The problem is that all these standards apply to large and small devices, and to software as well.
I was once tangentially involved with an app that was basically a weight tracker. It was supposed to be a simple, reliable solutions for doctors to prescribe their patients, that allowed doctors to export data, and did not have annoying ads.
Since doctors were supposed to prescribe the app, it had to be certified as a medical device. It was fortunately a self-certification process.
But still the certification process was 10x more expensive than just the app development.
The problem is that not every medical "startup" has multiple full time employees and millions in funding. Some are just a single doctor with a simple idea, and for them a few thousand dollar here and a few thousand dollar there quickly add up. The standards aren't their only expense.
I was once tangentially involved with an app that was basically a weight tracker. It was supposed to be a simple, reliable solutions for doctors to prescribe their patients, that allowed doctors to export data, and did not have annoying ads.
Since doctors were supposed to prescribe the app, it had to be certified as a medical device. It was fortunately a self-certification process.
But still the certification process was 10x more expensive than just the app development.
The problem is that not every medical "startup" has multiple full time employees and millions in funding. Some are just a single doctor with a simple idea, and for them a few thousand dollar here and a few thousand dollar there quickly add up. The standards aren't their only expense.