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Science Boosters

Continuous Improvement in a  Medical Device company

With Amanda Amell, Quality Assurance Associate at Shoebox

Picture of Amanda Amell, Quality Assurance Associate at Shoebox, guest of our 3rd podcast episode: Science Boosters - Continuous Improvement in a fast-growing Medical Device company
Enjoy the expertise of Amanda Amell, QA expert at Shoebox, who will explain the Continuous Improvement Framework, the main challenges, and the Shoebox case study.

Filip Heitbrink:

Hi, and welcome to another edition of science boosters. The podcast for life science professionals. Here you'll find the movers and shakers in the space, sharing their insights on the evolution of the industry and how to grow a thriving company in these rapidly changing times.

I'm Filip, the CEO of Scilife and we'd like to share with you today, helpful insights about continuous improvement in a fast-growing medical device company. During our conversation with Amanda Amell quality associate at Shoebox, we covered the continuous improvement framework, the main challenges and the Shoebox case study a Canadian software medical device company, and the market going quickest lightning from theory to action globally. Without further delay. I let you enjoy the session.

 I would like to welcome Amanda from Shoebox. So Amanda, if you want to present yourself,


Amanda Amell:

Hi, my name's Amanda Amell. I'm the QA associate at Shoebox limited. I for over the last 15 plus years, I've worked in pharmaceutical wholesaling, medical device, distribution and manufacturing industries with a focus on QMS or quality management systems and regulatory compliance.
So I really thrive on change and process and product improvements.


Filip Heitbrink:

Perfect. Thank you very much. And what does a Shoebox do? Exactly

Amanda Amell:

Right. Shoebox is a manufacturer of an automated iPad audiometer so we designed develop audiometry products as software as a medical device. We use iOS web technology to replace the bulky expensive equipment making it more affordable and accessible to.


Filip Heitbrink:

All right. Perfect. Thank you for that. Okay. So with that, I'll like to start mentioning what what are the main challenges that we at Scilife with our customers are encountering when we talk to QA people in, in the medical devices So, what are the main challenges when implementing continuous improvement?

One of the main challenges that are typically mentioned is, is instilling this quality mindset on all levels with, throughout the company, right? It's not only the QA department that should be QA or quality minded, but it's everybody within the company and that's not easy. Sometimes quality is seen as a necessary evil.

Which is just a, yeah. It requires people to follow up on quality events where on top of their day-to-day work or which is, which is a pain for them. So they just see it as. Something additional to their work and not something that is yeah. Fundamental to their work. So having this quality mindset throughout the whole company is definitely one of the important pain points that they mentioned.

Secondly, there is this the, the problem of once you have that mindset, people still might not be very fast with follow up on, on yeah. Actions that are required when some issues are arising. Or yeah, training typically is, is is problematic. You need to be comes constantly trained in procedures and processes that change over time.

So it's. Getting your training when you are a new employee and once that's done, you're done, it's a continuous process in which you need to be retrained according to constantly changing processes and procedures as the company grows and changes or the market or the product is, is yeah. Trying to keep up.

So I'm making sure that the people have follow up in a timely fashion. On on all these quality actions is definitely also a challenge and continuous improvements improvement processes. And then lastly is, is having the clarity. So even if you have the mindset, even if people want to follow up on, on these quality processes, there are quite a few, right?

You have a deviations nonconformities that might be handled differently. Complaints that might be handled differently or corrective and preventive actions that need to be. Locked managed, implemented in a certain way. So yeah. Internal audience management review meeting, whatever is, is part of your whole quality system has a process to it.

And employees typically don't do that. On a daily basis. So when something pops up that you need to follow up on having clarity on the process, how, and when you need to follow up is essential for, for people to feel comfortable and doing this as fast as possible. So, so you don't get behind with all these actions.

So the clarity part is very important. And that's definitely where, where our systems and software solutions can, can help, right? Because you're forcing the user through a very specific workflow, which makes it for them easy to understand and apply these these quality processes in a very logical manner who will explain a little bit the, the theory between behind, sorry continuous improvement framework, how to implement it.

What it consists of. And later we will discuss how it was implemented at Shoebox and how Amanda is managing that part. Right. So Amanda. Sure.


Amanda Amell:

So continuous improvement is a cycle and generally you'll the best, in my opinion. The best way forward is to plan, to do, to check to act. So with the plan stage of the cycle, you're going to establish your objectives.

You're going to plan the processes, basically plan for change and identify any improvement opportunities. In the do, you're going to implement this plan and execute the process. So you're going to implement whatever training's been identified in the check, you're going to check to determine if the change had the desired outcome.

You're going to compare it to. What the expected result was and what, what actually happened. And then moving forward to the act. I mean, if you're successful, you're going to implement it across the organization and across your processes. If it was not successful, then it would probably raise a corrective action where you know, you would follow a structure on a root cause analysis.

Why didn't it work? Why didn't it? Why didn't you get the expected? Essentially and then start the cycle again.


Filip Heitbrink:

Okay. So yeah, it's a, yeah, it's a continuous cycle that you, that you implement, but it never ends, right. It's ongoing at all times. All right, please. Go ahead.


Amanda Amell:

So there are seven QRAS principles quality management system.

There are two regulation or two standards, sorry, ISO 1345 for medical devices and ISO 9,001 basically has the same mindset. So when you're talking about customer focus organizations they depend on, on their customers and therefore they, they really need to understand what the current and future customer needs are and strive to meet the customer requirements and also to exceed their expectations leadership you know, establishing.

Purpose and direction for the organization. And w you want to maintain an environment where people can become fully involved in achieving these organizational objectives engagement of people at all levels are the essence of the organization and full involvement and. Their abilities to be used for the organization's benefits process or approach.

The desired result is achieved more efficiently when activities and related resources are managed as a process. And we moved to continual improvement. The continual improvement of an organization's overall performance should be a permanent objective of your organization. Evidence-based decision-making we got effective decisions that are based on analysis of data and information.

So what is a quality management system? Well, it's a formalized system that documents your processes, your procedures, and your responsibilities to achieve your quality policies and your objectives. So it's a systematic approach to ensure consistency in yours. And it supports continuous improvement.

Having quality management system also provides confidence to your customers that you can deliver a product or service that is safe and conforms to requirements. Having a quality management system reduces your risk of non-compliance drives accountability. It improves your product quality and safety, and it basically optimizes your operational effects.


Filip Heitbrink:

This is the theory behind how to implement the continuous improvement process. Right? What, what were the pain points that you encountered in those two years, to implement and maintain this whole continuous improvement?


Amanda Amell:

I definitely say firstly at the beginning not having a proper like process management tool doing everything manually and by paper like a paper-based QMS is not optimal.

So we did bring on Scilife as our quality management system to manage our doctors. And control our documents, assigned training and a number of other useful QMS role responsibilities we've used through Scilife, which is, which has simplified our life. So initially I'd say the manual paper-based system was definitely a pain point.

Most recently, I think because we're since the pandemic we became remote. Where there's only six of us in the office, the remainder are all working from home. So being able to kind of organize and schedule meetings, stuff's become a little bit more of a challenge. Just because, you know, everyone now has to communicate virtually and, and finding time to, to break down issues and you know, meet regularly was initially a challenge.

Other than that, I think the follow-ups also the follow-up actions. We've definitely improved since going remotely with our structure, we have really good structure for our campus system, and I think that's really important in order to kind of establish a cadence and follow up and get things done on a timely, timely basis.


Filip Heitbrink:

Yeah. So with 75 employees two years ago with a paper-based system, I mean, people. If not everybody is at the office, it's, it's virtually impossible, right? The paper needs to travel from desk to desk. So did that mean that that you went from completely onsite to almost completely remote in the, in, during the pandemic?

So you were 75 people working at the office. Yes. Wow. That's a very big change. Right? So, and how is it working for, a Shoebox? I, I assume it's quite positive, but that you notice that not everybody is into remote working, for example, that you see a lot of attrition with employees, people leaving new people, replacing them, or everybody accepted the change relatively.



Amanda Amell:

I think everyone was very easy with the change. A lot of people do prefer working from home and it's proven itself to be, we're just as productive. We're, we're just as efficient and effective. So it hasn't really hurt us too much.


Filip Heitbrink:

Okay. If you, if you would, if you would have still worked on paper before just when the pandemic hit, then definitely a.



Amanda Amell:

getting, getting people to sign off on training and whatnot would be next to impossible that way. I mean, pretty much impossible that


Filip Heitbrink:

way, having everybody on the same page in terms of this mindset, that this quality mindset, was it always there when you came in at Shoebox or is it also something that needed, needed some


Amanda Amell:

It needed some effort initially, but everyone's kind of grown into it and we're all fairly obsessed with quality.

So we work really well as a team and we all understand what is required of us, everything that we build, or it always has quality in mind.


Filip Heitbrink:

And, and how did you, what did you do to instill this, this quality mindset? So. It wasn't just through the training or did do some other actions or how, how, how did you manage?


Amanda Amell:

We were very transparent company as well. So when we have audits, for example, they're very open. They're very open and on the table for everyone. So everyone is involved. We communicate any issues. So they're they, they understand. The role of quality and in our


Filip Heitbrink:

business. Yeah. So, yeah, it's we also noticed that in silence, we were growing more or less with the same employee growth, in the past 15 months with one new employee per month.

And then it's, it's all about involving them into the process, right. It's really not having these audits and only QA handle them and shield of the rest of the company. It's really. No, no. You want to hear how this process works. You just involve the person, let the person explain. And then they say, oh, okay, this is how audits or asks questions.

And this is the information that we need to come up with. So they really feel the, seriousness of, of the whole matter and want to prepare to show everybody that they are doing it appropriately. Right. It's all about involvement and, and helping them to get involved. So how important is it for you, Amanda?

That what we know it is, for example, we're, we're not a medical device company. You guys have both the hardware and the software parts I guess, rights in the company, but we are a hundred percent software. So how important is it? All departments have this quality mindset and document their processes.

I'm, I'm thinking about customer success, seals, salespeople. I mean, they definitely document processes and, and train people, but have doing that from a regulatory perspective or even in a tool like QMS is not. Logical for them. So do you somehow lower the bar for these types of departments because maybe an auditor will not see them as critical to your products as obviously product development?

Or are you just saying, I don't know. The whole company needs to have the same level of quality, even if it's sales, marketing, or customer success, we don't care. So how do you think about?


Amanda Amell:

Well, we actually, one of our company values is to be quality-obsessed. So when you've come into this company, you're coming in knowing that this is one of our most important values.

So every department takes quality very seriously. Just some, some departments are more heavily involved in quality than others. So we share. The information. We train accordingly there's a periodic review of processes. We empower people to be involved in process changes


Filip Heitbrink:

et cetera. What are for you the most important tools within the quality system to make sure that this continuous improvement cycle is as optimal as possible?

Well, what would you say are the most, most important tools for.


Amanda Amell:

Well, our EPMS firstly, and then we have feedback customer feedback, post-market surveillance. We have our canvas system, which is a very important tool in, you know, managing potential nonconformances and nonconformances


Filip Heitbrink:

Yeah. The things, other thing that come to mind that we also do obviously is internal audits.

Yeah, management review. So internal audit. Do you, do you audit each process? How do you do that? Do you do one audit for process per year? More, often less.


Amanda Amell:

We cover entire QMS over the course of a year. So we do break up sections into quarters, into our quarters just to make it better feasible.

It's you know, it's okay to break it up. As long as you cover the entire system over the course of a year,


Filip Heitbrink:

how do you break it up, Amanda? So you, do you do like core processes or department wise? Or how


Amanda Amell:

can we break it up by sections of the standard? Okay. So, so we'll take section four and five and do that.

And whatever processes are applicable to that section and so on and so forth throughout the course of here. And internal audits are very important and we definitely use those as opportunities for improvement as well. We do discover, you know, potential nonconformances and non-compliances in our processes as we're auditing.

And I mean, it just ensures that your QMS is working or it's effectively. Implemented and maintained, right?


Filip Heitbrink:

Yeah. And I know who's auditing the QA process. Who's auditing you. Then


Amanda Amell:

we have an outsourced, you all sorts of audits. What we cannot, because it's a con you know, we can't


Filip Heitbrink:

audit our own, that's it?

Yeah. So you just, for that bar, do you have a, an external party that does the internal audit for. And then I assume that you'll get your, your certification audit from the whatever regulatory body and surveillance audits every year, right? Somehow clash with this more rigid regulatory requirements.

So. We definitely notice that I think that there are more and more medical device companies that have at least a part of software. And I think that 95% of companies are using an agile approach to software development. So I think it's quite a relevant question. So how, how does Shoebox tackle.


Amanda Amell:

Well, we do our best to build the regulatory affairs regulations into our agile methodology. And feature development is based on the, on the similar input. So it's not an afterthought. It is basically built into the process. It's a regulatory mindset, like any regulatory requirements are built to within the process and communication is absolutely key and you know, to prevent frustrations and risks from, from each side.

But yeah, we definitely have this in our minds. Design review every you know, any cycle that we do in, in respect to our agile system is always keeping regulatory in the forefront


Filip Heitbrink:

our minds, his Shoebox, really trying to hire only people that already come with this mindset. Because they know this space or, or do you somehow put them through a different training to get them up to speed?

In terms of understanding all the regulatory requirements, I'm thinking about software developers. But not only software developers, we have seen the same challenges with, with sales people. If they don't speak the same language as customers then, then it's very, very hard to sell your solution. I'm thinking about marketing.

If, if you don't understand the space in the market, it's very, very hard to get the messaging right to your yeah. To, to your potential customer. So, so yeah, I'm curious to know what Shoebox does in from a, from a hiring strategy.


Amanda Amell:

Well, I mean, we definitely want great people with experience, although we aren't restricted.

As far as I, I mean, I'm not involved with HR, but we do have several employees that did not come from regulated environments previously, and that's not what they're familiar with. So, and we have a new hire. We scope their job function. To. Type of training, what training plan will be assigned to these people based on their job functions.

And then again, all, all the, the open transparency we have throughout the company and on our all staff meetings and you know, the information that we share an open book to everybody. It kind of, again, just kind of instills that, that mindset a little bit. And then we have refresher training and, you know, every time, anytime there's a change in a regulation, whether it's a software standard or an audiometry standard or whichever the case is we would develop training.



Filip Heitbrink:

I guess that then somehow helps with this whole culture this quality culture that you try to instill. Right? So it's basically through training or are there other things that the Shoebox does to make sure that they have this, this mindset, this continuous improvement mindset?


Amanda Amell:

It's training and it's involving them empowering them to be part of the process.

You know, we collaborate across teams. So the discussion, like the words, quality and continuous improvement, and like, that's all we want. We w we are quality obsessed. We want to do the best. Product for our customers. Right. And meet all of their needs, exceed their expectations. That is our goal. I, yeah, actually we so customer feedback for us can come in different ways.

We have our customer support team or account managers or product managers. They all receive some sort of feedback. Different kinds of feedback. We get complaints potential software bugs, negative feedback. Feature requests. So it's, it all flows through a ticketing system. We have a ticketing system, so it gets assigned accordingly.

It gets categorized. I, you know in the flow that we haven't listed, you know, if it's a complaint, it gets, it goes through this process. If it's a feature request, it goes through this process. And then, and then we have like the complaint process. We talk about customer feedback and post-market surveillance also.

Is stuff that we need to monitor and maintain. We have to have. 


Filip Heitbrink:

So, so how much, how much would you say is customer feedback deciding the products direction? I a lot, right? The reason I'm asking is we have noticed the same where we have, we have the same system as you describe in terms of a ticketing system where everything flows through and we separate between Issues and feature requests or just questions to provide support.

So regarding the feature requests, there are tens of feature requests per month that, that we have this bras process in place. Every week. We have a fixed meeting where we try to go through each and every question and then customer success provides feedback to the user in question that that asked for the feature explaining.

If there's maybe a workaround, if there's another way to do the, what they want to accomplish or if we're going to do it in which version of the module in CA yeah. In question the upgrade will happen, right? And more or less when, so that's a, that's a huge effort, but it definitely accounts for maybe 80 to 90% of product direction.


Amanda Amell:

When, I mean, as soon as possible I, I think like for us, we're we have a fairly small quality team at the moment we're only like three people and we managed to cover a large territory of requirements per se With a small team it's not optimal.

Obviously having more resources I think would be more efficient, but that'll come as we continue to grow. But when, I mean, you have to evaluate what, what your business needs are and your customer needs. Like, are you going to implement, are talking, implementing a quality management system or


Filip Heitbrink:

The thing is. If you are putting on the market and medical device you will need to have a continuous improvement process in place. Even if you're just two persons, you need to have your quality system set up. Otherwise you will not get certified. So that's definitely a requirement. And then the team size doesn't really matter, but you need to have it.

Documented, written down and actually do it right. And show some proof that you actually do what you, what your processes say that you do. So I think it's not about how large should the company be before you implement this. It's really from a business need perspective. If you need the certification to go.

Yeah, before the go to market strategy and look there. So obviously, for a lot of medical device companies, there is a lot of our ID at the beginning for quite some time. But as soon as you want to go to market, it definitely needs to be in place. So, yeah. So what are the steps we can implement in order to encourage continuous improvement in a QMS?

And is this just the responsibility of the quality manager? What would you say to that?


Amanda Amell:

I'd say, no, everyone needs to be moving towards the same goal. Everyone needs to be involved. Continuous improvement is something that needs to be revisited regularly. And it's not. The quality manager's responsibility.

Everyone needs to be quality obsessed.


Filip Heitbrink:

Yeah, that's it.

I would like to thank Amanda for your participation, your clear explanation and your help with this.

One to continue the conversation? We're looking forward to your comments and feedback on our social media channels. We'll also let you know when the next episode of science boosters drops through these networks. If you're listening to this on a podcast player, don't forget to follow us. If you know someone else in the industry who would find this episode interesting.

Why not share it with them or with your network? A big shout out to everyone on the Scilife team who made this episode possible. Thanks for tuning in, and then looking forward to uncovering more life science knowledge with you soon.

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