[vjvjvjvjghv]

I am retiring next year. So that should solve my problem :). I don’t know how other medical device companies are working but in mine leadership is dominated by people who know medical devices from a sales or medical perspective. Software is kind of secondary to them although it’s becoming really important. A lot of our processes aren’t very good for software so we end up doing a lot of work that makes no sense and makes the product actually worse. It’s better not to fix bugs because a new release will take months of paperwork. The requirement structure doesn’t map to software but the SOP isn’t written by people who known software. It feels a little like the development speed of NASA with the SLS vs SpaceX who are basically doing everything faster and cheaper while still having high reliability . My company is NASA here. Just very frustrating

[jacquesm]

I've worked with a startup in the medical device space. Well funded. They were indistinguishable from most other startups, except in one detail: they did everything right. They made some extremely high tech stuff, very lightweight, and technology wise they were closer to watchmakers than to software and hardware people. I loved working with them and helped them to improve their yield (their QA was so strict that of their initial couple of runs more than 2/3rds of the devices got binned for the smallest infractions).

I suspect you may have just been unlucky with where you ended up. I'm getting closer to retirement myself but I no longer have to work for 'the man' so in that sense I got really lucky. But I really sympathize with how you feel. So, count the days, and look forward to something nicer. Best!

[vjvjvjvjghv]

From what I have seen startups have it a little easier. They are usually focused on one product and often just get acquired before having to go to market themselves. Selling multiple products worldwide and complying with regulations is a totally different ballgame.

[jacquesm]

These people are at the 'scale up' stage now and and - successfully - have a foot in the door and are shipping volume all over the world.

So it is definitely possible. But it isn't common, that's definitely true.

[nickpsecurity]

What you describe sounds nothing like most, safety-critical development I've heard of. Whereas, I've heard the other person's story countless times when I studied high-assurance systems. Very slow, top-down, process-heavy, paperwork-heavy, and outdated tools.

On the other hand, it sounds like the company you mentioned is worth imitating where possible. They sound awesome. Are you allowed to name them? Is there any writeup on how they balanced velocity and regukatory approval?

[jacquesm]

> Are you allowed to name them?

Unfortunately not. But the devices they make are absolute life savers and I found it one of the most interesting jobs I did in the last couple of years because I think I learned more from them than they learned from me. I was just focusing on a handful of details, they had to keep the broader picture in mind all the time and educate me to the point that my knowledge became useful to them.

You are probably right that they are uncommon, but the fact that the company was led by a scientist who was very much involved in the process and the mission and offloaded as much of the non-essentials of the CEO job to others made me feel I had gone back in time to be near HP when they were just founded. In the longer term I expect them to dominate the space.