How SHE is Improving Patient Care with AI Enhanced Medical Devices

Weronika Michaluk: 0:00

You can also just think about your software as a standalone software, because your other software's medical device is just one piece within the whole healthcare ecosystem. And if you want to be successful, you have to integrate with other systems. So like, for example,

Harsh Thakkar: 0:16

what's up everybody? This is Harsh from qualtivate.com. And you're listening to the life sciences 360 podcast. On this show, I chat with industry experts and thought leaders to learn about their stories, ideas and insights, and how their role helps bring new therapies to patients. Thanks for joining us. Let's dive in. Alright, we're live. So our guest today is Weronika Michaluk. She is the principal software as a medical device lead at HTD health. Welcome to the show.

Weronika Michaluk: 0:42

Thank you so much for having me. Harsh, Happy New Year. Yeah. I'm very excited to be here today with you.

Harsh Thakkar: 0:48

And you're you're based in Barcelona. Correct?

Weronika Michaluk: 0:52

Based in Barcelona, Sunny Barcelona in Spain, Spain.

Harsh Thakkar: 0:55

Right. I just visited there a few months ago for the cphi conference, and I loved it.

Weronika Michaluk: 1:01

Did you?

Harsh Thakkar: 1:02

Yes. Yes.

Weronika Michaluk: 1:03

It's a beautiful place.

Harsh Thakkar: 1:05

It is. It is. It's a I didn't get to see much. Because obviously, when you're at a conference, I was just tired of walking. And all I wanted to do at the end of the day is just get some takeout and go to bed. But yeah, it's a great city, I would love to come back and explore more some of the time.

Weronika Michaluk: 1:21

They're thinking and whenever you come please let me know. I will be your guide. There's so many places to see there in Barcelona. So glad you liked it.

Harsh Thakkar: 1:31

Yeah. So before we go into the technical topics, which I'm sure a lot of people want to hear from you, given your expertise in this space. Can you let us know a little bit about what do you what is your role at like HTD held like what do you actually do maybe your bread and butter projects that you work on?

Weronika Michaluk: 1:49

Definitely. So I HTD health. I am software's medical device Practice Lead and digital health principal. So my main responsibilities are to oversee all of the Sunday projects at HTD health to ensure that our teams are working accordingly to our SOP. So our procedures also ensure that we provide the highest quality of work of services for our clients, ensuring that clients are happy, and clients are receiving, let's say are successful because our clients and our partners success is our success. Additionally, I was also leading the whole team and our gather with our quality assurance team during our last year and our efforts preparing for ISO 1345 as audit and we we got this certification, so we're very happy for that. So the company's ISO 1345 certified. So it's kind of like a proof for us that we our services are high quality. So I also serve our clients, our partners with any consulting areas that say so if they have any questions regarding medical device strategy, I'm there to support. Also when it comes to technical strategy in Med-Tech, in med tech space, and in digital health space, as myself my whole career I've been in medical device, industry and in digital health space.

Harsh Thakkar: 3:25

That's great. So you I know you mentioned medical device strategy and working with clients. So I don't work much in medical devices, I do have certain people in my network who are way more experienced than I have. But my career has mostly been in pharma and biotech. But to ask you the question here is, do you get clients who are like in the early stages of development? And especially the question is around how do they know if they're working? Or they're trying to build a medical device or a software as a medical device? So where's that line? And the how do you help clients figure out how to find work with many companies

Weronika Michaluk: 4:05

So harsh? Actually, that's a great question. Because we work with many different types of organizations, and the bigger ones like enterprise partners, they have their quality teams and regulatory teams. So they have that figured out. But if there is a startup or entrepreneur that we work with, because we support many startups and entrepreneurs that have brilliant ideas, but not always are sure about whether their software is actually a medical device. So we can also help them with that is we have a team like quality quality team that can definitely support with that. But as a rule of thumb, I would we would again say is that the software to be a software's medical device must serve medical purpose like without actually being a medical device hardware itself. So the This medical purpose is to diagnose, treat, prevent, monitor any disease, or disease or health condition. So let's imagine, for example, you have a fitness app on your phone, everybody gets, it can just go on the like app store and download some fitness fitness applications that will just, for example, show you how many calories you burned, or how many steps you do, etc. But they don't actually diagnose you or they don't treat you. So this is just a regular fitness or wellness wellness application. But a good maybe example could be even an Apple watch that I have here on myself. This is actually class two medical device and application that would, for example, use data from class two from this Apple Watch, in order to diagnose you whether you have an arrhythmia, heart arrhythmia, or would tell you that, hey, your your heart rhythm is not good, please see the doctor, then it would fall on their medical devices. So what is important to think about is this intended use, right? So actually writing down the intended use and clarifying clearly as you know, what is the main purpose of our software that we want to build, and then we take it from there because intended use of rights, or whether it's class one, class two, class three, medical device, and then based on that, we will do different activities during that design and development.

Harsh Thakkar: 6:37

Yeah, and that's it's a very interesting space, because like medical devices, development has also come a long way. 20-30 years back, we didn't have that many devices that were sending data over the cloud into a portal or a dashboard or computer of that sort. But today, if you go to any hospital, or like any medical setting, there's a lot of different I don't know, I'm not a doctor, a physician, but I can see there's a lot of devices where the data is being pushed, or into a medical record or something of that sort. So yeah, it's a very interesting space. Yeah. So what is it when you're working with clients in this software's and medical device space? What is the one challenge that you're seeing one of the main challenges you're seeing frequently?

Weronika Michaluk: 7:26

Oh, you know, there are many, if I had to actually just choose one, that could be it'd be hard, let's see, like, maybe I will tell you a little bit about like different ones, but then focus on one because so for sure, like what you also mentioned, like data integration. So not thinking about interoperability and scalability, that's the challenge, because you cannot just think about your software as a standalone software, because your your software's medical device is just one piece within the whole healthcare ecosystem. And if you want to be successful, you have to integrate with other systems. So like, for example, big buyers, like hospitals, they prefer products that can adapt and grow with their needs, and not just be standalone. So that is one thing, then the other would be neglecting, neglecting, actually user needs. And be also, also forgetting about human factors. So when you create software's medical device, it's not just about creating beautiful application. But you have to remember that at the end is a patient, patient. And we have to remember about patient safety. So following standards, like usability, engineering standards, remembering human factors, to actually create the software that is not only intuitive, nice for the user, is it easy to use, but also safe, safe to use. So like patient centric, human centered design, is very important. And oh, maybe one more thing that I could I can mention is lack of knowledge, mainly and disorganized documentation on how to actually document everything. And then also like some of the some of the organizations they think when they when they think about medical device, they think that you can only develop medical device software, following waterfall methodology. But that's actually not true. Because you can be agile, and you can be compliant. But it really requires lots of knowledge and know how. So I will say like, these are the main three ones.

Harsh Thakkar: 9:34

Yeah, those are great ones. And as you were explaining that I was thinking about, like you said, having a medical having a software as a medical device that just doesn't work well on itself, but works well with other software's and there's big players in this space in the medical device, medical equipment space, and there's newer startups that are coming in. So and then you also mentioned about training which is, which is another point. Because if you're developing a medical device for a patient who it's, I don't know how to explain it in a in a nice way, maybe your you'll get my point. But if the patient is using that device just for one single function, then you need probably more training because they don't have a medical background versus if you're just replacing an older device with a new one for a big hospital and a physician is using, they can probably figure it out on their own what, without reading your training inserts and whatnot, right? But, but at the end of the day, it still has to be designed, easy to use. So and it takes it takes a lot of effort, like you mentioned an example of Apple, they've designed a phone that is easy to use, and many people love it versus other phones. But there's a lot of thinking that goes into designing something simple and effective.

Weronika Michaluk: 10:57

Oh, yeah, definitely agree. And also, when we think about actually a big issue in the healthcare, I can say like patient engagement, right. So it's one thing to design something but then it's another to actually make the patient to use it and to want to use it because it's not just about creating another app that they will have on their phones, but actually making them to see the value in there. And then if we get more engagement than we also can get more data. And then based on this data, we can also create more personalized treatments for patients. So then patient outcomes will be also better. So it's like a chain, let's say of things. But again, designing the software like well, thought software application, we're again remembering about patient safety. It's crucial.

Harsh Thakkar: 11:45

Yeah. And for any medical device or Med-Tech clients who are who are listening to this, if they're looking to build a software as a medical device or design a product, what what can you share with them about some tips of choosing the right partner to develop? Right? Do you have any checklist? Or here's the five things you need to look for when you're choosing a development partner?

Weronika Michaluk: 12:13

Another great, great question, Harsh choosing a great developer development partner is not easy, because there are many different players in the space. But what I would really recommend is to think, what are the resources that you don't have in house, what is the expertise that you don't have in house and look for a partner that would have had that also, what I would really recommend is that check somebody that they have experts in house, for example, you will have a great hardware device, but you're looking, you don't have software engineers. So we are looking for a software software partner, check also their references, check whether they have in house team, check, even the ISO certification, for example, just to know whether they actually even know the standards. Also, what I would really highlight is the importance of transparency and communication. Like it's very important to have this development partner, as a kind of extended will be an extension of your team to feel that you are partnering, you're not just like giving them requirements, please create the software for me, and we see each other in a half a year, because it doesn't work like that, that development partner must be kind of part of your team. And they really care about your your success. So I would say really pay attention to like their, their know how they're their team, what kind of team members they will bring in. And also check what kind of projects they've done in the past.

Harsh Thakkar: 13:56

Yeah, that's it's a it's a not only just in software as a medical device, but also in general life sciences industry. This advice can apply to pretty much a lot of areas, because that's the challenge, right? Like, at what phase or depending on where the company is and what kind of bandwidth or resources they have. It's this decision they have to make of, should we do this in house? Or should we outsource? Or should we do a mix of both? Right? Like, there's pretty much three ways to go about it. There isn't a right or wrong answer. It just depends, you know, on each company and like you mentioned, understanding what their strengths and weaknesses are right? And then maybe finding somebody where you have a weakness or you don't have a person with that knowledge. So and what are what are the trends you're either seeing in this space or what do you think is going to happen in the next five or 10 years in software as a medical device?

Weronika Michaluk: 14:56

I'm very actually excited about the future because I do We'll see a lot of progress in many different aspects. And everybody's talking about AI. Right. So I cannot skip that either. Even today, today I read about that government like the UK, there will be like in your roadmap to think about standards for developing AI as medical device. So not software as a medical device. But AI as medical device is, which is kind of like a subset of software, it's medical device. I found that very interesting, because I don't think that AI is like everywhere AI ML, right. And we should think about using it in the right way. And because I do think it can help us to improve like efficiency in healthcare, just worker support, it can improve diagnostic capabilities, analyzing patient data, streamlining vehicle processes. And also it's great to see that FDA is also thinking about AI. And he's like releasing a new guidances about AI, and the use of it and development of this kind of software. So I would say that, like AI will prefer play a big, big role. But also what I am seeing is that, like traditional medical device companies are also expanding beyond their core businesses. What they mean by that is that they don't only just create hardware device, and that's it. But they also now start to think about software, how could we even enhance patient experience example, you had a hardware company that, for example, develops deep brain stimulation for patients or pacemakers for patients. So what they can do is they can create, like a companion application that will be patient facing and will, for example, support patient throughout their career journey, will also gather some data and analyze the data to improve that patient care. Also some planning platforms that would have additional, let's say, applications. So I would say that now medical device companies are also thinking about ways how could they even have a better connections with patients through through software, and that also helps them to the labor, supply their offerings, expand health care services. And also there's maybe even thinking about new reinforcement strategies and ways how to how to improve that. So I would say that now everybody else is going like more into patient centering as centric solution, which is great, because we don't have to remember about the patient.

Harsh Thakkar: 17:49

Yeah, and definitely AI, like you mentioned is a great trend to watch for, it's already happening now. And in the next five and 10 years, it's going to be even more. And from what I've seen in just in life sciences and using software. Mostly, I work with clients who have software as a service or SaaS systems with some AI features, or they're interested in just a purely AI solution or a building AI model. But the biggest challenge, like with AI is risk management, right? So that area is still even without AI, we're as an industry, we have challenges with properly managing the risks. So I just feel like AI is just another is going to add another layer of complexity. So for us as an industry, whether it's Med-Tech, or software as a medical device, or life sciences, if we are serious about like incorporating AI into our workflows, we need to be better risk managers or risk assessors. So that's that's kind of my take from where I see it. And it's very interesting and exciting to to be working in life sciences right now.

Weronika Michaluk: 19:04

Yes, we agree. It's very exciting, but also challenging, right? Because what you mentioned that we really have to think about AI because like, it's like AI is learning the more data it gets, the more information gets, the better let's say it becomes. But you have to also like think about whether like over time, the intended use, for example of the device will not change because AI will come up with something new. So to your point, risk management is crucial. And we have to it's not just like ticking the box activity, but it's continuous activities activity throughout the call, just product lifecycle and on the other product device, but exciting about that excited about the future and what it brings.

Harsh Thakkar: 19:52

Yeah, yeah. And do you do you get people asking you on whether on LinkedIn or when you meet people and I at conferences or whatnot, how can somebody get into this space? Like, think about where you were five or seven years ago in the industry and where you are today? What advice do you want to give to somebody who's trying to enter this industry?

Weronika Michaluk: 20:15

Our Med-Tech industry? Yes. Yes. So our Med-Tech industry, I would say, just learn as much as you can, but read many like different, well, let's say articles from, from respected, let's say sources, they are some, some courses, certificates that you can learn. Of course, the best thing is to practice just to have a hands on experience. So maybe find a mentor, or maybe find a mentor, like expert in medical device space that have many years of experience, and could actually help you to upskill. And as I don't believe that this is, this is very important as myself, I do have a mentor, and I do have a coach. And that helped helped me a lot throughout my career. Also, just listening to podcasts like yours Harsh, I do think is great, a great, great idea and great way to learn, because you can listen to people that are actually doing the industry work that they are experts. So I would highly recommend just listening to podcasts like yours to learn more. And just never give up because med tech industry is not easy. So it won't be an easy ride? It's very exciting, right? But it's there are some challenges and obstacles. And we in the med tech industry, we have to continuously learn because they are like new things like AI new regulations, new guidances. So we had to stay on top of that. But this makes it very interesting. And also when you just think about the end, user patient. And thanks to your work, you can actually save or save or improve people's life. All right, it just great.

Harsh Thakkar: 22:06

Yeah, I mean, that's the that's the Northstar for most people working in the industry. That's what, that's what drives them. That's what pushes them. And also you mentioned about this podcast as a as a medium of content. And that's true, right? Because when I look back when I started this podcast, like there wasn't really a big goal or a big intention. Like, yeah, I had a consulting business, and I had clients. But it was just like, I was talking to so many interesting people offline with whether it's like a coffee chat or just a meeting. And then I would ask them all these questions to learn more about their space. And then I would get somebody messaged me and asked me that same question. But I had heard a better answer from another expert. So I was like, wait, I just, I just talked to X, Y, and Z. And they actually had a really good take on this topic. So that's how the idea for me was, how about I just merged this? Like, how about, I asked questions that I was anyways going to ask and just throw it out there. If somebody wants to listen and go in, that there's content there? Because I'm sure you get a lot of these questions every week in and out, right, like, whether it's clients or whether it's other consultants in your network asking you. So yeah, so it's great. Yeah, we're lucky to have the how easy it is to start something like this and distribute content. So that's, that's definitely exciting.

Weronika Michaluk: 23:35

And it's great, because he brings a lot of value for the community. And also I bet lots of people learn from it.

Harsh Thakkar: 23:43

Yeah, and it's not just about everyone learns from it, right? Like, I'm learning as well, because sometimes I bring people for a topic, and I have to actually prepare a lot to even ask them questions, because I have, I have very limited knowledge in that topic. And I don't want to come because there's this like, sort of you ask an expert who has a lot of maybe decades of experience, you don't want to ask them too simplistic questions. Or if you're asking them, they need some context, or they need to know where where you're coming from. And it's, it's a little bit challenging to, for me to go into those kinds of episodes where I have no idea about what that topic is, and I have to actually learn, so I can ask them good questions. So yeah.

Weronika Michaluk: 24:31

Fully agree but it's great that you're doing this.

Harsh Thakkar: 24:34

Yeah. So what's what are you looking forward in in 2024, and then any exciting projects that you're looking forward to or anything any kind of projects you want to work on that you haven't got a chance to yet?

Weronika Michaluk: 24:46

Oh, we are actually working on pretty many very interesting projects in like cardiology, in oncology and also neuroscience and also diabetics. So this is like it is great like So many different therapies that we are working on and just what you mentioned, like just working with different experts and having that, like, what I really love is that I kind of have a feeling that, Hey, I am a part of this project. And then I can contribute to that, which is, which is exciting. So what I'm really looking forward to 2024 is like just launching all of our products and see how the patients are benefiting from from that. And also looking forward to like some of them advancements, let's say in the regulations from FDA regarding, again, AI or even harmonizing QSR with ISO 13.5 by end of this year. So let's see lots of different things are happening. So very excited about about this year and up coming years as well.

Harsh Thakkar: 25:49

And for people who are listening to this or who want to connect with you learn more about your role, or what you're working on, what's the best way for them to get in touch with you?

Weronika Michaluk: 26:01

Yeah, the best way to get in touch with me just reach out to me directly on LinkedIn, just my name Weronika Michaluk. And also feel free to check out our website where I post bi-weekly articles about software's medical device and recent article was actually about human factors and their usability engineering. So highly recommend that it's HTDhealth.com. You can find lots of information about our company. And just feel free to reach out on LinkedIn. I'm more than happy to chat to meet over the coffee and discuss Med-Tech

Harsh Thakkar: 26:36

Yeah, and share the link of that article. So I can have that my team dropped that in the show notes of the episode. So people because otherwise people will message me. Oh, where's the link to the article she mentioned about? I was like, make your life easy. make everyone's life easy.

Weronika Michaluk: 26:53

Alright, I will definitely I will. Thank you,

Harsh Thakkar: 26:55

Veronica. It's pleasure. It was really nice talking to you wish you much success. And then let's stay in touch. If any way we can collaborate on any projects or be of help to each other. I would love to work with you and hopefully meet you someday when I'm in Barcelona.

Weronika Michaluk: 27:11

Thank you so much. Thank you. It was a pleasure to be here. Thank you.

Harsh Thakkar: 27:15

Thank you so much for listening. I hope you enjoyed today's episode. Check out the show notes in the description for a full episode summary with all the important links. Share this with a friend on social media and leave us a review on Apple podcasts, Spotify or wherever you listen to your favorite podcast.