I've been thinking about code hygiene of late. I recall Ekkehard (at the time the VP of engineering for Siemens OCS) giving a talk about code hygiene, arguing that diligence about design and coding was an essential part of device development. This was based on his experience involving a few instances where sloppy coding resulted in malfunctions in the field.
Having experienced similar field issues due to non-hygienic design practices, I do feel quite strongly that meticulous coding and design are an important part of medical device development. I guess you can't always know that a 'sloppy' design will invariably increase the likelihood of a malfunction, but it is a feeling probably somewhat akin to the OCD-like behavior that surgeons often exhibit outside the operating room (i.e. once you've developed a sense of hygienic vs. non-hygienic, its difficult to turn off that sense even in situations where there is a low likelihood of something bad happening).
Having experienced similar field issues due to non-hygienic design practices, I do feel quite strongly that meticulous coding and design are an important part of medical device development. I guess you can't always know that a 'sloppy' design will invariably increase the likelihood of a malfunction, but it is a feeling probably somewhat akin to the OCD-like behavior that surgeons often exhibit outside the operating room (i.e. once you've developed a sense of hygienic vs. non-hygienic, its difficult to turn off that sense even in situations where there is a low likelihood of something bad happening).
1 comment:
Code hygiene can only help an analysis like the FDA's Static Code Analysis research project.
Post a Comment