April 20, 2021
A year ago, the emerging pandemic brought Medtronic’s respiratory business front-and-center as demands for ventilators shot up to save the lives of thousands of people hit with COVID-19.
In this interview, the first of the MedtronicTalks Podcast Series, Medtronic’s Ariel Mactavish and Dr. John de Csepel detail how Medtronic answered the call in many ways.
MacTavish, president of the company’s Respiratory Interventions Operating Unit at Medtronic, said Medtronic quickly realize they couldn’t work alone. “We scaled as rapidly as possible internally with our own manufacturing facilities, but we also worked with partners to try to expand different areas of by sharing our ventilation IP, allowing others to manufacture it, giving good advice to others, to try to ramp that up,” she says in this interview.
Meanwhile, Dr. Csepel, chief medical officer and vice president of medical affairs of Medtronic’s Americas region, recalled his own experiences in the New York City hospital where he serves as a general surgeon on weekends. “What I saw there was a transformation like I hope I never see again for the rest of my life,” de Csepel said, recalling that the hospital had to set up several ICUs that he had a hand in running. de Csepel drew on that experience to help formulate Medtronic’s response to the pandemic, including developing a plan to care for employees.
Hear how Medtronic is taking lessons learned from last year to guide respiratory interventions going forward.
Hey, everyone this is Tom Salemi of DeviceTalks. Welcome to our newest member of the DeviceTalks podcast family it's called MedtronicTalks. Our constant search to find new ways to bring you insights in the MedTech industry led us to the fine, fine folks at Medtronic. They've agreed to make their senior leaders available to us and to you. In each episode we'll discuss the opportunities and challenges facing one of MedTech's clear leaders. So you'll have an inside view on what makes Medtronic go. We'll ask the questions. Medtronic will provide the answers and our great network of sponsors makes it all possible. So sit back, hop on a treadmill, take the dog for a walk, whatever you do when you listen to a great podcast and let's listen to how Medtronic is getting the job done. Let's go.
Thanks again for joining us on the MedtronicTalks podcast today, we'll focus on Medtronic Respiratory Interventions business. This is a discussion brought to you by Propel. Our first guest of this MedtronicTalks podcast are Ariel Mactavish. Ariel is the president of Respiratory Interventions at Medtronic and Dr. John de Csepel. He is vice president and chief medical officer for the Americas at Medtronic. A year ago, Ariel and John were among those leading Medtronic internal and external responses to the rising COVID-19 pandemic. In this interview will hear what they saw, but more important, what they did to help Medtronic answer the call for ventilators and other critical needs. But first we'll talk with Chuck Serrin. He is vice president of industry marketing for MedTech and life sciences at Propel, a maker of a cloud based tool to manage product development. Chuck, please tell us more about Propel and what it offers.
Propel is a product success platform that really enables companies to build better, safer, and more effective products and bring those products to market faster. We really do this from concept to customer and cover the entire product life cycle and also we're uniquely a QMS PLM and a PIM or commercialization solution all on one platform. So we eliminate what's commonly three disparate systems and eliminate those huge gaps in data leakage and connect these systems, people processes to reduce the cost of quality. We also enable you to design, make, market, and sell and service your products. So being natively built on Salesforce, we really unify that product quality service and customer records for true enterprise collaboration into the sales and service clouds, and then rest assured being built on the Salesforce platform. We also give you all that security, scalability, analytics, and reporting in a very high extensible to your processes.
All right, we'll hear more from Chuck Serrin and Propel a little later in the podcast. Now let's hear from Ariel Mactavish and John de Csepel. Our first guests on MedtronicTalks, John de Csepel and Ariel Mactavish welcome to MedtronicTalks.
Thanks. It's great to be here.
So we're about a year removed from when the world shut down and it was a time when we all found different ways to work, and we can maybe get into that a little later, but one thing that clearly happened, that happened immediately was an area of MedTech that really maybe didn't get as much attention as it might have in terms of innovation and ideas, and just consideration was respiratory and ventilation. I've covered MedTech for a long time. I could probably count on one hand how many stories is about innovative technologies in ventilators. We've assume that they're going to work. They very rarely get the center stage and get under the spotlight. All of that changed a year ago. And I want to just understand how, if you can recall a year back sort of how the crisis set upon you and Medtronic broadly, but also businesses you work in at Medtronic. Like what was the first indication to you that this was going to be a call that you had to answer.
At the very beginning of the year in January, we definitely were getting signals from China, that they were having this outbreak of this disease and it required ventilators in the ICU and that there was an inordinate demand and clinical need there. So the initial phase of it for us was really diverting all of our allocation of ventilators from the normal global customers to China, for clinical reasons, and really explaining to all of our existing customers and deals that we needed to allocate the ventilators there. But at that moment, I don't think any of us saw certainly the expansion of that beyond China, which was to come in the coming months. And then of course, subsequently to that as the pandemic continued to spread around the globe, we ended up with similar kinds of demands coming from all over customers, all over the world that needed ventilators right away.
There was also, like you said, there wasn't so much of an understanding of ventilation. There was a lot of confusion of between a respirator and a ventilator for example. There was definitely a lot of misunderstanding of quantities and what was really required and what degree the crisis would be. So we were working through all of that in say the March, April timeframe. And then for our business in particular, it was really in March when not only did we have the shutdown of our facilities and the lockdown of staying home, but right at that same moment, we started to do daily calls with the ventilator technical team and combined with our executive leadership team to address these daily kinds of requests and communication that was out there. So yes, reflecting back a year, it was a very intense moment in that March, April timeframe, for sure.
And John, I want to get to you in a moment just to talk more about Medtronic, but Ariel I'm just curious, was it clear early on that this is going to require some extraordinary actions or did you hope that, did you have any sense of how big the wave was, that was coming?
We definitely knew extraordinary action would be required. And we were just, I think, trying to do what we could do. And we very soon centered on the fact that serving as many patients as possible, getting as many ventilators out to patients that needed it, was our call to action. And that served us well. We could only do what we could do. We knew that there was no way we would be able to serve all the demand as a single company. And that really informed a lot of the work we did. We scaled as rapidly as possible, internally with our own manufacturing facilities, but we also worked with partners to try to expand different areas of by sharing our ventilation IP, allowing others to manufacture it, giving good advice to others, to try to ramp that up and bringing vents out of service. So there were, we definitely knew there was, it was extraordinary times that we needed to deliver.
And John, you're going to bring two different perspectives of the conversation. Let's first hit upon your role as a physician, you were still practicing and explain to me how your life changed a year ago in that regard. And that we can understand a bit better, how everything impacted Medtronic on a whole, but as a physician, what happened to you?
Yeah, I'm a general surgeon practicing in New York City, principally on the weekends because Medtronic is my full-time job. And so when I work on the weekends, working here in New York, what I got to see sequentially from each time they came to the hospital was just how bad it was getting. And as you recall, New York and particularly the hospital that I worked at was labeled to be the epicenter of the epidemic. And what I saw there was a transformation like I hope I never see again for the rest of my life, where we had to create ICUs, where there were no ICUs, whether it was a woman's health center or a recovery room, all of a sudden became an ICU. 1, 2, 5, 7 ICUs popped up around the hospital. We had to bring in clinicians from all around the country to help us staff it. We had one ICU was staffed by the Air Force, another one by the Navy.
And it got so bad that a general surgeon like myself who does trauma surgery at the hospital had to actually run one of the COVID ICUs, which is challenging enough if you're not an intensivist to be running an ICU. But these are some of the sickest patients, any intensivists would ever manage in their whole career. And then yet, we were thrown into it as general surgeons managing these COVID ICUs. And so I got to see it up close and that really helped inform me for the work that I did for Medtronic and helping guide our company through our crisis response.
What was your role in guiding and helping to develop that response?
I remember it pretty distinctly, getting a call from a member of our executive committee on January 29, to the exact saying, "We don't know what we need, but we need you involved in the company's crisis response, and we want you to be the medical leader." So I became the chief medical officer for the company's COVID crisis response team and that role has evolved not just over those first few weeks, but over the last year. I would characterize the outset of the epidemic as a period of great uncertainty. And we knew that we needed to educate ourselves as fast as possible. So we reached out to experts around the world to teach us so that we could at the same time, protect our employees while still making the life saving medical equipment that we need to make for the wellbeing of patients around the world, whether they're COVID patients such as Ariel's business with ventilators or other businesses that supply products that are for urgent procedures, such as cardiac valves and stents and such.
So it was a real challenge to balance the two, protecting our 90,000 employees around the world, ensuring their safety, at the same time, meeting our commitment to patients by continuing to make life saving medical devices.
You have obviously employees on the ground, in across the world, people in China as well. I'm wondering, did you gain insights from their, how much did you rely upon insights and experiences from Medtronics global employees in understanding what was going to be hitting your us offices and businesses?
One thing that we did right at the beginning was form what I like to call a private public health service. So we are fortunate at Medtronic to have a lot of doctors and nurses in our employ. And so we created regional medical teams. And so our China team, for example, became formed very quickly and worked very closely with our commercial leadership to understand how the epidemic was impacting our employees throughout China. We quickly set up a system where we contacted each and every one of several thousand employees in China, twice a week to ask them whether they had symptoms that might suggest that they had COVID. And if they did, then we had one of our doctors on the phone with them to better understand what they were experiencing, how we could get them help, and how we could keep them safe, and also keep them isolated from other employees. So we developed this internal public health service. That model really served us well when the disease then started to impact Europe and other geographies around the world.
Ariel, how did that impact your, the ventilator business? I have to imagine that you were all an alert that as essential can be. How did you manage that going forward?
Yeah, the work that John and his team did was instrumental in two things. One was the ability to scale up the manufacturer and our ventilator are all manufactured in Ireland, but we have the circuits and filters that are manufactured in Italy. So a hotspot there as well as in Mexico. So as the pandemic spread to those areas, there was a lot of high risk and a lot of regulations that were put in place, either trying to totally shut things down so that only essential workers could get through, or at least putting and some kind of social distancing and other regulations and checks in place. There had to be the ability to immediately respond to the regulations country by country, as well as our government affairs team for Medtronic was front and center as well in coordinating with the governments to allow these essential workers to get to the facilities so that they could actually build the products that were required everywhere.
And I think that we all felt very reassured by the fact that the employees' safety was at the heart of everything. And again, the work that John and his team did was very well recognized across the organization. And I think it gave our employees a sense of security that they could go into the workplace and that the right measures would be in place to keep them safe.
All right, we'll take a quick break to visit with Chuck Serrin of Propel. Chuck, how do MedTech companies use Propel?
Med device is really one of our largest focuses. So we've got customers like Zoetis in pharmaceutical, for many is Kobi. Inari doing medical devices for thrombectomy. Livongo, doing health monitoring devices for MedTech, but really we help them create commercialized and correct their products. So create meaning managing entire product development process, building up their products and documentation, their bill materials, their item masters, and manufacturers, and include that entire value chain for successful product launches. For commercialization, we give access to and manage to new and extended markets controlling what you can sell, where and when. So the product registration, the EI fuse, the environmental and packaging compliance and localize information that can be spread to the Omni channels. And also to correct, we manage the entire end enterprise quality processes. So your CAPA's, NCRs, audits, and scars, your training records, and of course, do customer incidences all the way to resolution.
So what makes Propel unique?
Having both product and quality in the same system and really allowing the only true closed loop quality and product solution out there. This is what really gives us tremendous insight in use cases of better NextGen designs or designing for quality earlier in the NPD process. That one source of truth really allows teams to collaborate, to unify their data, to streamline their business processes and be more simplified. And I mentioned the commercialization aspect of tying a service, field, assets, and sales. So we can you field service quality better by tying asset repairs to the latest changes. And then of course, being on the Salesforce platform, we can simplify your IT stack and your administration with a very easy to use modern interface, as well as having multiple three releases a year, give you those validations and allow you to upgrade or pull when you want to upgrade.
For more information, go to propelplm.com. Now back to our interview with Ariel Mactavish and John de Csepel. What were some of the greatest challenges that you face in ensuring that you could keep the lines moving?
The one that came up that I think for me, was the biggest surprise and maybe for others as well was the importance of our global international supply chain. So it wasn't just enough to expand manufacturing capacity, to hire extra contingent workers, to enable 24/7 operating shifts, things like that while important were relatively straightforward. But getting the actual components and for ventilators in particular. And we've learned this across the industry, that there's a lot of custom made components, things that are made at maybe boutique supply vendors. And we had to partner with each and every one of our component vendors to have them, help them scale up and help them to have. And they also, in many cases, if they had manufacturing sites in some of the hotspots, that we would help to help then convince their government, that these employees were essential for a component of the ventilator. So it was definitely a realization of the importance of our global supply chain and having to partner with all of these different companies to get the ramp up that we needed.
And I want to talk about the decision to open source with your ventilator plans, but John, on a company wide basis what happened company wide with ensuring safety of employees? How was it determined who's going to work? Who's not? How are people getting tested? How are people getting safe? What went into that process?
I think you're getting at it, Tom, is that it's all about mitigating risk and reducing the risk to the most minimal levels possible, because we're all at risk in this pandemic. So for us, it was a multifactorial approach and it all started with education. So we wanted to educate our employee base around the world about safe practices. And then in turn, we wanted to deploy safety protocols that would allow them to come to work, to continue to make these devices. And so instituting ideas like, "Don't come to work if you're sick," might sound simple, but is a really huge effort, because what is sick? This is a really tricky disease. And it started out by COVID being associated with just cough and fever and then the list grew and grew as we all recognize now and take yourself back for several months, it was quite different.
Keeping the sick folks out of the plant and creating policies around quarantining or isolation is critical. And then with those who do come to work, how do we do screening? Is it passive screening protocols or active? Whether it be asked questions before they come in. And once they're in the plant, how do we continue to produce goods at the same time, maintain adequate distancing. That's a real challenge. That's a real operational challenge. And then introducing masks, not everywhere are people wearing masks, even in our clean rooms, it was not required in some area in the past, but now you've got to equip an entire manufacturing operation with masks and not just any mask, but adequate masks. And we took an early decision for example, to go straight to surgical masks. And even in some cases, masks that have even greater filtration power than that. And so it's a matter of procurement, supply chain itself just for safety purposes. And then we go from there, then we can talk about the next steps around developing a testing program or further steps looking forward like vaccination.
And I would just add in terms of the employees safety and other important aspect for ventilators is our employees are the ones that in normal times, go in and install the ventilators, train the clinicians that are there, make sure that they're deployed and that they're able to, that they're working appropriately. And all of that had to continue to happen even within the restrictions that we saw globally around the world. So from China to New York City to various other places, we were faced with trying to keep those employees safe and also trying to find novel ways for them to set these things up. In some cases outside of the hospital and partnering closely with the hospital to make sure that they were safe and that they were also not bringing out anything into the hospital.
Maybe I could briefly add to that Tom, if I may. I think when people think of essential workers, they think of people in manufacturing right off the bat and I get that and they're critical, but at the same time, it doesn't work if we don't consider our field-based people as essential workers, because this disease is a complex one. And it requires for example, ventilators that are really sophisticated to be able to treat the sickest of the sick patients in the hospital, those afflicted with COVID. And so hospitals are making purchases of ventilators that they have no experience in the past with. So we need to ensure that we can get clinical specialists based in the field, into the hospitals to train the doctors and the nurses, how to use these to benefit their patients.
And so the focus is not just the manufacturing folks, but also on our field based folks, particularly our clinical specialists. And that's a real challenge, they're spread around the world. There's different challenges. The virus ebbs and flows in different places. And hospitals have obviously, as you can appreciate, a degree of restrictions when it comes to vendors. And so we have to work through all that to ensure that the lifesaving equipment was being properly used for these COVID patients.
It's remarkable having this conversation, you just don't realize how much your life has changed until you really look back and start calling all the things that, well you went through and others went through at this time. And you'd anticipate my question about the people going into the clinical settings. Curious at the time we were hearing about all these hacks that hospitals were doing, trying to put two or three or more patients on a single ventilator. As a manufacturer, and maybe it was not one of yours, but as a maker of respiratory systems, you must just be pulling your hair out of your head out of concern that our products were made for this. What was that period like? It was quite frantic people just trying to find different ways to save people's lives.
Yeah, I think that particular example is a symbol of how desperate that people were and how uncertain people were about what to expect. And the idea that rationing of ventilation would start to happen. And that you'd actually have people that couldn't get access to care. So for that particular example, we did very quickly on our side, we do have circuits that we produce and we were able to get our engineers to create one that could help to enable a ventilator to ventilate more than one patient. However, we internally, and John can probably speak to this, we had a lot of thoughts from our internal clinical community that this really wasn't the right way to go. We wanted to at least have a safe option available if it turned into something that customers wanted to do.
However, the good news is there is we actually never ended up having to deploy it. We developed it, we got emergency use authorization to bring it out. And then over time that clinical utility was never seen. But again yeah, it was a definitely an internal struggle between what we knew was standard of care, what was gold standard and what should be done versus what some of the reality on the ground was, that the clinicians were being faced with the crisis.
And let's talk a bit about the decision to open source the Puritan [Bennett™] ventilator and to make it available to everyone. What, when did that first come up as an idea of something we might consider doing and how difficult was that a decision to make to do it?
The idea came up early on. So probably in that March, April timeframe again, when we were seeing these enormous demand for ventilators, we were seeing all of these different companies that had very little or no medical experience coming in and saying they were going to design or manufacture a ventilator with more or less merit to them or not. So I think that the idea behind it really was, and it really originated from Omar Ishrak, who was our CEO at the time, was we have an obligation as a ventilator company to show what good looks like. And to help at least, if all of these different people want to help and try to manufacture a ventilator, that we can give them a head start and tell them what a design to of is required and what's really needed. We selected the PB 560, which doesn't have as many features and capabilities as the more sophisticated ventilator, but it has fewer, relatively fewer pieces and to the supply chain issue that I mentioned before. We knew that having a more sophisticated supply chain would be a challenge for a new person coming on board.
And in terms of the difficulty of the decision that part was really straightforward. As I mentioned, we put it as our mission to get ventilators to as many patients that needed them as possible. So I think there was very little, if any hesitancy at all about open sourcing this IP, the challenge really was it's one thing to say that, but then how do you actually do that? So it took a team of certainly from our IT group and from our legal IP attorneys, as well as our R&D folks, and our operations folks to get the documentation together and get it out in a digital format that was accessible.
John, looking back as to all that, that you've gone through, what lessons did Medtronic learn about? I guess everything about, we can talk about being ready for something like this. Because I think we're all aware now that this is something we need to really consider. We've always talked about pandemics, but now we know we need to have plans in place. What lessons have been learned and what are some lasting changes that we might see from this experience?
Two things happened at the same time, which was we have the pandemic and we also had a change in CEO and they oddly enough were rather complimentary. So one, for example, one of the things we learned from the pandemic was that our company could be more agile and react faster than we ever could have thought possible. And Geoff Martha, our CEO has made that a hallmark of the culture that he's building now at Medtronic is agility and decisiveness. And he often will cite the work of our COVID crisis response team as an example of we've done this before, we know we can do this. Now let's take these lessons, learn and expand them across our company. And I think you're starting to see that with every passing day at Medtronic.
Ariel, how about from your perspective?
You alluded to it in the introductory comments in regards to the fact that ventilators haven't historically been on center stage, but we see this as our call to action really, that now that there is an awareness of the importance of not only the technology, but the clinicians who manage the technology and the other products that go around the technology, as well as education and awareness. So this is an opportunity for us to leverage that, to leverage the expanded footprint of the products that we have. We have so many new customers around the globe because of the recent events. And our goal really is to continue to support those customers and learn from them, what their needs are. And as John mentioned, the pandemic caused a lot of less experienced clinicians to be put in places where they were being challenged, but that happens every day in some places in the world.
And there's not as much, there's nowhere that has a consistent clinical capability across the board. So there's so many opportunities for us to increase education, increase the ease of use of our products, so that it is more straightforward to lesser experienced clinicians and how to use it. And also just to raise awareness of purchasers and governments about the right level of ventilation to have for the population in the case that this happens again, that there won't be so much of a panic by kind of experience.
John, what about the internal changes that we may see, the pandemic and the lockdown has impacted all of us and how we live and how we interact with our coworkers? How will this change Medtronic going forward?
The one constant is our Mission. The focus is always been on the wellbeing of patients. So everything starts with how can we best meet the unmet clinical needs and how do we evolve as a company to do that? So the pandemic has taught us, has taught so many other companies, that virtual work is possible, and that you can maintain a level of productivity that you probably never thought was possible. So we want to be able to compete in the marketplace for the best talent and the best talent isn't necessarily looking to come to the office five days a week. And we've heard that loud and clear. So we're envisioning a future of work that is more flexible than what we ever could have imagined in pre-pandemic times, that people can work virtually a couple days a week to best suit their schedules, and yet still have the opportunity to come together to collaborate when needed.
Curious, as you said that I'm thinking about Silicon Valley and Facebook and all of it, they're going through similar conversations and it led me to think as well. How has all of this in your mind changed the broader perception of the MedTech industry, the MedTech industry, and Medtronic swept in and, and rose to the occasion and saved lives. Do you think you'll have an easier time drawing talent from engineers who may have thought it'd be cool to go work at Amazon. Now is it cool to work at Medtronic?
Yeah. I think as healthcare becomes more digital, we're competing for talent that might go work in tech. And if we're going to do that, then what can we offer that's different than what tech can offer. And one thing we can offer is our Mission because at the end of the day, everything we do is to help people who are in need or to help patients. So if this is something that we can lead with and attract the best and brightest minds to our company, then we can lead in the revolution that we're seeing in healthcare today, where it's a very strong move towards a digital product and a digital enterprise.
This had been an amazing conversation. I want to thank you both for joining us. And for, of course, for the work you did in helping us respond to the pandemic last year, both in the hospital at Medtronic and in the globe. Thanks for joining us on MedtronicTalks.
Thank you, Tom.
My pleasure. Thank you.
Well, that is a wrap. Thanks for listening to this very first episode of the MedtronicTalks podcast. Soon as I can figure out an audio form for DTF, I'll sell this thing for billions, but until then you can find me on social media. I am on Twitter @MedTechTom, you can find me on LinkedIn. I'd love to hear what you thought about the podcast. Please do subscribe to it. Please do share it. Please do let your friends and colleagues know that this is out there, because it's a great opportunity for everyone to learn about one of MedTech's leaders. And please do tune in next time. We'll have another great episode of the MedtronicTalks podcast waiting for you.