A leading supplier of bio sensors and medical instruments was extending their product portfolio to encompass more sophisticated and integrated offerings consistent with changing market demands.  This meant that products now had to be considered from a more system-based perspective.  This migration was presenting a challenge from a skills perspective since the client had limited experience in system development.   Our consultants developed, in conjunction with key members of the client team, a business process suitable for a more complex product systems development environment.  They provided practical ‘mentoring’ type support to key members of the development team aimed at implementing the philosophies described in the new process. This resulted in our consultants becoming actively involved in facilitating the ‘system’ design of the new product, from a functionality, reliability and risk mitigation perspective.

The client’s previous approach to design was based upon a rapid development of prototypes, which were then tested and refined through multiple iterations of testing. Testing included internal product testing supplemented by user testing.  The approach had delivered products in reasonable time frames in the past.  Previous products, however, had limited user interfaces and the ‘subsystem’ interface between the biosensor and the measuring instrument was straightforward.  The new generation of products was more complicated with more complex internal interfaces between subsystems aimed at providing a more fail-safe user interface.  Since the system was being designed to make it less susceptible to user-induced errors, this led to the need for a more quantitative approach to risk management, both from a product design perspective but also from a manufacturing process perspective.

Our consultants developed a design approach to address the challenges posed by these new requirements. They changed the design emphasis to ensure that the product was being designed specifically to meet market wants rather than to develop ‘technology’ and then subsequently try to find a market niche for the product.

The consulting team adopted ‘QFD’ principles in the new process introducing the client to concepts such as functional design, system design, structured risk analysis, integrated requirements setting, reliability design and linking this explicitly to the design ‘critical to quality’ (CTQ) parameters.  This led to the new product being designed in a more structured and consistent way, deriving system and sub-system requirements from the over-arching external customer wants.  This systematic approach enabled subsystems to be developed semi independently whilst minimizing the interface implementation risks.  Risk requirements were established through the system design phase ensuring that risk mitigation was integral to the design and subsequent test activity, a key need given the product market positioning.

The approach adopted allowed product performance to be understood in a more structured way, enabling modules within subsystems to be characterized and have their design envelopes established before being integrated with other modules at the next level of system integration.  This approach led to a more comprehensive understanding of the interactions within the products and ensured that as the system was integrated only interface performance needed to be characterised at the higher integration levels.  The consequent better understanding of the product, at the detail level, ensured that the design of the manufacturing processes and its control regimes was also better focused.

A new inclusive product/process development regime integrating function, risk and reliability aspects whilst ensuring that design ‘envelopes’ were being established throughout the process. The revised process provides the means to move towards satisfying the requirements of ICH Q8 Quality by Design and ICH Q9 Quality Risk Management.

The process ensures a more complete understanding of product performance and is reduced development cycle times by around 40%-45%. The detailed product understanding and its explicit links into process development provided the platform upon which the post launch support activities could be built.