processing to create systems that are reliable, manufacturable and intuitive to use.

With deep capability in microfluidics, optics and design for manufacture, we help you de‑risk your technical challenges early on, accelerating your development and ensuring seamless integration from laboratory bench assay to fluidic cartridge and complete system integration.

People sat at table pointing at device drawings

Intuitive product design

Our design and usability teams work alongside you to understand the product and its users. We develop a deep knowledge of the people who use the product and weave this into your development process to create intuitive, safe and reliable diagnostic devices. Our aim is to create products your users love, while supporting regulatory pathways such as CLIA Waiver and compliance with usability engineering standards including IEC 62366.

Diagnostic prototype deomnstrator rig

De-risking your development

We create laboratory demonstrator instruments and cartridge prototypes to allow you to address key technical challenges early on in your diagnostic device project. Demonstrators also provide you with a platform to develop your assay, enabling you to gather data as soon as possible in your project to inform your development.

Prototype diagnostic cartridges

Small batch manufacturing

We can generate small manufacturing batches of diagnostic devices, including the procurement and management of parts, assembly and test which are ISO13485 certified, allowing you to quickly progress to clinical evaluation.

Packaging concept for a diagnostics device
Quick reference guide in cardboard packaging

Read our diagnostic case studies

From a point of care platform that changed the face of healthcare, to connected at-home diagnostic solutions, find out how we’ve helped our clients develop novel diagnostic products.

View our case studies

Optics rig showing green laser
consumable strip showing microfluidic channels
Magnetic field
Microfluidic channels
Optics rig showing green laser
Laptop screen showing thermal imaging

Applied science and technology

Cartridge development

We design and optimise cartridges for high-volume, low-cost manufacturing without compromising accuracy. From early prototypes to production-ready designs, we ensure your cartridge supports rapid, reliable results and seamless integration with your diagnostic system.

Magnetics

Our applied scientists design magnetic systems that enhance precise sample handling and support high‑performance assay workflows in diagnostic devices. We balance spatial, cost and energy constraints using advanced mathematical modelling to optimise magnetic force, shunting strategies and material selection, reducing prototyping cycles and accelerating development. We also address challenges such as unwanted magnetic interference, designing shielding solutions that protect sensitive components while maintaining assay sensitivity. Through rigorous evaluation and bespoke test rigs, we ensure your magnetic system delivers consistent, repeatable performance even in demanding diagnostic environments.

Microfluidics

Our microfluidics experts develop elegant, highly controlled fluid‑handling architectures that sit at the heart of reliable diagnostic performance. We translate complex assay requirements into robust, manufacturable microfluidic systems that minimise sample volumes while maximising accuracy and speed. From early‑stage concepts to production‑ready designs, we help you overcome challenges such as metering, mixing and flow control, ensuring your device performs consistently in real‑world conditions. By combining scientific insight with rigorous engineering, we support you in creating diagnostic platforms that deliver fast, precise results and integrate seamlessly with the rest of your system.

Optics

Our optics specialists design and integrate high‑performance optical systems that underpin accurate, reliable diagnostic readouts. We balance complex performance requirements with practical engineering constraints, selecting optical solutions that deliver clarity, sensitivity and robustness across point‑of‑care and laboratory environments. From early concept development through to prototype testing on the optical bench, we validate performance to give you confidence in your design. Our team understands the physics behind optics and the challenges of integrating these systems into medical devices, helping to ensure your product meets your functional, manufacturing and commercial needs.

Thermal control

Our thermal management solutions maintain critical temperature stability for assays and instruments. We design systems that ensure accuracy and reliability, even in challenging environments, supporting consistent diagnostic outcomes.

Person working on code on computer
Three smartpones showing diagnostic application screens
Graphic-showing-data-flows-between-a-medical-device-and-the-cloud
Person working on PCB soldering
Laptop showing code alongside diagnostic devices
Diagnostic prototype deomnstrator rig

Bespoke software and electronics

App development

We develop connected apps that offer the seamless, intuitive experience users expect from leading digital products, while meeting the rigor of medical‑device development. Combining robust software engineering with evidence‑based UX/UI methods, we create interfaces that enhance usability, streamline complex workflows and support safe diagnostic use. Through iterative prototyping and testing, our team aligns your app with proven UX/UI principles, accessibility requirements and medical usability standards such as IEC 62366 and FDA guidance. The result is a user-centred app that delivers secure, reliable, real‑time access to diagnostic data within a fully integrated system.

Connectivity and cybersecurity

We create connected diagnostic systems that integrate smoothly with laboratory information platforms and patient portals, ensuring data flows securely and reliably at every stage. Our software specialists combine functionality and security from the outset, aligning your system with best‑practice medical device cybersecurity. By understanding how your device operates and how it is accessed, we build in strong safeguards early in development. Throughout the process, we apply advanced tools and continuous verification to maintain a robust, compliant platform that keeps information protected and supports confident, dependable diagnostic performance.

Electronics design

We focus on building a clear understanding of your device requirements, applying a system architecture that applies the right components, power needs and safety critical areas for your needs, in compliance with medical standards such as IEC 60601. Our engineers use circuit simulation, component selection and an optimised PCB layout to improve accuracy, reliability and manufacturability of your system. With expertise across low power, wireless, digital and analogue technologies, we support rapid, confident progression from concept to market.

Embedded software

We develop embedded software tailored to the precise control and data‑handling needs of your diagnostic device. Our software engineers work across bare‑metal systems, RTOS and Linux, selecting the right approach to match your performance, safety and reliability requirements. From the start, we align your development with standards such as IEC 62304 and ISO 14971, supported by automated testing and continuous verification to ensure high‑quality, maintainable code.

Image processing

We develop advanced image processing algorithms to deliver accurate, high-quality diagnostic results. Our expertise ensures clarity and consistency across diverse testing environments.

Matt Chandler

Meet one of our diagnostics experts

As Director of Mechanical Engineering, Matt Chandler has over 20 years of experience in technical consultancy, with a particular focus on diagnostic systems ranging from point of care devices to laboratory instruments. During his career he has held leading roles in diagnostics, responsible for business development and project delivery.

View my bio

Read our diagnostics client success stories

Gloved hand placing sample on diagnostic device
CASE STUDY

Transforming point of care diagnostics

Diagnostic packaging and mobile phone with device app
CASE STUDY

Streamlining the user experience of home diagnostics

Diagnostic prototype deomnstrator rig
CASE STUDY

A sophisticated and low-cost diagnostic technology demonstrator

Blood sample being taken from finger
CASE STUDY

Turning a rapid molecular test into a diagnostic device for home use

Quick reference guide in cardboard packaging
CASE STUDY

Packaging design for a handheld PoC diagnostics platform

What are your diagnostics challenges?

Get in touch to find out how we can support your diagnostic device development.