Understanding the Value of a Medical Device Guru

Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru.

Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "Guru Edge" has come to be one of Greenlight Guru's most valuable offerings to medical device companies around the world.

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Some highlights of this episode include:

• Role of the Medical Device Guru: Collect as much feedback as possible from customers throughout the sales process to determine why they select Greenlight Guru’s QMS over other quality management systems.
• Medical Device Guru Team Philosophy: Give peace of mind to customers and help them meet their goals, whether it’s to launch a product or pass an audit. Gurus want their customers to succeed the first time.
• Do you want to be a medical device guru at Greenlight Guru? You are encouraged to be curious, inquisitive, and willing to learn and help because you are exposed to different medical device companies and technologies.
• The process of setting up a medical device quality system, getting your product to market is much more overwhelming than it actually is. First, focus on design controls and risk management. You can add more later.
• Build as You Go: Use phased approach to implement a QMS to make paperwork less of a burden and less tedious to add value and improve business efficiencies.
• Market Research: You need to know your industry and understand your users and their needs. Talk to as many people as possible - clinicians, patients, etc.

Links:

Tom Rish

FDA - Medical Devices

FDA - Guidance Documents

510(k) Submission Process

FDA Inspections and ISO Audits: What is the difference?

Software as a Medical Device (SaMD)

European Union Medical Device Regulation (EU MDR)

In Vitro Diagnostics Regulation (IVDR)

Global Medical Device Podcast, Episode 177: 5 Actionable Lessons Learned from the RADx Initiative by NIH 

Global Medical Device Podcast, Episode 205: Global Medical - Things I wish I knew as FDA reviewer

Global  Medical Device Podcast, Episode 158: Meet a Guru - Tom Rish

Global Medical Device Podcast, Episode 155: Meet a Guru - Jesseca Lyons

Global Medical Device Podcast, Episode 153: Meet a Guru - Taylor Brown

Global Medical Device Podcast, Episode 160: Meet a Guru - Wade Schroeder

Global Medical Device Podcast, Episode 188: Meet a Guru - Sara Adams

Global Medical Device Podcast, Episode 206: Meet a Guru - Laura Court

Global Medical Device Podcast, Episode 207: Meet a Guru - Etienne Nichols

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable Quotes by Tom Rish:

“Greenlight Guru is more of an experience and not just buying software. We feel like the gurus are a big part of that experience and we want to make sure that we hold up our end of the bargain to that.”

“We found early that our customers are coming to us with a lot of different questions.”

“It’s very humbling and also encouraging to see how many people out there are just really passionate about their ideas.”

“You can do a lot of work to get your product ready to launch knowing that you can add stuff on later.”

Transcript:

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: I remember the day that my phone rang when I was at Greenlight Guru and the person on the other end was a guy named Tom Rish. Tom had just read an article or heard a story about Greenlight Guru moving into a new office space in Indianapolis and wanted to know more about the company. And long story short, we chatted, we had a need for someone of his background and we ended up hiring Tom. And that was almost four years ago. And so in this episode of the Global Medical Device Podcast, I catch up with Tom Rish. Tom is a senior medical device guru and manager of our guru team at Greenlight Guru. And Tom and I catch up on a few things, trends, things we're observing, things that are happening in the industry. So just a couple of product development and engineering nerds catching up and chatting for a few minutes. So I hope you enjoy this episode of the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. And joining me today is senior medical device guru, Tom Rish. Tom, good to talk to you again.

Tom Rish: Yeah, good to talk to you, Jon. I've done the podcast, never the video. So this is a new one.

Jon Speer: Yeah. Video, yeah. I forgot to tell you we're doing video.

Tom Rish: I do have a story, actually, if you don't mind. I was at a road show and we were doing a podcast, a live podcast, and it was a video one, and I did something where I asked the crowd to raise hands or something like that. And there was a mingling session afterwards and I heard somebody next to me, I was eavesdropping, and I heard them say, " Does that guy know how podcasts work?" So yeah, he did not know about video podcasts yet. Yeah, yeah. So I always thought that was funny.

Jon Speer: It's one of those areas that it's surprising we do so much and marketing and we focus so much on different content. It's like, let's be stronger in video, let's release things out. I mean, personally, I mean, I don't know if it's a COVID thing that triggered this, but a lot of the things that I watch are podcasts on YouTube. Oh, wow, you can do that while you're recording it since we have the technology. So anyways, if you're watching or if you're listening, you can watch this now. And if you're listening and you don't want to watch this, that's fine. If you're watching you can subscribe to the channel, Greenlight Guru's channel on YouTube and be sure to click the bell so you get notified whenever new episodes come out. But anyway, I thought Tom and I, we could catch up a little bit. Tom also manages our team of gurus at Greenlight Guru. I guess talk a little bit about that. I mean, because the guru team, I think it's good to give folks a little bit of an idea of, especially as our customers, the type of support that they have, not just from customer success managers, but also from gurus. Maybe talk a little bit about that, so people have an appreciation for the role of the guru.

Tom Rish: Yeah, definitely. So we are very proud of the guru team. I think one of the things we find, we try to collect as much feedback as we can, obviously from customers and throughout the sales process about, why do you select Greenlight Guru over other systems out there? And one of the things that always constantly rises to the top is that they feel like Greenlight Guru is more of an experience and not just buying software. And we feel like the gurus are a big part of that experience and we want to make sure that we hold up our end of the bargain to that. So the guru team it's grown to, there are six of us now, actually seven of us, and we've all worked in the medical device industry. We've got some electrical engineers, mechanical engineers, biomedical. And I think so much of this industry is all about finding somebody, a mentor or a colleague or connection that has done something before, because things aren't as black and white as people think. And so we help our customers by just saying, I've done this, here's what happened when I went through this audit or here's how my 510k submission went, these are some of the things we missed and whatnot. And I think that's the biggest thing. We give peace of mind to our customers that as they go to hit their goals, whether it's launch a product or pass an audit, we've done it. We can help them. We want them to succeed as much as we do. And so that's the main philosophy of the guru team is to help our customers meet their goals the first time.

Jon Speer: Yeah. I think the other interesting element about the guru team is the diversity. And you've hit a little bit on it already, but just the types of things that that group of people have done. I mean, they're not all same as far as career experiences. I mean, we have some folks who are product development oriented, others who are more manufacturing oriented, some are more quality oriented. Tom, and their prior experience is with companies of all shapes and sizes. Small startups to the biggest of big companies, all different kinds of products too. So it's a very diverse group of people with respect to experience. And I was talking to Etienne the other day on a Meet A Guru episode and I made the statement that, I'm pretty sure that if it can be done in the medical device industry, collectively speaking, one of our gurus has probably done.

Tom Rish: Right. You're exactly right. And obviously that was our strategy around building the team. I think you obviously, and Jesseca Lyons were the originals and you had a diverse background, and then I was able to come in and thanks to some of my industry experiences I did product development, but I was also thrown into some audits and remediation activities. So we found early that our customers are coming to us with a lot of different questions. So we made a focused effort to really find people focus, because part of what's cool about being a guru is being exposed to a lot of different things. But we have Taylor Brown, for example, that did so many audits before Sara Adams. She did an FDA audit and an ISO audit in the same day. And then Etienne, Laura, Wade, all extensive product development backgrounds. So we want to make sure we cover all the aspects of the customer journey and we've grown a lot in the last year and feel like we cover a lot of those areas.

Jon Speer: Yeah. And I'm sure I don't know if we have open positions in this current moment in time for additional gurus, but as the company continues to grow, we're always looking for strong gurus to add to the team. So if that's something that is of interest to you to learn more about, certainly reach out to us. I mean, I'll credit the man I'm talking to you right now a great deal with doing just that. You remember the first time you and I spoke, right?

Tom Rish: Yeah. I do. I heard about Greenlight through a news article, and I do remember that.

Jon Speer: Yeah. You picked up the phone... I don't remember exactly if this was the first point, but at some point you might have sent an email, but I remember getting a phone call and you were on the other end and you were curious, you wanted to know more. And the more we talked I was like, all right, Tom is going to be a great fit for what we're doing. So thank you for having the courage to pick up the phone. I mean, it's hard to believe, you're coming up on four years, right? In September?

Tom Rish: Coming up on four. Yeah, yeah. I think it was November. I think I started talking to you in September. I do remember. And I think for me it was like I loved the medical device industry. Being in Indiana and being in orthopedics, very biased, but there's no better industry than orthopedics in my mind. And I loved what I was doing. I had a great background and I was just like, you know what? I want to learn some different skills. I want to push myself in different areas. And I knew I had accumulated so much information regulatory wise due to some of those projects I was on. And I was like, this could be a really cool way to help build a tech company in my state and get exposed to a lot of different people in the industry. And it's exceeded my expectations. I've learned about cardiovascular applications, about so many softwares, med device applications these days where wearables are huge. Just the IVD industry is taking off and there is so much I've learned and I couldn't be happier that I saw that. I think it was an Inside INdiana Business article about Greenlight growing.

Jon Speer: I think we had just moved or something. And I think that's an important thing because, I mean, this topic is sort of two- sided. It's for, again, the guru who might be interested or someone who might be interested in being a guru. I mean, the one question that comes to mind is, ah, I'm climbing the ladder at my company, I'm learning all these great things, and yeah, that's true. That's great. I think the opportunity at Greenlight is you get to learn so many different things. I mean, because you will be exposed to such a diverse group of companies. Again, they're all medical device, but they're doing things from IVD to wearables, to orthopedic implants, to things that you just can't even imagine are possible, but you get to have that exposure. So you get to learn a lot more diversity from a device perspective. And one of the things that we encourage a great deal, or one of the things that's important I think about anybody that comes to Greenlight that we encourage is a learner's mind. You have to be curious and inquisitive and interested in learning more about something. And so, you and I were catching up before the show, you were sharing with me some of the things that you're doing with the guru team. Everyone has some initiatives that they need to go out and learn something. Something they didn't already know. That's pretty cool.

Tom Rish: Yeah. I think one thing I've learned early in the career, every company has kind of a go- to person for a certain topic. Maybe it's the biocompatibility person or the GD& T guy or gal or whatever it is. And at Greenlight, we get exposed to a lot of different things, which is awesome. And at the same time, I want to make sure the team has their go- to thing. And so we've all really tried to make an effort on figuring out what are we passionate about? What are the areas that we like and how do we become a thought leader or a go- to person for that? And we're in early stages, but we're rolling out some of those things and I'm going to get the gurus more exposed to your audience. And we couldn't be more excited to start doing some of that.

Jon Speer: Yeah. And I think for those companies who are listening and our customers, the benefit is our team is constantly leveling up and gaining additional expertise. And we're very hands- on with our customers. I mean, if you need somebody to help guide you through the process, this milestone, that milestone, we've got people who have done it before, and they're more than happy. They're thrilled, frankly, to do that. And some of our customers, they are like, it's not our first rodeo, we've done this several times before, that's great too. You still have the gurus in your corner if and when you need them. But if you can go off to the races without them, that's cool. We built the platform on purpose to help you with that. Tom, I guess I'm curious, I mean, you've been with Greenlight approaching four years. You've done quite a few different things that have tapped into your expertise with working with the customer success team as a guru, but also being a resource to help support sales as they're working with companies who are evaluating Greenlight. You've been exposed, probably I'm guessing, I have no idea. I don't even know, maybe you know, I don't know, but I'm guessing you have been exposed to probably a couple of thousand medical device companies over those few years. What are some interesting themes or trends that you have observed during that period of time? Anything come to mind?

Tom Rish: Yeah. It is over an overwhelming amount of companies that I've been exposed to and I think the first thing that I noticed is it's very humbling and also encouraging to see how many people out there are just really passionate about their ideas. Sometimes I think that, you know what? I don't know that I have that passion that a lot of these people have that they truly want to help people and use their market to, or their product in their market to help people. And I think the one thing that's awesome about Greenlight is it allows me to help a lot of different people that have their passions and they're maybe the experts in that area and can be a level removed. So I think first off, it's easy to come to work because I see the passion of our customers and of the prospects that are really truly trying to help people, which is one of our core values. I think trends in general though, I've said this for a while and I've probably said it on podcasts before, but I think the process of medical device, setting up a quality system, getting your product to market, is much more overwhelming than it actually is. I think that people think of this huge project and that they've got so many different things, and that's all true, but I feel like there are ways to break this down and really focus on the things that you need to focus on now. And I think one of the main things I've learned from Greenlight Guru that I didn't know before is you can do a lot of work to get your product ready to launch, knowing that you can add stuff on later. For example, let's just focus on design controls and risk now. A lot of our customers come to us wanting to launch those products and we've seen huge success saying, you know what? Let's take a step back, let's focus your time, your funds, everything, on certain tasks, and let's take a more step- by- step approach or like crawl, walk, run, as people like to say. And that's one thing that has been so successful with our customers that I didn't know and I always encourage people to do that. The second thing I would say is, when I was working in the industry I remember so many good engineers left because they said, I don't like paperwork. This is too much of a burden. And I think I've really seen people shift in their mind to, hey, using a software like Greenlight Guru or having a phased approach to implementing a QMS, even if it's in a paper system, can make this feel much less tedious. If we build as we go, it's not going to feel like paperwork. It's not going to feel like non- value added and it's going to help our business efficiencies as a whole. So I'm really big on breaking things down, focusing on what you need to focus on now, build as you go, and it's not overwhelming like it is for some people.

Jon Speer: Okay. Well, let me take a quick break. Let me remind folks I'm talking with Tom Rish. Tom is a senior medical device guru and manager of our guru team at Greenlight Guru. That's a lot of gurus. But anyway, Tom's been in the industry for, gosh I always forget. Tom, how long has it been?

Tom Rish: Yeah, I mean, it's been like... I started in 2009, so it's been like 10, 11 years.

Jon Speer: And he has a lot of experience prior to Greenlight working with very large orthopedic companies, as well as smaller orthopedic companies in a lot of different capacities. He is an engineer. He is a product development nerd. He knows a great deal about quality system implementation as well. And certainly if you're curious about the Greenlight Guru medical device success platform and how the software and our guru team can be a resource to help you achieve some key milestones, whether you're pursuing your first regulatory submission or you're getting your quality system ready for an ISO audit, whatever the case may be, we're there to help you. So I would encourage you to go to www.greenlight.guru to learn more. Tom, I mean, those are some great nuggets. I think the right sizing or the build it as you go, or however you want to phrase it, crawl, walk, run. I remember when that triggered with me, I was like, oh wow, wow, that makes a lot of sense. And at the time I was a consultant and one of the services that I sold was quality system services. And I'm going to be honest here, I made a lot of money selling the full thing to a startup, and looking back, I'm like, oh man, I could have been... And I stayed with them through years, generally speaking, so we had opportunities to do that. But looking back, it's like, oh wow, we should have done it more piecemeal because they might've had more of an appetite for it if we fed them a bite at a time versus saying, eat all this, consume it, before it expires. So I think that's a good point. I think a lot of people lose sight of that. Hopefully, engineers are realizing... Because I've heard this throughout my entire career, which now spans probably three years, so that's why. But engineers are like, I hate documentation. And I don't think that's really true. I think they're just working in systems that are cumbersome, overly burdensome, just not architected to be streamlined. I think that's part of the challenge.

Tom Rish: I totally agree. I tell people every day you're thinking of this stuff, take credit for it. Everyone's heard the lamest joke in the industry that if you didn't document it, the FDA says you never did it. And I think I always tell people you can either keep this stuff somewhere in your brain and at the end of a project you can build out an Excel matrix and spend a couple of weeks on it. Or when you're designing your product and you put a certain geometric feature on there, why am I doing this? Put that in a matrix right then and it will save you so much time.

Jon Speer: Annotate it too because, I mean, I've seen this so many times where, prior career stops where we launched the product, maybe we didn't keep a good history of all the different permeations and iterations and that sort of thing. And the product's in the market, it's doing okay, but we need to make a change for whatever reason. Fitting a dimensional tolerance, whatever the case may be. And we would go to make that change, and unfortunately in a couple of cases that happened, one of the engineers who was reviewing the change is like, whoa, why are you guys doing that? Well, this isn't working. When? And there was nothing in the DHS about that. I mean, there's a balance for sure, but I think capturing some of these things, even if they're not ideas that you pursue, but having that knowledge captured in some sort of design history file or note or report or something like that, it's just going to be beneficial because your product will evolve and iterate once it goes to market and you don't want to reinvent the wheel or invent a wheel that didn't work the last time.

Tom Rish: Yeah. I think that is huge. I mean, it's a mindset shift that you're not just doing this because the FDA wants it, but you're going to build an efficient business. And I think other industries have gotten this probably. I think the medical device, the margins were so high for a long time. And I think that is coming down a little bit, it's probably going to force people. But you have to run an efficient business alongside this and you're not just doing it for regulatory purposes. You want to make sure that you make good decisions and make money as a business.

Jon Speer: For sure, for sure. You mentioned a few moments ago that you've seen sort of an increase in wearables. When I was talking, I don't remember who it was, but I was talking to somebody the day and they were asking me why I'm excited about med device. I'm like, man, things like phones and things that I wear and all these things, I mean, there's this weird convergence or merging of med device in things that I use in my everyday life. And some of it is kind of terrifying at times, but I think there's a lot of good from that. So aside from wearables, are there other trends that you're noticing as certain device types or segments? I mean, I know you're a ride or die on orthopedics, just because of your... I'm a catheter guy. A lot of people know this. But any other things that you and the gurus are observing as far as product spaces that are kind of interesting right now?

Tom Rish: Yeah, definitely. I think I am orthopedics and I'm traditional mechanical type, but I did just see some news about more surgical robots being cleared by the FDA. And I think the biggest trend, which I'm sure everyone is well aware is technology. I mean, software is in so many products. I think we do a lot of customers data and a lot of people have software in their product, customers, and I'm sure the industry is even more. And I think one thing about software that's hard is the regulations were written before there was much software out there. So there's a lot of catching up to do. I know the FDA is working on things and other regulatory bodies, or the EU MDR is up classifying a lot of software products. So that's the biggest challenge I'll say is that to stay ahead and to stay on pace with the new technology, you probably have to have software involved. And how do you do that? We talk about the industry being pretty gray in general, but it's very gray when it comes to that.

Jon Speer: Well, I mean, I'll say I'll react with a caution too, because I think there are some people who are trying to be too cute. It's like they're making an app and like compliment their product, just so that they could be more on a tech space. And I was like, it should have value. It should provide some intrinsic value to the user or to the clinician.

Tom Rish: I think that's one thing real quick I do want to add, because I do think people overlook that. You need to know your industry and I'm sure most people do good market research, but some industries probably aren't going to be as reliant on tech as other ones. You might think that it's going to help, at the same time there is education and mindset shifting that will need to occur. So it's a good point that you bring up there like, you really have to understand your market. User needs should not just be internal marketing teams coming up or even engineering, you need to talk to as many people as you can.

Jon Speer: Well, and on that point, I think a lot of people make their approach if they do talk to external users, clinicians, patients, whatever the case may be, they do. A lot of times on the front end and then they put their heads down and then they do it again on the back end. But to me, you should be checking in with that audience throughout the entire design development because things shift a little bit and you want to make sure that your interpretation still is in sync. I'm curious, knowing your orthopedics passion and experience, are we seeing any sort of smart orthopedics? I mean, it seems to me, at least philosophically that I could put, and I'm not a software developer and I'm not an electrical engineer or an orthopedic engineer, but it seems to me that you could put some sort of a chip or something in a hip stem and it would know what sort of forces are happening. Maybe a mini gyroscope or something. I don't know, is there any smart technology that is standing on orthopedics?

Tom Rish: So I will say I don't keep up as much as I used to. I think most of the smart technology today that I'm aware of at least is during the surgical procedure itself. So helping position the implants on balance. Yeah.

Jon Speer: Orthopedic surgery, you've seen it. Oh my gosh, last time I saw a hip replacement.

Tom Rish: It's like a carpenter.

Jon Speer: Yeah. So it is good they have the positioning tools because sometimes man, it's like they're guessing, it seems like. And I'm sure they're not. But for the lay person observing, it's like they're grabbing all these different caps and stems and all that sort of...

Tom Rish: Yeah. They are carpenters or they are artists. They know what they're doing. So I think some of the technology around there. I'm sure in the future, there will be more. I know there's been a lot of advancements made in the material space to try to mimic the properties of bone and cartilage and different things like that. So every industry is growing chips and sensors. I think some people may like it and some people may hate it, but that's probably where things are going.

Jon Speer: Well, I mean, I think that's interesting. At Greenlight I know we try to monitor trends. I mean, some of the things that I'm seeing, and I'm guessing you're seeing as well, is there seems to be a lot more IVD companies, maybe. And I think that logically makes sense because with the EU MDR and IVDR, the MDR's upon us, IVDR still roughly a year away, but just that change in regulation pulls in a lot more companies that maybe weren't regulated before. So I think there's some of that. I think I got to wonder too if we've seen a lot more IVD because of things like the pandemic. I know a lot of the EUAs that were submitted to FDA were IVD type of technologies. I was catching up with Allison Komiyama from AcKnowledge Regulatory Strategies the other day and she informed me that we're still early in 2021, but the IVD office at FDA is not accepting any more pre submissions for the rest of the year. So there're things like that happening too.

Tom Rish: The IVD space is fascinating because to me it's like the tests are obvious, they're IVDs. Then there's like this balance between giving more information to clinicians or patients that are kind of on the edge. And crafting your intended use and your indications is very, very important because I think every clinician wants more information to make better decisions. And then there's a fine line between what's information and what's actually diagnosing things. So you need a good regulatory consultant or strategist in that space for sure.

Jon Speer: Yeah. That's kind of interesting. I mean, software as a standalone medical device or other products incorporating software. I mean, that is a thing that I expect to continue for quite some time. Tom, anything else on your mind before we wrap up this episode of the Global Medical Device Podcast?

Tom Rish: I think pandemic to me, you hear so many stories about industries really hurting, and even just going around in your neighborhood about businesses that are struggling. And it's very reassuring to know that the medical device industry seems to be standing strong, and even taking off in some areas. I can't even tell you how many customers shifted to help with the pandemic. And it's cool to see people put something above their business and say, we're going to help out. So I'd say to everyone listening, probably part of the medical device industry, be proud that you're in this industry and know that there are a lot of good people doing good things out there.

Jon Speer: Absolutely. And from a Greenlight perspective, we've worked with, to your point, a lot of customers who've made pivots. We've built resources to help them through that. We've done a lot of work with some programs from NIH, specifically the RADx program from NIH. There're a lot of companies that are trying to develop tests and other things to help in this time of need. And I think to your point, it's been awesome to kind of see how resilient the medical device industry continues to be. There was a period towards the beginning of the pandemic where we were kind of all freaked out, probably rightfully so. None of us had ever experienced anything like this, but to see how quickly the medical device industry just got back as quick as they could have businesses as usual was encouraging. And so we love hearing those stories. So certainly if you have stories about your success navigating through the pandemic, or just in general, of your medical device company's journey, we'd love to hear about that. So reach out to us and let us know. Tom, thank you. I know you got a lot going on and you work with companies and customers from all over the world, and you've got a whole team of gurus, so I appreciate you carving out a few minutes to chat with us on the Global Medical Device Podcast.

Tom Rish: Of course, yeah. Thanks for having me. It is a fun break from the normal, and I know our team loves getting on these. So invite us back anytime. Thanks, Jon.

Jon Speer: Hey, it's work.. Anyway, folks, thank you for listening to the Global Medical Device Podcast, the number one podcast in the medical device industry. As I mentioned at the beginning, and I'll reiterate, if you're watching us, that's awesome. Thank you. Spread the word. Be sure to subscribe, click the bell notification so you're getting notified when new episodes are available. And as always, this is your host and founder at Greenlight Guru, Jon Speer. And you have been listening to the Global Medical Device Podcast.

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