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What is true quality? How do you achieve it?

In this episode, Jon Speer of Greenlight Guru and Mike Drues of Vascular Sciences discuss habits of highly effective, true quality medical professionals. 

True quality does not simply refer to being compliant with regulations - but going above and beyond. It’s your responsibility to improve the quality of life.

 

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Some of the highlights of the show include:

  • Habit 1: Quality management system (QMS) should be simple and right sized; customize it to describe your business’ processes.

  • Habit 2: Move away from paper-based approaches - may make your QMS fragile and not scale; digitize documentation with a purpose-based solution.

  • Habit 3: Always be audit ready; if the FDA is coming, you shouldn’t behave differently or hide something. Be transparent, and let FDA show up anytime.

  • Habit 4: Implement risk-based approaches and decision making; understand the scope, magnitude, and potential impact of issues and complaints.

  • Habit 5: Be proactive rather than reactive to events; don’t wait for something to happen to do something about it. Monitor, evaluate, track, trend, and take action.

  • Habit 6: Break down silos/barriers by understanding the purpose and benefits of regulations and regulatory agencies.

  • Habit 7: Shift from compliance-minded to true quality focus; you develop, design, and test a product to make sure it’s safe and effective, but the ultimate power is knowing that it’s for real physicians and patients.

 

Links:

Mike Drues

Greenlight Guru

510(k)

The 7 Habits of Highly Effective People by Stephen Covey

 

Quotes:

“We’re all in this to improve the quality of life. We all have a quality role that we play into this process.” - Jon Speer 

“Sometimes, convincing companies to go above and beyond is what is required. It’s not always an easy thing to do.” - Mike Drues 

“Sometimes, people look at a quality system as a burden. I want you to look at it as something you get to do that describes your business’ processes.” - Jon Speer

“If you’re doing all the things that you should be doing anyway, then you have absolutely nothing to worry about.” - Mike Drues


Transcription:

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: In this episode of the Global Medical Device Podcast, we cover Habits of Highly Effective True Quality Medical Professionals. Now, you may be wondering what I mean by true quality, and I would encourage you to listen to this episode of the podcast to learn more.

Jon Speer: Hello and welcome to the Global Medical Device Podcast, this is your host, the Founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. And I'm pretty excited about this one because I'm gonna give you all a twist today. I've got a usual voice on the Global Medical Device Podcast, Mike Drues with Vascular Sciences. So, Mike, welcome.

Mike Drues: Thank you, Jon. Always a pleasure to speak with you and your audience.

Jon Speer: Alright, so Mike, recently you and I talked about the habits of highly effective medical regulatory professionals and I thought today that we would look at this through a slightly different lens and focus on some habits of highly effective true quality medical device professionals. And here's the twist, I thought that we would have a slight role reversal today, that maybe you could ask me some questions about true quality, and then we can dive right into that. Is that okay with you?

Mike Drues: I would be happy to do that, Jon.

Jon Speer: Alright, so I'm gonna sit back and wait for the first question. So, let's just dive right in to the habits of highly effective true quality medical device professionals.

Mike Drues: Well, first of all, Jon, for the benefit of the audience and also for the benefit of myself, you've used the phrase "true quality" a couple of times, maybe as a start, why don't you tell us what you mean by "true quality"?

Jon Speer: Sure, absolutely. I think we in this industry for a long time have been, I don't know, conditioned or maybe we've conditioned ourselves. I'm not sure of the root cause initially, but let's just say that we've gotten complacent and very focused on checking boxes to be able to demonstrate compliance. And I like something that you've said before, just being compliant with the regulations means that you're the equivalent of a C student. And I think if companies realize that, then they're average. And some of the things that we believe in at Greenlight Guru is that we're all in this to improve the quality of life and that the notion that "quality," I'm using air quotes here, is the responsibility of the quality department and not the responsibility of others, I think, misses the intent. All of us in the medical device industry have a responsibility to bring true quality to the table. And of course, it depends on the different roles that we play, but everything, whether it be engineering or manufacturing or quality management systems, or regulatory submissions and so on, marketing, sales, and so on, we all have a quality role that we play into this process. So, that's in a nutshell just getting people to think about this a little bit more globally.

Mike Drues: So to paraphrase, Jon, would it be fair to say that true quality is not just simply meeting the regulatory or quality requirements, not just being a C student but going above and beyond and doing what we as professional engineers know that we should be doing?

Jon Speer: That's a fair statement, Mike. Absolutely. I'm an overachiever, maybe not everybody else is, but I wanna know what I need to do to get beyond an A, and just checking a box on a form to say, "Yep, I'm compliant." Man, that's not a good... For me, it's not a good feeling. Maybe there are some out there listening who are just fine with getting by, but yeah, I wanna give people tips, some pointers, and some habits that they can embrace that can help them be A students.

Jon Speer: Well, Jon, as you and I have talked about in the past, we're both very much on the same page and you're preaching to the choir, and perhaps, as we continue through your seven habits, you can share with us how to implement that in reality, because as you and I have talked about before, sometimes convincing companies to go above and beyond what is required is not always an easy thing to do. So, let's move on to your first of Seven Habits of Highly Effective Quality Professionals, and that is, your QMS should be simple and it should be right-sized. So what does that mean, Jon? Your QMS should be simple and right-sized.

Jon Speer: Yeah. It's really a good place to start. And folks, I want you to hear this. Compliance with regulations is important and it's not enough. And I think sometimes when companies start to establish their quality management system, and it doesn't really matter if you're a startup doing this for the first time or you're a well-established business that has had a quality system in place for decades. This is a thing that without careful attention and focus, a quality management system can be unwieldy pretty fast. In my practice over the past 20 years, I've seen really two extremes. I've seen the one extreme where the quality system is ad hoc and almost non-existent at times, and then the other extreme that I've seen, typically employed by larger companies, but not always, is a quality management system that's overly burdensome and it creates a lot of minutiae, a lot of bureaucracy, a lot of forms and paperwork, if you will, that frankly, don't add value to the process.

Jon Speer: And so, my philosophy on quality management system is, let's keep it as simple as we possibly can. Let's not just make a bunch of rules for the sake of making rules. Yes, we, of course, want to adhere to regulations, but we need to have conscious efforts to make sure that our quality management system evolves and is right-sized to fit the shape and size of companies that we are. On the startup, that's probably gonna look quite a bit different than if I'm a company that's a multinational with a dozen different facilities at sites across the globe. But we need to be cognizant of, and we need to keep our quality management system as simple as it possibly can because at the end of the day, the employees, the people who need to... All of those processes and procedures that we're defining, they need to know what they're doing and they need to understand the intent behind that. And so, hopefully that gives you a little bit better perspective of what I mean about keeping a quality management system simple and the right size.

Mike Drues: Well, I love the idea, Jon. Keeping it simple and right-sized, and perhaps I could take it even a half a step further, I would say personalized or customized as well, because...

Jon Speer: Oh, for sure.

Mike Drues: And this is a recommendation that I make to a lot of the companies that I work with. Your quality management system should not be cookie cutter. It should not be the same as every other medical device company. Just recently, I have a company that I'm working with on the regulatory side, but they wanted some help on the quality side as well. And they were looking to purchase some, let's just say, canned documents, about design inputs and outputs and different processes and so on, from one of these outfits that sell, "Here's the form. Buy it. Put that in your QMS. It's essentially ready to go." And in my opinion, Jon, and you might agree or disagree, but that defeats the entire purpose of having a QMS.

Jon Speer: No, I do agree. Yes, folks, if you wanna be that C student or maybe even a D student, in this case, you can go spend a couple thousand dollars on the Internet and you can buy this canned package of quality system procedures. If that's what you wanna do, go for it. But please tell me when you do that because I wanna know what medical devices your company is developing and manufacturing.

[laughter]

Jon Speer: Because I don't know that I want those used on myself or anyone that I love and care about. But anyway...

 

Mike Drues: Yeah.

 

Jon Speer: Yeah. Wouldn't you agree? You gotta own this. Sometimes people look at the quality system as a burden, as something they have to do. I want you to look at it in a different way. I want you to look at it as something, this is something that you get to do, this describes your business processes. And of course, your business has unique characteristics, unique features, unique attributes, and your quality management system should be customized to reflect that.

Mike Drues: It's kind of on the regulatory side, Jon. It reminds me, there are, believe it or not, this is a true story. There is an outfit on the Internet that sells a 510 [K] template for $150. [chuckle]

Jon Speer: Oh, wow.

Mike Drues: Anyway, let's move on to your second of the Seven Habits of Highly Effective Quality Professionals, and that is, to move away from paper-based approaches. Now, I'll be honest with you, Jon, there's a little irony here because, as we speak, the notes for our conversation, I have written on a piece of paper. So, maybe I'm violating one of your seven habits.

Jon Speer: Yeah. [chuckle]

Mike Drues: But what do you mean by, move away from paper-based approaches?

Jon Speer: Sure. And Mike, I have a note pad and a pen that I take to every meeting and conversation that I go. So, for me, and some of it's generational, I think. But for me, I'm still an avid, a manual note-taker on paper. So I'm not saying that paper doesn't have a place in what you do. What I'm proposing here is that, if your quality management system and your processes and your approach to day-to-day activities largely lives, and I'm gonna use air quotes here as well around the word, "paper-based approaches" that that might be a little bit fragile and it might not scale. And now I use air quotes around, "paper-based approaches" for the reason because a lot of companies have digitized their approach.

Jon Speer: So think of the olden days, Mike, when you and I first started in this industry, the literal paper-based approach involved in a lot of cases, a little file cabinet. You open a drawer in a file cabinet and there's a bunch of folders or there may be binders, and when information is contained in that file cabinet, it is hard for that to be shared and it's hard to collaborate with others who have, the stakeholders, in that particular thing that you're doing. How do you get that information disseminated to others who are involved in either product development effort or manufacturing and so on? So, that physical file cabinet is a hard thing to maintain and scale, especially with the nature of companies these days. It is a rare thing for a medical device company to be completely vertically integrated at a single site or a single location. And so, information about your products and processes, it needs to be shared across multi-functions, multi-groups, and oftentimes multiple locations. So, what a lot of companies have done is, they more or less have replicated the old-school, the physical file cabinet and physical paper, and instead they've created the same sort of structure in like a server folder tree or maybe they've got a SharePoint site where it's folder upon folder upon folder.

Jon Speer: But basically what they've done is replicated a file cabinet in digital form, and that doesn't scale very well either, because information that people need to do their jobs is buried somewhere in a folder and they may or may not know where that is, or they may use the wrong version and that sort of thing. So, these approaches are very fragile. There's a lot of business risk that's tied up in these paper-based approaches. So, we're at a day and age where companies need to start to shift and transition to purpose-built solutions to manage their quality system, to manage their key documentation and records. And frankly, that's what we've done at Greenlight Guru is we've built a purpose-built solution for the medical device industry to help companies make that shift.

Mike Drues: Well, I like that phrase, Jon. Purpose-based solution. And you're right. Obviously, there's a lot of advantages of electronic files and so on as opposed to a paper-based system. But let me also compare that to the regulatory side. I see a lot of people today making electronic submissions to the FDA via PDFs or that kind of thing, but rarely do they take advantage of all the bells and whistles that come along with the electronic submissions. Like for example, hyperlinks and so on. So, the purpose here is not just simply to save a few trees, although that's certainly an admirable goal, but I think to go beyond that.

Jon Speer: Oh, for sure.

Mike Drues: So, let's move on to your third of the Seven Effective Habits of Highly Effective Quality Professionals, and that is, always be audit ready. That seems kinda short and simple. What do you mean by always be audit ready?

Jon Speer: Sure, well, let me share a story that... It's not a unique story, it's one that I have heard many, many times. And Mike, you probably have heard this as well. And the story goes something like this. A company gets a phone call and it's from FDA, and FDA is giving them notice that they're going to come and do an inspection of their facility, and it's gonna happen in two weeks. So the person receiving that call at the company sends out the APB to the organization and says, "Oh, FDA's gonna be here in two weeks." And now all of the different managers and VPs, now they're going around almost person to person, "The FDA is coming. The FDA is coming. And we need to clean this up. But we need to change this. And we need to make sure this is happening and that's happening." It's like all of a sudden, when a company realizes that they're going to have an FDA inspection or an ISO audit, it's like all of a sudden they start to promote that, "We have to behave differently." And that just drives me crazy. Folks...

Mike Drues: It drives me crazy too, Jon.

Jon Speer: I mean, why do you have to have a different behavior because FDA is there? Why do you have to have a different behavior because ISO audit is happening? It should be the same behavior regardless of who is in your facility. You shouldn't have something to hide, you shouldn't have something to share... You shouldn't change. You should be audit ready all day, every day. It doesn't matter if you know the FDA is coming or not, it shouldn't change your behavior. So that's what I mean by that.

Mike Drues: And as a result of what you just described, Jon, I think most of these audits and inspections are totally artificial because, like you just said, everybody is on their best behavior. So, what do you think of this idea, Jon? This is something that I've proposed before. Why should FDA provide any inspection notice whatsoever? Why don't they just simply show up at your door and, "Hi, we're here from the FDA, show us what you're up to." What do you think of that idea, Jon?

Jon Speer: Well, I'm not opposed to that idea at all, because, again, I'm a huge fan of companies being transparent with what they're doing, and theoretically the FDA could do that now. They don't have to give you notice. It is a courtesy when they do, they don't have to. And I think that's where another important aspect of this particular habit is, if you're of the mind that you have nothing to hide, then why should it matter who's there? You're right, a lot of audits, a lot of FDA inspections, they're very sterile, it's almost like they're rehearsed, and it's not a genuine activity. And that's concerning if we as an industry are behaving that way.

Mike Drues: Well, you know, Jon, it's interesting. Let's be candid here. You said it's almost like being rehearsed. I think it is exactly being rehearsed because it's very typical for companies to rehearse with their employees what to say and how to say it during an inspection. So, to our friends and listeners in the audience who might get a little nervous about the idea of having somebody just show up to your door unannounced, I would just say this. If you're doing all the things that you should be doing anyway, then you have absolutely nothing to worry about, and you should welcome that. On the other hand, if you have concerns about some of the things that you're doing, maybe now is the time to be a bit proactive and say, "Gee, maybe we should make sure that all of our ducks are in a row before somebody does come knocking on that door." So let's move on to...

Jon Speer: Well...

Mike Drues: Sorry, go ahead.

Jon Speer: Well, I just wanna add one thing before we leave that topic. There is advantages to doing some rehearsal, knowing what to expect during an FDA inspection and an ISO audit, don't mishear me, but it shouldn't change your behavior. So do be prepared and know how to navigate these particular activities, because granted, an FDA inspector showing up, it is gonna be a different day than if the FDA is not there, but it shouldn't be a whole new act, a whole new way of doing business, it should be business as usual for the most part.

Mike Drues: Your point is very well taken, Jon. Thank you for that clarification. And to be fair, this is something we do a lot as well, as we've talked about before. I also work as a expert witness in product liability cases for medical devices. And while I would never in a million years allow any attorney to influence the content of my message, I will always welcome their advice on how to spin it, how to present that information. So, there is a difference. Anyway, thank you for that clarification. So let's move on to habit number four of Seven Habits of Highly Effective Quality Professionals, and that is, implement risk-based approaches in decision-making. You and I have talked about risk many times. What do you mean by implement risk-based approaches in decision-making?

Jon Speer: Yeah, so every day you're gonna be faced with decisions that you need to make, whether it be about specific design features of your product, or you received a quality event of some sort, maybe it be a complaint, or you had a non-conformance in manufacturing. All of these things that happen, all these events that happen on a day-to-day basis, apply a risk-based logic to this. And what I mean by that is, try to understand the scope and the order of magnitude and the potential impact that this issue presents to your organization. A complaint is a good example to walk through. If you get a complaint from a customer about something about your product, you need to understand how big of a complaint is this. Is this something that's kind of a nice to have? Is it something that caused some sort of injury or has the potential to cause some sort of injury?

Jon Speer: And so, it's really being able to apply this risk-based decision-making to those types of events so that the thing that's kind of a nice to have, the actions that may come out of that risk-based decision, the actions might be drastically different than something that is a potential issue from a health standpoint, from an end-user health standpoint. I would hope that if a product or an issue has the potential to cause some sort of injury or adverse event of some sort, that that would be a much higher profile, much higher priority, that you will be very much more diligent in the types of actions that you're taking to address.

Jon Speer: So it's really about, I think, Mike, you and I have talked about this emergency room analogy before and it's a good analogy. If you think about, you're running an ER and patients are coming in off the street for anything from a stubbed toe to a heart attack. You're gonna treat those patients differently because of the risk that they present. And so you should think about your quality events, the things that are happening on the day-to-day with a similar type of lens.

Mike Drues: Well, you're exactly right, Jon, and you're referring to something that we talked about recently, your risk-based approach, which I 100% agree with, is similar to what I call my triage approach. And this is something that to me as an engineer makes sense. However, the unfortunate reality, Jon, and I would love to hear your thoughts on this. Right now, I'm working with a company who received a 483 because they are not treating all their complaints equally. They are addressing all of their complaints, they're all investigating them, but they are taking this risk-based approach, this triage approach. And yet, the inspector gave them a 483 because, at least in her view, she thinks all the complaints should be treated equally. What is your thinking on that, Jon?

Jon Speer: Well, I'm just gonna say, I don't agree with that. It's unfortunate that the company received a 483 observation 'cause it sounds like, the little bit that you've shared about what they're doing, it sounds like they're actually applying the risk-based approach and they're actually putting good business practices in place to evaluate and address those types of issues. Folks, not all quality events are equal, not all complaints are equal, not all CAPAs are equal. And what we do as medical device professionals, we have to apply some sort of logic to figure out what are the most important things that we need to be focused on. So, I don't know. I'm sure you've got a tough challenge ahead of you in trying to manage that particular situation. But it doesn't make any sense that you would handle all things equally. That's just not the way things happen. It's just not the way the world works.

Mike Drues: Well, I agree, Jon. That is not the way the world works. Not all events are equal and they should not be treated equally. But perhaps in this ultra-hypersensitive, politically correct society that we've evolved into, that's contrary to dogma. Everybody is equal. Everybody shows up to get the trophy.

Jon Speer: Yeah.

Mike Drues: I don't know. It's something to think about. Anyway, let's move on to the fifth. So we're in the home stretch now of your Seven Habits of Highly Effective Quality Professionals, and that is, stop reacting to events and instead be proactive. What do you mean by, stop reacting and be proactive?

Jon Speer: Yeah. There's a lot of symptoms of that that have led to this, but we as an industry have accepted for far too long now that it is okay for us to wait for something to happen and once we learn that something's happened then we do something about it. And maybe it's cultural too, because you think about, and don't let me go too far down this rabbit hole, Mike. Pull me out if I get too deep. But if you think about the healthcare in the United States specifically, it's a very reactive system right now. You wait 'til something bad happens, and then you go to the doctor. And then for all intents and purposes, a lot of issues, they're treated with "a Band-Aid." We didn't get to the root cause and we reacted.

Jon Speer: Instead, be proactive, and what I mean is that, don't wait for something to happen. Go out and try to learn about your products and processes. Always look for opportunities to improve those things and if you have the right KPIs, the right metrics in place, and you're not gonna get it right out of the gate, you need to establish some sort of means to measure your product and process performance. But you try to get as many leading indicators as you possibly can so that you can understand what's going on, what's truly going on and track and trend these types of processes so that you can learn about things before they become big issues, before they actually happen to become adverse events or negative effects. Monitor and evaluate, track and trend, and take an action before the issue becomes a big deal.

Mike Drues: Well, I think it's excellent advice, Jon. But it's also sometimes easier said than done. I hinted at the preceding of our conversation today, it's not always easy to convince the bean counters in our companies to go above and beyond, how do we convince the bean counters? And I'm using that phrase "bean counter" affectionately. But how do we convince them to spend the time and the money to try to stop a problem before it pops up? How do we convince them to build a quality system that is more right-sized, more personalized than what is required? How do we convince them to do more testing or whatever that might be required by the regulation or the FDA? In a succinct way, Jon, do you have any words of wisdom to share with the audience on how to win that argument?

Jon Speer: I have words of wisdom, I guess you can be the judge if it's succinct or not. [chuckle] But the words of wisdom that I apply is... I think this notion of concept of poor quality, I don't know that that's made it into our lexicon or even into our practices really in a significant way as of yet in the industry. But if you think about... A complaint is a good example because it is highly visible as far as product performance, ultimate product performance in the marketplace. If you think about the activities that you have to go through to address a complaint, even just to assess and apply some risk-based logic to it, there's effort that goes into that, and then you can look at like CAPA process, you can look at non-conformances, you can look at your overall document management efficiency and so on, you can pick any one of these areas, product development. The cost of being reactive almost always... Not always, but in many respects will rear its head in poor quality and it will be situations where you're gonna have to react and respond to events and situations.

Jon Speer: And if you think about it from a bean counter perspective, how many resources do you have dedicated or allocated to simply address these reactive events? Are those departments, are they growing in numbers? And people and tools and systems that you're putting in place just to deal with those things? That could be pretty expensive. Whereas, if you can address that ahead of time, maybe you don't need quite the resource allocation to react to situations. So, I don't know if that's as succinct as you are hoping for, but I think people should try to evaluate what is the cost of poor quality, what are the metrics and items that could be indicators of whether or not your products and processes are where they need to be.

Mike Drues: Well, I think that is good advice, Jon. Certainly, it would be difficult for me to provide any better advice, but we also have to acknowledge what is the unfortunate reality in our industry, in our business, and that is, in most medical device companies, it's not the regulatory or quality or R&D folks that are ultimately calling the shots, it's the business and the marketing folks.

Jon Speer: It is.

Mike Drues: And sometimes people don't wanna say that. I read in the mission statements of a lot of companies, we wanna develop and bring to the market only the most safe and effective products as we can, yada, yada. Sometimes I wonder, and I'll leave this as a rhetorical comment, Jon. But sometimes I wonder, does anybody really believe this stuff? [chuckle] Or it's just we're lining up to drink the Kool-Aid. Anyway, let's move on to the sixth habit of Seven Habits of Highly Effective Quality Professionals and that is, break down silos and barriers. That's very simple on the surface, but I have a feeling there's a lot that goes under that. What do you mean by breaking down silos and barriers?

Jon Speer: Yeah. That gets back to some of the comments that I shared at the beginning about being compliance-minded versus a true quality professional. The term "quality" in and of itself carries a lot of baggage, and I suspect in a lot of organizations it has a lot of negative connotations, unfortunately. I think a lot of companies, they do that quality department or that quality function almost as an extension of a regulatory agency like the FDA. They view the quality department as the department who makes a bunch of rules and establishes all the things that I have to do and they're creating a lot of burden, they're creating a lot of obstacles, they're preventing me from getting my job done. And it's unfortunate that a lot of companies, they are structured that way, which hopefully we get...

Mike Drues: Yeah, in a lot of companies, Jon, they're simply viewed as the police.

Jon Speer: They are, they are viewed as the police. Like, on my drive into the office this morning, there was one point on my drive, and I was going the speed limit and I was following all the traffic law and all that sort of thing, but I could see a police car, three or four cars behind me in my rear view mirror, and it's like all of a sudden, I behaved differently and it's kind of back to that notion that I mentioned earlier, why would I have to behave differently if I wasn't doing anything wrong? But it's like we've been conditioned this way, unfortunately. But it's at a time, where in a lot of companies... I don't know what it is. I guess I kind of equate it to... It's like this, it's like power. In some of the organizations, quality wields a lot of power within the company because they are the police, they make the rules, and sometimes it leaves other areas feeling disenfranchised, and other organizations I've seen where the human resource department wields a lot of power and that sort of thing. And that's not a healthy culture, it's not a healthy environment.

Jon Speer: And I can use Greenlight Guru, for example. We have our customer success department, we have our marketing department, we have our sales department, we have our development department, and our operations, and so on. We focus on cross-functional interactions because everything that each of us does has a relationship to another area of the business, and so it's very important we focus a great deal on that culture and making sure as best as you can that there are no silos, that there are no barriers, that there are no walls between these organizations, because we're all in this together, we're all trying to achieve that same thing. And to your point about the mission statement, I hope companies truly... If people in those companies truly do believe that they're trying to improve the quality of life, that they're trying to make sure that the products and the processes that are involved in these devices that they're designing, developing and manufacturing, that they they are making a difference for the patients who receive those. And I think if we all look at our world, our role, our business through that lens, that we can try to understand the purpose and the benefits of having this cross-functionality.

Mike Drues: Well, again, Jon, I love the sentiments, I love the philosophy. It sounds like we should break out into a harmony of kumbaya thing, but we won't do that. Let's move on to the seventh habit of Highly Effective Quality Professionals. And before I announce it, here's a little sound effect.

Mike Drues: So that was supposed to be a drum roll. My primitive attempt at levity here. Anyway, the seventh and final habit of Highly Effective Quality Professionals according to Jon Speer is shift from compliance-minded to true quality focus. I think this is gonna tie up a lot of what you and I have been talking about, not just today but in the past.

Jon Speer: Yeah.

Mike Drues: What does that mean, Jon? Shift from a compliance-minded to a true quality focused?

Jon Speer: Yeah. And folks, everything that I've been sharing with you today is really with this notion or this idea. My journey into the medical device industry, at least initially, was somewhat accidental; maybe serendipitous, I suppose. But I didn't plan on entering into the medical device industry out of school, and it really, the gravity of what I was involved with didn't really hit me until I had been at a medical device company for at least 18 months, maybe a couple of years.

Jon Speer: And the first moment that it hit me, I was working on designing and developing a new a catheter-based introducer product and I did a lot of work on the testing, I was "compliance-focused," at least on those early activities on the design and development of this particular device. It was making sure that I checked all the boxes, that I had all the biocompatibility, that I addressed the sterilization, that I had done the performance, and so on, and so forth. I was very task-oriented in my function or my job to get this product to that next step.

Jon Speer: And the moment that it really hit me was the first clinical use of this particular device. I was in the OR. I was 12 inches away from the anesthesiologist who was using the product, 12 inches away from the patient who was about to receive this device that I had designed and developed and tested and checked all the boxes on all the forms to make sure that it was "safe and effective." And then I had a moment where internally I was freaking out and I was internally freaking out because the gravity of that situation suddenly hit me and I was like, "Oh, my goodness. This is a real patient, this is a real doctor, this is a real procedure, and this is a real device that I had a hand in designing and developing." Everything went well and it probably just took a few seconds.

Jon Speer: But man, it's like... And in some respects it was like my entire life was passing in front of my eyes. It was a very intense moment, and from that moment on, I love what I do because I know that working in the medical device industry that I have an opportunity to help bring new, exciting technologies that are gonna make lives better for you, for me, for the people that we love and care about. And if we have that true quality focus when we consider what it is that we do, then I think that I'll always be in the medical device industry. Period. Because I believe in the ultimate mission for humanity that we can all play. And if you're just checking boxes on forms, I think you're gonna miss that.

Mike Drues: Well, I think that personal story of your first experience with the patient in the OR, in the Cath Lab, was a wonderful story, Jon. And it's particularly a propos here because as we just went through the Seven Habits of Highly Effective Quality Professionals, which is a riff of Steven Covey's Seven Habits of Highly Effective People, what you're describing, Jon, is what Dr. Covey calls a paradigm shift, where you have, based on one particular experience, a true shift, a true change in the vision and the purpose. So, thank you for sharing that story.

Mike Drues: And by the way, a couple of companies that I work with, they will try to do something similar with their employees. I've seen companies, and this is of course not required, but they will invite a patient to come in and talk to their employees. And oftentimes, this is done for the manufacturing workers on the floor to tell them as a result of using their particular medical device, how their life was changed, how their life was improved; in some cases, how their life was even saved.

Mike Drues: And so, you're exactly right, this is, though I make jokes about this sometimes, but this is high stakes bingo. So, Jon, thank you so much for sharing your Seven Habits of Highly Effective Quality Professionals. Before we wrap this up, if you were to summarize this into one takeaway, one lesson to be learned, one most important point to the audience, what might that be?

Jon Speer: Oh, wow! You're putting me on the spot. [chuckle] I think now more than ever, the things that you're doing, we certainly don't want them to be evening news material and if you're making headlines on the evening news or in newspapers, I think those are still a thing, or on the Internet, usually these days, it's not because of good news, and nobody wants to be known for the bad event.

Jon Speer: Hell, Mike, you and I both know they're making documentaries about all the things that go wrong in our industry these days. I guess, what I hope the companies realize and people listening to this will realize is, we have an opportunity to tell our story and we have the opportunity to be advocates for improving patients' lives. And we have I think also a responsibility to be that voice of customer and to make sure that the things that we're doing in the medical device industry are gonna yield positive patient experiences. I just hope people can change their mindset and to your point, shift their paradigm to realize that what each and every one of us does in this industry has an awesome impact. Awesome could be good, it can be bad. It really is your choice.

Mike Drues: So I'll let you wrap this up in just one moment, Jon. I just gotta add one last comment. I found it interesting that you just said that your goal is to avoid being on the evening news. My goal is actually to be on the evening news, but here's the difference. I wanna be on the evening news in a good way. I wanna be on the evening news announcing that we just came out with a wicked cool new medical device that has the potential to improve people's lives, save lives, and so on, and so on. So, is the glass half empty or half full? I wanna be on the news, but in a good way, not unfortunately in a bad way.

Jon Speer: Yeah, really good point. Really good point. So, Mike, thanks for being open to a little bit of a role reversal today and diving into this topic. Folks, as always, I would encourage you to reach out to a guy like Mike Drues with Vascular Sciences. The guy is simply a pro. He cares a great deal about the products and the processes and the devices that you're trying to bring to market in. And he is an advocate of your cause and he knows how to navigate these regulatory waters, which at times can be treacherous and it can be confusing and that sort of thing. But think of Mike Drues as the Lewis and Clark to get you... [laughter] or maybe the Sacagawea would be a better term, but truly Mike is the best out there and he knows how to navigate this process and could be an advocate for what you're doing. So I would encourage you to reach out to him if you have some questions or comments about getting your product to that next step.

Jon Speer: And then of course, as always, Greenlight Guru, as I mentioned earlier today, we have a purpose-built EQMS software platform that is specifically and exclusively for the medical device industry. And a lot of these habits that I've shared with you today and we've talked about today that is built into our entire culture at Greenlight and into our software platform. So if you're interested in figuring out how to adopt some of these habits that we've shared today, I would encourage you to go to www.greenlight.guru to learn more.


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