The Intersection of Technology, Engineering, and Patient Care

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Saul Marquez:
Hey, everybody! Saul Marquez with the Outcomes Rocket. Welcome back to the podcast. Today, I have the privilege of hosting an incredible leader in healthcare, her name is Weronika Michaluk. She’s an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. She’s a biomedical engineer by training and has a master’s in international business from the University of Miami. Currently, she serves as Digital Health Principal and Lead at HTD. In this role, she leads the Software as a Medical Device Department, which we all know is where med device is going. So, I’m excited to be having this conversation with her today. Weronika, thanks so much for joining us.

Weronika Michaluk:
Thank you so much, Saul. It’s a pleasure to be here.

Saul Marquez:
So Weronika and I met back in, it was 2019?

Weronika Michaluk:
2019, yes, four years ago.

Saul Marquez:
Oh, my God, the time flies. We were at the HLTH event in Las Vegas, and we just hit it off. We were having a great conversation. We’re like, let’s get you on the podcast. And it took us four years. But you know what? Better late than never, right?

Weronika Michaluk:
Exactly. So we will make the best episode ever. It took us like four years.

Saul Marquez:
We’ve been planning for four years. No, not really, but it’s such a pleasure, Weronika. And folks, Weronika is remoting in here from Barcelona, Spain.

Weronika Michaluk:
Yes, that’s it from sunny, beautiful Barcelona.

Saul Marquez:
I love it. So, look, Veronica gave the listeners a little bit about your background, but tell us what motivates your work in healthcare.

Weronika Michaluk:
Definitely, that’s a great question, Saul. For me, actually, my interest in healthcare started with my love to technology, engineering, and the human body. When I, actually, when I was a child, I wanted to be a medical doctor, but I was like, I cannot make it if my patient, for example, dies or there is some like disease that I cannot handle and/or cure, so I decided to help patients and doctors indirectly via technology. And even, I remember when I was just starting my career as a biomedical engineer, which you mentioned, I was working on wireless EKG system, and that was actually, the whole idea was to make heart monitoring just easier for people. And real inspiration really came from like really seeing how it can help doctors and patients. Also, what really motivates me is my personal also experience. For example, currently, one of my teams is working on the digital health solution in the oncology field, and where we will also implement machine learning, which is also like huge topic now. So the idea is actually to support patients with cancers and to also improve the processes around the whole oncology process and patient care. And I, myself, find it really motivating because my own family members, many of them, actually were diagnosed with cancer, so I have this kind of personal experience. And when I work on this solution, when I work on this project, it really just brings me joy and fulfillment, and because I know personally how hard it is. So, I also always say that healthcare is always changing. And as you know, it’s like full of surprises and obstacles and difficulties, but what, it really keeps it exciting and also inspiring, right, and motivating for you, because it’s not only just technology or like it’s not about creating new software, new algorithm, but it’s about making actually life better of people, of people like you and I, and of, to make their life just better, and that’s what drives me every day.

Saul Marquez:
I love it. No, that’s great. It’s personal. It’s intriguing. The problems are always changing, and they just keep going back to it. And that’s honestly why I love healthcare, too. And look, HTD, you guys are doing some interesting things. Why don’t you talk to us about how HTD is adding value to the healthcare ecosystem?

Weronika Michaluk:
Sure. So, HTD, we are a technology services company, and we specialize in transforming healthcare through development of custom software solutions. We are a team of 200 really passionate people that really want to make a difference in the healthcare industry, and we say that we are on a mission to imagine, design, and build a more human-centric, and accessible, and more productive healthcare industry for everybody, because at HTD we focus on human-centered design and health IT integrations, because we also know that it’s not just about creating software that, but also making sure that it integrates well within the workflow and within the patient journey. So we just, we don’t just create software, but we craft experience that then integrate into users’ workflows, delivering really best-in-class user experience. Because I used to be a professional soccer player, so I will say like.

Saul Marquez:
Oh, you did? That’s pretty cool.

Weronika Michaluk:
So I will say what my coach was always saying, that he has to tailor the training plans to each individual. So that’s how HTD designs solutions individually for each client to meet a unique requirements of patients, of our clients, and of end users, right? Because in essence, what I could say is like our approach, it’s blending cutting-edge technology because also we specialize in SaMD, which, what I mentioned, as I am leading SaMD. We are also focusing on artificial intelligence and machine learning. So that is a trend, let’s say, that, it’s not only a trend, but it’s something that will really help to make healthcare better, more personalized, more, just better for everybody. So, in simple words, at HTD, we are working to make health better for everyone and more human-centric.

Saul Marquez:
I love it, yeah, and it’s all about experiences. You can build products, but are you building experiences? That’s a question that I think we should be thinking about as we seek to design the latest innovation, the newest product, or the next solution. Are we creating experiences? And I love the call out to the integration as well, Weronika. Because look, we are in a space that is complex. There’s EMRs in place, there’s existing systems, are your solutions integrating? So, all key things. And if you’re a MedTech founder or a MedTech software founder, something to be thinking about or a large organization. These details, oftentimes, let’s be honest, they get missed, and when they get missed, they cost a lot of money, it causes a lot of pain, and you don’t want that. So you’ve highlighted how you guys are different. When you think about the projects you’ve done and work that you’ve done, Weronika, what are some of the biggest setbacks that you’ve seen clients experience, and where did it come from?

Weronika Michaluk:
Oh yeah, actually, I have a couple of them, and I will maybe tell you about the one that started like a long time ago when I just started my career, and it was actually more about the regulations and a little bit also about behavioral change design and just designing the experience. Because what you mentioned that we are sometimes just like designing the solution, but we are not thinking about the experiences. So I just want to come back to it to also mention that what we do at HTD, we put, really, a lot of focus on human-centric design and on behavioral change design. So we have our department and experts that really pay attention that the solutions that we are designing will be well delivered but also accepted by patients and will bring the real experience. So now, coming to the setback that we were you asked me about, we had a couple of different examples, like when clients came to us and they told us, and now I will link to the integrations and actually interoperability and scalability. So they had an amazing, actually, idea, an amazing solution. But it was, so we can say standalone project, standalone software that was not integrated at all with anything. So it was not possible to scale it. So that was not our setback, but I can tell you that this can be a setback for many, many people. But my personal setback that I remember from my early career and that I like remember every day and I put it at work, it’s like when I was biomedical engineer, we were designing a medical device, actually, and we had an amazing idea about the technology, but we didn’t think about the regulations, about meeting all the regulatory guidelines and about thinking, actually, about the future, about North Star, let’s say, what will be next. So we designed the solution, and that was actually a kind of good for one country, but then, actually, it was very well received. So again, I was designing that when I was still a student, this was still before my, actually, career, and we got also an offer to, got a grant for that and to, to just scale it up. But when you looked at the whole, like, regulations, etc., the technology was perfect, but we had to really redo a lot of work, like the documentation, traceability, etc. But that lesson was great for me, because now I am leading software medical device department and I am responsible for ensuring that all of the devices that are made by HTD will meet all the regulatory guidelines. And what we start with the client is like we do the discovery, and we think about the North Star, we think about what’s then, it’s not about what’s tomorrow, but okay, where do we want to be in the future? Let’s be prepared to first, to be, just to scale up, right, and to be open for global markets. And also like, the traceability matrix for the medical devices is crucial. So that’s actually, that happened many, many years ago. It’s kind of my biggest setback because it was like really lesson learned because it cost me a lot of time and work. So now I make sure that our clients will not have to do it. We’ll have everything done perfectly from the beginning.

Saul Marquez:
I love that. No, that’s a great one, Weronika, and certainly, one that all your clients now are benefiting from. It’s a very detailed process, and there’s so much that we have to think about. And so, as you think about software as a medical device, Weronika, what’s a trend or a technology that you see in this space that is going to change it as we know it today?

Weronika Michaluk:
Great question. Great question. So SaMD itself will change healthcare, but if we think about SaMD and AI, actually artificial intelligence or machine learning, that two combined together can really make a difference in healthcare. And also when you think about medical device, lots of people think about it as the very long and kind of waterfall process to create it, right? But when you think about it in actually in another way, when you create software, we follow Agile. So if you combine these three actually, Agile, AI, and SaMD, you can make a huge difference in the healthcare industry, because when you think about, actually, personalized care. So, AI, SaMD, allows healthcare providers to give medical care that’s just right for each person, and each of us is different, each of us has different body, different symptoms, different needs and diseases. So thanks to AI, we can actually, based on your medical records, based on your medical history, we can draw conclusions and give providers recommendations to then just improve patient outcomes, and again, what I mentioned before, improve everyday everybody’s lives. Another thing, it’s home-based. So when, actually, four years ago, when we met, so at HLTH, I was actually based in Miami, and I was in charge of digital health for Latin America region. So back then, when you are focusing on digital health, that was really helping for people that were in remote locations. So, as you know, in Latin America, it’s a huge, actually, issue that lots of people are in remote locations and don’t have access to care. So actually, through AI, SaMD, or through just SaMD we can provide, we can just give access to care for people that are in remote locations, which I believe also, it’s huge milestone for us, which also brings just easier access and faster responses. And also another thing would be smart diagnosis and treatment planning. Even now, what’s really great, it’s, like we can not only diagnose cancer based on some X-ray imaging, but we can actually now make prediction that, for example, if you get enough number of images of X-ray, the machine learning algorithm can actually predict that this specific person, let’s say, will most likely have cancer, will develop cancer within the next 3 to 5 years. So that is also a great milestone for me. Imagine you just go to a doctor, you get kind of like an X-ray, and you can get recommendations to actually prevent cancer happening within this 3 to 5 years. So I think AI and SaMD, this is future of healthcare.

Saul Marquez:
Agreed, yeah. And just to highlight, I think everybody captured it as SaMD, as Software as a Medical Device, but just to make sure people understand that, and yeah completely agree with you, Weronika. That’s the Holy Grail, right? Prevention. And that is the direction that we’re heading in, and it’s super exciting. And then the problems of accessibility and equity, right? These are all opportunities that now technology is giving us, so super exciting. Look, I love our conversation, Weronika. We’re here at the end. If you can, just leave us with a closing thought and where you want the listeners to learn more about you and the work that HTD is up to.

Weronika Michaluk:
Definitely, so first of all, once again, thank you so much, Saul. It was amazing to speak today with you because, again, as I mentioned, I used to play soccer professionally. So I can tell you like the sport is within myself all the time. So what I always say it’s, like it’s very important to stay focused on your goals. And even if you face, if you are faced with challenges, do not give up. Just keep on doing what you love, and you will achieve your goals, and also be adaptive because the world is constantly changing, especially healthcare. So, I think that flexibility can be your greatest asset. And another thing is never stop learning. I actually, also last week, I told my CEO, Zack, that the more I learn, the more I think I have to learn, and again, especially in SaMD, because, like there’s so many new regulations that you have to keep up with, etc., etc. But if you do what you love, it just makes you happy. So the last thing that I would say is the most important is to keep on doing what you truly love, and passion is your driving force. And that will just lead you to amazing accomplishments and achievements, so that will just make you happy. Also, as you ask me, how can you find me? So, for those listeners who would like to connect with me or just see my work, please feel free to connect with me on LinkedIn. I can share the link with you so we can then share with the listeners. I’m active on LinkedIn, and also, on LinkedIn, I released bi-weekly articles. So at HTD, we have SaMD, Software as Medical Device, series that we release every two weeks. And actually, the objective of this series is to explain for our readers what is SaMD from scratch. What is SaMD, how to build it, how to classify it? And also we share our tips and tricks, our expertise, and our experience. Really, if you want to learn more about SaMD and our work, just connect with me on LinkedIn, and then you will be up to date with all the updates. Also, if you would like to learn more about HTD, I will also share the website, the link to our website, so that you can also find my email over there, and we can stay in touch, definitely, but once again, keep on learning, stay curious, and don’t hesitate to reach out if you have any questions. Thank you so much.

Saul Marquez:
Weronika, thank you so much. And folks, hope you got a lot of value out of today’s episode. That is the beginning of it. The value continues by taking action, and maybe that next action is taking a look at the series that Weronika has put together. A lot of thought and effort has gone into that for your benefit. So we’ll make sure to link that in the show notes, as well as ways to get in touch with her. Weronika, thanks for today. This was fun.

Weronika Michaluk:
Thank you so much, Saul. Thank you.