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.
Transcript

00:00 - 00:18
When you're talking about speed to market, you know, return on investment and speed to market, you have to look at the effort. It's going to take you to put the quality system in place. Are you going to go and have a person who is going to know every nuance about your configuration?



00:18 - 00:28
Because that's what it takes for most other companies. You will need to know all of the workflows in detail to know exactly where they are, touch points, on what level of security you expect for each of them.



00:28 - 00:47
You're also going to need an IT component of it because most of the systems will need a local client of some IT support. You're also going to a need level of access. Cost is also a consideration that you need to have. Are you going to have cost that is going to support that? Most of the systems are high cost, high maintenance.



00:47 - 01:01
When you look at those front end costs and configuration efforts that you need to put, it drives the cost of the final product. Now you're going to still be compliant, but you spent a lot of energy doing that.



01:01 - 01:17
On the other hand, you have Unifize, which out of the box it can be applied. Out of the box, without a lot of configuration, you can still get the level of compliance that you need. Now, you don't need IT to be involved. You leave the configuration of the system with QA.



01:17 - 01:23
Now you've changed the responsibility, it's no longer IT getting in the middle of it, but you have now QA driving it.



01:23 - 01:46
Who would you rather have? You'd rather have QA driving it than have IT involved in it? Because that's another component you have no control over. So I think the best way and we had this experience with Unifize was to have QA drive and once QA drove it, it was easy for QA to make the adjustments without necessarily getting somebody else to do the configuration.



01:46 - 01:52
Somebody has to update somebody else to go the back and forth is really quite.



01:52 - 02:12
system that we, I have used in the past involved going back to the customer and having a project manager that managed all the changes. So, QA would go into an isolation, they would make recommendations. They would have a meeting, that meeting would drive a decision which would go into the configuration team.



02:12 - 02:33
Then the configuration team would have another discussion about the changes are asking before the changes can be made. So if I'm a Lean Six Sigma person or somebody who just wants to get there directly, I'm cutting to the chase. I'm giving the tool directly to the QA organization who are making and are responsible for the data.



02:33 - 02:40
I would rather have the right people configure the system than have others involved who may not have a stake in the system.



02:40 - 02:59
in terms of time to market, those two systems may get you there, but one is going to get you there faster because it goes directly For us it took four weeks for the other systems that I've worked with. It took us almost a year. Part of that is because the decision makers sometimes when not available, they took a vacation.



03:00 - 03:25
Sometimes the project managers that were involved scheduled calls and those calls were not decisions were not made during those calls. So those decisions were punted forward. Sometimes the configuration did not work. That meant they had to go back and reassess those meetings and circles and cycles that you go through are taking time while Unifize comes out of the box, has everything that you need.



03:25 - 03:37
QA was in control of it. They are showing you how to do it. Access is provided and everybody can use it. As soon as everyone is in the system. It's no brainer.

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.

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