Managing Product Lifecycle with Unifize
Delving into Harmonic Bionics' evolution, Michael Hogan speaks about the company's transformation from a small team of college students to a structured entity. As they scaled, the pressing need for robust documentation and product management became evident. The journey underscored the significance of an efficient QMS, ensuring streamlined operations and clarity in decision-making.

00:00 - 00:11
So when Harmony started, it was several grad students at the Renew Robotics Lab working on Robot designs in their spare time.

00:11 - 00:45
You know, it started as a company out of a house, you know, in a neighborhood somewhere in Austin. It was it was a very small team of essentially college students designing what would become the medical device robot. And as we grew, I joined on about two and a half years ago. It became very apparent that we needed a better way of doing documentation, of controlling records, of managing our device requirements and how that traces through to our design outputs.

00:45 - 01:09
In the medical device space. We have a product lifecycle that we need to go through. We need to clearly define our user needs. We need to define our requirements, the outputs that we need to test to and validate. And that's something that, you know, if you're a couple of guys in a college robotics lab, it's just not something that you're thinking about when you're putting together this thing that's never been made before.

01:09 - 01:14
So as we grew as a company, we got more serious about launch and we knew that something had to change.

01:14 - 01:27
What we started with was literally a pen and paper quality system. So like word documents that you'd print out and somebody would be signing pen on paper when let's say a part comes in, it needs to be inspected.

01:27 - 01:43
It was very tedious. There was no way of tracing the documentation when it was generated. There was no way to link anything. Somebody would have to literally sit down and go through a file cabinet to figure out what had what had gone on. It was just non workable, especially for a company that had at the time like seven people.

01:43 - 02:12
Like, what are you going to do, have three of your employees looking at a file cabinet? All that and it just wasn't going to happen. The so where Unifize came in and and we we did go from pen and paper to Unifize was that it procedure realized all of our processes right you know you can if you just have a pen and paper you can kind of and a you know, skip your way through a bunch of stuff that becomes tedious but Unifize it.

02:12 - 02:31
You are specifying a process that you have to follow every time. And that consistency helps, right? Whenever I'm looking back on something that's been done, if I'm looking at, say, our receiving inspector's comments on our material that we have, I know that it's going to be in the same format every time, which is it's nice. It's good to be able to go back and look at that.

02:31 - 02:58
The other thing is that the ability to link different quality system activities together helps tell the story of our product as it's being made. And so I can go back and look at the history of, you know, if we're trying to diagnose the root cause of some process issue, I can look through and find where that was. You know, it's like we have a virtual router that follows our parts and our device around until it gets into the field.

02:58 - 03:12
I think that that's something that's really invaluable about Unifize. And I think that it's probably the biggest benefit over our old system, which was once again, pen and paper.

Unifize Results

Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs

But what we've known from what I experience was, is we were able to get there with the system. We still there with the system. The system has what is needed to provide us what we're looking for, because every company, admittedly, is trying to get compliant. If we educate people, if we get people the education that they need and to get over the fear factor, I think 90% of those things can be resolved because most people will go to what they're most familiar with.What I worked with from a different company, but they're not willing to sit down and look at what the demographics are saying. People are into social media now. People are moving fast into fast paced world. But technologies are still antiquated. So there's a disconnect here, right? So while we're moving at a fast pace at home with dragging at work, so why can't we continue that speed while we at work?If your supplier has issues and you're not informed on time, you want to have an alternate supplier in place. If your suppliers are not qualified, you may not know that that needs to happen. And so when you have an integrated system that speaks to itself and is giving you all this data, you literally have the pulse of the organization in your hands as an executive at a money bound access.

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