In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS).
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Some of the highlights of this episode include:
- 3rd- party study by Hobson & CO that reveals significant reductions in setup time, full-time employee requirements, time spent on development and documentation, training time, and audit preparation time.
- The recent ROI Calculator developed by Greenlight Guru to help customers customize the study's findings to their specific inputs and demonstrate the value of the software for their business.
- The current economic climate, with budget cuts and limited investments, and the importance of efficiency and cost savings provided by a quality management system.
- Prioritizing success metrics, measuring outcomes, and holding ourselves accountable lead to better decision-making and improved effectiveness in the long run.
- Success criteria for customers implementing a quality management system include time to implement (time to value) and achieving specific outcomes.
- How Greenlight Guru aims to balance efficient setup and time to value for customers, focusing on milestones like entering documents and processing changes.
- The way different customer profiles require different approaches, such as providing guidance and templates for early-stage companies or assisting with migration for existing quality systems.
- The different functions Greenlight Guru offers, such as services like Guru Assist and GG Academy to support customers in their implementation and learning process.
Links:
- Medical Device International Consortium
- Case for Quality Working Groups
- FDA CSA Draft Guidance
- Etienne Nichols LinkedIn
- GG Academy
- Omnibus Bill
Links:
Memorable quotes from Wade Schroeder:
"I think ultimately this whole study was really illuminating because it was able to give executive teams, buying teams the numbers that they needed to make a smart decision." ~Fran Cruz
Transcript
Etienne Nichols
00:00:25.840 - 00:01:10.230
Hey, everybody. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host of today's episode.
And today I get to speak with Fran Cruz, chief customer officer from Greenlight Guru.
Fran Cruz
00:01:10.630 - 00:01:11.270
That's right.
Etienne Nichols
00:01:12.150 - 00:01:32.410
For a second there, I wavered. I'm like, oh, what is our actual title? I'm so excited to be with you today. I know customers are your passion.
You've worked in on both sides of the fence, as you know, working with vendors to help them implement solutions, but also help them find solutions. And I'm curious, why don't you go give us a little bit more detail of your background, if that's all right?
Fran Cruz
00:01:32.410 - 00:04:47.370
Yeah, yeah. I mean, well, I really, I. After I graduated from college, I was a teacher for four years. I taught languages. But when I pivoted into technology, I.
My first role was as an SDR, which is a sales development representative. And for those who are not as familiar with that role, it's basically somebody who takes folks who are either coming to your website and showing some.
Interested in. In interest in you. You’re offering and qualifying them, saying, hey, you know, what are the challenges? What brought you here is something that.
Is that something that we can help with? Right? Is that something that our technology or offering is going to help mitigate or resolve? And then that person, if.
If it's qualified, the SDR, hands it off to a salesperson and the salesperson can take them through a deeper sales motion.
And so, you know, the reason that that's kind of relevant in this case is because I spent a lot of time thinking about what are people's challenges, you know, what are they trying to accomplish? Are we a good fit?
And that is the first step in the customer journey, right, is deciding if this is going to be the right fit and if it's going to solve some of the pains that they're experiencing. And over time, I started managing an SDR team.
And then I got into sales and so I was leading that sort of second half of the process, which was, okay, we think you could be a good fit.
Let's take a look at the technology, let's talk to some other people in your organization and make sure that there's consensus around purchasing this offering, the software or service. And finally, you know, is the ROI there to prove that this investment is going to be the right thing for the business.
And so that means often working with the executives within these companies, often the CFO or a VP level or above, who is ultimately saying, okay, you know, we did all of the upfront research to determine if this is going to solve our need. How is this ultimately going to be measured in terms of success right after we buy this?
What are the things, the milestones we're going to hit or the return on investment we're going to get? That's going to be, that's going to make sure that this was the right thing to do. And so that's what a lot of people are concerned with.
And so, once I started working with customers, right, I think a lot of folks think that, you know, the customer journey is a lot about, you know, training and onboarding or support, and that is a part of it.
But really the role of customer success, especially within the SaaS space, which we're in, is about making sure that your customers achieve their desired outcomes. Right? That means that they're hitting their milestones, but also that they are seeing that return on investment.
And so, we constantly have to evaluate how are we doing on that front. Does this team understand what we've been able to accomplish versus what some of our blockers are so that we can overcome them together as partners.
Partners. And so, you know, I got into customer success because I was really attracted to that sort of symbiotic relationship, that value proposition.
I liked working with people after the sale to make sure they were getting what they paid for and that they were really seeing that the outcome of this decision was the right one for their businesses.
Etienne Nichols
00:04:48.090 - 00:05:21.760
That's, that's great.
And there's lots of different places I'd like to go with that, but the one I want to maybe hone in on for just a moment is you mentioned qualifying those customers early on. And there's multiple reasons for that, that, that needs to happen from a customer perspective.
Of course they want to, you as a customer, want to make sure this product fits. But a lot of times we look at a company selling to us, we think, oh, they just want to make a buck.
You know, they don't really care, but we do from, from a certain perspective. And I'm curious if you can maybe explain why we should care whether or not they're the right fit.
Fran Cruz
00:05:22.880 - 00:07:21.120
That's a great point. And you know, sales have changed a lot, is we've, we've migrated revenue models.
I love customer success because it was born from the recurring revenue model that SAS brings to the table. And you know, for those people who aren't as familiar with SaaS or the Revenue model we're in, to simplify it, it's a little bit like Netflix, right?
These are subscriptions people are buying. And Netflix is only as good as the customers it can preserve and grow over time.
And so, there's this really beautiful symbiotic relationship between the way SaaS operates and what makes SaaS business grow and gain and retain value and how its customers are perceiving the value of the software. And so, you know, long way of saying if the customer is happy, we're happy. The customer seeing value, we're seeing value.
And so, we're kind of on this journey together.
And customer success is the department that was built to ensure that that journey is going well and that we're unblocking those customers and making sure that we're pivoting as we identify areas where these customers are, maybe see new challenges and we can accommodate with product enhancements or things of that nature. So, you know, to your question, which is why does it matter?
You know, we could sell to customers who aren't a good fit for our business, but if ultimately, they don't renew and they can't grow with us, then it's actually worse from a revenue standpoint. So just the dollars and cents of it are not great. Obviously, you know, we are here to improve the quality of life.
Our goal as a business is to make sure that our customers are able to get life changing products in the hands of patients and clinicians around the world. If they're not going to be successful in doing that, we're not going to be successful in our overarching mission.
So, both from sort of a moral and integrity standpoint why we're here, and also from a pure revenue model standpoint, it doesn't make sense for us to do.
Etienne Nichols
00:07:21.680 - 00:08:27.330
Yeah, and just knowing the people, I could attest to the moral and the integrity, the goal of improving the quality of life. But a lot of times people on the outside like, okay, yeah, I don't know if I believe that until I see some money, but it makes sense on all fronts.
And I think that's really interesting to highlight that.
You also mentioned speaking to executives and that that's one thing that I think is always interesting because when you get into different levels, you start having to talk a different language.
And so that's one of the things I think would be interesting because just I should go ahead and reiterate what we're talking about to our, our customer or to our listeners, which is a return on investment to a piece of, piece of software like this for your company. But I've heard flipping the pyramid. I don't know if you've heard this example, but like people, a lot of engineers, they like to talk from a pyramid.
They talk about all the details and then they go a little bit more and then they tell you what they're actually trying to tell you, when in reality you should flip that pyramid, get to the point and then provide more detail. But I wonder what your tips are around speaking to executives, especially on this ROI type conversation.
Fran Cruz
00:08:27.900 - 00:12:14.960
That is a great point, and I really sympathize because I think a lot of the folks who come to Greenlight Guru who are looking for a solution, they're, they're either quality managers, quality engineers, sometimes product development managers. And so, they're coming to the table with maybe different access to budget. Let's take the quality manager as an example.
Here is in some cases they've been given this task of you're gonna do quality, right? That that's going to be your thing. And there might not be a great culture of quality within the business as it stands.
There might be, but there might not be, or there might simply be a lot of lack of education around it. And so, this person has been hired to just make sure that the quality stuff gets done. And that's a really tall order for those folks.
And they might not be given the big budgets that some of the other teams are or, you know, the company might be small, and cost constrained. It really just depends on the size, scale and life cycle of the company that's coming, that's coming to us.
But regardless, they may be coming to the table with what they consider soft metrics for the executive team. So, there are some investments that are really, really easy to quantify.
And you can just say, hey, executive, you know, if we put $2 in, we'll get $4 out. And those are the investments that often tend to get the most attention.
So, when you talk about the pyramid executives want, in simple terms, if you are going to spend X amount of money on this investment, what are we going to get in return? It doesn't always have to be a pure dollar figure, but things that these executives can easily correlate with value.
So, for example, in the case of our quality managers, one of the best things they can do for the business and one of the things that the executives are trying to drive the most is efficiencies and getting to market faster. So, efficiencies might be in the form of something like, okay, we have X number of people on our team. They can only do so much, right?
They can only do so much. They only have so many hours in the day, and most of them are working overtime anyway, let's be honest.
And so, if they can only accomplish so much, if we can give them some tools to either automate some of their time or remove some of that from their plates, can we move faster?
And if the answer is yes, then great, we can get this product to market faster, start getting revenue from this product faster, and that is ultimately what drives the business. So, an executive is going to be curious about how can you move faster? In many cases, they might be concerned with how can you move more safely?
Can you ensure that when we get to the FDA or whatever regulatory body, that they're not going to send this back to us, right? That, that we're not going to have to go and rework something or God forbid, you know, once this is on the market, that it gets recalled.
Those are all expensive things to occur. And so, you know, I think contextualizing those events in the form of both time and money can really help an executive prioritize.
And it's not because, again, they're Scrooge McDuck sitting in a vault counting their coins. Right? It's because they, as the executives, are responsible for funding the business.
And so, you need cash to do, and many people are either, you know, getting that cash from investment sources or, or just that product line needs to monetize itself to be valuable to the business. And so, they have to care about those things.
And so, you know, sometimes, unfortunately, software buyers and software, the executives in those companies are speaking slightly different languages.
And if they can just put those languages all into the same sort of vocabulary, then I think everybody will be gunning in the same direction a little more effectively.
Etienne Nichols
00:12:15.600 - 00:12:55.160
Yeah, I, I love that.
And I can think of even just one example, just anecdotally from a quality manager who was telling us about how long it took previously with the paper-based system or maybe their previous QMS for an audit like a three-day audit, then it went down to two days. And even the person auditing them said, man, I just can't believe how quickly you can find your documents.
So, you might think three days to two days, okay, that's one thing. How often do you have an audit, but you don't think about what about all the time leading up to get ready for that audit and all the time afterwards.
All of that is, is, is much more efficient as well. So, there's lots of different ways you could, you could look at and find those different efficiencies.
Fran Cruz
00:12:55.640 - 00:13:53.110
Exactly right. And I, I think in, in some of the cases where quality managers might be concerned, they could be coming from a sort of status quo bias. Right.
For a long time, medical device companies have gotten products to market on paper or maybe more recently some siloed technologies, and that's what they've known. And so that is considered the kind of the baseline you're working with.
And it might feel like it's more cost effective to pursue those avenues because that's what we've known. So, to do something on paper, for example, wouldn't require the investment in a technology.
However, if you can overcome that objection by showcasing what the technology can do, that will be far improved over the paper-based system. Like it will shorten our time to market. It will mean we have to make one less hire in the period.
That's something that an executive can really, can really understand and work with.
Etienne Nichols
00:13:53.590 - 00:14:09.690
Yeah. Okay, so there's different options out there. You mentioned a few other siloed tools.
What about the, the more pricey, maybe they're more pricey up front versus something that, you know, I could get by with this on a very much cheaper model. How do you, how do you see that?
Fran Cruz
00:14:10.090 - 00:16:38.490
Sure. I mean, I think there is a balance, right. You could, you could choose something that's really, really expensive.
And typically, with more expense comes more complexity. And so, you know, you might be talking about a really long time to migrate and to set up to be up and running with that solution.
And so that's something you have to take into consideration is how long is this going to take to implement? Can we implement it with the team that we have, or do we need to pay for additional professional services to make that work?
Are we coming to the table a really big existing quality system or do we not have much in place because we're relatively early stage?
So those are going to impact your decision on maybe something that is a more expensive software out there that takes a very long time to implement is going to Have a lot of areas of kind of deep customization. I think we also have to think about our vertical in particular. Right.
A lot of, some of the sort of larger QMS solutions out there are not medical device specific and so that can be really challenging from an onboarding standpoint because you know, the workflows aren't really customized to the regulations and so the team has to spend extra cycles ensuring that their users are working within the bounds of, you know, say ISO 1345 or you know, 4971, what have you.
Now on the flip side, if you are going to invest in say, I don't know, a siloed technology or you're going to do document management and SharePoint or whatever, you might be thinking more about concerns of, of, okay, what about traceability? Right. How am I going to be tying some of my design controls back to some of my policies and procedures or my cap is back to a design output?
You might be thinking a little bit about validation. Right. Which can be a really big overhead from a time constraint standpoint.
So, you know, if you're a, on the quality team and you have to validate all of these, all of these tools, is it really saving you a lot of money by investing in a bunch of siloed non-medical device specific items or is it actually harder to cobble those things together? They don't talk to each other in many cases as well.
So, you know, data migration, you might be spending time just getting data from point A to point B.
So those are all things that I encourage our users to think about when they're looking at their, they're looking at their landscape and evaluating expenditure versus, you know, efficiency.
Etienne Nichols
00:16:39.120 - 00:17:19.470
Yeah, that validation piece that you mentioned, a lot of people are shocked when they, they or. Well, let me back up a little bit.
So, some people in the industry just, they, they want to argue that well, you can't validate software before because you don't know what we're going to use it for. But that's.
And we haven't really talked about Greenlight Guru specifically necessarily and we've been speaking sort of generically on a return on investment for this.
But when you have a very purpose-built tool that is truly planning to be used for 1345, design controls and so forth, risk management with 14971 it can have a much more robust validation before it enters your hands because we already know what you're going to use it for.
Fran Cruz
00:17:19.470 - 00:17:20.790
Exactly, exactly.
Etienne Nichols
00:17:21.270 - 00:17:22.670
Helps a lot. Yeah.
Fran Cruz
00:17:22.670 - 00:17:55.280
That is honestly one of the most positive points of feedback I get from our customer base is just the validation relief. That burden is pretty intense.
And so in working with a lot of our customers, I'm always eager to know, you know, what about Greenlight is helping you every day and that actually, you know, a lot of this study was that it was going out to our existing customers and a third party was talking to them about what do you love about this? And you know, just the validation efficiency was, was a huge component is that they didn't have to spend all of those cycles validating systems.
Etienne Nichols
00:17:56.080 - 00:18:02.370
So how can someone start building that internal business case? What would be one of the first steps, would you say?
Fran Cruz
00:18:02.770 - 00:19:29.800
That's a, it's a great question. I mean, I think the first thing that I've, I've always liked to do in my own life, right.
Because I've purchased software as well, is document what we're spending time on today. Right. If you can take, you know, I actually did this with the customer success team when I first joined Greenlight.
As I said, let's sit down and let's look at what you're spending your time on, how many hours a day.
Take, take a two-week period and just log everything you're doing and then we'll take a look at that data across a few folks, and we will quantify actually in terms of dollars and cents because we all cost money, right.
Of how much time we're spending on X activity, on Y activity and then we can, you know, build a baseline of oh wow, did you realize that your teams are spending 80% of their time on this low value activity?
And I think part of the ROI story is not just, you know, how can we save money, but it's also, could our human resources be doing more high value activity? Right.
If we're spending our time validating, as one example, instead of our time, I don't know, building the product itself or you know, testing it, making sure it's working right.
There are so many things and you, as a person who's worked more closely in this industry than I have as an actual, you know, a product development engineer, you would know where you spent your time on administrative burden relative to actual like challenging, thought-provoking work.
Etienne Nichols
00:19:30.840 - 00:20:03.780
And I'll just throw in right there because that is a point that I am pretty passionate about.
I've actually seen engineers leave the industry because they are tired of just staring at a spreadsheet, trying to make sure everything matches when there's duplicative, you know, information, whatever, because they want to go somewhere where they could just be an engineer. Because that's what they want to do. So that is, that is something that is very, very.
I would rather engineers stay in the industry, cure cancer, than take us to Mars. As cool as Mars is, there are other things that I think we could be doing then. This is definitely one that I want to retain. Talent.
Fran Cruz
00:20:04.020 - 00:20:50.970
Yeah. I mean, yeah, talent retention is, is incredibly important for any business, obviously.
But, you know, you want your people to be working on the work that's going to motivate them and that's going to power their brains.
But, you know, more importantly, especially in this economy, right, where we're thinking about how do we get efficiency everywhere we look at having our people spend time on, you know, low value activity is just not a good use of time.
And so, you know, if we can automate some of it or if we can streamline education around it, for example, I think for many teams, just understanding what to do from a quality standpoint, from a regulatory standpoint, is hard work. And it takes a lot of time. And so, the more we can, we can speed that up, the better we can impact the business and the culture of the team.
Etienne Nichols
00:20:51.830 - 00:21:08.350
Yeah. I love the point that you made about documenting your time.
I remember one time at a project management training, the person said, do you know when you're, you're working too much? Like, well, some people said, well, when I'm having to go work overtime, like, nope, that's not it. What about this? When I'm working weekends?
Fran Cruz
00:21:08.350 - 00:21:08.790
Nope.
Etienne Nichols
00:21:08.790 - 00:21:26.160
She said, no. The way you know, when you're working too much is you document what you're doing, and you are literally doing everything you can do and you're not.
There's zero waste. You document all that, that, and, and you can't do any more. That's when you're working too much. And I think you kind of alluded to it.
We don't do that very often. That's really. That's a great tip.
Fran Cruz
00:21:26.640 - 00:21:59.770
Yeah. And, you know, it's from there that you can really say, all right, I was spending this much time on this, and therefore this many dollars on this.
And then once we instituted this technology or service that we purchased, you know, we, we changed the composition of how we spend our days. And that's actually something that came through in the study really well.
When we were able to look from a quantitative standpoint and what people were spending time on before and after, we were actually able to ladder that up to dollars, which I think has been traditionally very difficult in the space to do.
Etienne Nichols
00:22:00.250 - 00:22:42.010
Yeah. So, I almost look at this Like a, a little bit of a design project. Okay.
My brain just goes to, to that because that's my past sounds right, but I typically think, okay, I'm going to figure out what the problem is and then I'll solve it instead of just come in with a solution. So, you're, you're essentially what you're saying is you really need to know what your problem is so that you can show why you need to solve it.
So, if I go that, if I torture the metaphor, go one step further and say, okay, if I were doing that, I typically would have some sort of design team, whether it's a quality manufacturing design, who is it? In this instance though, when you want to analyze across for, for a soft piece of software like this, I, you.
Fran Cruz
00:22:42.010 - 00:24:51.090
Know, I think it depends, right, it depends on the size of your company, how well established you are.
Often the person knows when I've evaluated software in the past, I have project managed this effort simply because I was owning the evaluation process. And so it was, it was it. The burden was on me to prove or disprove the investment theory. That being said, you will likely partner with a few folks.
So, you know, I actually purchased some software internally, gosh, about 18 months ago. And one of the things we did was we created a task force around the purchasing process.
So, an executive sponsor who's going to be able to give this the financial lens and ultimate approval, the Personas who would need to be involved for this to be a success.
So, for example, for one of our customers that might be the quality person, the quality manager, the VP, whoever it is, who's been, who's really going to have responsibility over the quality functions, the product development owner, and there might be some other tangential, you know, teams, it could be regulatory, etc. Again, depending on how big and how well established you are.
So, I think first you have to identify your task force in not just the buyer journey, but the adoption journey. These are the people who are going to ultimately use the software.
So, you want them to be bought in, you want them to have evaluated their own investment criteria and they're all going to be impacted by it a little bit differently.
I think one of the biggest mistakes a lot of folks make when buying software, I've seen this from my perspective, I've seen it from the customer perspective, is because quality or product development, whoever it is, have been tasked with this, that they pursue it by themselves. And then after the fact they don't have the buy in from the rest of the team. They're like I didn't choose this thing; I don't want to use this thing.
That the implementation process becomes really challenging. And so, you're best to confront that at the beginning before you make the investment.
But you will also then better determine your success criteria because every team or every Persona involved will have weighed in on what they believe the benefit is. And then they will also have kind of skin in the game when it comes to getting that ROI. Why?
Etienne Nichols
00:24:51.410 - 00:24:55.690
Yeah, you mentioned success criteria and I wonder if we can hone in a little bit on that.
Fran Cruz
00:24:55.690 - 00:24:56.130
Yes.
Etienne Nichols
00:24:56.210 - 00:25:00.050
You talk to a lot of customers. What do you typically see as success criteria?
Fran Cruz
00:25:00.530 - 00:28:17.710
One of the first is time to implement, right. We actually refer to it internally as time to value and we measure it, right.
Which is we say to the customer, what's the first activity you're going to want to see to determine I'm getting actual value out of this thing. Right? Because there's a period where you're migrating data, you're getting users trained, right.
There's a, there is a little bit of a lift in every software implementation. I think at Greenlight, our, our lift is far lower again because we have a lot of the kind of purpose-built workflows.
So, you don't have to do a ton of customizing, especially like medical device customization that you might have to do with something more generic. But you know, there's still some work that needs to be done. Right?
Establishing a digital quality management system and product development system is a thoughtful process. And we don't. The goal is not to race, right. And can potentially make mistakes. Right. That's the worst thing we can do.
So, we want to find the balance between efficient setup and also, you know, great time to value.
And so, you know, for us, time to value and for many folks that is, I am entering documents into the system and processing changes through the system. All those sign offs are taking place, and this is becoming sort of that document system of record for me.
And so, we often focus on that first and as soon as we hit that milestone, we measure it and we say, okay, we did it.
And so, one of the first things we'll do with the customer in that pre-sale motion is say, what is that first thing you're trying to achieve and how quickly do you want to do it? And if they say I want to do it in 24 hours, you might say, I don't know. I don't know if actually that's a great time frame.
So, we try to help and consult with customers on what the right time to Value is because some folks who maybe haven't done this before or who have always been on paper, and we want to set those expectations appropriately.
But beyond that, there are other milestones that we would want to set up with the executive team and with that sort of task force who owns this software implementation. So, time to value is the first. But then some of those outcomes that they establish.
For example, many folks come to us and say, hey, I've got this product, and I want to get 510k clearance by X date. And you say, great. Typically, that takes, you know, so long for companies like, of your size and scope.
So, are we aligned around what those appropriate timelines are? And then that outcome is comprised of a series of milestones, a checklist of sorts.
And so, let's break those down into their parts and work toward those together.
And when we hit those milestones, you know, the idea is that we're doing it faster, more efficiently, potentially with fewer people than maybe you would have done on say, paper or we with, with siloed tools or something like that. And so, putting those up front and then creating the cadence of communication with the customer to say, all right, we're a quarter in.
Are we doing what we said we're going to do? Right. There's an accountability metric on both sides there.
And so, you know, part of my job and the team of the customer success managers and the gurus is to make sure that, you know, we are, we're keeping those timelines and honoring those timelines so that those ROIs are there as we establish them together there.
Etienne Nichols
00:28:18.190 - 00:29:09.570
Yeah, the gurus. You mentioned the gurus.
I've been really impressed with what they've built and your whole team, really about the customer journey and the way you can have a, take a more phased approach in building out a quality management system. So, there's two things that we're thinking about here.
We're talking about and I'll just kind of throw this out there just so we can kind of clarify terms. So, you have the quality, the eQMS, which is your electronic document storage change order’s Part 11 compliance system that, that has design controls.
And then of course at every company they have their actual SOPs on paper.
And if you have nothing, I've, I've actually been impressed having come to greenlight grew a few years ago, you could come to Greenlight Guru with absolutely no standard operating procedures. Use the templates, work with the gurus to put those in on a phase timeline and essentially a medical device company in a box.
You know, it's pretty amazing.
Fran Cruz
00:29:09.570 - 00:31:45.740
Yes. So, yeah, so yeah, we, you know, we have a few different types of customer profiles. Right.
We have folks who are coming to the table really early stage, no products to market, pre revenue, getting their first product kicked off. And some of their challenges are often, I'm a small team, I'm resource constrained, both financially and from a people standpoint.
Maybe I've never done this before, and I need some guidance. And so that's where, you know, our sort of quick start guru driven approach makes a lot of sense, is we have these 70 SOP templates.
So, they're not starting from zero. They can pursue guru services and work alongside a guru. Every other week we have something called Guru Assist, which is live chat in our app.
I like to equate that to TurboTax and talk to the accountant. Right. You want to talk to the expert. I, I'm not a tax lawyer, but I can still file my taxes. Right. It's, it's not exactly the same.
Definitely the stakes are higher, but, you know, inspired by a similar philosophy, which is if you're working with an expert, you can bounce ideas off them and just get that sanity check along the way. So, we also have a really robust learning management system.
And I know you know this well, but GG Academy has not just the materials to help you learn how to use the software, but it has a ton of great industry content on, you know, how to do something for the first time. So, you might check out, for example, the ultimate guide to Design Control.
And if you've never built a design control matrix, that's your first entry point. So, we have built a lot for that sort of, this is my first time. We also though have a number of customers who are coming to the table.
Maybe they're migrating off an existing quality system that wasn't efficient fit. And so, we spend a lot of our time up front instead of working with them on what is design control.
We're thinking about how do you migrate your design controls over to our software in a way that's going to make you faster and better and more collaborative moving forward.
How are we going to make sure that the design control process that you're in today is both compliant, it's fast moving, it is safe, how is it traced now to all the other components of your quality system? And so, we're focusing a lot more on linkages, on data integration, on process improvement.
And so, it really just depends on how you're coming to the table and what stage you're in. There's something for everyone. But, you know, we take drastically different approaches depending on, you know, what state the customer is in today.
Etienne Nichols
00:31:46.550 - 00:32:09.830
Yeah, that's a, that's a great point. I love that you mentioned the different, different types of buyers that there are.
If we go back to the buyer's journey and we say we, we built this business case and we're, you know, we want to move forward as far as pursuing something. What are some of the questions that you should ask? Do you ever see people having gaps in the knowledge because they don't know quite what to ask?
Fran Cruz
00:32:10.790 - 00:34:13.540
Yeah, I think, think that's, that's definitely a possibility is that, you know, folks will come to the table and think to themselves, I don't really know exactly what I need to do, so I don't know exactly what my pains could be. And so, in that case, often, you know, we have a really, really great sales team. They know this industry really well.
And I think when they talk to our prospects up front, a lot of the questions that they ask are, are, tell me about your experience with this, right? Have you ever brought a medical device to market before? What's your background? And often, you know, those folks will have a PhD, right?
They'll be really smart, and they have a great idea, but they haven't necessarily navigated the regulatory process yet. Or you might have really strong expertise in one area, product development, but not quality. Maybe the regulatory landscape is the complexity there.
And, you know, they have a really strong product development team. There’re just people can come to the table with different levels of expertise in different areas.
So, it's our job to evaluate the, what those are so we can be sure to fill any gaps with education, with, with services and what we're offering.
And then, you know, we will walk through what are your outcomes, what are your timelines, what are some of the things you're trying to accomplish first? And they may say something like, oh, well, you know, we want to, we want to commercialize in two years. And we kind of work backward from that point.
And by working backward from that, we can say, here are some of the things you're going to have to, to consider. How are you planning on managing that? Otherwise, okay, you had a plan, you didn't have a plan.
Here's how we typically see customers like you approach this process. And I think for greenlight, you know, we have over a thousand medical device customers.
And so, because we've seen the story, we know it works, but we can also ask the right questions to determine not only is this going to be a Fit. But hey, let me tell you a story about a company who looks a lot like you and what they then did.
Did to, you know, to, to navigate this process efficiently.
Etienne Nichols
00:34:14.500 - 00:34:25.580
Yeah. It's interesting how you mentioned a thousand customers. We all probably think we're very special. And we, we are, we're very special.
But we're also not alone or you don't have to be alone. And that's the way I like to look at it. So that's really.
Fran Cruz
00:34:25.580 - 00:34:37.420
Yeah, there, I mean, there are, there are nuanced scenarios. I know everybody is different and at the same time, there are a lot of patterns that we can follow and, and proven success. Success methods, for sure.
Etienne Nichols
00:34:37.489 - 00:34:47.009
Yeah. So, you mentioned this study a few times. I believe you were pretty involved in that.
I wonder if you could give us a little bit more detail about maybe why we did it and what it was.
Fran Cruz
00:34:47.489 - 00:37:36.810
Yeah, I mean, first off, one of the things we wanted to try to accomplish is like we said at the beginning of this discussion, it is hard for our industry, you know, the quality managers, product developers, to quantify the impact of great quality. Right. I think we, we have, we actually have a content piece, it's called the Cost of Poor Quality. Right.
And it talks about all of the pitfalls of not establishing a strong quality management system from day one and what some of the impacts could be. But a lot of folks don't understand those impacts or want to ignore that until it's too late, until the bad thing has already happened. Right.
Or maybe they don't know. Right. So, there are a few things that could go wrong.
But our industry has always struggled to quantify the impact, say a digital quality management system on the bottom-line metrics. And that has created some conflict between that executive layer that you brought up.
And it's sad because I think we, anecdotally, we all know that this improves outcomes. Right. It gets you to market faster. Maybe you don't need as many people or to, to do what you had set out to do, or you just become more efficient.
Right. You, you're using your people to do more proactive work and that makes you faster, that makes you better, that makes you safer. It avoids recalls.
Right. We can all of that in theory, but when people actually want to see the numbers, I think it's been challenging.
So, we actually, a third party called Hobson went out and talked to many of our customers and collected a ton of data from them.
It was, you know, without, without Greenlight's involvement and, you know, got this unbiased feedback around what what actually changed for your business? Were you able to do this in fewer days, weeks, months? Were you able to do this with fewer people?
What were some of the things that changed from your baseline to post technology that we can actually put in the form of numbers? And I think we all knew going in there's going to be some strong ROI here. We know it. But when we saw the numbers, they really were staggering.
So, it was really impressive to get a third-party company that's really practiced in building these ROI models, working with our actual customers and actual data from their real lives and putting it into context so that folks who are making this argument both, not just, not just for the first time, but at renewal. Right.
Right now, we've got a lot of customers who are coming up renewal for renewal and they might have a new CFO and they have to go to that new CFO and say, I promise you this was the right thing and it's really helping our business. But it's a lot easier to show them the raw number numbers. And so, do you want to talk a little bit about some of the findings?
Etienne Nichols
00:37:36.890 - 00:37:48.090
Yeah, I was just looking at some of them and I actually just kind of want to reemphasize what you said because we don't always think that you may have to reprove whatever it is that you purchase. I think that's a really great point.
Fran Cruz
00:37:48.090 - 00:38:05.650
Yeah, especially constantly, especially as, as budgets are cut and you know, investment becomes, you know, maybe more difficult to, to garner. Everybody's taking a look at their finances and saying, is this thing worth it? What about that thing? What about that thing?
And so, you, you want your thing to be at the top of the pile, right?
Etienne Nichols
00:38:05.650 - 00:38:16.690
Yeah. So, the results from the Hobson study, I'll just go through some of the percentages.
One of them was a 75% reduction in time needed to set up a quality management system. That's pretty impressive.
Fran Cruz
00:38:16.690 - 00:38:17.170
Yeah.
Etienne Nichols
00:38:17.410 - 00:38:40.070
The number of a full-time employees required reduced by one. That's, that's a big dollar amount right there. 50% reduction in time spent on development, design, documentation. I can attest to that.
I've lived Excel and that was a big struggle. When I handed off, I actually felt bad for the engineer. I handed that Excel document off to you. I said, please don't hate me.
This is gonna be your life for a while.
Fran Cruz
00:38:40.070 - 00:38:41.150
This is your new project.
Etienne Nichols
00:38:41.470 - 00:39:06.360
It could be a legitimate for 50% reduction. I could see it almost being higher, but that's, that's really good. 75% reduction in QARA, full time employees, time Spent on mandatory training.
That's, that's pretty impressive. Um, and then 50% reduction in time spent preparing for audits. And there are, there are so many more that. Those were the big ones that I thought were.
Any that stood out to you that you thought were pretty impressive.
Fran Cruz
00:39:06.840 - 00:40:23.520
I mean, I really liked. Not only.
Okay, so a lot of what happens in our customer base because I've seen it, and especially when somebody comes to us for the first time and they have an audit, say in two weeks, you watch them put everything on hold and all they're doing is preparing for this audit. Which really isn't the spirit of the audit. Right.
Like we can all agree, agree that the audit is supposed to come in and see you doing the things the way you normally do them and evaluate if that's right.
But instead, what happens is people are updating all this documentation, you know, because the documents hadn't been updated in a while or you know, trying to find it, making sure everybody's aligned and ready. And, and the reality is we should always be in an audit ready state. And I know that that sounds like wishful thinking, but it really isn't. Right.
I mean we can establish. I actually just used Greenlight for our 27001 audit. So, I was. And it was a very meta experience. Right.
Because I was using our quality management system and being audited.
And the auditor said to me there was both a gentleman and a woman who were auditing and they were like, I have never seen number one documents produced so quickly. And oh my gosh, you are doing so much more than the regulation requires. And so, I was like, I can retire now. That was the best feedback.
Etienne Nichols
00:40:25.120 - 00:40:32.920
I'll kind of throw one more stat on top of that because the. One of the other stats was there's a 40% reduction in number of audit findings.
Fran Cruz
00:40:33.000 - 00:40:33.480
Yes.
Etienne Nichols
00:40:33.560 - 00:40:37.080
A large part of it is due to the ability to find those documents that.
Fran Cruz
00:40:37.080 - 00:40:37.720
Exactly.
Etienne Nichols
00:40:38.280 - 00:41:09.090
Yeah. I actually was talking to one quality manager.
He was, he was talking about how they were in an audit, they were in the paper-based system and the, the auditor, it might have been an FDA inspection. So, the inspector was waiting for them to produce this document. Waiting and waiting. It took way too long. Long.
So, after that he just kind of kept hammering. He just didn't really think they knew what they were doing.
So, it's not even, maybe you have what you need, but if you can't, you, you set a precedent or an impression on the auditor. So that's another thing that's interesting to think about.
Fran Cruz
00:41:09.650 - 00:42:39.960
I think the Minute you, you know, can find what you need and answer the question speedily, it puts a lot of confidence in the auditor. They're like, okay, moving on to the next thing, right. It, yeah, it doesn't create the, that sort of unraveling of the ball of yarn, so to speak.
So, you know, I, I was really, I think, you know, the reduction in time to set up a QMS is great. It is a, it's a one-time efficiency metric, but it's not immaterial.
We all know that, you know, quality management systems take time to thoughtfully architect and maintain.
And so the fact that we've been able through both, you know, this sort of again, the workflows that are intended for medical device, so you're not creating all, all these customizations or hacks to make it work for you, but also that, you know, our training and onboarding team has put a ton of time and energy in prioritizing what you need to know, when you need to know it. So, let's say you know, you are starting with the document component.
We get those documents in quickly, we help you tag them in a way that you can find them appropriately and then you know, we're really streamlining the review and approval process and the change order process. And so, people like, like it, it's easier. They get up and running quickly.
They're not, you know, running papers around or you know, even digitally kind of knocking on doors and saying hey, can you, can you, can you write? Just, it's a lot, it's a lot simpler to use. And so, I think people really love just, they love the time to value that we can offer.
And so that's something we're, we're proud.
Etienne Nichols
00:42:39.960 - 00:42:54.660
Of man, that, that knocking on doors. You make me think of a certain VP of product development who continuously lost my report after other people had signed and get it signed again.
Oh, you talk about inefficiency. Anyway, I don't want to throw anybody though under the bus.
Fran Cruz
00:42:54.740 - 00:42:55.380
No, no.
Etienne Nichols
00:42:57.140 - 00:43:11.300
We’ll, we'll put links in the show notes to the Hobson study as well as the ROI calculator. I don't know if we mentioned the ROI calculator. We've developed an ROI calculator basically. I, I don't know exactly the internal backside.
You probably know more than I do about that.
Fran Cruz
00:43:13.300 - 00:44:55.330
We, you know, there are, there are about out 10 points of value that we've quantified with the study. So, for example, you mentioned, you know, potentially the reduction on average of a full time required headcount in order to get the same work done.
Right. So that is a very tangible expense reduction.
So, if you're looking to hire another person, you potentially might not have to because you can do more with less. And that is, that's really great, especially in this economy where efficiencies are huge. Likewise, we reported a 35% reduction in time to market.
That is probably the metric that's going to excite executives the most, is if it takes you a third of the time to get to market, you're realizing revenue faster. And that really gives you a lot more control over your financial destiny, either of the product line or the, or the business as a whole.
Now, what could happen, especially if you have a really, you know, kind of scrutinizing CFO or something of that nature, is they might say, that's great that companies saw that on average, but what are we actually going to see?
And so, we built an ROI calculator where we have a number of benchmark inputs, but you can adjust those based on what you know to be your actual inputs and partner with your executive team to customize the calculator that we used on our customer base to apply to your business.
And it will spit out a result that's tailored to you and it will give, I think, your whole team and you know, your executives, even your board, potentially a lot more sort of peace of mind because it's been, it's, it's been created with your inputs in particular.
Etienne Nichols
00:44:56.210 - 00:45:03.170
Yeah. And I, I want to just throw one more question out there because we are seeing kind of an interesting economic times.
Fran Cruz
00:45:03.650 - 00:45:04.130
Yeah.
Etienne Nichols
00:45:05.330 - 00:45:11.730
How do you see this being helpful or not helpful? You know, how do you see this being used with that?
Fran Cruz
00:45:12.210 - 00:47:03.360
Well, there are a few things that are going on in the industry and I think they impact small businesses and large businesses somewhat it differently. Right. Our large businesses are focusing a lot more on efficiency metrics like profitability.
So, they're cutting costs where they see them not being supportive or, you know, erroneous or things like that.
So, there's a lot more scrutiny in the big companies to look at expenditures on both headcount and on software and to ensure that those expenditures are worthwhile.
So, I think for your bigger companies, company that is under that, that microscope, being able to produce and reprove the value in your software expenses is going to be really critical for the smaller companies. What's happening in the market right now is, you know, the investment community is challenged.
And so, a lot of these smaller companies that are either bootstrapped or VC funded, you know, that they are maybe not getting the investment in the time frame or the quantity of investment that they had hoped. And so, their cash run runways are shorter, plus the cost of debt is a lot higher. Right. Those interest rates are up.
And so, every dollar counts and every minute counts because you're, you're working on time that you've financed.
And so, if you can get to market faster and with fewer people so that you can get to that revenue moment, that gives you much more security as a business of achieving those outcomes. And we, of course, again, you know, we want to help, help these companies get their devices in the hands of patients and clinicians.
And so, you know, if, if they're concerned about their investment Runway trying to get your revenue faster, you know, are the way we help them is by making sure they can do it with lean teams and that they can do it in shorter time frames so it will ultimately cost less.
Etienne Nichols
00:47:03.840 - 00:47:11.880
Yeah, that's a, that's a really good point that we want to help you get your, your device that is safe and effective to market faster and to stay on the market.
Fran Cruz
00:47:11.880 - 00:47:12.240
Right.
Etienne Nichols
00:47:12.240 - 00:47:13.760
So, yeah, that's a great point.
Fran Cruz
00:47:13.760 - 00:48:10.250
Right. Is we're talking a lot about speed, but a lot of the purpose of this, the FDA would say the real purpose of this is safety. Right.
And that is the truth. There's cost associated with unsafety as well.
So, if you again, you want to just go back to the dollars and cents argument, right, the cost of, you know, the, the 483, the recall, right. Those all have tangible costs because they prevent you from monetizing.
They take valuable resources to get through, etc, etc, and obviously the reputation of your business aside, so, you know, in the credibility of your product.
So, I think, you know, ultimately this whole study was really, really illuminating because it was able to give executive teams, buying teams, the numbers that they needed to make a smart decision. And I think right now most people are really just concerned with am I making. Making the best financial decision for my business?
Etienne Nichols
00:48:11.210 - 00:48:16.970
Yeah, that's really good. Well, Fran, thank you so much for taking the time to talk about this subject.
Fran Cruz
00:48:16.970 - 00:48:17.530
Pleasure.
Etienne Nichols
00:48:17.610 - 00:48:23.850
Yeah. Any last piece of advice that you want to give to the audience or where they can find you? Any last words?
Fran Cruz
00:48:24.170 - 00:49:56.380
Gosh, I mean, I think my, my best piece of advice right now would be the. The market has forced us to be a lot more cognizant of how our expenses, how our time budgeting, every. How everything ladders up to success metrics.
And so, if we start all of our purchasing decisions, in fact all of our project decisions with, with how are we going to measure success and then hold ourselves like accountable to measuring that success, then we're going to be putting into practice skills that will help us long after the recession ends. Right. I mean, these are things, I think often what we're finding is we're doing stuff we should have been doing anyway.
But now that, you know, maybe finances aren't as readily accessible or human resources are harder to come by, we're scrutinizing a lot of more, but it really, it's going to make us better and more effective. So, you know, I would say that while things can be challenging, at the end of the day, we're all becoming better at what we do.
And that, you know, that goes for customers buying software from Greenlight Guru. Right.
And how Greenlight Guru serves those customers is if we're all focused on value, we're all focused on output, then we're all going to be prioritizing the right thing. Things.
Etienne Nichols
00:49:57.020 - 00:50:06.580
Yeah. So good. Thank you so much, Fran. I'll let you get back to the rest of your day.
Those of you listening, you've been listening to the Global Medical Device Podcast and we'll see you all next time. Take care.
Fran Cruz
00:50:06.580 - 00:50:07.740
Take care. Bye Bye.
Etienne Nichols
00:50:10.140 - 00:51:18.650
Hey everyone. Thank you so much for listening.
If you're interested in reading more about the third-party report on the return on investment for an eQMS like Greenlight Guru, as we talked about during the episode, feel free to check the show notes for that that link.
We've also created an ROI calculator where you can plug in the details from your company and determine the potential ROI your company could experience. And this is based off of the experience of many other medical device companies. There's a link in the show notes. Also, the I can tell you the link.
It's Greenlight Guru ROI calculator.
If you're interested in learning more about how our software is built for MedTech, whether it's document management system, our CAPA management system, design controls, risk management, or the electronic data capture for clinical investigations, this is software built by MedTech professionals for MedTech professionals. You can check that out at www.Greenlight.Guru. lastly, please leave us a review on iTunes. Maybe you've never left a review on iTunes. Well, there's a first time for everything and we'd love for you to start with us. When you leave a review, it helps others find us. It also lets us know how we're doing. So, we always appreciate seeing that feedback. Thanks again.
Y' all are the best.
About the Global Medical Device Podcast:
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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.
