Short answer: No, none of this makes sense. Your two most likely options are:
- Convince the CEO that this is a huge mistake, save the company, and stay at your job.
- Or, if you can't convince the CEO: Quit your job, because the company is going to fail within one year or so.
I've seen the same story play out lots of times already. It all boils down to having completely wrong priorities in a startup.
I'll make the rather bold assumption that your CEOs goal is to ensure the success of your company. With that in mind, the priorities should be:
I'll make the rather bold assumption that your CEOs goal is to ensure the success of your company. With that in mind, the priorities should be:
- You develop your first prototype of your device to 1) show that your idea is feasible, 2) show that it provides value, 3) show that to current and future investors to get more investment and 4) use that as a starting point for your "real" medical device which you'll hand in for certification.
- No other priorities.
Anything which gets in the way of building your first prototype must be deprioritized. This includes any sort of compliance trainings and even documentation.
Unsafe Devices?
Quick side note as you'll now probably be asking "but dude, doesn't that mean that we're shipping unsafe devices and injuring patients?". No, because, at this point, you haven't shipped a single device yet, so you also can't harm any patients. Duh.
See, there's a big difference between a) being a startup which is working hard on its first prototype-device and b) being an established company which is working on an iteration of an already-existing device.
In the second scenario, you're already on the market, patients are already using it, your device is already certified, you're getting audited regularly, so yes, of course, your development overhead is rather high and you need to document a ton of stuff while you develop your software.
In the first scenario, however, you're not on the market, so any sort of regulatory compliance should take a backseat to your product development.
This includes those useless trainings.
See, there's a big difference between a) being a startup which is working hard on its first prototype-device and b) being an established company which is working on an iteration of an already-existing device.
In the second scenario, you're already on the market, patients are already using it, your device is already certified, you're getting audited regularly, so yes, of course, your development overhead is rather high and you need to document a ton of stuff while you develop your software.
In the first scenario, however, you're not on the market, so any sort of regulatory compliance should take a backseat to your product development.
This includes those useless trainings.
Trainings = Wrong Priorities
As always, I got quite side-tracked here. But maybe it still is relevant, because all those trainings are more a symptom of a larger issue, which is about wrong priorities; and that needs to be fixed.
Like, it won't help much if you convince your CEO to cancel the trainings, while the CEO might still want you to create a gigantic ton of documentation alongside your (prototype!) development. That will still kill your company.
So it's about priorities, and at a startup, you must prioritize building your product over everything else. Sure, regulatory compliance is also important, but that happens later.
Here's a rough timeline:
Like, it won't help much if you convince your CEO to cancel the trainings, while the CEO might still want you to create a gigantic ton of documentation alongside your (prototype!) development. That will still kill your company.
So it's about priorities, and at a startup, you must prioritize building your product over everything else. Sure, regulatory compliance is also important, but that happens later.
Here's a rough timeline:
- Build your first product prototype, deprioritize everything else (1-6 months).
- Document it, get it certified (6-12 months).
- Try to sell your device to customers.
- Check whether your company still has money, probably look for investment.
- Maybe ship another version of your device.
Conclusion
And.. I'm still not done with my rant.
The sad reality is that I haven't been able to convince a single startup CEO of changing their course, so I had the unfortunate chance to witness many companies fail due to having wrong priorities.
Unless you're the CEO and have some control over this (chuckle), chances are that you should probably start looking for another job now, because you're company's priorities are all wrong and it's likely going to fail in the mid-term future. The first symptom of this is usually that software developers start leaving and, later down the line, (prototype) product development gets delayed, while people start arguing over extremely useless things (should be add flowcharts to our SOPs?).
Get out while you can. Good luck.
The sad reality is that I haven't been able to convince a single startup CEO of changing their course, so I had the unfortunate chance to witness many companies fail due to having wrong priorities.
Unless you're the CEO and have some control over this (chuckle), chances are that you should probably start looking for another job now, because you're company's priorities are all wrong and it's likely going to fail in the mid-term future. The first symptom of this is usually that software developers start leaving and, later down the line, (prototype) product development gets delayed, while people start arguing over extremely useless things (should be add flowcharts to our SOPs?).
Get out while you can. Good luck.