Accelerating SaMD Development in a Compliant Agile Way

In this episode, we explore the impact of software development methodologies in the medical device industry.

With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru), and go-to-market challenges for innovative medical devices.

Zach Markin, CEO of HTD Health, is a self-taught software engineer turned serial entrepreneur. His first venture, Fresh Corner Cafe, served fresh food in Detroit's food deserts for eight years. He then founded HTD Health to craft digital health solutions, pioneering the shift to virtual care. The company supports care providers, device makers, and life sciences. Zach also founded Exos, a governance SaaS, and sold it in 2022.

Weronika Michaluk, a jack-of-all-trades in biomedical engineering, business, and public health, leads HTD's Software as a Medical Device unit. With degrees from Miami and Warsaw, plus a Doctorate in Public Health, she's worked on everything from wireless ECGs to digital health consulting. At HTD, her laser focus on quality and customer satisfaction drives organizational success.

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Some of the highlights of this episode include:

• An introduction to "Compliant Agile," a balanced methodology for MedTech development that prioritizes customer interaction while maintaining regulatory compliance.
• The importance of choosing the right Quality Management System (QMS), highlighting the flexibility and feature-rich experience of Greenlight Guru.
• The need for companies to focus on their core competencies while being adaptable and compliant.
• The importance of a positive mindset and a well-defined success metric for any MedTech project.

Links:

• HTD Health page
• HTD SaMD Insights
• HTD SaMD Chassis
• Zach Markin LinkedIn
• Weronika Michaluk LinkedIn 
• Greenlight Guru Academy
• Greenlight Guru
• Etienne Nichols LinkedIn

Memorable quote:

"Our mission is to make the industry more accessible, more human centric and more productive" - Zach Markin

Transcript:

Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host of today's episode. With me today is Zach Markin and Weronika. I don't remember your last name and it's not in front of me.

Weronika, I am so sorry but maybe let's start just by giving a quick introduction and in which you can include your last name.

Weronika Michaluk: That's totally okay at the end and that's actually, you know what makes me memorable. Let's say I always say that.

So, my name is Weronika Michaluk. I'm Polish, as you can tell by my accent.

A little bit about myself. I'm biomedical engineer by training.

Have started my medical device career as an engineer was actually coding and designing and developing devices myself. I designed and built wireless EKG system and after that I decided to have period of my career in research.

I went to South Korea and was working there in neuroscience department in optogenetics.

But after that I decided to move to US to do my master's and MBA there in Miami. Beautiful sunny Miami and I was working there in US for big medical device company in digital health and digital department and was mainly focused on Latin America and East coast on US and after that I joined HTD Health, and I started as product owner at HTD and currently I am a digital health principal and SaMD at HTD Health.

So, my responsibilities are mainly around software as medical device department ensuring that we have a culture of quality and we develop high quality products that are compliant and delivery highest possible value for our customers.

Etienne Nichols: So that's yeah really glad to have you. And we actually did a virtual summit. The weeks are running together. I don't know if it was last week or the week before but we you did a session for us on software as a medical device, and I believe it was Agile method methodology.

So, we'll link to that in the show notes as well. If someone wants to check out that webinar, there's a lot of good information.

I'm we'll have to talk about this some other time but the I've never been to Poland but I'm curious if there's a difference in Poland and Miami. But we don't have to go into that today.

Weronika Michaluk: But not to.

Etienne Nichols: Okay, some other time. Zach, why don't you tell us a little bit about yourself? Can't hear you. We'll cut it out. No worries. Just take your time.

Zach Markin: I. I accidentally pressed something. Can you hear me now?

Etienne Nichols: Yes. Here we go.

Zach Markin: Sorry, I don't. I. It was. I literally just like turned this thing and then I noticed that a button was pressed, and I was like, I don't know which way it's supposed to be.

And I was like, he already started.

Anyways, my bad. Do you want to ask that again and then I can, I can answer.

Etienne Nichols: Sure thing. Zach, why don't you tell us a little bit about yourself?

Zach Markin: Sure. Hey, great to meet you. I'm Zach Markin, a co-founder of HTD Health, CEO. Today I've. I've done different things in my career. I. In the past, I started a food business where distributing healthy food in different parts to small stores.

And then I got really interested in tech. I started building a lot of software for that company to run the invoicing, logistics and operations. And then I became a software engineer, started different, different SaaS products with nothing really like that.

That, that became like a major, major SaaS product. And then at some point, like around 10 years ago, eight years ago, I was freelancer and independent consultant and somehow found my way to technical services as a business.

And so, I started doing that and then happened to have just one or two clients that were healthcare focused and started to learn more about the industry and get more interested in healthcare as an industry as a whole.

And that really is the origins of HTD Health. And then from there we grew to be the technical services group that we are today. And as we spent more time in the industry,

we became more opinionated about what parts of the industry were really important to us, where we wanted to spend our focus.

And one of those areas became devices and companion applications for devices and software as medical device more broadly. And so all that together kind of, kind of brings us here today.

So, thank you for having me and looking forward to the conversation.

Etienne Nichols: Yeah, glad to have you both really excited about it. And it's funny, Zach, I know we had an issue with the mic earlier with the button. It makes me think of, you know, medical devices that's almost unacceptable.

Is it pushed in or pushed out? You have to know.

And so, you didn't. The device failed you in that moment. And it's one of those things that I love that you guys are dedicated to making sure that doesn't happen in the medical device industry.

So, tell me a little bit more about the mission of HTD. I mean you kind of touched on it briefly. But I'm curious to hear a little bit more about you’re the nitty gritty brass tacks of what you guys do.

Zach Markin: Yeah, maybe I'll start. And Weronika, you know, I'd love to also hear your reflection. I think it might will be very similar, but also, you know, be interesting to hear from your perspective. But you know, fundamentally the mission of HCD Health is to make the healthcare industry more human centric, accessible and productive.

So basically, if you look at the, you know, the challenges facing the United States and maybe the west, if you use that phrase more broadly, you know, there's all these challenges around population, demographic trends, cost of care.

We have other underlying trends like advances in treatment for what previously were morbid diseases like cancer that are becoming more like chronic diseases. And so all these things together basically are, as I'm sure our listeners know, increasing the demand on healthcare in general, the needs that as an industry we need to fulfill.

And at the same time there's fewer working people to pay for that and justify it. And so fundamentally our mission is to is to help meet that challenge ahead of us by thoughtfully applying technology to the industry.

And one of the areas that we think will be a driver for those massive productivity gains is hardware transformations that are happening in devices. And just like we saw hardware transformations like when computers became mobile and that totally transformed the software ecosystem and then the applications that were built in that way, we see something similar happening in devices space. And so particularly our work in devices is aligned with that mission more broadly.

Etienne Nichols: Great. Weronika, I know who's going to pass the mic to you, so I'll let you kind of add on if you have anything.

Weronika Michaluk: Zach just covered that all. What I can just add is like also what I love about HVD and working here is we always think about this end user, and you know, our mission is to always remember that at the end is this patient and the patient safety is our priority and our customer, you know, just happiness and satisfaction is also our priority.

So, what we always say is we are always partnering in this field. We are not just developing, you know, end product, but we feel like we are always a partner because we are part of this device that will be then used by patient and can improve patient outcomes or even serve their save their lives.

Zach Markin: And building on Weronika 's comment around partnership, you know, if you I touched a little bit on this idea that you know, we believe that thoughtful application of technology will drive productivity, and you could say that's true.

In any industry, but particularly in health care, the framing of it in the, in the way that Weronika was describing as partners informed by domain thinking about the. And as you were alluding to at the end, human factors both facing, you know, patients and clinicians, you know, all of that informs the consultative strategy and the way that we think about applying, applying technology to this domain.

Etienne Nichols: Okay, that makes sense. Tell us.

So, when I hear these background stories from different people, it it I sometimes I think of a physical body. How your feet are the what touches the earth and your hands are what grips and moves that force to other things.

And hearing your origin story and then talking about what you do, it's kind of like filling in the outline but. But the hands are the part that's interesting. How do you actually interact with your clients to accelerate software as a medical device development?

I hope that clumsy metaphor made sense.

Weronika Michaluk: Oh, you know, we are very flexible. So, I can start Zach and then you can also fill in. We are flexible actually by also again because we are partners. So, we want to ensure that our clients are happy, and you know, then their end, let's say their end mission is fulfilled, let's say.

So, we work with our, with our clients on like in different ways let's say. But we are flexible. So, depending on their needs we can support them with building their strategy.

We can build there even go to market strategy. We can support with quality with compliance regulatory aspects.

And the big thing is also what we do, we accelerate the development by actually just domain knowledge. We have really experts in house that have helped our many organizations and have just expertise in that.

And also, apart from that we have a very interesting internal product that maybe Zach can tell you a little bit more about. But this is actually real accelerator of the future products.

Zach Markin: Maybe before getting into that, just coming back to mechanistically how we serve our partners and how we work together.

Fundamentally we are a consulting organization and basically what that means in the context of medical devices and digital services for medical device companies.

We, we have many roles internally that together fulfill the product and the digital product and engineering needs of and, and you know, quality and, and validation and other needs as well.

But basically, everything comprehensive, you know, everything that comprehensively can cover the full range of needs for producing digital aspects of, of medical devices. And so, the way we think about that in the context of service delivery is what is the right subset or selection of those capabilities and services to work with our partner.

So, in some cases we fulfill the entire product engineering and quality function for the part of the application or the infrastructure that we're delivering.

In other cases, we just support and focus on a client application or a component that is included in a broader, broader offering or device. So, Weronika talked a little bit about understanding what is success and what is the value driver for the partner organization.

Basically, we start there, and we think about together with them, what are the capabilities that they have internally and then we compose the right services offering that then we, we bring to the table and work together to deliver.

And Weronika started to talk a little bit about our chassis accelerator, which is basically a starter application for utilizing the most common capabilities that we've, we've built internally and, in some cases, can be a way for a partner to move more quickly in creation of their, their companion application.

Etienne Nichols: That's really cool. And it kind of segues into the question I wanted to ask, which was, you know, medical device companies, they all face different challenges. I know they, they're gonna, they, they have funding, they have new product development challenges, supply chain, especially more recently since 2020, I suppose.

But there's an additional layer and that's that regulatory layer. And so, I was curious if you see any trends, I guess, across the different customers or the different clients that you work with that you, you pretty much guarantee someone's going to have fallen into this pitfall.

Sounds given to this quite a bit of thought if you're building a chassis that could potentially be, if I'm understanding it correctly, where it could be a platform someone else could build off of.

But what are some of those common execution challenges that you've seen?

Zach Markin: Maybe I'll, I'll pass to Weronika in a moment. And also, just, just clarify a little bit. I, I wouldn't refer to the chassis as a platform in the sense that it's not a.

You know, there, there are a lot of great platforms in the space, including some that we're services partners for, like Extra Horizon is one.

But there are other, other platforms in the space, like Bright Insights, et cetera. The way we think about chassis is more like a software library. So, lots of capabilities we see over and over again existing in different, different devices in the ecosystem.

And coming back to your, your original question around quality and pitfalls and other things like that, you know, you see, you see the wheel getting, getting reinvented, you know, common things like identity authentication, role management, et cetera. And those are things that just make sense from a, from a product perspective.

They're not fundamentally differentiators or core competencies of the, of the companion application itself.

And so, there's really no advantage for an organization to rebuild those or re implement them in a bespoke. There can be, I shouldn't say in all cases, but generally speaking there can be a cost to rebuilding without necessarily a competitive advantage coming from it.

And so we think those instances are opportunities where leveraging an accelerator package can basically advance the organization, advance the speed of delivery and improve quality, safety, security, all of those things because you benefit from all of the historic validation and verification that have done not only by us, but also by anyone who used a version of that and then, and then it got tested. So, Weronika, would you add something?

Weronika Michaluk: Yeah, so very good point, Zach. And just to also link to this, to our chassis accelerator, you know, at the end, one of the challenges, big challenges that we can see now, you know, it's like just time to market.

So, as you can, as you know, probably like in when you develop regular, I can say software, not a software medical device, you can get to market much quicker because you don't have to comply with all of the regulations.

You don't have to do such a rigorous testing because in some detesting, it's super crucial.

And you don't have to do the, you know, either 510k, the Novo or other regulatory pathway. So, time to market is one of the challenges. And we, that's why we also developed this chassis because by using that we can accelerate the time to market.

But another awesome challenge that we see, it's just regulatory compliance because we serve different sizes of organizations from startups to huge corporations.

When we support startups, sometimes they just don't have enough resources in house. So, they don't have regulatory or compliance expertise in house.

And that's when they also reach out to us or to other experts in the fields because we believe that if you don't have the resources in house, it's really wise to reach out just for the help.

Another thing, it's data privacy and security.

And also, we can tell that based on the new FDA guidance related to actually cybersecurity we know that this is a big thing, and this is a really challenge. And even FDA released the new guidance which actually now tells that all of the medical device manufacturers must have like software bill of materials, must have a plan for the maintenance of the software, must have a plan for the updates. So, this is also new.

So even like changes to the regulations are the challenge for the, for the companies that do not have these experts on board.

And the quality management system, you know, quality management system is another thing that is very often required to, to have. And again, many, many startups just like having quality management system.

But one thing is to have a quality management system, but the other one is to have it that will work and that quality management system will actually be, you know, actually working as your company works. Right. It will not be just created out of some basic template but will actually show how your company works and will be created in a way that the processes are optimal.

And so, I think these are like the biggest main challenges that we see right now.

Etienne Nichols: Yeah, you covered a lot of different things. So, my brain's kind of going different directions. One thing I wanted to touch on was you mentioned the software time to time to market.

I feel like there's been a lot of influx of software developers into medical device space that maybe don't understand Medtech to the, to the extent a lot of old school like myself, I was a mechanical engineer.

So, I built a device, it took, you got your prototype, you got all the tooling up and eventually you, you took it to market. So, you expect a very long timeline.

So, it's a little bit different. We're starting to meet in the middle a little bit. And so that's, that's really interesting that you mentioned that and I'm curious if you maybe have some more.

I'd really love to hear any specific stories, if you have any, anything specific that you can share about how you've mitigated that or accelerated those or overcome those challenges.

Anything come to mind. It's okay, we don't have to if, if nothing's coming to mind.

Weronika Michaluk: But you, you know, even like the, the example. So, first of all, like just using the chassis, that would be the first one. But the second one, what you mentioned that the mechanical engineer starts with building something and just follows the stages.

And the first stage, let's say design must be finalized before actually doing that. Then the testing which actually falls into like waterfall methodology.

Etienne Nichols: Don't judge me.

Weronika Michaluk: And actually, we talked about it recently during the Risk Management Summit at the end. So, we at HDD we follow what we call compliant Agile. This is the methodology that will enable us, that enables us to be compliant, but also adaptive to change and Agile.

So, what Agile says, you know that it's like the customer interactions over documentation, right? What I also mentioned during the summit, but Agile doesn't say without any documentation. It's about the necessary documentation that is needed and that is also up to date.

So, what we do in order to also accelerate the process, we follow compliant Agile where we actually developed our internal step by Step process. So, what must be done, let's say during the Agile methodology we have sprints, right?

These are like iterations, normally two or four weeks long iterations.

And we developed like a process what must be done before the start of the sprint, what is being done in the first part of the sprint, second part of the sprint and by end of the sprint and then each of the team members in the team, if you have a tech lead backend, a front end developer, UI engineer, designer, product owner, each of the team members, they have their own tasks that they have to fulfill, you know, to, in order to complete the sprint.

So, by doing, by dividing this also these responsibilities and including them into the, the Agile methodology into sprints, we can also accelerate development and also be adaptive to change because by following Agile we can make changes quickly but still be compliant with all the regulations.

Etienne Nichols: I love that, and I saw you come off mute. Zach, did you have something you wanted to add?

Zach Markin: It was related to your prior question about other kind of recurring challenges. So maybe we can come back to that if you want to. If you're going to comment on Weronika's.

Etienne Nichols: Well yeah, sure. Just a real quick comment. I love that you're developing that and sharing that with the industry because it does feel like there's been a bit of a struggle in well, how do I apply and is agile okay?

And obviously it is.

FDA doesn't regulate how you manage your project. They just want to make sure that you are developing a safe and effective product. And so, I'm a believer having managed projects, the waterfall, I'm not going to lie those my roots are hard to leave.

But I definitely am a believer, and I appreciate all the things that you're doing but yeah, go ahead Zach, what was your comment?

Zach Markin: Yeah, I mean naturally I tend to look at things from more of like business centered mind. And although I, you know, like you, I was previously an engineer, certainly I'm not my thinking is less, my approach these days is less, less technical than the approach that Weronika is taking particularly with our customers.

But you alluded a little bit to this idea and challenges that maybe more traditionally hardware centric companies have now sort of with a wave of digitization or an imperative to bring companion applications together with a traditionally hardware portfolio.

And I think that's definitely something we see particularly in the world that we're supporting.

There are even one step further of challenges that we see among some of these next generation devices which is that not only is there a novel hardware that's been developed and subsequently there needs to be a software layer to enable that hardware to be functional and add value.

But particularly the software value or the software layer, excuse me, needs to operate in a way that's consistent with the rest of the digital infrastructure that the device is used within. And so, you see hardware companies not only having to face challenges around software implementation, but then also very specific and relatively domain centric software implementations like integrations with health record or you know, certain clinical informatics challenges that you see.

And then, you know, particularly with, you know, those are pretty tactical. But if you, if you back up and look at that sort of chain from an even higher level, particularly with new devices that are coming to market that are maybe more, more disruptive in the way that they're used. Say it was a, you know, previously there was a device that was always in a fixed location, that is now handheld and can be used in the field.

A lot of those device companies are subsequently needing to go to market in a new way. You know, one company that I was speaking with and spending time with some time ago, they had a very small and portable dialysis machine that they had built.

And you know, today there's not a lot of buyers for a device like that who are, you know, someone like a DeVito or the existing infrastructure for delivering dialysis is not necessarily going and saying, hey, how can we go out and replace our whole fleet of equipment?

And so, the ways that those products may become more broadly adopted may actually be through a, you know, through a go to market motion that's actually in the form of new clinical service delivery.

And so, the range of challenges that someone bringing a product like that to market are pretty broad.

And so, you know, one of the things that we see as our role is for the parts of that obviously we're not going to run someone's business for them, but for the parts of that where we can be helpful and where we, where we do have a lot of domain knowledge like integrating or like other aspects of the software ecosystem connected to those companion applications, we can help de risk accelerate and let people let our partners focus on the, maybe the most novel or most challenging areas of their novel go to market or business operations.

Etienne Nichols: The fact that you encourage or try to provide a way for people to really focus on what differentiates them makes a lot of sense. You know, sometimes we, you mentioned reinventing the wheel and I wrote that down because I think that's a really important point to think about companies, medical device companies, especially when I look at those companies, I look, I kind of think of a three-legged stool. Obviously, they have to make money at some point. That's the air companies breathe.

But they also have to be, you follow the regulations wherever they're going to submit those things. But then there's an ethical responsibility and usually you think well there's overlap there.

Well, there doesn't necessarily have to be overlap. There should be. You would expect it. But those are the three things we're thinking about.

But like you said, you should focus on what differentiates you. But you also have to be able to make money, you have to be able to be profitable. So that's that that high level view of seeing all these different companies,

I could see that being pretty powerful to say well we've seen this, but we can also you know share learnings from across that are, that are more just from a go to market strategy.

That's really cool.

Zach Markin: What you highlighted in different words is the fundamental role of a consultant or of a consultancy which is what is the thing that is critical but not, not the core competency of the customer and you know, find that space and consistently deliver in that space in a way that's more effective and lower cost total in much the same way that we've chosen not to have a competency in maintaining an eQMS which is, you know, why we work with, with Greenlight, for example.

Etienne Nichols: Yeah, and I wanted to ask about that actually because Weronika, you, you mentioned several things that I mentioned that my brain went different directions. But we're going to get back to the one thing you mentioned too is, was that quality management system.

I am curious. Obviously, you have to have a quality management system.

So, what were some of the criteria that you had in mind or what led you, you already mentioned Greenlight Guru. What led you to Greenlight Guru?

Weronika Michaluk: Yeah, very good, very good question at the end. So actually, before we decided that we will go with Green Light Guru we did tons of research, tons of work together with Zach, it was myself, Zach and other management, management board members.

And actually, what drove us to Greenlight Guru is that your, your customer, you know, success manager. I can say like just being customer centric, this is the first thing being customer centric. The other one is like Greenlight Guru enables us also to follow Agile methodology because your QMS is adaptive.

You can adapt the different workflows in a way that there will be actually compliant with our way of working but still meet all of the regulations. Because I really like also that you have specific rules set up there that will just help us to stay compliant.

But also, another thing is that you Keep on adding new features there. And the newest one is this risk intelligence one which I'm very excited about. So actually, it will help us with making the risk management activities there within the Greenlight Guru, which is actually very, very helpful as well.

So yeah, these were like the, the main, let's say things that guided us towards Greenlight Guru. And because we are also software development company, we use Jira, you know, so you also integrate with Jira, which is also another thing that was driving us towards the choice. And I don't know Zach, if you would like to add anything else.

Zach Markin: Well, you know, you're the, you're the expert on our use of the tool and really where it, where it drives value. But I can reflect at least from our selection process.

We, you know, we, we based both on, you know, a sort of like a bottoms up approach which was we started by articulating what we really need, but then we also took a more top down approach based on Weronika's experience building devices in much larger companies and just surveying what options we had. And you know, there were a couple that looked like they could support the direction that we wanted to go as an organization.

But when we really unpacked and particularly when we, when we asked difficult questions that required some thoughtful analysis of where we were headed as an organization, the individual that we were working with was far and away coming back with the most thoughtful answers. Clearly was, you know, either an expert themselves or consulting with internal experts in a way that, that we didn't see in other places. So, it actually made that choice very easy.

Etienne Nichols: Yeah, yeah.

Weronika Michaluk: I can add to this to your last also point Zach, that yes, what I can tell, it's like within Greenlight Guru you have also your gurus, which are compliance and regulatory experts, which is also great because to Zach's point, you know, when we were discussing different like points and asking hard, difficult questions, we were receiving, you know, answers that made sense. And also, we can feel this support along the way from the experts from Greenlight Guru.

Zach Markin: And I would say it's funny because when we were going through that process, that's exactly the process that we lead our customers through a lot of time not about a QMS or an eQMS, but about a selecting. You know, there's lots of different infrastructure tools that make up the modern stack in next generation care delivery and other contexts.

And so, we end up in the position of guiding our customers a lot of times through selection of a product.

And so, a lot of times, you know, in support of our partners and our customers, we're asking questions of a, of a platform provider. And so, we see the different level of depth that come back. And you know, generally everyone says, well, we, we can do that, and we check that box.

But then when you push a little farther, you could see, well, did someone have a real justification for saying that? So, it was a nice experience for us, and it was, it was something we were comfortable with, but it was one of the rare times where it was both us running that process and us paying for and owning the, the results that, that, that go along with it. So it was, it was nice.

Etienne Nichols: That's good, it's really good feedback and I'm sure it probably gave whoever was discussing it a run for the, a run for their money because obviously you've been through the process on both sides, so you, you probably do a very good, thorough job.

So, I can respect that for sure. You mentioned the customer success. I don't know exactly who your customer success manager is. They probably wouldn't mind if you mentioned it, but don't feel like you have to mention their name.

But I was on the customer success team at one point, and they only hire the nicest people in the world. So, it really is a great team. So, I'm glad, glad you appreciate them for sure.

I'm curious if there were any other goals or high level, maybe initiatives that prompted you regarding timing or decision to buy. Were there any things that, that really pushed you over the edge?

Weronika Michaluk: You know, also what you were thinking, because we serve our, we serve different customers, right? So, we do not develop software medical device for ourselves, but we develop it for our customers.

So also, another thing was that whether we could use the QMS for our customers or maybe whether our customers could have a separate, let's say instance in Greenlight Guru, which is possible as well.

And another thing is that now we are also in the process of obtaining ISO 13485 certification, which is a big step because it will really show that we are compliant and we are reliable partner.

So that was also another thing that drove us, and we wanted to choose a right, let's say partner, right. For, for eQMS as Greenlight Guru.

Etienne Nichols: That's good. The QS, QSR, FDA moving to QMSR is kind of pushing us to, it's almost a requirement for ISO 1345 at this point. So that's really great.

Weronika Michaluk: It is, exactly.

Zach Markin: And I would just say in a phrase, you know, if you, if you backed up and said like, what was our guiding principle in that thinking it was what is the tool that will let us go where we want to go as an organization.

And you know, we were, before we took that on and decided to build, you know, build the quality program and the, you know, get the 13485.

We, you know, we'd worked with, with some of our customers, QMS and other things like that and we'd, you know, there are options to maybe get to a, you know, get to a passable quality program more quickly, but it doesn't necessarily mean that it's, it's going to be something that is sustainable or durable for the long run. And what we wanted to, it was very important to us particularly because of the internal technical culture that we already had.

It was very important to us that our technical teams didn't feel that what we were bringing to them in the context of devices was something that made their lives worse.

And so, we had a very clear perspective. And Weronika spent a lot of time with our CTO and co-founder Wojtek thinking about, you know, how we saw our current Agile process or our current preferred implementation approach, but also how we saw that evolving over time and making sure that any tool we picked was sufficiently extensible and sufficiently flexible that we could more or less bring, bring our preferences and approach, but also, you know, not bring so much of our preferences that we, that we risked coloring outside the line, so to speak. So, it was a good fit. Nice, nice fit, nice approach and really nice experience so far.

Etienne Nichols: Fantastic. Weronika, you mentioned that Weronika is probably the one who uses a little bit more. I'm curious who else on the team uses it or, or just who, who's on that side.

Weronika Michaluk: Yeah, so I, I am a, yeah, the big user of Greenlight Guru. I use it every day, a couple of times a day. I was the one also like creating the, the QMS together with our CTO apart from myself, we also have a quality assurance lead product owner.

Also, one of our management board member is there and in our Agile leader.

So, we, we mainly have product owners there, quality assurance lead, you know, the CTO there and myself. And depending on the projects that will be mainly the team over there. And of course, you know, quality assurance lead is, is responsible for all the kappa and audit related things.

Then each product owner manages their own project within a Greenlight guru and myself, I oversee all of the actions in there.

Etienne Nichols: So, you know, we just recently published an ROI calculator, and I don't know if you've seen that or experienced that. Maybe it's brand new and one of the things that we found was that consistently companies and my own experience as well was that there was someone who would make sure, they were a QA person who their full-time job was checking rev control and things like that.

So, I don't.

That seems to have been done away with for the most part with Greenlight Guru. So maybe we shouldn't tell Zach. He probably doesn't need to know that. You know, you can eliminate a lot of hours with that sort of thing.

But I'm curious if there's any area that you've really found the most value out of, if there are any specific features that have benefit your work more than others.

Weronika Michaluk: Yeah, definitely. You know, ensuring compliance. Because in Greenlight Guru we have very nice features that actually in order to complete specific action, you have to follow the specific direction. Right. Okay.

You can change this if you have admin rights in Greenlight, but this actually allows you to ensure that your new team members will actually will, will be compliant even if they miss some, some knowledge, let's say. But with all this, I can say gates or like blockers that are set in the, in the process, in the flow, we can really ensure that each and every project and each and every activity will be compliant with the regulations.

So, this is great.

Etienne Nichols: Okay, I have kind of a lightning round that I want to ask you about Greenlight Guru. So, we'll just kind of go through that quickly. If you have an answer, cool.

If you don't, that's okay, we can pass.

And then I want to get back with the last few minutes that we have remaining about the growth and success of HTD. So, if you'll bear with me for just a moment, I'm curious if you can provide us with a number, a metric to go along with the following questions.

Number one would be how much time or reset sources would you estimate you're saving by using Greenlight Guru?

Any idea?

And maybe that would be comparing if you were on paper or, I don't know, however you want to compare it, maybe we can qualify it somehow.

Weronika Michaluk: That's a very good. That's a good question. You know, and it depends, I believe on the size of the team and on the project that we work, that you work on.

But definitely a lot I can say, I will not tell you like just the number, but I can say a lot, definitely.

Etienne Nichols: Okay, that makes sense. How has Greenlight Guru impacted timelines for development and or your quality milestones? Any thoughts there?

Weronika Michaluk: Accelerated? Definitely it helped us because if you just go from even for example, from a paper based QMS to eQMS, like green light guru. It makes huge difference.

So, it can save you a couple of months for sure.

Etienne Nichols: Okay.

Zach Markin: I would say it also improves visibility. You know, just from my perspective, that's valuable to me. What's going on? How far are we.

Etienne Nichols: Absolutely.

Yeah. What actually is able to be seen by those in charge is really what really matters, that that's what actually drives results. That makes sense.

Okay. Last question, I guess, would be, and this is probably my favorite, and you. You may have alluded to it already. Zach, what impact have these results that accelerate the timeline?

What. What impact have those results had on your company, your people, your offerings?

What would you say?

Zach Markin: I would. I would start with our level of confidence, particularly interfacing with clients or customers or partners that have demanding regulatory needs or perspectives themselves, which is, you know, it's valuable to have an sop. It's valuable to have a quality program.

But for me, typically when we do work, there's also some kind of contractual obligation, some kind of warranty, some kind of promises that we're making as a service provider. And so, it's very important that we have confidence and clear systems for.

For documenting our fulfillment of the promises that we make to our custom.

That is a value that is not easily aligned with your first question around FTEs or hours or other things, but there certainly is a specific, quantifiable value, if you consider, and I'm sure the listeners of this audience do consider risk to be at least quantifiable in some ways. So very important, very valuable in that regard.

Etienne Nichols: No, that's a great answer. Did you have something to add, Weronika, or.

Weronika Michaluk: That covered that all what I can say is, yes, that what is really important for us is that we actually deliver on our promises. So, this is. This is crucial for us.

Right. And that we will fulfill the requirements and the expectations from our partners.

Etienne Nichols: Well, the mission at Greenlight Guru is to improve the quality of life. And that's not just for the inpatient, although that's the goal. Obviously, people who interact with our products, those who work within Greenlight Guru as well.

So, I would say if we're able to somehow instill confidence in the people you're working with, that would. That sounds like it would improve the quality of life. So, in the long run, thank you for. For putting up with those questions. I appreciate you kind of humoring me there. I am curious.

I love this question. I want to ask this question. How do you at HTD define success?

It's a little bit broad, as Though feel free.

Answer however you like.

Zach Markin: Any thoughts?

Weronika Michaluk: I can just start by like one sentence. I can say that success of our clients is our success as it really goes hand in hand.

So, if our clients are successful, we are successful.

And Zach, if you would like to add something else, I would say the.

Zach Markin: Same and maybe a slightly different dimension. You know, as I alluded to at the beginning of our time together, you know, our mission is to make the industry more accessible, more human centric and more productive. And so, we are intentionally qualifying and filtering the customers and partners that we work with to make sure that there's alignment with that mission.

And then in our execution, it's exactly as Weronika said, which is improve the success of our customers and accordingly deliver on our, on our broader mission.

Etienne Nichols: Okay, that's great.

Last one of the last questions I suppose would be what would be next for HTD? You mentioned the chassis. You're obviously doing a lot of things both internally, externally. What, what would you say is next for HDD?

What can you say?

Zach Markin: We, we have one exciting development.

We have a team member joining us later this summer who is an old friend of mine, but an MD, PhD in artificial intelligence and he's joining and will be leading, leading our practice in that space.

And as you, I'm sure you know, and our listeners know, there's huge overlap between AI and SaMD and so we see a lot of opportunity there. But you know, we're also not going to get too distracted. We have a lot to do in our core swim lanes which are, you know, really focused on tech enabled care delivery, companion applications for devices and then bringing the AI practice which is really fitting together with those two items and continuing to allow us to address the customers that we currently address.

So, I would say we're excited for the new, but we're also excited for more of the old.

Etienne Nichols: Excellent. That's really good. A lot of people may be getting distracted, but I think it's good to have a blend that's a solid approach. I really respect that.

Any last piece of advice for your customers or any thoughts that you want to share? Not the customers, but the listeners though those of you who are listening today, Weronika or Zach, any last, any last words both how we can find you and piece of advice so how you can find us.

Weronika Michaluk: You can find us on LinkedIn; you can find us on our website.

I actually I will do some self-promotion because couple of days ago I released my first SaMD article from SaMD serious. So, what we are doing, as we mentioned that we want to partner with our clients, we want to also share the knowledge. So, at HDD we are also sharing bi weekly articles that will then create like complete guide about software as medical device.

So that is just the knowledge sharing and why we do the knowledge sharing because kind of what you, what you just asked Katien is the, the advice is sometimes it might, might look very difficult to enter some space, especially if somebody is new there.

But what I would say is just not to be afraid of the new challenge, not to be afraid of this, all of the regulations because they are people out there that can help you whether it's HDD, whether it's, it's us or somebody else.

And what I always tell to Zach is I think the future is bright if you have a positive mindset.

So that's what I would just say.

Etienne Nichols: Love that Zach.

Zach Markin: As Weronika said, you can contact us on our website which is htdhealth.com There's a contact form there.

You can also email, and you can if you want to just write me. My email address is my first name Zach.

So zachdhealth.com so would love to be in contact with anyone who's a listener here with respect to advice. Building on Weronika's comments, I would say the most important thing,

at least in my opinion for any organization building software or companion software, is to have a very clear perspective about what is success, what is the value driver for your organization that the software will deliver and clearly define that and communicate that to your own internal teams, to your partners.

Because the more clearly that is defined, the more clearly, it's communicated to everybody working together on it. It empowers people like us to be proactive in advocating for one path or another.

That is it will deliver on that.

Etienne Nichols: So yeah, all right. What is success? Very cool.

We'll include all of those links link to Zach's email link to Weronika's article as well as the webinar we did with Weronika as well and might link to the chassis accelerator if there's some something we can do to give a visual there and understanding and but all of those will be in the show notes so check those out later.

I want to thank you both for being on the show. It's been really fun conversation for me, and I've learned a lot, and I really appreciate it. We'll see you all next time.

Take care.

Zach Markin: Thanks for having us. Take care.

Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.

Email us at podcast@greenlight.guru.

Stay connected for more insights into the future of MedTech innovation. And if you're ready to take your product development to the next level. Visit us at www.greenlight.guru until next time, keep innovating and improving the quality of life.

About the Global Medical Device Podcast:

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

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