Recall Prevention for Biotech (Medical Device) Systems
Recall Prevention – what does that mean?
- What biotech risks are we referring to, what is their impact, and how are they reduced?
- Advantu Recall Prevention Program Benefits
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?
One – identify 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
Seven – update 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
