Managing Business Risk as a Medical Device Company

May 3, 2021

It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant. 

Together, Michael and Jon talk about how medical device companies should approach and manage business risk, which systems and tools can help, and advice on how to review contracts and terms and conditions.



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Some highlights of this episode include:

  • Are you ready to grow your company? Is it the right time for a business owner to think about the business, liability, and intellectual property? Time to engage Mike.
  • There are consequences to a company’s distribution model and selling strategy.  Each has a different set of contracts and risks that need to be assessed and receive recommendations.
  • Insurance is there for when you need it, even if you don’t understand it. Contractual liability is usually the biggest risk for entrepreneurs and startups.
  • Mike often says that there are three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.
  • Jon defines risk management as a platform with intentionally built workflows related to ISO 14971. Greenlight Guru mitigates risk for companies as they operate quality systems to manage information and handle audits.
  • What you do and don’t do influences and represents your risk profile. Don’t make insurance an afterthought to achieve better outcomes and goals. 
  • Do everything you can to be the best company. Don’t just do the minimum, but go above and beyond to change the quality of life.




Mike Cremeans on LinkedIn

Mike Cremeans: Risk and Insurance Consulting

FDA - Device Approvals, Denials, and Clearances

FDA - Guidances

ISO 14971

ISO 13485:2016

Greenlight Guru Academy

MedTech True Quality Stories Podcast

Greenlight Guru


Memorable Quotes from Michael Cremeans:

“What I’m going to do is help people map out where they’re headed. What could go wrong? Who’s going to be upset at them? What are they going to be upset about? What are the financial damages? What things should you be focused on?”

“How can you figure out what they need if you haven’t asked them about their company?”

“There’s three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.”

“Do not sign a contract until you’ve talked to me.”


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: All right, I'm going to say a word you may have to face or a reaction to, insurance. Yeah I know sometimes when you hear that word, you may roll your eyes or you may groan, but it is important. Especially as a medical device company, you need to make sure that you have the right coverage in place for the type of company you are, for the types of products that you have, and all these sorts of things. You got to consider that your entire risk profile as a business, not just the product risk, but what systems do you have in place? What about reviewing contracts and terms and conditions and all of these sorts of things? And joining me on this episode of the Global Medical Device Podcast is Mike Cremeans. Mike is the Life Science Leader with Hylant. You can check out more about Hylant by visiting hylant. com, H- Y- L- A- N- T, and enjoy this episode of the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast. Of course, wherever you're listening, that's terrific. Keep doing so, but we have video now so you can watch us as well as we do these episodes so check it out. We're definitely on YouTube, we have a Greenlight Guru as a whole YouTube channel. There is a playlist dedicated for the Global Medical Device Podcast. We'll be pushing content as well through LinkedIn and all the usual channels. Joining me today is Mike Cremeans. Mike is with the Hylant Group. So Mike welcome.

Mike Cremeans: Thank you, Jon. Thrilled to be here. We were just talking off- camera a few minutes ago. I think I had the pleasure of being at one of the earliest podcasts, listened to a digest the other day and it was really great. I'm proud to be part of your podcast then now webcast. That's awesome.

Jon Speer: Thank you so much. I remember back... Gosh, it's couple of years ago, some of my colleagues wanted to celebrate episode number 100 and they reached out to you and quite a few other folks to record short little snippets. So I don't think I ever thanked you for that, but that was great when you were willing to take some time and record something and send it over. So thank you.

Mike Cremeans: I've had a blast. No problem at all.

Jon Speer: Absolutely. Well, Mike, I guess probably a good way to dive in today... I mean, risk management is one of these topics that is certainly prevalent and top of mind for most medical device professionals. I think a lot of times when we think of the term risk management is probably... And maybe rightfully so very product- centric or product- focused, but there is an element of risk that folks need to think about especially those smaller and startup companies when it comes to business risk. So maybe take a moment and tell the audience what you do Mike.

Mike Cremeans: Yeah, I'd be glad to. I believe really in helping my clients solve problems and challenges. I've worked with several companies, I've been in the highly innovative space and more specifically the medical device and med tech space for about 27 years. And what I try to do is help people understand how risks affect their businesses. We do a lot of lifecycle presentations. As you were describing let's stay within either the startup or a growing company mode and the med tech space, they need to understand what it's like at the next milestone. What kind of contracts are they going to see? What kind of risks are they going to face? How is their business going to change? So the discussions I have with entrepreneurs at this particular stage are basically not focused on product. I try to stay at a really high level and look at things at an enterprise risk basis. And by the way, I happen to be in the insurance business. So that's essentially what I do. Try to keep people out of trouble.

Jon Speer: Well, I think that's something that... I started a business... Well, I've started a few, but the first business I started way back, I knew I had a product that I can offer, knowledge that I can offer, and so there was a need for that. And the thought never crossed my mind. I was like," Oh, I probably need to protect myself and my business. And frankly, my family through some insurance, liability." And things of that nature. And I think it's complicated a little bit when you get into the medical device space, maybe those early days, maybe it's no big deal because you're only interacting with your team and maybe you're building some prototypes, but there's a magic moment where boy, you better have your act together on the business side, from a liability side, from that perspective. So what are your thoughts? When is the right time that a business owner should start to think about these sorts of things?

Mike Cremeans: It's a great question. I haven't met a C- level person yet who likes surprises. So after you get through the setting up the company, you get your intellectual property secured, you start making your filings with the FDA, maybe you've got some friends and family that have decided to put their money into the company. So now you step back and say," Okay, now I need to grow this thing." That's probably the place that is the best for me to get engaged. What I'm going to try to do is help people map out where they're headed, what could go wrong? Who's going to be upset at them? What are they going to be upset about? What are the financial damages? What things should you be focused on? Honestly in my business, there's a lot of risk and insurance professionals that just send out applications to people and say," Okay, fill this out and let's go get you some insurance." Well, how can you figure out what they need, if you haven't asked them about their company and try to really dig in and find out what their passions are? Where they're headed? What their culture is? But really try to get engaged at that particular time. That's probably the best time, is just before they start to get into complicated contracts and look," Hey, the great news is, and we can celebrate with a favorite beverage that you got FDA approval." Now y'all look around and say," All right, how are we going to sell this thing? How are we going to move it?" inaudible.

Jon Speer: And I think a lot of startups, especially are trying to... Usually there is an element way before that FDA clearance or approval or whatever the case may be, where they're wanting to get into that some sort of clinical study or some sort of investigation. And you mentioned fundraising, there's all these trigger events I think that are really important from a company perspective to consider... Okay, what are my risks?

Mike Cremeans: Exactly.

Jon Speer: How do I manage those risks?

Mike Cremeans: Well, that's right, and there's consequences. And if I could put people in a situation where... Okay, when you reach this stage, here's what I think you're going to see. Once you get FDA approval and you start to look at your distribution model, are you going to go through the group purchasing organizations? Are you going to go to surgery centers? Are you going to use physician champions to get you into a particular hospital? Are you going to use independent distributor networks? What's your strategy to actually get these devices sold? And each one of those individual strategies has a different set of contracts, a different set of risks. And what we're going to try to do is figure out," Okay, you tell me where you're headed. I'm going to help you customize what that assessment looks like and what our recommendations are." And then that way, honestly Jon when people tell me," Hey, I got it, just go do it and leave me alone." Then I guess I feel like I've done a good job because that's going to enable the CEO to go out there, the CFO, all of the folks that are part of the management team actually execute. Because they know that their risks are identified, they know that things are taken care of and they can just move on and run their business.

Jon Speer: I think there is a parallel, like in my personal life, I'll use this as an example. Probably all these days require that a car owner has auto insurance. And for probably obvious reasons and you hope you never use it, and you probably are grumbling every time you have to pay an insurance.

Mike Cremeans: Absolutely, I do.

Jon Speer: And then you have health insurance, like a hotly debated topic. But there again, there are times where it's there for when you need it. Life insurance might be another one of those things. So, I know from my personal perspective, I have to look about the entire continuum and understand where am I exposed I guess as a good word, and crosstalk that up.

Mike Cremeans: And Jon, I think also if you take a look at that, let's just stay focused on that time period where I was talking about where I like to be in first engaged, where we start to have these serious discussions. Contractual liability is probably going to be the largest risk for you. And what I mean by that is, think about a... For those entrepreneurs listening, think about a term sheet. Well, a term sheet not only has terms about the investment, but there's usually two insurance requirements in that term sheet. There's a life insurance requirement and there's a directors and officers liability requirements. So a contractor agreement created risk for you and it created the need for insurance. You get into some of these and some of those that are listening have looked at those 85- page contracts of group purchasing work stage. They've looked at how sophisticated these hospital risk management departments are. You got these contracts, there's all kinds of language in here that nobody understands, it's funny. I usually say there's three truths in the insurance business. We have our own language, we like to confuse, and we're really good at it. So when you look at these words you're thinking," Ah, primary noncontributory." What is general liability? What does cyber mean? What's an umbrella? I don't get all this stuff, would you just help me interpret it. Help me understand what this is. And think about it Jon too. You've got all these jurisdictions within the United States that require the auto insurance that you talked about. Well, all of them are different. Think about a company that wants to go outside of US for their craft clinical studies or clinical trial. But every single one of those jurisdictions is going to have a local competent authority that has very unique laws or regulations you must comply with. So in our particular case, we try to help people anticipate as well," Hey, if you're going to Germany, these are going to be the requirements." If you're going to Sweden, if you're going to South Africa. Doesn't matter, anywhere around the world, there's going to be certain local laws, customs, regulations that you're going to have to deal with. So again, contractual liability is where I spend most of my time.

Jon Speer: So let's learn a little bit more about how you engage and how you help people. So contractual liability, term sheet, you mentioned a couple of examples there but let's say I'm early on and I'm prototyping or whatever the case may be, but I'm working with some suppliers and maybe I've got a contract manufacturer that I want to start doing some work with. I should have a contract in place. I mean, that makes good sense.

Mike Cremeans: I can guarantee you that there's a contract. Those contract manufacturers are becoming much more sophisticated and not only the services that they offer, but also they're getting a little smarter about what the insurance and indemnification terms look like in those agreements. And the prototyping stage is a perfect example Jon, of when you're going to be confronted with one of those contracts, and then you look at it and say," Okay, what are you guys going to do for me? And when are you going to deliver it? And how are you going to deliver it? And what kind of services are you going to offer?" What I do is I say," Okay, so what happens in the process if right before you get your prototype developed?" Jon, I'm a disaster guy. I have to think of it. Their facility blows up. That's not the time when you want to say," Oh, well you have insurance for that, don't you?" Actually, no. If you look at the contract or agreement, you are supposed to have insurance for that. So it's best to figure out who's responsible for what, what happens in the event of, and those kinds of things. And you just have an understanding of, if it hits the fan, who's going to be responsible? And how can we get back up to where we would have been, had we not had some type of a disaster or a loss?

Jon Speer: So I'm in that situation, do I pick up the phone and call you and say," Hey Mike, I need your help with this?"

Mike Cremeans: Yeah. Hopefully what I've done if I've met them at that stage where I say to them," Do not sign a contract until you've talked to me." That's usually one of the first things I tell people. As we start to map these things out, don't call me after you signed it and say," Hey Mike, guess what? There's a$ 10 million requirement for product liability." That's not going to cost me much, is it? That's the worst time to have those kinds of discussions. So I think that again, it's that initial planning stage where we can try to map out where you're headed, that's the perfect situation. But let's say it happens Jon, like gets in the way, and all of a sudden you're confronted with a contract and say," Now, what do I do?" There's no question that I have people calling me all the time with," Hey, somebody told me you know what you're doing, can you just take a quick peek at this contract?" We'll help them sort it out.

Jon Speer: Folks. I want to take a moment to take a brief pause. I want to remind you all Greenlight Guru, we have the only medical device success platform on the market today designed specifically and exclusively for the medical device industry by actual medical device professionals. Our customers are all over the globe ranging from early stage startups to very large companies. And they all have one thing in common. They're trying to be more efficient with their time, their resources, and to introduce new products into the market to help improve the quality of life. So if you'd like to learn more about the Greenlight Guru Medical Device Success Platform, then I would encourage you to go to, learn more about the platform. If you're so inclined, we'd love to have a conversation with you, understand your needs and your requirements, and see if we might have some products and solutions that will meet your needs. Also, while I'm taking this brief pause, I want to remind you that Greenlight Guru also has a brand new academy. In the Greenlight Guru Academy, we have some courses on design controls, on risk management, on regulatory submissions and so on and so forth. And we're continuing to add new courses throughout so that you can have an opportunity to learn a little bit more about a topic. Maybe you already know something about, or maybe one you don't know anything about, well, we've architected it in a go- your own pace style so that you can consume and learn something new and exciting about these topics that are important to the medical device industry. Also want to remind you all that I'm talking with Mike Cremeans. Mike is the Life Science Leader with Hylant. So Mike, do you mind taking a few moments and share a little bit more about Hylant and how people can contact you and the website and those sorts of things?

Mike Cremeans: Sure. I'd be glad to. Jon, I have the great fortune of working with an amazing organization. It's essentially a family office that happens to be in the insurance business. Based here in Ohio, about 800 employees, probably by the end of the year we're going to be closer to 900 employees, we've done extremely well. It's a family run organization soon to be... I believe the calculation is fourth generation. There are actually fifth generation people that are working from the family in the office. So we're a privately held company, should be privately held for quite some time. And I think that's what really makes it such a great organization because I could pick up the phone and really have a substantive, great conversation even with the CEO today. It's just a very close knit family, very close knit organization. And we got some really smart professionals in various types of businesses that I absolutely love to work with. And we have a lot of different verticals and certainly one of those verticals is in the quote unquote life sciences space, which is really FDA regulated companies. And that's the practice that I run for the company. My focus for the last 28 years again, is really been mostly in the med tech med device area. But certainly we have a lot of other customers inaudible regulated space. Do you mind if I go and work off the description of Greenlight Guru for a second?

Jon Speer: Yep.

Mike Cremeans: Obviously as someone who is an insurance professional, one of the skills that I have to have is I have to be a storyteller. I have to be in a positive way. I have to be able to describe a business and the most effective way to the insurance underwriters. And those are the folks that are actually offering quotes. John, I have to ask you a question. When you think of risk management as respect to what Greenlight Guru does, what's your definition of risk management?

Jon Speer: Well, from a Greenlight Guru perspective, I would say well, there's a couple of ways that could address this. The first and foremost is... Maybe the most obvious is the workflow that we have and the platform that's structured for product risk management. And I guess to get a little jargony or use some terms and numbers, ISO 14971 is an industry standard for product risk management. So, we have intentionally built workflows to help companies with ISO 14971. I think there's another angle to it too from a risk perspective, it's a Greenlight Guru mitigates a lot of risks for companies as they operate, especially with respect to quality systems, for example, an audit is an event that as a medical device company you will be exposed to, you will have probably numerous audits probably throughout the calendar year.

Mike Cremeans: Absolutely.

Jon Speer: And these can come from suppliers, that can come from customers, that can come from regulatory bodies, et cetera, et cetera. So the Greenlight Guru platform is a single source of truth where all of your documents, records are kept managed and maintained. We've recently incorporated some AI and machine learning aspects with crosstalk digitalize and some things and this actually shows a connection at the ecosystem. So that's a risk management activity too from more of a company perspective, to make sure that everything is where it needs to be, identifying the gaps or issues and those sorts of things, to help streamline that.

Mike Cremeans: So if you think about that Jon, think about me as the person who has to represent a customer that is a customer of yours. If I can show that their quality system, that how they manage their Kappa management I believe in your space, that's some of the other things you do. That there are processes and procedures in place. That there's a very sophisticated way that you're managing that information. Jon, that's very powerful information that I take, and that I can then describe to the underwriter to say," Look, we've got a company here that cares very very much about their quality system. They've got some people who are dedicated to this, they use a very sophisticated process in order to manage all this information. So what it does is it relieves subjectivity perhaps in the mind of the underwriter. And what's the output? You're going to get better terms and conditions. You're going to have people fighting over you as a customer if you can prove that you've actually gone through those kinds of meds. So that's why I love working with companies like yours because you're making my job easier if I can describe to those underwriters, how much these guys actually care about quality and putting a great product on the table.

Jon Speer: Absolutely. I mean, going back to the personal life example because I think there's a lot of parallels, if you've ever applied for life insurance, you're going to be asked questions about your lifestyle.

Mike Cremeans: Absolutely.

Jon Speer: Do you do this? How old are you? And do you have any pre, prior history and those all crosstalk So all those sort of those things have influence on your risk. And I think that's a great parallel from a business perspective. What you do or what you don't do is a representative of your risk profile to someone who might be underwriting and providing insurance.

Mike Cremeans: A hundred percent. You know Jon, many times insurance has been an afterthought. All you got to do is look at the television. It's state farm, it's all of these companies. I can do all the jingles for you if you'd like but if I just say one word you're going to say," Oh, I'll stay." If I say another word," Oh, that's state farm." So, and what is their premise? Get in touch with us and we're going to competitively bid your business and we're going to save you some money. Well, in the medical device field, it's a little more complicated than that. It's not just," Hey, let's go out and get 15 quotes. Why not improve your risk profile? Why not really make you a world- class admission for a guy like me that's able to tell that story, describe your business in a much higher level as a world- class organization." I can guarantee you that that's going to ring very well with the insurance underwriters. You will absolutely positively always get a better outcome.

Jon Speer: Well, and I think this is important because I think a lot of times when a company is thinking about risk, like I said, at the beginning, very product centric and you should be focusing on the risk of your product for sure. But you have to get as a bigger picture. It seems like this is more of an enterprise wide type of a thing, right?

Mike Cremeans: It is. Your area is going to help me tell a better story. As we do go back into that discussion of the enterprise risk discussion, look, there's human capital risk, there's turnover, training, employee engagement. Think about a remote, how remote we've been in the last hour, whether you're over insuring, whether you're under insuring, how should you finance some of the risks that you have? Life insurance benefits. There's just so many different kinds of risks. And what we're going to try to do is really help them figure out all of those things. And then once we get to the point where we understand what they're really concerned about... If somebody wants me to sell them an insurance policy for every single risk, believe me, I'm glad to do it. I've got a wife and four daughters. I need a lot of shoes and purses in my life. But that's not going to... The only person that wins is me. I want the customer to be able to tell me what it is that they're really concerned about, what they're afraid of and then let's put a plan in place, and let's figure out how we can make sure that you achieve your goal no matter what it might be.

Jon Speer: I think that's really smart. You've got to balance all of these things depending on where you are in the company. But the thing that I think is really intriguing about all of this is there's actually a regulatory premise or foundation for this. If you've read the most recent version of ISO 13485, the 2016 version, it introduced this concept or notion of risk- based approaches for your quality system. And I know sometimes people are like," Ah, it's just quality stuff." But to me, it's like, a QMS is how I operate business as a business. And so if I'm articulating and describing all of the key processes to operate my business and I'm doing so this risk- based, well then good. We're speaking the right language.

Mike Cremeans: Jon, think about this at another standpoint. Let's think about the worst case scenario inaudible fail for a CEO. Unfortunately their product caused bodily injury to someone. It really is and I can guarantee you because I've been in these situations. It's devastating to a CEO or to a president of a company if injury actually occurs. And if the CEO or the president is on the witness stand, if you're involved in some kind of litigation... And I'll never forget this, a plaintiff's attorney told me this story one time. And the CEO explained, he said," Look, I followed all the FDA guidelines." And the attorney looked at him and said," Is that all you did?" So just because you have certain guidelines that you think you met that are the minimums, that doesn't mean that you've put yourself in a position where you can describe yourself as a world- class company, then it takes much more. And your company realized that a long time ago, that's why you do the training videos. That's why Hylant does training. That's why we get our employees are required to do additional training. In my area I have to, or I insist that all the people who are in my team are actually familiar with FDA, they're familiar with how products get out to market, they're familiar with a lot of the processes and procedures and what the life cycle looks like within a company. So they can truly understand what it's like to be a world- class company. But going above and beyond, and making sure that you absolutely are doing everything you can to be the best company you can, then I look for those customers. I want those customers every single day and I think you and I probably share that same belief.

Jon Speer: Yeah, absolutely. I think it's important. I talked to so many companies who have some really exciting technologies that they will change the quality of life. There could be a day that someone I know personally is going to need something, I hope not, but that's reality of life. Sometimes things happen. And I want to know that those products... There was times that I was in the ER, a kid for something, relatively benign. And I found myself looking over that... Like this was earlier in my career. I still do it every time I'm in the hospital, but I'm in the ER room and I would see all the different medical devices that they're like," Oh, that's by this company. Oh, that's by this company." crosstalk. And some of them are like," Ah, that company has a lot of issues with product safety. And this one, eh, that's so good, or, wow. I was." Crosstalk So you kind of do this, but I want to make sure that if there's some part that I can play and some part of that Greenlight Guru can play in helping companies be cream of the crop premium world- class, best- in- class, high quality companies, that's what I want to try to do if I can play a part.

Mike Cremeans: Absolutely. And Jon insurance underwriters know this. They subscribe to FDA announcements, they know when a company gets into trouble. They understand when there's been an FDA inspection, they know if there are 483's that are coming up and they monitor this stuff very very carefully. So not only you and I are doing it. Because I did the same thing. I started to smile and I thought you're sitting there in a doctor's office and you're looking around," Oh wow!" I actually was in a doctor's office the other day and I said," Holy cow, that's my customer."

Jon Speer: And you can smile and be proud about it too in that case.

Mike Cremeans: A hundred percent. Well,"Ah, that's my customer inaudible" I was very... Because I knew the passion of that CEO and the CFO and all the people involved that's why they're sitting in that hospital room or doctor's office because they do have a first quality product.

Jon Speer: All right, Mike. So as we wrap things up today. One of the things that I picked up from our conversation is that it really doesn't matter what stage I am as a company it's worth a phone call to Mike Cremeans at Hylant to learn a little bit more. And you can find out more about Hylant by going to highland. com, H- Y- L- A- N- T. com.

Mike Cremeans: That's one way. If I may, you can go to my LinkedIn page. So if you just put Michael Cremeans in there, I should come up at the top. I actually have my own personal webpage which is mikecremeans. com. So M- I- K- E- C- R- E- M- E- A- N- S, mikecremeans. com. It talks about me, it talks about my approach, it talks about a lot of the services that we offer, some of the engagements, what some of those things look like, so it's very easy to find me at those places. You can go to hylant. com, there's a section in there about life sciences. You can see a lot of my white papers, blogs, and some of the life cycle presentations that I do, but there's all kinds of ways to find.

Jon Speer: All right. So as we wrap up, what is one thing that listeners should do today on the topic of enterprise risk management?

Mike Cremeans: Do not do it as an afterthought. Pick up the phone and talk to somebody, get some information. I'm easy to deal with, just call me even if you're acting to become a customer of mine, call me, see how I think, let me be able to give you some advice on what a contract, what a situation, what a problem looks like. Just pick up the phone. Don't be afraid to call me.

Jon Speer: All right. Well, folks, I want to thank Mike Cremeans for being our guest today. Mike, it's great to reconnect on another episode of the Global Medical Device Podcast, it took me way back earlier reminded me that we might've been in the single digits of episodes fully last crosstalk.

Mike Cremeans: I think. Pretty amazing. I'm thrilled to do it Jon. Thank you for your business friendship. I love hanging out with you guys and I know we're probably going to see each other I think pretty soon in another episode.

Jon Speer: Absolutely.

Mike Cremeans: I'm looking forward to it.

Jon Speer: All right. Terrific. Well folks, thank you as always for listening. And hopefully now watching the Global Medical Device Podcast powered by Greenlight Guru. As always this is your host and founder at Greenlight Guru, Jon Speer. And you have been listening to 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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