Scaling Your MedTech Venture: Proven Strategies for Early-Stage, Compliance, Quality, and Risk Management

Full Transcript Below:

Rodney Moses

Good afternoon, depends where you are. Welcome and thank you for joining us today in this webinar, which we are having. Just to quickly introduce myself, I’m Rodney Moses. I’m from MedTech World, and today we’re going to be talking about things that are really affecting MedTech companies in the early stages, or whether it’s early-stage strategies, compliance, quality, risk management, and these pillars are quite essential for growth in this forever evolving industry.

But before we even get started today, I would like to introduce the speakers we have. We’ve got Markus from Arena, we’ve got Amy from PhenUtest

Markus, just to start with you then with the introductions, would you like to introduce yourself?

Markus Fleckenstein

Sure, thanks Rodney. Hey, my name is Markus Fleckenstein. I’m working with Arena leading there, the solution consulting team. I’m 13 plus years within that QMS PLM space. Worked in quality before I joined PTC, so I’m happy to be part of that webinar and looking forward for a great conversation here with the rest of the guys.

Rodney Moses

And Amy, would you like to go next?

Amy Bennett

Sure, thanks, Rodney. My name’s Amy Bennett. I’ve been working in the quality regulatory space for about 10 years now. Before I was in orthopedics and now I’ve transferred over to IBDs.

A little bit about PhenUtest where I work. We aim to revolutionize the way that antibiotics are prescribed for UTIs. We aim to remove the need for empiric prescription by identifying the right antibiotic for the patient first time, every time with our point-of-care device. I’m really looking forward to these discussions that we’re going to be having today. Thank you.

Rodney Moses

Okay. Why are we here today? Just to kick it off, starting with the global landscape that MedTech companies are navigating today, the global economic climate that continues to evolve with funding and investments increasingly focused on companies that are able to show that they’re being innovative, but also that they have a good operations systems in place.

And investors are seeking companies that show this clear pathway to compliance and risk management, especially with the increasing regulatory demands that are becoming more strict and stricter. And the biggest change that has happened in recent years, starting from I think 2021, was the MDR. The MDR stands for the medical device regulation, which actually replaced the MDD in 2021.

And the MDR brought a huge change, more stricter rules, more tighter things in terms of post-market surveillance with these medical devices. For companies looking to expand into the EU, like navigating these essential regulations and to get product approval or to maintain market access has become quite important.

And then crossing over to the pond like in the U.S., where they’ve introduced like the new QRS system, and the FDA which is also outlining tough guidelines for manufacturers to establish that good quality system to ensure the safety and effectiveness of these medical devices. I mean there’s been talks regarding how these standards can be harmonized, meaning to find a way in which they can all work together. And the FDA has focused on risk-based quality systems, which means that MedTech ventures or companies must be flexible to these expectations.

And on the technology front where we are seeing a rise in AI, digital health, advanced robotics, revolutionary growth in R&D, with the average company in this industry in MedTech spending about 5.1% of their annual revenue alone on R&D just to keep ahead of the competition, to keep continuously creating these new innovative ideas.

However, the regulatory bodies, they are catching up to all this new techs and they’ve introduced guidelines and all this innovation and the FDA amongst many other regulatory bodies, have issued a guideline for AI in terms of how AI-driven medical devices will be evaluated for safety and effectiveness.

And for startups, this means that it’s really important to get that good foundation in place, a good QMS system, a good, the structure, whether it’s new production, your multidisciplinary team so that you ensure that higher compliance. And obviously now with an aging population and the rising chronic conditions, the increased need for accessibility and efficient healthcare has also grown. And this means that there’s been a lot of pressure now on MedTech companies to deliver solutions that not only improve patient outcomes, but also satisfy the regional regulations or the standards that are being set out for them to meet.

And that’s what today’s discussion is really about. Looking at strategies to manage that risk, maintaining high quality standards to ensure compliance in ways that ensures the safety of all stakeholders, that satisfies regulators, that also means that the patients will be in a great situation.

Yeah. Then just to get started with Markus, just throwing the first question at you, Markus, in terms of effective regulatory strategies. The question is: how can MedTech manufacturers develop effective compliance strategies to navigate this rigorous regulatory environment?

Markus Fleckenstein

Yeah, I think that’s a good question to start with, Rodney, and thanks for setting the scene here with kind of all the evolving standards. And I think that’s kind of where everything starts really, making sure you understand your regulatory requirements.

Being on top of what’s going on in the markets and into the markets you are shipping to, or you market to, and making sure the people in your organization are on top of that as well. Making sure training and education is really done well because this is kind of crucial as everyone needs to understand what’s happening and why this is important.

And then for sure, maybe on top of that is kind of making sure you have the right technology in place. Because I think with all those changes that happening, and sometimes happening fast, you need to stay on top of that. That means you need to utilize ideally some software tools that help you automate that and making sure that you’re adjusting the arrows of the manual work and kind of just stay on top of that.

But for sure that’s coming more from a software vendor point of view. I guess, Amy, you might have a different view coming from a manufacturer.

Amy Bennett

Not entirely. I agree with absolutely everything that you’ve just said. I think as a software tool to keep on top of your regulatory intelligence is really important because it’ll just make your lives so much easier.

For me, what we start with is that regulatory strategy. Having a chat with your commercial team, finding out where exactly that you want to market your device first is really, really important. Also having you think how about markets may be able to influence access to other markets. Something quite close to home is obviously the MHRA have recently announced international recognition, so having market access in certain countries may actually provide access to the U.K. market as well.

But yes, your regulatory intelligence is so, so, so important. Whether you do that with a system, attendance at meetings, going to industry conferences, there are multiple ways that you can do that. But also just make sure that you are defining who is responsible for this within your job descriptions. There’s roles, responsibilities, and authorities within your team, making sure that you do have somebody who is responsible for that and who is able to communicate those changes.

I would suggest using your management review as a really good starting point to communicate any sort of changes within the regulatory environment is definitely a good place to start.

Rodney Moses

Thank you very much. And obviously I think everyone knows what happens if you don’t meet compliance—obviously that could result in your product being pulled from the markets as we’ve seen with some medical devices that are in the past.

But now I just want to focus on mostly in terms of how recent legislative changes in key markets impacting MedTech companies and essentially what steps can this company take to adopt to these changes, and looking at also in terms of how the essentiality of a good QMS system.

Markus, would you want to answer that to start off?

Markus Fleckenstein

Yeah, I mean it’s referred a little bit to the first one, staying on top of everything. I think this is key. Making sure you can mitigate the risks that kind of occur and making sure there are no surprises. You do maybe regular internal audits, making sure you are staying on top of that documentation, making sure all documentation is up to date and all your processes, decisions, and all the changes are well documented so that there is not another surprise there.

But again, coming more from a solution perspective or a software perspective, that might be just my view because I think software will help a lot in that case as well, mitigating this kind of risk.

But again, pushing, kind of giving this question to you, Amy, as well because I think similar like in the last question, pretty much aligned, but there’s, I guess, definitely some additional flavor that you can add to that.

Amy Bennett

Yeah. For me, the fundamental aspect of regulations for me, it all comes down to risk. Colleagues of mine will laugh because I say this a lot: what is the risk? What is the risk of what we’re doing? That’s a fundamental concept. Bearing in mind obviously you got your ISO 14971 and a really handy guidance document as well, TR 24971.

Having those really ingrained in your QMS is really of utmost importance. Yes, you have your benefit risk ratio because I think as manufacturers we are in this industry because we want to improve people’s lives, so only we know what the risk is in terms of our device. Standards and regulations from my perspective will only get us so far, but they’re always playing catch-up. I mean we know we’ve got constantly new guidance. The MDCG documents are constantly coming out all the time, which is obviously the importance of the regulatory intelligence, which we’ve just touched on.

As manufacturers, we need to know the risks of our devices. Building that risk management process within your quality management system for product development is really, really key. By making sure that you are identifying those risks, building them into your design verification, your design validation testing, and before you get into your pre-clinical testing, you may actually find that you’ve got some residual risks that are left that you need to plan for within your clinical evaluation process.

Making sure that you are looking at your risk acceptability threshold, this concept of risk is going to come out. Obviously it’s all right, this conversation that we’re having, because it is so fundamentally important to your product development and therefore your compliance with your regulations. Making sure that you are having a think about your risk acceptability thresholds, bear in mind that should these thresholds be breached, they could represent the change to your benefit risk ratio. You need to take appropriate action.

Looking at literature, current literature, this is where your clinical literature review comes in as well and having a look to see if any similar products on the market could actually guide you in terms of what risks that you should be really looking out for.

Rodney Moses

Thank you. Thank you very much for that comprehensive answer, really, both of you. And in terms of obviously the big question, what everyone wants in this industry, how can companies prepare for FDA and the EU MDR approval? How can companies better prepare for this?

Markus Fleckenstein>

Yeah, I mean again, I might share just my view from a software perspective because I think making sure, for approval, I think we all know number of documents you need to have ready and therefore having all those documents in order and ready when you need them.

And also making sure you have business reviews in place when, and maybe even calculating backwards until when you need what, because I remember back in my quality days where, oh, there is an audit coming, we need to have some, some parts, some product audits ready and I said, “That’s not audit ready, it should be there already.” We are not doing it for the sake of the audit, we are doing it for the product itself because we want to do something and want to release great products and therefore I think that’s where, I think, even for that getting the approvals, I think having the QMS in place that provides you with that possibility to collect all the data, make sure you have everything notified or tracked, all your audit trail of the modification and so on.

I think for me, this is part of the whole story, but this is more like from a technical point of view, I guess, from process point of view and from bringing products really to market, Amy, that’s probably then better with you.

Amy Bennett

Thanks, Markus. I agree with everything yourself have said bringing it back to right in the beginning, it’s the regulatory strategy, isn’t it? I was like, we’re going to be talking about this.

We can keep talking about risk management all over again, but it is really fundamentally important. When we are thinking about the FDA, your regulatory strategy should be seeing whether you are bringing something completely new to the market. If you are going to be using the De Novo Route or are we able to use any sort of predicate devices? Would we be using the 510(k) route? If there are any predicates, knowing that you can actually use multiple product codes here, what regulations apply? Are those devices associated with any product recalls that might actually be permitted to your device? If so, if they do apply to your device, maybe this is something that you should be feeding into your risk management process.

Again, guys, it all comes back down to risk again, doesn’t it? This is something that your clinical literature review will pick up on and therefore feeding into your risk management process. Talking with the FDA, most definitely. Doing any kind of seek pre-subs and having a chat with them as soon as you can. I would advise having a chat with the FDA no matter how early you are in the design development of your device, getting that early feedback from the FDA is really, really important and is really beneficial and can really help you build on your regulatory strategy.

In terms of your EU. Thinking about the EU here, so going to be looking at the risk classes as a device, are there any requirements for that? The Periodic Safety Report, there’s obviously different requirements there depending on your risk class as your device. Looking at your GSBRs, your SPRs, your general safety and performance requirements, how are you going to address all of those?

What standards are you going to be using to make sure that you have mitigated your risk? And again, feeding back into your clinical evaluation if there are any sort of residual risks, making sure that you’ve those got risk-accessibility thresholds in as well.

Rodney Moses

Yeah, no, thank you very much, Amy. I’m coming back to you so I’m not done with you, but I just wanted to also take this opportunity to ask the next question which is linked to, that is in relation to the cloud-native quality system. How does a QMS help mitigate risk in early-stage testing, implementing robotic testing protocols to identify those early issues in the development cycle?

How does that come about?

Amy Bennett

It identifies them quite simply enough. If you have, for example, if you are manufacturing and your risk management has identified that there’s a QC process you want to keep an eye on, you could perhaps automate some sort of trending data.

Knowing when you are, if you are just seeing there’s a slight trend outside of your desired ranges, then it might be time to take some action on it. Having that automated approach to trending is definitely really, really useful and really important from the product perspective and also from a QMS perspective as well, not forgetting that some of your QMS processes actually have a direct impact on your product quality.

There is a really, really helpful GHTF document, the Global Harmonization Task Force, which talks about nonconformity grading. It relates certain sections of 13485 to indirect processes and other sections of 13485 to indirect processes. Section 4.1 to 6.3 where we have indirect processes there and section 6.42 all the way to section 8 where they’re known as direct processes.

You may find that you want to do trending data on all these different processes, but those direct processes you’re probably going to want to handle slightly differently to your indirect, to your supporting QMS processes there. By identifying what you need to look for in terms of your QMS, in terms of your trending perhaps via automated electronic system, that’s going to take time off your hands as a manufacturer and really get to the integrity of what you need to find out about your product.

Rodney Moses

No, thank you. And then because the follow-up question is linked to Markus, so Markus, there’s a question for you. In terms of having that good quality management system, the QMS, why is it important to have traceability within an R&D process?

And by R&D I mean research and development, so other people call it product development. How does that all tie in together with that as well?

Markus Fleckenstein

Yeah, I mean it starts with your requirements, your design inputs, right? And you want to make sure you’re developing product that really sells the market in term of the people that you are want to sell this to. Although really to help sort of making sure, having your early requirements then either incorporated into the product design and all the way then into your verification validation processes, making sure having that to have that whole traceability within your R&D as you just said.

But I would even take this a little bit further and saying it is important to get all your post-market surveillance data, or any kind of field feedback that you have, and incorporate this back into your next-level design, maybe next-generation design, or even to update or modify your product, because I think this is coming then back to Amy’s favorite topic about risk management.

Whenever it happened already in the field, there might be a chance that this happened again and there is the best data that you could have as your intel. For sure, you do your market screening and making sure you are looking at FDA database for example, for any kind of record or issues.

But I mean the field data that you can collect yourself and feed this back directly into your engineering or into your design process and up to your requirements, and as we said, the regulatory requirements also updated and making sure you have all of that linked together, making sure you’re not missing any. And I think that’s kind of the core benefit of having all those links together and the data in one system ideally, or even a link together if it’s in multiple systems, or where it can more easily pull that data when you need it, and making sure you’re not missing a trick.

Rodney Moses

Thank you very much. Thank you very much. Then coming back to you, Amy, because I wanted to just get the questions in that order to build the context. And with this system you have this, what you call integration benefits, and what do you mean, what you define for that?

Could you define what integration is for us? Because obviously it’s not the integration we did all in calculus in school, but obviously it’s an integration within your system. What could you tell us about that?

Amy Bennett

Yeah, so I’ve got the privilege of implementing my second QMS alongside implementing electronic QMS as Arena as we all know. And the real benefits of that is that your record, your absolute record and document protection, you haven’t got a worry that a document’s been misplaced, you haven’t got a worry that your record’s gone missing, because exactly where it is within your system.

Also, having things that are automated, streamlined, making sure that people are trained in their processes. We all know auditors, they love training, don’t they? If you are ever going to get a finding on something, what is it? It’s normally records, sorry, training or labeling or documentation or something like that. All of that stuff in terms of your training can be easily automated within an electronic system.

One of my favorite things is, as a document that’s been updated, the training automatically goes out to everybody that needs it and then they go, there’s your training record, it’s all located in there. In addition, your regulatory files, they become so much easier to maintain. As we all know, there are so many different files when you get into product development. I was like design history file, risk management file, yeah, all all of these different files.

But we know that documents, they don’t just end up in one file, often they are referenced across multiple files. Being able to sort of locate these in a sort of central repository and knowing where they are located within the system. Having them housed in the separate files as well as being easily located is such a benefit. I’ll also say sometimes early-stage MedTech, they perhaps don’t want to invest in electronic quality management system, but it is really fundamental. It’s so necessary even at this very, very early stage because you are either going to be investing in your electronic quality management system or you’re going to be investing in someone who’s literally just doing document control.

I mean each to their own, but for me, I don’t think I would like to be all day mastering documents. And also the electronic quality management system will make sure that it can grow with you as well. Adding new users and everything becomes very, very easy. And just maintaining your documents, having also that automated document review process as well. As we know we have to review our documents in the quality management system. Having that automated, it sends a notification off to whoever needs to review a document. We know that that task is going to be done. It’s just these kind of automations that make any quality manager’s job so much easier.

Rodney Moses

Thank you. Thank you very much. And just another question for you, Amy, is since you mentioned all this, the wonders of a good quality management system, I mean the FDA, ISO standards which are basically international standards, the MDR, like for the European Union, to get approval of all of that, something that every company needs to have as a MedTech company or a MedTech manufacturer, the question is, how did really get the best QMS that really aligns with their approval?

And of course I’m going to pass the same question to Markus, but I would like you to have a go at it first and please hit on why we needed for approval.

Amy Bennett

Yeah, sure. It is a really good question, like the Holy Grail really, isn’t it. Again, it comes down to your regulatory strategy. You see the importance of this document and why you want to get together with your commercial team and then make sure where you’re going to be selling.

That document will identify any sort of nuances, any differences between the regulations for your quality management system. It would be lovely, wouldn’t it? If everyone was harmonized. It would be wonderful if everything was the same. But sometimes things like document retention can be different, things like the periodic safety report, the different reporting mechanisms to less and constant authorities learn about your product can be different. Also remembering that 13485, you have your certification, but the amount of times that actually does reference applicable regulatory requirements, so that’s mentioned so many times.

It’s up to you as a manufacturer to firstly identify what markets you’re going to go in, what nuances, what difference there are between those different territories, document those in your regulatory strategy, communicate those within management review to say these are the resources that we are going to need for perhaps these different territories.

Perhaps they’re going to need, you would need something like your authorized representative. For example, if you’re selling within EU, that’ll be some more resources that you’ll need that will need to interact with your quality management system as well. Again, all these different nuances, so making sure you identify them, identify your markets within your regulatory industry, create a gap analysis, talk to your senior management, making sure that you’ve got your resources there as well. And hopefully we should be fine.

Rodney Moses

Great.

Markus Fleckenstein

Before we go. I have one question for you, Amy, because I wanted to ask it for a long time because you said auditors love the eQMS.

Amy Bennett

Oh, they do.

Markus Fleckenstein

I’m speaking with companies, there are two opinions of it, so we don’t want to show the eQMS audit because we want to ask for stuff that we don’t want to show or there are the others that for sure happy to even give the auditor access kind of so that to review documents or find stuff. There’s those two opinions in there. I think from an overall approval perspective, I think everything should be there though, there should not be a surprise, or you should be ready.

What’s your view on that? Really curious because it’s always …

Amy Bennett

What’s my view? I mean I’m a very open kind of person, so in my personal opinion, I think that for me, if there are any problems within my QMS, I want to know about them because I’m not in this business to hide anything.

I’m in this business to make people’s lives better and that’s honestly something I really, really hold true. If there are any deviations that need to be discovered to make our QMS better and therefore our product safer, then I want to know about them.

But I mean, I’ve been in audits with a QMS, eQMS, and audits were out on eQMS many years ago and the differences between them. The one where I didn’t have electronic QMS, there was a whole back room. It was a big company, I’m not going to say who it was, it was a big company, it was a whole back room involved in just generating all this documentation. And I remember having just people communicating via web-based chat, oh, they’re after this document now and people have to go find, and piles of paperwork everywhere.

And for me, I just would just rather everything be electronic and you can just get the record, it’s right there. There’s no worrying and it’s just that instantaneous kind of the review of the document and review of the record, it shows that you’ve just got complete control of your QMS from my perspective, why would you not want to demonstrate that?

Rodney Moses

Thank you very much…

Markus Fleckenstein

Any way to your market approval, right? You need to have it ready anyway…

Amy Bennett

Oh, yeah.

Markus Fleckenstein

You better know yourself early on or find out for them. Therefore, I think, because for me this ties directly into those two things, as you just said, developing products to make people’s lives better, not building products to fulfill the standard.

It’s first kind of…

Amy Bennett

Yeah, yes.

Markus Fleckenstein

Bring to the market to make people’s lives…

Rodney Moses

Thank you, Markus. Thank you, Markus and Amy. I’m going to have to jump in now, but the next question, I think, is also something that’s quite vivid in my memory.

I remember when I started working five years ago, I think two months into my placement here, et cetera, all the management was stressed about audits and everyone seems, it’s like the company, MedTech companies seem to stop when audit time is around, no one is going on leave, no one is taking days off, everyone is stressed.

What could you say, Amy, in terms of how can companies prepare for future audits? And on top of that, I’m not mentioning the unannounced audits that can happen once every three years depending on which regulatory market you in, but how can companies prepare for future audits?

Amy Bennett

Yeah, it’s something which rings so true. Again, I remember having to do all this audit prep, FDA is about to arrive, and we had to make sure we were all together, all of our records and everything were up to date, which in essence, if your QMS is running properly, then your QMS documentation and your annual records, they should be up to date, right?

I think we can all agree upon that. In terms of, I think there’s always going to be that nervousness that you get before you go into an audit, but I think training effectively, that’s where it all comes back down to. Informing your staff, what exactly will it entail? For example, if you’re going for your ISO 13485 certifications your first time, you’re a small MedTech, usually it’s divided into two sections.

You’ll have a stage-one audit, which is generally maybe about over a day and all that is going over your QMS and making sure that you have everything to comply with requirements of 13485. That’ll be your first check. After you get over that first little hurdle, then you’ll get into your stage-two audit. Your stage-two audit, again depending on the size of your company, between three and five days. That would be an audit of your QMS and your records alongside it. I like to get everybody involved in these audits. I think it’s really, really important.

When you are developing your QMS, this highlights the reason why it’s important to get everybody involved, everyone’s feedback, you want to have proactive feedback from everybody on the shop floor all the way to your senior managers. Do they understand why the QMS has been built in the way that you built it? Have they been involved in that feedback mechanism? Are you actively, proactively gathering that feedback to make sure that the QMS doesn’t only work for 13485 but actually works for them as well? Do they actually understand these processes?

Again, so having that training, making sure people are aware, they understand you’ve incorporated this requirement because it comes from this standard, and also because obviously you’ve got product development which has been very much intertwined with your QMS, any of the outputs of your product development, have you incorporated them into your QMS?

It’s very, very circular, very, very circular mechanism. But making sure does people understand, you’ve trained them, you’ve built them with confidence, essentially. You’ve empowered your individuals within the company to know that they can go into this audit feeling confident because they know exactly how it works. For me, that’s fundamental and that’s definitely what I’m doing here or hopefully that’s what I’m doing here at PhenUtest.

Rodney Moses

Just to come back to you, Markus, in talking about the importance of the good QMS because as much as they can do with the unannounced audits when they show up at your door, having a good system in place does help.

From your point of view, Markus, how would you say companies can better prepare for future audits?

Markus Fleckenstein

I mean, the main thing is, as I said earlier, is not prepare for audits. I mean ideally you don’t need to prep because you need to document it anyway. That’s the ideal scenario, right? Remembering my productivity, be audit ready. And I said, “No, it needs to be ready all the time. We need to have a certain we need to have documentation done.” And this is for sure, we discussed about the standards earlier, the standards and some documents give you guidance, so what to do and when.

Therefore, I would say the best way to get audit ready is not thinking about audit readiness, thinking about product documentation and product readiness at all. Just my two cents on that.

Rodney Moses

Thank you very much. Thank you very much. And just the last point before I start passing most of the questions, just last question for now Amy, is in terms of easily tracking changes and making amendments, because I mean I worked on the MDR team at J&J and it was important to create those, what they call revision one, revision two, and sometimes we had to basically do what we call redline the changes we’ve made so we can change over time.

How does this system help people? Because this takes a lot of time. Sometimes if you’ve done changes and you’ve not tracked the changes you’ve done, you have to kind of restart again before people approve the documents. What exactly is this system really doing in terms of increasing the efficiency around this type of work that needs to be done?

Amy Bennett

Yeah, changes like document change control is so fundamental to any quality management system. Yeah, using Word Track Changes is certainly very useful. I think what the system is very good at is that you can track your additions as well. You can track the changes that somebody has made to the document. You can see the differences between say revision one, revision two.

It makes all of that a lot easier. And you can also use it for training as well, which is what I’ve been doing. When somebody’s made a change to the document, are they making the right changes? And you can sort of track that back from the original document itself. In addition, I will just say that obviously not every change should be looked at in the same way.

For this reason, we’ve got two separate processes for change here. We’ve got a change control process that will take part of those bigger process changes. Things like changes to the design of the device, maybe major changes to the quality management system, but then we also have a document change control process. This process will make sure that that changes so maybe grammatical things, maybe slight clarifications, but we’re not actually changing the process, are a lot quicker and streamlined.

And by having an electronic system it makes that easier. You can get those approvals first. You can check with your quality team—hang on, should this be a document change control or is it a change control? Am I using the right process here? Making sure that you… And you have all those reviewers in as well and you can make that as automated as you like, which is really, really, really useful. Really, really fundamental. Really, really useful.

Rodney Moses

Thank you. Thank you very much. And I think just to add on to that, just one joke to add to that is that when I went to J&J, we had a question in terms of what’s considered a significant change and what’s not considered a significant change because in some documents maybe a full stop was left and we’ll debate or should we create for a full stop to that document or not?

It’s not good to do all of that, but we did also have that change trace document to say that protocol’s not significant enough. For some things like that, it’s okay, semicolon, full stops, it’s okay.

With respect to that, what advice would you give, Markus, to manufacturers looking to grow and scale their businesses successfully and also in a way that they can meet the compliance long-term? Because it’s not just about getting market approval and being on the market, it’s just about staying approved and making sure you stay certified, et cetera. Yeah, what would you say?

Markus Fleckenstein

I mean, always have your future goals in mind, I would say, because you might be quick now with setting up a QMS-type system with using Excel and Word and then trying to stitch everything together with Scotch tape or how you want it, but if you want to scale, if you want to grow, that’s tricky, I guess, because to Amy’s point earlier about eQMS and the benefits of how to scale that this kind of will enable you.

It’s adding new users, just having a standardized onboarding process, making sure people are trained on the SOPs and you keep track of what people are trained on, easy. That if you have a system in place, fine. If you don’t, a lot of… I mean it’s still doable, right? Don’t get me wrong, it’s just kind of the amount of people you might need in order to get this done is just increasing.

I remember discussing with some larger medical device companies where they said, “Well, in order to make sure we can bring our product to market and get market approval, we need to hire 40 more people in order to get this done just for documentation.” That means they had to triple the amount of people that they currently have just to make sure that they have all the documentation. That means even if, yeah, sometimes the investment early on in an eQMS sounds maybe a lot, but thinking about the long term and how this would help you to scale either product-wise, market-wise, or people perspective, I think it is worth the investment.

And I think from an investor’s perspective, what we have seen in the last two years or so, working with startups and grownups that are investor backed, the goal, having systems in place in order to make the company more valuable, I think, is also a thing to consider because it makes the company more efficient and therefore the investment is way better placed.

Even if it sounds like spending money on software is maybe not necessary early on, but long-term kind of from a company value perspective, I think that’s important as well.

Rodney Moses

Thank you. Thank you. You emphasize a lot of return on investment, which is fantastic. But yeah, Amy, I’ll pass the baton to you. What advice would you give to manufacturers looking to grow and scale successfully long term?

Amy Bennett

That’s such a good question. I agree with everything Markus has said, unsurprisingly. Investing in a eQMS if you want to grow for all of the points that Markus has mentioned, absolutely.

In terms of other things to consider is invest in your resources. When you are starting up your MedTech, think about the type of people that you want to have in your organization. Think about the skill sets that you’re going to need in your organization. Invest in their growth as well. You grow people and then they’ll stay with the organization, that’s going to pay off dividends in the future.

Making sure that you’re invested in your growth through people, that training. Also, that human resources training, all of that goes in together. Making sure that you are constantly monitoring your processes. Remember I was talking about direct and indirect processes and therefore you can target the areas that you need to grow and develop and improve upon is ultimately going to help you stay in compliance with all the changing regulations in terms of your QMS certification as well.

Regulatory strategy, again, it’s coming back again, isn’t it? Making sure you’re always on top of that. As all medical device companies, we’re not just going to sell into one place are we? We’re always going to be constantly looking into other places. Making sure you’ve got your regulatory intelligence, defining who is going to be in that, stay on top of your job descriptions. I mean everything about a QMS just relates in terms of the growth of your product because your products is going to grow into multiple different locations, the growth of your company, whether everything just all relates back to your QMS.

Invest in your resources, your human resources, make sure that they’re growing. And yeah, just staying on top of your QMS, finding out whether it is still fit for purpose. That’s the important thing, isn’t it? Making sure you’re monitoring, not constantly changing if you don’t need to change, but monitoring whether your QMS is still effective for the purpose that you need it.

Rodney Moses

Thank you. Thank you very much. And of course, I was just looking at that time and getting pinged and everything, so I am really grateful for everything that you guys have said. I think you provided a lot of value and, sorry to the listeners, there’s no time for Q&A’s, but of course we’ll still be taking some questions afterwards, so feel free to send them via email or in the comments or whatever social media platform we’ll be putting this in.

But I just want to take this opportunity for the last 30 seconds to just say thank you to everyone for coming on, some really great answers. I learned a lot. Hope you also took a lot of value from this as well. Yes, thank you very much.