Gauging Interest in Using LabVIEW for Regulated Markets

[DanRichards]

Hello All,

As I mentioned during the last user group meeting in Woburn, about a year ago I started on a project where our goal was to prepare LabVIEW software as part of a Class II medical device. We were initially told by "experts" that since LabVIEW does not have a certified compiler, "real" static analysis, and some specific error insertion functions (found in other embedded products they had previously used) that we wouldn't stand a chance. We also didn't have the Quality processes in place yet to support a LabVIEW project - we were essentially starting from scratch. What we did have was a small, highly-motivated multidisciplinary team, and we sincerely focused on what the FDA ultimately cares about: safety and efficacy.

When we got started, it was difficult to find information about what to expect using LabVIEW - a map of the landscape, so to speak. Now might be a good time to share what we learned so that others interested in using LabVIEW in a regulated market can get an idea of what's involved.

I will likely submit an application to present at NI Week 2016. But, in the meantime, I would appreciate seeing any initial questions from folks like you in industry. Does this make sense as a topic at a user group meeting?

Lastly, I have not heard recently about someone doing what we've done, but that might be a bad heuristic to gauge market experience. Have you used LabVIEW as part of a medical device? How about using LabVIEW in another safety-critical application in another regulated market? Perhaps there would be additional value in exploring a joint presentation and/or panel discussion, whether it's as a part of this group or otherwise.

Best regards,

Dan

[JohnShannon]

I would like to see this topic at a user group meeting. 

I do have some limited experience using LabVIEW for an end-of-line manufacturing test fixture for some medical devices.  This was many years ago and I was a minor part of the team, but I do remember some of the hurdles we had to overcome to make it FDA compliant. 

John

[DanRichards]

John,

Thanks for the input. Would be interested in discussing some of those hurdles with you if we can find a minute to connect. Can you estimate roughly how many years ago, and whether the software had a specific safety classification (e.g. Class I, Class A, etc.), or if you remember the "level of the concern" of the system?

Best,

Dan

[JasonDMC]

Dan,

While I'm not in Boston much these days, I think it would be a great topic. On a sidenote, here in Houston there is a well respected Alliance Partner called Velentium. If you're looking for benchmarking and learning about using NI products in medical applications, they would be a great group to reach out to. They've been doing a lot recently to collect all the necessary certifications and put the required procedures in place and have been quite successful.

Jason

[DanRichards]

Jason,

Really do appreciate the tip. I will reach out to Velentium later in the week. If you know the right contact off-hand, message me and let me know if you would be willing to swing a mutual intro.

Best,

Dan

[JohnShannon]

Dan,

It would have been 2002 to 2005. The software did have a specific compliance standard (FDA 21 something?). The 2 projects that I worked on were for end-of-line test fixtures. One product was a plastic vial that had certain color & clarity specifications. The other was for the thing they have on a hospital bed which allows you to call for a nurse, control the TV, etc.

The software had to be tamper proof and had to be able to verify that it was the correct software and had not been changed. Sorry I do not remember more details, but my part of the project had very little to do with the FDA compliance part of it.

John Shannon

LabVIEW Software Engineer

Nuvera Fuel Cells

Work (617) 245-7638

Cell (585) 329-8589