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.
Transcript

00:00 - 00:27
I think the main thing from our experience with Unifize and the rest of the systems that have implemented there is an inherent fear of technology. There's an air in fear of not knowing, not being comfortable, not having enough of confidence that it'll get you there. But what we've known from what experience was, is we were able to get there with the system.



00:27 - 00:50
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.



00:50 - 01:19
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're at work?



01:19 - 01:49
You know, I mentioned Jim Collins, companies that are good to great companies that are good become great because they attach to innovation. They're agile. They move with what is moving and transforming. And that's what you want to have as an organization. You don't want to be stuck in antiquated because that's what you're comfortable with. But you need to grapple with the reality of where the world is going now, which is fast dick talking and Instagrams, Instagrams, right?



01:49 - 02:09
You need to move to the next level and that is what Unifize is about. It's about going instead about being at the time present to make those decisions because we're in an artificial world after all, whether we like it or not, you can try and stay integrated, but you will be passed over because companies that go fast are more innovative.



02:10 - 02:14
They able to go into the market faster like we've seen with the Unifize.

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

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.
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.
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.
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.
How Unifize makes audits easier
Jesse Kolstad highlights the revolutionary change Unifize brought to Biovation Labs' internal audit process. The platform facilitates direct capture and storage of visual evidence like photos, ensuring context and clarity. Drawing a contrast with past practices of manual note-taking and subsequent transcription, Jesse appreciates Unifize's real-time documentation that eliminates back-and-forth and enhances audit efficiency.
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.
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.
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.
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.
Why Biovation moved from MasterControl to Unifize
Jesse Kolstad reminisces about his journey with quality management systems, notably his pivotal role in deploying MasterControl. As he navigates through the landscape of electronic documentation circa 2016, he highlights the challenges presented by platforms like SharePoint. While acknowledging MasterControl's early advantages, Jesse candidly critiques its user interface, shedding light on why a transition to Unifize became essential for Biovation Labs.
Reducing lot release time down to minutes with Unifize
Jesse Kolstad highlights how Unifize has dramatically curtailed lot release times at Biovation Labs. By optimizing the process, Unifize ensures lot releases are executed efficiently, reducing times to mere minutes.
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.
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.
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.
How Unifize ensures everyone is trained on the right version of documents and SOPs
Jesse Kolstad sheds light on the intricacies of document control, a critical component across regulated industries. While debunking common myths, he underscores the importance of more than just maintaining master copies. With Unifize, the emphasis is on ensuring that everyone in the organization is well-trained and aligned with the most recent versions of documents and SOPs, guaranteeing compliance and efficiency.
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.
Getting engineering to adopt a new eQMS
Clarissa Archer reflects on Harmonic Bionics' transition from a research-centric organization to one focused on compliance. She reminisces about the sudden surge in documentation and the challenges it presented to engineers and product developers. Accustomed to flexible laboratory environments, the team had to adapt to the structured, documentation-heavy world of compliance, making the choice of a user-friendly system like Unifize crucial.
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.
About Tedd and The Will-Burt Company
Tedd Carr, with 40 years at The Will-Burt Company, oversees a broad quality assurance and control remit that spans beyond the traditional confines of the department. His role touches all company areas, emphasizing the diverse and complex quality demands of their varied customer base in sectors such as aerospace and military, which presents a significant challenge in meeting each sector's unique requirements and expectations. The Will-Burt Company, an employee-owned enterprise, prides itself on a century of business, specializing in proprietary products and services for emergency communications, warfare, and payload elevation, as well as offering comprehensive manufacturing services.
How Biovation manages Supplier Quality on Unifize
Jesse Kolstad delves into the challenges of juggling multiple suppliers at Biovation Labs. He candidly shares the complications of dealing with myriad versions of similar products, like green tea extracts. With Unifize, Jesse found a way to seamlessly consolidate suppliers, bringing clarity to ingredient and inventory management, and ensuring quality standards are met consistently.

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.