How do you build a company that puts culture before function? Results before profit? Building a culture of quality to improve lives for a better world is more than just a slogan, it's a shared mission.
In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Dan Purvis, CEO and co-founder of Velentium, about building quality-centric, life-changing products for the medical device space.
Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. Its staff does meaningful work on clients’ behalf to bring products to market.
Would you like to participate in an AMA (Ask Me Anything) session with this speaker? Head over to community.greenlight.guru and use the access code TrueQuality2022 to see what AMA’s are coming up.
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Dan describes quality through culture as a way to move beyond compliance to get true buy-in and engagement throughout your organization.
Quality through culture is like a three-legged stool consisting of people, business, and quality. The three legs must work together and learn from mistakes.
Dan’s definition of quality depends on industry. In the medical device space, quality aligns with risk and safety. A risk-based approach is needed to understand the harm that will ultimately happen to someone using your device.
Compliance obviously matters, as much as safety. A medical device could be fully compliant and still unsafe, or it could be fully safe and not compliant.
Team Effort: A high-performing organization needs a dedicated leader and excellent talent. If you’re teachable, there’s always hope. Also, even if you can’t hire perfectly, you can fire perfectly.
The culture of quality management can be considered a partnership or the police. Create a process, not a problem for people to conduct reviews.
Instill quality and get people to say ‘yes’ by creating and crafting a culture-forward company for people to be ready for anything at any time.
Dan wrote the book, 28 Days to Save the World, which details how Velentium partnered with a small medical device company and large vehicle manufacturer to increase emergency ventilator production.
28 Days to Save the World by Dan Purvis
Quality Is Free by Philip B. Crosby
Brian Tracy - Motivational Speaker
Turning the Flywheel by Jim Collins
Zen and the Art of Motorcycle Maintenance
Paycheck Protection Program (PPP)
FDA - Corrective and Preventive Actions (CAPA)
Greenlight Guru YouTube Channel
MedTech True Quality Stories Podcast
Global Medical Device Podcast Email
“In our space, quality really, really aligns itself well with risk and safety.”
“Quality - it really is driving your organization towards perfection. That doesn’t mean perfect people. That doesn’t exist. We’re all fallible. But how have I created the processes, the thinking, and ultimately, the culture that gives us the best shot at removing risk and creating devices that are not only ethical and helpful to people but safe for the long haul.”
“You could be fully compliant, and still unsafe. You could be fully safe, and not compliant, and so compliance obviously matters. You can’t go to market with non-compliant devices because you’ll get shut down, and you should be shut down.”
“The only rules in this company should be rules that are inspiring.”
Etienne Nichols: Hey everyone, welcome back. Today we're going to be talking with Dan Purvis. Dan Purvis is the Chief Executive Officer and Co-founder of Velentium, a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices.
Dan is a serial entrepreneur. He's the founder of six companies and Dan has fulfilled his dream of building a company that puts culture before function.
One of the things we're going to be talking about in today's episode, he also talks about results before profit, improving lives for a better world. It's more than a slogan for Dan.
It means Velentium staff is doing meaningful work on clients’ behalf so they can bring life changing products to market. By building a company that talented people want to work for, and other companies want to work with.
Dan has led Velentium to become a world class engineering firm and averaging 50% year over year growth. Dan has more than 25 years of experience in software, electronics, test systems and medical devices.
He's earned a Bachelor of Science in Electrical Engineering from Texas A and M University and a Jones Scholar MBA from the Jones School of Business at Rice University.
But what you'll really get is his experience.
He has a lot of good experience to offer. I think you're going to like this episode. Hey everyone. Welcome back to the Global Medical Device Podcast. This is your host, Etienne Nichols.
Today with me is Dan Purvis from Velentium. How are you doing, Dan?
Dan Purvis: And I'm doing great. It's great to be here at the end. It's fun to be back again on your podcast and just excited to talk quality.
Etienne Nichols: Awesome. Well, and speaking of quality, we do have an event coming up that you're going to be speaking at. I don't know if you want to mention the topic you're talking there, but.
Dan Purvis: Sure, yeah, no, it's fun. I'm actually going to proctor a session and it's a panel session and so we pitched this to you guys the idea of bringing several of our clients.
Velentium does design, development and manufacturing, four medical device firms.
And so, my idea was to bring several CEOs from our client to come sit on the podium and talk about exactly what we're going to talk about today and have me question them and just hear face to face.
If you come to the conference from other CEOs about their experience with building quality centric life-giving firms through the medical device space, that's awesome.
Etienne Nichols: And so just so everybody's aware of just kind of the topic we've thrown around, if I put it in a sentence, quality through culture, moving beyond compliance to get true buy in and engagement throughout your organization.
It's a little bit of a mouthful, but I think everybody can appreciate this topic. Culture over compliance or quality over compliance through culture. What does that mean though to you and what do you expect from that panel?
Dan Purvis: Yeah, there's really three legs to the stool, if you will and if you cut any one of the legs off, you don't want to sit on that stool, you're going to fall over.
It's the people which are the core to any endeavor, any organization. There's the business and people say, well no, we're not here to make money, we're here to make a difference.
I'm like great.
But cash is the heir of a business and without air we're all dead in six minutes. And without cash your business will be dead as well. And then there's quality.
And so, the idea of having business and quality together is something I work on all the time. And so, talking with the different panelists about how they merge their business and their quality together, but then merging quality with your people, you want to make sure that they really breathe and bleed quality like they understand quality in all they do. But then also your people in the business.
And so just the way that all three of those work together and then stories from the trenches, if you will, of different CEOs saying, well yeah, here's where it went awry and here's how we fixed it and cause it's, I think it's oftentimes in the messiness of our world that we get the best lessons.
And so, if you can learn from the messiness of others, then as long as they're humble enough to share those stories candidly, it's, it's kind of fun to learn from their mistakes and hopefully not repeat them.
And then we'll is that we can then share at a panel someday future.
Etienne Nichols: So yeah, so and when you talk about quality, I'm curious what your definition of quality is. And before you say, I'll let you think this for a second. So, someone gave me a book once, I think it was Phil Crosby.
Quality is free. He said quality is adherence or conformance to the standard. And my thinking has evolved a bit since then. But I'm curious what your definition of quality is.
Dan Purvis: It's really interesting. It depends on industry, right. In consumer electronics, you want to make your device good enough that only a select few are going to take it back to target.
Right.
But they'll get a new one and life will move on. It's hard to take your pacemaker back to target. Right. And so, in our space, quality really, really aligns itself well with risk and safety. And you have to have a risk-based approach where it's like, what is the harm that will ultimately happen to somebody with a name?
Your mom, my mom, my Sunday school teacher, your coach, that person that goes, yeah, it was all going great until it wasn't. That just cannot happen. And so, in a lot of different spaces, some tolerance of the nines, if you will, 99.99% sure, you know, is fine in our space, you really can't leave any stone unturned. And so, when I talk about quality, it really is driving your organization towards perfection. That doesn't mean perfect people, that doesn't exist. Right.
We're all fallible. But how have I created the processes, the thinking and ultimately the culture that gives us the best shot at removing risk and creating devices that are not only efficable and helpful to people, but safe for the long haul?
Etienne Nichols: I see. Yeah, that's great quality. It's a slippery concept, I guess sometimes, but I think you nailed it as far as taking a risk-based approach, taking all of those things.
Dan Purvis: So, you could be fully compliant and still unsafe. You could be fully safe and not compliant. And so, compliance obviously matters. You can't go to market with non-compliant devices cause you'll get shut down and you should be shut down.
So, it's like the idea of saying that what we do in regulatory compliance is a part of quality, but not the whole part of quality. Because the overarching desire to do good for society in the lives of people that have the devices that we have created is the ultimate goal.
And then whether it be your 1345 auditor or the FDA or any other government entity coming alongside to assure that we're all doing the job that we say we should be doing is great because it forces us to adhere to standards that keep people safe.
Etienne Nichols: Yeah, you mentioned something earlier too, when you were talking about business and money being the air you breathe or the air that business breathes, I thought that was a really good line.
You know, early in my career I would hear things, and maybe I still am. Early in my career, I don't know, I hear things about, or terms, the, the catchphrases.
And one is, you know, the word team. Team gets thrown around a lot. And at first, I didn't like that as much, you know, well, it's a department. But really team is almost a better word than family.
Maybe I should ask you this. What are your thoughts on this? Because in a family, you really, you're there, you know, but a team, you are expected to pull your weight.
I don't know. What are your thoughts on that? Or do you have any.
Dan Purvis: Yeah, no, sure. So, when we talk about a culture of quality, there's like a baseline. We play a fair amount of poker in our house, and my kids are like, when are we going to play more poker in blackjack?
And I'm like, yeah, with my money. I like how that works. But there's ante, right? You've got the big blind, small blind. You put in the chips to start the game.
If you don't have ante, you can't play the game. And so, we like to say that there's a base level of talent in the organizations, in the industry that we happen to play in.
You just have to have. And so, without that ante, without that talent, there are other places for you to pursue excellence. And we invite people to pursue excellence elsewhere. Often, I say you can't hire perfectly, you can fire perfectly, and you really should in your organization.
Because what we found is that team versus family is different.
For years, the goat played for New England, right? The Patriots. And I'm not particularly a New England Patriots fan. I live in Houston. I love the Texans. They're abysmal, but that we still like them.
But for years, Belichick had no sacred cows. If you were not going to help the team excel and exceed the expectations of the league and win, then you had to go.
And that's not family, right? Family is. Family is. Family is. Family is family. And that's great. And so. But having an attitude that says, hey, this will be a high performing team.
And as the leader of an organization, I would challenge each of you to say, I will dedicate myself as a leader to making sure that I am dealing with the emotional baggage, the emotional strain to assure that this is a high performing organization.
And so, we have found that when we part ways with people, it is not uncommon at all for two or three or four high performing individuals to come to me offline and be like, man, thanks, that's awesome.
Like, I was doing that guy's work or whatever, you know? And so. And it really does play out in different ways. There are times that you can get great work done, but you don't do the documentation, right?
You don't do. I got the product where it needed to be, technically, but I don't have any of the package together, technically. We deal with this in our clients all the time, where I say, wow, Mr.
Client, that looks great. And, yeah, we'd be happy to help you with that. But you realize you have just a glorified science fair project, right? Because there's no design history file.
Where's your DHF? And they look at you blankly and say, DH.
Etienne Nichols: What did you just call me?
Dan Purvis: Oh, yeah, exactly. And so, you're gonna want that if you'd like to sell that product ever.
And so, which gets us back to cash being the heir of any company, right? So, lots of people say, no, I'm passionate about my business. I'm passionate about making a difference.
I'm like, well, great. Show me your numbers. Well, you know, the numbers aren't important. I was like, well, okay, tell me about that in six months, you know, when you're not here anymore.
Right?
Etienne Nichols: So, yeah, well, you know, you mentioned you can fire perfectly. And I've heard you say, as long as you're teachable, there's always hope. What do you mean by that?
Dan Purvis: I like to say that if you're teachable, there's always hope. And what that essentially means is have a humble attitude. Have a fun, loving, not taking yourself too seriously attitude, such that, for example, if I hear an acronym that you tell me in this podcast, I'll be like, it's in.
Hang on, what's that mean? Yeah, and you'd be amazed. I would say 25% of the time, the person giving me that acronym has no idea. They're like, not really sure.
And I'm like, the fun part about that is if I don't know what that acronym stands for, chances are someone else on the podcast, someone else in the room doesn't either, and we're all going to learn.
And so, when I say if you're teachable, there's always hope, I like to say that if I don't know something and you do, and you're willing to share it with me, I'd love to learn.
Now, it's my job for that to stick, right? So, if I'm asking you the same question over and over and over again, that's more of a challenge. Maybe you're not the right fit for our organization, but if you don't know something in our organization and you're willing to humble yourself and say, hey, I don't know what that is, can you tell me or can you tell me where I could find that out? And I'm willing to go put in the work and the effort to learn that.
It's really, really remarkable what you can gain. Brian Tracy is like a motivational speaker from yesteryear and back in the 90s, I went to one of his seminars and he said, let me tell you the secret to career dominance.
And I'm like, leaning forward because I was younger. And he was like, read in your field. Read in your field. If you will read in your field 30 minutes a day for the next 10 years, you'll be one of the leaders in the world in your field in 10 years.
And I was like, holy smokes. Okay, let's do that. And I read. I read avidly because if I'm teachable, there's always hope. So, there's this idea in our quality system, in our leadership team and the way we run our business of I want this quarter, this month, this week, this day to be a little bit better than the last one. And I don't know if you're a golfer. I have an amazing gift for golf ATN, in that I can make you feel great about your golf, because I'm that bad.
But there's this concept in golf of swing thoughts, right? When you're swinging a golf club, you can really think about two things in the three or four seconds of a golf swing.
And so, the challenge for any young or old but young-looking bad golfer like myself is to keep practicing around two swing thoughts until those swing thoughts become muscle memory.
And then you can add two new swing thoughts because the ones that you worked on and worked on and worked on become muscle memory, and then you can work on the next ones.
The same idea happens in this teachability, right? So, if I struggle to get design reviews signed off, and that hypothetically could be a problem in companies like ours. And so, like, how do you create muscle memory within your organization?
That's like, okay, when we finish this design review, it goes straight to DocuSign and I send it before I leave the room. Now it's sitting in everyone's inbox. They could all check the box, and it's done.
Or it goes straight through the Greenlight Guru interface and it's done. And so, you build into the rhythmic Action of the organization, something that becomes muscle memory and then you can work on the next thing. And so, as you work thing by thing, week by week, month by month, quarter by quarter, year by year, your quality system, your just ability to perform gets a little bit better each time.
If we're teachable, there's always hope.
Etienne Nichols: I love that just kind of example that you showed where you know, a person learning versus the organization learning. That's a great, great correlation. That's pretty impressive. I do want to kind of swing back to one question.
It's kind of a selfish question on my part. So, I love the idea of reading 30 minutes a day and I do try to read a lot, but I guess the question in my mind is how do you choose what to read?
There's so much out there to consume.
Dan Purvis: Yeah.
Etienne Nichols: What's the top criteria there?
Dan Purvis: So, if you're not an audible account holder, you should be right like that. I guess I would say there is so much time in our day that gets lost when you're exercising, when you're driving, when you're driving, when you're driving.
You know, it's like I'm a parent of four non driving kids, although one of them is about to become a driver. That's been terrifying, I might add.
Etienne Nichols: AI, we're not getting there fast enough, is it?
Dan Purvis: Yeah, we're getting there. And so, I've got a 16, 15, 13, 11-year-old and I am an Uber driver by afternoon and evening and sometimes in the morning. And so first and foremost, when we get in the car, we play a book.
So, I've got books I listen to with my daughter, I've got books I listen to with my oldest son. I've got books I listen to alone. When I start to find things are getting stale, it's time to change genre.
And so, I will do business books, I'll do self-help books. I'll do biography, I'll do sports biography, I'll do historical biography.
And so, you could kind of bounce around. And I find that when I'm hesitant to hit the audible button on my screen there on the car and I just want to play music or whatever, I'm like, well, why is that?
What got stale? Okay, well what else do I have in my library? And then I have a personal policy. Whenever anybody recommends a book, I hit buy. I usually add it to the audible account.
My wife makes fun of me all the time because I listen at 2x and they're like, how do you hear that? I'm like, well that's the point. It forces me to concentrate.
Otherwise, it kind of can drift.
Wow. Drift at 2x, which I kind of find it gamifies it a little bit because I'd like to get through it quickly. Incidentally, our name Velentium is Velocity momentum and ingenium is the Latin for talent.
So, velocity momentum, like speed is kind of built into who we are as a company, reflecting my. I just like things fast. And so, you can't work here by being talented.
Ingenium only. You have to really enjoy speed and then you keep that speed over time. And that's momentum. And so, the idea of switching genres, I think is really important.
And then you end up with different authors that are go to.
Right. So, my favorite author by far is Jim Collins. Somebody said if you can meet somebody and have dinner with them, who would it be? I'd pick Jim Collins. Other people want to meet LeBron or something.
It's like, no, like I'd love to sit down with him just because. Good to great, built to last. Great By Choice. How the mighty fall. They're just so.
Etienne Nichols: I just got this. So, I use.
Dan Purvis: I will love it.
Etienne Nichols: I haven't read it yet. Just came in my inbox today. So, yeah, Jim Collins, yeah, he's a data guy.
Dan Purvis: So, it's all based on data which as quality people it's. You let the data drive you, right. And so, and he does these comparisons between successful and less successful companies in the same comparable space and then they tease out the difference statistically and then they write observations around that.
And so Great By Choice is really, I think my favorite one. But they're all great.
Etienne Nichols: And so, I haven't read that one. I guess I'm going to have to adopt your policy and hit buy on that.
Dan Purvis: So just real quick. I sat in an airplane once next to the head of operations of a pretty well-known home builder here in Houston. And I was like, no way.
David Weekley Homes. What a great company. And he was like, yeah, it's been really fun. I've been with David from the beginning.
And he goes, we have a book club. And we've read a book a month since like 1991. And I said, would you send that to me? He said, absolutely. And he sent me his book list.
And so, we have a book club here at Velentium now and we read a book a month. And sometimes it's in self-help, sometimes it's in business, sometimes it's in biography.
And like in the summer it's fiction just kind of for fun and so yeah, reading together is great. It gives you something to talk about. That's not always work, right?
Etienne Nichols: That's awesome. I could see that even playing into the culture as we were talking about a little bit earlier. Maybe if we swing back around, if we go back to quality management for a moment.
So, I worked as a manufacturing engineer, then product development, as a project manager. And I had a mentor who told me, now quality can be a partner, or they can be a police.
You need to treat them as a partner. So, I'm curious what your take is on that. Have you seen that? What, horror stories or happy stories?
Dan Purvis: Yeah, no, for sure. So, this would be my chance to plug management review. If as a company you're not involved in quarterly management review, highly encourage you to comply with the standard because we have embraced that. That would be an example of me not using quality as police. But it's like, no, I look forward to the quarterly management review meeting because our CTO attends, our head of quality attends sometimes, our head of operations attends and I attend.
And I am always fighting for any time I sniff out a business quality, I'm like, no, no, hang on, hang on. We're not adding that rule. This becomes a rule that everybody has to do.
I'm like, stop, dissociate, spread your wings and find this. And until we do that, that's way harder. But who is it harder for? It's harder for the management team, it's harder for the leadership team to come up with the process that truly does this.
Who is this easier for? Everybody else in your organization. Right. And so, it's just an example for me of saying, no, I'm not going to let it ever police at the management review level, which forces us here.
Etienne Nichols: Can you give an example of where a situation where that might occur?
Dan Purvis: So, quality says you will do design review, design inputs, design outputs, transfer to manufacturing, you know, phase zero, phase one, phase two, et cetera. Requirements review. We want a culture review, right?
So not only do I want all of the mandatory reviews by the quality system, I want micro reviews happening all the time. Hey, come take a look at my code.
Do you mind just taking a second and looking at my code? And so, two things we've. Let's talk about people in business, the other two parts of the stool, right?
So, the people side of that stool, how do we get people to be interested in interrupting their day and saying, come take a look at my code? First of all, when that happens, even in the informal, not informal design review, I say it all the time.
90% of the fines in that meeting will be by the person presenting it to the other one. They'll be like, oh, hang on there, you know, like. Like here.
But just the act of presenting it to a peer gives you a different perspective. It forces you out and looks you in differently. So how do we motivate that at this company?
If you want to have free lunch at any time, you could eat free lunch five days a week. Lunch is on us if you're conducting a review.
And so, there's the people quality side, the business quality side. If I have somebody come to me on an informal review in Slack, when you invite them or in email where you invite them, you put our project number.
Because when that person comes in, helps you review, they should build to that project. We should get paid for that time. Because the act of interacting together like we are on this podcast, we're promoting knowledge in both of us and hopefully and in the audience.
And so, if we could do the same thing around code that's valuable and it should be valuable to the client and if they balk at paying, that I'm happy to talk to them about.
I'm like, look, when Etienne took a look at my code, it made your project better. And hence, yes, that 20 minutes got billed. And so, one is enforcing a culture of billing on the business side, one is enforcing a culture of food on the lunch side.
And together, all three of those, then when it's time for design input review and design output review, that is required.
I've already had 17 different little micro reviews and oh yeah, this one we're going to sign off. Right. Do you see how that links?
Etienne Nichols: Yeah, that makes sense. Okay. I love the different things that you put in place to make that, I don't know, just incentivize those things.
I don't like the word hacking necessarily, but hacking our mentality, you know, we're all driven.
Dan Purvis: I talk about cheat codes all the time. You know, you can build your hay day farm like my wife likes to do it, but if you can find that cheat code and suddenly you have a thousand coins, like, yes, long as it's not illegal.
Let's go.
Etienne Nichols: Right, absolutely.
So, on that note, since you've been building this business in this different way, obviously we've just gone through a big, you know, upset. The entire world has gone through the upheaval of the pandemic.
Did you have to kind of reorient or were there any things that you.
Maybe that's a dumb question. What did you do?
Dan Purvis: It's such a crazy Deal, right. So, like most of your listeners, there's the PPP program which allows you to get some assistance from the government to help pay your people. And we're in a senior leadership meeting talking about the PPP program.
This is in March of 2020.
Then I've got a draft email, literally a draft email in my inbox about like, hey guys, here's where we're headed. We're going to work really hard to keep everybody, but we're not really sure what's going to happen.
And it stayed a draft because three days later I was in Bothell, Washington with Ventec Life Systems and General Motors and the federal government on a project that came out of nowhere to build a ventilator factory from scratch.
And it was by far the busiest six weeks in my entire 20 something year career.
And the most exciting moments in my career where like you're watching from the White House lawn where the President is introducing your project. Project on video. It's like we have something with General Motors here and then the vice president from the Rose Garden is talking about the project.
And they talk about like one of the things that happens when you're going crazy is you have this heightened view of yourself. Like, you know, yeah, you could think you're, you know, a hero, you could think you're God or all that.
And. And in the midst of all this crazy, I'm like, is this happening to me? And then you turn on the news when you finally get back to the hotel at 11 o' clock at night in Kokomo, Indiana, next to this General Motors plant.
And there they are, the talking heads talking about your project. You're like, no, this is real, this is happening. You know, and it was crazy. We built 142 test stands to automatically verify and validate ventilators in a brand-new factory that came out of nowhere in six weeks.
And then we built 30,000 ventilators in partnership with the federal government, Ventec Life Systems and General Motors. Over the next several months, really, really remarkable times.
We like to say in our company that we exist to change lives for a better world. It's our passion. It's the core of who we are. It comes in front of money.
Not in place of money, but in front of money. We exist to change lives for a better world. I always tell my staff that we exist to change lives for a better world.
And that starts with you and your family. And so, when we talk about our vision as a company, we dream of a day that we'd have a thousand families we don't say a thousand staff, we say a thousand families.
Because if we can teach our passion and our values to each of the thousand people on our staff, in time they'll go home and teach that to the people in their dog park and their churches and their, their YMCAs and their athletic teams and.
And slowly but surely, you'll put a little dent in society for good through changing lives for a better world and our three values.
But I sat there back in March of 2020, and I sat with a group of leaders, and I said, look, I say it all the time. We exist to change lives for a better world.
That starts with you and your family, except for when the whole darn country just stepped in between you and your family.
So, I'd like you to lead on this project, but I'm going to need 16-hour days until it's done, seven days a week. When your body gives out, go home and go to sleep.
When you wake up, come back and we'll keep doing it. And to a T, everybody but one signed up right there. One of them was newly married and said, I need to go back and talk to my new bride.
And the next day he signed up as well. And so that's kind of a culture.
Is that a culture of quality or a culture around a passion of changing lives for a better world? But I guess I would say yes, right? So, the idea of changing lives for a better world in the medical device industry cannot be sans quality.
And so yes, we need these test systems out as quickly as possible. Yes, we doubled the size of our staff in a week because we went and hired a bunch of laid off oil and gas workers to be technicians and to turn the wrenches to build these test systems.
But yes, every last one of them has to be certified because they're going to say this ventilator works. And I don't know about you, but if you have Covid, they're about to stick that thing down your throat, you kind of want to know it's going to work, right? So, it was a really, really remarkable time that pushed our quality system really to the hilt because we had to double the size of our quality group at the same time.
But if you have a solid process, you have solid documentation, you have solid procedures. Here, read this. Great. Now let's go do it. You know, and so really, really neat time.
Etienne Nichols: Well, I'm just kind of pointing to my career. That is impressive. That is very impressive. I'm amazed at the thought of even combining with other companies to almost, you know, Build this cohort almost.
The quality management system is so specific oftentimes to a company that you were able to make that work well.
Dan Purvis: So, it was interesting. We read an article in Forbes from the CEO of Ventec Life Systems, a small startup in Bothell, Washington that said if we have more resources, we could do more.
And so, Tim Carroll, my co-founder, reached out to Chris Kipel and said, hey, you know, we built all your test systems so that you can build about a hundred ventilators a month.
I mean, we know your stuff, how can we help? And they were pretty overwhelmed. And they said, well, we have a war room meeting every morning at 8am I said, it sounds to me like we should be there.
They said, okay.
I said, somebody from our organization will be there tomorrow. And on two hours’ notice, in the beginning of the pandemic, I went and told my wife because I was working at home and said, I'm going to go get on a plane and fly to where the first deaths in America were, which is seven miles south of Ventec Life Systems.
And it's kind of terrifying back then because you just didn't know what was about to hit you. And then ultimately it comes down to, like you say, quality systems have got to weave in as a provider of design, development and manufacturing services to the industry.
You can buy from a supplier in one of two ways. You can buy under supplier controls. You know, if I buy a widget, if I buy this mouse, I could say, you know, we looked at the quality system, we verified you as a supplier and now when I buy mouse's mice from you, mice are from you, I know that they're right. You could do the same thing with design development. You can buy a design which is a set of services leading to a design history file under supplier controls.
So as a smaller company, you could come to an even larger company like me if you're a small startup and say we have the funding, we have the IP and we want to buy a design from you and you're still involved in the day to day with our engineers, but ultimately it's just coming over from our quality system to you as a finished product. Or you could say, no, we have our established quality system, we want you to run under it.
And so, our staff then comes in, trains under your quality system, authors, documents that are on your templates and everything resides within your design controls and your reviews.
Etienne Nichols: Yeah, I love the different paths that you laid out there. That's really cool. So, I'm curious, 16-hour days, seven days a week, that's impressive that everybody except one, and then even he showed up later to join the front lines.
How do you instill. And maybe it's not instilling, maybe it's drawing the right type of people. I'm not sure. Maybe you can clarify. But I know medical device quality, when I was in manufacturing, maybe kind of let me lead with the story here.
So, we were a small volume but very high cost. So, it was a neurosurgical piece of equipment. Sometimes marketing would say, we need more, we need more. This month. We've got big orders.
So, I go out there and give my speech. I'm like, guys. Everybody just groaned. They're like, oh, he's gonna give his speech.
Dan Purvis: Here he goes.
Etienne Nichols: In college, my brother, you know, he had Crohn’s, and he spent all summer in the hospital.
I laid there with him. I learned the medical device equipment. You know, we were tight. And I say, you know, when we're doing this equipment, it matters. You know, quality matters.
And I would give that speech. I don't, you know, who knows if it made an impact or not. But that's what drove me to do things correctly, I guess, because like you said, you got a name behind the person that potentially could be used on.
But I'm curious, do you have any stories like that or what instills quality for you?
Dan Purvis: Yeah, I mean, how did we get everybody to say yes, really? Begun in 2012 when we started the company. Tim and I have been together at another consulting firm for 14 years, since 1998.
We decided to start our own deal. And from day one, our goal was to have a culture forward company. In fact, we took the story of the ventilator build and the 28 days from when we first started to when the first ventilator came off the line.
And we've got a published book that's coming out this fall called 28 Days to Save the World. Creating a culture, crafting a culture to be ready for anything. And so, the premise of the book, and really the premise of most interviews I do, is that you start laying the foundation and root building long before you're battle tested.
And so, we had been building culture for nine years. And so, when we finally had this once in a lifetime type moment where you're seeing like where you were like 10 minutes before you got left and went to the hotel on the worldwide news, right.
You know, you're like, holy smokes, this is the real deal. We were laying that foundation for years before. And so that's what the book talks about. It tells the story of the ventilator factory, but it also tells it from the story of, like, how to build up to that.
And so, one way you build up to that is you've shown for years that you're true to your culture. So, at our company, muffins with mom or donuts with dad at the preschool is not just allowable, it's expected.
I'm like, don't come ask me for permission to show up at 9 o' clock because you're going to be at the preschool eating a muffin. Like, go and then get your butt in here and get your work done, right?
It's like, so you get with that freedom, with that trust comes way, way, way more. Because people here know that we're not going to put rules in place, quality or otherwise.
For the bottom performer. I like to say, if there's a rule that's about to happen and it's going to have a name associated with it, if it's the NTN rule, because you were an idiot, like, we're just not going to do that. Like, yeah, we're either going to coach the individual, release the individual, but, like, if the only rules in this company should be rules that are inspiring and leading out in front of our top performers.
Motors, right? And so, for years, people saw that, and then ultimately it comes down to, like, you say, like, if it's your mom or my mom and one ventilator left, I didn't want that to happen.
Right? And so there were only a few disproportionately small amount of companies in this world that could do it. In fact, General Motors saw our bid as part of General Motors, like, world.
You have to have other bids. And so, they asked the guy who had been working with me, you know, like, where can we get some other bids? And he told me, he said, I gave him three or four other names.
I was like, oh, no, you know, like, come on. He goes. And then I said, but if you want it done in 28 days, there's one company in the world that could do it.
Because we had years of experience with Ventec, right? And so, it's one of those situations where for whatever reason, we were thrust into this fray. And in moments like that, whether it be, you know, this particular neurodevice that you're manufacturing is needed in 17 more hospitals this month than normal because it just so happened that more people need it or that the world needs ventilators, or we're going to have to, like, manually ventilate people with national guardsmen, like we're in this industry because ultimately we care, right? I mean, yes, it's a regulated industry.
Yes, it involves more documentation, but yes, our ultimate client has a name. It's a little girl with long hair that happens to have seizures three, four, five times a day that doesn't have to anymore because of one of our clients, Cyberonics. Now, Livanova, it's a soldier that lost his ability to walk because he was paralyzed from the waist down. And you can look and Google the company onward, which is now rehabilitating people and giving them their ability to walk again.
It's people that can't see anymore, but they can put on a pair of glasses from second sight, and they can stimulate the optic nerve and allow them to be able to see again.
And, like, this is remarkable stuff. And my youngest son, Elliot, he had a version of epilepsy that you grew out of, and he has grown out of, but I've held him while he's seizing.
And, man, when you start to hold someone who's seizing, who, like, you bring your oldest son over, you both lay your hand on his back the first time it ever happened, and it's like, Jesus, please protect Elliot.
Jesus, please protect Elliot. He's just begging the Lord to like, I don't know what's happening.
And then the paramedic comes, he's like, oh, he's seizing. And I'm like, you're not concerned? No.
Oh, whoa.
Okay, deep breaths, deep breaths, deep breaths. But it's like, no, we can make devices that end that. I mean, there's now with the Medtronic 670G closed loop insulin dosing pump that reads continuous glucose and automatically doses it, is an artificial pancreas.
That's unbelievable. For people with type 1 diabetes, it's game changing. And so, the world we are playing in, which is mirroring microprocessor technology that is smaller and faster and denser than it's ever been before. Moore's Law, right. For years it's been happening alongside of our understanding of neurology and the way that, you know, we've done all kinds of stuff in cardiac for decades, but there's one heart and there's millions of nerves.
And so, if I stimulate that nerve, I can now deliver therapy directly to the place where it's happening, as opposed to pharmaceutically, where I swallow something and it goes to the entire body and hopefully to the place that is happening.
The world is at our footstep. Like to be able to just make unbelievable, dramatic changes. So that's the passion that we try to share with every candidate. And so, when we're interviewing, by the end of that, they're not going, oh, my gosh, oh, my gosh, I really want to work there.
You know, like.
And it's like, well, forget it, you know, like, we'll move on. And so, when we were looking at oil field technicians who are going to become test system assemblers in the ventilator project, if their first question was, what's the hourly rate?
We moved on. And it wasn't that we didn't pay well. In fact, we paid pretty well. But I didn't want people coming in. You're not going to work 16-hour days for money, at least not for very many days in a row.
But if you're working 16-hour days to keep Etienne's mom alive or Dan's mom alive or both of her mom’s alive, then okay, I could do another day. I could do another day. You get to a point where I almost got thrown out of the plant once up there in Kokomo, Indiana.
And the guy was pretty gruff with me because it was the safety officer, and I was tooling around without my mask on.
Etienne Nichols: Oh.
Dan Purvis: Because I had gone out to get food for everybody. I tried really hard to keep our staff nutritionally fed and not fast-food fed.
And I was just so exhausted. I left in the car, right? And he was like, you come in without a mask again, you're done. And I was like, oh, man.
And I was like, why don't I have my mask? And it was like, okay, guys, time out. Now I'm out. And I went and I slept, I think, for, I think, 18 hours.
And then he could do it again. Right. So, it is what it is.
Etienne Nichols: That's huge, though. I mean, just servant leadership really shows, you know, it really rallies the troops. I can see that though, man. So, I appreciate hearing your passion. I can't wait to hear it at True Quality. Can't wait to meet you in person at True Quality. If you're listening and you're thinking about going to True Quality, it should be a great topic panel that you're putting together.
Any other stories or thoughts, recommendations you want to give the listeners?
Dan Purvis: I guess I would say the hard work of quality at the process level, if a lot of your listeners will be leaders in executive management or leaders in quality. Right. So, the hard work to go just a little bit further with your effort makes it that much easier for everyone else in your organization.
And so, I'll tell a quick illustration and then a story. So, the illustration. And somebody told me about this recently. They were like, you've got a block of ice sitting on a table in a frozen room, and that room is 21 degrees.
And you work and you work, and you work and you work, and you get it to 22 degrees, and nothing happens to the block of ice. So, you work some more, and you really toil, and you get some new processes, and you make some procedures, and you get to 27 degrees, and nothing happens to that block of ice.
And then you work some more, and you really get after it. And you do some teamwork, and you do some team building and you do some free falls and whatever you do, and.
And you get to 31 degrees, and nothing happens to that block of ice. And you're like, well, I guess it just isn't going to happen. I guess we're done here.
And you are one degree away from seeing dramatic change.
And I find myself thinking that all the time. It's like, if you feel like your culture is fighting you, one more degree, one more degree.
If you feel like regulatory affairs, like you're getting hammered, or your 43 letter or your 1345 audit, or, you know, just all this stuff is happening, one more degree, one more degree.
Because the spoils in the American economy don't go to the most talented, they go to the most stubborn. The person that digs in and says, I'm not going anywhere. And eventually you see a little drip on the side of that block and then you see a slight stream, and next thing you know, you've done it, you've melted the block. Right? Either you made it, and that gets into muscle memory, it gets easier for the next time.
So, what are those things that even though it's not quite coming together, if you gave it just a little bit more effort, another day, one more day, one more degree that you could get there.
And so, for us, that comes out.
You see a lot of problems in quality systems around the CAPA program, corrective and preventive analysis, right? So, I'm a huge fan of preventive. Preventive means we've looked at our business proactively and come up with things that we think we can make better without having to have something fail to create it.
And lots of Companies don't have PAs because they don't want to create extra work for themselves. But every time you do a pa, you just created what was gonna be a CA on a CAPA.
Etienne Nichols: That's a good point.
Dan Purvis: Without having the problem, right? So, it's like, so I would say those are the degree movers, right? That gets it from 27 to 28 to 29. Getting closer to 32. Where you start to see the block, melt are the PAs where you go out and do it proactively.
And then once you're in your CAPA world, the extra effort. To true root cause.
To true root cause. What does that really mean? So, man, I can't see very well. And it's like, okay, well, I look here and I'm like, yeah, there's some smudges there. And I fix it, and I can't see very well. And you keep working it, and then you finally realize that you've been sitting here like this the whole time.
And my kids will look at my glasses. My left eye is nearly blind. My right eye is pretty good. So, they can all see through the right lens. They can't see it all through the left.
They're like, how do you see through the left lens? I was like, because I've got a jacked up left eye. That's happening.
As long as you don't turn those glasses around, like, until you turn them around and get them right. Left eye on left eye, right eye on right eye, it doesn't matter how much cleaning you're going to do. And yet I feel like we do that all the time, right?
It's like, oh, okay, we cleaned the smudges, and we're good. Okay, well, great. But I saw the carnage from that that led to that CAPA. Are you sure that the smudge was the problem?
Well, we'll go back and look again. Okay. Yeah. Now. Oh, we found another smudge. And I'm like, like, doing the real work to get to the root cause that, you know. So, we keep having supplier quality problem. Okay. And we audited the supplier. Now it's fixed. Hang on.
Where did this part come from before that supplier. What came from their supplier? Well, let's look at their supplier quality process, you know? And so, you see what I'm saying?
It's like to dive deep enough to really get to it, and people go, well, how do I know when I've dived enough dope enough?
How do you know when you've gone in enough?
And I think the answer to that is maybe hard, but the answer is you just know, like, there's a point in time where you keep trying to do this with your quality in your business.
And then you go. And you go, oh, wow, that really worked. It's the same thing that happened for us in our culture when we went from a thousand staff as our vision and our goal, to a thousand families, and boom.
The energy that came from that, like. So, when you go to true root cause, when you get to that root cause, everyone in the room goes, yeah.
You know, when you see it, okay, okay, smudge, smudge. That's not the thing it was.
Now we've got it. Right. You see what I'm saying? So, yeah, I guess I would say one degree further, one degree further until you really get there. And that shows up in your quality system through preventive action and true root cause.
Etienne Nichols: You know, I've talked to another guest about this. When we talk about the definition of quality, Zen and the Art of Motorcycle Maintenance. That book you dreaded reading in high school, I read it later on in life and like, wow, he's talking about quality.
It's so, you know, it's something, you know, but how do you grasp it? How do you define it? But like you said, you know, the constant pursuit of quality is important.
And another person I've talked, you know, CAPA is the heart of your quality management system. If you don't have a good, solid CAPA system, how are you going to improve anything, really?
Dan Purvis: Right. It improves teachability. Right. It builds teachability into your organization.
Etienne Nichols: I love that. I love that. Well, anything else? I mean, I feel like that's kind of a mic drop right there.
Dan Purvis: Yeah. No, no, Love it. I'm glad I got to come on at a shameless plug for the session we're going to have at True Quality. I'm pretty sure I've seen the weather.
I think it's going to be 73 and sunny, so like every other day in San Diego. So. But yeah, so it should be a fun time, a good time to connect, and then some informal times around the coffee and just in the hallways to share war stories together.
Because I think it's in those conversations, less formal, that you get some real growth where you're like, oh, okay. I think I have the emotional motivation now to take it that degree further, to try to see the effects that I'm going for.
Etienne Nichols: Yeah, yeah. Expand the borders and, yeah. Your network. That's awesome. Well, looking forward to it. I can't wait to meet you in person. Those of you who've been listening, you've been listening to the Global Medical Device Podcast.
We'll put links in the show, notes to Velentium and where you can find Dan Purvis and what he's been up to and what his company is doing.
Any questions, obviously let us know. We'd love to help you in whatever it is, whatever challenges you're facing. If you're more interested in the medical device success platform that Greenlight Guru offers, feel free to head over to www.greenlight.guru and schedule your first session to see how we can help you maintain compliance and establish quality within your organization as well.
For those of you been listening, thank you. We'll see you next time.
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