Those of us that are involved in critical medical devices and those that directly deliver therapy should be closely watching events in other industries, such as the Tesla issue in the article linked below. One way to view this issue is in the context of software control authority – a term used in the aerospace world. How much authority does the software have to make its own decisions, and how critical is the potential outcome of those decisions?
As software control authority begins to take significant leaps forward, are our software safety processes able to keep up? Do we really have the means to do adequate analysis and testing? Is our current risk analysis methodology able to deal with the complexity? Are our regulatory bodies ready to cope with the changes?
Should we be going to other industries that are already dealing with rapidly advancing software control authority (including automotive and aerospace) to ask about lessons learned and ideas for a path forward, as this becomes more and more relevant to medical devices?
We have to believe that these and other questions are on our horizon.