00:00 - 00:14
As an engineer, right, my job is to solve problems with the product and make sure that we have a good saleable device that hits the market and does what it needs to it. That helps people. And if I do that, if I do my job as the engineer,

00:14 - 00:30
The way that we've set up our QMS with Unifize I'm just writing what I've done and that's the process, right? It is a time saver for me because ultimately I need to think about the system less and I can just focus on my job more,

00:34 - 00:51
Hi, my name is Michael Hogan, I'm a mechanical engineer here at Harmonic Bionics, and I deal with the nuts and bolts of Harmony. We are a medical device startup and we're working to bring rehab robotics into the upper body stroke rehabilitation space.

00:51 - 01:04
Our flagship device is Harmony SHR. It's bilateral upper extremity rehab exoskeleton. So my day to day work here at Harmonic Bionics, I primarily interact with our change order process.

01:04 - 01:13
I interact with our deviation, non conformances, and quality notification processes for material that comes in and has issues, that sort of thing.

01:13 - 01:28
For my workflow in my day to day work, I probably spend about 30 to 50% of my time interacting with Unifize in some way. That sounds high, but that's because we use it as a document of record for engineering outputs.

01:28 - 01:48
You know, I might be making a PowerPoint presentation for a design review that's intended to live in Unifize, right? That that's part of that 30% of that time. Or I might be looking at supplier information that is stored in Unifize. It is the easiest source of record for things that I need to find to do my job.

01:48 - 02:07
Some people maintain a nice file system on their computer of all their engineering work. Our Unifize system is kind of set up in that way or most everything I need if it's information about our product or about our risk management file or about our design requirements, I go to Unifize to get that. That's where I go.

02:07 - 02:14
It is very responsive. And if I need to get something done now, it gets done now. I can cut to the chaff and get with them what needs to get done.

02:18 - 02:33
The relationship I've had with a quality management system in my previous roles has more or less been: Get your design together, throw it over the fence, and two or three weeks later you might get an email saying that you need to add some field to a part property or something like that.

02:33 - 02:51
There's no communication back and forth. As far as I knew, it was just sending parts out into the void. With a smaller company, you cannot do that, right? There's nobody in the void to send it to. And more importantly like that, those two weeks you don't have. We need to get this stuff out now.

02:51 - 03:00
And So what I like about Unifize is that I see exactly what's happening with the information or the designs that I am putting forward to get released.

03:00 - 03:16
Everybody's looking at the same files. Everybody has the same chat history. There's no obfuscation of what's going on. Having a common understanding of the process that our parts designs, our deviations, quality notifications are going through is really useful.

03:16 - 03:28
I mean if you think about in just raw turnaround time to close out an issue. In the past, you know, a design update where I'd get all my paperwork ready, send it off, wait two weeks to maybe get a response.

03:28 - 03:34
Now, like literally after this meeting, I may go out and submit a Change Order and it will be approved, maybe even by the time you guys leave, Right?