SRI Product Development system engineers provide a key role in the product development process. Our customer's products generally require a combination of software, electronic, mechanical, industrial design, and disposable design expertise. The SRI system engineering team includes personnel with multi-engineering discipline experience such as software, electronics and mechanical engineering. In addition, the system engineering team has a strong background in mathematics.

The SRI system engineering team performs the following activities:

• Requirements Definition and Management
• Algorithm Development
• Simulation/Modeling
• System Risk Analysis, FMEA,FTA
• Platform Selection

Requirements Definition and Management

Requirements definition, decomposition, and management is key to the success of our product development process. The SRI user research team interviews current and potential users of the new product. The system engineering team transforms the results of the user research into product and customer requirements. A System Specifcation is developed based on the product and customer requirements. The System Specificaiton is further decomposed into .Electronic, Software, Mechanical and Disposable requirements.

Requirements decomposition is achieved through:

• Requirements analysis and architecture construction
• Functional decomposition
  
• Requirements allocation (implementation/testing)

Algorithm Development

At the heart of most complex systems is an algorithm that defines the behavior of the software, electronics, and mechanical subsystems. The system engineering team is responsible for development and test of algorithms. In addictions, the system engineering team is responsible for generating Algorithm Description Documents that are used by the software, electronics, and mechanical teams.

Simulation/Modeling

Simulation is used when possible to prove the correctness of algorithms. The system engineering team performs simulations with MathCad, MathLab, and Labview.

System Risk Analysis (for safety critical systems)

System Risk Analysis, Failure Mode and Effects Analysis, Fault Tree Analysis are performed on safety critical systems to prevent injury to the patient and/or the user. SRI performs risk analysis activities on all of its medical device projects. In addition, SRI has performed 3rd party risk analysis on projects that it did not have direct involvement.