Speaking of Service

Karl Storz Connected Medical Devices Software Service: Speed, Cybersecurity, and Compliance

May 24, 2023 PTC Episode 18
Speaking of Service
Karl Storz Connected Medical Devices Software Service: Speed, Cybersecurity, and Compliance
Show Notes Transcript

Service Your Products Better with a Connected Strategy

Original equipment manufacturers like Karl Storz are looking to systems that provide their customers with the most current connected medical devices software updates that increase uptime, medical device regulatory compliance, and connected medical devices cybersecurity. But those systems must also provide a fast time to value for the ORs that use them. Listen to how Karl Storz address these points and how they keep equipment safe and current in a constant effort for improving patient and health system outcomes.

Welcome to speaking of Service, the podcast that uncovers practical ways to grow service revenue, control costs, and improve customer satisfaction. If you're looking to innovate, gain a competitive edge, or just learn about the latest service trends, you've come to the right place today. Chris Wolf, VP of Strategy Partnership. Joins Marco Zeller, director of Remote Service and I O M T at Carl Stortz to discuss how speed cybersecurity and compliance is crucial to keeping equipment safe and current in a constant effort to improve patient outcomes.

Chris Wolff:

If you've ever been able to lead the hospital with a small bandage instead of an incision and an overnight stay, there's a good chance you have Carl Stewarts to thank for that. For more than 75 years, this brand has been associated with instruments that enable end. Or scope surgery that allowed doctors to do minimally invasive procedures, where in the past you might have involved a multi-day hospital stay and an incision. But that's not all that this brand does. Carl Stewarts is synonymous with the superior visualization technologies and the surgical instrumentation that a accompanies that, that are revolutionizing the way that care is provided both to people as well as to animals. This is great for patient outcomes for effectiveness. For human health, animal health, but it's also great for business. Medicine is a business after all. So the availability of these life-changing, life-saving technologies are important to the revenue streams of the providers who use them. I'm delighted today to introduce a member of the Carl Stewart's team. He's an engineer, he's a bonafide techie, he's also a patent holder. Welcome to speaking of service, Marco. Please tell us a little bit about yourself and your role at Carl Stortz.

Marco Zeller:

Yeah, hi. Yeah, I work for Stortz since almost 17 years and started as a software developer. And I went to different stages at the company from software to scrum master two project management, two system engineering project management and now ending up in the world as director for remote service and I o. In my role today, I'm responsible for the connectivity of our devices to the cloud, making sure we get the data from the devices and establishing the, let's say, the digital backbone for the device to the business communication so that we can establish new capabilities, new value for our customer. Beside the core we have today I know your

Chris Wolff:

customers care tremendously about having top quality, efficient equipment that's readily available, flexible for repairs, but you have to deal with the sensitivity of equipment in a hospital setting that involves patient outcomes, but also the continuity of the availability of that equipment, making sure it's always fit for duty, and that the software that's involved is constantly up to date. That seems like a tremendous array of challenges to both establish the connectivity in the first place and then to provide the over the air updates. Tell me what a day in the life is like for your team and delivering that kind of service. It's

Marco Zeller:

really difficult because the we sit between two chairs. On the one hand we have the cyber teams in the hospital and the IT guys that want to have a secure. That want to limit the access to the machines from the people outside. And that's really important for the hospital and we totally see that. On the other hand the products become more and more connected. And if you have connected devices, even in the war, you have to secure those devices with patches and. The only way to patch those units is to provide connectivity to the cloud and establish a digital way to, to update the units. And this is really a challenge. And it's a challenge for us because we have to convince the it, and we have to convince, let's say, our customer to take over the responsibility to install, for example, the software before the car starts, technician. There is a lot of value in that approach for the customer, but we have to learn how to communicate that because today, if a car starts, technician visits the customer the hospital has to plan the time when the cu the surgeon, the customer technician visits the customer, and during that time slot, they cannot execute any search. So this is a huge block for the customer. And now, Capability to do install the software without a car storage technician, they have the chance to plan it more easily. They can update the units easily during the day. Whenever there is a room available, they can update in the evening without blocking time. So that makes the life of the customer and of the biomed, the technician of the customer, really easier than.

Chris Wolff:

Let me unpack that just a little bit. You mentioned the term biomed, which I think in Europe is a common title, but in the US we might refer to these folks as the technicians who are responsible for the wellbeing of the medical equipment that are used in a clinical setting or in an operating room if the surgeon is the king in the or arguably the anesthesiologist. The biomed or technician really has tremendous amount of authority in whether a particular device is connected or not. How do you convince these technicians to get on board with you and connect the equipment in the first place?

Marco Zeller:

I would say the biomed is easier to convince than it. What we see it today is a change of that role in the past, the world between biomed and it was separat. The, IT was responsible for IT equipment, PCs, and so on, and the biomed for the boxes for the devices. And now that the products, the medical products become more and more PCs, this world is more or less merging together. And we can see that the Biome Biomed needs more and more IT background. And when we talk about connectivity, Biomed is easy to convince because there is a clear value for them. Let's work easier to plan more transparency, that's easy and that's convincing. But on the other hand, we have the IT department with the strict tools. And so I would not say challenge, but the most discussions we really face with the IT depart. They have good questions about security and they have good reasons why they ask questions. And the only way to convince the IT department is really by providing transparency to them, give them the ability to understand what happens between the device and the cloud. And that transparency helps them to do their job, make sure that only data exchange that should be exchanged.

Chris Wolff:

So you have the twin responsibilities of patient privacy. As well as the cybersecurity of the data that's involved in that whole operation, no pun intended. Yeah,

Marco Zeller:

exactly. And we have that weird situation that we have to make sure that we are secure and the only way to make our product secure is by installing the latest software. So we have to connect to the cloud. That's really weird. And more or less contradict. We don't want to have connectivity, but we need the connectivity to be secure. And that's the challenge. And that's more or less the message we have to send out, that we need that to be secure and that the connectivity is not against security. It's the only way for security.

Chris Wolff:

So over the air updates are the most important thing that you can provide to assure your, the devices your customers are using are fit for purpose. Are fit for patients, but also secured from cyber threats. How do you deliver those over the air updates? What are the particular challenges you face in the med tech world? I would say

Marco Zeller:

the biggest challenge for updates of medical equipment is to control, again, all about control and transparency. If you update a consumer device, it's easy. You. Them whenever you want. You can update your Windows PC or Microsoft can update the Windows Pan C PC whenever they want. Even if they shut down your PC while you using it, actually they can just shut it down. Not the big deal for you as a consumer, but in the medical environment it would be horrible if you shut down the OR in all the software. So our biggest challenge is, let's say the safety during a software. So how can we install the latest software on a machine without breaking the safety of the u of the device, of the system? And so at the moment we decided to go the Safeway by, let's say, hand over the responsibility to trigger the installation to the biome. So they still have to go to raw and trigger the button. With that approach, we, like I said, we hand over the control to the biomeds and they have the chance to verify, okay, this or is not in use and it's safe to update the, to our, that's one piece. And the second piece is we really have to make sure that the software fits to the unit. So we heard a lot of challenges. Consumer areas where smartphones are updated and then somehow they have problems and that's not possible in the medical area. All the software updates. Have to be verified, have to be approved, that they work on a specific version of the unit. And so before we can ship a software to the customer, there is a huge process to make sure that the software works on the defined version. On the defined version of the hardware. And we. Do not break anything. If we update the box to a newer version,

Chris Wolff:

that's a tremendous number of variables that are involved in making sure that the right software is on the right machine at the right time, approved by the right person. How do you keep track of that sprawling amount of data and all the different ways that could go

Marco Zeller:

wrong? The key element to everything is to eliminate the human factor of within the whole process wherever a human is involved, there is a risk of making. So the goal is really to automate as much as possible. So we started to automate the whole chain from a final release to the deployment to the unit. So controlling where the software is rolled out, in which region, in which country do we have to registration or not for that software in that area. That's one piece. Really automate as much as possible, it's a journey for us, but we are on that journey and it's a key. It does not only reduce the resources, the people we need to deploy a new software, it really makes that secure and safe, really reducing the mistake. And on the other side, the reporting back, the tracking of the software changes is also a piece that has to be automated. So in the past when the technician went out, they have to fill out papers to track the. The bios have to fill out paper. And with the digital connectivity of our devices to the cloud, we have the chance to automatically collect the information about the units and track those changes in the device history record. So we really know when that unit receive, unit received the software, at which time really tracking of all the changes. And so we. Our tracking requirements from the legal aspects and the standard aspects and make sure we, we really understand how our installed base work works out in the field and where we may have to push a little bit harder to get the latest version out and installed on the units. When I

Chris Wolff:

visited the Carl Stewart's website to learn a little bit more about your company, I saw that service is now an important branded offering right up alongside, the human instruments and the animal instruments. Tell me about getting service provided as a branded offering by the company. When did that begin, and then when did your team enter the picture to start providing, over the air software controlled devices as part of the service? Internally, we

Marco Zeller:

had the discussion of service as a product since a long time. And I would say the last seven to eight years we really start to, to build this capabilities. And now the last years we really defined solid goals for that activity to build service as a value because service is more than just repairing units service. Is a part of the customer experience the customer satisfaction. And that's one key element of that whole move. To provide service as a product, really customer satisfaction, and really make them happy. Increase the efficiency of the products and equipment, make. The customer has create experience with the product from the first day to the last day, and with the last day have the opportu has the opportunity to move to the next generation of our products. That's the story about service and talking about technology and the remote service and iot story. We work on that since I would say 10 years to. Build the base. It's really important to have a solid concept and a solid infrastructure to, to maintain that globally. And all the activities we have today in my team is really to make sure that our latest product support is connectivity. And what we see today is the starting point. Software is a low hanging but important food and the key element for. But we, again, on a journey and the last 10 years was, we're just the beginning and we will see a huge let's say increase of the performance in the next years.

Chris Wolff:

What are the goals in the metrics that you use to measure the success of that initiative you have? One

Marco Zeller:

key element is the tracking capability. How many units can we track with remote service? Really get rid of the manual process to the digital process. This is one, one measurement where we identify, okay, how good we are with the connectivity and with remote service. The second thing is, or are the costs for the software maintenance? At the moment the costs are really high because sending out technicians and sales is a huge effort and If we can reduce those costs we have a huge value. And finally, but not so easy to measure. It's also the ecological part. So how much energy can we save? If you have not to send out the technicians to a customer. That's also one key element looking around in our environment and understand that, that let's say green service is a key element for the future to save our planet is another aspect. But like I said, that's not so easy to track. But there are elements of that have that are part of our.

Chris Wolff:

How are you using PTC software technology to enable all of these goals?

Marco Zeller:

PTC offers the sync platform, that's our iot platform, and it's the backend for our device communication. All our units our new device devices are connected to Syncros and Syncros. Get, gather the data from the devices in. And on Thingworks we have the capability to visualize the data for our technicians or share the data with other systems like EER, P Systems, CRM systems, whatever. Thingworks is really our, let's say, iot core used to share the. In our company, Marco,

Chris Wolff:

you and I have spoken about cybersecurity and the way you need to assure your devices are secure and meet the test of the IT organizations. You also have a requirement for compliance with all kinds of regulations internationally since your products are distributed. So broadly, what do you play a role in compliance for the company?

Marco Zeller:

Compliance hits us on different levels. The basic level is really. The level of tracking. So around the globe, the whole tracking of software changes is a key element. Like I mentioned a few times already tracking is required for the fda, for the MDR markets more, less really around the globe. And that's one, one element. The whole connectivity helps us to ensure we can track changes to software, changes to the unit. That's one piece. Then we have the cybersecurity compliance. The cybersecurity compliance comes more or less together with the connectivity. So by supporting one, one scenario, the tracking, we open up another topic, and the cybersecurity has a lot of requirements when it comes down to the hardening of the system and to the managing of the data in the. And with the solution we have in place with Thingworks in a certified environment and with the features we implemented in the products for the security, we are able to meet those requirements. And the third point is the whole GDPR topic. And in a GDPR topic, we more or less avoid huge discussions by really separat. The patient data, the private data from the machine data. Our goal is to focus on the machine data, really make sure that we only collect machine data and transfer them to the cloud, so it's much easier for us to handle the whole scenarios around the globe. Outpatient data you don't want into challenge us with. Local hosting of data in the different regions. You really have the chance to have a global central hosting for your iot server. And so we have a chance to start easily and in the future we may see changes there. But for today, this is the way how we handle this GDPR compliance topics.

Chris Wolff:

And so look into your crystal ball for a minute. You mentioned the future. What do you expect the future will? For providers, for suppliers like you and for patients like me,

Marco Zeller:

I can see that in the future we, we will see more and more connectivity. The connectivity in the, OR in the medical environment is an a change that will not stop. We can see that, or we saw already the changes in other industry industries and more or less other industries are leading. Medical is always. Five years behind. But the distance becomes shorter and shorter. And the things we saw in other environments is something we, we also can sooner or later expect in the medical environment with better connectivity of our devices and to the cloud and indoor, the connectivity we can increase the performance of the R. We can reduce human to human factor in the. And we also can reduce the human factor for the maintenance of the unit making, or enable our customers to fully, really focus on the core of their work. And the core of their work is to ensure that we have great patient al outcome, and that the biomeds the, it can provide a full and secure service that the units are available as needed and. Whole environment is secure. So I can see a lot of let's say data exchange and interaction on a digital layer more than we see today.

Chris Wolff:

It's clear that your customers are, have a duty to provide outstanding medical care, but they're also running as businesses that have to operate. Operational efficiency and effectiveness with safety and data is only getting larger and larger for them. And the importance of your over the air connectivity and the ability to service these devices remotely is essential, both for safety and operational excellence. I just wanna thank you for the innovation that Carl Storz has been provided for 75 years, and the innovation you and your team are bringing to delivering remote service that will make those ORs even more effective for us. Congratulations, Marco, and thank you for being on Speaking of service,

Marco Zeller:

thank you. And it's always a pleasure to talk about service because service is is my passion. I love service, be at love to provide service and love to provide better services for our products in the future. So not only having outstanding patient results, also provide an outstanding result for the maintenance and support of our products. Thanks for listening to the Speaking of Service podcast brought to you by ptc. If you enjoyed this episode, please subscribe wherever you get your podcasts and leave a rating or review. And be sure to check out other episodes to hear new perspectives on improving life for aftermarket professionals, service teams, and the customers they support. If you have a topic of interest or want to provide feedback, email us at speaking of service ptc.com or visit us at ptc.com/speaking of.