Weronika Michaluk 0:06
Steve, hello, everybody. Welcome to this session. Whether you are here because of your passion to software's medical device development or you just mistook the room for a coffee, I promise you this session and the sessions of my presenters will be definitely more stimulating that the best shot of double espresso. So my name is Weronika. I'm a principal and software's medical device Practice Lead at HTD health. And at HTD , we specialize in design and development of software's medical devices. And myself, I'm biomedical engineer called an MBA and Doctor of Public Health, and I am truly passionate about what we are doing as we are supporting organizations like you to design and develop best in class software as medical devices. And I want you today to think about software as medical device design and development as kind of a hiking up the mountains as we are at the emerging summit event, we are we're going to emerge to the summit today, and I want to be your guide of this amazing journey. So what we're going to talk about today, we're going to talk about achieving the mission impossible, which is accelerating some development while decreasing the cost. But before we jump into the main topic, let me ask you the question, how much do you think does it actually cost to develop medical device software? A lot then how long does it take? You know, the answer is, actually it depends. So it depends, of course, on the medical device class on the markets that you are launching it in but you know, it can vary from couple of 100,000 to millions, and it can be from months to years. But the true question we should ask ourselves today is like, how can we make it actually cheaper and faster and still make the highest quality products? So I'm going to tell you today three simple things, as we don't have a lot of time. So let's start with the first one, waterfall versus agile. When we start software's medical device development, we should choose the methodology to follow. So let's think about waterfall as actually a train ride, as a well planned train ride that you know the schedule, you know the plan, but you miss one station and the whole journey gets delayed, and it's not fun to wait for the for the train being delayed, and it's not fun to delay your product development, neither. On the other side, agile is kind of like backpacking. You can adjust to the weather condition, to your budget, to feedback that you get, and it's the same. In software development, you can adapt based on the user feedback, based on your budget, based on regulatory requirements that are changing as well, thanks to which you will optimize the process, decrease the cost and accelerate development. Another thing is compliant starter pack. Again, we are hiking up the mountain, so let's get this protein bar, the rainy code, the tent that will just help you to start off the journey. And it's the same when you develop software. There's so many already existing solutions off the shelf, software, and we at HTD, we partner with best in class cloud provider, solution, backend as a service. And ourselves, we developed modular, compliant starter pack called Shazi, thanks to which you can really focus on your market differentiator and on the end users, and we take care of the rest. So thanks to this, you can also accelerate the development. And the third thing are the right partners. You know, when I was hiking Kilimanjaro, I could do it myself, but the journey would be really hard without my guides that really helped me how to get there. They showed me the way to go. They knew it. They knew that the path and it's the same when you actually partner with the right partners that have been there have done this many times, and actually can share their experience with you, and thanks to that, actually you will not make the mistakes that they have done before, so you will definitely accelerate the whole development, and your journey will be just more enjoyable and successful. So I hope you know these three things, in kind of a nutshell, will make your journey emerging to the summit just more enjoyable and accelerated, as I'm telling you. The software development can be challenging, but once you get to the top, the view is simply stunning, and the feeling of being there, it's also just amazing. So if you would like to chat about software's medical device development, and you would like to embark with me on this journey, or just simply talk about doing a split on top of Kilimanjaro, connect with me on LinkedIn, as I would love to chat with you and help you get. To the top. So enough from me, and now let's introduce amazing speakers, and we will start the session with Robert nussner, the CEO and CBO of BMI Organ Bank.
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