Director of Quality and Regulatory Affairs, Harmonic Bionics

Denis Machoka

Denis is an accomplished quality and regulatory leader with over 25 years in quality systems compliance, mostly in the pharmaceutical and medical device industries. Denis is a Certified Six Sigma Black Belt from the Juran Institute of Quality Management and received his MS in Quality Systems Management from New England College of Business.

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
Unifying Quality Assurance with Unifize: A Transformational Journey
Quality expert Denis details his transformative journey with Unifize. He praises its efficient design, user-centric approach, and the system's ability to streamline data handling and accelerate time to market.
Unifying Quality Assurance with Unifize: A Transformational Journey

In an environment where meticulousness and prompt decision-making are paramount, Denis Machoka's interaction with Unifize provides an insightful look into the profound effects of integrating advanced solutions into standard operations. Denis, an esteemed customer of Unifize, came from a sector where the importance of clear communication and timely documentation cannot be overstated.

When he initially engaged with Unifize, Denis faced the burdensome challenges of fragmented communication, delayed responses, and an absence of a unified system for documentation. These barriers hindered efficiency and occasionally led to errors. Realizing the significance of these issues, Denis sought a streamlined platform to enhance both productivity and compliance with industry standards.

Unifize emerged as the answer. Upon integrating this platform, the advantages were immediately noticeable. Unifize centralized all crucial communications, decisions, and documents, eliminating the need to toggle between multiple tools or seek frequent updates from colleagues. The user-friendly interface of the platform ensured that every team member could engage without technical hindrances. Notably, every modification or decision was transparently recorded, allowing for a clear audit trail.

One of the most impactful results of Unifize's integration into Denis's workflow was the substantial decrease in processing times. Activities that once took extended periods, held back by miscommunications or bureaucratic delays, were now finalized much more swiftly. Denis's ability to initiate and oversee a project in real-time, making necessary adjustments along the way, significantly enhanced operational agility.

In summary, Denis Machoka's experience with Unifize underscores the potential of adopting the right technological tools in contemporary business settings. It showcases the importance of not merely adopting technology but selecting solutions that align with specific challenges. For Denis, and indeed many professionals in similar settings, Unifize has proven invaluable, bridging operational inefficiencies and promoting a collaborative and streamlined work environment.

[00:00 - 00:20]  
If you're watching this and you're on the fence on what quality system you need to get, I highly recommend it. It's very easy to implement. It's one of the easiest systems I've ever had to implement. I've been to Documentum and all the big other companies out there, the MasterControls, I've implemented some of those systems.

[00:20 - 00:29]  
I have never found a company that was so easy to implement. This company specifically was very intuitive, with lots of support.

[00:29 - 00:43]  
We had maybe two or three calls and we were off running. We had access to the system almost instantaneously based on our initial discussion, which is unprecedented. Most companies take much longer, but we were in good shape in a very short time.

[00:43 - 00:58]  
The second reason why this is a no-brainer for me is the simplicity of it. Most other companies have master courses on being certified in managing information. Why would you do that?

[00:58 - 01:10]  
You don't need to be certified to manage a quality system; that's counterproductive. Now you're spending resources on training to manage a system, which doesn't make sense to me.

[01:10 - 01:24]  
The last thing is compliance. The system is compliant. We checked it and looked at all possibilities. It passes the sniff test, the predicate rule test, 21 CFR part 11. It's a validated system.

[01:24 - 01:37]  
Your data is not getting lost. There's a lot of backup, and there is security involved in the system. If you have security, simplicity, and ease of implementation, I don't see why you couldn't use it.

[01:37 - 02:04]  
My name is Denis. I'm a Quality Systems expert, if you can call it that way. My background is in chemistry, so I'm a scientist by application. I went to Iowa State. I was a vice president for quality assurance and regulatory affairs for Harmonic Bionics in Austin. For that organization, what I did is all things quality related to making decisions based on what information needed to be kept as part of our regulations.

[02:17 - 02:34]  
The main thing other companies or tools are missing is separating the conversation from the data. A lot of systems have a conversational piece, which is email, and then you have the data which is totally isolated.

[02:34 - 02:47]  
To navigate that, you have to know the system and where the data is located. Then you have to go and navigate where the message is, which means channeling through thousands of emails to get the right information. That's a lot of time wasted.

[02:47 - 03:06]  
What if, and this is why it's a beautiful tool to have, this could be done together? There's nothing in the regs that says you can't do this. This tool allows for that to happen together, and that's the power of the tool. When you merge the data and the conversation, you have a full picture of the data.

[03:06 - 03:24]  
Now you can do something about the data. Now, you can talk about the data, and everybody's vision, concern, and opinion of that data is all documented. You can search on that data, do data aggregations on different conversations, and find the latest information.

[03:24 - 03:41]  
One of the best things I noticed is how easy it is to get audits and preparations through. I'm able to see the conversations, which means I'm able to know what the latest information is, and that is invaluable. Instead of going through emails, all that information is there, right with the data.

[03:45 - 04:03]  
When you're talking about speed to market, return on investment and speed to market, you have to look at the effort it's going to take you to put the quality system in place. Are you going to go and have a person who is going to know every nuance about your configuration?

[04:03 - 04:20]  
Because that's what it takes for most other companies. You will need to know all of the workflows in detail to know exactly where they are, touch points, on what level of security you expect for each of them. You're also going to need an IT component of it because most of the systems will need a local client of some IT support.

[04:20 - 04:41]  
You're also going to need a level of access. Cost is also a consideration that you need to have. Are you going to have cost that is going to support that? Most of the systems are high cost, high maintenance. When you look at those front end costs and configuration efforts that you need to put, it drives the cost of the final product.

[04:41 - 04:59]  
Now you're going to still be compliant, but you spent a lot of energy doing that. On the other hand, you have Unifize, which of the box, without a lot of configuration, you can still get the level of compliance that you need. Now, you don't need IT to be involved. You leave the configuration of the system with QA.

[04:59 - 05:12]  
Now you've changed the responsibility, it's no longer IT getting in the middle of it, but you have now QA driving it. Who would you rather have? You'd rather have QA driving it than have IT involved in it? Because that's another component you have no control over.

[05:12 - 05:26]  
The best way and we had this experience with Unifize was to have QA drive and once QA drove it, it was easy for QA to make the adjustments without necessarily getting somebody else to do the configuration.

[05:26 - 05:51]  
Somebody has to update somebody else to go the back and forth is really system that we, I have used in the past involved going back to the customer and having a project manager that managed all the changes. So, QA would go into an isolation, they would make recommendations. They would have a meeting, that meeting would drive a decision which would go into the configuration team.

[05:51 - 06:11]  
Then the configuration team would have another discussion about the changes are asking before the changes can be made. So if I'm a Lean Six Sigma person or somebody who just wants to get there directly, I'm cutting to the chase. I'm giving the tool directly to the QA organization who are making and are responsible for the data.

[06:11 - 06:18]  
I would rather have the right people configure the system than have others involved who may not have a stake in the system.

[06:18 - 06:37]  
In terms of time to market, those two systems may get you there, but one is going to get you there faster because it goes directly For us it took four weeks for the other systems that I've worked with. It took us almost a year. Part of that is because the decision makers sometimes when not available, they took a vacation.

[06:37 - 06:58]  
Sometimes the project managers scheduled calls decisions were not made during those calls. So those decisions were punted forward. Sometimes the configuration did not work. That meant they had to go back and reassess those meetings and circles and cycles that you go through are taking time while Unifize comes out of the box, has everything that you need.

[06:58 - 07:10]  
QA was in control of it. They are showing you how to do it. Access is provided and everybody can use it. As soon as everyone is in the system. It's no brainer.
How Denis builds a quality culture in MedTech companies
Denis Machoka, a Six Sigma black belt, highlights his transformative approach to Medtech companies. He shares insights on assessing an organization's current state and vision, the critical role of communication in building a quality culture, and the essential tools to foster knowledge and improvement.
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Why Unifize’s unique approach to collaboration helped Harmonic Bionics
Denis Machoka discusses the unparalleled collaborative approach of Unifize, highlighting its ability to centralize and streamline conversations, reducing the traditional reliance on emails. He praises its efficiency in consolidating information and contrasts it with the inefficiencies of managing multiple systems in other platforms.
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Accelerating feedback loops by creating transparency using Unifize
Denis Machoka highlights the transformative power of transparency through Unifize, emphasizing clarity in responsibilities and priorities. He praises its capability to communicate seamlessly with a broad audience and values its mobile integration, enabling real-time updates without the need for multiple tools or email checks.
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What other eQMS are missing- Separating conversations from data
Denis Machoka pinpoints a critical shortfall in many eQMS: the division of conversations and data. He critiques the inefficiencies of navigating isolated data and scattered emails, championing Unifize's innovative fusion of both. By merging discussions with data, Unifize presents a unified, actionable view, streamlining decision-making and collaboration.
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Evaluating other eQMS software tools
Denis Machoka delves into the evaluation process of various eQMS tools, citing considerations for present needs and future growth. Comparing Unifize to platforms like Ignite EDMS, Veeva, and Greenlight Guru, he underscores Unifize's ease of implementation and its integrated conversation feature as standout advantages.
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Why it was easy to win the hearts and minds of engineers about Unifize
Denis Machoka reveals how Unifize's simplicity and instant information accessibility resonated with engineers at Harmonic Bionics. The platform's integrated conversations enabled engineers to quickly grasp expectations and engage in substantive discussions, streamlining communication and boosting efficiency.
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Connecting the dots- managing a DMR & DHF on Unifize
Denis Machoka emphasizes Unifize's prowess in managing DHF and DMR data, highlighting the platform's traceability, accessibility, and real-time status updates. He appreciates its ability to keep users informed about the latest file versions, preventing potential confusions. Denis also touches upon his AI background and experience with IBM.
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The ROI of a collaborative, configurable eQMS
Denis Machoka elaborates on the ROI derived from Unifize as a collaborative eQMS. He underlines that true ROI is reflected in compliance, data accessibility, and the defense of information. Denis commends Unifize's capabilities in showcasing regulatory control and its adaptability to adjust control levels based on data sensitivity.
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Speed to market in Medtech is about empowering the quality team
Denis Machoka discusses the factors influencing speed to market in Medtech, focusing on the complexities of implementing a quality system. He underscores the detailed understanding of workflows, IT support needs, security considerations, and the potential high costs and maintenance of many systems, emphasizing their impact on the final product's cost.
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Unifize - a validated QMS software
Denis Machoka elaborates on the validation credentials of Unifize as a QMS software. He underscores that Unifize is pre-validated, comes with a comprehensive validation package, and emphasizes the simplicity of its configuration, stressing the need for proper documentation.
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The simplicity of the Unifize onboarding process
Denis Machoka praises the effortless onboarding process with Unifize. Pre-established access matrices ensured a smooth transition. He lauds the platform's ease of setup, where users quickly received access links on their devices, and emphasizes the consistent user experience across multiple platforms, highlighting its adaptability.
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They key to configurability- make it simple & easy
Denis Machoka extols the straightforward configurability of Unifize, contrasting it with the complexities of other systems. He appreciates its pre-configured design, likening it to object programming. Denis believes Unifize's inherent simplicity is testament to its creators' deep industry understanding and their aim to simplify user experience.
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Using dashboards on Unifize to make Management Review Meetings Easier
Denis Machoka underscores the significance of Unifize's dashboards in streamlining management reviews. Highlighting the need for quick access to high-risk data points, he appreciates the platform's ability to present crucial insights on-demand. Denis contrasts Unifize's efficiency with the traditional, tedious method of manually collating data, emphasizing the time savings.
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Closing the loop- Traceability and lot tracking using Unifize
Denis Machoka elucidates the intricate process of traceability and lot tracking at Harmonic Bionics, especially for their robotic devices. He details the meticulous tracing of parts, their consumption, and potential issues. Denis highlights how Unifize is instrumental in ensuring precise tracking and updating of materials consumed during the device development.
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About Harmonic Bionics- a robotics MedTech company in Austin, Texas
Harmonic Bionics, based in Austin, Texas, designs robots to assist in upper chest healing for patients with mobility challenges, especially those recovering from strokes. By facilitating limb movements, these robots aid in retraining neural connections. The company is FDA-registered and collaborates with the University of Texas for research.
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Avoiding the mistake of thinking you need a complex QMS software to scale
Denis Machoka addresses misconceptions in QMS, emphasizing the value of easily accessible information for compliance. He challenges the notion that larger, more complex systems are inherently better, suggesting that simplicity and efficiency should be the focus.
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Get to market faster by enabling agility and overcoming fear
Denis Machoka emphasizes the importance of overcoming the inherent fear of new technologies in the quest for compliance. He advocates for education to bridge the gap between rapid societal advancements and slower professional tech adaptations, stressing the need for agility in today's fast-paced world.
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How to digitally transform your MedTech company without slowing things down
Denis Machoka recounts his pursuit of a swift digital transformation for Harmonic Bionics, leveraging the latest technologies. Drawing from his transformational background, he emphasizes achieving goals rapidly with minimal effort and gauging the team's adaptability to fast-paced changes and technological innovations.
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How quality leaders can get the pulse of their organization without stifling innovation
Denis Machoka redefines the concept of 'quality', highlighting its role in transformation and enablement, rather than mere control. He underscores the need for effective systems that aggregate organizational information, emphasizing the importance of addressing non-conformances, failures, and supplier issues promptly to maintain high standards.
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How to take the plunge on an eQMS- build consensus across the company
Denis Machoka shares Harmonic Bionics' collaborative approach to choosing an eQMS. The team collectively identified and categorized desired system attributes, ensuring the chosen system reflected the team's consensus. This method involved engaging with vendors that met their defined criteria.
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Three reasons why Unifize is the easiest QMS- Security, simplicity, compliance
Denis Machoka advocates for Unifize as a QMS, praising its exceptional ease of implementation and intuitive design. Drawing a comparison with other renowned systems, he emphasizes Unifize's simplicity and rapid setup, making it a standout choice in the realm of quality management syst
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About Denis Machoka and his role as VP of Quality at Harmonic Bionics
Denis Machoka, VP Quality at Harmonic Bionics, shares his evolution from a scientist with a background in chemistry and biology to a Quality Systems expert. He delves into his experiences in laboratories, IT systems implementation, and his expertise in qualifying systems within regulatory frameworks.
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How Harmonic Bionics benefited from Unifize

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
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