Why is the state of MedTech culture and tools the way it is? How should the industry be thinking about moving away from generic compliance and toward MedTech Lifecycle Excellence?
Jon Bergsteinsson, the founder of SMART-TRIAL, is a MedTech professional and Clinical Affairs expert. Jon is also involved in educating and helping the MedTech industry get safe and effective devices to market faster and more efficiently.
Listen to the episode to learn more about how MedTech is different from pharmaceuticals and other similar fields in the industry, why it’s important to look at the entire lifecycle of a medical device, and where the MedTech industry is going.
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Some of the highlights of this episode include:
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The gap that medical device technology companies experience
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How regulations are changing and how it could help the industry
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What could be accomplished by pursuing MedTech Lifecycle Excellence
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How people in the industry feel about sharing information
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Where the MedTech industry should be going
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Keeping talent in the MedTech industry and drawing more talent into the field
Links:
Memorable quotes from Jon Ingi Bergsteinsson:
“When you start working in MedTech, and you have experience from other parts of the life science industry, you start to realize how different it is from pharmaceuticals and other similar product developments like biotech, for example.
“It’s easier to innovate medical device technology.”
“Ease of use has a lot to do with the fact that you haven’t involved your end users well enough, or you haven’t involved the right end users.”
“When it really comes down to it, you can’t really help or facilitate growth and development in the industry without experiences and insights from other industries.”
Transcript:
Etienne Nichols: Hey everyone. Welcome back to the podcast. Today with me is. Okay, and here we go. Jon Ingi Bergsteinsson.
Jon Ingi Bergsteinsson: Yes.
Etienne Nichols: So good to be back with you. So, we talked about whether or not we go with English versus Icelandic. I always, you know, let's just, let's just go on and, and, and I'll let you decide that on your own some other time. But I'm excited to be with you today to. You know, we talked a little bit about what we're.
What we wanted to have a conversation about.
And one of the big conversations that we're having with a lot of different people is, is something that we've turned the MedTech life cycle excellence just kind of that. What is that?
Medtech lifecycle excellence? How do you achieve MedTech life cycle excellence?
And just to kind of preface this conversation, you know, we, we have sort of repositioned ourselves.
Greenlight Guru and the, the offerings that we have to try to fill a void that the MedTech industry has experienced for a long time.
But I won't just dive right into that. I wanted to get your thoughts on what you've seen in the industry and your experience. I know you’ve; you've seen a lot of different things and maybe we can kind of start the conversation there.
Jon Ingi Bergsteinsson: Yeah, thanks for having me, Jen. It's a very good starting point because it's a conversation that, you know, we've had internally, but also on my side of my, my team for years.
And I think to start off and frame it a little bit, we need to look at the life science industry a little bit differently because when you, well, when you start working in MedTech and if you have experience from other parts of the life science industry, you start to realize how different it is from pharmaceuticals and other similar product developments like biotech, for example, because medical devices and MedTech in general is very much influenced by people.
The way that we use it, the way we apply it in practice and the way that we conduct research, the way we develop and design them is very differently from what you're used to in other parts of the life science industry.
So, a big, well, a big characteristic of the MedTech industry is that it is very often low budget or companies within medic industry tend to have lower budgets than what you see otherwise in pharmaceuticals.
There are multiple reasons for that which heavily Influences how they run their organizations.
So, me being in the medic history now so far for at least 11 years, if there's one thing that I've learned is that medic companies, they care about every single dime, right? If there's a decision to be made, whether it's design control or if know quality management or clinical, like every single dime is being counted for.
And Metric Europe has been doing this survey every year where they've real, where they've demonstrated that 95% of the industry is small medium enterprises.
So, we're not talking about Johnson and Johnson and, and, and Phillips and all the big ones, but most of the companies are small medium enterprises.
And because of that fact, the way that they've been run is very much startup bootstrap liked.
So, these companies have been acquiring, you know, consultants and services from pharmaceuticals and non-pharmaceutical industries to support them with the different areas of the medical device lifecycle.
And when I got first introduced to the MedTech lifecycle excellence ideology, there was a light bulb that turned on in my head like wow, this is the reason why we have been struggling for so long in the industry because medical device manufacturers and diagnostic companies, which are also considered med tech, have been, you know, they've been struggling with figuring out how can we manage our device and technology life cycle in an efficient way.
There's never really been a focus on providing these MedTech companies with services and solutions that are designed towards that part of the life science industry. It's always been the focus has always been on pharma.
And that is largely due to the fact that you know, pharma is just a, you know, I don't know how many axes, but it's a couple of axes bigger and bigger and billions of dollars of industry every, you know, every year.
Etienne Nichols: Yeah, then. And I've actually seen graphs of all of the different potential ideas that kind of lead into one final pharmaceutical product. All of the work that leads up to that involve a lot of people.
So, it kind of makes sense a little bit when you look at it from the dollars and people perspective that work in pharma. But at the same time the MedTech life cycle or the, the MedTech industry itself, it's, it's far reaching as well. But I, I really like that statistic you brought up about. You said 75% to how many?
Wow, 95%. That's incredible. Our small to medium medic medicine medical device companies. That's incredible.
Jon Ingi Bergsteinsson: At least those are the numbers from Europe. But I, I mean we can, we tend to be able to compare both Europe and North America with Europe in terms of market size and MedTech.
These are the two biggest markets.
I have not to date seen numbers that specifically highlight the size of the companies, but I would assume that they will probably be similar.
Might not be 95, but you know.
Etienne Nichols: It wouldn't really surprise me because, you know, you and I probably could start a company if we wanted to and you know, with a small medical device just to. Yeah, so absolutely.
Jon Ingi Bergsteinsson: Well, I'd say it's easier to, it's easier to innovate medical device technology because when you talk about pharmaceuticals, it's very highly, highly like influenced by research, biology, chem, like chemistry.
It's a very complex area when it really comes down to it. Whereas medical devices is also complex, but it's still usually something that you can, you know, build out of already existing components.
Yeah, not always, but you know.
Yeah, the, the way that you innovate is very different.
Etienne Nichols: Absolutely. Yeah. Okay, so if, if we, if we take a step back from that. Okay. So that you've got the differences in pharma and medical device, I. There's obviously a gap there. What is that gap in your mind that you've seen medical device companies experiencing? It's, it's a lack of maybe, maybe that they act a little bit more nimble, they're a little bit more bootstrapped.
But what does that really come down to? I mean, I have my ideas, and I might.
For example, when I was working in the industry, I can remember there's a lot of Excel based things. There's also a lot of maybe general based tools where you might have a general PLM or a general document management system.
You're trying to make those things talk to each other. But what is your experience and what do you really see as a pain in the industry?
Jon Ingi Bergsteinsson: So, I am lucky enough to not have been involved specifically in medical device development, but being an observer of multiple companies that are developing medical devices and what I have seen is exactly the same thing.
Most MedTech companies have had to acquire solutions and services that facilitate their product design and development, production, clinical research, quality, regulatory, which is based from other industries, whether it's other life science industries such as pharmaceuticals or general industries like aviation or, you know, the car, automotive industry.
And they're often not trying to apply technology and concepts that do not originate from EdTech, do not, you know, facilitate ISO standard compliance and so forth into their organization simply because there's no other, you know, option.
And they tend to go back to using Excel or other general tools because there's simply not a viable, cost-effective solution out there that is designed to facilitate the MedTech life cycle as it is.
And that's really where, when I first heard about the idea of MATIC lifecycle excellence, I realized that we've been working towards, and I say we when and I'm referring to smart trial. We, we've been working towards facilitating clinical operations, a clinical data management, a clinical data collection for MATIC companies specifically for years.
But what I've come to realize is that that is just one part of the life cycle.
There are numerous, numerous parts of the medical device or the MedTech lifecycle that have exactly the same problem.
They've been applying Excel or using other solutions or outdated, you know, solutions in their operations to try to get by, whether it's, you know, for quality, regulatory or anything else.
And there's really not been a, a place where everything can be aligned and connected and integrated to facilitate MedTech development or MedTech lifecycle as it is, as it's supposed to be, you know, according to the regulations.
Etienne Nichols: Yeah, as it could be, ideally, I guess.
Jon Ingi Bergsteinsson: Yeah.
Etienne Nichols: And you know, there's, there's sometimes when I hear about things that are coming, I think about why, you know, what's the point? What, what are we really trying to accomplish? Are we trying to make it cheaper?
Are we trying to make it easier? And obviously I think those are two are. But you actually mentioned something there, you mentioned regulations, and I want to dive just a little bit into that because I mean, we've been able to meet regulations up till now.
Why do we need to change anything? Does it really help?
And is there anything else that maybe we could be accomplishing by, you know, achieving a MedTech lifecycle excellence, you know, situation that we're, that we've kind of been discussing.
Jon Ingi Bergsteinsson: Yeah, I mean, when it comes to regulations, regulatory compliance, a lot of the issues that companies observe during their regulatory submissions is related to how they document things.
They're being challenged on how they document the products or the medical technology itself might be fantastic and great.
And it usually always comes down to how your regulatory submission and your technical file and how your documents look like and work and how you've told your story that, you know, that really, you know, impacts how your product will be perceived by the regulatory buddies.
So, when it comes down to looking at, you know, how can we make that more effective and how can we ensure that fewer companies will have that issue?
We need to look at the whole life cycle as a, as one process Instead of siloed teams and siloed productions, whether it's, you know, design controls or quality assurance or clinical, we need to look at it from a holistic approach and say, how can we first of all ensure that they communicate better?
Second of all are in line with the ISO standards that we need to comply with because there are ISO standards that specifically have stated how we are supposed to design a medical technology, how it's supposed to be tested, how it's supposed to be document it.
Why can't we not facilitate that across the whole life cycle instead of just focusing on individuals?
And that's where the biggest challenges come up in these companies. That's where the QA and RI people have the most headaches like, okay, this team is going, doing great, but how do we make sure that that team also is doing great and they communicate together and that's where the stars start to align.
Right.
That's really where you start to think, why is there no way for all of these departments to work together so that we can create a more efficient way of producing the regulatory needed submission documents and, you know, processes that need to be implemented to get our products to market.
Etienne Nichols: Yeah, we talk about that in product development sometimes how you should involve manufacturing or involve quality so that when you're going through that design controls process, it's, you know, eventually you're going to have to pass that off to manufacturing. Eventually quality is going to have to defend that.
But the other thing that I was thinking about with that is with that regulatory submission, I heard a story recently about a guy, he was so proud of his submission, this is several years ago, but he has a picture of himself standing next to a pallet of documents.
All of the different things that he had to do. I don't know what exactly that device was, but sometimes we talk about high documentation.
He was pretty proud of the amount of documentation, but at the same time when you zoom out and you look at that again, that's inefficient.
So maybe he gets it, maybe he gets it submitted, maybe he gets it passed. He's never going to be able to go back and look through those documents or update those documents as his design evolves.
That's just one little zoomed in example.
Jon Ingi Bergsteinsson: So, I really, I've seen the same problem when it comes to clinical.
I've seen and I've been standing in, I've stood in a room where I've, you know, touched boxes that are the same height as myself that include clinical data from a clinical investigation for a medical device to be, you know, submitted for approval in an Asian based country and they still haven't transcribed the data yet. So, they, they weren't unsure of, you know, what was, what was really the outcome of our trial there.
They had some idea, but they really did not have an idea.
So, I guess when you're right, it doesn't just relate to the fact that we need to be, that we need to enable cross section, cross department communication and, and, and collaboration.
It also touches on digitalization.
Are medical or MedTech companies too old school?
Is that one of the reasons why there are so many companies that are failing and having a trouble in getting their submissions through and devices to market is that simply because they've had to rely too much on old school methods not being digitalized enough, not being effective enough in terms of their, like you said, design controls and matching and change management and so forth?
Yeah, that's really where we start talking about products like okay, so what digital products, you know, can be offered in terms of enabling MedTech lifecycle excellence?
Etienne Nichols: Yeah, I, I have my preferences, you know, it's interesting. So, I, when I was a product development or a project manager, I, you know, we were trying to implement a solution at one point in my career that we finally just decided, you know what, it's just too complicated. We're going to stick with what we know and whether it's efficient or not.
We knew it.
And so digital is one thing, easy to use is another and so they almost have to work together if you're really going to use, have humans using them. Oh yeah, so yeah, go ahead.
Jon Ingi Bergsteinsson: You know, use ease of use has a lot to do with the fact that you haven't involved your end users well enough or maybe haven't involved the right end users.
So, I think a lot of the reasons why, for example, some of the pharmaceutical solutions that have been implemented in Matic industry to date that touch upon, you know, QAR clinical, they often do not work because it's been designed with another different type of end user in mind.
So, ease of use has a lot to do with the fact, has a lot to do with focus as well.
Have you developed a product that is designed to address the MedTech lifecycle or is this, is this a generic solution or service that is designed for the lifestyle industry as a whole?
I mean it's, I, I tend to compare math tech lifecycle excellence with, you know, paint because it's the most simplest way of, of saying okay, you know, explaining the concept.
If you were to paint a house in different colors, you're going to make sure that your family is satisfied with the, you know, colors of the wall.
You would not take, you know, paint that's used to paint a boat or a bathroom paint only and just wipe it on the, all the walls.
You're, you're buying paint that suits the wall in your ceiling, you're buying paint that suits the wall in your bathroom. You're buying paint that suits your living room walls.
And it is different types of paints. They're different, you know, consistencies and they're different, you know, glance, you know, levels, whatever it is.
That is exactly the same thing with Matic.
With a medical device or medic life cycles, you can't just assume that you can use, you know, one solution for everything or try to, you know, use a pharmaceutical service or solution here and expect to get the same output.
You need to, you need to get a hold of something that has been specifically designed and created to enable you to be best in what you do. And that's medical devices and MedTech.
And nobody is really taking that approach to the MedTech lifecycle as a whole. There are companies in the industry that try to do it for different things like in the management, but nobody's really taking that approach and said, hey, let's do that for the whole life cycle instead of just focusing on silo departments.
And that is something that the industry just is just now realizing that that actually an ideology that can work.
Etienne Nichols: So MedTech lifecycle excellence, before we started this conversation, we were just kind of talking about a few different ideas about it and you had mentioned the three pillars in your mind that you saw as kind of supporting that.
I only kind of, I don't. We can, I didn't mean to necessarily bring them up directly, but the industry focus and why you even need MedTech lifecycle excellence, obviously the things that you can have to support those focus.
But then the third one is community that, that you had suggested. And so, I wanted to talk about community.
There's lots of different communities around the MedTech industry, you know, and, and community, right. There is a slippery word in, in and of itself, but a place for knowledge sharing and you know, just the discussion of, of this type of thing. What have you seen up until now and, and what are you a part of?
Jon Ingi Bergsteinsson: Good question.
Because like you said there, there are. To explain the metric lifecycle excellence ideology, you really need to think of these three pillars and that's the focus, the services and products available and then the community. And I think the community is one of the most Important ones to maybe start by talking about. Because when it really comes down to it, you can't really help or facilitate growth and development in the industry without experience and insights from others.
That's a fact. I mean, a lot of the conferences that are going on right now these days, since in Europe, are conferences focusing on assisting each other in ensuring MDR compliance and IVDR compliance.
So, no company can do this alone. Very few companies can do this alone.
Some companies have years’ experience and the right people hired to, for example, get through FDA or MDR compliance with any product.
But most companies can't because we do not simply have enough people in the industry to be experts in everything.
So, if we are to facilitate a global metric lifecycle excellence, we need to facilitate communication, insight, sharing knowledge, sharing experience with each other and we need to break down the walls of competition because every single medical technology that's available out there in the market is designed to help the individual to facilitate better health.
And if we're not sharing our knowledge within the industry with each other, we're not.
We're not, you know, in line with our true goals and values, are we?
And when I get questions, for example by in our existing customers about why should we ever participate in a community where our competitors are hearing about what we're having challenges with, I would ask the same question, say why would you not? Because if you're competitors that's fine. But you know, there is always a way to tweak things that you don't have to, you know, explain in detail.
You don't really have to even use your own name if you don't like to. But sharing an insights and knowledge with the rest of the industry is vital for the industry to get by.
And if we're going to facilitate metric lifecycle excellence, we need to start thinking about how can we create communities and ways and platforms for people to do that.
And today there's really no like one way of doing it. I mean, we have LinkedIn, but LinkedIn, like any other social media platform, is getting flushed with all sorts of ads and, you know, newsletters and stuff like that. You don't really get the news that you may be wanting to get to see unless you're really active in terms of telling LinkedIn what you want to see.
We have LinkedIn groups, we have Facebook groups, but those LinkedIn groups that I see, they tend to be flooded with ads as well and people that like to proclaim themselves as the expert instead of people that are looking to share knowledge.
And I mean There are conferences and summits out there, but you know, they're held maybe once or twice a year.
If I am a QAR or clinical expert in the math industry or product engineer or anything, and I have a question, I would probably start by going first to my colleagues, but if none of my colleagues know the answer to that, where do we go? Well, we go to Google probably for first, but what if there was a space where anybody in the industry could go to and just share their ideas?
And that's, that's something that the industry has been lacking, I believe. In my opinion that's where I think the MedTech Lifecycle Excellence community that we're establishing right now could be a potential answer to that question.
Etienne Nichols: Yeah. With a specific focus on MedTech itself.
Absolutely.
I really want that to be a possibility in the future where you could go to one place and have a trusted source of that information.
When I was in the industry, you know, you would go to certain colleagues. You know, I don't know if you've experienced this, but in my experience, medical device companies are very, or the industry itself seems very tight knit. You brought up competition, you know, the competitors and not wanting them to, to hear what you're doing. That seems to be a very real, I don't know if fear is the right word, but you don't really want to let other people know what you're doing necessarily.
If I leave this industry for just a moment and think about a different one. So, I, I had actually considered starting a bicycle company just in 2020. Everybody was doing something, you know, we're all going to do something different.
And I was like, well, I'm going to make bicycles. I was shocked that every bicycle company online gives every specification. It's the thickness of the wall, you know, the tubing, the, the actual geometry, the measurements and all that sort of thing.
It blew me away. And then I got to thinking, well, there's two things that most people cannot replicate with the best manufacturers. They can't scale to their ability.
And they also don't have the quality of welding or whatever else however you're building that bicycle.
And so, it made me think those are the two competitive differentiators for those companies, for medical device companies. If you're truly achieving true quality, you know, people can follow you into the FDA with the 510(k), so they can still follow you and do those things. You may try to cover your tracks, I guess, by, with your proprietary information, but a lot of times that could be sort of reverse engineered.
But we are, we are Pretty fearful of sharing our information, and justifiably so. It's a company. What are your thoughts on that? And have you.
Have you seen any good stories? And I don't know, I don't mean to go too off track here, but.
Jon Ingi Bergsteinsson: No, I think it's worth mentioning because I think this is, like you said, it's one of the biggest fears that most people have with sharing experiences. They.
I mean, almost every single talk that I see on a conference is always, you know, starts off with a disclaimer of some sort of like, this is not the, you know, official statement for my company. This is my personal opinion alone, and et cetera, et cetera.
And we really need to look at a community from a different angle and say, okay, if you don't want to share enough information to, you know, that could potentially risk, you know, any competition to utilize that for their better good, for their, Their good.
How can we create a community that enables you to do that? And that could, for example, be by enabling people to ask questions anonymously or enable people to be, for example, working in closed groups or closed subgroups within the community so that that can be facilitated somehow.
But in the end, we have the same question in every single industry.
Like, if you're a startup and you're pitching your idea, there are hundreds of people that can probably steal that idea, but just by you pitching it.
But like you said, you as a manufacturer, you have other uniquenesses or unique factors involved that will enable you to potentially utilize your product a lot better than the competitor will with that same information.
So, I think we just need to break down the barriers a little bit for people and explain that you don't have to share everything, but you should be able to share enough in a piece of question to be able to acquire what you need for that purpose instead of saying too much.
That's at least in my opinion.
Etienne Nichols: Yeah, I agree. I think most of the time the things people are looking for is not competitive information.
So, I think that could also be something just a bit.
As you focus, as you look to help people or get that information yourself, most of the things that we're asking about are things that other people have struggled with as well. Not necessarily something that's very specific to your product, although that could be the case.
Jon Ingi Bergsteinsson: So true.
But again, getting back to your question about other communities you've seen out there, and what are, what are we seeing now?
I think when it really comes down to it, we need to start utilizing the expertise and knowledge that we have within different areas of the MedTech industry in a different way than we've done before. Because most of the information that we've been sharing with each other have been at conferences where we're holding lectures.
There's really no way for people to ask questions specifically about a very specific issue or problem or challenge.
And that tends to be the most popular thing at every single conference. People get a chance to ask specific questions, and I've heard so many ridiculous specific questions being asked.
The conferences where the lectures are just like, you know, I won't be able to answer that.
But if we can create a community online that enables people to do that, that will be a game changer.
I mean, first of all, you don't have to pay for it because even though you would find a consultant that was willing to take on your questions and you have to pay for them, that's just one person.
But in a community, you can ask a question to a group of individuals that might have that same question before.
So, the spread is just a lot bigger.
And I think slowly, if we continue building this ideology, we continue, continue facilitating this community and we bring in more people, I think it will automatically mature into something that will, you know, become alive and become more of something that, you know, the industry will be able to cope with.
People are just always afraid of change. And this is just, you know, the competition question is just one change factor that we need to take into account and try to figure out how we can facilitate that.
You know, one simple way to facilitate is just being, enabling people to ask anonymous questions.
That's how Facebook is chackling it right now, with groups, for example.
Etienne Nichols: Yeah, that makes sense.
And yeah, those, those specific things on how we can do that. I'll, I'll put a link in the show notes to our community so that people can go check that out.
I'd love to hear, hear any feedback and, and if it's in line with what we're talking about, if it needs to change, I'd love to hear it either way.
One of the other things that I was going to mention about that though, so with this MedTech lifecycle excellence, this ideology that we're talking about, we kind of mentioned. Well, you know, there's, there's, there's the past and, and how we're maybe the MedTech life cycle or the MedTech industry is sort of living a little bit in the past. Maybe they're old school. I like that phrase.
But also, there's, there are things that are coming around that are, but yeah, that maybe are connecting the industry.
What I would be interested to hear is we've talked a little bit about the past. Where do you think we are currently and where do you think you'd really love to see the MedTech industry go?
Jon Ingi Bergsteinsson: I've, I think that the industry has changed a lot just in the past two, three years. And I think a lot of it has to do with the fact that the MDR has come into force because the MDR in Europe introduces a lot of new additional requirements that basically eliminate the possibility of you being able to operate and to create your technical file only on paper.
For example, most or you know, you know, or using old school-based methods.
There are solutions popping up every year that now claim to be able to do this and that digitally to support, you know, this part of the lifecycle and that part of the lifecycle.
And I think companies in the MedTech industry are starting to notice them and starting to implement them. You know, one of the solutions that a lot of the MedTech industry has started implementing and it's probably one of the first digital solutions is probably the eQMS, you know, concept. Sure. Document management and so forth.
Now in our industry, in the clinical operations in the last two, three years, many of the medic companies that are starting the first studies or continuing supporting the devices out there in the market have started to implement digital solutions as well.
So, I think the industry is becoming more digitalized than it was before. Definitely that's where we are right now going forth.
I would say within the next five years we're going to see an even bigger change with companies looking to stop buying siloed solutions.
And we're seeing this trend already in the clinical world where they're not, where companies that have contacted studies realize that they're, they're not going to use this system for that, for, for patient reporter outcomes, which is like a question tool for clinical investigations and they're going to use another vendor for physician questionnaires or eCRF.
They want a solution that does both.
So, if we're already there within clinical and eQMA has already tackles a little bit on, you know, document management, change control and CAPAs already as well. We're, we're combining things together.
Wouldn't the next step then be within the next five years to have not only that but also the parts of clinical work together with reporting functionalities and document management, working with design controls and risk and then also product strategy design and regulatory management and intelligence in terms of post market surveillance and document control, references to predicate and equivalence stuff like that, doesn't that make sense to start looking towards that?
And I think most people probably nod to that ideology because it does not facilitate growth. To keep everything siloed, you need to enable integrations between those teams and between those departments.
And so, I think within the next five years we'll definitely see more companies look towards doing that, implementing solutions that are tackling the process, the life cycle as a whole, instead of individual departments as silos.
Etienne Nichols: You know, I'm gonna go back to the beginning of what you were talking about there because I, I should have interjected, that was really interesting when you said the EUMDR is, is almost forcing some of this change.
And a lot of the reaction I've seen from, you know, maybe US based companies is, you know, well, we've decided to let our CE mark up. We're just not even going to go.
It's too, it's too difficult.
But the fact that you brought that up, that, that difficulty is forcing a change in the industry, potentially forcing streamlining, which I think you're probably, I've never really thought about it like that, but I think you're right.
That's really kind of interesting. I, you know, I'll leave my opinions out about whether. But that's really, that's really interesting.
Jon Ingi Bergsteinsson: It is, it is a, it is a competitor factor as well. I mean, there are companies, like you said, there are US companies or companies outside of Europe that will make decisions on, you know, pulling the products out of the market where there will be a gap for other competitors to come in and, and gain market share.
But when it really comes down to it, I don't think the EU MDR really is driving all of the chains. I think some of this is also influenced by just the general predictioners and patients and buyers realizing that in order to use a medical technology we need to be a little bit more, we need to start questioning more what is wrong or what is right, what is good, what is actually not good.
You can't really rely solely on regulators to do that for you.
Which is also why a lot of, for example, buyers, you know, in Western healthcare systems are starting to focus on value-based care.
Value based care has everything to do with how well is the product performing out in the market, how well is a product performing based on what you've sold us on?
And that requires an extensive approach towards, you know, efficiency and safety when it comes to product development, design and the, which is a big part of the life cycle.
So that is something that's also happening in Europe.
There's a lot of buyers focusing more on that, which might not have nothing to do with C Mark, but it's introducing changes that influence the EU MDR to become what it is.
For example, and we're already seeing FDA doing something similar with post market surveillance being increased.
So, it's not only the regulation change, but what's happening in the industry that has influenced that change.
Etienne Nichols: And, and it's very needed. And I'm, I'm really glad that it's happening too because I actually had friends and I've mentioned this on the podcast before, but maybe they, they looked at those regulations and they said, well, you know, I, I love the medical device industry, but this is just too much for me.
You know, the different solutions and things like that they were having to deal with, they might go, I know some people have gone to SpaceX, some people have gone to Tesla, some people have gone to these other industries because they want, they want to do big things.
They want to, they want to focus on their talents where they really belong, you know, eng and design.
But we want people in the MedTech industry saving people's lives.
And so, if this is going to keep the talent in the industry or draw more talent, I really think it has the potential to do that, to truly achieve a MedTech life cycle excellence.
You know, achieve that ideology to where the things that you're focusing on are a holistic approach. That's, that's that the IND individual contributor level.
But if you look at it from an entire company level and the holistic product life cycle, that's,
I think it's huge.
Jon Ingi Bergsteinsson: And it is huge, like you said, because since Greenlight Guru announced our new initiative to become the leading MedTech lifecycle excellence platform in the world, I've had a lot of questions from my community in my network asking me what is that specifically?
Because this ideology has never been presented to nature before.
The people have a, people are having, having to digest the idea because it's not something that we've been able to, you know, offer to the method industry, you know, and it's in, in, in the state that we're thinking of it.
So, but we, we can, we can compare this to other industries as well. Because if you really think about it, this is very similar to what for example, companies like Airbnb or Uber is doing.
They're cutting out all the middleman’s.
They're taking on an industry that is well established, but they're lacking the common framework to facilitate, for example, transport. I mean, Uber started with only transporting individuals, but now they're doing food and deliveries as well.
Why can we not offer a solution that is also tackling clinical and quality and regulatory and document management, design control as well as.
Why does it have to be siloed across different vendors and services that are focusing on different things?
Because, for example, you know, you wouldn't ask DHL to deliver your food, right? You would want somebody that is designed something specifically a service around delivering food.
But you don't want only to hire somebody that can only deliver food only. You want somebody that has knowledge of transportation, of, you know, people, you know, different cooling scheduling environments. You know, they have the platform around it that can facilitate that to be effective and price, you know, priced according to what we expect it to be and so forth.
So, this is a trend that we're seeing across many parts of other industries.
It's just ha. This is just the first time we're trying to apply the same ideology towards MedTech.
Etienne Nichols: Well, I'm excited for the future and I think the future. I was talking to Daniel Kraft recently about digital health and I said, what do you think the future is? You know about this?
He's like, I think the future's here. And I don't know if we can 100% say that in this aspect necessarily, but I think it's very close and it's coming and I'm excited to see that.
See it come.
Jon Ingi Bergsteinsson: Yeah, I think you're right. I think you're right.
Etienne Nichols: Okay, so I'll, like I said, I'll put in the show notes the community, how you can find our community and maybe talk to us about what we can do to, to make this a reality.
What parts have we not thought about? I'd love to hear any thoughts on this conversation if you have them. You can, you can message yon as well.
However, you'd like to reach him.
We'll put links as well to get to him. Yeah, go ahead.
Jon Ingi Bergsteinsson: Yeah, we'll put some links in. That's fine.
Etienne Nichols: So, yeah, all right, thank you. Anything else you want to leave with our listeners today? Any one big takeaway you'd like to, to, to remember?
Jon Ingi Bergsteinsson: Well, if there's anything, I would, I would suggest people to reach out to their peers in the industry through your community.
Take a look at that. Because I really believe that what we're building, what you started with the Medicare Lifecycle Excellence community earlier this year, is going to make a big change for a lot of people.
So, I would highly suggest that people take a look at it because some of the content that I've seen so far has been very, very interesting.
So, we've only just, you know, take a look at it, see what you feel about it, and then, you know, you can make a decision after that.
Etienne Nichols: Yeah, I think you're right. We've scratched the surface, but there's a lot more to come. So, I'm excited.
Jon Ingi Bergsteinsson: I'm excited for the future, definitely.
Etienne Nichols: All right. Thank you so much for being with us. Thank you for listening. You've been listening to the Global Medical Device Podcast, and we will see you all next time.
Jon Ingi Bergsteinsson: Thanks, Etienne. Take care.
Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.
Email us at podcast@greenlight.guru.
Stay connected for more insights into the future of MedTech innovation. And if you're ready to take your product development to the next level. Visit us at www.greenlight.guru until next time, keep innovating and improving the quality of life.
About the Global Medical Device Podcast:
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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