Navigating MedTech Biocompatibility & Risk Management

August 4, 2025 ░░░░░░

#418 Navigating MedTech Biocompatibility & Risk Management-1

This episode offers a "biocompatibility brief" with guest Marina Daineko, a MedTech expert and chemist specializing in biological evaluations. Marina shares her perspective on the critical role of chemistry and critical thinking in assessing the safety of medical devices. The discussion highlights the need to look beyond simple pass/fail tests and delve into the nuances of raw data analysis, material composition, and manufacturing processes to uncover potential risks.

Marina emphasizes that biocompatibility is not an isolated task but must be fully integrated into a company's quality management system (QMS). She explores the connection between biological safety and key QMS processes such as change management, post-market surveillance, and CAPA. The conversation also touches on the shift from a reactive to a proactive mindset in the industry, driven by new regulations like the latest revision of ISO 10993-1.

Using real-world examples, Marina illustrates the importance of considering long-term patient exposure and cumulative effects. She provides clear explanations of complex concepts like the difference between extractables and leachables. Her advice to MedTech professionals is to always be curious, ask questions, and prioritize communication across all teams to ensure the safety and efficacy of medical devices.

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Key timestamps

01:37 - Importance of a Biological Evaluation Plan and in-depth data analysis
03:48 - The need for critical thinking in biocompatibility, highlighted by the silver ion example
06:03 - How a chemistry background informs a deeper understanding of materials
08:06 - Real-world examples of biocompatibility risks from the Netflix documentary, The Bleeding Edge
11:20 - Discussion on cumulative effects and long-term exposure to materials
12:56 - Applying a risk-based approach beyond standard tables
15:39 - The difference between extractables and leachables
18:18 - Integrating biocompatibility into the QMS (change management, CAPA, post-market surveillance)
22:01 - The shift from reactive to proactive biocompatibility approaches
23:55 - How to explain complex biocompatibility concepts to non-technical teams

Top takeaways from this episode

Go Beyond the Checklist: A biological evaluation plan and critical thinking are essential. Don't rely solely on standard pass/fail tests; analyze raw data and question unexpected results, as seen in the silver ion example.
Assess Cumulative Risk: For long-term or implanted devices, consider the cumulative effect of chemicals that may leach from the device over time. Proactive risk management should account for this long-term exposure.
Integrate Biocompatibility into the QMS: Biocompatibility should not be treated as a standalone task. It must be integrated with core QMS processes like change management, CAPA, and post-market surveillance to ensure continuous device safety throughout its lifecycle.
Communicate Across Teams: Effective communication is paramount. Technical biocompatibility information must be translated for different teams—from regulatory and quality to marketing and sales—by highlighting the impact on deadlines, compliance, and patient safety.

References:

Netflix Documentary, The Bleeding Edge: A documentary that exposes systemic flaws and risks within the medical device industry, featuring the case of the Essure device.
ISO 10993-1: The international standard for the biological evaluation of medical devices, which is undergoing revisions to emphasize a lifecycle-based approach to safety.
Etienne Nichols' LinkedIn: For more insights on MedTech and quality management, connect with Etienne at https://www.linkedin.com/in/etienne-nichols.

MedTech 101: Extractables & Leachables

In simple terms, extractables are all the potential chemicals that could leak out of a medical device under harsh lab conditions, like high temperatures or strong solvents. Think of it as a comprehensive stress test to find every single chemical component.

Leachables, on the other hand, are the chemicals that actually leak out under normal, clinically relevant conditions. This is what a patient's body might be exposed to during the device's actual use.

Regulatory bodies like the FDA often require both types of analysis to ensure a comprehensive understanding of a device's chemical profile.

Memorable quotes from this episode

"Biocompatibility is not a bubble. It must be integrated into the quality management system." - Marina Daineko
"Don’t be shy and ask the questions. Stay curious... and communicate." - Marina Daineko

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Transcript

Marina Daineko

00:00:34.380 - 00:00:56.400

Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode.

Today with me to talk about biocompatibility and an episode that we want to kind of call the biocompatibility brief because we're not going to get super deep, although hopefully we'll get into some things that will be applicable and useful. But with me today to talk about that is Marina Daineko.

Etienne Nichols

00:00:56.880 - 00:01:00.480

Am I saying your name correctly? Correctly, yeah. All good.

Marina Daineko

00:01:01.600 - 00:01:03.720

No, it's D. Is that correct?

Etienne Nichols

00:01:03.720 - 00:01:04.400

Daineko?

Marina Daineko

00:01:04.400 - 00:01:05.880

Yep, Daineko. Okay.

Etienne Nichols

00:01:05.880 - 00:01:06.200

Yeah.

Marina Daineko

00:01:06.200 - 00:01:37.330

Marina Daineko.

It's a passionate explorer turned MedTech expert with a deep-rooted love for chemistry and a mission to make medical devices safer through rigorous biological evaluation.

Her journey began with curiosity and evolved into specialization, biocompatibility where she uh, she sits at the intersection of science, regulation and patient safety.

So, she has a strong background in chemistry and hands on experience with a wide range of medical devices and she supports teams in planning, executing biological evaluations in place.

Etienne Nichols

00:01:37.650 - 00:03:48.150

Right. Because we can't do anything properly and have acceptable results if we don't have this acceptance criteria set up in advance, you know.

So I would say biological evaluation plan is very important and we have to have into it then going into details because again I face several times when I request, I'm requesting usually a lot of information and you know, regarding suppliers, regarding raw materials, technical data sheet, how many samples were sold during specific period, like a lot of different information and for instance I can find the gaps and it's important to go even deeper and find what's like what, what are for instance disinfectants that are used to clean manufacturing lines. You know, that's important. For instance, work instruction may not list these solutions, but we need to find what are used to be able to assess it.

Because there might be the case when these disinfectant solutions go to medical device and then to the patient. So, it depends, we have to assess all the things and be attentive. Yeah.

For instance, again just recently I have got results for cytotoxicity and it was a component that contains silver ions, and I have got zero for cytotoxicity. And by the way, silver ions are very known to cause cytotoxic effect. And then I was like, oh wait, what's going on here, you know why we have zero?

Because I was expecting to have like three, but at least two, but you know, like three or even maybe four and I have got zero. So, I had some additional questions like hey guys, I was expecting to have a bit different results because of silver ions. What's going on here?

You know, and we have to be very attentive to these details as well. So, it's just several ones, but I would say they are most common. Like to be attentive to the details. Don't believe anyone, just check everything.

Go as deep as you could to find this information and don't be shy to ask questions and prepare your biological relation plan.

Marina Daineko

00:03:48.150 - 00:03:58.550

Yeah, I love that specific value or example I guess because that just kind of highlights the, the, the need for the critical thinking side of things and.

Etienne Nichols

00:03:58.550 - 00:03:59.150

Absolutely.

Marina Daineko

00:03:59.390 - 00:04:49.420

I, I want to go into a little bit more details on some of these things and maybe how companies can miss the real signals.

But I, I want to just kind of do a quick sidebar and you can, and you can comment on this or not if you like, but I think of obviously biocompatibility. We think of physical devices and as a mechanical engineer, that's where I prefer to live my life with physical devices. But, and so feel free to punt.

We can move on from this if you want, but software is a medical device. They would probably typically kind of shy away from anything like this.

But if I think about biological safety, what about devices or software that changes the biology of the brain from a neurological standpoint like AI or different neurologic and, and if that doesn't fall, that's totally fine. It just popped into my head, and I have no filter.

Etienne Nichols

00:04:49.900 - 00:05:06.900

I am kind of following Neuralink because this brain interfaces are so impressive for me and because look, when we have like software as a medical device and standalone software, biological safety is not applicable at all to it. Why? Because by definition related necessarily.

Marina Daineko

00:05:06.900 - 00:06:01.890

But with, with things like social media, AI, all these different things changing the way our brain is shaped that I think someday if I look at the past of the FDA, for example with CDRH, the center for Devices and Radiological Health, that radiological history as to why they're over radiological is interesting. It wasn't just because there's medical device is because they're radiological devices out there that were harming people.

Maybe I'm getting onto a different subject. So, let's get back to it. Let's get, let's come back to, to, to where we belong. I do want to know how you approach RAW Data analysis.

You already mentioned some with that, those silver ions and so on. Is it different than how you. How you approach data analysis in other fields?

It sounds like you really draw from a lot of previous or a well of knowledge.

Etienne Nichols

00:06:03.680 - 00:07:00.890

Yes, because I have my background in chemistry. It helps me a lot to understand what's going on here actually, you know, and have a look and understand like. Okay, I mean, basics even there.

There is like polypropylene. But what type of polypropylene, whether it's like mixture with something or like, what are possible residuals in. In this polymer? Okay.

Or if we are talking about, you know, some polymers. Okay. What was the reaction to produce this specific polymer? You know, was it like polymerization or poly condensation?

Because there might be different residuals on it. And when I'm looking into this raw data, I'm really like thinking about it and describing it within my biological evolution.

Because again, it's very, very important to not be shy and ask questions, even if these questions are not very welcome. If I can put it in this way. Okay. Yeah, yeah.

Marina Daineko

00:07:00.890 - 00:07:10.650

Well, I was just gonna say I would imagine a lot of people are looking for a pass. Fail. Just tell me if it passed or failed. But it sounds like it's a lot more nuanced. There's context, there's exactly. Patterns.

Etienne Nichols

00:07:10.650 - 00:07:46.430

Yeah, exactly.

And for me, it's exactly the beauty of biological evolution because you can just copy and paste or some information from one biological relation to another. No, it doesn't work in this way because again, we have to start from the very beginning, meaning from the intended use.

We have to know our devices, like what materials are used, what disinfectants, what processes, etc. Etc. And then we have to assess available information as well as test available test results through this prison. So that's the beauty.

That's why we always have a lot of fun here in this field.

Marina Daineko

00:07:47.870 - 00:08:05.400

Yeah. I'm curious if you have any specific examples of when this wasn't done well and maybe later on you found out there were some biocompatibility risks.

I know we keep going back to the watch that causes a rash or something like that, but anything specific to the medical device field that you've seen that you're able to share?

Etienne Nichols

00:08:06.200 - 00:10:59.910

Yeah, I want to share the example from the Bleeding Edge by Netflix. Maybe you have seen this video. Yeah. Movie. It was really, really great. And a friend of mine, Angelina, showed me this movie and I was impressed.

And really great example that I would like to mention here is the issuer. Issuer is a Device for women contraception.

And it was sold for a long time, and it was found out later by women that this device causes adverse effects such as very different. So, I just, yeah, even deaths. I mean it was super like sad and unfortunately. So, ladies provided say feedback, you know, like post market surveillance.

Hello. And complaints and all the things, but it didn't change anything.

But in the end of the day, thankfully to their organization because women just united and they started to be loud about this device. Okay. And in the end of the day this device was canceled from the production and actually sales.

So here I would say that we have to be very cautious, especially with the devices that are implanted or are used for a long, long period. Because look, one thing I really love this example. I had even a post on LinkedIn about it.

For instance, I applied a tissue mask to my face and when I get rid of it, I found out that I have allergy. Okay. Everything was like red rash and all this. And so, it's visible, it was like immediate. I just applied it, throw off and here we go. Okay.

But for long term, when for instance I used to work at the lab and I worked with nickel solutions and during the years I have got kind of sensitization because I have got allergy on nickel, but because I worked with it during a long time period, it accumulated my body and that's why it was, I, I have got such kind of reaction.

So, what I'm trying to say is that we have to be especially attentive to the medical device with long term contact duration because we can have some chemicals in our body accumulated because they are leaked from this medical device. And yeah, right now I'm really happy and excited to see that regulations and requirements to biological safety consider this aspect as well.

And as I mentioned in the very beginning of our discussion about what I mentioned.

Marina Daineko

00:11:00.310 - 00:11:20.070

Yeah, yeah, yeah. Just the, yeah, yeah, yeah, yeah. The, the, the examples of actual cases. I think that's really valuable.

I mean you; you actually make me think of the accumulated exposure to. What is it? I think latex gloves too, that can cause allergies as well. And I think it's something to think about. Yeah, there's lots.

Etienne Nichols

00:11:20.070 - 00:11:36.690

Yeah, yeah, yeah. Cumulative effect. Yeah, we have to consider it. And as I mentioned in the very beginning with this infusion sets, okay.

They can be used for lifelong period. So, we have to consider it. And all possible chemicals that can go through this bag as well as tube to the body. So that's important.

Marina Daineko

00:11:37.090 - 00:12:56.400

I love the idea of thinking of it from, from the very I don't know, the, the smallest component inside the device all the way to the time it gets thrown away. I, I look at that as kind of like the supply chain of your medical device. You know, when I did, I deal a lot in design controls.

So if you're designing a medical device, you have to design it to where you're, you're thinking about um, for example, maybe you have a device that a nurse is going to carry into a room and it's sterilized, but maybe she opens it up, gets it already at her desk, puts it in her pocket, then goes to the room. It's that you've kind of defeated a little bit of the purpose here. So, you have to think about all the way through.

And so, in the manufacturing, you mentioned a few examples there. I love that one of them that's very common that I experienced as a manufacturing engineer was the mold release in a multi cavity injection mold.

Know they spray something on the mold so that it will easily come out of the cavity and that can cause problems. I think you already know where I'm going with that. So. Yeah, I think those are great examples. What you're.

The, the way you've described this, it makes me think of, you know, in the medical device industry we talk about a risk to bas risk-based approach to everything. We like a risk-based approach.

It feels like the focus is less in your mind, maybe less on what tests do we run and more what, what risks are we mitigating? Is that accurate or how would you describe.

Etienne Nichols

00:12:56.400 - 00:14:22.710

Yeah, absolutely. Yes.

Because look, we have right now in the current version of ISO1093, one very well-known table where there is like classification of medical device as, I mean as per biological safety, not like for instance medical device regulation as well as these biological effects like cytotoxicity, irritation, synthesization, et cetera. But the case here might be that for instance, there might be hazards that are not mentioned within this table.

But just thinking and applying common sense, we can find out them.

For instance, if medical device is applicable for adults, we need to think that also for instance, pregnant women can use it until it's mentioned in contraindications to this medical device.

And from this perspective we need to have a look and also consider developmental toxicity of this medical device, whether there would be any effects on, on pregnant women. And there are. Yeah. So, we have to apply common sense here. Surely standard helps us with it.

But it's not about testing, it's understanding what are specific hazards associated with these specific medical devices. Produced within these specific processes, you know, and used as described within instruction for use. So, it's, it's, we have to focus on it.

Marina Daineko

00:14:22.950 - 00:14:32.630

Are you able to talk a little bit more about the risks associated with pregnant women? Because I feel like historically, we just don't have a lot of data on that. How do you go about evaluating that?

Etienne Nichols

00:14:33.110 - 00:15:39.020

Yeah, absolutely, you're absolutely right that unfortunately there is no, there is just a bit data regarding it. And for instance, when we found that, okay, we have to consider developmental toxicity.

So, we need to have a look into extractables and leachables and the chemical characterization and this aspect especially, and I'm highlighting it especially if we have a long-term content curation of this medical device with a patient. Because again talking about risk, we have to consider whether it contact with intact skin and here we have low risk or high risk.

If you're talking about the implants, okay, it's like first step we were what we have to consider here.

Secondly, if it's implant like high risk with a long-term contact duration, we need to have look into extractable stitchables, what are potential chemicals that could leak from the medical device. And I don't know whether I need to explain a bit the difference between extractables and leachables.

Marina Daineko

00:15:39.020 - 00:15:39.460

Please do.

Etienne Nichols

00:15:39.780 - 00:17:35.690

Yeah, mutable is something that can leak in like normal conditions when we have like 37 degrees C. If talking about European temperature. Okay, so it's like clinically relevant what can potentially go in actual clinical, during actual clinical use.

And when we are talking about extractables we are talking about all possible chemicals that could go at all. And this, this is from very strict approach and FDA for instance especially … to consider it.

And here we are using conditions that are not clinically relevant but for instance elevated temperature like 15 degrees C. Our body temperature is 7 is 36 degrees C and 50 degrees C is like elevated temperature. You know, so I mean it's, it's a bit too harsh but okay.

As well as like specific solvents like hexane for instance, not similar to blood solution that is like clinically relevant but okay.

So here talking about extractables and digitals, we have to analyze what are the chemicals that could potentially go from this medical device and assess do perform toxicological risk assessment. And we have the value; it's called margin of safety.

And we have to calculate and understand whether it's safe to use this medical device for this audience or not considering this margin of safety. I'm not toxicologist, I'm just chemist who is doing biological evaluation. But it's like a very high-level approach how to do it.

There are a lot of tricks here because we have to consider uncertainty factors also like no adverse, not observe adverse events, etc. Etc. But it's like I believe high level is enough.

Marina Daineko

00:17:36.170 - 00:18:17.680

Yeah, no, that's great. I really appreciate you going to especially the difference in extract extractables and leachables.

I don't think I could have articulated it that well. So that was great. It makes sense.

It sounds like though I could see a company looking at this and saying okay, Marina's over there, I'm going to take her the device, she's going to do her thing, then we're going to get back to business. You know, that's not really the way it should be. But I can see companies maybe treating biological safety or biocompatibility this way.

And correct me if I'm wrong, what does it mean to in practical terms to really evaluate that or integrate that into your QMS? Or is it possible with design control, supplier management, CAPA, do you have any thoughts or opinions on that?

Etienne Nichols

00:18:18.160 - 00:20:49.100

Absolutely, yes. I also did a series of posts on LinkedIn that biocompatibility is not a bubble, and it must be integrated into quality management system. Why?

Because quite a lot of different events can trigger biological evaluation. For instance, changes in design, changes in materials. So here we go. Here we, we have direct connection with change management process.

Also, right now there is more and more emphasize on using post market surveillance data because one thing is to evaluate medical device during design verification phase. You know, and another thing when the medical device is kind of test drive on real patient in. In actual clinical use.

So, we have to consider this information and boom. Here we have direct connection with post market surveillance, surely risk management.

Because biological evaluation is based on risk management process. Okay, another thing you mentioned, it's about CAPA and here it also connected. Why?

Because we can have some complaints that related to biological hazards, for instance. And in this way, we have to have a look into our biological safety and consider what is the risk here.

Whether it's low risk or high risk or moderate risk. And also take some steps like for instance perform some additional investigation or for instance even perform some additional testing if required.

If we have this quite a lot of complaints related to bio specifically to biological hazards, not like possible complaints. So yeah, biocomp is not a bubble.

And that's why I also said that biocompatibility is not just a science, it's about communication because we have to talk to each other and Information should flow freely here because we need to know what's going on.

Another thing that I would like highlight separately is changes related to different regulations because we have to be aware like for instance carcinogenic, mutagenic, toxic to reproduction list has been updated with a specific chemical. And we have to check whether our medical devices contain this chemical or not.

And if they contain, we have to update our biological evaluation because we need to perform analysis whether it's still safe or we need to do something with it, you know. Yeah. So quite a lot of connections as you may see.

Marina Daineko

00:20:49.260 - 00:21:31.420

Absolutely.

I think every system within your QMS should know how the device touches the body and know how, you know how the change changes or the suggested changes should, should, would, would impact other people. I can just imagine. I, we really hit on the watch. So, let's go with clothes. Let's say, let's say you have a medical device that's a wearable.

I don't know, of some sort. And, and one person complains about it itches or it, it's, it's, you know, I caused a rash in me or something like that.

I say okay, well you're just, you probably, I don't know if you write it off as the person is different than the rest of the population, that's not really helpful. But it, you, it could be an input into your risk management. Say, okay, maybe a few things need to be evaluated.

Etienne Nichols

00:21:32.220 - 00:21:32.660

Yeah.

Marina Daineko

00:21:32.660 - 00:22:01.200

Are there reactive versus proactive mindset shifts that could happen and do you, see? Well, let me kind of reel that back in. I can a lot in a lot of different ways. I see companies that are reactive versus proactive. QMS is a good one.

CAP is a good one. All of these can be examples of a reactive mindset versus a proactive mindset. What about with biocompatibility?

Are there companies that you see doing it a lot better than others? And why?

Etienne Nichols

00:22:02.560 - 00:23:30.510

You know, I strongly believe that this publication of new version of ISO 10 NS3.1 A lot of companies would force to apply proactive approach. Why? Because a new revision of this is standard tells us that we have to assess biological safety throughout whole life cycle of medical device.

And even when we have just prototype phase, okay. We have to evaluate whether these materials are safe. And unfortunately, I still can see that it rather it's.

Unfortunately it's not still proactive but we are going to it because look, we have changed this checkbox approaches and right now more and more companies like okay, it seems like we need to do some literature review, you know and they're Doing it and they are having publications and they are doing quite a lot of work related to biological evaluation as well as.

But I still can feel that there is such kind of, you know, thinking that okay, we just need to, to send this medical device sample to the lab, get some testing and that's okay. Okay. But no, it doesn't work in this way.

You have to know your device and do some homework, at least gathering the materials and analyze these materials. But hopefully, hopefully with this new revision things would change.

Marina Daineko

00:23:30.910 - 00:23:55.630

Yeah, well, I'm looking forward to hearing more about that at some point here, but we don't have to go into that just at the moment. I know in the previous conversations you've talked about how you train other or train different teams at companies, cross functional teams.

How do you explain some of these complex bios. Biocompatibility aspects to those cross functional teams, especially if they're non-technical. Are there things you go into with them?

Etienne Nichols

00:23:56.750 - 00:25:16.380

Yeah, it's great question. Thank you very much for asking. I'm trying to use examples and trying to. Yeah.

So, first of all, examples like I provided this example with allergy or what is it difference between irritation and sensitization. When I applied this tissue mask on my face, I have got allergy, like almost immediate allergy. So, I have got irritation and sensitization.

When I worked in the lab with this nickel solution during long time, I have got this reaction to nickel, and I have got sensitization. So first of all it's about examples. Secondly, I am explaining like what's going on here and what is the goal?

So, what why we are doing it or why is it required? For instance, some people are saying like okay, we did Cyta so we don't need to do irritation and synthesization.

And I said like no, because we have to check different aspects of interaction with human body.

Because when we are talking about cytotoxicity, we are talking about cells and cytotoxic effect actually how cells react on it, you know, so it's a bit different than other aspects. So I'm trying to use examples, I'm using simple words and I'm explaining why we need to do something or what is this concept?

In a very simple words, as much.

Marina Daineko

00:25:16.380 - 00:26:15.180

As I could actually, I wonder if there's ever any.

Well, so when, when quality talks to marketing for example, or sales, you know, and I don't know if you ever get that far down the path or upstream, downstream. However. Yeah, I, I imagine that there's going to be things sometimes that you have to translate your speak into their language.

Just like when you're talking to a CEO, you have to have a different, maybe a different way of speaking.

If I said something like this material could cause a release in chemicals that maybe causes inflammation, that might mean pain complaints and recalls or bad publicity. Okay, now I start paying attention. Maybe I, I wasn't paying attention yet at pain or irritation, but complaints and recalls and bad PR.

I can get that if I'm not on the technical side or maybe I'm less empathetic of a person. I don't know.

I want to, I don't want to throw anyone under the bus, but you know what I mean, there's always the economic drivers really speak loudly sometimes. So.

Etienne Nichols

00:26:15.420 - 00:26:30.660

Yeah, yeah, yeah, yeah, yeah, absolutely. When talking, for instance to regulatory affairs, we are talking about deadlines, about submissions.

And if we don't start right now, you know, we will fail to meet this deadline and not get this document to, to your submission for your technical file, for instance.

Marina Daineko

00:26:30.660 - 00:26:31.380

Man, you're good.

Etienne Nichols

00:26:32.260 - 00:26:49.380

Or for instance, for quality. If talking to quality, I'm talking like, okay, we have to do something with it.

Otherwise, we have to like stop production because we have this complaint and we have to do finally with some. This is, you know, kind of. And yeah, I, I totally relate. But yeah, absolutely.

Marina Daineko

00:26:49.380 - 00:26:52.340

She's got. Pick one of the speed, cost, quality, you know which one.

Etienne Nichols

00:26:52.340 - 00:26:53.540

Yeah, yeah, yeah, yeah, yeah.

Marina Daineko

00:26:53.540 - 00:26:55.060

We're going to impact something. Yep.

Etienne Nichols

00:26:55.060 - 00:26:55.820

Yeah, yeah.

Marina Daineko

00:26:55.820 - 00:27:02.940

What advice do you have someone giving that would. If someone came into the MedTech field or biocompatibility field, any advice that you would give to that person.

Etienne Nichols

00:27:05.020 - 00:27:24.270

Don't be shy and ask the questions. Stay curious meaning and don't be afraid to go even deeper to understand the reason, to understand what you don't understand yet and communicate.

Because I believe that communication is the key here and we have to talk to each other as much as we can because information shelves.

Marina Daineko

00:27:24.340 - 00:27:38.740

Oh yeah, absolutely. And maybe that's the answer to the next question.

But my last question I wanted to ask you was if there's one takeaway that you take give the audience or if you wanted them to take away from what would that be.

Etienne Nichols

00:27:40.580 - 00:27:41.780

About? Communication.

Marina Daineko

00:27:42.260 - 00:27:49.780

Communication. Hey, we had mentioned maybe a, a giveaway. Do we have something like that? I should have asked you before we started recording.

Etienne Nichols

00:27:50.660 - 00:27:50.980

Oh.

Marina Daineko

00:27:52.900 - 00:28:04.980

We’ll talk about it afterwards. Those are listening. Just assume we do and go check the show notes so at least you can maybe get something from Marina. We'll see what we can.

What we have. If we do. Maybe we didn't talk about it. So, if we didn't forgive me. So, let's. Yeah.

Etienne Nichols

00:28:05.060 - 00:28:05.980

All good. All good.

Marina Daineko

00:28:05.980 - 00:28:10.580

Marina, this was great. Anything we missed or you feel like you want to just touch on one more time?

Etienne Nichols

00:28:11.380 - 00:28:22.880

No, I believe that's it. I just have a question, but we can discuss it after we already know. It is so smooth. I love it. Interviewing thank you so much.

Marina Daineko

00:28:23.040 - 00:28:56.140

Yeah, it was so good talking to you. Thank you so much. Really appreciate you sharing all this information.

And I'm looking forward to the webinar in a few months and I hope those of you listening are able to attend. It's a chance where you can ask questions directly. We always have the option for you to do that.

And even if we don't get all the questions, we forward them on to the presenters. So maybe Marina is able to interact a little bit as well.

And I will also say follow her on LinkedIn because she is very active and very educational and entertaining. And I just, they just. It clearly shows that you care about what you're doing and I think that's really valuable.

Etienne Nichols

00:28:57.100 - 00:29:06.700

Oh, thank you so much. And I'm here. Very happy to be here and enjoyed our conversation. And please everyone join our webinar in a few months. It would be a lot of fun.

Marina Daineko

00:29:07.260 - 00:29:42.310

Awesome. All right, we'll let you all get back to the rest of your day.

Until next time, take care of 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:

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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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Etienne Nichols

Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...