The Importance of Full Product Lifecycle Traceability

January 26, 2017 - Brad Milos, Principal Development QA Engineer



In December, I was invited to participate in a panel discussion at the Opal Medical Device Summit in Scottsdale, Arizona.  Minnetronix’ reputation for quality earned us a spot at the Summit that provides a platform for bench-to-bedside discussions and attracts professionals from Medical Device, Pharma, Biotech, and Drug Delivery industries.  The 2017 summit included a series of discussions on topics such as 13485:2016 compliance, design control process, medical device innovation and funding, device connectivity, cyber security, lifecycle management, human factors, and combination products.

Specifically, I joined a moderator and another subject expert to discuss “Full Product Lifecycle Traceability:  The Golden Key to Proof of Compliance.”  An estimated one hundred people participated in the town hall forum.  The panel discussed traceability best practices for compliance to ensure business and engineering alignment, information management, and contextualized communication from start to finish.  Specific topics included:

  • Importance of identifying critical to quality (CTQ) requirements:  By identifying critical parts and processes in the design, extra rigor can be strategically applied to the critical areas of the design.
  • Significance of traceability matrices for continuation engineering :  Traceability matrices (Hazards -> System Requirements ->Software Requirements -> Tests) provide engineers with the tools to ensure that they are not missing the “big picture” when making changes to devices after initial release.  Because these matrices provide the context to mitigate risk, they are invaluable continuation engineering tools.
  • Need for manufacturing documents to trace from requirements:  When manufacturing inspection and test procedures are requirements based, they lead to a consistent manufacturing output and a more robust product.
  • Effective tools for tracking changes in requirements and design documentation:  Rapid product to market design models introduce significant churn in design requirements. Because of this, it is important to have an effective tool to track changes in requirement and risk items.  Additionally, it is critical to track their associated traceability to verification methods to support regression and impact analysis.
  • Effective Quality Management System (QMS) Traceability:  Having a QMS that provides outputs from one activity into the next and allows for feedback to previous activities as new discoveries are made are key because it gives you the ability to make accurate risk-based impact assessments.

In a single year, Minnetronix does numerous design iterations across multiple customers spanning all classes of medical devices, providing me with a unique and broad perspective to add to the discussion.  At Minnetronix we believe that full product lifecycle traceability is critical to project success. Our protocol (or process) results in a comprehensive Design History File (DHF) and ensures alignment across internal and external customers.  I view traceability as the “long term memory” of the design process, ensuring alignment and accountability.

Participating in conferences, such as the Opal Medical Device Summit, encourages the exchange of best practices and ideas that benefit the medical device industry.  It also underscores Minnetronix’ commitment to quality as we create new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies.