Lessons from an Industry Leader: Playing the Long Game of MedTech

What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway? Will you know what it is if you encounter it?

In today’s episode of the Global Medical Device Podcast, we have a wide-ranging conversation with Mike Baca about the lessons we can learn from him as an industry leader and about the long game involved in a MedTech career. Mike is currently the president of White Rook Consulting, and he has more than 38 years of experience as a quality professional working with medical devices, including classes I, II, and III. He worked in a variety of quality roles for Johnson & Johnson, Medtronic, and Stryker before starting his own independent consulting firm. 

Today’s conversation covers a lot of ground, including the three phases of Mike’s career, how understanding VULCA can help you handle a black swan event, and how adopting a set of principles and values will guide you through challenging times. We also discussed “badge on the table” situations, speaking the language of other departments, and working through and getting rid of imposter syndrome.

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Some highlights of this episode include:

• The tough moments that medical device professionals are going to face: There’s the unique issue that the work they do will impact someone in the most personal way possible. 

• The languages of other businesses and how Mike learned to navigate that

• Mike’s definition of a mentor: not an advocate, not a sponsor

• The three segments of Mike’s career: Learning, Contributing, Returning 

• How Mike might hold the record for most 483s

• How to process the black swan moments without breaking down emotionally: accepting that you acted in accordance with your principles and values

• What VUCA means and how to approach it: Volatility, Uncertainty, Complexity, and Ambiguity

• The differences between ego and self-confidence

Links:

Mike Baca

Etienne Nichols LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru

Memorable quotes from Mike Baca:

“It’s my responsibility to do everything I can to make sure that everything I’m responsible for is done the best that it can be so that outcome is going to be favorable to that ultimate patient who is going to have the device used on them.”

“If you see something that needs to be fixed, something that can be improved, seek that out.”

“As a leader, you should consider adopting a set of absolute principles that define how you will lead and how you will be.”

“If you’re going to delegate something, you need to be willing to stand behind, but when you delegate, you need to delegate at a level that failure will not be fatal to the business or that individual. Because guess what? Sometimes they’re going to fail.”

Transcript

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

Etienne Nichols: Welcome back to the podcast. My name is Etienne Nichols and I'm the host of today's episode. In today's episode, we spoke with Mike Baca on a variety of topics that we've put under the heading of Lessons from an Industry Leader: Playing the Long Game of the MedTech Career. Mike Baca is the president at White Rook Consulting, he has over 36 years of experience in medical devices as a quality professional, and guys, that's dangerously close to how old I am. Mike has worked with Class I, Class II, Class III devices, he also has an impressive background having worked for 22 years for Johnson& Johnson in a variety of quality roles. He worked as vice president of Quality Assurance for Medtronic and Vice President of QARA and Clinical Sciences for Stryker, and he now runs an independent consulting firm. He was on the way to the big five, he covered a lot of ground in his career. So with Mike's background, we covered a lot of ground. We talked about things like number one, Mike's three phases of career learning, contributing and returning. We talked about understanding VUCA, the volatility, uncertainty, complexity, ambiguity, and how to use that framework to handle a black swan event and what that even is. We talked about adopting a set of principles and values, and how that can guide you through challenging times. He has a story about a badge on the table situation, which is really fun to listen to. He talks about how to be a business partner in the world of quality, learning to speak the language of other departments, we even talked about how to do away with imposter syndrome. So we covered a lot of ground, like I said. If you'd like to hear another episode with Mike Baca, then shoot me an email and let us know. Without further ado, please enjoy this episode on Lessons from an Industry Leader: Playing the Long Game of the MedTech Career with Mike Baca. Hey, it's good to be back with you today. Today we're talking with Mike Baca. You know what? I should have asked, how do we pronounce your last name properly?

Mike Baca: It's Baca.

Etienne Nichols: Baca, that's what I thought. Okay, so good to see you. I hope things are going well, really appreciate you coming on the podcast. How have you been?

Mike Baca: Things are going well. I really appreciate this opportunity to talk with you folks.

Etienne Nichols: All right, well, the episode that we talked about before we got together, when we were thinking what do we want talk about the title we came up with, we'll see if that stays throughout the episode, is Lessons from an Industry Leader: Playing the Long Game of Your Career. And when we were talking about this overarching topic, your career really is a long game and it's hard to talk about it in one fell swoop. So we kind of broke it up into three areas, preparing for those tough moments in your career, carrying yourself through that moment, and then third, the retrospective, how you process those tough times. And in the medical device industry, I don't know exactly where you want to begin, but if you wanted to talk to us about the tough moments in medical device. Does anything specific come up in your mind when you think about the tough things that medical device professionals are going to face?

Mike Baca: Well, when I think about that, one of the things that always hits me is unlike a lot of other industries, and I don't want to say anything to denigrate any other industry, but when you look at medical devices, one of the things that is very unique to us is that the work that we do, at the end of the day, when that product is being used, is going to impact somebody in the most personal way possible. And the thing that's always driven me is that really understanding that I've had a series of great leaders and mentors who have helped me along the way. And what I understand is that I fit in that chain somewhere and it's my responsibility to do everything I can to make sure that everything I'm responsible for is done the best that it can be, so that that outcome is going to be favorable to that ultimate patient who is going to have the device used on them, and as importantly, that physician and that position in that healthcare team, so that they know when they go to use my device, they don't have to think about," Is it going to work?" That needs to be a given. And that's part of my responsibility. And so as I talk about preparing for the tough times, and there have been a couple, because I talk about preparing for those things, the thing that always drove me is what can I do, what can my team do to make sure that we're doing everything we can to get that best possible outcome? So that if and when those tough times come, we can always draw back on the fact that, at a minimum, we've done our absolute best to get that device out there. Now, when that worst of all possible times comes and I've experienced three of those in my career, then the thing that I draw back on are what's the foundation that's prepared me to get here? How have we prepared? What are the things that we have done? What are the things now that I can do to address whatever this issue may be? The issue may be something that we did or didn't do, and that has happened. The issue may be something that is outside our control that we had no ability to control, but now we have to deal with it, and I've dealt with one of those. So all of those just goes back to what have you done foundationally to prepare? And one of the things I learned way back in my initial career in the Army was that we used to train a lot. Train, train, train, I was always training. And thank God I was never called upon to actually fire rounds in anger, but the training was such that you're prepared for that situation when it comes. And the same analogy goes into medical device, is that the training is different obviously, but you prepare and you train and you prepare. And that's where one of the things that one of my mentors taught me is he said," Mike, you need to become the master of your craft." And I said," What does that mean?" And he said," Okay, you've elected to be a quality professional," and I said," Yes." And he said," Okay, so you need to become a master of that craft. You need to learn as much as you can continually. From the day you start til the day after you retire, continue to learn because when you get hit with these situations, you're going to have to draw back on what some of that experience has been." And without going into too much detail on some of these, but for example, on root cause analysis, I was privileged to listen to your podcast on root cause. And when you're faced with some of these things where these root causes to actually fix a problem can be complicated to get to, having more than one thing in your toolbox is important. So you maybe try, Okay, I'll just use a fault tree analysis. Oh, that didn't answer it. Okay, I'll use five whys. Nope, that didn't answer it. I'll use FMECA. Nope, that didn't answer it. And as we talked about in the podcast, one of the things that pulled my rear out of the fire a couple of times was going back to taking a Kepner Tregoe and modifying it for quality use. And it got to that very small little root cause that was hiding amongst those million needles that you were able to pick out. Now, get to that root cause and actually fix a problem.

Etienne Nichols: That's a great point. So when you talk about preparing, you actually made me think of a saying, and I can't remember what general it was that said this, but the more you sweat and peace, the less you bleed in war. It made me think of that a little bit. Also, that preparation, when you're preparing for something continually, I've used this analogy in the past too, the best engineers I ever knew were not only engineers at work, but it was their hobby. They were always hammering on their craft. So I love that you point that out. You mentioned three times in your career where you had those tough moments. I wonder if it would be maybe beneficial to talk to some of those, or I don't know what detail you can provide, but just to put this in perspective.

Mike Baca: Yeah, for confidentiality purposes, I'll be purposely vague.

Etienne Nichols: Yeah, that's fine.

Mike Baca: But for example, in one instance, we had a situation where positions were misusing the device. I mean, in a couple of cases, they did not comply with the standards of care, they did not comply with the instructions for use. And the device, when it's applied, did what it was supposed to. So let's take, for example, a very simple example, a scalpel. When you put a scalpel in somebody's hands and you apply that to tissue, it's going to cut. If you take that scalpel and you use it to open up the skin and then do the appropriate thing with viscera in order to get to your operative site, that's a great thing and that's what it's supposed to do. If you're rooting around inside that body cavity and you use that scalpel and you cut the aorta, and the patient bleeds out, that's a misuse of the device. So you can't really blame the device. In our situation, it wasn't something quite as dramatic as that. But we had a device was being applied, and when it was applied, there was a very bad outcome and a couple of patients died. As a result of that, we got into discussions with FDA. There were some things that didn't go as well as we would've planned with them, and they also made some of their own judgements on some things. To make a long story short, the FDA looked at the device and there was a faction in FDA that thought the device was dangerous. So they went back and looked at our clearances, et cetera, et cetera. To make another very long story short, we had to institute a Class I recall. But as part of that Class I recall, we also had to issue what's called a certificate of medical necessity. And the certificate of medical necessity was such that in order to continue to use the device that the CEO of the hospitals had to sign the certificate of medical necessity. The other downside to that was because of this unique device, if the hospitals didn't use it, they wouldn't be able to do surgery, period. So that's a rock and a hard place. And working through that, what I was able to do and what the team was able to do was to sit down with these, and I think I lost count after about 300, but on these calls, explaining to hospitals exactly how the devices is to be used, how it can be misused, the fact that it had been in used for over a dozen years with tens of millions of uses was something different. But basically, to be able to weather that storm was to explain to your business partners out in the hospital world," This is how the device is used, this is how you must not use it," and then have them make their own decision," Do I use this device under a certificate of medical necessity?" Now, without getting, again, in too much detail, but a very, very large percentage, well over 90% of all the hospitals said," Yeah, we've been using this device for years without problem, and if somebody's going to misuse it, we don't do that, we're going to continue to use it." It was a responsible thing to do. And when we did come back to the market, we came back even stronger than we were. And I think when I left, we were at probably 90, 95% of that market.

Etienne Nichols: So you used a word multiple times already, and you're talking, and that is the word responsible or responsibility. And I've heard you say this in the past, seek responsibility. I wonder if you can expound on that and if that's applicable in this scenario, or maybe not. But I wonder, why do you say seek responsibility?

Mike Baca: Well, the reason I say that is no matter where you are in the organization, whether you're a brand new quality engineer going in for your first time and helping out a production operation, or if you're a global VP responsible for multiple operations worldwide, which is where I ended up. But one of the things in my upbringing, when we talk about responsibility, and it's kind of funny because my wife said I was born with the responsibility gene, but in my upbringing, it was no matter where I fit in whatever organization I'm in, I have a set of responsibilities, and that responsibility goes beyond me. And I will be honest, it took me a little bit of, especially in business, I had several mentors who took the time to take me under their wing and teach me more about that because initially, as I got out into business, one of the things I was very focused on is," Hey, where's my next promotion coming from?"" They tell me I'm a high- potential guy, where's that next promotion coming from?" And I had a very, very wise mentor who told me," Mike, you're looking at exactly the wrong thing." He said," Wherever you are landed, look at what are your responsibilities to those beside you, below you, above you." Ultimately, because I spent all my career in medical devices, ultimately, what is that responsibility to the patient and to the physicians? And what you need to consider, what you need to focus on, is what are you doing in your areas of responsibility to make that better? And if you see something that needs to be fixed, something that can be improved, seek that out. And if you're not the one to do it, partner with somebody who is. Some of the best business relationships and partnerships and friendships that I've ever made in business were with reaching out to people on something that wasn't under my direct purview, but I had an idea," Maybe we could make this a little bit better." And when you reach out to those folks and you say," Hey, I'd like to partner with you. I know it's not necessarily my direct area of responsibility, but if I can help you and your goals in obtaining that, maybe we'll make that better." And at the end of the day, it makes it better for everybody. And it is liberating and it makes you feel good.

Etienne Nichols: Yeah, you talk about those different conversations you had with people. I think this came up in that discussion that you were referring to earlier about root cause analysis, but that was the languages of other businesses. I wonder if you can expound on that. How did you use those relationships? Because sometimes, people across departments don't always speak the same language. How did you learn to navigate that? And do you have any recommendations for people currently navigating that? Okay, I don't want to make you just repeat everything you just said, but we did have a little bit of a technical issue. So we were talking about speaking the language of those other departments, those other people around you. Do you mind giving a little bit more detail about that one more time?

Mike Baca: Yeah, so I'll go back over some of that again. And really, again, as I was saying, I had some really, really bright leaders and mentors who taught me how to speak basically in the language of my business partners. And so when you're talking to somebody in sales and marketing, they want to know first to market, how soon can I be to market? How can I capture market share? When I was talking to my folks in R& D, they want to know, how can I reduce my time to market, my development time? How can I reduce the time and resources that are needed for verification and validation? How can I prove that my device has the reliability that I want it to have? Et cetera, et cetera. So as an example, there was one time I was looking at trying to buy a 3D X- ray CT, which is a machine basically that can look inside things at a very, very detailed, I mean, almost down to the micron level, very expensive machines. But what it allowed us to do was to take, for example, let's just use this as a pen, as a solid object. And I could look at this object from the inside out and the interfaces of everything that was in there and how everything worked. And what we found that thing to be very valuable for is anytime we were doing, let's say, something was failing, we could go in, take a look at it from the inside. Because a lot of times, when you have a complicated device and you disassemble it, you've destroyed your evidence. And as an example on this one, when we finally got this 3D X- ray CT, we found out that during the assembly process there was something that was mating together and was causing one little wire to bend back on itself that caused the device not to act the way we wanted it to. Never would've known that, okay? And another one, I wanted to get a scanning electron microscope with elemental analysis. We were able to use that because we were getting a handpiece we were sending out, we were finding out that it was flaking, we couldn't understand why. And so we utilized the electron microscope with elemental analysis and found out a contaminant that we didn't anticipate would be there. They did root cause analysis, going back to the other podcast that you had, found out where that contaminant came from, eliminated the contaminant, was able to get to market. But we wouldn't have been able to do that because we never anticipated that particular contaminant would be there. So when you talk to somebody in sales and marketing and say," Hey, I'll get you to market two months quicker, three months quicker," what's that worth for you? If I talk to somebody in product development and say," Hey, we can compress your development cycle, and you can get this to marketing two months earlier," and you're going to be a hero for them. Or if you've got a problem, if I can find the true root cause, the true root cause of what this issue is and fix it, how's that going to help you? And in post- market, we used it a great deal in post- market because you get stuff back and you're looking at it, and again, when you disassemble it, you can destroy the evidence that you needed. And to really find out, these are some of the ways that people are abusing your device, as an example. We had one time where we were getting some devices from post- market, but it was in testing. And what we found out, and you'll find out in the new regulations and requirements, you also have to account for a foreseen misuse of your device. And what we found with one of our devices that was actually a heavy- duty saw, sometimes in surgery, surgeons needed to pound something, they had something in their hand already, well, I'm not going to put it down and pick up the hammer, I just got to give it a little bit of extra." So they were actually using some of our devices as hammers. When we found that out, we found out, wait a minute, we need to design something that will absorb shock that is higher than what we anticipate. Well, by putting that new design in, looking at a 3D X- ray CT, found out we were to alleviate a problem that never occurred because we anticipated it, we were able to design around.

Etienne Nichols: Wow, that's great. And so just the ability to say," This is why it's going to benefit not only my department, but your department as well, the bottom line of the company." Having your ability to see those different things really is what, I guess, enabled you to purchase that in the beginning, that's what you're saying.

Mike Baca: Right. And then what happened after that is I had them run an ROI, I want you to now track all this stuff.

Etienne Nichols: Yeah.

Mike Baca: Track this test that was taking two months and$ 100,000 dollars to be done outside, track us doing it inside in a week for$ 10,000. And we had a great big old ROI. What I was able to go back and tell them is that you spend a million bucks on us and I'll probably give you back around five. And that enabled them. And the other thing is, I called them my mad scientists. These were these guys in the lab, and basically I said," You have carte blanche to think up whatever you want." Some of the things worked pretty good, some of the things didn't work at all, but some of the things they came up with were wonderful. And they came up with unbelievable, so we had 3D X-ray CT, LC mass spec, we had stuff that counted colonies, we had stuff for sterilization and everything.

Etienne Nichols: Wow.

Mike Baca: And eventually they got the lab fully certified. And now that lab is the model for the rest of the corporation. But with these guys and ladies, basically I said," You have carte blanche, think something up. I'll try to get you the money." And they really came through.

Etienne Nichols: So there were a couple things you mentioned in there when you were talking about basically that as an example of speaking those different languages. You said something about, I don't know if it was applicable to this story specifically, but a mentor told you that you need to be thinking this way or that way. So let me skip to the end of my question. What was it that led you to the ability or taught you, I don't know, how did you flex that muscle or grow that muscle to where you could do those things and lead in that specific way? I mean, not everybody naturally has that. What would you say?

Mike Baca: Well, I'm definitely not the master of that. If you look at one of the quotes from Honda, the guy that kind of founded the car company, and he said that 99% of all success is failure. So I've had a lot of failures, and I also had a little bit of hubris for a while, I'll admit to that. And I had some very wise mentors and leaders who basically said," Baca, what'd you learn from that? So you tried that, didn't work out so good. So we're not going to fire you, but what did you learn from that?" Okay? And as I like to tell some folks," I made about every mistake you can make and still stay employed." So as I did some of those things, they were helping me to understand, I really don't have all those answers. I need to start surrounding myself and seeking out people that have different viewpoints, and can look at it from a different direction. And part and parcel with that was now starting to work with my business partner. One of my great mentors also told me, he says," Mike, understand if you're in a medical device business and you sit in the quality chair, you work with all these business partners because you are all in an enterprise." And some people will sit in the quality chair and I'm just total quality, total quality all the time, quality all the time. This is why you can't do that. And say," No, no, no, no. How are we going to get this done? And I will satisfy the requirements of my discipline, but how am I also going to help each of these other departments to also be successful?" I know you've probably heard in your career where they say," Well, quality and regulatory, they're department of no," okay?

Etienne Nichols: Yeah.

Mike Baca: No. There was another great individual that I had a chance to work with and she was, I promoted her to VP of regulatory. One of her, let me see if I can remember it correctly, but it was like, we will give and stretch to grow, which means we're going to follow the regulations, we're always going to follow the regulations. But we are going to consult with our business partners, are these are the options and avenues that you can go down to. This person was so brilliant that what I used to like to say is she could see around corners.

Etienne Nichols: Oh wow.

Mike Baca: She would anticipate things, okay? And there were a couple of times, to get off on a tangent, but a couple times I'd work with her and something would happen, and I would be like," Oh God, what do we do now?" And she was like," No, I already anticipated that and I have a plan for that." And what I would find out when we worked through some of these issues, there were plans that were never implemented, but she had always considered. And that may be why she's now the global head of quality regulatory for a Fortune 100 company. So it's that ability to listen to your business partners and listen to what do they really want. Because what they really want, as important as quality is, may not be exactly what you think they want. Ask them what they want and then decide," How can I help them get to that?" And I remain true to my discipline, but I help them get to where they're at. If you got time, I'll give you a story about what that looks like.

Etienne Nichols: Yeah, let's hear it.

Mike Baca: Okay. So this was in another company. We had a device, again, it was being misused by surgeons. And on this particular device, if you misuse the device and you didn't feed the device what it was supposed to have, the device would fail. And this device failed, it was an implantable device. If this device failed, best- case, patient goes into withdrawal, worst- case, with one of the therapies, the patient would go into withdrawal and could possibly die. These are bad things, okay? And what we found out that physicians were compounding drugs, they weren't using the regular drug that you had to use. And without getting too technical, the drug you're supposed to use is compounded in a certain way to interact with the pumping system of the device so that it works exactly as it should. But if you compound it, there's a lot of things a compounder doesn't do that a pharmaceutical company will do, and therefore your stability is at risk. The ionic charge that's within the drug itself, which has meaning to the pump isn't there, and it can cause this device to fail. So when this was occurring, we were getting these failures, and obviously those are serious injuries and MDR reportable and that's a bad day.

Etienne Nichols: Yeah.

Mike Baca: So marketing and sales were trying to talk to physicians about that, and physicians weren't really wanting to hear that. So what I ended up doing is taking these devices, disassembled. I was able to take these devices, go into the hospitals and physicians' office, disassemble the device, explain to them the physics of how everything worked, explain to them why what you are doing is hurting your patients and can kill your patients, you must stop this practice. If you decide to continue this practice, all I can say is that I have explained to you exactly the physics of failure down to the molecular level of why what you're doing is harming your patients. Now, in some instances, I was thrown out of offices because there's not an MD beside my name, okay? But in a lot of instances, the lights went on and said," Yes, it's more expensive to use the drug as you should, as opposed to having somebody down the street mix it up that isn't putting in everything that they need to do." And so with that, and if I had the time, I go get you, I know I've got the thing somewhere, but the marketing when I left that company gave me a big old picture. And I believe that was the first time in the history of that company where a quality guy got an award from marketing.

Etienne Nichols: That is awesome. Wow, that is really cool. How many hospitals did you have to go to to talk to people about that?

Mike Baca: Let's just say I went double platinum within a year on airlines.

Etienne Nichols: Oh man, oh man. Wow. Well, that's dedication.

Mike Baca: But see, the thing for me though, is that knowing that directly or indirectly, we've now precluded, I don't know how many patients having to go into the ER because of a withdrawal symptom. And I've seen this withdrawal with my own eyes, I've seen this withdrawal on a child with my own eyes, and it will rip your heart out.

Etienne Nichols: Yeah, so I'm curious, and we already started talking a little bit about the mentor thing, and every now and then I hear you say, I had a mentor who said this to me, or an individual said this to me. So I can tell, in your career, even people you respect, there's two different categories, I guess. What is your definition of a mentor? And maybe a quick follow- up question, I hear people say, you need to find a mentor, but oftentimes we'll say," Okay, I need to go find someone who is an official mentor," but I don't know if it's really that formal. What is your definition of a mentor and how do you go about finding one? What are your thoughts there?

Mike Baca: Wow, I have several. So, well, let me just say this, I have, at least in my own mind, a very specific definition of what a mentor is, okay? A mentor is not an advocate. And I have been an advocate for some people, okay? A mentor is not a sponsor, it is not a sponsor. And I've been a sponsor for people. But I've been very fortunate because I've had so many good mentors. And when I finally got some experience, I became a mentor. So during my time in business, I always had a mentor, at least one or two. And I was always a mentor to at least four mentees at any given time, okay? And the mentor is a person, one I believe you can have safe conversations with. I don't know if you've ever heard of the imposter syndrome, but I got a little bit of that.

Etienne Nichols: Oh yeah.

Mike Baca: And there are times when I'm not going to go to my boss and admit," I don't know what the heck I'm doing here." There are times I'm not going to go to my peers or even my subordinates and say," Hey guys, I don't know what to do here." I almost look like I'm panicking. I used to go to my boss to have dark conversations. I've been unbelievably fortunate to work with principled people and tremendous leaders in my career. But there've been a handful of times when it wasn't always thus, and say," How do I handle this? How do I handle somebody who is being dishonorable? How do I handle somebody that I know is lying? How do I deal with this?" The other thing is with a mentor is someone you can have these difficult conversations with, but also someone you can ask questions of, about anything. And the flip side of that...

Mike Baca: Ask questions of, about anything. And the flip side of that is that mentor will ask difficult questions of you. Remember, I told you a little bit earlier I was very concerned about getting my next promotion?

Etienne Nichols: Yeah.

Mike Baca: And it was one point in my time I had worked at a place for five years, and I hadn't been promoted to manager yet. And so, I was talking with my mentor and I had my paper out on the street, and I had some things. And I had people that were looking at me as want to bring me in and talk to me about managers and senior manager. And one guy even, an assistant director position. And I was like," There's my golden ticket. I want to go get that golden ticket." So I sat down, talked with him, his name was Brad. In the military, they had a thing called a stacking swivel that you stacked your rifles up on. He grabbed me by my stacking swivel and threw me against the wall. And he said," Okay, what are you going to do here?" Said," I'm looking to leave J& J." And he said," Well, let me ask you a couple of questions." He said," What do you think about J& J?" Now, this was back in the early'80s. And I said," I love J& J." I was there for Tylenol and I was feeling pretty high on J&J for Tylenol one.

Etienne Nichols: Yeah.

Mike Baca: Then he said," What do you think about what you do? We make pretty important products and we make it by the train car load that people are using every day and it's making their lives better." I said," That's why I got into medical devices." He Said," Okay, what do you think about your staff?"" I love my staff. I do anything for my staff. I really care about these people."" What do you think about your current leadership?"" I got great leaders. They've been mentoring me all along and we're getting ready for stuff." And he said," So why are you leaving? You're leaving to get a title in a company you don't know?" He said," Mike, I will support you in anything that you want to do as long as you do it for the right reason." And he said," Bacca, you're an idiot because that's not the right reason." I went back and thought about it and I said," You know something? He's right." And so, I stayed there for another 22 years.

Etienne Nichols: Wow. I love the definition and the interaction, the description there. How did these people come across your path and did you see them? Was it a slow burn, like they eventually became relegated to or delegated to mentor in your mind? How did that happen? Was it formal?

Mike Baca: I was a little bit shy at... Maybe that's the right word. I was a little bit shy at first, I didn't want to go out. But then again, I had another person that I did glom on to. And the thing that I looked for personally, is when I look for a mentor, number one, somebody who is successful at what they do, not necessarily have to be in my arena. In fact, as a good portion of my mentors were not in quality, but somebody who is successful in what they do. Two, somebody who espouses and lives the principles and values that I want to try to emulate. And it's basically somebody I admire. And I started going after these people. I started going after these people and say," Look, I need help. Are you willing to give me some time? Are you willing to mentor me?" And when I talk about being a mentor, it's not," Yeah, we'll talk, let's meet over coffee, have a nice polite, superficial discussion." That's not a mentor. That can be a friend and a colleague and I had some of those, I think. But I want someone who can help me develop. I talked to you about Dorothy.

Etienne Nichols: I don't think so.

Mike Baca: Anyway, at one point in time I took a demotion to go work for somebody and I went to work for this person because she was one of the first female directors at J& J in 1981. And there were not a lot of those around in those days. And I took a demotion to go work for her. And when she asked me," Why are you interviewing for a supervisor job when you are a manager? And why are you moving into this arena?" And believe it or not, that's how I got into quality. I got into quality because I wanted to work for this individual. And I said," Dorothy, the reputation is you develop people, you will bring people in and you will push them, but you will develop them. And that's what I need. That's what I need." Because I was coming fairly fresh out of the military, I didn't know what the heck I was doing here off to some things. And I had had some different experiences, but I'd looked at quality and said," I really like that and I'm willing to take a demotion and go work for that person." To make a long story short, I did and she taught me a whole lot. I think I sent you a presentation on leadership lessons that I learned, and she's prominently in there. Fast forward, I remember my last mentor was actually the COO of Striker and this is a very, very busy guy, a tremendously gifted and principle guy...

Etienne Nichols: Can't even imagine.

Mike Baca: Running a huge organization. And I went to my boss and said," I'm thinking about going and asking him to mentor me," because now I had risen to a global VP position. And I said," But I know how busy he is." And he said," Mike, the worst thing that can happen is he can say no." So I went and talked to him and he said," We'll do that." He said," But Mike, I have a pretty busy schedule, as do you." And so, what we did is we used to meet 6AM at least once a month, go for breakfast. We'd have our conversations in a quiet corner in a restaurant. I can't express to you the help that he was to me as I was dealing with some of the issues that I dealt with. Because as you continue to progress, the complexity gets more and more and more. And as that happened, he allowed me to deal with that complexity because there's some things that came up and I can almost guarantee that had he not sat down and talked to me about it... And the great thing about a mentor, and also when I was a mentor, I have never ever told a mentee exactly what to do. All I've given them is," These are your options, these are your risks. Have you thought about this? Have you thought about that? Have you thought about that? Think about what you want to do because at the end of the day you are going to own 100% of that decision, not me. I'm here to help you, but you're going to own that decision."

Etienne Nichols: You actually take that request to the person, or during your career you did, and said," I would like to be your mentee."

Mike Baca: Yeah.

Etienne Nichols: That's great. You mentioned something in there about imposter syndrome, maybe having a little bit yourself. How did you deal with that? Maybe it's through mentors, but how did you deal with that? Did you ever manage to get rid of it completely? Curious what your thoughts are.

Mike Baca: Oh, wow. I was as a child. No, part of imposter syndrome actually started back in high school. And back in high school, I actually joined Junior ROTC. This was toward the end of the Vietnam War. It wasn't exactly a popular place to be. But as part of that, I also knew that I would be going into the military. All the males in my family, my dad brought me up, says," You have a duty. You have a duty to pay back some of the freedoms that you've been given without waxing too eloquent." So I said,"Yeah, I'll be going into the military." And everybody in my family had always been enlisted. But in this Junior ROTC thing, there was this guy name of Colonel Baldwick who ran it, and he's the one who said," I want you to apply to the military academy." And I said," The military academy?" I said," There's no way on God's green earth. Number one, I'm not a big guy." I said," I don't fit the mold." But to make another very long story short, I applied, I was able to get in and people still scratching their head on how I made it all the way through, but I did. But then, there was that part of me is that I don't know if I'm good enough to do this. And then, when I got into business and then given more and more responsibilities, there was always this little thing in the back of my mind of," Am I really good enough to do this?" And fast forward a decade or two, and this was another mentor that I had. And we actually brought this guy in to look at systems engineering and he had a six month tour of all the facilities and he was told," Look..." Because our projects weren't getting done on time. And to make a long story short, he came back and he said," I've looked at your systems processes and your systems engineering, there's not a problem with that." And the VP at the time said," Well then, what was the problem?" He said," Oh, that's a different question."" You asked me to look at your systems, but I have formed a very strong opinion of why you are not getting things done." He said," Why is that?" And he said," With one exception, the leaders you have on the staff couldn't lead their way out of the wet paper bag. Your people don't respect them, they won't follow them. You have pretty bad leadership with one exception." And he said," Whoa." So we hired him. And to make that other very long story short, to get to the answer to your question about the imposter syndrome, he basically boiled it down to one question. And the one question that he asked all of us, because when we were doing this as a team over six months and going all around the country, he said," I want you to answer me one question. And the question is,'What are you afraid of? As a professional sitting in your chair, what are you afraid of?'" I'm not going to ask you to think about it, I'll give you the answer. The answer was that as a professional, we were afraid of being exposed as incompetent and a failure to our peer subordinates and superiors. And as a result, some of us would do some things that... We looked at each other as just people, was like," Hey, we're pretty nice people. We did some pretty ugly things because we were afraid of having that failure being exposed." And the thing that he taught us that finally came home was that you are in that chair because somebody believes in you. You didn't get that chair by accident. Whatever chair it's in, your chair, my chair, whatever chair. You didn't get there by accident. Are you going to have failures? Yes, you will have some failures. Are you going to have successes? Yes, you will have some successes. Celebrate your successes, own your failures, own up to them. And in the long run, he says," If you do that honorably, you do that honestly, you're going to be looked at as being stronger, not weaker." And it took me a while to internalize that. And I can tell you there have been times when I have stood up in an all employee meeting and said," Ladies and gentlemen, I'm messed up."

Etienne Nichols: Man.

Mike Baca: And I said," This is what I did. How it affected any of you, I apologize and I will try to do better to do with what I learned from it. And now, we drive on."

Etienne Nichols: Wow, you got my brain thinking about what am I afraid of? And I remember a moment the first time I was ever asked to go speak at a conference. They sent me to South Carolina. During the evening, whatever, when everybody's talking together and the networking event, I called my wife because I didn't really know how to start a conversation at the moment. So I called my wife and I'm like," Man, I don't belong here. I don't even know why I'm here." And she told me something similar. She said," They sent you there for a reason. And second of all, everybody else probably thinks a little bit of that themselves as well." And it gave me the kick in the pants to go do what I had to do. But that's such a powerful question. What are you afraid of? I love that.

Mike Baca: Well, I was honored to speak at the closing keynote with Dave at True Quality. And I went up and I can't remember his name, the guy that was talking about mindfulness, but I talked with him for a while because I hadn't spoken in front of people for almost two years.

Etienne Nichols: Kevin Bailey.

Mike Baca: Kevin, yeah. Great guy. And I was like," Can I still do this?" And I'll tell you, after talking with him and what he made me think about, and you know Dave, and just sitting down and being able to talk with. Honest to goodness, because of lights were so bright, but it was like I was having a discussion with David and it felt just so natural and it got me emotional and the whole nine yards. But it was that thing that there will be things that I will fail at. I've got a particular hobby that I compete in and believe me, I'll fail on some of that quite regularly. But I also have days where I will be in the zone and I will be able to follow through. And I was like," Wow, that's a good feeling." So my failures, I'll learn from them and I'll own them, and my successes, I will celebrate.

Etienne Nichols: Well, that's great. And very good advice as far as the imposter syndrome because I know a lot of people I've worked with, they've expressed that, I have it expressed myself, and had to overcome that. That's powerful. Another question I had, we talked earlier or at the beginning that we were going to break this up into three different phases. So in my mind, I've been thinking," Okay, from a early career, how am I preparing my career?" And we've talked a little bit about mentors and mentees a little bit, that relationship. But can you speak to the phases of your career? Because a lot of times we think early and late, but are there more? What are your thoughts?

Mike Baca: Well, personally, I break my career into three segments. My first segment is learning. Going back again to my very first duty assignment, when I went in and I was a field artillery executive officer. And I'd been through school, I'd been through all my training, I knew how to move the things around and shoot the things and blow stuff up. It was all pretty cool and fun. But I went into my first role and I had a sergeant, his name was Sergeant Marcellus, great big monster of a man. And you can't tell it here, but I'm only 5'7". I looked up to him in many different ways, but he had been doing this for quite a while. And I remember one of the first things I did when I went in and we had our first meeting. I sat down and said," Sergeant Marcellus, I just graduated West Point, this is my first assignment. And you know what? I have no idea what the hell I'm doing. However, I have to command this area. However, you know exactly what you're doing and have known so for dozens of years. You're going to run this. So if we can agree that I will command and you're going to run it, and every day you and I are going to sit and meet behind closed doors and you're going to tell me what I did and what I did wrong." And he said," You know what lieutenant? We're going to be okay." So it's that first part of learning. And then, when I got out, and remember talking to you about Dorothy?

Etienne Nichols: Yeah.

Mike Baca: As soon as I joined quality, she said," Okay, Mike, now for the next three or four months, you're going to give up all of your Saturdays because I'm sending you to become a certified quality engineer." So we had a session there and they met on Saturday. Said," You're going to go do that and you're not getting paid, so you go do that and I expect you to pass the CQE on your first attempt. Any questions?"" No, ma'am." And after that, then I started studying Crosby and then I studied Deming and all the other gurus and I became a little bit fanatical, and still am, about quality. But that first part is learning. How do I learn? Remember I talked to you about being a master of your craft?

Etienne Nichols: Yeah.

Mike Baca: The second part of my career is what I call contributing. Now that I know these things and as my career progressed, I still kept kicking that imposter syndrome in the back when I got promoted to manager and then senior manager, director, senior director, VP and global VP. Just keep that one in the background. Because somebody believed in me, but during that time, it's like now... It goes back to the thing you were talking about responsibility. Now that I'm in a position of some level of influence, how do I contribute to what we're doing? What can I do to make that product the best that it can be? What can I do to maximize that experience that physician is going to have? What can I do to maximize the outcome for that patient? How do I make this business successful? Because we're not the government, we can't just print money and hope somebody's going to pay it back later. We have to make money, so how do I be that business partner that's going to continue to do that as we satisfy our roles and responsibilities? And how do we do that in a principled way with principles and values that everybody on that leadership team agrees to? Which by the way, is a secret sauce. I've worked for such tremendous leaders that have a set of principles and values that everybody has aligned around that are explicit. Not implicit, explicit. And no matter what hits us, we're going forward, we're going to be successful. How do I contribute to that? Okay, I retired full time. I retired about five years ago. Now I'm in that other part of my career. It's not necessarily downward, but it's different and it's what I call returning. And in that part of returning, it's now I'm taking all that stuff that I've learned. I no longer have those responsibilities, but are there things that I have learned that I can now pass on to other people? Are there things that I have done on lessons that I've learned? When I was raising my son, one of the things that I like to do with him is we would sit down and talk. He had a lot of leeway. He had a whole lot of leeway to do whatever the heck he wanted to. And what I told him is that you can do whatever you want, but you are responsible and accountable to all your decisions. I will love you unequivocally, okay? But you're responsible. Okay, so now if I can keep people from having to plow some of the same ground that I plowed and falling on their face, if I can let people know about that, how do I keep them from doing that? And how can I return? It's kind of funny, I was just actually talking to a client a couple days ago and what I was telling them is they wanted me to come in and talk about some things and do some things. And we got into this thing about leadership and purpose and it's something you think you know that I got a little bit of passion around. And I told them," Look, if I come in and I do some technical consulting on product development and risk management and quality systems and how do you do a FDA inspections, all those things, you're paying me my consulting rate. If I come in and you want me to talk to your people about leadership and mentorship and purpose and why they're here, all of that's pro bono." So they said,"That's fine." So what I'm trying to do now is to give back.

Etienne Nichols: When in reality, it's funny, a lot of that stuff you could get from a lot of different places or even free on the internet, but the true experience is for leadership. Maybe it's pro bono, but it seems like it may even be worth more as far as.. But just an opinion.

Mike Baca: All I tell them is," You pay my expenses and feed me a meal and I'll come in." One of the things I said, and I told this to David, I said," You give me a captured audience and a microphone, talking about something I really believe in, we will all be there a while."

Etienne Nichols: And that's totally fine with me. And those who are listening, hopefully it's fine with them. But I wanted to mention something. Since you mentioned that leadership and so forth is a passion of yours, you mentioned their principles and their things like that. As a leader, how do you know when to stand up against something or force something, or push people to let them lead? All those different aspects, what are your thoughts there?

Mike Baca: Well, remember, I talked to you about this other mentor we had named Pete?

Etienne Nichols: Okay.

Mike Baca: Named Pete Hartwick. This guy was a phenomenal guy because prior to him getting into business, he was an Air Force pilot. He got shot down over North Vietnam flying in F105. He went on and did some great things. He flew in SR71, he flew with the Thunderbirds. So this guy was the real deal. But one of the things that we got into, this whole discussion about principles. And if you get a chance to look at the discussion that I had with David, because I actually had my list of principles. And what he said was,"As a leader, you should consider adopting a set of absolute principles that will define how you will lead and how you will be. And to some extent it defines how you will be and how you will lead as just a person, not necessarily running organization." So what we did is we sat down and we defined those and actually codified them. And then, the other most important thing that he said," Once you codify one of these things as a principle, that means that by definition, a principle is never violated. A principle is never violated." And so with that, and what I used to do is actually print that out and I'd give it to new employees coming in, because they had to go through my eyes wide open speech, every new employee. And I'd say," You are now my accountability partner. These are the principles that I espouse to and you are solicited. And I actually direct you that if you see me not following any of these, you are to challenge me." And sometimes I would get challenged, saying," Mike, are you sure you're doing that?" And I would look at it," Yeah." And remember I told you that greatest person about VP of regulatory? And she'd walk into my office and close the door and say," Mike, have you considered I knew I messed up?"

Etienne Nichols: Oh, no.

Mike Baca: "Have you considered?" That's the way she always started. And it'd be something where I was approaching doing those principles. But basically what it says is once you adopt those principles and you say," This is what I stand for," if something comes up against that and is asking you to violate that, then you have to stand. And it's what I call a badge on the table thing. If there's something that has happened, that I'm being asked to do something or being directed to do something or I'm about to do something and say," I can't do this, I can't do this." And I have to put my badge on the table and say," I can't do that." I've been involved in a couple of situations where one was of my own stupidity, but some other ones were things that were thrust upon me. And I basically said," I cannot or will not do that. If I do this, I am no longer tenable as a leader and I can't be here, so I have to put my badge on the table if we're going to do this because I will not." And that sounds all great and wonderful and good, but that truly comes with a price.

Etienne Nichols: So let's talk about in the moment. You said you had a few of those moments and there's lots of things I want to ask about. I try to make notes so I can come back to some different things. I don't know if you want to just pick one that you can talk a little bit more freely about, but when you had that badge on the table moment, can you talk a little bit about what was going on and maybe what was going through your mind, as well as maybe the repercussions? Anything you can add?

Mike Baca: I'll talk to two of them if we have time.

Etienne Nichols: Yeah.

Mike Baca: Okay. On the first one was my stupidity because I didn't think things through. I'll try to make these into long story shorts. But I had an individual, she was my admin. And part of my career development with her, she had always wanted to go into marketing. She had a high school diploma. I said," Well, here, you got to have a college degree before you can go into marketing." Say," I've tried to have, but I've got family and kids and whole nine yards. And I said," Okay, we're going to work something out to where you're going to go and you can get your degree, okay?" Fast forward two years, she gets her degree. Immediately recommend her for a position. They actually had an entry level in marketing open up. She went in, interviewed, got the job. I hated to lose her as an admin, but just a wonderful person. However, when you go from being an admin to a salaried marketing individual, twice the salary. So then, I went in and we said," Okay, when does she start? When are you going to pay her?" Well, the business was having some challenges, they said," We can only give her half of her raise now. We'll give her the other half in six months." I went back to her and said," This is the condition." And she was like," Yeah. Heck yeah, this is my dream." We went in, she got the job. Six months later, they came back to me and said," Mike, the business is still not doing well and we can't give her the second part of her raise." And I said," No, you don't understand. I gave her my word that she was getting the second half and I gave her my word because you gave me your word." And I said," Come Monday, if she doesn't have her raise, I have to resign because I'm no longer tenable as a leader." I spent a very long weekend. I was scared to death. Luckily, they came through and they did it. So that was one.

Etienne Nichols: Can we take the time out just before you go into the next one? I want to ask you a question about that. It sounds like you're going back to your principles and you're like," These are my principles and if I cannot violate this, I know I'll violate one." I assume that's what was driving that thought process in your mind. But I had a question about those principles. What do you recommend as far as... Nitty gritty, how many can you have? It almost goes back to the question, how big can your SOP be before you forget what's even in there and you're not actually following it. You know what I'm saying? But do you have any thoughts or recommendations there, so that you actually can keep those things at the forefront of your mind?

Mike Baca: Yep. We're going to do a little walking around here.

Etienne Nichols: All right, let's go. And those who are looking at the video, you could see he's wearing a GG shirt, the Greenlight shirt, so he's one of us.

Mike Baca: All right, let's see. How do I get...

Etienne Nichols: Oh, wow.

Mike Baca: All right. You can't read that, but the left part of that is a vision that we wrote. The right side of that is the guiding principles of character and conduct that we talked about in my discussion with David at the keynote. And honestly, got 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, about 11/12 of them. And these principles, you have to put a lot of thought into what they are and what they mean to you. So for example, one of them,"Begin with the end in mind. If it isn't, we won't. We'll be honest all the time, no matter what. Our words and actions will be open, forthright, direct, and truthful. Public issues dealt with publicly, private issues privately. We will never, never, ever cop out on tough issues. We'll never stop learning. Questions are valued more than answers. Our commitment is to the team while honoring the integrity of the individual. Ultimately, it is the people who matter. Find the good and praise it." This is my biggest one is," Fear is our common mortal enemy. We will not contribute to it, ignore it, tolerate it, or sanction, ever. We take our work seriously, but not ourselves. And leaders are servants, not overseers." And one of the biggest ones is... Remember I talked to you about Brad? Brad's the one who taught me a lot of what I needed to know about servant leadership. I had some great commanders in the army. They also taught me about servant leadership. A lot of people really don't understand the army. What they really don't understand is that the leaders are very personally engaged and involved with everyone that's under their command. HR used to talk to me sometimes because I still carried it over. When we'd have a meeting and I talk about my people, these are my people. I'm going to take care of my people. And they go," Mike, these are not your people. You might be their boss, but these are not your people." And I say," Oh yes, they are. Every single one of them. I'm concerned about them and their family and their kids." You can wax eloquent about some of the things that we did there, but it was how do you establish that relationship that goes beyond this business facade? I used to call it the business facade. And you can have a great business facade. And in many instances, I did have a great business facade, but my relationships with those people that I cared about and I had a rumor that some of them cared about me, is such that it goes beyond that. And when you have that, you can do anything. I think we talked a little bit about leaders' intent. In the army, it was the commander's intent. I morphed it into the business for the leaders' intent. And I said, very succinctly," This is what I want out of the organization. I want a high performing, interdependent team that functions on trust based relationships." And I found that if you have that, no matter what you're faced with, we're going to be okay.

Etienne Nichols: Okay, that was really good. I appreciate you letting me take that little detour rabbit trail, whatever you want to call it. But okay, you were about to start into the second badge on the table moment.

Mike Baca: Oh, yes. I was hoping you forget about that. All right, so this happened relatively early in my career and I'll have to change the names to protect the innocent and everything. But we had a situation where we had to completely redo all of our sterilization, which meant that we had to get away from Freon. We used to use Freon and ETO, and we had to go to 100% ETO because of the Paris Accords and we couldn't use Freon anymore. We were paying fines for doing it. To make a long story short, we brought in all new sterilizers. We had to get them all validated. It was millions and millions of dollars. Very complicated project. And I had one advanced quality engineer who was another brilliant individual. And I signed this person. I said," You are going to work with our business partners and you speak for me on this project, and there's a lot we got to go through." So to make another long story short, they did it, they got it in, but it wasn't really ready to go. But there was a lot of pressure to make it ready to go, so they brought a bunch of people in, had the corporate jet, everybody flew in, and I took copious notes. I still have that book somewhere of all...

Mike Baca: And I took copious notes. I still have that book somewhere of all the things that were TBD or had failed or needed to get done. And so they're saying, we're going to go into production in a week or two and we're going to sign off on all the validations. This is back in the days we did everything on paper, with all these big binders, with all the stuff in there. And people were signing these. And the first line said something to the extent that we passed the criteria for success. And I agree. And people were signing these books, we're going to sign these books. And I knew it wasn't going to fly. So I called my boss who was in New Jersey at the time and I said, look, you need to delegate your signature to me on this project because it is not ready to go. And everybody's flying down, saying it is. And I say it is not. So we did. To make another long story shorter, went all the way around the room after I told my engineer, do not sign the book, pass it on. And it got to me with all these signatures on it and then I had to stand up and I said, ladies and gentlemen, I cannot sign this, I will not sign this. Then I just read everything had been presented during the entire day and I said, until these issues are resolved, I can't and I won't sign this. Additionally, my engineer has told you all along, these things need to get rectified, you elected not to, therefore I cannot, will not sign this. And so a lively and spirited discussion ensued and then the end result was that, okay, tell you what, Baca, you don't sign it until we get these things taken care of. Said yeah, once these things are taken care of, sign this book post haste. However, I cannot explain why your signatures will predate my signature and why your signatures will predate all of the final reports. Should that come to light? I will have no comment on that. So then they had to basically stop. And that did come with a price, because there were a lot of people that were really not happy with me.

Etienne Nichols: So my mind's got in a couple different directions. I'm thinking about how had an engineer in that room, he knew your principles. You had mentioned when you became a manager over these certain people that you told them. Anybody who is new comes in, you basically tell them, these are my principles and you are my accountability partner. Tell me if I start to miss in any of these different areas. I guess you can almost see anybody as an accountability partner provided they know you and they know what you stand for. At that point they're probably going to hold you accountable if they're thinking, and I don't mean to go too far off track here, but do you have any official accountability partners or is that a role that you see people playing in your life in different ways? Can you speak to that a little bit more?

Mike Baca: Well I haven't led a couple of different levels. My biggest accountability partner is my wife. Believe me, she will call me out in a heartbeat, anything that I'm doing wrong. My mentors were always an accountability partner because I really relied on them to give me the straight poop, tell me exactly what's going on. As I developed those relationships with my subordinates, they were great accountability partners. When you do get to that, people think all this stuff just comes automatically. It doesn't. It is hard work. In the 36 years that I was in business, I think I can say I truly achieved everything. And that high performing interdependent team working on trust based relationships, maybe three or four times, everything else was a work in process. I'm not saying that I had lousy organizations under me, that I was a lousy leader. I'm just saying that it hadn't reached that level where I could look at myself in a mirror and say, by God, we've got here. In fact, just FYI for you, every time I got there, then I went to look for another assignment, because there's nothing more I can do here. But regardless, also some of my peers, I don't know if she'd ever be listened to a person in the name of Alex, she's now a VP over at J and J working in one of their companies. I glommed onto her. She came in as a new person. She and I shared something that we came into the business as outsiders at senior VP levels, which was something that they didn't do very often. And I had some growing pains and some challenges doing that and getting accepted and establishing my brand and letting people know what I was and what I was not, et cetera, et cetera, et cetera. But when I saw her, she was... I mean, I can't tell. I've had the ability to work with so many brilliant people. She was one of the most brilliant, most highly EQed person that I have ever seen on the planet and I've seen a lot. And so I glommed onto her because I wanted her to teach me and she became a great accountability partner, because if I was doing something wrong, she just walk into my office, say, Mike, this is what I observed. Is this what you meant? And sometimes that brings you another whole topic of this thing called intent versus outcome. Sometimes I have had the greatest wonderful intent and just totally bomb the outcome. I have so many stories about those where luckily an accountability partner would come in and say, Mike, you did this. This is the impact it had. Is that what you wanted? And I go, hell no. Well that's what it is. So you need to do something about that. You need to recover from that. And literally I would have to. I would have to go out and apologize to people saying this was my intent and what I was trying to do and this was the outcome. You want to hear one of those?

Etienne Nichols: Yeah, I do. But before, so what's this word you're using? You glammed onto, I'm not familiar with that phrase.

Mike Baca: You haven't glammed onto anything?

Etienne Nichols: Glammed on? Okay.

Mike Baca: You see someone, you just go glamm on.

Etienne Nichols: You just become part... Yeah. Okay. No, I just wanted to make sure. Yeah. Cool.

Mike Baca: Yeah. You youngsters don't know those things.

Etienne Nichols: Well, educate us. Okay. Yes. I do want to hear the stories about hearing that intent versus outcome though.

Mike Baca: Okay, here's one that's always stuck in my mind. So I had a new engineer, not an engineer, but she was a manager and I had promoted her to a director and she dealt in a very technical portion of the business sterilization. And this is not the same one I was talking about before, this is years and years later, but I still had some responsibility for sterilization. And we're dealing with a very technical issue and the rest of the business isn't getting it. But in sterilization things are pretty prescribed. You do something in your SAL and you can't prove your SAL 10 to the minus six, you're in deep trouble. So we're working through this technical issue with the sterilizer and whatever these things are going on. And I see her up there and these people are just firing questions at her, just left and right. It's watching somebody in the tank and the rounds are going off and I'm like, oh my god. And I see it as getting a little bit more intense and I step in there. And so I step in as a VP and I basically take control of the conversation and I don't want to say shut people down, but I get them to understand the rationale and logic by what we're doing. And so we get all that done and we go out and I'm feeling pretty good about that. I'm saying, you know what? We haven't had the discussion of when do you stand beside, in front, or behind your people. And this time I decided, I'm going to go stand in front of her. I'm going to support her, show her how much I care. I went and stood in front of her and I basically took control of that and shut that thing down. I felt really good about it. About a week later, I'm doing my MBWA management by walking around and as I go into her office and trying to see how's it going. And she's reserved for some reason, which she's normally not. And I finally questioned it to get her to open up and I said, what's wrong? And she said, Mike, my first time as a director, I finally got a challenging situation and instead of you letting me fix it and figure it out, you stepped in and cut me off at the knees. And now all those people don't know that I could have handled that because you stepped in. That almost brought me to tears because I know what I intended then I know what the outcome was and I totally looked at up.

Etienne Nichols: Wow. So having been through and seen that situation, now you mentioned the when to stand in front of, beside, and behind. Well first of all, that's amazing that she was willing to just say that to her answer. I mean, I don't know many people who'd be willing to do that. Just be willing to be that open. That says a lot.

Mike Baca: Well, that is a person I had a trust based relationship with.

Etienne Nichols: So having said all that, the when stand in front of, beside, and behind, can you speak to that, then having gone through and seen that and learned those things?

Mike Baca: Well, behind is probably the easiest one. And you've probably been to your own courses on delegation, et cetera, and learning how to delegate and things like that. One of the lessons learned from one of my mentors about delegation is, if you're going to delegate something, you need to be willing to stand behind. But when you delegate, you need to delegate a level that failure will not be fatal to the business or to that individual. Because guess what? Sometimes they're going to fail. But in those instances you may have to stand behind and let them fail a little bit. The other portion of that is when they succeed. When they succeed, you should be very far behind. You should be very far behind. I can't tell you how many all employee meetings or other quarterly meetings or whatever things that I'm... And because of my position, I would be the spokesman. And one of my other mentors said, Mike, whenever you are giving one of those briefings, you are not allowed to use the word I, a single time. This will always be about what did the team do? You didn't do anything. That's all on them. So behind is that, you are behind them and you make sure that they get the accolades.

Etienne Nichols: And that's specifically for success with that word I?

Mike Baca: For success. When you stand beside your people, when you're all working toward a common goal, that is where the rank doesn't come into play. We are working together as colleagues. There was this little award I won once at in Medtronic Star of Excellence and we went through and we redesigned a quality system. But I did that in conjunction with a bunch of different people that were at levels equal to or lower than what mine was. We were together as that team working together and we owned it. If it succeeded or if it failed, we all did that together. If we succeeded, yeah, I worked that and I did that and I'll take some of that accolade. If it failed, I own that. Is what I'm going to learn from it. Then there are the time that you stand in front of your people. I guess the starkest example that I can use is... And again, this was decades ago. Things were a little different 30 years ago, but decades ago I've been promoted to a plant quality director and I was walking back to my office and I literally heard some very loud voices, almost screening voices coming out of one of my quality managers offices. And it wasn't my quality manager that was doing a scream. So I stopped for a second and I went back and just hung back and listened to what was going on. And I had some manufacturing director that was berating one of my quality managers for a big rejection they had done that was going to cost this guy a lot of money, because it wasn't going to be able to be reworked. And there's a whole long story how he got there, but regardless, so he was berating my manager about rejecting his product and I'm a director and you're not, you need to go, and when he was doing that, my guy was holding as well as he could and he wasn't backing down, that's for sure. But after a while, then I went in there and I literally got between him and that manager and I raised my voice a little bit and let him know, number one, he may not be a director, but I damn sure I am. Number two, this is unprofessional and you will not speak to any of my people this way. And number three, if you got a problem with anything going on in my organization, and my people, you come to me and I will resolve that problem. And one of the times you stand in front of your people is, if somebody's got a problem with your people or your organization, you take the ownership of that. So that meant, and that's also leads to another little offshoot, which is my quality subordinates always had to know you have complete latitude to do your job correctly in accordance with the principles and values that we've espoused and the regulations. Nobody can interfere with that. If they're going to do that, I will immediately stand between you and them because you need to know you can do your job without any fear of reprises. And once they know that, then they're liberated to do that job. And if they believe and know that wait a minute, he will stand up for me, he will go into that tray for me. And that also can lead to a little bit of loyalty too.

Etienne Nichols: So I can almost see that standing in front of them in those really critical moments actually gives you the ability to stand behind them later on, it sounds like, gives him that freedom. That's cool. So I didn't ask this question, and I don't mean to go all the way back to your second badge on the table moment, but using that situation that, that quality manager was involved in and maybe combining it with your own, So you saw somebody in a... I don't know if that would've necessarily been a crisis adversity situation, your situation where you stood up in front of everybody and said, I will not sign this. Standing up for what is correct and right. Those different adversity moments, they obviously test us and they form us, but sometimes they destroy us. Do you have any stories or thoughts about how you can get through those moments being a phoenix versus just being on fire?

Mike Baca: Actually, that's more of a marriage example for you. If I've been married 45 years and we've been through ups and downs and we lost a child, and when you get into those periods of extreme adversity, another wise guy I knew that was also married longer than I was, he's passed away. But he taught me and he said, Mike, when you get faced into adversity and this pressure is there, can do one of two things. One, that will be there and it can just blow it up. It can just totally destroy it. It can be in a marriage, it can be in the business, it can be FDA consent decree, it can be warning letters, it can just, and boom, it's all blown up. Or two, that pressure can form you together like a diamond. And when it formed you together like that diamond, the hardest substance known to man, nothing can break that apart. Now, in a marriage, I've seen that and we've had some adversity that's put us together. But in business I've also seen that where you get hit with one of these Black Swan Events and if you've done the preparation, if you've got a group of people that are functioning on trust based relationships and believing you and believing what they do in whatever you throw at us, we're willing to do. Whatever you throw at us we're willing to do. And you know what? We're going to do it without complaint, on one Black Swan Event where we got a little bit sideways with FDA and we had to get something done within a certain period of time or it would've been a whole nother ramification. And we were going in there and we had to get this whole, essentially an 18 to 24 month redesigned done in six months. There was a reason for six months, but we only had six months. I had people working nights, weekends. I had people with cuts in cubicles. I didn't hear a single word of complaint because everybody knew why we were doing this and everybody knew that we were right and so they did it. And so that pressure, instead of doing this, it did that. We came out of it a much stronger team.

Etienne Nichols: So we've talked about what a Black Swan Event is, but just in case anybody else is not familiar with that term, can you give a definition and love to hear any other situations?

Mike Baca: For me, a Black Swan Event, a pure black swan is exceedingly rare in nature. So when you see one, you look at that and go, wow, that's something you don't see very often. Well, in business, a Black Swan Event is, wow, you don't see that very often and it's not very good. So I've had a couple of those in business, without getting in too much detail. We had one where I was talking, one where people were... No, that's a different one. But I had one where people, again, were misusing the device. Couple of deaths ensued, we got a bit south with FDA and we had to do a class one recall because of my hubris and my inability to listen to somebody I should have at other regulatory VP, single handedly managed to take a regional recall and turn it into a worldwide recall. So that was fun. So you had all these things that were coming together, more certificates of medical necessity that needed to get done and tremendously expensive to the business. I'm talking tens upon tens of millions. And I mean it was... There's another, but I can't use that term here, but there's another word we used in the Army that talks about how that happens. And now you got to deal with that and it's like, oh my God, this is going to test everything that I possibly know and I've got to keep my head around me as I do this. And now I have a choice. Do I blow up or do I come together? And luckily for me, and again thanks to a lot of the mentors and leaders I've had, I've been able to come together. But when that happens, it's a very, very stressful event. And careers and livelihoods are definitely on the line.

Etienne Nichols: But it sounds like getting your team to align with the mission, I mean the ability to do that, it's incredible. When we were talking through getting ready to do this episode, you told me just briefly a story about how you might hold the record for the most 483s in one. And I don't know you specifically, I mean maybe. I wonder if you could talk a little bit about that story because I think that could be valuable for our listeners.

Mike Baca: Well, this happened a little earlier on in my career and we had just been promoted to a director level and we had an unannounced FDA investigation inspection. And as this person came in, I was all full of myself because I'd been promoted. I'm the guy running this place now and I know exactly what I'm doing. And okay, we're going to run an FDA inspection. I've been practicing this, we've been doing mock inspections, I am ready. So this lady comes in and we tell her, instead of just saying, ma'am, we have specific rules about makeup in the clean rooms, therefore it will be important that you not approach any of the product as we walk through the clean rooms. Instead of that, I said now, and she was a very nice looking young lady, a qualified FDA investigator, and I told her, we'll send a guide with you. You need to go into the lady's room and you need to remove all of your makeup. You can have no makeup on my floor. So took her into the lady's room to remove all of her makeup. And she did. I don't know what happened while she was removing the makeup, but somehow makeup got into her eyes or whatever and she came out and her face was puffy and she went from this beautiful lady to looking like Quasimodo. And we started from there and she was not in a good mood. And then we went out and she just started writing and writing. And I mean to this day I think I still set the record for the most 483s. And she was writing, I think in my reply over half of it was like, this is not a violation of any regulation, so we're not doing anything. But my hubris from there was that I thought I knew everything and I thought I was going to impose my will and I wasn't considerate to exactly what was going on there. And I paid a price for that. Took us a while. Luckily we didn't get a warning letter, but I had a lot of explaining to do.

Etienne Nichols: And so I don't know, for some reason my mind went to the woman you were talking about with the highest level of EQ that you ever had. I wonder how much you learned after that as far as the EQ goes.

Mike Baca: Yeah, my EQ is about a negative 10 at that point. So like I say, I've tried to learn a little bit since then.

Etienne Nichols: That's one thing that I've always been curious how you learn more EQ, but I don't know that's out of context or not here are relevant.

Mike Baca: A lot of that is through things that I've messed up and things where I've tried to learn from my mistakes, but I've also had a lot of positive things. And that little presentation I sent you, there's this thing about Donna, and Donna is the person who probably did the most for me learning about EQ, because at that point in my career, my wife had a way of describing it, I can't describe that here either. But she said I was a little bit stuffy and the way I was raised, I was raised that men don't show emotion. And she's the one who finally taught me about emotion. She's the one who finally taught me about connecting with people on an emotional level. And for a long period of time, quite honestly, as I started out, I thought the whole business facade thing was the way you're supposed to run business. I mean, literally when I started out in J and J, we wore white shirts, black ties and black slacks out on the production floor. I went through a lot of white shirts. And I thought the military had a case chain of command and it was even more so. And I was told exactly what you were supposed to do and how you were supposed to communicate and who you could communicate with, and God forbid you do some of these other things. And when Donna came along, she said, Mike, forget all that. That's not the world today. And she helped me quite a bit with that. And there was a book on EQ. If you haven't read it, you need to reach it. It can be helpful.

Etienne Nichols: Okay. I probably have it on my bookshelf. I don't think it's one that I've actually read. It's funny, my bookshelf winds up being a library of books I haven't read so that I could go reference them. But maybe it should be the opposite. I love how we've progressed through your career to agree and maybe we've been a little bit meandering. That's totally fine. I do want to talk about a little bit more like post- mortem. When you go through one of those crisis black swan situations, what are the repercussions and how do you handle those things? Because in my experience, I've been through where it was maybe a guided FDA audit where they were actually coming specifically for FDA inspection. They were looking for something because they knew there was an issue. And that was just a tremendously difficult several weeks and it weighed on my mind for months afterwards. It just, things played, maybe I should have said this, could I have said this? The conversations. I don't know if that's something that you suffered through or anything like that, but when you go through those Black Swan Events and those crisis moments, how do you process those to where you do become better and you don't just break yourself down emotionally?

Mike Baca: Well, I hate to keep going back to these old principles and values things again. But when I look at those events that I've been through and honest to God, and one of them, I actually stood in front of a mirror and said, okay, you comported yourself in accordance with the principles and values that you said you were going to do. Now the chips are going to fall where they make. And you have to accept that even though I've made a light of the fact, I made every mistake you can make without get terminated. But there were a couple of times I was wondering, a little iffy, if the mistake that I'd made is going to cause a problem. But at the end of the day, I knew that I could be comfortable with that because I'd already accepted it. And so I learned from all of those. And in the last two that I had, I did go back and do some retrospectives on those. And what are some things that I should have done better? One of my primary learnings on the last one that I went was, if you have someone that you trust and you know that they are probably smarter than you and they offer you solid advice and you think you know better, you're wrong, You're just wrong, you may go ahead and do what you're going to do anyway. But you need to step back and think about that very critically, because it was two big failures on my part. Number one, she would not have told me those things that she told me had she not believed me when I said you were my accountability partner. Number two and the biggest one, and my biggest failure was she would not have told me those things that she told me unless she cared about me. And the two biggest red flags I had staring me in the face and I just walked right past both of, because my hub was... So that one I remember now to this day. So when I have people that are giving me some advice about something where I think I know better, I will take a step back and say, wait, let me think about this a little bit more in more detail. Let me find out a little bit more.

Etienne Nichols: That's good. So you mentioned the presentation you sent me a couple times and there were several notes that we took from our conversation around that. One of the things that stood out to me was the line, in the end, you may love the job more than loves you. That's okay. You can be replaced in an instant. What did you mean by that? And what value do you want to basically pull out of that, if you don't mind going that direction?

Mike Baca: A couple of things. There will be businesses where you say, well, this person is indispensable. There may be some places where that is, but usually not. But the thing is, what I tried to take away from that is that my dedication to what I was doing, my dedication to that job was because of what it meant to the people that were going to be the beneficiaries of what everything that it was that we did. And for that, I'm willing to dedicate myself totally. And I did that and I did love that job. I mean, I'm not waxing eloquent when I say even on the worst days, you got back to back meetings and then you got budget things you got to go through. And then I got complaints and oh my God, we've got an FDA inspection company. We got all this stuff that you're dealing with. But imagine waking up every day and being excited to say, this is what I get to go do today. Working with the people that I care about and a couple that care about me. Imagine being able to do that every day. Every day. And the joy did that, and I actually had that joy. But I also recognize that once I step away from that, the business isn't going to shut down and go, oh, woe is me. Mike's gone. Oh my God, we're all going to sit here and nothing's going to... No. The best legacy you can leave, and one of my mentors taught me this, the best legacy that you can leave is that when it's time for you to go, you leave. And there's not a ripple in the wave. Not a ripple in pond.

Etienne Nichols: Wow.

Mike Baca: Let me give you one of the best examples I've ever known about that. And this guy's name was Jim. He was the president of our company. He had been there decades. He had risen up through the ranks to become president. He was the guy that could walk out on the production floor and be calling people by their first name. Everybody called him coach. He used to coach like APAC 10 or Top 10, whatever university.

Etienne Nichols: Wow. That's impressive.

Mike Baca: So he got the nickname of coach before he went into business. And one of the greatest leaders that I've ever known, and when you talked about our company, it was, we're talking about Jim, because that's just the way it was. When Jim decided to retire, they had a new guy that they went out and they found, and he's also a great leader, guy named Spencer. They went out, and I had him checked out. They told me ahead of time something was happening, had him checked out. I got thumbs up from colleague over at the business he was in and I said, that's great. And Jim called me in the day before he left, or the day he left, ahead of the big meeting, told me what he was doing. And he said, Mike, we're going to have this meeting. I'm going to announce that I am retired. The new president is going to walk in and now you all belong to him. And I literally lost it in that meeting between Jim and I, because it was emotional. But that's what he did. And he understood that, yes, everybody had been so involved and identified, but he also recognized his responsibility was that when he retired, that he wanted to set up the next person coming in for the same level of success.

Mike Baca: He wanted to set up the next person coming in for the same level of success, and as emotional as it was for, honest to God, the entire business. We had the emotional ripple, but there was no other ripple, because he understood the best thing that a leader can do is prepare that next leader to come in.

Etienne Nichols: I'm glad you specified that because when you said the best legacy you can give is to be able to leave and there not be a ripple, I thought to myself," I don't know if I necessarily agree with that." Because of the emotional side of it, you would hope people love you enough to care. But separating those two makes it make a lot of sense to me. Maybe there's an emotional ripple, but there's not a production ripple per se. You're passing that torch on so that somebody can do the exact same things you did.

Mike Baca: Well, that's exactly the same that I read about the Joy in Life, and that's exactly what it says.

Etienne Nichols: Yeah. That's so good. I'm trying to think. So, one other thing that you had written down was to understand the VUCA, the volatility, uncertainty, complexity, ambiguity-

Mike Baca: Yeah.

Etienne Nichols: ...I didn't know if that was something you'd want to expound on.

Mike Baca: Oh wow! That's a whole four hour discussion just to-

Etienne Nichols: And we probably need to figure out a specific end in mind. I was thinking if we could cut it off whenever you're ready, but we'll stop at noon, yeah.

Mike Baca: Well, when we talk about volatility, it's a challenge where you have the unexpected, or the unstable, or you're in an unknown situation, it's kind of like," I haven't been here before, so I don't have a frame of reference to fall back on." On a great, many of the things that I faced in my career I was like," Oh, yeah, I've been through this before. There's some differences and I may have to adapt some things but, yeah, I've been through this before. I've been through an FDA inspection before. I've been through death cases that have to be investigated before. I've been on that fricking witness stand before." Okay. So, some of these things that I've done, but sometimes something will happen that you've never been faced with before. So, now, you go," Oh my God, what am I going to do about this?" Okay. So, some of the things you can do is one, seek out some help or find somebody who has been through this before and start getting some counsel there. Uncertainty is, despite the lack of other information, the basic cause and effect are known, but changes is possible, but not a given, but there's a lot of uncertainty that's built in that I don't know how this is going to go. I don't know how this is going to go. And so, for example, we had in one area we were like 90- plus percent of the market and we had a new competitor come in. And the new competitor, as the new competitors will do, will claim the sun, the moon, the stars, and all of you are going to be millionaires if you go with us. So, we came in and we didn't know how that was going to happen. So now, you," What are you going to do about that? Are you going to go after them directly or you going to concentrate on what you've got and are you going to stay in your own lane? What are you going to do?" In that particular case, they came in making all these claims, and basically, part of our attitude was," Okay, we've already proven ours, let's see you prove yours." And over a short period of time, they were unable to prove that and they just kind of faded away. Okay. So, you've got some of that. When you talk about complexity, the situation has many interconnected parts, so it's not just one thing. And that's one thing that I saw so much when I was looking at root cause. Everybody's looking for that one silver bullet. And I'd say that silver bullet very seldom is there. It's going to be this, leading to this, when it's exposed to this, results in this. And all those things got to line up and finding that. But all we want to do is we got all this and I've got this 43 citation because Susie, Sally, and Jenny didn't sign the maintenance record. So, what's the reply? I'm going to train Susie, Sally, and Jenny to try to sign. No, you never found root cause. You got to ask why. Remember the five whys? Why did that? Why did that? Why did that? Why did that? Why did that? Did you do your FTA? Did you find out what faults led to that? Did you get to the true root cause? Getting to understand the complexity of it and willing to put in the work. Just kind of aside, when I was sitting in my chairs and people would come in and we'd have this big cap, and they'd say," Okay, we found a root cause."" What's the root cause?"" Training."" Nope. The whole time I sit in this chair, you get to use training one time and you've already used it. So, go back and find me a real root cause, okay? Because you've got to find all those in order to address the complexity to get your output." And then ambiguity. Sometimes, the causal relationships between one and another is not known. No precedents exist. You have the unknown unknowns. Okay. I got a funny story if you want to know more about ambiguity.

Etienne Nichols: I do, I do. Yeah, for sure.

Mike Baca: All right. This is a funny one. Okay. So, we're getting ready to launch a new product, and as part of this new product, we have to anodize a component. And you're familiar with anodization, you take aluminum, you put it in and it gets the anodization to put it on.

Etienne Nichols: Yeah. Certain amount of penetration and growth-

Mike Baca: Yeah. So, you got to have so much penetration and it's going to be going through. And if you don't do it right, it flakes, or bubbles, or inflate, or it comes off. It's like," Oh, wow. It's not right." And so, we were doing all, manner of root cause, we're looking at the process, we've been using this process for years, never a problem. The suppliers is like," We've never had this problem ever." They're like," Oh my God." So, we just can't find out. Just can't find out. And we're doing everything, we resort to Kepner- Tregoe and we're looking at some of the things that are going on. And then all of a sudden, and one of the things about Kepner- Tregoe is you look at what was my steady state, what is my state now, what changed? No matter how small, what changed? And so, we finally came down and also helped member, I'll tell you about 3D X- ray CT with-

Etienne Nichols: Yeah

Mike Baca: ...electron microscope elemental. We found this element and this element was tied to an organic compound. You got no organic compounds that are taking place anywhere in this process. But through understanding VUCA and going through that and understanding the ambiguity and looking at some KT stuff, and I said," The only thing that's really changed, we have a new operator on second shift." What's that operator doing? So, people go and they look at this new operator and new operator is coming on, great guy, and it's a lower level supplier. They have a controlled operation, but it's lower level. And so, what's the difference between that second shift operator and the other one? Same training, same machinery, same everything except this operator brings their cat to work.

Etienne Nichols: Oh.

Mike Baca: Just what the cat was doing in one of the vats.

Etienne Nichols: Oh, no. Oh, no.

Mike Baca: Altered some chemistry and the anodization wasn't working. So, that's some ambiguity. Som just trying to understand how does all this stuff fit together? So, that's a short course on VUCA.

Etienne Nichols: Yeah. Wow. I can only imagine the Kepner write up on that one, as far as the... What's the root cause? A cat.

Mike Baca: Well, to this day, I believe it. I wasn't there, but I believe it.

Etienne Nichols: Interesting. Wow, that is really good. You kind of just offhand mentioned, just kind of off the cuff," Well, I've been in witness stands, and I've done these things, so I know how that goes. But there are other things that are uncertain." I was like, Whoa, whoa, whoa. Hold on, hold on just a second, so you've been in witness stand. You mentioned some of the things that had happened maybe pulled in a recall. You also mentioned some of the failures in certain aspects of the product that led to patients dying and so forth, so I'm assuming here that some of it's related to that. But I wondered if you could talk to some of that experience and how you prepared bleeding up to that being in the witness stand. I'm sure that must have been a lot of things going through your mind.

Mike Baca: Yeah, there's a lot going through your mind. Well, a couple of things. If you ever find yourself in product liability and you're going to be up on the stand, take full advantage of the company lawyers that are offered to you and understand the situation you are in. Okay? By definition, it's an adversarial relationship. So, where I'm at, I'm trying to prove that we did the right thing and the people that are adversaries are trying to prove that we did the wrong thing. The thing that actually has gotten me through all of those, every deposition that I've had, every time I've been on a witness stand, remember those principles and values I was telling you about?

Etienne Nichols: Yeah.

Mike Baca: You go back to those as a starting place. And then, you remember this thing about being the master of your craft I was telling about. So, I absolutely knew my processes. And if you have that, then you can then straightforward, dispassionately, logically and truthfully is to talk about these are the questions that you're asking me, and I know the light you are going to try to put me in. I absolutely know the light you were going to try to put me in. And so with that, and armed with great preparation, then when they ask you those questions, then you know what you need to answer. Here's an example. I was on a witness stand one time. I put a product on hold, a lot of product on hold, and there was an unfortunate incidence. And again, someone had misused a product, someone had gotten injured in it. And I don't know if you've been through some of these, but when they go through discovery, they will, anything has got your name on it over the last five, 10 years, it will be there. I literally walked into this conference room and there's like this 15 foot long table and it's just ringed in binders, and all these things have my signature on it. Okay. So. They're talking about this, in this particular instance, well, I put product on hold. And the specific question is," Mr. Baca, did you put all this product on hold?"" Yes I did."" Mr. Baca, did you not release that product two weeks later back into commerce? One of which ended up seriously injuring my client."" Yes, I released the product. Noticed I didn't say my product hurts your client. Yes, I released the product."" Mr. Baca, isn't it a fact that the sales and marketing people pressured you to release that product because of the impact it was having to the company revenues?"" No, that is not correct. I released that product when subsequent to the investigation we conducted, I was able to prove that all product that was being held, in fact, met all of it's finished goods release requirements and all would perform to it's validated state." Okay?

Etienne Nichols: Yeah.

Mike Baca: So, if I had just said," Mr. Baca, did you release that product because of the pressure for sales and marketing impact it's having on revenue?" If I said," Yeah." And then," It hurt my client." And just said," Yes."" Oh, you admit your product hurt my client. You just said so." Okay? The second one that they try to do is," Wouldn't you agree Mr. Baca, as a normal person, wouldn't you agree to doing this and this?" And when they did that, my standard answer was," If they're talking about a meeting or something that occurs, I was not in that room. I didn't hear what was being said. I can't give you an opinion because I wasn't there. I can't give you an opinion." And I can't tell you how many times the lawyer would say," Ask and answer. Ask and answer." Okay. So, just recognize what you're there, but be in a position that you know exactly what you're talking about. And just like an FDA inspection, know what you're talking about, give your answer and then shut up.

Etienne Nichols: Yeah, that's really good. When you're in the field, or at least in the roles that I was in, I'm sure when you get to Global VP and so forth, the higher levels, you probably think a little bit more about those situations, the potential litigation, potential liabilities, and so forth. But anyone in the industry, potentially, they are liable for the things that they're doing. I don't know if you have any stories, I'm sure you probably have some, but to basically highlight the intensity and the level of care that you should be putting into your work, because what we are doing does impact patients, everything, have you think of that?

Mike Baca: Oh gosh, yes.

Etienne Nichols: Yeah.

Mike Baca: There's courses that are called Right. And I'll share with you another little story of litigation that I was not involved in but I know about, and this happened decades ago, but it happened with a particular company with a device, and the device failed. When the device failed, it led to something happening in surgery and the person didn't get blood and oxygen, and they basically became a vegetable, and they uncovered a message from an engineer going back to another person on some testing they were doing that didn't pass as they were developing. And the engineer said," We got to fix this or somebody's going to die." Okay. Remember I told you about all that material they're going to go find and discover it?

Etienne Nichols: Yeah.

Mike Baca: Okay. They found that email and they presented it, and all the company did and say is," How big of a check are we going to write?" Not necessarily even involved with what exactly what was going on, because I also know exactly how the device failed and the device failed because another misuse. However, the company wrote some figure check because of what somebody wrote and what they were doing. So, you got to be aware of what do you have in your writing. If there's something you don't agree with or BML you don't agree with, that's why you make face to face meetings. And if you're in different places, that's why you use a telephone. But just remember, anything you write down and goes through anything that belongs to the company, that is discoverable, because it exists and will exist, almost forever, but it will exist.

Etienne Nichols: Yeah.

Mike Baca: So, thinking about what am I writing and what is the point that I'm trying to get across?

Etienne Nichols: Yeah, that's really good. So I know we're kind of coming up close to the end of the time. We talked a little bit about from an overall standpoint, your career is the long game. That's kind of the overarching theme that we've tried to have here. I love that you keep going back to the principles, but are there any other things that you would give as advice and recommendations and maybe almost two personas when you think through that, like the mentee, early in his career, trying to get ahead, he's probably thinking about the next promotion, kind of like you said, but also those who are on the second half of their career, looking back, how can they contribute even better to those? You could just pick 1 persona or both. Any thoughts, stories, specific advice-

Mike Baca: Well, some of the strongest advice I got was actually from Pete, he's that pilot I was telling you about. One of the things that he told me is that," Mike, a true leader is going to lose his ego once you recognize this ain't about you anymore. This is about something bigger than you." And I kind of knew that when I got out of the army. Because when I went into the Army, I said," I want to do something bigger than me." When I got out, I said,"I want to do something bigger than me." But I've made more money doing some other things that I've been a multi- millionaire entrepreneur. I don't know, probably not. But could I have done other things? When I chose what I chose, I chose because I did say I want to do something bigger than me. And once I finally recognized bigger than me also means dropping that ego part. And now, it's about my team, my business, my patience. What am I going to do for them? Then at each part of my career, I can look back and do that because if the first part of it, I got to learn so I can be a better service. I got to learn statistics, I got to learn all these techniques so I can apply that to what I'm doing and help out my business partners and my patients. Okay. And now, when I get to that second part of my career, how do I take that stuff that I've learned and now I can apply with more influence? And now that I'm at that third part of my career, I really am dedicated to trying to give back what I can. I've had a couple of people approach me out of true quality, and were talking about me going and talking to them about purpose and leadership. And I say," Oh, I thought you wanted me to come and talk to you about technical stuff."" Well, you can do that, but we want you to come and talk about purpose and leadership." And I said," Is that just because you get that for free or what?" No, no, no. That's really what we wanted to talk about. So, we're talking about doing some of those things. And so now, in that third part, you can think about," How do I give back to some people?" Okay. I do some volunteering work and I try to give back a little bit of that. I do some instruction work. In fact, I had a class last Friday and brought some new people into the sport. So, now we're doing that and hopefully, I got them doing that safely. So, how do I give back now that I've taken all this that I've learned and given back to the people, some other people that might be able to benefit from it.

Etienne Nichols: Well, I got a question about one of the things you said. So, you said something about," A true leader loses his ego." And I think that's really powerful. And you also mentioned when you came out of the army, you kind of recognize that you've got to put that down and be part of something bigger than yourself. But I would guess it's kind of cyclical in nature. Because if you're anything like I am or if you were anything like," I am nice", you might have that thought intellectually, and then you get back into the work and, it's like, you zoom out, you see the forest, but then you get into the work and you're seeing the trees again and you forget the forest-

Mike Baca: Yeah.

Etienne Nichols: ...how do you come in and out of that?

Mike Baca: Now, understand, there's a difference, at least in my mind, and maybe it's semantics for other people, but for me it's not. There's a difference between ego and self- confidence.

Etienne Nichols: Okay.

Mike Baca: Ego means that I'm trying to get across as somebody that I am better than you. Okay? I know more than you. I am better than you. I am more capable than you. And you should acknowledge that, that I am your better.

Etienne Nichols: Yeah.

Mike Baca: That to me is ego. Self- confidence doesn't mean I go up and I'm wishy- washy, I don't know what I'm talking about and," Hey, would you guys mind following me?" No. Self- confidence means I am self- confident in what I do. When I instruct, believe me, you can ask people, I am self- confident with what I do. Okay. My wife would say," I may not always be right, but I'm seldom in doubt." So there's a difference in my mind between ego and self- confidence. Because in the other lessons learned, when you're a leader, if you don't have self- confidence, your subordinates, and your peers, and sometimes, you're superiors, those people are looking to you. And especially when you get into a VUCA situation, they're going to be looking to you for leadership. You got to lead, you got to go in there. But for me, it's not from an ego perspective, it's from the perspective of," I have the self- confidence. When you follow me, we're going to get through this because I will get through this."

Etienne Nichols: Thank you for clarifying that. But I also want to ask, do you have any specific strategies or tactics in building that self- confidence? I could probably answer my own question there, but I want to know what you have to say as far as that goes.

Mike Baca: My one is know what you're talking about, don't think you know what you're talking about. Know what you're talking about and recognize where you come to that limit and stop at that limit. Because if you don't stop at that limit and you think," I was really good down here, but I've now reached the limit of my expertise. But if I continue to talk up here, I still have that level of expertise. Pretty soon if anybody is really listening, they're going to recognize,'He doesn't know what the heck he's talking about. Now, he's talking BS.' So I'm talking BS, and how do I know if I can..." So, when I get to here, I'd say," That part, I don't know. I'm going to have to get some more help, or somebody else is going to have to get you to that." But in those things that I am confident in and I know I can do, yeah, I will do that.

Etienne Nichols: So that's kind of the line between self- confident and ego almost, I guess. When you cross that-

Mike Baca: Yeah.

Etienne Nichols: ...then you're back into ego or potentially-

Mike Baca: Yeah. The guy with the big ego will go on that second and he'll take you right over the cliff. Okay. The guy who is self- confident is that leader, will get to that point, and say," Now, I need help. Now, I need help." Okay?

Etienne Nichols: Yeah.

Mike Baca: So, for example, if I'd be sitting, when we used to do our FDA inspections, the way we would do it is you would have me as a company executive at the chair, you would have your subject matter expert who could speak to the technicalities, and you have your briefer. Your briefer may or may not be the same as your SME. The SMEs were my geek engineers, and they could talk to you about this is how many volts and ohms are going to be going through this that will give you this many RPM, and this is how much... Okay. The investigator may not know that. The investigator may want to know,"Okay, so how does this thing work in surgery again?" All right. And then my role was to make sure that I kept everything on track. So, when I got to the level of what I needed, I turned to my presenter, my SME, and they present what they need to know. I don't see that as my weakness. I don't see that as my weakness. If I'm leading folks and I'm going through a VUCA situation, I can give them my best estimate of what it is that we need to do. And then I'll ask for more information. I don't know if you haven't had a chance to look at the presentation I did on Risk Management Board, but one of the tenets of the Risk Management Board during discussion of the problem is once we're in there, once we're talking about what's actually occurring here and all the entities are in that room, nobody has a rank. There is no rank in the room. Everybody's opinion will be listened to, because we're trying to get to what is a solution. Just because you're a VP, you know what? You probably know less than that individual who actually assembles the device.

Etienne Nichols: I can get on board with that intellectually. How do you make that happen in practicality, in a real situation?

Mike Baca: Well, if I'm running the meeting, I make it happen.

Etienne Nichols: Yeah.

Mike Baca: So, look at my presentation on RMB, you can see exactly how I make that happen. If I am not running the meeting, and there are many times I'm not running the meeting, I have been known to interject that," Hey, wait a minute, we really haven't heard what Jim has to say here. So, why don't we just take a minute and listen to Jim has to say." I've yet to be in a situation even when it's getting a little heated that someone's going to say," No, I don't want to listen to Jim."" Well, wait a minute. Let's listen to Jim." And I've kind of been very fortunate being at the level I was at the last 20 years that, well, at least that's one time where maybe position has something to say because I haven't ever had someone say," No, we're not willing to listen."

Etienne Nichols: Yeah, that's good. Well, you got about 10 minutes left. I could probably go on for hours too. I actually have 15 more points that would be fun to get to. But considering time, do you have any, maybe one last story or thought that you could leave the listeners with that you think would maybe motivate us to do a better job in the future? Yeah.

Mike Baca: Wait one second. All right.

Etienne Nichols: The Joy of Life.

Mike Baca: Okay. Okay. I kept this in my office for over 25 years. Somebody gave this to me and this helped to point me in a direction that I wanted to go. Actually, I memorized it and talked about it at the keynote. But I actually read this at my retirement too, because I was on a side, when I retired, I had two people that more than deserved it and had been promoted to VP. And when I left, I made the recommendation to the president that they not replace me in kind because I said," Quality and regulatory are two intertwined, but slightly different sciences. And I believe you should have a VP of quality and a VP of regulatory and eliminate my job," which is what they did. Okay. But this is what I read, and it talked about the joy in life, and it says," This is the true joy in life. By being used as a purpose, recognized by yourself as a mighty one, but being a force of nature instead of a feverish, selfish little quad of ailments and grievances, complaining that the world will not devote itself to making you happy. I am of the opinion that my life belongs to the whole community. And as long as I live, it is my privilege to do for it what I can. I want to be thoroughly used up when I die. For the harder I work, the more I live. I rejoice in life for it's own sake. Life is no brief candle to me, it's sort of a splendid torch, which I've got to hold of for the moment, and I want to make it burn as brightly as possible before handing it on to future generations." And that's from George Bernard Shaw.

Etienne Nichols: That's really good. That's awesome. I appreciate it. So, those of you who've been listening, you've been listened to the Global Medical Device podcast, but also we're going to put in the show notes, some different links so that you can find other things that Mike's been up to. The keynote, he mentioned a few different times, that should live in the academy. I'll hunt that down and see if we can put a link in the show note for that. Mike, where can people find you? Or I don't know if you're active anywhere as far as what you're up to. Can people find you and see what you're doing these days?

Mike Baca: Well, yeah, I'm active on LinkedIn, so I've got that going. I've got an interesting business model for White Rook Consulting, which is I do no advertising. Everything I do is only word of mouth. I find myself in a wonderful position and that I only take on things that grab me intellectually and emotionally. I've got a couple of things that I'm working on right now, trying to help out some people on a couple of things, and it's really satisfying for me. If someone wants to send me an email, it's mikebaca1 @ yahoo. com. M- I- K- E B- A- C- A, the number 1, @ yahoo. com and it's White Rook Consulting llc.

Etienne Nichols: Okay. And we'll put links in the show notes so that people can easily access that as well.

Mike Baca: Oh, cool.

Etienne Nichols: Yeah. Mike, thank you again. I really enjoyed this conversation and there's so much more. I don't know if you'd be willing to do another one sometime, but maybe at some point. We'll see.

Mike Baca: Well, I told you I got a special place in my heart for Greenlight.

Etienne Nichols: Yeah.

Mike Baca: So, if there's anything I can do for you guys. You have so many new people, I was so excited to talk to all the new folks, and it was funny and, well, I guess, interesting.

Etienne Nichols: Yeah.

Mike Baca: Because I would introduce myself to a bunch of new people and they were like," You have Mike Baca?"

Etienne Nichols: Yeah. I know I told you this before, you didn't really, I don't know how you feel about hearing this, but you are something of a celebrity to those at Greenlight Guru, because the quality over compliance is obviously a major tenet of ours, and you've lived that, so we admire that and appreciate all the things that you have to offer the industry. So, all right. I will let you get back to the rest of your day, but thank you so much. Thank you all. Those of you who've been listening, as I mentioned earlier, it'd been listed to the Global Medical Device Podcast, look at the show notes to see other links where you can find other things that Mike's doing, and we will see you all next time. Thanks, everyone. Thank you so much for listening. Just a few of the points I took away from this incredible conversation where black swan events are incredibly rare, but if you're in the game long enough, it's very likely that you will encounter one. So, adopting a set of principles and values can guide you through that challenging time. Also, I learned that you need to learn to speak the language of the departments and the types of people you'll be working with. Too often, we just look at our roles in quality and regulatory and we say something along the lines of," We have to do this. Why are we even talking about it?" But if you understand the reason and you can convey it in a way that appeals to those across the aisle, you'll get much farther. Also, we talked about how eventually there may come a badge on the table moment. What are you going to do in that moment? Are you going to fold under pressure or are you dedicated enough to your principles and for standing up for quality that you'll be able to handle that pressure in that moment? Mike mentioned that he expected his entire team to hold him accountable. And if that doesn't prepare you for those intense moments, I don't know what will. If you enjoyed today's episode, reach out to Mike on LinkedIn and let him know. Also, I'd personally love to hear from you via email at etienne.nichols@greenlight.guru , or look me up on LinkedIn. You can learn all about what we do if you head over to www.greenlight.guru. We're the only med tech lifecycle excellence platform, and on top of that, we've built both a community and an academy where you can go to join the conversation or learn more about the things we discussed on the podcast. You can find those at community. greenlight. guru or academy. greenlight. guru. Next week, we'll be speaking with Orla Connaughton on the topic of design assurance. Not only this is a fun and timely topic, Orla knows her stuff and she was an absolute delight to speak with, so definitely stay tuned for that. Finally, if you enjoyed today's show, please consider leaving us a review on iTunes. It helps others find us, and it also lets us know how we're doing. Thanks again. Y'all are the best.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is 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.

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