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 first-hand experience of working in point of care diagnostics.
We help our clients develop commercially successful, world-leading diagnostic devices from concept generation to transfer to manufacture.
How can we help you?
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.
Developing connected in vitro diagnostic devices for the digital era
Our software team develops in vitro diagnostic medical devices (also known as IVDs) for the digital era. We integrate your device with remote laboratory information systems and create bespoke patient access portals. We assess and manage cybersecurity considerations from the project outset to ensure your platform remains safe and secure throughout its lifecycle.
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 that users love and which meet the regulatory requirements such as CLIA Waiver and usability engineering (IEC 62366).
Our multi-disciplinary team of engineers and scientists can help you integrate the full system: assay, cartridge and instrument. We review your system as a whole and can help you understand its performance, solving problems as needed to optimise your diagnostic device.
We can help you take your idea or concept all the way to manufacture or support you with discrete packages of work.
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.
Our expertise includes:
With our knowledge of the regulations in key markets across the world, we can help you navigate through existing and emerging in vitro diagnostics regulations including FDA, IVDR and UKCA.
Liz Thorn is passionate about IVDs and brings over 25 years of experience in the industry. She has worked in large diagnostics organisations and helped start-ups get their diagnostic devices off the ground.
In the early stages of my career in IVDs, I was struck by the impact that simple devices can have on patients’ lives. This has motivated me through all the development projects I have been involved with. I really enjoy engaging with clients, learning about their new technologies and being able to use my own experiences to help them on their journey.
Team Consulting has supported LumiraDx with the development of their PoC Platform.
LumiraDx is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, the company manufactures and commercialises an innovative diagnostic Platform that supports a broad menu of tests with lab-comparable performance at the point of care.
Looking for detailed insights into diagnostics device development? Request your free copy of our Diagnostics Handbook below.
Within it you’ll find our expert advice on what it takes to develop an award-winning medical device, from initial concept through to industrialisation.
"*" indicates required fields
