Medtronic wins

Devicetalk:

Medtronic has won a case that went to the U.S. Supreme Court over whether patients could sue manufacturers of PMA-approved devices in state courts. The high court ruled 8-1 that because FDA has already made a determination about the safety and effectiveness of the product, state lawsuits are barred when they would impose different requirements. The ruling, which pertained to a patient named Charles Riegel who was injured by a Medtronic catheter, was released this morning, reports the Associated Press.

Medical device news of the decade! I'm not really kidding either, no one talks about medical devices. It would be mildly entertaining if a medical device maker tries to convince the FDA that they fall under a PMA instead of a 510(k) now.

Finally sorta done

We finally managed to "sorta" finish enough of the 510(k) to send it to the regulatory consultant. If we hurry it will only be submitted 2 months behind the original schedule, I have a big horn tooting post planned for then. By sorta finished I mean I need to slip a few more details into the software section before its final and the poor VP is double checking my traceability analysis line by line and he'll probably have a few changes. That is the reward he gets for also being the management quality rep.

You can drive yourself nuts attempting to second guess what the FDA wants as far as a software validation, it is almost purely a judgment call. I could easily write another few months software testing into there, would it be useful testing? 99% of it probably not, but it takes that 99% to find the 1% where there may be an issue. Is it worth it to spend half a day rigging up a test to show that if the hard drive is full the software can deal with it? At least 20 gb of free space, and the files are less than 100 kb, if someone fills that up we sold them tens of millions of dollars of disposables- if only! Much of this has to come down to trust on the FDA's part, because outside of having 2 guys test the machine for 6 months (in my experience they don't ask to even see the machine), it is difficult for them to judge the quality.

It was getting a little tense at work for a while, hopefully with the 510(k) out of our hands we can get back to normal. There is still a lot of work to be done, a couple items in the 510(k) we told the FDA we'd finish before clinical use, but the bulk of the work has moved from product development work to mostly manufacturing fine tuning. Everything needs fixtures and some bugs in the process need worked out to get the product consistency we need. If that wasn't enough we're also moving the company, which is scheduled to be a one month delay, but I foresee a three month delay in progress.

PS My wife has assured me that the new header matches the rest of the blog, green and brown matches, who knew?

Sterilization wrap up

I promised a while ago to summarize the sterilization situation, hopefully someone will find our experiences useful. Our disposable product was designed for EtO sterilization, an important potential add on to the product made by another company has been approved using EtO and changing their sterilization method at some point would be a huge hassle. So we built the validation samples, shipped them off to the sterilizer, they wrote the batch release protocol, based upon the add on's protocol and we ended up failing sterility testing for both the half cycle and full cycle.

A QA and I forced a meeting and flew immediately to the sterility test lab, I think the lab is still unhappy with us for this- they avoid talking to the QA at all now, but thats what we were told to do. Anyway, we sat around a table with the lab personnel and they told us in not so many words, what we already knew because they said the same things on the phone, its just one of those things. The lab actually handled it very well and had some useful minor suggestions, but there is not much they could do. You don't want to do sterility testing if you can avoid it because these things happen, obviously you have to do it a few times to validate. We made a few very minor changes to the testing procedure, doubled the sterilization time and flew back to help finish build more samples, working through many a weekend. When we tried again with the new protocol it worked out well for us, and it was done quickly enough.

Since at the time of the failure the company had more money than time, we decided to hedge our bets and also approached Anderson to run a batch release in almost parallel. The Anderson folks wanted to do some development work first, due to our previous failed sterilization attempt as generally their sterilization method is gentler than standard EtO sterilization so there was some question about if it would work at all. We got the samples to them, they ran the development work and everything came out roses- it was on. They sterilized the samples and sent them to Apptec for sterility testing and everything tested sterile. FWIW, the Anderson half cycle process sterilized what the 2 hour standard EtO cycle did not, but I don't put too much stock into that bit of info, as I know several devices which use a sterilization time less than ours and are triple the size and more complicated. Overall, the Anderson sterilization cost about half as much and was performed more quickly from start to report, if you take into into account that they did some development work first.

Going forward we're going to file the 510(k) initially with the standard EtO sterilization, but in the future add Anderson, especially since we have plans for a series of low volume, high cost disposables that would be perfect for Anderson. The FDA considers the Anderson sterilization a "non-traditional" method, but I don't think it would be much of a problem to get approval for as the method is becoming more common and is well documented.

Theoretically you can use 3 successful batch releases to validate sterilization, if they are exactly the same composition, that is not going to happen. I've been pushing the company to go through a full sterilization validation, but I don't think that is in the cards for this year. I have theoretically officially turned all sterilization duties over to QA although I think that will be forgotten next time we need to sterilize something.

Software Design Specification Writing

I spent the last week and today (minus time out for inane tasks that get us nowhere, focus people!) writing the software design specifications (SDS) . Honestly, I could probably spend another week on it. The SDS is key part of FDA 510(k) submission software section and verification and validation (V&V) and I suspect the software section is the section the FDA will rightly focus on. Unfortunately, the guy who wrote the software has a hard time transferring his thoughts from code into English, he wrote a really rough draft then I had to take over once we started looking at it. It is difficult to split the SDS and software V&V into parts that more than one person can work on, which means I get bugged a lot about progress by people who don't understand how one document could take a whole entire week to finish when we had a draft last week, then have other documents to write after that that may take even longer.

Before I left on vacation in December the V&V was scheduled to be done the next week- no one followed up on it and since only one person can really work on it at a time if that person is bugged to do other things, no progress is being made. I posted about getting a draft V&V before. How did it look? Brutal. Now it looks like I'm going to spend next week writing most of it. The software guy thought he should write the V&V first before the SDS and then we could work on the V&V while he wrote the SDS, but that just turned into a big mess. The company is kind of schizophrenic lately and can't seem to focus properly, which is why they had me do the SDS this week instead of two weeks ago right when I got back. If the software documentation is holding you back, every minute engineers aren't working on software documentation is delaying the submission, just keep that in mind before talking to them about anything at all, really.

Anyway, I think ideally you take the software design requirements, add to it so it becomes the SDS, then take the SDS and add the V&V steps, that way your traceability is covered without sitting around cross referencing documents for two days.