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.

Unifize Results

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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.

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