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.
Transcript

00:00 - 00:08
When we started this journey of going into finding a quality system, first, let's go with who I am as a professional.



00:08 - 00:39
I'm into the transformational space, right? Six Sigma, Black Belt certified, and I went into studying the quality systems management. And so I'm familiar with all the best ways to get a quality system, the best way to transform organizations and all of that. So when I went to Harmonic Bionics, my first inclination is how do I transform this organization fast using the latest technologies and get there the easiest way.



00:39 - 01:08
So I had two things that I needed to make sure that most companies and I'm sure most managers would empathize with this. You want to get there fast with the least amount of effort. So when you look at those two things, the first thing you have to do is who I'm working with. What have they adapt to that possibility that you're going to move at a faster pace because things are moving faster and that they're going to adapt to that technology that you're bringing because you don't want to bring something so complex, you want to bring something simple.



01:08 - 01:29
So it had to be simple, it had to be nimble, it had to be easily adaptable, which means that I didn't have a big curve to go through and explain everything it needed to be somebody who can come in and understand how to click on an object and open a file. You should be able to understand what your device is about.



01:29 - 01:58
And so going into that space, knowing that I needed to be fast, nimble and direct with my approach and transform the organization within the shortest time possible, you had to have a tool that supports that. Majority of managers have to grapple with that balance because at some point you inherit a system, but you can change from that. You don't have to stay with a system that doesn't work.



01:59 - 02:21
Agile companies agree that for us to be agile, we had to stop doing certain things. We had to change from other thinking. It's a way, a process of thinking as a way of looking at things. You have to stop thinking how you been thinking and start thinking a new way. And the new way has to involve fast, nimble, agile and to the point.



02:21 - 02:44
If you're not in that space, then you're going to be left behind. May not happen soon, but at some point you're going to have to grapple with the truth. Now, is it only for small companies? No, it's actually for any company. And a lot of companies that are looking to manage information, transform the company, do that by using data.



02:44 - 03:03
So you have to look at your data within your company and say, I have a lot of data in my company. Any transformational company and transformation engineer and transformational manager will tell you that you have to look at the data that's available in your company. You have to assess, that data, determine the validity of that data, and do something about that data.



03:03 - 03:42
It's a data driven world, but a lot of our managers, we're not making decisions based on data. Now, where's that data coming from? It's coming from a system. So get the right system, get the right data, make decisions, transform an organization. That's how you transform. But you have to have the right tools that lead you there. And if you're in a quality space and you're manufacturing a product or you're doing something related to managing compliance or managing non-conformances or things that may not go correctly, you're managing customers, you're managing suppliers, That's another workflow that we had with Unifize.



03:42 - 04:05
If you're managing that, you need to have a way to communicate with them fast or to notify them of an issue Unifize does that I know we had Unifize where we had suppliers, where we were able to communicate to suppliers. We could literally go into Unifize and communicate with supplier and supplier would respond right into Unifize. It becomes part of the communication within, Unifize, and that is invaluable.



04:05 - 04:12
There is no emails involved, you know, that is amazing. And that's how fast things need to happen.

Unifize Results

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Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
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Faster time-to-market
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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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