In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development.

Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuring product safety and regulatory compliance. They dive deep into IEC 60601, ISO 15223, and the regulatory landscape across global markets.

Leo also shares actionable advice on avoiding pitfalls, prioritizing standards, and ensuring compliance to bring safe, effective devices to market without delays.

Key Timestamps:

• [03:20] – Introduction to Leo Eisner and his background in medical device standards
• [10:15] – Why standards like IEC 60601 are crucial for medical device development
• [18:45] – Steps for identifying the right standards for your product
• [27:00] – Common mistakes and the consequences of ignoring standards
• [38:50] – How to integrate standards into your design process
• [47:35] – How startups can navigate standards with limited resources
• [58:00] – Tools for staying updated on changing standards and regulations
• [1:09:40] – Final advice from Leo on ensuring regulatory success

Notable Quotes:

• "When you really think about it, all this work leads to safer medical devices on the market—that’s crucial." – Leo Eisner
• "Standards may seem like obstacles, but they’re design inputs that ensure your device will work as intended in every scenario." – Etienne Nichols
• "If you don’t integrate standards early in the design phase, you bring design risk later into the project, which can be very costly." – Leo Eisner

Key Takeaways:

MedTech Trends:

1. Regulatory Compliance as a Design Input – Standards such as IEC 60601 are not just hurdles but key design inputs.
2. Global Market Variations – Different countries have unique regulatory demands; understanding these early can avoid costly delays.
3. Atomic Standards – Future standards are becoming more "atomic," meaning they’ll be broken down into more easily applicable, smaller parts.

Practical Tips for MedTech Professionals:

1. Start Early with Standards – Review applicable standards in the initial design phase to avoid costly delays later.
2. Use the Right Tools – Tools like MedBoard and the FDA’s guidance database can help you stay updated.
3. Seek Expert Help – If you're a startup or lack in-house resources, work with a qualified consultant to navigate the regulatory landscape efficiently.

Questions for Future Developments in MedTech:

1. Will the move toward "atomic" standards streamline regulatory processes for startups?
2. How will global regulatory bodies harmonize standards across different markets?
3. What emerging standards will impact next-gen MedTech innovations like AI and robotic surgery?

References:

• Greenlight Guru - Quality Management System & Electronic Data Capture solutions built by Medtech professionals for Medtech professionals.
• Leo Eisner on LinkedIn – Connect with Leo for expert insights on compliance and regulatory standards.
• IEC Standards – The international standard for the safety of electrical medical equipment.
• ISO 15223 – Standard for symbols to be used with medical device labeling.
• MedBoard – A platform for regulatory intelligence, tracking medical device standards.
• Etienne Nichols on LinkedIn – Connect with the podcast host for ongoing discussions on medical device development.

MedTech 101:

Consensus Standards – These are standards developed by experts in the field and recognized by regulatory bodies like the FDA. While they are technically voluntary, using them greatly simplifies the regulatory approval process.

Audience Poll:

What aspect of medical device standards do you find most challenging?

1. Understanding which standards apply
2. Incorporating standards into product design
3. Keeping up with regulatory changes
4. Managing costs associated with compliance

Send us your thoughts at podcast@greenlight.guru!

Sponsor Mentions:

Greenlight Guru – Today’s episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Built for MedTech professionals by MedTech professionals, Greenlight Guru’s EQMS software helps you manage compliance, quality, and innovation all in one. Learn more at greenlight.guru.

Rook Quality Systems – Need quality expertise on demand? Rook Quality Systems provides “quality as a service,” giving you access to their seasoned quality professionals as quickly as you need them. Whether it’s for a project or ongoing support, Rook offers tailored consulting services to help meet your quality and compliance needs. Learn more at rookqs.com.

Feedback Call-to-Action:

Enjoyed this episode? We’d love your feedback! Please leave us a review on iTunes and let us know what you’d like to hear next. Have questions or suggestions? Email us at podcast@greenlight.guru.

Etienne Nichols: Welcome to the global medical Device podcast, 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.

Etienne Nichols: Oh, great. Thanks for asking, Etienne, you pretty much nailed it. Do you want me to read the nomination wording or not?

Leo Eisner: Yeah, let's do it.

Leo Eisner: Yeah. Yeah. Well, it should. I mean, you have put a lot of years in and a lot of effort, and I appreciate that. When you really think about what really is the outcome of all this work, is safer medical devices on the market, that's really important. So I appreciate all the effort you're putting into that, because some companies who are out there may look at all this mountains of standards that they're going to have to go through as pure obstacles, but in reality, what it's doing is making sure that you have a device that is going to work in every scenario that it should. So before I just go down that rabbit hole too far, let's explore the medical device compliance as it relates to standards and guidances. And maybe to begin with, because we talked a little bit about your experience, how did you even get involved with medical device standards?

Etienne Nichols: Well, it's a little long and woolly story, but out of college, I got a couple offers, and one of them was underwriters labs. So that's a test lab. And I didn't do medical products, but I did everything under sunbutt, and I got sort of disillusioned with UL after nine years for three attempts to leave, Ul only took three attempts. Yeah, exactly. And I went to Austin looking for a job. Texas, of all places, from Santa Clara, California, to Austin, a little different. And I couldn't find a job, but I met a headhunter, and the headhunter the next day calls me and said, I've never met a safety engineer before, but I have a potential situation for you. Would you like to live in San Diego and go, hmm, sounds pretty interesting to me. I'm game. So I talked to the person on the phone for an hour and a half, 2 hours from my friend's house. And they said, can you come down next week for an interview? I said, sure, why not? Talked to my boss. He said, yeah, no problem, go on. Disappeared all day interview and is asked at the end of the day, do you have an idea when you'll have a decision? We already made up our main mind, we got the job. When do you want to start? It's like I'm there. Give me two weeks, I'll make notice. So I started. Yeah, pretty well recognized name in the industry. So I learned MDD and auditing. And 601, when it was second edition, wasn't third edition yet. Oh, Ul 544, because it was still a lot of national stuff. There was homologation in France and every country did its own thing. It wasn't all organized yet because MDD was just starting to come into play.

Leo Eisner: Okay.

Etienne Nichols: And I've stayed with medical ever since. And starting with 601, I started reading standards, obviously more and more at that point. And when I was, I went to Carl Sturt's imaging a couple years later, and I started seeing the development of 601 and 218, which I was involved in because cameras, I had to track the development. So that's when I got into knowing about the development of standards and then some time into my consulting career, I started into it when I got offered by several companies, came to me and said, we got the standard. We need to get into Japan for regulatory purposes primarily, we want you to lead the charge. I said, okay, I'll learn how to do it. I connected with the vice chair of 62 D at that time, and he was more than happy to help mentor me through the process.

Leo Eisner: Wow, that's really interesting, because I meet some people who have helped or been involved in the creation of and publication of standards. But to a lot of us, it feels like a little bit of a black box, maybe a mysterious process through which these things arrive in our inbox or whatever requirements and standards. So we could go down that path at some point. Maybe. Maybe it would make sense, though, to go ahead and get into the meat of the topic, which, which maybe the next question I would have is why? Why do we need all these standards? You mentioned the different countries that have different ideas, so I'm guessing that kind of is, is part of the answer. But why? Why are standards so crucial in medical device development?

Etienne Nichols: Well, we had a post conversation today, actually, on LinkedIn about design inputs. So they're a great source of design inputs. As you and I will not disagree on that point, even though we had a slight, we had a slight disagreement on semantics, as you and I said earlier today, about the wording design inputs and how it's interpreted a little bit. But standards are a good source of design inputs. And that's one of the first things we deal with, with my consultancy, with a lot of our clients, is we look at applicable standards, laws, guidances and regulations as inputs into your design process. And then also, obviously, for supporting regulatory submissions, looking for evidence of consensus to the requirements as standards are the easiest paths forward. So look at FDA for recognize consensus standards. They say it's voluntary, but if you don't use that voluntary standard or guidance, you're going to get a lot of pushback from the regulator, FDA, or the notified body or TGA or whatever regulator it may be. Even if they say it's voluntary. Some regulators may say some standards or guidances are mandatory. And in some cases, even FDA has some documents that are mandatory.

Leo Eisner: So maybe we could walk through the process a little bit on how to do that. How, how my medical device that I am developing, how I know that it needs this or that standard, this consensus standard, that consensus standard, or maybe with my specific medical device, maybe. Let's just. I like to use the example of a insulin pump. I know there are insulin pumps that have come before me and there are going to be insulin pumps that come after me, but I feel like mine's special and it doesn't have to follow this particular standard for whatever reason, or maybe it does. How do I determine what's required for my particular product?

Leo Eisner: Sort of almost like if I were.

Etienne Nichols: To use a cross breed, if I.

Leo Eisner: Were to use almost a different example, like building a house in the US, there are certain things you have to maybe federal requirements. I don't know if there's actually federal requirements about building, but did you get into the building codes in each county and you. And. I don't know how it goes for Europe, but I know each individual county would have their own specific requirements or township. So it's almost something to those levels, I suppose. So making, knowing where you're going to be marking the device makes sense to me.

Etienne Nichols: Yeah. So going down below the international, you have the national standards organization. So, Amy, for the US is one, they're not the only one. And then for the yen, like I said sentence, and like Canada, which is can CSA, okay, or can slash CSA, then you can look at your own manufacturers back is not a standard, but it's still a requirement. So you have your specifications, you can look at. And then what I use a lot is regulatory databases, which I have a preference because I've been working with this group for quite a few years, is med board. I like a lot, but I have a direct association. So I'm going to disclose that because I'm very transparent with my clients and everyone I work with. I don't like hiding anything, it's just not my style. But there's also other really good groups out there. There's Rimsys, I think is how you would say it. There's emergo, there's a razzie group, and that's just to name a few. There's a slew of other regulatory databases out there, but you need to decide what works for your organization, what functionalities that your firm for the current and also future needs, and also your cost, what's reasonable for where you're at and where you're headed. Right. Because you're going to grow over time. What do you need?

Leo Eisner: Yeah, and it kind of begs the question, so if I were starting down the path of creating my insulin pump, because in this case I'm going to go look and see who it's who I'm targeting, what the indications for use are, the intended use, all of the different regions I'd like to market. Maybe, maybe eventually, I guess you would start with, I like to think expansively first and get all of the data, and then you start paring down process of elimination, get a little bit more restrictive or constrictive. But what are the steps once you've identified this massive stack of ISO standards or en standards or at the international and the national level, I think that's interesting that you broke that down into all the different levels where you might be targeting. That's a good categorical way of looking at all the standards that may apply. What are the steps of incorporating that into your design? Because that seems like a huge undertaking.

Etienne Nichols: So then you go into the actual standard and the guidance is. So then you look at the product and you go, okay, what are the features and functions you have of that device? And go against the standard and go, what are the requirements that fit that? Okay, this requirement now applies. This item doesn't apply. This item does apply. And pull them out now, the standards, as they're written now, are not very atomic, so it's hard to do that. So some paragraphs are written that they go on and on and on and on, and other requirements are written very atomic. So it depends on the standard or the guidance out there written. Some FDA guidances go on for pages for one item, and it's really hard to pull apart. Yeah, same, same for some of the standards. 601 is just as bad in many cases. I won't say it isn't fourth edition that we're developing now. That's one of the requirements, is that we are writing atomic requirements. That is one of the design specifications to make it more atomic and to make it so it can turn into a design, into basically a specification. Once you classify based on all the different classifications we're going to set up to make it, you pick your classifications based on your device, and it should pretty much fall out that you can almost get your requirements out of it. That's the end goal. I don't know how close we're going to get to it or not. We're five plus years out from there, maybe ten.

Leo Eisner: Do you see other standard committees kind of applying that same rule or the goal to be somewhat atomic?

Etienne Nichols: Yeah, definitely. I think that's more forward facing.

Leo Eisner: Very cool. One of the things then, I guess, that comes to mind is prioritization, because when you have this, and I don't know how, I don't know a good number on how many standards I've been, I've worked in product development at different times, and I couldn't even tell you the number of standards we were using or applying. But how do you prioritize the ones in your sign?

Etienne Nichols: Well, it's hard when there's so many standards that apply, and I could see that's sort of where your questions headed down the path, I suspect. And I know we come up with a lot of standards and guidances for our clients, and their eyes sort of blaze over, usually, especially the newer ones, to the industry. So I really had to think about this a little bit, and I'd say the standards that impact your quality system, your design, your testing and your products. So look at risk to the overall design and the timeline, but realize that these are all design inputs that should be addressed as early on in the project as possible. If not, what happens? You bring in design risk later in the project. So it's a balance and it's a business decision that you have to make that what's the risk that you're bringing into the project?

Leo Eisner: Yeah, yeah. I suppose if you look at it from, I don't know, project management view, you say, okay, this standard is going to require a feature XYZ that maybe we weren't planning for. So we're going to eliminate some of these options, maybe even refining your indications for use. I see an expansive indication for use, likely increasing the timeline and design risk and so on. Or is that something you see, or how do you see companies handling that, that overwhelming stack of standards that they would have to meet and balancing the project itself? Do you see any of that?

Etienne Nichols: So we're working on a project right now where we, I don't want to expose too much, obviously. So we see in the design concept that they're trying to do a little too much. And so we've been guiding them to sort of box in the indications a little bit more and keep it a little more contained so the requirements aren't as onerous on them. And it's going to be design requirements, it's going to be to meet EMC requirements, it's going to be to meet physical grounding requirements, and how, if we even have an applied part marking or not, which we're still deciding how to approach that because there's no physical applied part on this product. It has energy that comes back and forth at you. And under the definition of medical electrical equipment, you don't have to have an applied part, which a lot of people don't understand. In 601, it's not written that. It's so clear as mud.

Leo Eisner: What do you mean by the applied part?

Etienne Nichols: The applied part is something that touches the patient, that is intended to touch the patient to. I'd have to look at the definition because I'm really bad at definitions.

Leo Eisner: I know they're, well, they're so specific.

Etienne Nichols: They are. And you have, and I try not to memorize the definitions. So I'm going to actually go there because I am just so part of the equipment that in normal use necessarily comes in physical contact with the patient for the equipment to perform its function.

Leo Eisner: Okay.

Etienne Nichols: It says a few more words than that, but that's the gist.

Leo Eisner: Okay. Okay. And so you have this and we're.

Etienne Nichols: Talking for electrical equipment specifically.

Leo Eisner: Okay. No, that makes sense. So as a result, it sounds like maybe some of the indications for use would be paired down in a situation where, well, if we don't, we're going to have this seemingly irrelevant standard applied to our products, which will increase design requirements, it's going to increase testing, it's potentially going to increase timeline and so forth. Is that accurate?

Etienne Nichols: Yeah, but I wouldn't say the intended use or indications for use is where it's changing, it's more the design itself.

Leo Eisner: Okay.

Etienne Nichols: How it's approached, I think is where we're working on it in this case. Another case is how, and this does affect intended use, I believe is right. I always get intended use indications for use a little mixed up. It's not my. Oh, I know exactly that. So devices that are not used in clinical setting ends up being what's called home use. Home use is anything outside the clinical setting, outside a hospital, a doctor's office, surgery center, whatever you want to call. All those type of indications are like a clinical setting. But the home, the sports center, the pool, the school, your cardinal, that's all home use as Puma from the Lion.

Leo Eisner: King said home is where the rump rests. So I guess whoever knows that. So go on.

Etienne Nichols: But that's not clear. When you see home use, you think of the home, right?

Leo Eisner: Yeah.

Etienne Nichols: And the wording in the standard, you have to really read it over and over again to understand it's not just the home.

Leo Eisner: Yeah, good point. So, and I know there's a lot of guidance out there now, or coming anyway about home use. The FDA seems to be increasing some.

Leo Eisner: I guess I'm talking about.

Etienne Nichols: My fingers have been in a lot of things.

Leo Eisner: Have you seen the simulated home that the FDA is working on? That's the one that I was thinking about. I don't know what.

Etienne Nichols: Oh, I've seen something about it, but I haven't really.

Leo Eisner: I'm curious about what that's going to be like, but it doesn't matter. But anyway, you mentioned guidance documents in addition to standards, so I know there's, there's, you mentioned the different levels of standards. We talked about regulations, we talked about standards, and then there are the guidance segments as well. How do you advise companies handling that level? Or. I know some people want to treat them as optional, but they're not really which ones to apply and which ones not.

Etienne Nichols: So again, you need to know what your device does, what's the intended use, indications for use. That's all really important because that guides you to know what to look for. So the FDA guidance database is great because you have that search feature, so you can search for like wireless EMC, home use, biocompatibility and you can find the documents very easily. So it's a great database. And most, I mean, you can find MDCG guidance documents for Europe as well. And there's a lot of other regulatory guidance databases. I know Saudi Arabia, you can get their guidance databases pretty easily too. Oh yeah. And TGA and most of the other countries if you know where to search. That's not always easy. Without a regulatory database. I have that easy access because I use that a lot more. But you can go to each country and look, but a lot of times they're not translated, so then you need to translate, but go and search them out for each country. You need to know what countries, again, you need to know your markets. Right. So that was every country. Their guidances aren't going to be the same. Also used IMDRF, which is what replaced GHTF.

Leo Eisner: GPF.

Etienne Nichols: Yeah, I said that. I said that. Right. Workgroup. And I can't remember the exact abbreviation for that. And I think there's another group that's joining together with asian work, but I dont know that off the top of my head.

Leo Eisner: Jeff, you mentioned something about the translation. I want to go back to that just briefly. I can imagine if you just randomly use something like Google Translate to translate a guidance document or a regulation, there are potential errors in translation or the whole lost in translation issue. How do you recommend people translate these things? Or does it matter that much?

Etienne Nichols: That's a good question. I haven't approached that question yet, so I don't know the great answer. I mean, if you're using it as something that's an official document within your company, which you should be doing, you probably need to vet that translation. And as an auditor, I would have question that translation. If they don't have an english source for that document to use the translation process that they have within the company, which should be a SoP within the process within the company, they should have a standard operating procedure ready for translation.

Leo Eisner: Yeah, I guess in the conversation, in the conversation of standards, I mean, it's inevitable that we talk about the standardization of your translation ability. So. Yeah. What are some examples of the impact of failing to adhere to standards? Do you have any, do you have any examples of someone who maybe they didn't follow the standard?

Etienne Nichols: Well, got lots of good ones. They're not so nice. So I'll just go down a mental list. Delays in safety and EMC testing, that's not terrible, but it's going to slow you down. Getting to market, not receiving safety certifications or passing the EMC requirements. You don't have a certification with EMC testing, typically, rarely, if you don't follow standard. Yeah, yeah. But you go through EMC testing, you don't get a certification in most cases, safety. You can get a safe certification mark or label, whatever you want to call it. You could have a recall that's getting pretty bad. You could have a lawsuit that's even worse. Right. Delays in regulatory product approvals, not receiving product approvals by national regulators. That's sort of similar, but not receiving it now, company failing to get funding, or you could not go to market or folding your doors. And ive seen pretty much every single one of these. Ive had a client that came to me after they worked with another consultant, and the consultant just gave them really bad advice and they got a, I cant even remember, I think was an 18 or 20 page list from a notified body that said, here are all the issues. So I worked with them for like six months or so to get through all these issues. And then, I don't know, six months or a year later, they faulted because they were just too late to market by then. That delay just really hit them hard.

Leo Eisner: Yeah. And so had they followed the standards required, they might not have ever had those issues.

Etienne Nichols: If they did the work up front, they would have been better off. Or if they spent the time earlier doing what they needed to, I think they would have been better shape.

Leo Eisner: Well, why do you think people don't, do you think it's ignorance or do you think, are there other challenges that are going to come up when they're trying to implement standards or what's the.

Etienne Nichols: So I've seen with some startups, they just don't have, they don't feel they have the money to invest upfront sometimes, that they'd rather do certain things in a different approach, or they don't think investing the time and money upfront for that review upfront is worth it? They'd rather focus their money elsewhere, or they're ignorant of not understanding the process well enough that they realize they need to do it that early on. Because a lot of my clients are too far in the process when they come to us.

Leo Eisner: Yeah.

Etienne Nichols: We always really push to do this review, like at the very beginning of design inputs, nothing so far down the line that you're almost at the line of switching to really being at the sign in flip phase. Yeah. Because standards, I don't think I said that quite right.

Leo Eisner: Right. It makes sense that this is something that you would want mixed into the development of your device, not just a bolt on later you don't just bolt on electrical safety after the medical device has been done.

Etienne Nichols: Not just electrical safety, but any of the standards.

Leo Eisner: Right.

Etienne Nichols: Guidances or regulations and law.

Leo Eisner: Yes.

Etienne Nichols: In fact, human factors might be one of the strategy.

Leo Eisner: Yeah, yes. Yeah. Human factors might even be one of the more expensive ones. When you consider the injected molded parts that are interfacing with the patient themselves, the cutting of that steel is not cheap. If you decide you need a concave button versus a convex button or whatever the case may be.

Etienne Nichols: Well, cutting the mold applies to. So electrical safety is a misnomer for 601 because 601 covers electrical safety, mechanical hazards. There's a lot of additional stuff that's outside of just electrical. It's not just an electrical standard, toto, dare I say it that way, there's a lot more to 601 than just electrical.

Etienne Nichols: That more deeply, but that'd be fun.

Leo Eisner: Any. How do people overcome or how to cut? Maybe what we could do. We've talked about some of the issues if you don't implement these standards. But how do the best companies implement these standards?

Etienne Nichols: They research the standards up front. They do their work, they do their research. So, um, just knuckle down and do it. That's the case, yeah, yeah, they knuckle down into it. That's right. So they have the resources in house to do it, typically, or if they need to, they hire the resources, but hopefully they have the resources in house, because if you don't, you're not going to learn in the long run. Right. So it's always better, it's always better to have in house resources, but if you're a small firm, sometimes you don't have the bandwidth to do that. So you might have to rely on some external resources if it is a.

Leo Eisner: Smaller company with limited resources. Any recommendations on how to go about doing this?

Etienne Nichols: Yes. So for standards to start off with, Estonia is always the best resource. And any good, the country will tell you that Estonia standards is not the country itself, but the standards organization.

Leo Eisner: Okay.

Etienne Nichols: Yes.

Leo Eisner: Okay. Estonia standards. Okay.

Leo Eisner: Hopefully that doesn't get back to the IEC, but I don't know if they listen.

Etienne Nichols: I'm sure it will. They won't be offended, I don't think. No, no, no. Hopefully.

Leo Eisner: Okay, so Estonia standards, the Amy database.

Etienne Nichols: Database. Let me think about that. Oh, and if you can be on a standards committee, that's a good way to also get access, because you can get drafts of the standards that you're working on, but also whatever committee you're on. So, like, I'm on way too many committees at this point because I'm on the TC 62, 62 a, 62 D, which I get a ton of drast because of all that. And then also TC 210 on the ISO side. Yeah, I think between all that, I get a lot.

Etienne Nichols: It's some type of sterilization or cleaning.

Leo Eisner: It sounds like packaging for terminally sterilized product. So that was good.

Etienne Nichols: But, yeah, anyway, it's a good learning. You need to be somewhat involved. You can't just sit in the background. If you do, some committees will knock you off over time. Some national committees will, some won't. I've seen dead people on the rolls for IEC, you can't kid them off sometimes. I've complained to my leadership about my standard committee that I'm a convener of. There's people that have been on this list now for ten years that haven't been active and I can't get them off the list.

Leo Eisner: Okay, so maybe, maybe I should ask this question because you're not going to want to have to get them off later. But how could someone get on a committee if they wanted to be on a committee?

Etienne Nichols: So each country has their own roles. So I only can talk to the US. So. And I know the IEC side, I don't really know the ISO side very well. Be honest. Even though I am on a couple ISO committees. So with IEC, for the Amy, it's, I would, I'll say for the medical standards, let's talk that way. Instead of just IEC, you would go contact Amy and they would, they have a whole bunch of national. So there's national committees and then there's the international level. So for the national, you contact the national committee chair, whoever that is. For the US, it's Amy. And you can ask them what are the roles to get on the committee? For that you need to be a corporate member of Amy in this case. And then they ask that you are an expert within whatever committee you want to be within that. So like surgical robotics, you have to have, basically, I would say someone that knows the IEC standards in the 601 series and has had some experience in surgical robotics in some way.

Leo Eisner: Okay.

Etienne Nichols: And if you have some industry experience or test lab experience or 601 experience in that, and pass your cv, and then it gets passed the committee for a month to review, I think, roughly. And if you pass muster by the committee and no one objects or you have no major objection, you would get added on to the committee. Now for some committees, they limit how many people are allowed on based on that. Either there's too much country representation, especially on the international level, or there's too many members already on the committee. So it depends. It could be committee based or it could be national based, or it could be international based. So every committee is a little different. Every national committee is a little different. How they structure things.

Leo Eisner: Okay. The listeners are probably going to be upset with me for getting off track on that, but I was curious, so I had to ask.

Etienne Nichols: No, not at all. I'm sure they were interested if we go.

Leo Eisner: Yeah, I would hope so. I would hope so. I always hope they're interested in the same things I'm interested in, because I, and if you're not, those of you listening, please let me know what you'd like me to ask. I'd love to hear any, any comments or any feedback. What about? Okay, so we have someone that we hopefully is staying informed on these standards, regulations, but regulations and guidance documents are coming out all the time and it's hard to rely on just that. I mean, I recommend that people subscribe to the FDA site, but aside from that, there's got to be other ways to do it. What do you recommend?

Leo Eisner: Okay. And that's on ISO website or ISO website?

Etienne Nichols: Yeah, on the ISO website if you go ISO.org and then right on the top there's three little sort of white little icons and it says OBP. Okay yeah, online browsing platform.

Leo Eisner: Got it.

Leo Eisner: Okay yeah, that's cool. And I'm sure there are people out there who are listening, who are walking their dog or out for a run or at the gym. So we will put these links in the show notes. So don't worry about running the gym, out of the gym. You need to get your workout. Very cool.

Etienne Nichols: Don't come home just for this.

Leo Eisner: We'll get all those links and so that it's easy to find all of those things in the reference section of the show notes. That's very cool. I know we're coming up close on time. What advice would you give? Do you have any other advice that you give to the professionals who are considering this or regarding the use of standards since they are going to be interacting with them?

Etienne Nichols: Sure. Always have advice if you can't tell, just like you always have advice too.

Leo Eisner: I always have opinions.

Etienne Nichols: Okay, if you say so. Know your product and intended use indications for use. As I've said a few times, environments, as we sort of discussed a little bit with home use is a good example. What environments are they being used in? What markets are they being sold in? So I'm beating that home a little bit. Do your research early. As we discussed, you hit problems if you don't do it early. Understand the scopes of the standards or the documents you are researching, which could be guidance, regulations, laws, directives, not just standards. Some people call standards other documents too. So things get interchanged depending where and who you're talking to. Break down the requirements and the standards into requirements, sort of like we were talking about. What are you doing with these standards or your requirements that apply to your product as inputs? Are they user needs, are they design specs or what other design input documents do they apply to? Last point, I think if you dont have the resources, seek out high quality help if you need it, but vet your resources well, pay for it now or in the long run, which is a lot more costly and it may run your company down into the ground, which id rather not see. Id rather help the client get them to the point that they are successful. That's my goal. That's always been my goal, but also to get a safe product to the patient.

Leo Eisner: Yeah, it's that it's a little bit of attention. You don't want one without you can't have one without the other. Really. So very cool.

Etienne Nichols: I balance.

Leo Eisner: Yeah, it is a balance. Yeah. There's a lot of interesting dichotomies in life where balances tensions and maybe another episode at some point.

Etienne Nichols: That sounds like project management, which is not my thing.

Leo Eisner: I'll find someone who's willing to argue with me on it.

Etienne Nichols: Oh, I'm sure about that.

Leo Eisner: Oh, Leo, this is really good. I think this is going to be a very valuable episode. Again, we'll put the links to the show notes. So if you want to find Leo, or if you want to find what he's doing, where could people find you? The easiest?

Etienne Nichols: The easiest is LinkedIn, which I'll make sure you have that. And my website, Eisner safety.com, i have a blog which also ends up on LinkedIn all the time, as you know. Yeah, I think those are the easiest. And if you need to talk to me, you can schedule a meeting on my website.

Etienne Nichols: So thank you. It's been a pleasure today.

Leo Eisner: All right, we'll let you get back to it. Everybody, thank you so much for listening to the global medical device podcast. We will see you all next time. Take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app, scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer just look for that leave a review button helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening and we'll see you next time.