The development process is critical in delivering products which meet requirements and production timescales, provide a satisfying user experience, and are suitable for manufacture, maintainable and profitable.
Sagentia has the depth and breadth of understanding to integrate engineering disciplines with science and technology teams, providing unrivaled system design capabilities. We balance complexity, performance, cost, time-to-market, usability and other product requirements.
All product developments begin with a rigorous requirements capture process. Requirements typically include, but are not limited to:
- Functional requirements – what is the essential function of the product?
- Monitoring requirements – what parameters must the product monitor?
- Safety requirements – what safety measures must be implemented?
- Environmental requirements – in what conditions must the product operate?
- Usability requirements – how do people interact with the product?
- Legislative requirements – to which standards must the product comply?
- Manufacturing requirements – eg where / how will the product be made?
- Testability requirements – how will the system be tested?
- Business requirements – eg how much must the product cost?
With requirements in place, the system architecture can be specified and developed by a mixed-discipline team. Decisions such as using off-the-shelf components versus custom developments can be made and major functional blocks can be defined, with measurable sub-system requirements being linked to product requirements and testing protocols.
Functions will be clearly specified and decomposed into design items with clear specifications and requirements. Examples of subsystems include power delivery systems, system monitoring, HMI/GUI definition or platform/key component selection.
Detailed design will follow the functional decomposition. This uses our capabilities across the engineering disciplines including electronic systems design, mechanical systems design, and software design.
Verification and testing
We will then test the systems and sub-systems against test protocols, derived from functional requirements, proving that products meet their requirements. Our systems engineering-led approach ensures that your product designs are partitioned in a way that simplifies verification, and therefore reduces cost and time-to-market.
We have vast experience of product manufacture, from small/medium volumes up to millions of units per year, at facilities in Europe, the UK, and the Far East. With our manufacturing knowledge informing system design early in and throughout the design process, transfer to manufacture is greatly simplified.
Safety critical system design
We adopt defensive design techniques in hardware and software, and have experience of safety critical system design and functional safety system design, to various standards, including, but not limited to:
- Safety critical software up to SIL-3
- Medical software to IEC 62304
- Software to MISRA
- Medical product development to IEC-60601 Ed.2 and Ed.3
- IEC EN 61508
We have completed over 10,000 projects for start-ups and global market leaders alike, from understanding the market & technology landscape through to developing and delivering complex products.
Our scientists and engineers redefine what’s possible and help R&D groups across the medical, industrial, oil & gas and consumer sectors achieve commercial return from their most complex technology projects.