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- Fortune 500 Medical Device Manufacturer
- Challenge:
- Develop the first requirements specification for adding HL7 communications protocol to an existing product line for a major Class III medical device manufacturer.
- Solution:
- The specification was developed at the system, subsystem, and software/configuration item levels. Requirements were developed concurrently by systems engineering, software engineering, human factors, and verification. Requirements traceability was inherent to this effort.
- Result:
- The product worked correctly the first time when field tested at multiple major medical facilities and has successfully transmitted several million messages without error. This effort also greatly improved the company's position relative to achieving FDA compliance objectives.
- Fortune 500 Medical Device Manufacturer
- Challenge:
- Develop the first requirements specification incorporating wireless capability for remote monitoring and programming of implanted/inserted devices for a major Class III medical device manufacturer.
- Solution:
- The specification was developed at the system, subsystem, and software/configuration item levels. Requirements were developed concurrently by systems engineering, software engineering, human factors, and software verification. Requirements traceability was inherent to this effort.
- Result:
- This was the customer's first experience with incorporating wireless capability for an existing product. It was successful, tested well, and also greatly improved the company's position relative to achieving FDA compliance objectives.
- Fortune 500 Medical Device Manufacturer
- Challenge:
- The customer desired a complete development process but wanted to reduce the time and cost spent in the software development life-cycle for their medical technology effort. They also wanted to increase the effectiveness and unity of the groups contributing to the software development process.
- Solution:
- Defined and implemented an agile software development environment incorporating Scrum. Systems and software engineering roles, objectives, products, and tools were defined and implemented to meet customer goals. Areas of design impacted also included safety, human factors, verification and software quality.
- Result:
- Decreased development cycle times, increased reuse, reduced cost, more rapid design change incorporation, and enhanced competitive position. Product functionality was defined, developed, and verification and successful acceptance tests performed at a rate eight times that of the pre-existing process.
- Fortune 500 Medical Device Manufacturer
- Challenge:
- Provide expertise and direction in support of a major medical company's division-wide Requirements Engineering Initiative (REI) related to the identification, selection, and purchase of a CASE tool to provide the foundation for requirements and software development, traceability, and management to meet current and future business needs as well as FDA compliance objectives.
- Solution:
- A methodology for tool selection was developed, including the identification and tailoring of tool selection criteria to meet the needs of the medical device manufacturer. Inputs from multiple stakeholders were incorporated into the criteria. Candidate tools were ranked against criteria and scores determined. Criteria included breakdowns of required tool functional capabilities, cost and schedule to purchase and implement, and training time needed.
- Result:
- A report on candidate tool selection was issued. The best tool for requirements traceability and management for this customer was determined to be DOORS. The tool was purchased and implemented in the Systems Engineering organization with licenses and training provided to multiple stakeholders. Projects with previously completed manual traceability could be automated with this tool as well as new programs introduced. FDA compliance objectives were achieved with less cost and schedule utilized.
