Due to cost and efficiency pressures, we are seeing a growing transition from 'traditional', largely immobile lab-based equipment to portable devices in both the home and the hospital.
The global Point-of-Care (PoC) diagnostics market continues to grow rapidly, at a rate estimated to be in excess of 7% per annum even in the current climate. This is resulting in devices needing to be smaller, faster and more cost effective. As home use diagnostics also develop, human factors is becoming increasingly important and combining product development with voice of the customer research and user validation is crucial to ensure the final product is fit for purpose.
Areas of expertise
- Thermal and fluid flow modelling
- Microfluidic design within high volume consumables
- Complex automated instrumentation
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Diagnostics devices
- Assay development
Whether there is a need to achieve cost reduction on an existing portfolio, develop next generation products or address the opportunity presented by the emerging markets, we are ideally placed to help clients develop a stream of innovative and successful diagnostics products – from novel consumables through to complex systems integrated with simple user interfaces.
Hand-held diagnostic device
PoC equipment is designed to be used outside of the clinical laboratory environment, often in emergency settings where rapid test results are essential. Here, Voice of the Customer (VoC) research and User Validation are crucially important to ensure the final product is fit for purpose. PoC uses smaller body fluid and reagent volumes than traditional laboratory based equipment. Here, Sagentia’s in-depth knowledge of the underlying science – including microfluidics, liquids handling and the physics of material surfaces – are all integral parts of the product development process.
With a focus on delivering practical but commercially viable solutions within demanding timescales, we work with both start ups and multinational companies to develop complex diagnostics products from front end innovation, through product design and development, to transfer to manufacture. Our approach, underpinned by our ISO medical development accreditation, combines strategic market understanding and world-class engineering with science, design and usability to get the right product to market.
Recent examples of project work for clients operating in the diagnostics sector include:
- The design and development and of a real-time PCR-based diagnostic unit which was central to the subsequent development and transfer to manufacture of the full system, The PoC unit has undergone full clinical trials and has been successfully launched into the market.
- The thermal and optical modelling of the key component in a complex PoC consumable. Our input resulted in a production ready design suitable for high volume manufacture
- Significant cost savings for a sophisticated hand held diagnostics device. This was achieved by undertaking a structured Product Challenge project based on concept generation and Design for Manufacture and Assembly (DFMA) principles. The project also led to a range of quality improvements over the existing product
- The in-house development of a platform using coded functionalised beads for multiplexed DNA and protein assays. Sagentia’s interdisciplinary team developed proof-of-concept for the entire system including bead manufacture, surface functionalisation and detection, prior to the technology being spun out and subsequently licensed. Additional assay development work includes a toxicology assay designed for the Luminex® bead platform on behalf of a major pharmaceutical company