Recall Prevention for Biotech (Medical Device) Systems

Recall Prevention – what does that mean?


Risks inherent with development of software applications, medical devices and hospital systems

  • Product recalls caused by inadequately tested devices and integrated systems
  • Budgets blown due to costly rework and excessive tech support issues
  • Escalating costs and consequences caused by late detection
  • Poor user experience due to ineffective human factors engineering
  • Patient safety impacted by unexpected user interaction and abnormal system behavior

How does the recall prevention program work?

Oneidentify all high risk areas within the application, device and system

{if a new App: identify critical path, all ‘must work’ user and connected system work flows within the application, device or system}

{if existing App: identify all potentially impacted functionality by code}

Two create ‘what if’ scenarios for all high risk features and functionality

Three – convert all ‘what if’ scenarios into targeted negative test cases (for R&D/QA teams)

Four – prioritize all scenarios/targeted negative test cases utilizing probability versus impact process

Five – feed high risk scenarios/targeted negative test cases directly into R&D and QA Plans

Six – keep entire project team tightly focused on high risk plans and tasks until release

Sevenupdate process documentation for ongoing team training and process improvement

Advantu Recall Prevention Program Benefits 

  • Significantly reduced Time To Market
  • Measurably improved reliability and scalability
  • Increased profits and revenue via best in class processes
  • Predictable forecast accuracy and delivery dates
  • Increased confidence with new feature/product releases
  • Early risk detection prevents escalating cost and impact on deliverables
    • Contributes directly to recall prevention
  • Improved user experience and customer satisfaction with your products
  • Expanded market share with dramatically improved customer feedback

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