The Future of Medical Devices and Pharmaceuticals – Part 2 – Transcript
The first series of podcasts on the Industry Forward Podcast featured Jim Thompson, Sr. Director of Digital Strategy for Medical Devices and the Pharmaceutical Industries with Siemens Digital Industries Software. Dale, Jim, and I talked about the major trends in the medical device and pharmaceutical industry, and dove into how software and electronics are driving changes in how care gets delivered.
You can listen to part 2 of the podcast here, or read a transcript of the conversation below!
Conor Peick
So, hi there and welcome to transforming industries with Dale Tutt. My name is Conor Peick, and I am a writer for Siemens Digital Industries software thought leadership team and your host for today’s podcast. Today we are bringing you Part 2 of our conversation with Jim Thompson, Senior director of digital strategy for medical devices and the pharmaceutical industries with Siemens digital industry software. As we continue the discussion, Dale, Jim and I talk about the role of software in the future of medicine and how medical companies are approaching digital transformation preset back and enjoy.
Dale Tutt
Yeah. And certainly, I mean I think about, you know the watches or the Fitbits, those devices that started counting people steps and it became a bit fascinating for people to realize some cases how little they actually walked and in other cases I was talking to somebody that was out of the Consumer Electronics Show. And they commented that they were walking 45,000 steps a day.
And you know that kind of knowledge. It’s like, no wonder your feet were tired at the end of the day. But so, it is. It’s interesting to see how people use those kinds of devices. They’re elevating their own personal Wellness. But that distinction that you made about with these medical devices and how they’re regulated and how they’re used. So, as we talk about all this.
Electronic cell the with you know using these sensors to monitor your diabetes or you know to actually manage this. You know, I’m curious about the software and electronics aspects as we are seeing in so many other industries, especially like the automotive industry right now with software defined vehicles where you can get an over the air update and you get new features on your car. We’ve been seeing that in aerospace as well for years where you can update your software, the performance of your product is often defined by the software and so do you see the same thing happening in medical devices you know? Are they becoming more reliant on software more defined by the software?
You know, you know, such as the core functionality of that device is being able to be more enabled to have other functionality being enabled through the software or is it or is that still being managed as part of the regulatory environment?
Jim Thompson
So yeah, software as a source for innovation absolutely is, is seeing a significant increase over the last, you know even you know, 10 or 15 years and continues to. And in fact, there’s even, you know, in in a medical device industry context, there’s even an extreme example in which there’s this notion that’s referred to as software as a medical device in in which the device itself is, is, is just software running on a computer somewhere and there are regulatory pathways associated with that. So let me let me let me talk a little bit about the regulatory framework as it relates to software, so.
So, the software on its own, or the software, if it’s a software as a medical device or software that’s running on a medical device, or maybe even as a companion to a medical device. So, you might have a device with some software running on it and it’s talking to some software, maybe that’s running on the cloud or on some computer system in a hospital or something like that.
All of these uses of software still have to go through this rigorous regulatory clearance process and in the development of them and in the build or the manufacture let’s say of the of the software and the device that’s combined all has to comply with the regulatory frameworks that come along with this clearance. So, you know this is this is an added step for medical device manufacturers, you can’t just come up with a new piece of software and just release it without, you know, going through this this clearance activity.
So I think we do see, and we’ll continue to see, you know, things like the possibility and the execution of over the air updates and whatnot, but I’ll just say that the medical device industry is going to be particularly cautious about doing that. You know, I think that like take the example of a pacemaker. The implant in somebody’s heart, there have been, you know, those device makers have been for many, many years able to do, if you will, over the air adjustments to the device.
I don’t actually know this, but I’ll just use this as an example. I don’t think they’re updating the software on the device itself, I mean like, hey, I’m going to, I’m going to shut down your pacemaker for 10 minutes and hopefully I’m going to load this new, new version and upload it. But they’re certainly doing parametric updates and then depending on the device.
If it could be offline for a while, sure though you know software updates will go on. So, everything we see happening in the consumer industry associated with cars and electronic vehicles and electric vehicles in particular, that have a lot of software on them, we see happening in the medical device industry as well, but again I’ll, I’ll, yeah, say that the regulatory framework absolutely adds this layer of you know, risk assessment clearance and assurance that the quality and the performance of any updates are not going to introduce problems with the delivery of the healthcare that’s associated with the device.
Dale Tutt
Yeah. I think as you were talking about the over the air updates and I realized how correct you are that they’re most likely going to just be adjusting the gains or a few settings here and there as opposed to totally re resetting the software. You know, I think about some of the stories about some of the spacecraft that they’ve, you know, they like, upload new software to it and they have a period of time where they you just don’t know if it’s going to work or not, and so you can’t really can’t really have that with, you know with the device that’s inside someone’s body so.
I am kind of curious, just real quick follow-up questions. So you were talking about some of the regulatory standards, I know that in some of the other industries, automotive and aerospace especially they there have been developed standards on software certification and the integrity level of software. So you know if it’s super critical, where you know, then it has to be developed and tested to a higher level of integrity. Have has the medical device industry and medical industry. Have they developed some of those same standards that companies can use as they develop this their software or is it still a bit ad hoc?
Jim Thompson
No, I’m going to say it’s, it’s actually quite rigorous and it’s actually been that way for quite a while because you know there been medical devices particularly medical, medical equipment that’s used you know either in the hospital or a lab for diagnosis in which software has been running on these kinds of devices for you know decades. So there are, you know, ISO standards that you know, help to find the expected practices, you know for both software development and the use of let’s say that that software as part of the device.
But then there are also some newer standards that are being recognized particularly, you know, we’ve been talking about, you know, this idea of software as a medical device and you know remote devices for sensing and you know over the air, you know, communication, whether it’s, you know, Wi-Fi or Bluetooth or whatever. And the whole new world that that we’re living in some of some of the older standards and regulation didn’t you know really fully contemplate that or address it.
So, so the FDA and other regulatory agencies around the world have been coming up with a variety of new standards and guidance documents. So, so in some cases maybe it’s not as uh, standardized as much as it is, let’s say you know the term is a guidance document and then even more recently, you know maybe the, the latest big challenge and guidance is around cybersecurity. So that’s been a newer concern that’s been introduced particularly, you know with remote devices and monitoring and over the air communications.
Conor Peick
So maybe as a follow up to the follow up that got us on this, this tangent, Jim, I was curious if you know as Dale talked about this kind of growing trend of software defined products. Are like service-based models. Is that something that you’re seeing in in the industry as well subscription type, you know software as a service type offerings? I’m just wondering if medical devices are a little bit different from some of the more consumer focused industries where that’s obviously becoming a pretty a pretty major way of doing business.
Jim Thompson
I’m going to say not yet. You know, normally you know still, you know, these days the vast majority of healthcare costs come through insurance payments, whether through it’s a private insurer or a government insurance plan and so you know the idea of like a consumer-based subscription is you know not a big part of the healthcare and the medical device ecosystem today maybe, maybe in the future, uh, you know, certainly for some kinds of devices, maybe more of the equipment and devices that are used for diagnostics like MRI or CT machines or, you know, blood testing equipment. You know, large scale blood. You know that that’s sitting in a lab somewhere. It may be that the contracts that those companies have with hospitals and healthcare delivery networks could be kind of like a subscription. And because they’re kind of delivering value on a per use basis.
But to the end-user if you will, or the patient or the physician, it’s more of a, you know fee for service you know incremental cost you know which you could use you know, over a period of months or years, continued use of software, but that tends to just get paid through normal insurance payments as, as other healthcare services are.
Conor Peick
So I think as we’re as we’re kind of moving through it, you know, talking about some of the changes that have been going on in the industry and how it in some ways does align with some of the other, the other industries that that we’ve talked about.
I’m wondering how does digital transformation fit into this equation, you know? Are and if so, how are medical device makers and pharmaceutical companies, how are they making use of like the digital twin and digital threads? And what are the differences between those two worlds in that regard devices versus like a pharmaceutical maker?
Jim Thompson
Yeah. So, digitalization and digital transformation are top of mind in, in every you know, medical device and pharmaceutical company. They’re probably, you know, if you look at the industry as a whole, both medical device and pharmaceuticals is probably lagging in terms of adoption and wide scale deployment of digitalization technology, say versus maybe automotive as maybe a more leading industry. But they’re absolutely on the path to making the best use of digitalization that that they can.
Medical devices probably a little bit ahead of the pharmaceutical industry, and some of the reasons why I think that that there is a little bit of a lag there is I’m going to call it this risk-averse nature of the industries, right that that they do have to be fairly careful about not breaking an internal process, just because you know digitalization seems to offer some economic and productivity, and maybe even cost benefits. You know, if that results in poor quality products or you know, worst case, you know, some kind of a patient injury or problem, you know that that’s a bad trade off.
So the industry is kind of intentionally cautious but the use of digitalization technology and digital twins is absolutely growing. I think maybe one comment about the pharmaceutical industry and this kind of applies to the medical device industry too, is that they are very focused on the science and the engineering associated with the with the device where the drug delivery, that is their primary concern. And so, digitalization isn’t necessarily resulting you know directly in a better drug or in in a better medical device. So that’s all about the bioengineering, the bioscience. You know, the biochemistry that’s involved. And there are digitalization techniques that help with that. But it is, you know, kind of fundamentally a science driven industry. And so that’s really where the primary focus continues to be. And to the extent that digitalization can help, and it is and it’s growing, you know that that that’s where we’re seeing an impact.
Conor Peick
This has been the industry for podcast with Dale Tutt once again, I’m your host Conor Peick. We’re really excited to kick this series off with the first of three parts of our discussion with. We hope you’ll join us again to hear more about the challenges the industry is facing and the potential future direction in part 3. On behalf of Dale and the whole team at Siemens digital industry software, I’d like to thank you for listening. Hope you’ll join us again in the future.
Siemens Digital Industries Software helps organizations of all sizes digitally transform using software, hardware and services from the Siemens Xcelerator business platform. Siemens’ software and the comprehensive digital twin enable companies to optimize their design, engineering and manufacturing processes to turn today’s ideas into the sustainable products of the future. From chips to entire systems, from product to process, across all industries. Siemens Digital Industries Software – Accelerating transformation.
