About Harmonic Bionics, an early stage med device company
Clarissa Archer sheds light on Harmonic Bionics, a robotics startup. Their flagship product, Harmony SHR, assists rehabilitation for those with shoulder impairments due to neurological or muscular issues. Initially research-driven, the company now emphasizes quality assurance, aligning with FDA regulations and recommended ISO standards.
Transcript

[00:00 - 00:16]
Yeah. So Harmonic Bionics is a startup company that focuses on robotics, our primary robot is Harmony SHR, and that is to help people with either neurological impairments or muscular impairments rehab their shoulder.



[00:16 - 00:52]
So our customers are primarily going to be rehab physicians or hospitals, rehab facilities and the people who will be using it. Our patients are going to be people who've, for example, have stroke Guillain-Barré or other neurological disorders or even just injuries, sports injuries where they don't have the proper mobility in their shoulder in the beginning of Harmonic Bionics, we were very research focused company really focusing just on the development of the robot, ensuring that what we were building is something that would work.



[00:52 - 00:57]
And so when I started, we actually started to move towards a more quality focused organization.



[00:57 - 01:16]
And so we have to follow the FDA 21 CFR 820 it's not required by the FDA to follow ISO 13485 or 14971 or ISO 9001, but those are heavily recommended. And so we also try to follow compliance to those ISO standards.



[01:16 - 01:32]
I think we also are moving looking at IEC 60601 62304 from like a software and robotics side. And so there's a lot of different standards and regulations that we need to follow and keep compliance too.



[01:32 - 01:43]
We noticed a lot of gaps in what would be needed in order to take our company from research focus to medical device compliance focused, regulatory focused.



[01:43 - 02:10]
And so with that involved, you know, noticing those gaps was, you know, there was a lot of focus on change control documentation. But there was difficulty in the communication of change control and actually documenting what changes were being made. So I noticed that was a big difficulty and a lot of the users didn't quite understand the importance of something as simple as change management, for example.



[02:10 - 02:38]
I keep going to that because that was, I think, one of the biggest pain points. And of course there is documentation being lost having to be rewritten because it was lost and being able also, we had some individuals who were working remotely or from different areas to have people who were in different states having to come down and physically sign something or use DocuSign or something like that, that was a big pain point for us.

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Transcript

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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