Digital Transformation and Patient Safety Featuring Sarah Haake Schäfer and Sarah Panten

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ladies, what do we have in store for us today?

Thanks, Sean. So, Sarah, should I start because you are still in the car. Is that okay?

So I will stay as well in the car. So yes, but of course, stop, please.

So 1st of all, Sean, thank you so much for inviting us. And I mean, you probably know that this is our favorite hobby or topic. So we are talking the whole day about digital transformation. So it's a pleasure to have the opportunity to have the discussion today. And so Sarah and I. We have prepared a few slides with some content. But of course it shouldn't be a monologue here so hopefully, if you have any questions, please. Yeah, add your questions here in the chat. So I have the chat open on the second screen here, and I'll try to have a look at the chat as well. So that we have a yeah, as Sean said, Yeah, an interactive session today. And hopefully, I am able to share my screen. Let's see.

where do I find the possibility to share the screen? Let's see there it is is it working.

Yes.

Sean is nodding. Okay, so we thought about how to start and what kind of what should be the focus topic for today, because digital transformation is a huge buzzword. I think we can talk for days about that topic. But yeah, maybe let's start 1st about about the pain that we have in our industry. And Sarah, I mean, you're working for a medical device manufacturer. So, Carl, size you probably know much more about the pain on a daily basis. Would you like to to? Yeah, start with an introduction about the current situation here.

Yeah, of course. So I would not raise just just with us, but of course, in general with manufacturers. So what I listen. So some of them already sent. So for Europe, of course. 4 years back, the 1st technical files into notified bodies and they didn't get response or couldn't release their products. It's still a little bit of challenging with the new requirement of cyber security. So in an international environment, there are a lot of there are a lot of submissions already sent back, of course, to the manufacturer, just for the reason, because they forgot cyber security or even adoptions of new requirements. And there are so many things for interpretation and misinterpretation in the requirements that it depends on the reviewer sometimes how to interact and how to react.

and even on the other side, and in the manufacturers itself we have a lot of additional requirements which which we need to analyze and need to bring into the organization on top to yeah, re-registration and and all of the other things. On the other hand, if I switch to the side of the notified body. the notified body is claiming as a technical file is not good enough. There are too many mistakes, and it's they they redone the review many times a lot of measuring activities, and so on. So I would say, from my perspective, this, this are the main points, for now.

So yeah, a lot of inefficiency, I would say. And when I was working for a startup company in 2014, and we started from scratch right? There was no documentation, no processes at all, and I was responsible to implement the processes to lead the development project of the medical device. And it was like, after 2 or 3 months, that it was just too much documentation. I wasn't able to handle the complexity and also to track all the changes and what really was annoying. And I know that a lot of people are frustrated by that is, when we create the different elements of the technical documentation for medical devices.

There's a lot of copy and paste of information, and you have to do consistency checks at the end, and a lot of reviews to ensure that all the required content is there. And in summary there's a lot of manual work. And if we have a look at other industries, for example, like automotive, they are working with software tools for development for so many years. And in my former company in the Startup, I said to my superior look. I can't work like that. It's super inefficient. Can we please start to implement the software here? And that was really eye opening for me? And if you have worked with the software and digitalized processes, then it's it's just yeah working with word and excel is like going back to stone age. So for me. That was an eye opener, like 11 years ago, Sarah, in your company. When did you start to think about digitalization of processes and the documentation.

So, of course, requirement tools or Erp system was already there, right? So big big company. This was not the topic, but of course, for going, for reviewing the technical documentation automated, or even to use different tools for quality management system, or to bring and to streamline what you described as well is the most inefficiency. All the things started around about 6 and a half years ago, maybe round about 8 years ago, with the 1st thinking of how we need to implement the Mdr requirements and how to gain efficiency by reducing the burden of redundant or rework of the whole technical documentation. And then the 1st real project starts round about 5 years and finally ago.

where we implemented or started to implement or to buy. Of course. Firstly, then, the 1st requirement tool on top, and we have by heart a lot of software solutions. But of course not for the purpose of streamlining technical documentation, or even helping for getting submission faster.

But you had the vision to have one day a fully digitalized process landscape right.

Yes, so, of course, dream big. Right? So yes, it's good that like I said some years ago on the meetings. So I said, I want to have the in Germany, Ireland. So, of course, the animal which can solve every problem. And this was my starting point the last time. Of course, as I jumped in into the whole topic of digitalization. And yeah, I want to have everything in just one tool. So this was the 1st idea.

But I mean honestly, I think that your company was one of the 1st movers, because when I have a look at the current situation. There is still a lot of companies who don't have that big picture, that vision. As you said, maybe they started with a tool for requirements engineering, maybe test management. Some companies also have digitalized their risk management process and documentation. But I haven't seen a lot of companies who really have that vision of a integrated end to end digitalized process landscape. So I would say that your company and your mindset was one of the 1st here in the industry, at least in Germany. I don't know how it is in the Us. Or other countries, but so here on the slide, where we have summarized all the pains that we currently have. So like you, said one side is the side of the manufacturer, and it slows down

the development of new devices. The submission, the review cycle and 3. I think 3 or 4 years ago, when an auditor from Tufsud mentioned that they need 80 to 90% of their time just to search for information. I mean, you pay those people right, a lot of money, and they search for 80 to 90% of their time just to find information that's super crazy. And I mean, the session is also about patient safety. The effect is that new devices come later to the market, and that manufacturer have higher burden here have to pay more money. It takes more time. So at the end the patients suffer from the situation right?

And I think there's also one where you're saying. Somebody raised the hand. but I can't see the name, Leonard right.

Yeah. Leo.

Do you? Yeah, do you.

Yeah, I have personal experience as an auditor from Tuv sued, and also Nsai and I wouldn't totally agree on the review side. As a reviewer. It was really manual and really hard and arcane to deal with. I left auditing probably about 3 years ago now but back then and way before TV suit was way before it was really painful.

So how many pages in in the submission do you have to review round about like hundreds, thousands.

Yeah, in that range it varies, depending on the product. And I dealt with mostly electrical equipment or active compliance.

So complex devices.

Yes, very much so.

Yeah. And was it frustrating for you.

That's an understatement. Yeah. My head against the wall would be a nice way to put it.

Okay. So you would also then agree that this is a situation that we should change right.

It would help everyone, and it speed up the process. And since we have such a backlog with notified bodies getting prost product certified, yeah, I think it would help everyone.

For sure. Yeah. And luckily we see more and more companies that started their digitalization journey. And thanks, Sean, that we also put that topic here on your agenda, so I think it's time to change it. And, Sarah, I think there was a Linkedin post from you where you said the time is now, so we have to act now, right.

Yeah. yeah. So of course, it is not not just time for waiting any longer. Right? And you can't say it's gone. Of course you have to have it otherwise, you're not capable to scale the business and to support the business and make the product available. For the different markets. Of course there is, or there may be might might, a topic for for smaller companies that they just started in paper. But even for this companies I see their big benefit if they generally started in digital solutions.

Yeah. And I see that there's a question in the chat. What do you mean? I guess, by digit digitization, and we have a slide for that. So we will explain the words in a second, because we thought, what kind of content should we talk about today in the session? And we thought that we would like to share our experience with digitalization project within the company. When you want to digitalize processes. And, Sarah, you're not only working for Calt size. You're also involved in some industry associations who are also working on solutions. Right? Maybe you can say one or 2 sentences about your role here.

Yeah, of course. So on one hand, I'm leading regulatory from a very strategic point point of view. And, on the other hand, I'm as well responsible at Spectarius Industry Association for the working group of digitalization. So what we do there is we bring a group of people together and share as well. A lot of knowledge which comes comes then automatically in the room. If we start to to bring one, or just just one problem in the room, of course, and what we released some some weeks ago, of course, was a white paper. It's currently just available in German. So I'm sorry.

But of course, you can reach it via the spectatus webpage and you can download it. It's a full explanation. What you have to consider how you have to digital start digital projects where to get funding, how to how to do this. Right? So it's a paper full of experience from different people. So this was the 1st project we realized with the working group of digitalization, and the second one was now a workshop, where we explain each other about how to use AI and what are the topics of using AI for regulatory? And it was really, I would say, eye opener for the whole group. What is still, or what is in the meantime possible for using AI for reviewing activities, or even for bringing content together for rewriting, and so on. And there was a lot of experience change.

And on the other side we give as well a lot of different companies which provides software solutions, the opportunity to present their software solutions for the group of Industry Association members, and sometimes even just interest parties which can also also add there. And by the by adding. adding this as well, I'm also in the empty. in the European Commission, in different groups there. And so yeah. So of course, I don't have a boring life. Of course I would say.

And so that the white paper is, is it like 40 50 pages or so? And there's really a lot of content. And I mean? You said it's in German, but what works pretty good is if you upload it in Chat Gpt, and ask for a summary in English that works, and then you have an idea what is in inside of the white paper and also the key information. So. And I think, Sarah, you planned that one day it will be available in English, right?

Yes, so cross the fingers that we can publish it soon in English and as well with our Chatbot, and there is as well the possibility to bring it in to different learning language models as well, so that you already can chat with this paper and get all the information out of it. So there are a lot of possibilities there.

Yeah, looking forward to that. So you said that the most important starting point, when you think about digitalization is the why? Right? So, and you prepared a slide for that.

Yeah. And like, I said, so it's now, now is the time for going for moving. So and by now, of course, we have all the different technology tools available that make speed or that can generate speed. And we are currently in a very fast technical disruption. And this fast moving increments, and we are as well requiring agile compliance models to fulfill the different regulatory requirements. So if we just wait for somebody will solve the problem as an example I shared earlier. This is cyber security.

If I just wait for somebody will solve it. No, there will be no nobody solve it. So I have to create something and bring the requirements in. Otherwise the markets are dead. Of course.

And I mean, like you, said cyber security is just one aspect. So we have more and more and more and more regulatory requirements and faster changes. So it's also the complexity that is challenging right.

Yeah, so maybe yeah. So of course it is. It's a difference between navigating into the regulatory landscape. And if I just have to consider one country. It may be not so so difficult, but it depends on the product. It depends on the country. It depends. So, of course, the word depends. You will always hear from a regulatory person. Right? It depends on the circumstances. And what we see is currently that the navigating into this complexity is really hard. So if even if you want to scale the global business, then you have to consider maybe just 100 or whatever different country country legislations. And then, of course, in each country there are special things.

Of course, we have into the different companies as well, old techniques. So what I? What did I mean there? And you you wonder, maybe, why I point this out? But of course. even old Erp systems, even old it infrastructure which are available at the different medical device companies, or even general companies, make, as well as not quite easy to implement new tools and new technical alternatives. Right? And then, of course we have as well the knowledge gap so many people don't even know. So I had during the last weeks a very interesting discussion with a friend of mine, and he always mentioned, I never know what I have to ask in AI. So if I don't know the question, I can't get an answer.

So it is not just the just the starting point of how to how to go into the world of AI data and cyber security. This is one part, but the other part is we need to make the people capable to use all the different tools and what they, and explain with some examples what they have to raise as a question. Otherwise, we we have there still cultural challenges as well. And there's a lot of resistance into the organization which said, Hey, I don't want to have another change. Right? So why did I have now to change into digital? So I love my paper.

Thanks, Sarah, and there's a question or comment from Alan.

Yeah, Mike, thanks. My question has to do with this last issue of the edge. AI education. development, and training. And it. It's kind of a 2 part. Question. One is, what is the regulatory affairs community doing to educate your stakeholders in this process of using artificial intelligence to do what you do. And the second, it's the same question. I'm a a surgeon by training. So I deal with this issue from the physician, entrepreneur, med tech, innovator perspective. And it's the same issue. How do? How do we incorporate artificial intelligence in the initial innovation, discovery, transformation, commercialization, process?

And and how do you integrate the 2 parts? So if I'm AI naive and you're not, you're fairly advanced. How do we? How do we become bilingual. What? So? How do you? How are you dealing with that.

Yeah, I would say, education, education. So really identify what kind of knowledge someone needs in a in a particular role. And then, yeah, try to identify possible like, I don't know masterclass or training training sessions, or maybe also invite consultants to bring in knowledge and and let them help help you. But maybe, Sarah, what are your thoughts about that.

Yeah, of course. So on on one hand. So the workshop which we created in the Industry Association with people which are interested in to learn about it really helped, of course, for for that. So we generated a lot of of questions. Of course we collected them. We shared examples where to use AI, and so the next one will be how to use. So everything starts like Sarah nicely switched the slides. So coming from this as well, so the vision before tools. So you have to have an idea for what? You need something. And then you have to erase the question, why, what? How so it starts

even with the strategy. So and without this strategy, transformation effort will later not be possible on one hand, but, on the other hand, coming back to your question. It's just it's just it's training, it's exploring. It's to be brave, of course, and to try new things. Try to to raise questions in in an eye tool. And even firstly, it starts with, in which environment I am able to use an an AI. What kind of data could I go send into? And what is a bias then? And so on. So of course, you have there both ways the bigger companies which are selling software as well. They already implemented AI solutions in their software. They trained them in accordance to the data which are available and the structure their software solution solve.

But, on the other hand, yeah, for sure. So we have the different different participants. If you talk about surgeons. So maybe it is an application training Academy, which we need to think or rethink on the side of the from from all the manufacturers, as well.

Hmm! And I think there was another slide from you right.

Yeah, so I,

That's more on the processes, on process, perspective.

So of course. So the biggest. Why? So why did we do all these things in digital transformation? And I know it's a lot of words here. Right so. But what I want to bring here is we don't do regulatory purposes, or of course we we finally what is our biggest purpose. Right? So Sarah and I discuss it very often. So we want to give the the patients the opportunity to solve a problem, so to help them to get a better life, to treat them, to to make therapy, and so on, to have a diagnose, and so on. So finally, if we want to ensure. Then, with creating medical devices, we want to ensure this, then we have to have efficient, transparent, and adaptable processes depending on.

Sorry you went on mute. Go off mute. You're muted.

We can't hear you, Sarah. Now you're back. Yeah.

Now I'm back. And yeah. So of course, what is relevant is the efficiency, transparency and the adaptability of processes internally into the manufacturer to make available a fast fast product. And but of course, what did we want to change into the world of digitalization? We want to cooperate. We don't want to have zeros any longer with into the different departments we want to think end to end and and as well, we want to to speed, and we want to integrate compliance so that nobody really have to recognize. Oh, I have to think about that, or that. So it should be an automation.

And to think about the integrated compliance, to have this there, and to continuously demonstrate, then, the safety and performance for product and as well as a quality management system, not just for the product, but as well for the quality management system. for internal purposes, for having remember internal audits, or even for external stakeholders like notified buddies or different authorities. So I would say. something like this is the bigger vision. And with this vision the strategy starts, and then you can start to. to change and to switch into the digitalization.

And maybe we. That's the point we should. We should talk about the words that we use.

Yes.

So, and I've put up a few words here. So the digitalization is like, I said, it's a huge topic. And, Sean, you announced me as co-founder of the Mdku, which is a nonprofit organization, and I will talk a few slides later about that organization. But it's like I said, nonprofit. So it's voluntary work. And my paid job is actually that I'm working for a company that implements software and develops software. And I thought that it might be really helpful if I share some of the insights with which I'm dealing on a daily basis. And when we start to implement software in the company. The 1st question, like Sarah said, is that there is resistance. People are like.

What should I work with another tool? And what is transformation? And so on. But, like Sarah said, if we really want to support patients at the end, and I think that's our shared goal here in the industry as a company. We want to ensure that we are innovative, that we can bring new devices on the market here. Right? And if we, if we have that long term vision. We have to think about the digital transformation of the organization with the overall goal to become future proof, efficient, innovative through the help of digitalized processes and integrated processes. But that's just one step, the other step. That is important when we talk about digital transformation is that we also change the way how we work.

Yeah. So that's it's a huge, huge project to transform a whole organization here. And how does it start? So if we have a look on the left side. Here we, the 1st step is that we need to switch from analog formats of documentation to digital formats. That means we need to convert information. So that's the 1st step, and that I mean, some years ago we started to scan papers and work with Pdf rights. That's the 1st step we typically say that a Pdf is a dead document. There's a lot of information inside, but we cannot process it. We cannot efficiently analyze it, summarize it. Maybe with the AI nowadays. But it's not really digital format that allows us to connect single information and really integrate information here.

So the 1st step, when we only digitize information. So, for example, we scan a word, a printed document and have a Pdf, that's a digit. That's digitization. Yeah. And then we can organize information. So the Pdf on a share file, for example. But when we talk about digitalization, and that's a slightly different word here, we mean that we use digital technologies and digital data formats to transform the way how we work. And then we can automate processes. And then we can optimize processes and the overall goal. When we talk about digitalization here is that we want to transform a single process or single process steps or an organization within your company. And yeah, increase efficiency here. And you know what? That's so nice that we have those 2 words. So digitization and digitalization, because in Germany we don't have the 2 words. We just have one word. And

it's super hard to explain people. You know what digitalization is, not digitalization. There's a difference. And that's that's really really great in the in the English language that we have. So there was a question in the chat, what does digitalization really means? I hope that this question was solved. Otherwise let me know if you need a few more examples here. But I hope that that helps to. Yeah, to tell you that you know. Okay, what are we going to talk about on the next slides here? So when we start with that digital transformation, there are a few elements that are necessary. The 1st is that we need to convert the process and the data that we create as part of the process and then optimize the process.

The second part is like Sarah said, we typically have some software tools somewhere like Erp system, like sap or so. And we need to integrate the different systems. Right? So we need to remove the barriers between the different silos and the different processes here. when we have that, and we start to document a process in a digital format. Then we have the possibility to work with. The data, have, like digital dashboards, automated notifications, and so on, analyzes, automated creation of reports, a lot of opportunities which we can only use when we have done the work before, digitalize and optimize the process here.

And in particular, when you're a company with different locations across the world. It's essential that different people from different time zones and locations have access to the data. That means there's also a lot of that. You have to change in your infrastructure here. So a lot of technical aspects. And I'm not an expert here. And, Sarah, I think you're also not an expert here, so we will not talk about that aspect. But what is important at the end is that the people who should work with the software who should work with the digitalized process. Here they need to be empowered to work with the tools.

And at the end it's change management and a new digital culture that a company needs to. Yeah, be successful with the digital transformation. And if you have the goal as a company to improve your processes and work more efficient, agile, and improve the quality of your process and the documentation. You must not forget that at the end. It's about people. And it's about the change in the mindset. And what we see a lot is that such projects are started like it project that some guy from the it is leading a project, and that they don't involve the people that are actually working with the 2 later on. So it's not about software. It's about the people at the end. Correct? Sarah. Yeah.

Definitely. It's it's not an it project. It's, of course, a shared project ideal. Otherwise it needs a driver which has a lot of experience on both, or even on data, and even on regulatory and quality.

Hmm. so, and the next step, if you want to understand, how does a typical digitalization project looks like, here's an overview. So typically we start with a situation where a process is based on word or excel files here. And the 1st step is really that you start with the transformation of the process and the transformation from documents to data. And that's quite challenging. And so we see that a lot in the project, when I'm on conferences presenting what we're doing, that it's really difficult to explain to people that there is another option to work besides the documents that we have worked with for ages. Now, right? So we can also work with data instead of documents. And we can also combine data with documents.

And we typically say that a document is only a representation or a visualization of information in a particular context, in a particular sequence or order. Here, right? So 1st step is really, we analyze the process. And we analyze which data which data sources are used. What are the interfaces where we get data from? And what is the source where we can get the data from and based on that, we can define requirements for the digitalization of the process. And for that step you need people who understand the process and who understand the regulatory requirements. So you need quality and regulatory perspective.

Then the next step is that we digitalize the software with the help of a software solution here and here you need now technical expertise. So people who understand what is the system architecture? How do I model data models here? How should I define rights and permissions? So who should have access to which data, what are workflows, for example, like automated notifications, review and approval processes? And then, of course, there is a testing phase. We talk about the migration of the legacy device data. And as part of that process step, there's also an activity where you create the documentation for the users, and, of course, training material here.

And then the next step is, and you probably heard about that the validation of the implemented software without validation. We can't use the tool right? So the validation has to be done according to the internal process of a company. Then the final solution is deployed on a productive server here and then, typically, we have training of the users, and we have initial training. But we also have recurring training for updates and new users, and so on. And if helpful, then there's also the possibility to migrate the old data and continue to work with the data now in the new format here and.

1 1 adding, here, of course, it is also helpful to have their scent boxes, so not going directly into the productive topic, so of the productive system, so you can use their different kind of sandboxes, which you then even can use for the future.

For predicting.

What kind of consequences have regulatory changes. So there are also different concepts available for doing here. Dressed.

Good point. Yeah, so that people can try out and and get to know. Get to get familiar with the software solution here, right.

Yep.

Yeah. yeah. And the last step. And that is really important. And companies quite often forget that when the software has been implemented the project has not ended here. Now the real work begins, the transformation of the way how you work so the users need constant support to get familiar with the way of the new working. And what we also recommend is not simply migrate the data as it is, but transform the data also, because what we typically see is that you have to restructure the old documentation with word and excel files into a completely new format, because working with data models is completely different than working with documents at that point, and.

But.

Yep, Sarah, of course you can use the example with the intended use you.

Give, of course, just to give everybody here the hint. What did you mean? Of course. in the past it was intended use was in round about 30 different documents. And now what changed.

Now we have a single source of truth, right? So.

Yes.

Yeah. And people get used to the new way of working here, they need support. They need ongoing support here. And typically also when the people work with the software tool. Then they have a lot of ideas. How you can further optimize the process. So we always say after a release of a software implementation is before the next release of a software implementation. So it's an it's really an ongoing process. When you start with digitalization of processes here, and what you can also see on the slide again on the bottom, that in that phase it's also important to have quality management and regulatory people involved as well because they are the experts for the process for the regulatory requirements. And if there are any changes, any regulatory changes, you have to update the process and the software as well.

So let me check the chat. So there was a lot of discussion in the chat. There was one question, what are some of the processes you found most valuable to automate. So I would say, all medical device lifecycle processes are somehow linked to each other. Right? So we have requirements linked to the risk analysis linked to usability, engineering or human factors, engineering in the Us. Wording to clinical evaluations in Europe, and so on, and so on. And whenever you have information items that are connected to each other, it makes sense to digitalize the process so that you have a full traceability of information across the different processes here.

So and when we, when we digitalize processes here and we talk about data models and content, what we have realized over the last years is that the more standardized data models we have the faster is the implementation of a software tool here. And I think there was also a comment in the chat, like something like user structure that is used for pharmaceuticals, I think. And 6 years ago we had the idea with a group of people to develop a unified data model for content of the technical documentation for medical devices. And there was no group working on that at the moment. And we also talked with a lot of different institutions here. And as a result, we founded the nonprofit organization, Mdku. So medical device knowledge units. And yeah, a few years later we are close before the 1st release of the 1st version of the data model.

And what I have to say here is that currently, the work here is really focusing on Europe and the requirements of the medical device regulation, because it's a huge and complex topic. And we said that we have to start somewhere, and that's the reason why we said, Okay, we have the most pain that we have at the moment is in Europe with the Mdr and Ivdr. And that's the reason why we said, okay, let's start with the development of with such a unified data model with the focus on the medical device regulation. So that's the idea that we have a standardized data model here, and that we can use for acceleration of digitalization and to reduce the complexity of the regulatory language that we're using.

And I could talk about the Mdku for hours here. And I have prepared. Yeah, of course, that's the key goal that we have to reduce. The costs get faster market approval enable more innovation and, of course, better patient care. And there are a lot of information on our website that you can check out. And we also prepared an Miro board with a lot of information about the Mdku, how we develop the data model, and it's available for free. So you can access the information. The Myro Board has a password which you can see here on the slide. So feel free to go to the website or the Myro board and check out what we're actually doing here.

But there's a question from Faizan. I think.

Yeah. Hi, so I'm working on something similar to what you've described. Like, going from just digital documents like word and excel files to like a proper like system. So I just like have a little bit of confusion like. So, to give you an example. I have a assembly process procedure and assembly procedure. That's like, in a word document. And when I have to like get it approved the reviewer can see like this was the last document. These are the changes that we have done, and this is now the new assembly procedure. Right? But if I do it in like a software where, like the end user, the technician, he can see the summary process. And he's just writing the values or like doing the check marks. So how do you control the changes and get them formally reviewed? Because in a system, if the Admin does the change. Now, that's the latest version.

Yeah. So what you're talking about is is basically to digitalize a production process right? And I, I haven't. I haven't worked in production before. But what I have heard is that typically there are specific software solutions for production processes. And as part of those software solutions, there's also a what's it called version control system. So they have it because they know that you need an audit trail to be able to show the the different versions of the procedures here, but honestly, have never worked with such a software because I was always involved in product development processes, you know, like design control, risk management and so on. But maybe, Sarah, have you seen software solutions for production processes?

And yeah, of course, if you work with Slp as an example, use signavio as an addition. So, and then you see in Signavio very easily, the whole version control and and everything. And there are also some other tools available which I saw. Also, if you send me a message, I can also share it, or we can edit here later on. So there are different possibilities. So sometimes it's just with an increment which is fixed, and for circumstances, so that you can review that this is the least version, and there are as well quality systems available at the moment, which

do all the rewriting of procedures by their own for production, so and releasing them by their own. Of course you can decide how often how often you want to release their something.

Was that helpful.

Yeah, yeah, the version control thing. I'm kind of familiar with it. So I think that I kind of answers my question, yeah.

Thanks.

Perfect. Okay? So, as you can see, there are a lot of things going on or yeah in the last years, and at the moment as well. So a lot of things are changing here. And what Sarah and I agreed when we prepared the content for today is that we really want to point out how important the people are, and because the people have to work with the software at the end. and so on. That slide. Here is a statement from a customer that I received a few weeks ago in an email, and that company implemented a software tool like 7 years ago. And they implemented the software like an It project. So it really was initiated by R. And D,

and the statement is from an R. And D. Director. And he said. I noticed persistence to digitalization and the tool in our company. The reason what people are saying is they don't have time for such new tools and too much to do, and he asked me to work together to highlight the advantages, and why the team should start to invest time in a new tool and the change of the process. And that's what we really see a lot that companies don't think about the mindset change, and really to involve the people here. And I also summarized the key learnings from my perspective here when you start, digitalization projects. So, as Sarah pointed out at the beginning, it's very important that you have a clear vision where you want to go as a company in the future.

Why, you are doing digitalization projects. So what is really the benefit here, and you have to communicate that over and over again to motivate the people, to get involved in the project. And you have to set realistic goals. That's also what we see a lot, because such project really requires time. And the bigger the company, the more time you need, because the more stakeholder you have here. then the second point is, I know that in the medical device industry we all know the waterfall model right when we develop something. This is not working for digitalization projects. It's not so. You really need an agile iterative approach.

And when you plan the project, it's also important to plan a sufficient internal resources. So even when you have external partners that support you with the implementation, you need people from your organization that are involved in the project that are involved in the when you derive requirements, who test the implemented solution, who play with the sandbox like Sarah said. and of course they have to do that beside their normal job. Yeah. So that's what you have to consider when you set up such a project.

And even to add as well. So you have to accept and inform the business that not everything is in parallel possible. So you have bring this to the awareness of the different stakeholders, of course. So we need. So this is a prerequisite to be fast in the future, to change everything right to have their get them more output. This is really the I could say infrastructure. I use this wording here so and and this is really important to understand, for for every stakeholder, otherwise there will be too much pressure, and the people are overloaded and overloaded with additional projects and additional projects.

I'm gonna make sure we get to everything. So please put up all the do's and don'ts that we can read through them in case we don't have time to.

So.

Every single one of them.

Yeah. So basically, that's what we already mentioned, I think, involve the people. Ensure that you have all stakeholders on board communication, very important user support and the don'ts is, don't expect that you can digitalize a process as it is. Really, it's important that a transformation is needed. What else was not mentioned don't underestimate the complexity. I just want to say that digitalization projects are super complex. And basically, that's the key message. And the last slide sean, when we talk about digitalization, it's more than a software. It's about people and mindset shift.

Yeah, I agree completely. I've been integrating software and information solutions into life science companies for 2 decades, and the resistance to change is not to be underestimated, not only the resistance to change from the end users, but also this idea of oh, look! We built this better tool. Everyone's going to want to use it, and it couldn't be further from the truth.

Actually.

They're extremely resistant to change at almost every single level. And so what I would do is I would actually write marketing campaigns for the software to be launched inside the company, because if we relied on the information professionals inside the company to do it, they didn't do a very good job. they said, well, we sent an email. And I'd be like, you need to touch these people with every channel you need to push the information to them. You need to remind them. Remind them you need champions. You need pizza parties. You need. You need all sorts of things, but they're not going to do it just because you built it

so on that note. I would like to turn it over to Mark to do our AI minute. Thank you. If you can hang out for a minute. I would like to introduce Mark Omo from Marcus engineering.

Hey? Can you guys hear me? Okay.

We can. We can.

Awesome. So today, I want to share with you guys something really cool that just came out. Called vo, 3. So it's Google's new text to video and image to video model. So it's available through Gemini pro, which is their Google's paid Llm Chatgpt type, product. Lots of people. You might have it for free with various other Google services, payments, that kind of stuff. And it can generate video with audio from images. These things have been around for a while, but this is really the latest generation that's really useful and good and doesn't produce some kind of like dystopian, misshapen, weird output.

So these videos are limited to 8 seconds, which is actually still plenty for lots of really cool applications. I'll tell you real quick how you should prompt these systems. So the main thing is, you got to tell it. What you want the video to be of the context like, what is it around, what's there? What's what's inside? What's part of your system? The actions like what's actually going to occur. We don't want a video of an image that would be a big waste, the style. So you might want a 3D cartoon. You might want an animation. You might want something moody. You might want something clean and professional and bright.

Camera motion, so you might want a static shot zooming in zooming out composition. So this is, do you want a wide shot. Do you want a close up shot? If you have a small thing you're trying to look at, you have a very large video. It may not be useful, or vice versa. If we see just a teeny pinhole that's not going to be useful as well. and the last one is the ambience. So the mood, usually light and professional. Sometimes it might be. You know, I said, dark and moody, is fun, but not terribly useful. That kind of stuff the main thing with this thing, or in the last one, I should say it's special about. This is the audio, so you can do speech of sound effects, descriptions, all that kind of stuff.

The main thing is that you got to be descriptive. It can't read your mind if you tell it to make a video, and it makes something completely different that you might be like, oh, that's that's obviously not for my application. It doesn't know. It has no idea you have to tell it. And so their Google has a great detailed guide for how to use this. The application I thought, was really interesting is generating product demonstration videos from renders. So I often get these Pd renders from people, and you show it to the investors, or you show it to the users, or you're trying to shared around the team. They're like, Okay, but what what do you do? How do you use this product? And so it can take this image and turn it into

a actual description. So here I have the prompt that I wrote, and I kind of highlighted the different parts. You know the shot type. You want what it is. You know, the action that we want to have. We want the user to reach in and press the button as it glows, and then try to play a sound when we press it. The display should respond, it should be animated, and we should zoom in on it to kind of see this start happening? And sometimes we want to tell it about the aspect ratio we want and the the tone as well. And so you can use Chat, Gpt, or Gemini to help you write good prompts. So I can share the video here. And we can. We can try to do it live, which always works really well.

let's see, all right. So here is my window. and so I can go ahead and copy prompt. I have here and paste that in. And so I actually want to hit video down here. So generate video with Vo. and then add it in, and you can add a photo. And I think this is the most powerful part. You can generate stuff cold, but it often doesn't come out like you want a video helps frame it for the system oops. Something went wrong. Oh, no. See this. This frequently happens. It's a new service. It might also tell us that it's busy and I have a backup prepared. All right. I have a backup prepared. It would work. It was working moments ago.

so here is a video from this prompt I generated earlier. So this is the just clean from the image. It animated it. You come and you press the button. You see lines come across the screen. Your engineers will yell and say, that's not at all what the blood oxygen level looks like over time. But that doesn't really matter for your investors or for people trying to understand how the product is used. What the feel is that kind of stuff? Yeah, does anybody have any questions?

That's great. Mark. Thanks thanks for sharing that with us. We're at the end of the hour, probably a little over. But if you have questions for Mark. Please connect with him. His name is Mark Omo, probably the only one on Linkedin, and please feel free to connect with him. I want to thank our speakers today, Sarah and Sarah. Thank you so much for the wonderful presentation on digital transformation, such a huge and relevant topic. And I think that. Yeah, I was thinking about it in terms of you know, if you're going to position yourself in the regulatory and quality space as an expert. You cannot overlook this area.

You know a lot of people with those jobs are going to get wiped out by AI or change dramatically, at any rate. And I think that in order to prepare oneself for that, it's important to stay as educated as possible and to actively participate in any opportunities that you have for digital transformation in your own company, in your own projects, and to embrace the wonderful technologies like the one that Mark just showed us any closing remarks. Sarah Sarah.

I have to unmute myself. No, thank you very much, Sean, and I think, like you said at the end, it's communication. What is important most important aspect, communication.

Yeah, I would also just thank you. And even adding, just with communication people. So getting people with you. helping to understand have the calm as well, to understand their situation, and to bring and to give them the opportunity to try and error by themselves what's even possible, and don't give everything up front as a solution, but of course, being there to help.

Awesome. Thank you. I'm putting my email in the chat. If I can type my own email and if anybody wants to submit their comments for the crowdsource. Linkedin article. You have an hour to send them to me, which is what do you think are the biggest is the biggest challenge or barrier to digital transformation. Given what we've learned today from our speakers. Thank you again, both so much, you know. and and and send me a sentence or 2. We'll publish it, you know. and your name and link to you, and then everybody can go about sharing the article. Have a sharing fest, you know, support each other. Be kind to each other. Have a great week and a great weekend. Thank you. Everyone for your time and attention today.

See you next week, Ronald Bauman with Baumans, with Prr. C. Mini masterclass. Thank you all.

Thanks, sean.

Bye, bye.

Like.

Bye, everyone.

Next week.

Bye.

Bye.