Mechanical Engineer, Harmonic Bionics

Michael Hogan

Michael Hogan, a  mechanical engineer at Harmonic Bionics, specializes in optimizing the company's groundbreaking rehab robotics. With a focus on tangible results, he seamlessly integrates quality management systems, ensuring rapid, efficient design iterations for the transformative Harmony SHR.

About Harmonic Bionics
Harmonic Bionics, led by a highly talented and successful leadership team with vast medical device experience, is a commercial-stage robotics and digital health company that aims to unlock human functional capabilities through robotics.
Medical Devices
Austin, Texas, United States of America
Engineering Efficiency with Unifize: Michael Hogan's Insights from Harmonic Bionics
Mechanical Engineer Michael Hogan elaborates on how the integration of Unifize at Harmonic Bionics has streamlined his engineering processes, promoting transparency and rapid turnaround in the medical device domain.
Engineering Efficiency with Unifize: Michael Hogan's Insights from Harmonic Bionics


Harmonic Bionics, a pioneering medical device startup, has revolutionized its engineering processes with the integration of Unifize. This case study delves into the experiences of Michael Hogan, a mechanical engineer at the company, highlighting the substantial improvements in workflow, communication, and documentation since the implementation of Unifize.


Before Unifize, the engineering team at Harmonic Bionics faced delays and a lack of communication in their quality management system. Designs seemed to be thrown “over the fence” with little to no feedback, leading to a black hole of information. This lack of transparency and delayed responses were not conducive to the fast-paced environment of a medical device startup where time is of the essence.


Unifize was introduced to address these inefficiencies. A platform designed for real-time collaboration and documentation, it quickly became the central hub for all engineering outputs. Michael Hogan's day-to-day activities, ranging from creating PowerPoint presentations for design reviews to managing supplier information, were streamlined as Unifize served as the single source of truth for all product-related data.

Real-Time Collaboration

With Unifize, the entire team could see the progress of designs and documentation in real-time. The common chat history and file access eliminated any obfuscation in communication, fostering a transparent environment where everyone was on the same page.

Documentation as a Record

The platform also functioned as a living record of engineering work, replacing the need for individual file systems. Whether it was about product information, risk management, or design requirements, Unifize provided a responsive and reliable source.

Accelerated Turnaround

The change order process, which once took weeks, was reduced to the possibility of being completed within the same day. This efficiency was not just a time-saver but also a game-changer in the competitive field of medical device innovation.


The impact of Unifize at Harmonic Bionics was immediate and profound. Michael Hogan noted a significant reduction in turnaround time for closing out issues. What previously took weeks to get a response now could be initiated and approved within a day, ensuring that the company could move quickly from design to production, thereby accelerating the time-to-market for their flagship device, Harmony SHR—a bilateral upper extremity rehab exoskeleton aimed at revolutionizing stroke rehabilitation.

Efficient Utilization of Time

Michael estimates that 30 to 50% of his time is now spent interacting with Unifize, which sounds substantial, but it is indicative of the platform's role as a comprehensive tool for engineering outputs, thereby allowing him to focus more on his role as an engineer rather than on system management.


Unifize has not only simplified the documentation and quality management processes at Harmonic Bionics but also empowered the engineering team with the tools to perform their roles efficiently. Michael Hogan’s testimony stands as a testament to Unifize’s capability to transform the engineering process, making it more transparent, collaborative, and significantly faster, thus aligning perfectly with the dynamic needs of a medical device startup.

[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?
About Michael Hogan & Harmonic Bionics
Michael Hogan, a mechanical engineer at Harmonic Bionics, paints a vivid picture of the company's origins. He recounts the early days when it was just a group of grad students from the Renew Robotics Lab passionately working on rehab robotics. Their flagship device, Harmony, emerged from these efforts, aiming to revolutionize the recovery process for stroke patients.
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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.
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How a configurable QMS helps engineers
Highlighting the practical challenges engineers face, Michael Hogan emphasizes the value of a tailored QMS. With Unifize, they had a system that catered precisely to their needs, without unnecessary overhead or constraints. The flexibility to mold the QMS to their unique processes proved invaluable, contrasting starkly with other restrictive systems they'd encountered.
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Problems I faced with other eQMS that Unifize solved
Michael Hogan candidly shares his past frustrations with traditional QMS platforms. Recounting experiences where designs were sent into a seemingly endless void, only to receive feedback weeks later, he stresses the inefficiencies of such systems. For dynamic startups like Harmonic Bionics, where agility and promptness are paramount, a responsive and interactive QMS like Unifize became indispensable.
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How Unifize helps save time and get things done faster
In this video, Michael from Harmonic Bionics celebrates the transparency and coherence Unifize offers. He values the platform's ability to keep everyone synchronized, viewing the same documents and chat histories. This clear and shared understanding of processes, from part designs to quality notifications, not only fosters efficiency but also lets Michael concentrate more on his primary responsibilities, enhancing productivity.
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How we use Unifize as an engineering system of record
Michael delves into his daily tasks, emphasizing his continuous engagement with vital processes such as change orders and quality notifications. He reveals that Unifize constitutes a significant chunk of his workflow, attributing this to the platform's central role as the engineering document of record. Whether it's creating presentations for design reviews or other tasks, Unifize stands as the go-to platform for all engineering outputs.
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How we manage change on Unifize
Michael offers a behind-the-scenes look into the engineering practices at Harmonic Bionics. He talks about his reliance on tools like SolidWorks for computer modeling and Apache subversion for version control. Despite a limited software stack, there's a hands-on approach to their work, encompassing tasks from debugging robots to prototype development. Michael underscores the systematic approach they follow in documenting design outputs, hinting at the role of Unifize in this process.
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Managing part revisions on Unifize
Michael sheds light on the intricacies of managing part revisions at Harmonic Bionics using Unifize. He describes their systematic approach, where each part is tagged with a specific revision. This setup allows team members, like purchasers, to seamlessly access and review older versions of parts when needed. Michael values Unifize's capability to store and present all relevant information, from product definitions to design files, ensuring a comprehensive understanding of each part's evolution.
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Building a knowledge base in a startup with Unifize
Michael delves into the distinctive aspects of working in a compact company setting. He underscores the pivotal role of relationships, whether with colleagues, suppliers, or clients. Highlighting the importance of human-centric approaches in startups, Michael contrasts this with the rigidity and compartmentalization of vast corporations. His reflections shed light on the balance between the personal touch and systematic workflows in different company sizes.
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Collaborating with vendors using Unifize
Michael elaborates on Harmonic Bionics' systematic approach to documenting design outputs, emphasizing their reliance on definitive documents such as step files and PDFs. He offers a peek into his daily routine, which frequently involves addressing quality notifications on Unifize, collaborating with vendors, and updating specifications. Through his narrative, the importance of Unifize in streamlining vendor interactions and ensuring accurate design documentation becomes evident.
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