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.
Transcript

00:00 - 00:20
I'm a Six Sigma certified Six Sigma black belt. And because of my background or my training, what I do is transformational. I do a lot of transformation of companies. One of the things that I do and I typically try to do is look at an organization and determine what is the best way to achieve the results of the organization and to build that culture.



00:20 - 00:26
First of all, is to understand where the company is, what is the status of the company and where they want to go.



00:26 - 00:37
There are certain things that may work in one company, but may not work in another company. So I typically try to identify what that meant or the easiest way to communicate what the new transition ought to be.



00:38 - 00:53
Communicating that intent is really important. So methods of communication and how people relate culture basis is really going to determine that. The next thing that I try to do to build that culture is to have the tools that assist in building that culture.



00:53 - 00:59
If you want a culture of knowledge, you have to have tools that allow you to have access to that knowledge.



00:59 - 01:22
If you need a culture that allows for collaboration, then you need to build tools that allow for that type of collaboration. It's hard to build a culture if your tools are not supporting that. And so leverage what is available, you know, if you go to an organization, look at an organization and see what type of tools are available to allow you to build a culture that you try to build, the next thing is build, be deliberate.



01:22 - 01:38
A lot of companies look at cultural elements and how to build a quality organization is something that happens. It's deliberate. It needs to be deliberate. Most companies who have succeeded in building that do things deliberately to try and make it happen.



01:38 - 01:40
I tried to be deliberate as much as possible.



01:40 - 01:56
At Harmonic, one of the things that we did is create a culture of sharing information. We created a mission, a mission that specifically put the culture of improvement and the culture of thinking about quality forefront in everything that we wanted to do.



01:56 - 02:16
So we created a mission statement, a vision statement. Everybody participated in our Kaizen as we call it, and we decided that we are going to be deliberate about our actions. We did things that are human centric, things that allowed us to collaborate. We leverage tools that allowed for that collaboration.



02:16 - 02:24
We were also very deliberate in the items that we talked about. What were the things that drove the company forward?



02:24 - 02:50
What were the pain points? Those were brought up. We were willing to listen to feedback. That's really important. We wanted to get a feedback of how we were doing and we became the beacon of this is how we are going to do this. If the company can hold us accountable to all the things that we wanted to do on our mission vision statement and we stood in front of it being deliberate and saying, This is what we stand for.



02:50 - 03:17
One of the other things we did is increase the knowledge. We tried to improve our knowledge. When you improve the knowledge of the organization, you will find out that people start in giving back that feedback, understanding what the regulations needed, what we were doing about it, where our gaps were, and we deliberately started doing things that we needed to do as part of meeting that challenge.



03:17 - 03:34
At Harmonics, one of the challenges that we had is knowledge level. Harmonics is a startup company. It's a very young company, and as a result of that, there was a gap in terms of expectations, in terms of building that core knowledge that you would expect.



03:34 - 03:50
Most of these other companies, you see mature organizations having competent people, having people that have been in industry for many years. When you go to start up with small and medium size companies that are starting out or may need to go in, you have to argument that level of knowledge.



03:50 - 04:02
One of the things that we did was deliberate trainings. Kaizens sharing knowledge, expectations, talking about regulations, presenting all those activities. And that's what we did.



04:02 - 04:14
Unifize was a big part of this because Unifize was one of the tools that we use for collaboration, Unifize put everything together. It was easy to follow organizations, it was transparent.



04:14 - 04:36
Whenever you want to make change you need to know what the changes it needs to be transparent, it needs to be visible, and it is to be visible to the right people, right? So it's not just a matter of being visible too. We know a few that need to have it, but there are others who may be viewing that information and being influenced by what is happening in that level.

Related Videos

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

Managing the product lifecycle and ensuring efficient traceability with Unifize
Jesse Kolstad underscores the imperative of traceability in regulated industries. Drawing from his experience at Biovation Labs, he illustrates how Unifize seamlessly interlinks finished products, ingredients, formulae, and even packaging artwork. The platform's collaborative nature fosters real-time discussions, merging processes that were once scattered across emails and calls into a unified and efficient workflow.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
How Unifize's no-code configuration speeds up implementation
Clarissa Archer emphasizes the significance of adaptability in Harmonic Bionics' choice of a QMS. With Unifize, they could shape the software to their specific needs, bypassing the rigidity of traditional systems. The power to make direct adjustments without relying on external teams was a game-changer for them, speeding up processes significantly.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
How conversations in Unifize foster better collaboration
Tedd Carr is enthusiastic about how Unifize's conversation-driven platform has revolutionized collaboration at The Will-Burt Company. He observed a significant uptake in engagement following a refresher course, likening the buzz of activity to a lively slot machine. This surge in conversations among varied personnel didn't lead to confusion but rather an organized flow of information. Carr takes pride in witnessing the team's proactive interactions and the smooth progression of tasks, indicating a thriving, collaborative environment.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
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.
Watch Video
Streamlining Change Control on Unifize
In this video, Clarissa shares her experience with Unifize, emphasizing its impact on change control and document management in quality management systems. She highlights the challenges of maintaining up-to-date engineering drawings and documentation, particularly in a traditional pen-and-paper environment. Clarissa illustrates how Unifize streamlines these processes, ensuring engineers access the latest revisions, understand changes, and comply with FDA requirements. She praises Unifize's integrated checklist feature and approval process, which simplifies change orders and prevents delays, even when key personnel are unavailable. Clarissa's testimonial underscores Unifize's efficiency, detailing how it transformed their change control process from a lengthy endeavor to a more manageable and efficient system.
Watch Video
How Unifize helped reduce $60,000 of material cost on just one product
Jesse Kolstad shares a transformative experience at Biovation Labs, emphasizing the power of perspective. With Unifize, he could holistically evaluate their ingredient performance and volumes, enabling him to whittle down from 16 SKUs to just two. This consolidation not only simplified management but also resulted in substantial cost savings for the company.
Watch Video
Implementing a collaborative eQMS in 4 weeks
Clarissa Archer recalls the initial days of Harmonic Bionics' adoption of Unifize. While they had experience with systems that took ages to configure, Unifize stood out with its rapid setup. Working closely with the Unifize team, they tailored the system to their unique requirements, finding it far more adaptable than larger systems like Agile.
Watch Video
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.
Watch Video
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.
Watch Video

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.