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.
Transcript

00:00 - 00:11
I think in terms of the system, one of the things that we did at Harmonic Bionics that really helped the organization was we did this as a team.



00:11 - 00:34
I took myself out of the picture as an executive and kind of let the team make a decision on what an ideal system would be. We literally had meetings where we said, what would be our best quality system? What does it need to be in, needs to have all these attributes and we put them on the board and we also said what attributes we must have good to have, must have, could be great, and all those things.



00:34 - 00:54
And then we went around and found all the quality systems that fit those criteria. As one of them, we had to be online. It had to be less i.t intuitive, you know, I can go on and on and I'm sure I would attest to this. There's a lot of things that we put together in ideas that we wanted to have with our colleagues system.



00:54 - 01:27
Once we did that, we started interviewing all of the vendors that fit that criteria and every vendor we fit that criteria. We had a mark on what we did and how they fit that criteria. When we came to Unifize checked out all the criteria, and so we bought new intuitive leave without. After about a few minutes of talking to the CEO we knew that we were on to something.



01:27 - 01:47
So it became a question of, you know, you have the right product, but are you willing to jump? And that's usually where most people get stuck, right? You intuitively know this is the right tool, but now you have to go and sell to the executive, to my CEO, that this is the right tool and this is why I think it's the right tool.



01:47 - 02:09
And my CEO, Chris Prentice, came up and gave me a mandate and said, I trust you, which is a big, big vote. I trust that you will make the best decisions for this organization. And that's exactly what I said I took and I took upon myself to make that decision. And one of the trainings we've had in Six Sigma transformational.



02:09 - 02:32
When you know something is right, it's right regardless of base. And knowing that you can have that no one can explain. And that comes from intuition, knowledge, experience. And sometimes you just know this is the right tool and you may not have all the understanding of it, but it just feels correctly because it checks all the information that you needed.



02:32 - 02:53
So the rest is just fear. And I think some of us get paralyzed with that. We want to jump, but how do we know? Then we start talking ourselves out of it. But once we jumped and the decision was jump, it was probably the best jump because the landing was so soft. We looked around and say, Did we miss anything?



02:54 - 03:16
And that's where you want to be, is you want to jump while knowing very well that there's a very good chance that it's going to work because the landing is going to be soft anyway. We had that experience and everybody at Harmonic Bionics really likes Unifize, and there were several members of the organization that are singing praises to Unifize at the moment.



03:16 - 03:21
So we have no regrets and I'm very happy with the product.

Unifize Results

10x
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs
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.

Related Case Study Videos

What attracted us the most about Unifize
Tedd Carr recounts The Will-Burt Company's extensive search for the ideal quality software, vetting over 30 options before discovering Unifize. The decisive factor was Unifize's user-friendly interface, akin to social media, that required minimal training and ensured swift adoption across their teams. This ease of use, combined with comprehensive onboarding support at no extra cost, distinguished Unifize as the superior choice, fostering its enthusiastic embrace within the company.
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.
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.
How to make facing FDA audits easy
Clarissa Archer talks about the daunting experience of preparing for audits, especially from rigorous bodies like the FDA. She stresses the importance of a robust documentation system, serving as a "source of truth" during these audits. With Unifize, they could effortlessly produce, present, and recall documentation, simplifying the audit process and instilling confidence in their decisions and actions.
How Unifize helped build our processes efficiently from scratch
In this video, Jesse Kolstad of Biovation Labs contrasts his experience with MasterControl's structured modules to the flexibility offered by Unifize. Reflecting on the early stages of his career, Jesse appreciated the structured guidance, but as his expertise grew, he found immense value in the "blank canvas" approach of Unifize, allowing for tailored and efficient process development.
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.
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.
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
Unifize's lightning fast customer support
Jesse Kolstad lauds the unparalleled responsiveness of the Unifize support team. He recounts instances where he received almost instantaneous assistance, highlighting their record response time of just 12 minutes. Jesse values the platform's collaborative capabilities, allowing him to make real-time changes with both his team and the Unifize support team. The genuine partnership feeling resonates throughout his experience, showcasing their commitment to customer success.
Problems with managing quality at nutraceutical companies
Jesse Kolstad paints a vivid picture of the recurring challenges he's faced in the realm of quality management. From overloaded file cabinets to underutilized QMS systems, he's seen a pattern of data not being harnessed effectively. Jesse shares his thoughtful approach to quality enhancement, highlighting the importance of keen observation and understanding before diving into reforms, reflecting his depth of experience and commitment to excellence.
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.
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.
My role and prior MedTech QMS experience
Clarissa Archer, a Quality Assurance Engineer at Harmonic Bionics, shares her decade-long journey in the medical device industry. Beginning in product development, she transitioned to quality assurance, drawn by her passion for risk analysis and compliance. With a biomedical engineering background from Texas A&M, she emphasizes the importance of hands-on experience in understanding regulations in the medical device space.
How Unifize speeds up approvals around product specifications
In this video, Jesse Kolstad of Biovation Labs elaborates on the intricacies of product specifications, from dosage forms to market presentations. He underscores the comprehensive role Unifize plays in the process, highlighting the platform's capability to manage, collaborate, and monitor all aspects of finished products. Jesse reflects on the transformative shift from traditional email-based approvals to the more efficient system provided by Unifize.
How Unifize helps quality leaders take better decisions on Out of Specs
Jesse Kolstad revisits a challenging situation from his early days at Biovation Labs — a significant backlog of Out of Specifications (OOS) cases. Determined to enhance the OOS process, Jesse embarked on a deep dive into the existing procedures and systems. He emphasizes the value of having a clear understanding and the ability to trend data, showcasing Unifize's instrumental role in bringing clarity and improved decision-making.
Reducing the time to resolve customer complaints on Unifize
Jesse Kolstad highlights how Unifize expedites the resolution of customer complaints. Offering tools for rapid issue identification and fostering team collaboration, Unifize streamlines the complaint resolution process, ensuring accountability and efficiency in addressing customer concerns.
Breaking organisational silos with Unifize: Centralizing knowledge and achieving organisational alignment
Jesse Kolstad emphasizes Unifize's instrumental role in dismantling organizational silos at Biovation Labs. By centralizing knowledge, the platform promotes a unified information hub, fostering organizational alignment and consistent collaboration, ensuring everyone operates in harmony.
Why Unifize's approach to collaboration is transformational
Describing the communication challenges Harmonic Bionics faced in the past, Clarissa Archer praises Unifize for its centralized approach. Unlike previous tools where information often got lost in the shuffle, Unifize provided a consolidated platform that made tracking and acting on feedback more streamlined, especially during multitasking.
Establishing Accountability and taking faster decisions with Unifize
Tedd Carr expresses how Unifize transformed The Will-Burt Company's approach to quality management. The previous system, a chaotic mix of emails and ad-hoc methods, lacked clear ownership and accountability, leading to prolonged issue resolution times. With Unifize, they have consolidated five systems into one, establishing defined accountability and enabling rapid task completion—what once took weeks or months now concludes in days, significantly optimizing their operational efficiency.
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.

Experience the benefits of Unifize

4x Faster time-to-market

Map Unifize to your processes and streamline workflows, process automation, and prioritization

70% Fewer meetings

Less meetings with in-app collaboration, real-time updates, and decision logs

10x Speed to compliance

Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices

View More Case Studies

Here’s how Biovation Labs reduced testing costs from $146K to $65K in two months

Learn how and why Biovation Labs, an FDA regulated nutraceutical manufacturer based in Salt Lake City, took the decision to transition from MasterControl to Unifize for their product lifecycle (PLM) and quality management (QMS) processes.

Here’s how Harmonic Bionics slashed time to market by 80%

Clarissa Archer shares her experience integrating Unifize into Harmonic Bionics, underscoring its value in streamlining change control, facilitating communication, and ensuring robust documentation for regulatory compliance in the medical device sector.

Will-Burt's game changing boost to quality process cycle times

Learn how The Will-Burt Company was able to implement and adopt a new quality management system across 8 collaborating teams in less than a day and streamline internal / supplier non-conformances, customer complaints (VOCs), internal / supplier audits, 8D reporting, corrective actions and preventive actions.