Evaluating EQMS: A Crucial Step for Medtech Success

Andy Rogantino: 00:00:00

Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Etienne Nichols: 00:00:31

Hey everyone. Welcome back to the Global Medical Device Podcast.

My name is Etienne Nichols and today I want to talk about when and how the most effective companies, teams or medtech teams, are evaluating EQMS platforms. That's electronic quality management system platforms.

Most medtech companies wait until something breaks or until they're in the thick of the regulatory submission before they even start thinking about a QMS platform or, or a document management system, et cetera. But the most effective teams are the ones who are looking at EQMs as earlier in the process.

So I wanted to unpack when and how the top performing teams are even making that call. So if you're kind of in that process or line of thinking, this episode should be for you. I brought in Andy Rogantino.

Andy began his career with a mission to improve lives through science, conducting cutting edge research in preclinical pharmacology at abvies. I don't know how to pronounce. Signal therapeutics.

Andy Rogantino: 00:01:23

Signal therapeutics.

Etienne Nichols: 00:01:25

And in vicro.

After years in the lab pushing the boundaries of neuroscience and oncology, Andy pivoted toward building meaningful connections, which I've seen him do firsthand. But first by launching Linskin Golf, a social app for golf golfers.

And later by helping property managers elevate tenant experiences with resident benefit packages at Second Nature. But now he's an account executive at Greenlight Guru. And Andy's. He's back to his roots.

He's empowering medical device innovators to bring safer, more effective products to market through purpose built QMS software. And so his path may have shifted a little bit, but the mission remains the same.

Makes the world a better place by driving impact where it matters most. As Andy put it, one sim not be researching drug efficacy or routes of clearance anymore. But I still aim to make this world a better place.

One device, one. One team, one conversation at a time. So if you're interested in talking more about medtech golf, making history, send Andy a message.

We'll put links in his email and LinkedIn in the show notes. But Andy, welcome to the show. How are you doing today?

Andy Rogantino: 00:02:21

I'm doing so much better after that lovely introduction at you. And that was. That was nice. I. I gotta, I gotta send that to all my relatives. No one's ever talked that nicely about me. But no, I'm.

I am Stoked to be here and to think about a. A topic near and dear to me as I am in AE now here. But you're right, I. I did start off in this space where I was trying to, you know, impact the.

The medical industry and to like you put it, you know, groundbreaking new things. I like to think of it. This job is. I don't know if you're a Seinfeld fan, but this is two worlds colliding, Jared.

Etienne Nichols: 00:02:58

Colliding.

Andy Rogantino: 00:02:58

The worlds are colliding. This is me. So when I. When I had the chance to speak with the team at Greenlight about this, I was stoked and super excited. So I. I am.

I am grateful that you have me on the show, but I'm ready to dive into this thing. This is a great topic.

Etienne Nichols: 00:03:13

Awesome. Okay, well, yeah, let's talk about it.

So when we talk about quality management systems, particularly electronic or an eqms, when is it time to evaluate? Are we just waiting for something to break or does it make sense to plan? Sometimes it feels like a dumb question, but what are the intricacies there?

Andy Rogantino: 00:03:29

So there's like, there's, there's two trains of thought here. Okay. There are the people, there are the procrastinators, and that's okay. I was one for many years. I still might be.

And then there are the people that plan and plan and plan. I would say in my, you know, expertise now, you are more likely to be prepared for what's to happen before it happens than when it's happening.

Long way of saying, like, prepare now. If you have goals and visions, it's important to set yourself up for success as early on as you can.

When your house is already on fire, it's a little late to install some sprinklers.

Etienne Nichols: 00:04:06

Yeah, no, and that makes sense. I think common sense would dictate that. What I think most companies probably get in trouble with is there's so many priorities.

How is this the priority? Or how do I prioritize something like building out an eqms? How do you determine that priority? Any thoughts regarding that?

Andy Rogantino: 00:04:27

Yeah, I mean, you have to think about the life cycle of your device. Right. If this is something you care about and you want to do it the right way. Your quality system is the backbone of all of this.

And without that, you're not going to be able to walk and then run and then, you know, ultimately. Because what are we doing here is impacting patient lives and hopefully saving them. Right.

There's definitely a way to think of your quality system as more paramount than I think most people do. And I would caution a lot of the folks that hopefully listen to this, you should probably take this pretty seriously.

Think about every relative, friend, acquaintance that's ever had a minor surgery or gone to the dentist. Like you're gonna want something that's ran through the proper channels to get to a place where it's impacting actual lives.

Can't overstate that enough.

Etienne Nichols: 00:05:15

And I think, you know, it's interesting you're talking about. I think most people would agree with that. When I think about a medical device company, people have probably heard me say this before.

I think of three legs. I think of the regulatory or the legal side of things, which is kind of what we lump QMS in a lot of times.

But then there's that ethical side of things. Do you actually want your brother, your sister, your mom, your dad, your kid to. To use this device? So there's that ethical.

You would think regulatory and legal could handle it, but there is, and there is overlap, but it's not completely. So those are slightly different.

And then the third one, which sometimes as medical device companies, we forget about is the financial, the economic side. You have to make money. So I actually, personally, and I'm curious what your thoughts are about this.

When I'm thinking about a qms, it should be positively impacting all three of those legs of that stool. And most of the time you think, okay, I'm going to pay money for software. How is that?

That feels like it's dragging me down economically, but it should. It should have a greater roi. Can you speak to that roi? Or is that.

Andy Rogantino: 00:06:17

Yeah, yes, absolutely.

Etienne Nichols: 00:06:19

So.

Andy Rogantino: 00:06:20

So think about it. Put yourself in a CEO, a doctor in a dream's shoes. Your obviously front part of your brain is gonna say, I can't get below my bottom line.

I'm not gonna put myself in the red to do something that I might not necessarily need.

Now, the way that I've tried to shape some thinking within the conversations I have in this industry is that you shouldn't be thinking about right now and more, what are the impacts of the decisions I make now, later, roi, that's everything. Does it affect all three areas like you just said?

But the ability to have a. I would say a system that can quantify that and show that for you is very important. Can't. Can't mince words there. Like, you have to have end results pointing to something positive, obviously.

But a place where you can quantify it, I think is huge, and it's scary. You can't plan for 12, 18, 24 months from now. But a quality system can actually keep you on track so that you can.

Yeah, so that's what I'll say about that.

Etienne Nichols: 00:07:28

Yeah. And I want to add just one thing, and I don't want to belabor this point too much, but I think of two different tracks. There's two levers.

When you think of. All right, I'm going to go little lateral thinking here. When I think about happiness, for example, I think of the two levers.

You've got the dopamine, you've got the cortisol. I want to reduce my unhappiness. So maybe that's exercise, maybe that's good sleep.

That doesn't make me happy, it just reduces my unhappiness and I want to increase my happiness. Spending time with family, eating great food, things like that make me happy. Similar things going on here.

When you invest money in a qms, there is the likelihood that you're going to reduce the amount or the likelihood that you could get a 43 in the future or a audit findings that will slow you down. Reverse engineering a lot of those different things. That's the negative side. You want to reduce the negative side.

And the problem with reducing the negative side is you don't really feel it until something negative happens. If you reduce a bad event, you never can log it. You never log that. We had the bad event that we. So that's just one problem.

But it is a very real benefit. It's an upside, the other side. And I'm going to let you talk here in a minute. Don't mean to steal the mic here, but no, I love this.

Andy Rogantino: 00:08:36

Keep going.

Etienne Nichols: 00:08:37

The positive side of investing in the QMS is that streamlined efficiency. So you should be moving much faster.

You should be getting to solutions a lot faster, collaborating, breaking down silos, all of the different things that we look for in business, the qms, your approach to quality should really be weaving that, that quality into your product. And so that's kind of how I see those two different LE levers. But love it. If you have any, anything to add there or adjust what I said.

Andy Rogantino: 00:09:04

No, I mean perfectly well said.

I think at the bottom line of like this first part of our conversation is like the time to evaluate is probably when you think, is it now time to evaluate a qms? Isn't that always like that moment where you say, should I be doing this?

The answer is yes, and at least the right one for you, maybe gg, hopefully it is right. There are ways where you can measure the impact of that streamlined approach, like you said, and be thoughtful about it. And you know what?

Be a little selfish.

If you're listening out there, you really do take into account how your team works, how your, you know, your monetary vision might be two, three years from now. You have to be a little bit selfish. That is something I do like to stress during my conversations.

Etienne Nichols: 00:09:53

Two things you said there. I can't help. You know, I gotta focus on one, because two, I can't. I can't. This is gonna take too long.

But one, you said, ah, what was it you have to think about? If it's. If you've thought about, is it time? If you're asking the question, is it time? Or if someone is asking the question, should we build a qms?

You probably should. I think of it like, all right, I'm gonna. Confession time. I got a haircut the other day, and the lady asked, do you want me to trim your eyebrows?

And I looked at her, I'm like, is this kind of like when someone offers you a mint? You always accept it.

Andy Rogantino: 00:10:22

I think.

Etienne Nichols: 00:10:23

I think, go for it. If someone's offering, hey, you. It's time to evaluate the cms. At least do the evaluation. Okay.

Andy Rogantino: 00:10:29

Mm.

Etienne Nichols: 00:10:29

Forget my eyebrows. Let's move on. Well, I wanna ask a question first.

Are there any triggers that you feel like maybe we haven't questioned whether we should evaluate in EQMs. Are there any triggers or milestones that you would recommend? This is a time to be thinking about this.

Andy Rogantino: 00:10:45

Yeah. And a couple of those are dependent upon, like, how quickly, you know, your device came together. I. E. I immediately think of, like, a design freeze.

If you have a planned freeze, like, at any time, and you're gonna evaluate, like, what's happening at a specific moment along your device's journey, let's say. Absolutely. If any consultant you have hired has said those words, think I probably have to stand up my foundation of quality.

The second thing also is if your data comes back from some preliminary, you know, maybe whether that's an in vivo model or an ex vivo model, like, wherever that is, and you have actionable data that comes back that. That may even surprise you. It looks so good. And you now have to think about what's my next data step is a clinical trial. Oh, my goodness.

Call your local QMS ae. Right. There are. There are triggers, obviously.

If someone says, we'd like to, you know, submit for my 510k submission for Pathway, or a de novo or a PMA, you know, all the acronyms those buzzwords should trigger. Would I pass an audit for from any of those areas right now.

Etienne Nichols: 00:11:53

Yeah. Yeah. Okay. So let's say we're in the evaluation phase. Who should really be involved in that evaluation?

Andy Rogantino: 00:12:00

You know what? Most people. Oh, you know what? At the end, what would most people say? Who needs to be involved in the process? Actually, I'll turn it back on you.

Etienne Nichols: 00:12:08

I think. Well, most people. That's a tough question. I think most people say, well, it's the quality person's job. Let's let the quality person handle it.

Andy Rogantino: 00:12:18

Yeah. They would say that's a job for the quality people that live on Quality Island. And we never have to. We don't visit Quality Island.

There's only one ferry. Like, you can't go back and forth in my, you know, not necessarily professional, but we'll call it that opinion.

This is both a product engineering quality leadership problem.

Etienne Nichols: 00:12:42

Yeah, I think I, I will emphasize the leadership section.

And if you are leadership out there listening, whether you're in the C suite or just management director level, whatever, there's a book I recommend if you have not read it, I think every medical device leader needs to read. Cardiac Arrest.

Five Years as a CEO on the Fed's Hit List by Howard Root tells the story of how his salespeople sold off label, quote unquote, which turned into five years of litigation. A hundred, you know, I think it was a hundred million. I don't know how many million dollars, but a hundred lawyers at least.

And he was acquitted on all fronts. But it's. It's an educational piece on the things that could happen if you don't do things appropriately. And now Howard did do things appropriately.

He was just accused and it just. Even if it looks inappropriate, that's what he went through because it looked inappropriate. So I totally agree.

I don't think it should be Quality Island. I think it should be all of the different people involved. And I'll add one thing about that.

One of the things that I personally love about Greenlight Guru, because I come from product development background, not a quality background. I come from a quality.

I was a project manager, I got my pmp, worked at a drug delivery combination product company and managed the design controls, risk management.

And the thing that I was impressed by Greenlight Guru is the amount of traceability for the design controls piece, the traceability matrix and the interconnectivity and the ability to link all of those different test protocols, test reports, to always have the right version, always have everything up to date, always have a DHF compiled where in real.

And I'D say real world, like, like the Excel world that I came from, that was a full time job and people just die inside when they, when that lands on their desk and they have to review a several thousand line Excel document. But anyway, yeah, I don't mean to go too far down that path but so that's a. Yeah, that's a real.

Andy Rogantino: 00:14:41

Concern especially for companies that have begun to design their device within an Excel sheet. Linking any sort of like input or output to any other area of the business, your risk, you know, whatever.

There are national championships for Excel speedrunning and like those are the people that, that can read those.

Etienne Nichols: 00:15:01

Yes. And so yeah, include the product development people.

And I would actually go so far as to say if you have any sort of project manager on your team, those are the people who could really champion a product like this. So if, if quality professionals are able to partner with project managers, those people can really make things happen. So just a thought.

Andy Rogantino: 00:15:21

Yeah, agreed. And you know, we're not. Greenlight isn't a project management software. But you know what it does?

It does allow you to work on things in phases and it allows you to have accountability throughout an org where. When everybody is rowing the same boat. God, I'm just full of analogies today.

When everybody' row in the same boat like your device becomes stronger because of it. When quality is siloed from R and D and leadership and even PMs, that's where findings will come from.

Auditors will sprint to areas where they see gaps in this.

Etienne Nichols: 00:16:02

Yeah. What about it?

I've always, that's been one of the things that I've always seen in the past life and other tools that we are purchasing slows down quite a bit. Any thoughts on that?

Andy Rogantino: 00:16:15

You know, I'll say this. I've. I've worked in this, in the software world for, for a little while now. It would be who of you to include your IT or procurement professionals.

While I'd love to say that anybody can just go buy a software and just use it, whatever you want. Right. Not necessarily the case. It's important to have those internal people behind the scenes that are going to make this thing run smoothly for you.

You forget that a whole company's infrastructure actually lies in the hands of the IT department. Right?

Etienne Nichols: 00:16:45

Yeah, yeah.

Andy Rogantino: 00:16:47

It's important that they have their own concerns around security or around, you know, an area that we've addressed more recently at least. Myself in some of these partner conversations is like are you guys compliant? Where's your security coming from?

Like those are questions That I can almost guarantee the engineers don't care about. And the QA person might think about it, but then they'll just say it's probably fine if they're selling it. Right?

Etienne Nichols: 00:17:12

Yeah, yeah, I, I'll, I'll emphasize the engineers don't care. They'll find workarounds if they don't like what they have. So. Yeah, that's right. It's a whole different story. But I, I totally agree.

Well, if we talk about. All right, when's time to evaluate who should be evaluating? Maybe we should actually talk about what you're evaluating. What.

What are some of the things that they really need to be thinking about?

Andy Rogantino: 00:17:33

There are different schools of, of thought out there, as you know. Right. About what is the most important thing when standing up a. Or, you know, when really leaning into a quality footprint.

When you're starting this and we're coming from the perspective of the young startup, is it important to be able to do whatever I want, or is it important to be able to do whatever I want within the constraints of the thing, the goal I'm trying to accomplish, whether that be, again, submission, some clinical data, things like that. People can get lost. And I think this is where you're leading me.

People can get lost thinking they need to make everything the way they want it to look or feel or, you know, or the data that you pull from a place. That's not always the case. And I think that's where we're going here.

Etienne Nichols: 00:18:23

Yeah. Well, so in my past, I've used. I shouldn't use names, I guess it was a very large enterprise quality management system software that was actually.

It's very robust. You could use that all across any industry is huge.

Took us forever to get to where we could use it because we were trying to mirror our process exactly, which required a lot of validation, a lot of time. Yeah, I think about the toothpaste aisle. Oh, yeah, I told you. I can't think if I don't think laterally.

But if when you walk down the toothpaste aisle, I look at it, I'm like, you know, where's the sort and filter button? And that I have on Amazon where I say, okay, filter everything out. That could potentially cause me cancer in the state of California or whatever.

So now we got three brands left and okay, I'll pick from these three brands. That would be so much easier.

dical device eqms vs just ISO: 9001

Andy Rogantino: 00:19:24

And that's the difference. I think there's some.

I don't know, I don't know if it's misconception or just like the natural thought when coming to this is like, okay, I understand you're going to give me a place to house my documents and that's all well and good, but my device is so different than everything, anything you've ever dealt with. Right. I feel like you always get that feedback where you don't want to knock somebody down.

You're, you're, you're making a novel medical device here that's going to impact some lives, obviously, but you're not alone. And actually I'd like to provide you with some stories of how these built in guardrails may be helping you instead of hurting you.

I think that the first thought with people, and I don't know why, is that they need to, they need to be the ones making the decision on how this looks and feels and tastes. Right?

Etienne Nichols: 00:20:11

Yeah. So, yeah. And so what to evaluate, if we go back to that question, what should we be evaluating?

The real answer in my mind, because I think you kind of said it, I'm gonna flip that negative and make it a positive because I think it is a positive or medical device companies could see it as a positive. We want to be unique, we want to be innovative. And that's true. You, you really are.

But on the flip side of that, here's the positive to the fact that the regulatory process is pretty much okay. Your Class 3, you go PMA pretty much. So Class 2, you're either 5, 10K de novo.

The path is well worn and you shouldn't be worried about that regulatory path.

ent? Not necessarily. FMEA ISO: 4971

What's going to be expected from the consensus standards? Will it, will it handle the document control per the requirements of 21 CFR part 820.40 document control.

, ISO: 1345

You know, whatever else you may have, those are the very least, those are the things that I'm going to be comparing this software to. And so when I'm evaluating, that's what I'm thinking about.

Andy Rogantino: 00:21:41

Yeah. And the last thing I'll say about the evaluation is there's also a hidden layer behind this.

You want to be able to obviously have your doc controls in one place, manage a RISC file that's constantly changing as well as linking together like a fully traceable design file. Right.

hose, the, the intricacies of: 134852

I can, I could build it out of Legos.

But if it doesn't have those five, you know, we'll call them, you know, totems of your, just of your design process, then you're not, you're not getting to market.

Etienne Nichols: 00:22:54

Yeah, yeah, it's true. So the must haves are obviously what you have to think about the most. And nice to haves obviously have your list of those things.

And I think that nice to haves.

I'm gonna, I'm gonna stop and move away from the regulation for a moment and I would talk to the quality manager who's going to be working in it day in, day out.

Andy Rogantino: 00:23:13

Oh yeah.

Etienne Nichols: 00:23:15

What, what, what they're up against with the possibility of purchasing a software is what if it fails? What if it doesn't get adopted? So that's one of the issues that, that I think that they have to think about when they're. You don't.

I mean, that's a big risk. The other thing that they need to think about is how does this impact my day to day? How does this impact my weekends and my ability to sleep?

I actually think about that a lot. Okay, if I, if I purchase the software, can I sleep better at night? I can if I know okay, we got an inspection coming up.

But I, I've already done the work. I don't have to worry about anything because everything's already been done. I have to get ready because I've, I've, I'm always ready.

That's a, that's a difference. So you've got to think about both of those different things.

The other thing I'll mention, I'm building a house right now and I went to the, the electrical store and I said, do you have any rocker arm? Those are the, the switches that are the, the rocker arm switches.

Andy Rogantino: 00:24:08

I'm pretend like I know what you're talking about.

Etienne Nichols: 00:24:11

It's versus the little finger, you know, you flip it up and down. They're just, they're just a little bit more fancy where you just push it like that. I just feel like they feel better.

So you pay 99 cents for the old style or 2.99, like $2 more for this other one. And I'm thinking, why would I not get rocker arm styles?

To me, we spend so much money on the different houses, but we don't worry about the interface. The part that I'm going to touch. I care about the parts that I touch, that I interact with. I care about how it feels when I work in this thing.

So I don't know, I, maybe I'm prejudiced or biased here and thinking about this, but I, I want whatever I'm using to feel good when I'm in it too. But just a thought, right?

Andy Rogantino: 00:24:48

I think that's a really, it's a really important piece of your evaluation of a, of a foundation of quality system. How does it feel for me to be in here? Am I able to find something?

Obviously, you know, you see a demo and you click around a little bit and it's not the most in depth part of like the process, but once you've purchased this, you have to envision yourself in there. There's, you know, I'm a, I'm a big video game player.

Probably not a surprise to a lot of people when Hulu hired the director of UI UX from Activision who makes, you know, Call of Duty and several other titles. For years, us in the video game community have been complaining about how bad the Call of Duty UI UX really was.

Like, it's just not, it's just not great. I don't know, find where am I playing? Where are my buddies?

And as someone who uses Hulu for live tv, it's the same thing impacting the end user me by a Decision that could be, AKA management makes to purchase a new software. Did you consider how it looks and feels and operates to the people using it every day?

Etienne Nichols: 00:26:01

Yeah.

Andy Rogantino: 00:26:02

Now that was probably a long winded example to say, like, it's really important that you like how it works, literally, not the functions and features. It's really great. Everybody can talk about functions and features. And this is so cool. It does this thing you might use one time in two years.

No, no, no. Like, you have to boil it down to like, can I find a TV show easily enough that I want to watch?

Can you find a document within your quality system via one word or a sentence? Things like that I think are overlooked.

Etienne Nichols: 00:26:32

Yeah, we'll have to see whether or not the CEO of Hulu or Activision watch. Yes, we'll wait for their comments, see what they have to say. But okay.

Andy Rogantino: 00:26:40

Big listeners of the pod.

Etienne Nichols: 00:26:41

Yeah, yeah, the big, big, big listeners. So, all right, you mentioned a demo. Are we. How does this work?

What kind of walk us through the actual sales process so that we can get a feel for what that's even like.

Andy Rogantino: 00:26:53

Yeah, and this, this is probably, maybe not unanimous, but like most of the time the process is I got to figure out what you need and find out where your pain lies, even if there isn't any. Like, I need to, I need to see what's this compelling event that has brought you to me.

But secondly, when you're doing these demonstrations of a software, is there anything worse at him when you just like tune out for an.

And these people just lecture you and it's not really relevant to you and there's, oh, they're talking about software and I don't have any software in my device.

Like, I think it's important that during a demonstration of these things, like I said, be a little selfish that this is about you and like your situation. Something that I always try to think about. This isn't demo for me. I've seen the demo. This is about them.

Etienne Nichols: 00:27:44

That's a really good point. You know, being selfish, it, it helps everybody if you actually ask those questions and make it a conversation throughout the whole thing.

And I've had, it's, you know, I get pulled into doing demos every now and then and, and it's fun for me because I get to talk shop with the people on the other side of the, the screen and.

But I definitely want to hear, okay, if you don't know anything about design controls, in fact, maybe you're a Class 1 device and you're planning a QMS and you don't plan to pursue design controls. Let's skip that. Let's do. Even though it's my favorite part of the software personally, but I'm willing to skip it if we gotta. So it's true. Yeah.

Andy Rogantino: 00:28:20

And having that storyline is important in any conversations that lead up to it. If I'm, you know, Mr. QA from ABC Medical, like, I want, hey, I want to see the platform demo. Here are the things that I care about.

So, again, like, for whoever ends up listening to this, the five people in my nana, like, just come into it with, like, show me what I need to see and make it about me. And you're going to get me so much more engaged and. And my questions become so much more thoughtful that way.

Etienne Nichols: 00:28:49

Yeah. Do I have any clear success criteria when it comes to partnering? And I've always.

Sometimes that word is kind of funny when we talk about, okay, you're just selling software. Is it partner? Well, it actually can be a partnership, depending on how it works.

But what are, what are some clear success criteria that changes from a transaction to a partnership?

Andy Rogantino: 00:29:09

Yes. So, I mean, the first one obviously is ROI on money spent.

of: 2026

When I was actually in a sister company like Moderna, I worked for the sister company of them. But the. Thankfully, not for them. I would have. Covid. Would have been hilarious.

But the, the plans for the future and being able to say, all right, I know in 18 months, we're going to be growing by 33% and can you handle that? And my success criteria for me is going to be all of my users have seats and everybody has their defined roles in 18 months.

Etienne Nichols: 00:30:00

Yeah.

Andy Rogantino: 00:30:00

Another thing, obviously, as I'm sure where we were going to go with this is like, audit readiness. Hey, I have a deadline. You know, it's July 4th. Like, I have a July 5th deadline for an audit that's gonna be.

If I feel ready by that day, we'll call that a success. And again, get a little more personal.

If you're the one evaluating these things on what matters, don't just say, yeah, if it works and it stores my documents, that's great. That's not a success criteria. That's like, you know, that's a baseline expectation.

Etienne Nichols: 00:30:30

Yeah, absolutely. So I'm, I'm thinking about the different teams And I would think you need to come with different lenses. Well, I don't know.

Ideally you would come with multiple people, but if it's a smaller group that comes those different lenses, what does product development care about? That would include project management with that group. What does quality care about? What does regulatory care about?

I actually kind of differentiate those two, quality and regulatory.

So once your defense one's, your offense, the quality, they, the, the FDA comes in knocking on the door, you defend the processes, whereas the regulatory people, they take run the ball down to the other global organizations, whatever management, management review, responsibility, et cetera. What do they care about? All of the different things.

Everybody has a slightly different perspective on it, what the, what the expectation or, or what their definition of success really is. So I think that's important to think about as well.

Andy Rogantino: 00:31:20

I agree. It, it comes down to like, can collaboration happen on a company wide level or does this feel siloed? And I think it's, I think you said, well said.

I got nothing to add there.

Etienne Nichols: 00:31:32

What, what about the negatives? I talked earlier, I got a little bit too philosophical, I guess, with my happiness project. But what to avoid?

You know, you got the things that we're looking for, the success criteria, but what's, what do we want to be avoiding in this process?

Andy Rogantino: 00:31:45

I think in the process you've got your evaluation and you're assembling the, the goods and the bads of everything. It's really easy to get drown. And what's the good word for it? Cool things you may not use.

I think extraneous modules or processes that don't necessarily apply to you might sound really cool. That's definitely something to avoid. Don't get lost in like, well, what could be. You forget this is to stand up your foundation of quality.

At the very least, we're doing that right.

I would also say, you know, avoid a place where, hey, I'm going with this because I like the guy and I think their company's great and it's someone I want to invest in. Again, get a little selfish. This is about you, not about the partner you're going with, but it all depends on funding.

So I guess that's a larger conversation.

Etienne Nichols: 00:32:41

But that would be difficult too, because if you're only buying it because you like the guy, I mean, that would be difficult. But we could probably find someone you don't like to determine whether or not you really want it.

Andy Rogantino: 00:32:50

Exactly. Well, I mean, what do you think at Siena, when you, when someone approaches you for podcast equipment, like, what are the things you avoid.

What are those buzz phrases that you're like, oh, I'm all set.

Etienne Nichols: 00:33:00

Yeah, yeah, the. Well, anytime. It's just buzz words or, or just business speak, you know, I think, I mean, I'll just.

When it comes to podcasting equipment, I use a certain piece of software that is very stripped down and I actually like that it's simple, it's easy to use and I don't have to worry about it. I mean, you talk about those extraneous details. I do like a lot of the different options. I will explore a piece of software to the nth degree.

I will click every single button. Just. I don't know, it's just the way it's hardwired into me.

But I do think that's a really good piece of advice is think about how, what is this going to really accomplish for me and don't get caught up on this specific detail or the specific feature like, oh, that's cool because it does that, but you actually can ever use it. Yeah, yeah.

Andy Rogantino: 00:33:47

Some of the best software as a solution platforms are often the ones that have the simplest use case is I'm, I'm, I am accomplishing the task that you're seeking out to do for you in a streamlined, efficient way. And here's how we're going to do it and we're going to guide you through it and we're here when you need us.

Like it doesn't need to get more complicated than that.

Etienne Nichols: 00:34:09

Yeah. I think it's important to remember the support that you're going to have fast. Support. I, I didn't used to care about this.

Cause I'll figure it out myself. It's always a DIY guy.

Andy Rogantino: 00:34:20

Yeah. Oh yeah.

Etienne Nichols: 00:34:21

I've learned that some things are beyond me. So I want customer support and I want it now, when I want it.

Andy Rogantino: 00:34:27

That's right. I would also say the last part of this on like what to avoid when you're doing this would be avoid the really quick process.

I think this, this should take some time.

I personally, you know, in my day to day as a, as an AE here at gg, I get a little worried when folks are like, you know, show me how much this costs and what I'm getting from it and, and, and when can I be ready? And those are great questions for the last conversation we have right before some sort of formal agreement. I think try to avoid doing this too fast.

Take your time like this, this stuff matters. Think about the person on the other end like that. That's what I try to Think about.

Etienne Nichols: 00:35:13

That's. That's a good point because I mean, you think about it from a holistic view or a life cycle product view.

It takes a little bit of time to get into something. No matter what you do. Paper, generic process, generic software, just specific software, whatever.

It's going to take a minute to get in and it's going to be somewhat difficult to get out no matter what you're talking about. Not, not even that. It's. I actually think, you know what we get married to, whatever we get married to and you just.

The cost of changing is pretty high.

Andy Rogantino: 00:35:45

Well, there's a worse cost which is doing nothing.

Etienne Nichols: 00:35:49

Yeah, yeah.

Andy Rogantino: 00:35:51

Like I think.

And again, I mean I could tell a quick story like I used to be in the labs in the, you know, in 12 foot by 12 foot concrete room with my podcasts and I would do my work and head home. And I loved the way I did it and that was comfortable. And when a solution would come in to. At the time it was, you know, it was formless.

It wasn't necessarily the same thing, but the same, the same software solutions do exist where they're coming into streamline a pipeline of drug and what you're doing and they oftentimes people get caught up on like here's where you're going to be and not like here's where you're gonna stay actually if you don't do anything.

Etienne Nichols: 00:36:36

Yeah.

Andy Rogantino: 00:36:37

When teams don't do anything and I'm sure you have more experience with this than I do, like you're only increasing risk as you don't deploy a tool to help you get to what your end goal is.

Etienne Nichols: 00:36:53

Yeah. I can't help but think of compound interest when you talk about that. Yeah, yeah. I, I talk to young people.

I feel like I'm getting old when I say that. I can't help it, you know, now that I'm, I don't. I'm not gonna admit how old I am, but I would remember standing in the.

At A P. I was supposed to pick up a bunch of pizzas. We were having a get well, we were having a tornado party. Really. We were in someone's basement.

They're like, you know, we're all just hanging out here. Etienne, why don't you brave the storm and go get us all pizza? I'm like, all right, well whatever. The guy from Oklahoma, he's. He can handle it.

So I get out there and I'm standing there in line. Everybody had this idea, I guess. And so this, this girl standing there and I'M like, I just, I can't help it. I'm like, hey, do you have 401k?

Do you have a HSA? Do you know what that is? An IRA? Roth versus conventional. You know, use all the tax shelters. Compound interest.

You're young, you could be so rich by 40. And they just laugh at me like, whatever, I'll worry about when I'm 40. But that's the problem. Do nothing.

And in 10 years, when the FDA or, or whoever comes to inspect you and says you have to rework, you have to do a recall because you didn't get all of your, your.

The risk management is, is completely out of whack or all different reasons for 43 is CAPA, customer feedback and, and design controls, risk management. All those top three reasons. You didn't do those in the beginning, that compound interest, it can be positive or it can be negative.

So if you do nothing and you can get that compound interest. So someday you're going to be cleaning up for weeks. And, and when I say weeks, their weeks compressed into one week at a time.

Andy Rogantino: 00:38:24

One week.

Etienne Nichols: 00:38:24

I remember, I remember an FDA guided inspection where we were there from. Now I was actually there for 24 hours in a row one day. And they wanted us to be back. They're like, no, you still have to.

We're doing this again tomorrow. I'm like, how? Yeah. Anyway, it's just, it can be insane. And so think about the compound interest, both negative and positive.

Andy Rogantino: 00:38:43

So, yeah, and to like relate it to where most, you know, founding members of a medical device team are coming from. Like, I, I mean, I was. That. It's an Excel sheet, it's a Dropbox, it's a Google Drive.

And whenever I talk about that, I'm getting very Italian with the hands. Whenever I talk about that with folks, I always remind them this is something that you do need to do eventually. And I'm.

I don't blame you at all for starting it in Google. That's just like the logical thing, right? Yeah. You're gonna do that. And it's a good system for one person where they know where everything is.

Etienne Nichols: 00:39:20

Yes, exactly.

Andy Rogantino: 00:39:21

And the second that there's any sort of version control or when I have to email you to ask where something is, that might be your green light, pun intended, to search out a quality system. And again, you can do it. Wouldn't recommend it. It gets really hard.

Etienne Nichols: 00:39:42

So anything we missed or anything else we need to talk about, do you think or. I know you. You deal a lot with clinical. So there's there's lots of different options.

You know, I, I mentioned because I think it's important that people know with Greenlight Guru the different types of software.

Most people think of us, if they know about our software, they think of the quality management system, whether that's capa, document management, et cetera.

ility matrix tied to your ISO: 14971

Any thoughts you want to mention about what people should know about?

Andy Rogantino: 00:40:23

Yeah, I think the last piece of context is I did work up here in Boston at Beth Israel for, for a couple years in clinical trials. So that was very near and dear to my heart when I learned that Greenlight also had a clinical indication, an ED for that.

I think it's also important to remember that the best companies are always looking for feedback and using feedback to make their thing better.

How's the way to, what's the way that you're going to do that is collect actionable data from, you know this from a clinical research setting that is a part of like the offering of gg. Can't understate enough how important the real life data is. You can plan something to death and you don't know what, how something will react.

It's, it's playing, it's playing any sport.

You can game plan all you want, but when you take the field and there's 11 other guys out there that are trying to take your head off, you're never gonna know. You know, you can't adjust on the fly if you don't do these things.

It's important to note for companies that are moving into some sort of clinical trial, setting up a study is the hardest part.

Just establishing, you know, selection criteria, how we're going to report on patient outcomes, where do, where do our non conformances and customer feedback, where does that go? Are we going to set exclusion and inclusion criteria really early on? What's our trial schedule?

All of those things I just said, that was a lot, that was a whole clinical trial in one sentence. All of those things have to be planned.

And the hardest part is getting that off the ground because anybody can say, hey Etienne, you know, here's a new piece of gum. It's, it's kind of minty. Try it out, man. Sounds good. Let me know how you like it. It's another thing to over a month if you keep chewing the gum.

How did you feel? Did it make. Did it. Was your breath any better? Things like that. But planning for that process is the hard part.

Etienne Nichols: 00:42:19

Yeah, that's really good.

All right, well, we'll put links in the show notes so that people can find both the software from quality management, design, controls, clinical evaluation perspective, all of those different things. If you're interested, feel free to reach out either to Andy or myself. We could talk more about that.

I'll put the Andy's information as well, like I mentioned, maybe his email, maybe his LinkedIn. However you want to get spammed.

Andy Rogantino: 00:42:44

Snapchat.

Etienne Nichols: 00:42:44

Yeah, yeah. Reach out to Andy and, and tell them what you thought of this episode. If it's, if it's negative, if it's positive, reach out to me. Or vice versa.

Thanks, Andy, for coming on the show. Really appreciate it. Always enjoy getting to talk to you. Can't wait till we are passed across again in live in the real world out there. One of these.

Andy Rogantino: 00:43:01

That's right. Oh, thank you so much, man. I. I love doing this. So, yeah, if anybody has any comments, concerns stick, sick of our jokes, let us know.

Etienne Nichols: 00:43:10

Yeah, give us some feedback. We want to hear it. All right, everybody, we'll see you next time. Till then, take care. Thanks for tuning in to the Global Medical Device Podcast.

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