This is a controversial and not fully formed opinion, but I think a big part of the problem is the regulations are no longer fit for purpose.
Outside of healthcare if you see something broken then you can just fix it, maybe rope in your manager.
Inside healthcare regulations you have to start a massive change control process which involves several busy people to approve it. Those people are busy and focused on getting a few priority items approved. Starting a change control process without a customer request doesn’t make you any friends.
The reasons this process exists is so that patients are never harmed by changes. But patients are also harmed by software that’s difficult to use. They’re harmed if you don’t make a change.
The regulations were designed for blood pressure monitors and insulin pumps. A patient data portal is orders of magnitude more complex. Outside of healthcare teams iterate towards a good solution. Inside healthcare teams cannot iterate, because of the regulations. This stops healthcare teams from making good software and ultimately harms patient safety.
Outside of healthcare if you see something broken then you can just fix it, maybe rope in your manager.
Inside healthcare regulations you have to start a massive change control process which involves several busy people to approve it. Those people are busy and focused on getting a few priority items approved. Starting a change control process without a customer request doesn’t make you any friends.
The reasons this process exists is so that patients are never harmed by changes. But patients are also harmed by software that’s difficult to use. They’re harmed if you don’t make a change.
The regulations were designed for blood pressure monitors and insulin pumps. A patient data portal is orders of magnitude more complex. Outside of healthcare teams iterate towards a good solution. Inside healthcare teams cannot iterate, because of the regulations. This stops healthcare teams from making good software and ultimately harms patient safety.