Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

February 10, 2016

podcast_leo eisner

Standards are absolutely critical when you are developing a medical device.

You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end.

Today's guest Leo Eisner from Eisner Safety Consultants is a leading expert in medical device safety standards. He even has built a database to help you navigate the process.

Leo has over thirty years of experience in product safety and is a leading speaker and author when it comes to medical device safety. He knows quality systems, knows how to audit and test. He has recently released the “Standards Reconnaissance Database” so that medical companies can leverage his expertise.


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Some highlights of this episode include:

  • How Leo’s career in standards began
  • Why standards are important
  • Why should I care about standards regarding my medical device
  • Standard IEC-60601
  • Standards Reconnaissance Database
  • Benefits of standards
  • Updates to standards
  • Classifying your product, drafting a test plan, checking against standards

Leo’s best recommendation when it comes to standards is to know your product well enough to know what standards apply early in the development process - from there you’ll know how much preparation and testing it will take.


Episode quotes:

"The most important reason you should care about standards is because of your regulatory submissions and your design process." - Leo Eisner

“The standards are rigorous and it’s for good reason.” - Leo Eisner

“Your indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.” - Jon Speer


Announcer: 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.

Jon Speer: Standards. Maybe you don't think that standards apply to you. But I assure you if you are developing a medical device, standards are definitely something that you need to be aware of. Standards like IEC 60601, IEC 62304, IEC 62366, ISO 14971, I could keep going on and on and on. There are a lot of standards and you need to know why this is important to your medical device product development efforts. If you wait until the time that you're putting together that submission and you haven't addressed your standards and things that might apply to your product, chances are, it's too late. Well, it's not too late. It's just gonna mean a longer time to market. It's gonna mean a more difficult and time consuming regulatory review process.

Jon Speer: So understand what standards apply and how to incorporate those as part of your design development process towards the beginning, rather than the middle end. And so today on this episode of the Global Medical Device Podcast, I've got Leo Eisner from Eisner Safety Consultants. He is a guy that knows a lot about standards and he's built a database to help you navigate through this process. So listen in, kick back, relax, on this episode of the Global Medical Device Podcast.

Jon Speer: Hello this is Jon Speer, the founder and VP of Quality and Regulatory at greenlight.guru and welcome to another exciting episode of the Global Medical Device Podcast. We have a special guest today, Leo Eisner from Eisner Safety Consultants. He's joining us and let me tell you a little bit about this guy Leo. Leo has over 30 years of experience in product safety and is a leading expert and author when it comes to medical device safety. Leo has worked for a lot of these safety firms that you've heard of, places like UL, Underwriters Laboratory, TUV Product Services. Leo has also been a notified body auditor under the MDD for both TUV, ANSI, so he's got a lot of experience folks, he knows quality systems, he knows how to audit you, he knows how to test your product.

Jon Speer: But let's talk a little bit more about the specifics about Leo's background. Leo's been very focused when it comes to electrical safety testing, specifically standards, like IEC 60601-1 series. Leo has a wonderful company, Eisner Safety Consultants. Let me spell that for you, E-I-S-N-E-R. Eisner Safety Consultants specializes in helping medical device companies navigate product safety submission processes, regulatory submissions, and quality system requirements. So I'm gonna tell you here in a moment, when I think about IEC 60601, which if you have an electrical medical device, you need to think about that standard, the first name that always comes to mind is Eisner Safety Consultants.

Jon Speer: Leo has recently also released the Standards Reconnaissance Database, which helps medical device manufacturers with tracking electrical standards and also looking at what drafts are in the future, so medical device companies can focus on their expertise of designing their medical devices and leverage Leo's expertise on standards. Again, you can find more about Eisner Safety Consultants, just visit Eisner Safety E-I-S-N-E-R S-A-F-E-T-Y dot com. And you can learn more about the Standards Reconnaissance Database, eisnersafety.net. Alright, Leo, welcome to the Global Medical Device Podcast.

Leo Eisner: Well, thanks, Jon, and thank you for that great introduction.

Jon Speer: You're welcome. So I want to talk a little bit, I wanna share a short story about a time in my past. It involves standards. So that's good news. And then you could talk a little bit more, share a little bit more about your expertise on why standards are important and then share, of course, all this knowledge and expertise and information that you've been gathering in this Reconnaissance Database. I had a chance to peek at that and I was blown away by the homework that you've been doing that's gonna help a lot of medical device companies navigate this process of standards. Okay?

Leo Eisner: Sounds good.

Jon Speer: So I'm gonna go back in time for me a few years ago and it was the first time that I was working on an electrical medical device. And I had heard all this chatter and talk, I think it's probably second edition, it might have been first edition, I think we're on fourth edition now, right?

Leo Eisner: We're on third.


Jon Speer: Third. Okay, so, see I'm already behind or ahead or whatever, but anyway it was the first time I was working on an electrical medical device, and I didn't know that much about 60601, and we had to obviously go through all of the testing that was involved with this product 'cause it was electrical device and I was just blown away by the level of sophistication and details and requirements, and for the first time in my career, going through that project, I really felt like I was uninformed, uneducated, and just had zero knowledge on that topic. And I think that was probably one of the first times that I crossed your path. So talk a little bit about your expertise when it comes to standards. I mean I'm sure you can speak quite a bit about 60601, but talk about some of the other areas of expertise that you have on standards.

Leo Eisner: So, I started in standards right out of college when I went, started at UL. I didn't work on medical devices back then, but I worked on anything else under the sun you can think of, from home-use equipment, microwaves, computer equipment, and lots of other things. So I got a lot of really broad background in component information and end-user products and sort of how the whole process happens. And then I got into medical which I'm thrilled because I love working on medical devices. They're so much more fun than boring computer equipment, I guess, that's at least my perspective. And I got really intrigued because 601 is a very, very extensive standard, a lot of detail with it. And I was lucky enough to be able to get involved in standards development process.

Leo Eisner: About eight or 10 years ago, a couple of companies came to me and asked me to help write a standard for them, which I never have done before. And I was very fortunate, a secretary, that I work with in the group that I'm in, helped me learn about the process and I've learned a lot in those eight or 10 years. And now I'm in, I can't even tell you how many committees I'm in, there's so many. I'm in charge, I'm the convener of 80601-2-58, which is lens removal and retracting the equipment. Not the most glamorous topic, but you have to learn somehow. And I learned a lot that way.

Jon Speer: Sure.

Leo Eisner: So since then I've gotten involved in home-use equipment 'cause I think that's an exploding market, and I wanna help people there, and a lot more into the 601 world as well. And I'm also involved in the technical interpretations group for 601. So if people get stuck that there's a problem with the standard, which there's lots of them 'cause it's a huge standard so there's a lot of issues, the interpretation document is a great document to get you out of the corner potentially too.

Jon Speer: Right. And I'm guessing in addition to that interpretation document, picking up the phone or shooting you an email and getting you to help navigate additionally through that process is also something that the Eisner Safety Consultant does quite a bit.

Leo Eisner: Oh yeah, definitely, we get questions from all over the world on so many different things that blow your mind.

Jon Speer: Yeah, so I think from my, I shared my short story about my first exposure to IEC 60601. And of course, that's just one of many standards. We've got all kinds of standards organizations out there, IEC, ISO, ANSI, of course, there are dozens of others, but the whole process of understanding what a standard is and I guess a few sentences, can you describe why I should care. As a medical device company, why I should care about a standard? Why does that matter?

Leo Eisner: Well, probably the most important reason would be because of your regulatory submissions and also your design process. So with regulatory submissions, most regulators really encourage. They don't always mandate but they say it's voluntary, but behind those words voluntary are, if you don't use it, you're gonna make your life a lot harder. You need them to support your submissions like a 510(k) or PMA or whatever from FDA or when you submit to notified body in Europe or for Canada for Health Canada. Almost any country you go to, they're gonna wanna see some standards based on whatever your product is. Some specify the specific standards and others say, use whatever you want, if it's not in a category that's not as well controlled.

Leo Eisner: So using a standard, it's gonna make your life easier 'cause you have a base that's common that everyone knows. If you don't use the standard and you come up with something else, you got a much higher burden to show the regulator how you meet those requirements.

Jon Speer: Right. That makes total sense to me. If I had come up with Jon's method, it may be completely valid as a method, but now I have to spend all my time, effort, and energy explaining to that FDA reviewer why Jon's method is better than IEC 60601.

Leo Eisner: Yeah, exactly.

Jon Speer: Right. You've been doing a lot of hard work on this and there are others like you as well, who spent a lot of time developing these standards and sort of these methods and approaches so that it could be consistent and repeatable, from device to device, from company to company.

Leo Eisner: Yeah, sounds right.

Jon Speer: Alright. So here's the other thing that can be overwhelming. Where do I go to determine what standards apply to my product?

Leo Eisner: Well, if you have a medical electrical piece of equipment, got a great resource, it's my website, eisnersafety.net, which has my Standards Reconnaissance Database, which I've developed to help specifically medical device companies 'cause that's what I work with, that's my expertise. That they can look up the standard, they can find out the information. What's the current version? What was the previous one? What's the changes to that? And also what's coming up? So if there's a draft in existence, it's in the database as well. Also, I'm doing a once-a-year report. I have two parts of the database.

Leo Eisner: One is the medical electrical equipment and systems side, which is the broader group and then the more specific subsection is home-use equipment, which there's a couple of standards and then a lot of the same standards applied if they're specifically for home use, which is in the scope usually. And then there's also a new committee, brand new committee, it's about a year old, I think. It's called the Active Assisted Living System Committee and a system committee is a totally different concept. It's not specific to a specific type of product, like a medical device, it's broader, it's a whole system. So assisted living means basically someone in a house, in a home, of some dwelling of some sort that needs some medical assistance. It may be a very minor medical device that might not even be categorized as a medical device to something like a ventilator.

Leo Eisner: So in the home-use environment, it's so much different than in a clinical setting. If it's not as controlled, the environment is gonna change a lot. You might live in a house that has no air conditioning. Wherein a hospital, you have a very set environment that's very well regulated and you have backup generators and other power related things that are really important, where in a home you don't have that. The medical device companies really have to design devices for home, in a very different concept than for a clinical setting.

Jon Speer: Right, right.

Leo Eisner: So it's a very interesting committee. They're still trying to find their legs, I think, to figure out...

Jon Speer: Sure.

Leo Eisner: Exactly what they're doing.

Jon Speer: Sure, and I wanna dive into that a little bit here in a moment, but let me summarize. If you're developing an electrical medical device, go check out Eisner Safety Consultants' Standards Reconnaissance Database at eisnersafety.net. And certainly get ahold of LEO 'cause, trust me, folks, if you are developing a medical device, you wanna focus on what's important. You're trying to advance your technology and Leo is the expert when it comes to what's happening on the standards world, especially when on the electrical side of things. So if you have questions, you need to know what you need to do from a design and development standpoint. It is very, very important early on in your design and development process to know what standards you should be aware of and potentially applying to your product.

Jon Speer: So, do yourself a huge, huge favor. I mean, I can tell you, horror stories. I'm sure Leo's got a list of horror stories as well, but nothing is worse than getting to the point where you're thinking, "This is the last test that I have to do to get my product to market," only to realize that you failed ESD or you're not compliant with the EMC requirements or what have you, and it's a very simple change that you should have made much earlier on during the design and development process.

Jon Speer: Alright, so I'll get up my soapbox now and we'll get back to the program at hand. Alright, so Leo this area of home use is, I wanna talk a little bit about that because I mean obviously I've got family members who are aging and a grandmother who's in an assisted living facility. And by and large, her health is pretty good, but we can see this emergence happening of a lot of smart, "smart technologies" and apps on phones and wearable devices, and then people wanna be maintained at some standard living in their home environment and if we can provide them as a med device community, portable electrical medical devices, that's gonna make the standard of living and the quality of living even better for people who may need some medical assistance. So I can see where there's a lot of things that are just gonna interfere, play with, or interact with these devices that have Wi-Fi and Bluetooth and all these other things. So let's talk a little bit more about that space.

Leo Eisner: So FDA has been considering this a lot lately 'cause they have a whole bunch of guidance that have come out in the last couple of years. There's the home-use guidance which calls out a ton of standards, and it's changed. I think they've updated it two times already, since it went final. And then there's the wearable guidance, not wearable, what is it, mobile medical patients guidance and there's also, there's a couple other guidances and I can't think of them off the top of my head though.

Jon Speer: Right, that's fine.

Leo Eisner: But there's a lot of guidances. And in those guidances, they call out a fair amount of standards. Each guidance is a little different. The home-use guidance is a very detailed document. It calls out the usability standard, 62366, I believe. I think it calls out the software lifecycle guidance, that means standard which would be 62304, risk management, which you're an expert in is ISO 14971 and FDA is getting much more involved in that and also usability, they're getting much more interested in. The home-use guidance is sort of leaps and bounds ahead of some of the other more clinical standards or guidances in the sense that they've really thought how is it all interacting together and making sure the product really could sustain the abuse that's in the home environment.

Leo Eisner: You have someone that puts a Coke can on their device and it spills. You have to deal with that. You also have to deal with communicating that data back to the doctor or the hospital. So like you talk about Wi-Fi and self-service, that's all considered to some extent. And also FDA has been looking at the signals intermixing and how those affect your product and other products.

Jon Speer: Yeah very important. I was a part of a team developing an electrical device that, well we were considering the home environment for an application as part of our indications for use. And basically the long story short, it became very clear that if we were gonna go into the home environment, that the design, the robustness, the level of testing that we were gonna have to put this product through was much more significant than if we stayed in a controlled or semi-controlled environment as the hospital or a long-term care facility and that's important for a development team to realize your indications for use, your intended use, and Leo we're not gonna split hairs and go argue or discuss the difference between indications for use and intended use, for the sake of this conversation, we'll just kind of bundle those things together.

Jon Speer: But your indications for use are directly impacted by the markets that you plan to use, where you plan your product to be used, and depending on those markets where you plan for your product to be used could totally dictate the standards that apply and certainly the type of testing that's required. So it's very, very important. If you want to make a home-use device, the rules are gonna be different than if it's gonna be used in the hospital.

Leo Eisner: Very much so and I was yesterday actually looking at a list of standards for a client for, and I did a direct comparison between the clinical setting and the home-use setting, and I'd say there's more than double the amount of standards involved in that project, for home-use versus just clinical setting. So, it's significant. One thing I didn't mention very clearly is the EMC requirements FDA is basically insisting to use the fourth edition of the EMC standard versus what most people are using is third edition currently. And the difference is basically most products are gonna have to be redesigned to meet the fourth edition because there's such significant difference in the test values.

Jon Speer: Right.

Leo Eisner: Which is huge. I mean that's stunning to be thrown that in the middle of the project. You need to know that upfront. Like you said, getting early in the development cycle, this information is critical because it can throw your whole project off timeline-wise.

Jon Speer: Yeah. Another thing that shifted that sometimes companies I talk to even today are still not aware of is, you know, that regulatory piece for sure. And let's go down this scenario that a company is developing a Class II device and they're gonna have to put together a 510(k) submission and get clearance from the FDA. And I can remember once upon a time, not that long ago, where there were certain cases where you did not have to have the actual testing completed prior to your 510(k) submission. The old adage was you can provide an I promise statement to the FDA that says "I promise to do my IEC 60601 testing" and what have you.

Jon Speer: And that was a strategy that was employed by a lot of companies because they're like, "Oh, I can gain some time" because that IEC testing is not a trivial activity. It does take some time to go through all the paces of going through that particular standard. So there used to be this idea, you could do this I promise statement. And that day is gone. I think it's important for companies to realize when you submit your 510(k), you need to have the objective evidence, the proof, that you have tested your product to IEC 60601. That's very, very important for companies to realize. There's no more I promise.

Leo Eisner: Yeah, that's definitely true. And one thing that we haven't talked about that's important also is on the front end, before you go into the test lab, the work you have to do upfront. 'Cause if you just throw it into the lab and don't prep, the likelihood of passing it's pretty slim, especially with the third edition of 60601-1. The general medical electrical equipment standard is that there is this requirement that from second edition to third edition was a huge change, a paradigm shift, is risk management file, which is a requirement of basically saying, you've already done all your risk management under ISO 14971, now add one month of one person's time to fill out a whole bunch of paperwork that happens to be useless, dare I say it, but true, is total worthless, it adds no value to the product or the design process.

Leo Eisner: Basically saying, here are the 100 or 125 requirements saying, risk management file needs to be reviewed for compliance with this requirement or this requirement. And it's a lot of work, it's a lot of paper, and it's usually at least, I think, we charge about 100 hours for that or more, depending on the product and the type.

Jon Speer: Yeah.

Leo Eisner: It could be, or more. And it's 30 days of one person's time when they are up to speed on it in a company typically, if not more.

Jon Speer: Yeah.

Leo Eisner: And that's just one piece of the puzzle. But that's one of the bigger pieces of chunks. You need to draft the test plan and know what you're getting tested. Before you do that though, you have to classify your product under the standard so you know, is it a BF or a B or CF type of applied part? Are there applied parts? What's your power source? Is there ingress protection requirements? Which means basically if fluid, if you're in an environment that it's really wet or you're in an OR, you're gonna have some type of ingress protection requirements. If you're at home, the home-use standard has some requirements. They're not too stringent. The Emergency Medical Services Standard, which is 1-12, 60601-1-12, is more stringent 'cause that's even more... That's a worse environment. You are outside, in the middle of a blizzard, you still have to use the equipment. Hopefully, for the poor person on the road on the side, they want it to work obviously.

Jon Speer: Yeah, absolutely.

Leo Eisner: And there are several other classification issues. You wanna do upfront 'cause that's gonna affect your test program.

Jon Speer: Sure. Sometimes it can feel as a medical device product developer that all these standards are just in my way of making progress. But I think you just said something, I'll touch on it. I think you just said something that's very key that we can all imagine and resonate with a little bit. Imagine you're stranded on the side of the road and suddenly you need a medical device and that EMT is going to use this medical device to save your life. Or you have a loved one that's in the home that relies on a medical device to live. These standards now become pretty important as a consumer, as somebody who might be the recipient of this medical device. Dammit, I wanna know that that product has been through the rigors of IEC 60601. I always look for it on the back of the device to make sure it's got the little sticker. So, it's very important to make sure that that product is gonna work when I need it.

Leo Eisner: Yeah, totally agree. I mean the standards are rigorous, but it's for a good reason. And standards are developed in a consensus environment where there are multiple parties involved. Typically, there's manufacturers, there's regulators sometimes, especially for the quality system standard. There's the test houses are involved, and sometimes there's even consumers involved, but that's pretty rare because one of the problems with the standards development process is it's voluntary and everyone that goes in pays their own expenses. So, me going to Kobe and to Tokyo in November, I funded myself to go there because I wanted to be involved, but also it's helping my clients, which is important to my business. So, I needed to take that step.

Jon Speer: Sure. So, Leo, we're going to need to wrap up our conversation today, so is there one tip that you can recommend to the medical device community when it comes to standards that we haven't touched on today? I know I just put you on the spot.

Leo Eisner: Of course, it's part of the fun. Well, I think one thing is you've sort of touched on a little bit is early in the development process, as early as possible, you need to know what your product is well enough to determine what standards apply so you can put that in your project plan and schedule out how much testing it's gonna take, how much prep it's gonna take, and really know what are the standards that apply. Look at the guidances, look at the scope of the standard, 'cause if you're out of scope of the standard, it gets hard to deal with. But FDA puts you in that spot occasionally where they say, "You have to meet 60601," but the product is not in the scope of the standard. You need to now figure out how to navigate that, which is a big challenge for the clients.

Jon Speer: Yeah, yup. Well, Leo, I appreciate you being the guest on today's episode of the Global Medical Device Podcast. Hey, Leo, today rattled off, it sounded like an alphabet soup at times. ISO, IEC, ANSI, ASTM, there are a lot of different standards organizations and he rattled off even more numbers. 60601, 62366, 62304, 14971, all kinds of numbers. It sounds overwhelming, it can be, that's why you need a guy like Leo and Eisner Safety Consultants on your team. So, be sure to check them out, eisnersafety.com, E-I-S-N-E-R S-A-F-E-T-Y dot com.

Jon Speer: One of the things that Leo hit on was risk management. If you're gonna be dealing with electrical medical devices in any way, shape, or form, it is very clear that ISO 14971 is definitely something that you need to deal with. And, hey, what better way to do so than to use the only software package known to man that actually complies with ISO 14971 and fully integrates with your design control activities. Yup, that's right, folks. Check out greenlight.guru, request the demo, learn more about our software package. Until next time, this has been Jon Speer, the founder, VP of Quality and Regulatory for Greenlight Guru on this episode of the Global Medical Device Podcast.

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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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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