21-03-2014, 10:49 AM
Seminar Presentation Retrofitting software-safety in an implantable medical device
The TOPIC - What is says ?
-Regulatory agencies like the US Food and Drug Administration, which
oversees the medical device industry, are requiring companies to provide
explicit and rigorous evidence that they followed a safety-driven process for product development and manufacturing.
-For software-controlled systems, much of this task involves identifying and
mitigating any software conditions that can lead to hazardous system
behavior.
-These regulatory requirements are not for future developments alone.
-Existing and ongoing products must also conform to strict standards,
and for these, software developers must demonstrate that their existing
software is safe.
- We call this retrofitting safety into software.
What are we doing? The Aim ?
One way to do this is to conduct a systematic software-safety analysis to identify -
(a) safety faults,
(b) modify the software to mitigate those faults,
© verify overall system safety.
We will do such an analysis and apply it to an Implantable Cardiac- Rhythm – Management System, commonly Pacemakers and Defibrillators.
Cardiac- Rhythm – Management System is developed by Cardiac Pacemaker, Inc ( CPI)
CONCLUSION OF THE ANALYSIS
-Thus, if the entire software-safety analysis can detect and mitigate a single safety fault that can potentially lead to a product recall, the process would be readily considered worthwhile - and we succeeded
in identifying and mitigating more than one such fault.
-On the basis of this experience, we have learned more about building safety into software in forward engineering. We have devised a process and are currently applying it to ongoing product developments.
- We are also working on building tools to assist in deriving fault trees from formal system and software specifications.
The TOPIC - What is says ?
-Regulatory agencies like the US Food and Drug Administration, which
oversees the medical device industry, are requiring companies to provide
explicit and rigorous evidence that they followed a safety-driven process for product development and manufacturing.
-For software-controlled systems, much of this task involves identifying and
mitigating any software conditions that can lead to hazardous system
behavior.
-These regulatory requirements are not for future developments alone.
-Existing and ongoing products must also conform to strict standards,
and for these, software developers must demonstrate that their existing
software is safe.
- We call this retrofitting safety into software.
What are we doing? The Aim ?
One way to do this is to conduct a systematic software-safety analysis to identify -
(a) safety faults,
(b) modify the software to mitigate those faults,
© verify overall system safety.
We will do such an analysis and apply it to an Implantable Cardiac- Rhythm – Management System, commonly Pacemakers and Defibrillators.
Cardiac- Rhythm – Management System is developed by Cardiac Pacemaker, Inc ( CPI)
CONCLUSION OF THE ANALYSIS
-Thus, if the entire software-safety analysis can detect and mitigate a single safety fault that can potentially lead to a product recall, the process would be readily considered worthwhile - and we succeeded
in identifying and mitigating more than one such fault.
-On the basis of this experience, we have learned more about building safety into software in forward engineering. We have devised a process and are currently applying it to ongoing product developments.
- We are also working on building tools to assist in deriving fault trees from formal system and software specifications.