510(k) filed

Our company finally managed to file our 510(k) with the FDA last week and of course I have some random thoughts about the whole thing, I also have planned a big toot my own horn post later. It took approximately two years and $10 million (very approximately on that number) from concept to filing of a disposable and the (non-disposable) electronic controller "me too" device (filed as one 510(k)). There are still some kinks (mostly software) to work out before we are ready for clinicals- but we are pretty close.

In our case, I think it may have been possible to cut costs by 30% or so, but hindsight is 20/20. If we stuck to the long term vision, that could have saved us money. For example, the software guy was rushed to get a working demo up and going early on to show off to an interested third party, then had to go back and reprogram a lot from scratch as the demo didn't have the proper coding structure. Additionally, better management of some consultants could have saved us money and time. I don't think it is insulting to have a consultant doing an hourly or four hourly log sheet and then checking it every now and then against work done, at least for new consultants. Asking them to do mundane things that an assistant should be doing is also not the greatest idea, of course they are eager to do it, they are making $80 an hour + expenses to drive across town and pick up that stuff.

The software turned out to be the hold up and better planning could have saved us a good amount of time. Having an engineer working on just software issues would have helped, having weekly meetings with everyone involved didn't always help because the software guy wasn't able to prioritize correctly. The basic functionality must come first, the screen layouts and some other minor things are just too tempting for some people not to lay off of.

The last device I worked on the disposables packaging was a major problem, and I'm happy to say we managed to avoid most of that this time. The packaging is hard to do (IMO) because you really can't simulate EtO sterilization unless you actually EtO sterilize something and that will cost you probably at least $10,000 and a month and a half. We did the best we could, running the shipping simulation and the sterilization (time, temp, humidity) conditions beforehand, but I still notice some different effects when compared to the actual sterilization.

Getting FDA approval is the next step, but I'm not overly worried about it, the FDA is generally not unreasonable (in my experience) and honestly, the most likely outcome, one set of questions then they require clinical trials before final approval, would benefit the company in a number of ways. I think the hardest part will be after that, selling these things, doctors and nurses are keen on new devices and competition in general, but getting them to actually buy from the new guys is a different story.