GMDP-header-Dan-Purvis

Why is design, manufacturing, quality, and culture so important in the medical device industry?

These key elements must exist and function in synchrony so that a medical device can save and improve patient lives.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufacturing firm that takes medical devices through an entire lifecycle.

Dan gives listeners an update on Project V, an initiative involving the mass production of ventilators comprising five separate devices aimed at saving lives and meeting worldwide demand in response to COVID-19.

 

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Some highlights of this episode include:

  • Velentium partnered with Ventec Life Systems, General Motors (GM), and the U.S. Government to build 30,000 ventilators and 141 manufacturing test stands in a 6-8 week period for Project V.
  • Managing Manufacturing: The challenge with COVID is that so much is unknown. CDC provides guidelines for who can/cannot be in your facility, but not for who should/should not be allowed in your facility.
  • Humans are hurting because of COVID. The gain or loss of productivity focuses on these key areas: Messiness of COVID, quality manufacturing, and culture of safety. How can a company maintain a culture of empathy, and at the same time, get a job done to pay the bills?
  • Top Tips and Best Practices: 
    • Data Repositories: Move, store, and transition source code files, data, and other information as soon as possible to the Cloud.
    • Design and Development: Foster a culture of understanding, efficiency, and flexibility.
  • Four Variants of Design:
    • Design for Manufacturability: Device passes design controls and receives approval, but it is extremely expensive and/or impossible to make.
    • Design for Test: Testing throughout as you go, including product characterization testing and design verification testing.
    • Design for Longevity: Manufacturable but think about design materials around longevity-oriented parts.  
    • Design for Quality: Analyze for number of times used, shelf-life, patient safety, and cybersecurity.

 

Links:

Dan Purvis on LinkedIn

Velentium

Medical Device Cybersecurity for Engineers and Manufacturers

Embedded Cybersecurity Training and Certification

Global Medical Device Podcast, Episode 151: Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

Ventec Life Systems

General Motors Helping Ventilator Maker Boost Production During Coronavirus Crisis

Centers for Disease Control and Prevention (CDC)

ISO 13485 - Medical Devices

ISO 14971:2019 - Application of Risk Management to Medical Devices 

IEC International 62304 Standard

FDA - 21 CFR Part 11 Electronic Records, Electronic Signatures

FDA - Medical Devices

European Union Medical Device Regulation (EU MDR)

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable Quotes by Dan Purvis:

“That project was extremely successful. Thirty-thousand ventilators were built in Kokomo, Indiana, in an automotive factory that had not ever built a ventilator before.” 

“When you send these devices out into the marketplace, one hospital at a time, you can be assured that they’re going to do good just like they were intended to.” 

“Remind people that this is the real deal. Most of us, if not all Americans at this point, know someone who has passed away. Or, they know someone who knows someone who has passed away.” 

“The science is clear that when we are masked up and distanced, we have a much better chance of not spreading the disease.”


Transcript:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: On this episode of the Global Medical Device Podcast, I had an opportunity to catch up with Dan Purvis. Dan is the CEO at Velentium. If you remember, a few months ago, we spoke to Dan about the Project V project that Velentium and a few others were working on to manufacture ventilators in a time of need. Dan gives an update on Project V as well as talks about the importance of design and manufacturing and quality and culture, so I hope you enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer, and I've got a return guest joining me today. Joining me is Dan Purvis. Dan is the CEO of Velentium. Dan, welcome.

Dan Purvis: Hey, thank you. Glad to be here.

Jon Speer: Absolutely. So Dan, the last time you and I spoke was a few months ago and the topic of our conversation then was about Project V and I'd certainly like to get a little bit of a recap about that today. Then there's a few other things that I thought I'd pick your brain about today. So I guess maybe a first place to start, telling the folks a little bit about who Velentium is and then maybe just lead into a synopsis of Project V and where that stands as we chat today.

Dan Purvis: Sure. Sure. So Velentium is a design development and manufacturing firm where we take medical devices all the way through the entire path, all the way to the manufacturing. One of the clients that we had was Ventec Life Systems and they're a ventilator from up in Seattle, Washington. We had the opportunity to build for them many of their test stands on their manufacturing floor. So when General Motors partnered with Ventec and the U. S. Government to build 30,000 ventilators over last spring and summer, we had the good opportunity, then, to step into that fray and build, as a result, 141 manufacturing test stands in about a six to eight- week period, so that project was extremely successful. 30,000 ventilators were built in Kokomo, Indiana in a automotive factory that had not ever built a ventilator before, for sure. They converted that plant and built 30, 000 ventilators from first meeting the people at Ventec in March through the end of August here at 2020, and so it's great. Every one of our test systems either tested a sub- component of that ventilator to make sure that it was correct before it went into a ventilator or it was part of the final test where you make sure that if somebody wants a certain mix of oxygen, that that's exactly what that ventilator is delivering so that when you send these devices out into the marketplace one hospital at a time, you can be assured that they're going to do good just like they were intended to. So it's been a lot of fun to see it work, for sure.

Jon Speer: Absolutely, and folks, and we'll provide a link to that previous podcast regarding Project V that we did a few months back, but a really exciting adventure, just pulling a lot of different resources together. Some folks who are familiar with medical device design and development, some who are not above making an app and in a time of need and in the world and in our country, so you'll want to check that out. It's definitely one of those great stories. There have been quite a few, fortunately, during this period of time; it's not all doom and gloom. But, Dan, being a design and manufacturing firm, number one, I can imagine there's a ton of challenges just by blending those two things together, but since COVID, I'm guessing you've been remote and distributed workforce like most of us, how do you manage such a thing in this day and age?

Dan Purvis: Yeah, no. That's a great question. It's something that I think a lot of the industry is wondering and, essentially, wading through in a very difficult way. That's the challenge with COVID is, that there's a lot of unknown. The CDC gives you guidelines for who can be in your facility and who cannot, but it doesn't give you guidelines on who should be in your facility and who should not and so the productivity hit of not being in the facility or the productivity hit of people trying to do work amidst all of their kids at home Zooming in classrooms and pets and spouses and everything else going on at home or the productivity gain of somebody working at home instead of coming into the office. There a lot of business decisions and technology decisions that have to be made and so we've had a lot of internal discussions as a senior leadership team around really three key areas. One is the messiness of COVID. Just to be real sensitive here, you hear people saying that it's just a political thing. You hear people saying that it's not a real disease or it is a real disease and we've been real careful in our company to remind people that this is the real deal. Most of us, if not all Americans at this point, know someone who's passed away or they know someone who knows someone who's passed away. So first just a shout out to anybody on my staff or anybody out there that is grieving. We hurt with you, and so we've worked real hard at the company to remember that we're a company, first and foremost, of human beings. The humans of the world today are hurting because this is a hurtful situation. So how do you maintain a culture of empathy and, at the same time, get a job done that can pay the bills so that we can all go to the grocery store, et cetera?" So the second aspect has been the culture of safety. So we're real big at Velentium on the CDC guidelines of... I had my company meeting, which we have the first Monday of every month and we reviewed once again," Here's the protocol for why you should or shouldn't be here, and by the way, if there's a way for you not to come, please don't. But then if you do have to be in the office, here's the protocol for whether or not you can. Then more importantly, now, here's the protocol for if you can't be here, when you can come back." That can be a little confusing at times because it's different based on whether or not you've tested positive; maybe you've not tested positive, but you're showing symptoms; maybe you haven't tested positive and you're not showing symptoms, but you've been exposed and then the different regulations around that can be confusing. Sometimes, they're even more stringent state by state or jurisdiction by jurisdiction. So the ideas around when can you come back to the office, if you should come back to the office and then how do you behave is a third one when you're in the office? So it's clear, the science is clear, that when we are masked up and distanced, we have a much better chance of not spreading the disease. So when is a mask necessary, when is a mask unnecessary? It's clear, a mask is not necessary when you're in your office bedroom, at home, on a Zoom call, so that's just easier all the way around. When you're in the office, then, when is a mask necessary and when is it not? Certainly, if you're in the common areas, certainly if you're coming in and out of the building, if you're in the restrooms, et cetera. Then we've had a lot of discussions about productivity in the workforce, in the cube, away from people, but still on the same air handling system. Lots of neat technology coming out, even now in the med device world about sanitizing buildings from viral contamination and so we're looking into some of that technology, involved in some of that technology and trying to keep people safe.

Jon Speer: Yeah, for sure. At the same time, I appreciate the sentiments and the message and I think that's very important for people to understand the situation and circumstances, but again, you're a design and manufacturing firm. Design, maybe, you can figure out, I can imagine juggling schedules and things like that becomes a little bit of a logistical challenge and you probably got deadlines and certain things that you have to manage and maintain it and," Oh yeah, by the way, there's this other thing that's really important." You still have to maintain the same quality that's important to your business and to your products and processes. That just seems like an awesome challenge to juggle. Maybe there's some tips and pointers that you and your team have picked up that could be relevant and important for the rest of the industry to learn a little bit more about.

Dan Purvis: Sure. Let's start with design and development and then we'll move into manufacturing because they really are two different animals in the sense that manufacturing, by definition, is going to happen most often in some kind of a plant environment, certainly under 1345 compliance. But on the design and development, if you, as a listener, are not already storing everything in the cloud, I would highly recommend that that transition happened as quickly as possible. We have been in a source code control type of environment for some time and so when we moved remotely, it was more around ergonomics and distraction and less about data and data movement because the data and data movement was happening with regular check- ins of code and designs and drawings already and had been for months and months on end. So repositories where you're checking in and checking out and things that are stored in the cloud is an absolute must in today's COVID and post-COVID world. Then on the design and development side, what can you do to foster a culture of understanding of everybody's individual predicament and then also to foster a culture of efficiency? So where we've done that in the design and development is around the idea of understanding and flexibility; flexibility, in that the timing of each individual worker's most productive time is going to vary based on their personal schedule and their home life and how that best intersects or does not intersect with their work life. Then on the understanding is that we've entered the world of dogs barking at business meetings and doorbells ringing. I don't know about your home, but our home is heavily guarded by two miniature Labradoodles that take it as a personal affront every time the FedEx guy arrives. So it is what it is, and go,"Oh, I'm so sorry about all this noise." I'm like," No, it's life. In fact, it's delightful. It's kind of fun to see the human side of some of the colleagues, clients, suppliers, et cetera, that maybe you didn't get to see in a sanitized office environment. Should I move on to crosstalk

Jon Speer: I was just going to chime in on that piece. I totally agree. We're all suddenly a little bit more vulnerable and maybe have a little bit more humility because we're all working out of our home. We don't all have ideal office set up in our houses and things of that nature, but it's brought the human side, to your point.

Dan Purvis: For sure. My office here at home is in a corner of the bedroom because it allows me to shut off from our master bedroom wing and have some privacy. But for the longest time of recent here, in the background of any video Zoom meeting is what I call the COVID bed, because my youngest son was tested positive and hence, there's a mattress on our floor because it's an upper respiratory disease and we wanted the peace of mind of knowing that he was still breathing. So rather than try to pack that up every morning so they wouldn't be in the background of my Zoom meetings, I was like," Forget it. It's the life we're all living, right?" So you do what you do.

Jon Speer: Yeah, for sure. The other thing that's intriguing to me, and it's been intriguing for much of my career, is you're a business that focuses on both design and manufacturing types of services and there's an important dance or rhythm or, collaboration, I think, is probably actually a better word that needs to happen between design and manufacturing. I'm sure that since you're offering all of these types of services at Velentium that you've focused on that a great deal, but maybe talk about some of the challenges that you've seen that you wanted to try to avoid when merging these two disciplines together at Velentium.

Dan Purvis: Yeah, for sure. There is really a whole assortment of different things you have to think about and I like to categorize them into four areas. Having manufacturing and design under one roof allows those areas to be fluidly communicated across, right? So the first one is design for manufacturing. So you can design this amazing device that passes all of the design controls for quality systems and it gets through FDA and gets approval, but it's extremely expensive or even impossible to make. So how do you make sure that when you're designing, you're designing for manufacturability and then design for tests? We talk a lot at Velentium about testing throughout and what I mean by testing throughout is product characterization testing, and so that's as I'm designing a product, as I'm writing firmware, as I'm designing a circuit, having a test platform that can run through all the permutations of this device, so every possible voltage with every possible current, every possible reading with every possible other reading, et cetera, and well beyond the design constraints. That would be product characterization. So you can test things as you go, finish your next build of the firmware, set the automated test system off and running and on Monday you get a test report, then it can help you tease out bugs. The beauty of comprehensive product characterization testing is that you can come back a level to design verification testing. It's not as exhaustive as product characterization. It's less exhaustive because it's just around the design that it was actually built for and that can verify the design, but then you can go back one step from there using the same code base and the same hardware and do manufacturing testing. So now every device that comes off the manufacturing line, is it according to what was approved by FDA? If the answer is, yes, I know not only that, but it was using the same code base in the test system that was used at the product characterization and at the design verification. So designing for tests where my design and development engineers have been using a test suite that has been developed for quite so many months, both in characterization and design verification, is now the same tests we've been using across the wall over manufacturing. Those two, I think, you've talked about a lot, design for manufacturing, manufacturability and design for tests. The two that I think that are really important that sometimes get missed are design for longevity. You do all this great work. It is manufacturable and yet, nobody thought to think about," Well, where is that particular underlying chip in this life cycle? Is it going to be by that chip manufacturer two years from now, eight years from now, 10 years from now?" So you ended up falling into lifetime buys because you didn't design your bill of materials around longevity- oriented parts. Then finally, design for quality. So if it's an implantable device and I'm going to start receiving X- plants and I have to analyze every X- plant, have I designed for quality in a way that I can do that X- plant analysis well? If I've designed this for one- time use, what's the shelf life? Is there battery usage as it's being shipped or is their battery usage as it's finally being opened? How do I assure that if it's designed for one- time use, it's only used one time and how do we ensure patient safety if somebody tries to use it more than once, et cetera? So alongside the design for quality, you end up with this whole idea of cybersecurity, which we can talk about, if it makes sense, later on.

Jon Speer: Yeah. I'd love to dive into that here in a moment. Folks, I want to take a brief pause and remind you that I'm talking with Dan Purvis. Dan is the CEO of Velentium and you can learn a whole bunch more about Velentium's products and services by visiting their website. It's VELENTIUM.com, some really great information on their website. We're going to talk a little bit about cybersecurity and culture here in a moment with Dan, but before we do, I just want to remind you too, that Greenlight Guru, we're here to help. We have the only medical device quality management system software platform in the industry today. It's been designed specifically and exclusively for the medical device industry by actual medical device professionals, so FDA, ISO, EU MDR, 14971, 13485, Part 11, all those things that are really important to you as a medical device company that are incorporated into the workflows in the Greenlight Group Medical Device Quality Management Systems. So if you'd like to learn more, go to www.greenlight.guru. We'd be happy to have a conversation and learn about your needs and see if we might have products and services that are fit to help you out. All right. So Dan, I do want to learn a little bit more about cybersecurity. I know before we started the session today, we were catching up a little bit and you shared some pretty exciting things that Velentium is offering in the cybersecurity spot. So maybe talk a little bit about that and then we can get into the importance of why this is such a hot topic these days.

Dan Purvis: Yeah, for sure. So medical cybersecurity is different than IT cybersecurity, and then medical cybersecurity in a hospital or on a network is different than embedded cybersecurity. So when we talk about cybersecurity in our design and development, we're talking primarily around embedded cybersecurity on devices that are either worn or implanted in the patient. So how do you make sure that your design and your architecture and the way that you've laid everything out is set up in such a way that, out at the tip of the spear, so every patient that is having the device in them or on them is not a target for attack? So it's a different mentality because a lot of times in IT- based cybersecurity, you place a firewall in a place that's in a piece of hardware that's 19 inches and it goes into a rack in a server room. That doesn't work in embedded, right? So ultimately, what you have to do in cybersecurity is think from the ground up around vulnerabilities." How do I assure that my vulnerabilities have been eliminated?" We at Velentium take it really seriously. We wrote a book on it. Chris Gates is our lead cybersecurity engineer, along with Jason Smith, our tech writer, and Axel Wirth, a colleague in the industry. They teamed up to write Medical Device Cybersecurity for Engineers and Manufacturers. It was an Amazon bestseller in the engineering category over the fall and it walks through the process for starting with vulnerability analysis and then moving through a cyber secure design development where you have a cybersecurity plan and then architecture, et cetera, very similar to what we saw in the late'90s, early 2000s around risk and risk management. Then you see similar things in cybersecurity, although within risk, you're always looking at severity and likelihood. With cybersecurity, likelihood is one. You can't say,"I don't know, it's fairly unlikely," because by definition there's a nefarious element to cybersecurity prevention, and hence, just like your dog in the backyard, if you leave a hole in someplace in the fence, eventually your dog is going to get out. So you can't say," Well, I don't think it's very likely that he'll find the hole. If the hole's there, it's going to be exploited." So you have to attack cybersecurity from that perspective. In response to the industry in the book, because of everybody's interests, we have a companion set of three courses that go along with the book that you can take and actually take exams at the end of those courses and be certified as a Certified Embedded Medical Cybersecurity Expert. So it's been really fun to help the industry begin to standardize on a methodology that not only works to keep everybody secure, but is embraced by, the FDA now has with their pre- market guidance. If you don't have a cybersecurity plan in your submission, then they don't review your device. You have to have cybersecurity addressed as part of your submission. So from an FDA perspective, it's necessary; from a general safety perspective it's necessary; and now in today's world, from just being a responsible engineer, it's necessary.

Jon Speer: I think that the topic of cybersecurity, well, I don't know, I think when I first started hearing about it, I had some impression about what it is and what it is not, but certainly, an important topic that impacts a lot of medical device companies these days, in fact, it's probably rarer that cybersecurity does not impact your company these days than the fact that it probably does. I think with technology and the connective nature, we always want to push information here or there, or connect this to that and that sort of thing. There's a lot of use cases or situations where cybersecurity really needs to be top of mind instead of an afterthought. I guess, what are you seeing? Obviously, Velentium wrote a book about it and you've got some pretty awesome courses around it to teach and educate people, but what was the symptoms or the circumstances that you all were observing that drove you to explore this further?

Dan Purvis: Sure. So first and foremost, we see trends towards just patient safety requirement as a mandate. We see trends in medical quality where FDA, as a result of where cybersecurity, globally, is happening is requiring it. But then more importantly, the consumer is driving medical devices to be more and more connected and so IEC 62304 talks about medical grade software. If you have a Class C device that means significant harm could happen. If you can't pull the software out and put it more into firmware or put it more into FPGA where it's actually in the hardware, we always want to try to design the Class C component to be as tightly wound as possible. So if it's just the firmware, then the app doesn't necessarily have to be in Class C. But to the extent that you have this Class C software where patient harm could happen, you have to make sure that it's secure. So increasingly, consumers and myself included, I want the data from my health and my devices reported to me on my smartphone. I want to see that data. So increasingly, you're going to see more and more App Store, Play Store apps that connect to wearables, they connect to implantables and they give you actual real time response on what's going on inside your body or on your body and then you go to the next level where that app can also be therapeutic. It can dial in your therapy and deliver a drug from that device, deliver some kind of electrical current or voltage from that device. So if you're going to start delivering things from the handheld wirelessly back to the device, usually through BLE, then you better make sure it's cyber secure. But then, even more importantly, you're seeing more and more of the connected world where I'm going to have sensors and control on my body, either on my body or implanted in my body, going out to the handheld, maybe even running to the cloud, running algorithms and making decisions for me, closing the loop, so to speak. So you see this as the Holy grail for type 1 diabetes, where I've got continuous glucose monitoring. I've got the ability to run advanced algorithms and I've got the ability to dose insulin. So if I can close that loop or base it also on maybe some diet apps, et cetera, in the phone, now you've got the artificial pancreas. So if you're going to start doing these types of therapies, when they go awry and there's nefarious intent and there's high danger, even while there's high flexibility and usability, and so you have to make sure that you don't compromise safety when you move towards this usability.

Jon Speer: Yeah, absolutely. Folks, I would encourage you to go check out the book that Dan mentioned. Dan, remind us again, what's the title of the book?

Dan Purvis: Medical Device Cybersecurity for Engineers and Manufacturers a real stellar-

Jon Speer: No, it's the title crosstalk It says what it is, right? So-

Dan Purvis: Yep. It's by Axel Wirth, Chris Gates and Jason Smith and it's published by Artech House.

Jon Speer: All right. Again, folks, if this is a topic that is important to you, which chances are it is if you're in the medical device industry and you're listening to this. Velentium also has a course or a multi- level course, actually, on cybersecurity, so I definitely encourage you to check that out. Again, we'll provide links to Velentium's website and the training that they offer on this particular topic. Dan, I thought we could wrap up the conversation today on culture and I think, specifically, quality culture. We put a lot of emphasis on that at Greenlight Guru. Having building true quality into the culture of your business as a medical device company, I think, and at least in my opinion for much of my career, I think we, as an industry can do a much better job of that. I think sometimes we get stuck in this rut or this rhythm of being so compliance- focused that sometimes we lose the essence of what this is all about. So what are some of your thoughts about the importance of quality?

Dan Purvis: Two thoughts on quality and culture. One is training, and one is the character, the underlying ethos of quality. So let's talk about training first. When we talk about training to quality or training as a culture of quality, I say it all the time around our company," Simple isn't easy, but simple is worth it," that for quality and the business to really work together, you have to continue to work hard on your processes, procedures and then, ultimately, on a quality system like with Greenlight to assure that it's intuitive, it's simple, it's straightforward. We find that as engineers, you know when it's not. When you raise your eyebrow at the end of that meeting or you tilt your head, then there's more work to be done. When you finally get there you go," Oh yeah. Now I can finally see how my quality system overlays my design process, overlays my business needs, overlays my deadline, and I can see how we can actually work together to make things quicker and better." So that only happens with the simplicity that comes from lots and lots and lots of hard massaging, hard work to get it going. The next part is training that if it hasn't been documented, it hasn't happened. That's really hard because you can do 90% of the quality work, but then not do the signature or not do the CFR Part 11 electronic signature or not document the meeting actually occurred, so if that review is not documented, if that analysis is not documented, then there's no artifact and hence, there's no proof that it really happened. So the rigor around documentation built into the culture and built into the training towards the culture that we have this culture of review and then we have this culture of documenting that review. So we found that different electronic signature tools can be very helpful to lower the bar of efforts necessary to finish off the review because it's not just a review that's reported on, it's review that's reported on and signed by the appropriate people. Then the final part of training is the shampoo side, the lather, rinse, repeat, consistency of culture like," Yep. Okay. I got trained. Yep. I got it. Yep. I did it. I was doing that last month and kind of haven't been doing it recently."* It's like," No, the idea of every week, every day, every hour." Because it's in quality lapses that you end up with quality problems and those quality problems, ultimately, can hurt people. So we try, at Velentium, on a regular basis to remind people that the quality, it's simple and integrated into who we are as a company, but it's also basic to creating good products and it needs to be every day, every hour, every week. So that's the training side on the character and quality. I think, ultimately, as medical professionals, we are all in his industry, usually for the same reason, which is, we want to make a difference. We can be in lots of different industries. We chose this industry because we wanted to make a difference and so continuing to hone your staff towards people that want to change lives is huge. We had a supplier recently, and she's a graphic designer supplier, and unfortunately, she lost her husband unexpectedly in November. So we, as a company, were able to give her another water and work with her to help. But then we just put it out to our company, as a whole," If anybody wants to help her in this time of need with her mortgage, just let us know and senior management will match it." Over the course of about a week and a half, our company was able to pay four months of her mortgage and it was just remarkable. It was really fun for me to see at the head of this company, that we have a company of servants. We have a company of people who ultimately care and so you can't really train that. You can't train people to care, but if you hire for that, people who care, then you give them a simple quality system, it's not an easy system, but a simple system, one that's intuitive and people that care and they work together to build quality products. That consistency remains because it's inside of who they are.

Jon Speer: It's so key. I remember really early in my career, and we talked a lot about the blend of design and manufacturing earlier, the company I worked for, I guess my title was product development engineer, but we were sort of a lean and mean and small engineering team, so we also had quite a bit of responsibility for manufacturing support. One of the things I picked up on pretty early is when I designed and developed a product. First and foremost, I needed to make sure that the intent of the device and its requirements and characteristics, that the physical attributes, that those who were going to manufacture the product had knowledge and understanding of that and went beyond just putting in specifications and drawings and things of that nature. It was really having a conversation with them. But something innate tuned into me and I was like," Yeah. Make sure you're informing and telling the people who are involved in making this product what it is used for, what types of procedures, what types of patients are going to benefit from this technology." I think that was something that I just, fortunately, picked up on. But when you can humanize that and get people to understand," Oh, wow. I'm doing this thing," and even if they're doing just a small step in that device or in a particular process, but they know that that small step relates to the quality of that product, which it relates to the outcome of that patient who's going to receive that, it makes all the difference. It makes the understanding of quality and what we do so much more important and so much more real. I think, again, as I hinted when I introduced the question to you a moment ago, I think we, as an industry, can do so much better. I think we've lost our way a little bit. Any thoughts or tips or pointers above and beyond what you and I have shared on this topic, on culture or frankly, anything else that you think is important for listeners to take home as homework for them to try to improve upon in their world?

Dan Purvis: Yeah. So two things. One is, we're creatures of story, so it's how we remember things. It's how we connect mental work to emotional work. When mental work is charged with emotion, it's way easier to retain. When I ask you for stories from your youth or stories from your college years, you're going to tell me life lessons, but they're going to be rooted in story. So to the extent that we can link the work that we're doing here in the medical device field, with the stories of surgeons inserting these devices and changing people's worlds for good, it's one thing to say that sentence; it's another thing to put a name and a face and see the emotion behind that person. We had the opportunity at an epilepsy benefit once to watch a man speak about the device he had received. It was a LivaNova device for vagal nerve stimulation. He broke down in the middle of his story and couldn't finish because he was so overjoyed with the way he had had his life back. His wife finished the talk. As you listen to him speak, it's so charged with gratitude and emotion that then you go," Wow, that's why we do this." So that whole aspect of storying and connecting whatever you're doing each and every day to a grander story that is meaningful and changing lives is key. Then the other thing that I would leave you with, we've done a fair amount of work in our company around the concept of flow. The flow state mentally is one where powerful biochemicals are being released by the brain and deep levels of concentration and productivity are unleashed as a result. What I found of recent as we've studied this is that the flow state requires you to push yourself beyond your comfort zone, but not to just crazy levels. Research has shown about 4% beyond your maximum capability is where you need to push yourself for. So if you'll consistently push just a little more, but not too much more, and just learn to enjoy that mental discomfort, that mental strain, it will push you towards a flow state, which you will see unbelievable gains. So we continue to think about that as a company, how do we get groups of people into flow states together? How do we prevent people from interrupting the flow states of other colleagues? How do we get flow states to happen in homework environments, et cetera? Because as research has shown, you can see two, three, four times productivity in a flow state versus out. So anytime we're trying to growth hack productivity, especially in this COVID world where your life is being interrupted all the time, how do we create two, three, four hour states of time where people are extremely productive, which then, can free up some time to grab lunch with your family or help a kid on a Zoom call with their school, et cetera?

Jon Speer: I feel like we could talk for days about flow state. I'm a fan and a student myself. I think what I've found is when I really enjoy and I'm passionate about the thing that I'm doing, it's just flows, it seems to just click and tick and it's really awesome that when you're around another group of people working collectively toward a common goal or objective how that group of people can get way more done as a team than they can as individuals. So it's really awesome to hear that you're incorporating these types of practices and this mindset and things at Velentium. Dan, I've really enjoyed this follow- up conversation, to hear the follow- up on Project V, to the importance of design and manufacturing, to quality and surviving and thriving during COVID times with a distributed workforce and quality, you've contributed a great deal of this conversation. Folks, I hope you all picked up at least a nugget or two that you can take home and apply to your everyday life. So Dan, excuse me, Dan Purvis, CEO of Velentium, thank you so much for being a guest on the Global Medical Device Podcast.

Dan Purvis: Thank you, Jon. I appreciate the time. Take care.

Jon Speer: Absolutely. Folks, as always, thank you so much for being loyal listeners at the Global Medical Device Podcast, the number one podcast in the medical device industry, and continue to spread the word with your friends and colleagues. As always, if there's anything we can do to help you at Greenlight Guru to embrace true quality and incorporate that as part of your culture and give you purpose- built workflows to help manage your day- to- day lives as medical device professionals, then please go visit www.greenlight.guru to learn more. As always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.


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