We support you with an systematic and structured process to establish stakeholder and system requirements that builds the base for solid and innovative product development. As a base for defining stakeholder requirements and deriving system requirements, stakeholder needs must be identified. mind4medical provides in cooperation with Vendbridge a systematic method to identify the stakeholder needs and categorize and quantify the needs for stakeholder-focused innovation. We don’t ask the customer what they want, we negotiate what he needs to achieve his goals.

“If I had asked people what they wanted, they would have said faster horses” Henry Ford.

min4medical applies a systematic syntax to describe stakeholder requirements based on needs, which are structured into usage, performance, market, organizational and legal requirements. We recommend to structure the requirements into these groups for further development and validation activities. Use requirements are covered by usability validation, whereas the market and performance requirements are validated by the clinical evaluation and if required clinical investigation. We provide support and expertise in converting stakeholder requirements to system requirements specification. Depending on the complexity of an treatment the system, it is recommended to split into subsystems and interface to other medial devices. A solid structuring of requirements enables the use of subsystems in other systems modular block.

We are capable to integrate the requirements into a holistic treatment centered risk management approach that returns the risk management control measures as stakeholder or system requirements.

It is all about framing and the level of abstraction.