Friday In-Focus · 13 June 2025
MedTech leaders discuss what makes a team, how to build trust, break silos, and lead across large medtech organizations.
Summary
The session began with informal pre-call chatter, technical setup, and introductions from attendees, including Steffen Ruschinski in Germany and Ian Tovey, who described 41 years in the medical device business. Sean Smith framed the topic: what it is like inside large medtech OEMs and what teamwork looks like there. Monika McDole-Russell and Angelina Lisandrelli then introduced their regulatory careers at Medtronic, J&J, Teleflex, and Philips. They defined a team as people pulling toward a common goal. Angelina added camaraderie, culture, and a shared philosophy, noting that a goal alone can coexist with dysfunction. Participants discussed trust-building: listening to understand rather than to respond, sharing the grand vision, explaining requirements and regulatory context, and letting people carry out their ideas. Jose Bohorquez and Leonard Eisner connected vision and requirements to commitment and design decisions. The conversation covered silos in large organizations and the difference between managing and leading. Monika said leaders must work across silos and set the tone; Angelina described sharing information consistently and holding one-on-ones with leaders. Paul D'Souza shared listening to frontline employees and using their insights; Monika emphasized one-on-ones and psychological safety. Sean argued that managers who think they have nothing to learn are often the worst, and that leaders set the tone. The session ended with Paul asking for guidance for consultants.
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Transcript
Edited for readability: filler words, false starts and Zoom housekeeping removed. Times run from the start of the recording.
One John, now.
On my bar.
So it's the weekend so.
Minimize. I just updating. Oh, last minute, people who I don't know can't get in make sure that.
Will you edit this part out.
Yes.
Who's can. Would you be able to send me a list pending.
So afterwards. Yeah, I can send you a list absolutely, absolutely. Let's see who.
So rainy here in Minnesota. It's been raining for this.
Is coming here tonight.
Oh, it is!
Yeah. It's gonna rain all weekend.
So then if it comes to California first, st it always well, I don't know. It's a that's Southern California. We will see to say Ankara.
Do it.
You said you had a cough for a while.
Let us see!
Yeah.
See Angora Chinquisitti mane.
Did you get Covid.
No, I don't know. It's cause I smoked for 20 years.
That, too. That could do it.
But I quit 20 years ago.
I know. But the damage is there, Shawn? I mean it's good that you stopped. But the my husband he's been smoking, and when he gets a cold it burns for him because it's just hard.
Right.
Hmm! I have some books to give as examples, too.
I like it.
Yeah.
Everybody's gonna join all at the same time. And then I have to promote everybody to panelists like it's like, I'm gonna be like, you know. always happens. I have to get a I have to get a helper.
Don't you have your nephews that you can ask.
Yeah.
Or maybe you can have one of the, you know there, there is the frequent ones that always come. Maybe you can always ask them to help.
That's true.
Yeah.
Here they come!
Hello!
Hello! How's everybody?
Doing well, how are you.
Very well, thank you.
Morning Monica.
Hey Angelina!
And everyone else. Hopefully. It's morning for you guys. I hope you know I don't know where everyone's calling from, but.
Stefan, why don't you introduce yourself.
Yes, for me. It's 7, 8 o'clock in the afternoon. I'm sitting in Germany.
Good.
Very hot.
Yeah.
What part of your main.
Pardon.
What part of Germany.
North Wind, Australia. It is a very, very small city that nobody knows. but probably may be somebody knows Cologne.
Yeah. Oh, okay.
And do you know, do you also know Frankfurt.
Of course. Yes.
And when you put a line between Cologne and Frankfurt just in the middle, there's my place very, very small city called Netflien, because nobody knows.
We know the secret now.
Yeah, I love it.
Quite in the middle, totally in the middle of Germany.
Nice to meet you, Arlene. Aline, do I say your name correctly? There.
Arlen.
Yeah. Thanks.
Hi leo!
Good morning. You're Angelina. I'm only gonna stay on about half an hour.
Okay. Well, good. To have you.
Support Angelina.
Oh, and Shawn and everybody.
You.
Okay, everybody's joining all at the same time. Now.
Hi Michelle, Mark Victoria, Julia.
So I'm trying to keep up with promoting everybody to panelists. If you don't want to be on camera, just decline. If I happen to invite you twice. I apologize, but it's not intentional. It's that there's no systematic way to do this. And So I'm just trying to keep up with all, everybody joining.
Is that an automated way for you to do that? No, I I need to get a helper zoom. People need to zoom. People need to write a script for for.
There's a way you can do that when you set up the zoom call. I don't know whether you control that in the settings. so that everybody gets to get in and even have to do that. There's a button that put them in a waiting room, not put them in and waiting, and then everybody could.
Correct.
Oh, I see. Well, so the plan is to switch over to a call format where everyone can raise their hand and speak. But the like a like. The problem is with Webinar. There's there's drawbacks to both having it set up as a webinar, and having it set up as a as a as a call. So it's like neither. Neither one is particularly perfect. So we're we're we're working on it. And we're working on the transition But while I'm promoting everybody to panelists, do we have any 1st time callers on today
that maybe would like to say Hello. no.
I think Jose is a 1st time caller is, can I? Can everybody hear me? This is Ian Tovey.
Yeah, see you in.
Hi, happy Friday, everyone.
Happy. Friday.
Ian, where are you calling from?
I'm calling from St. Augustine, Florida. and I don't sound like it because I'm British. There you go. That's all. I'm gonna say, I have my. My background is a whopping 41 years in the medical device business. Starting from the early days of stapling devices, laparoscopic devices, orthopedic devices. You name it. I've done it.
Wonderful.
And about 10 years ago I kind of switched over to the regulatory quality side, more focused on Qsr. And and quality manuals and that kind of thing so well done 41 years in a nutshell.
I don't know, and I mean I with the Buddha and Mark Twain. I kind of want to get to know you better, you know. Sounds like it looks like you're a fascinating individual.
Mark Twain was brilliant. I used to be a member of his house in Hartford when I lived in Connecticut. I moved to Florida 8 years ago.
Cool.
Thank you for finding me interesting. Mark Twain just fascinates me because he was such a stoic character, right from his telling his butler to tell people he'd stepped out, even though he'd just stepped out onto the balcony. I like that attitude.
On Linkedin. If we, if we aren't already connected, let's connect, and we'll we'll have a chat.
Okay, perfect.
Yeah.
Okay? So while I continue to allow people in. Let's let's start with a general question which I have. How many of you have worked for a large oem, a large medical device manufacturer, and you can just put yes, in the chat, if that's the case, or how many of you have worked for one as a consultant. and then you can put a C in the chat for consultant. And this is my low tech polling technique.
Hey Sean!
Yeah.
When you say large size is by number employees or by the revenue.
Take your pick, I mean, really, you know, would would you see their name in the top 50, you know. And And yeah, I mean, because the reason I ask is that today's speakers, come to us from top med tech companies and are gonna offer us the perspective of what it's like to work there, what it's like to work your way up the ladder there, what it's like to be in senior management there. What it's like to work with consultants there, you know. Just sort of the range of experience, so that we can get a flavor of you know. What's it like inside the castle? I think that as vendors as consult as vendors consultants, you know there may be, there may be some misconceptions about how many resources they have and how easy they are to come by. And you know any number of of other things. So it's
I mean, I find that the employers that I've had in the past, and clients that I've worked with in the past have said, Oh, if we get you know, name the company as a client. We're going to be golden. We're going to be set, and you know, or if we could, just, you know. if I could just get a job there, then my life would be perfect. So you know, myths, realities. illusions. You know, we all have our own ideas, but they're gonna Tell us firsthand what it's like, and with that I encourage you to raise your hand. If you have a question or you know you know the drill, so thank you all for joining. I'm going to turn it over to Monica and Angelina now.
Thank you both for coming.
Thank you for having us absolutely. This is something that we're really we've been looking forward to. Angelina and I work together for years and are still friends, and we enjoy riffing off of each other. So yeah, I'm so I maybe we start with introduction. So Monica Mcdoll Russell. I am in the process of exiting Medtronic and at Medtronic I was a senior director of regulatory affairs for the endoscopy business unit so led the entire global enterprise for endoscopy in terms of regulatory. Prior to that, I was in the peripheral vascular business unit of
medtronic and kind of just going back down the line. I've been a tarumo interventional at J and J. At Teleflex. So I'm really kind of a big company girl. That's where I grew up but I also have experience with startups and and small and medium sized companies. So it's I've been in med tech almost 20 years now it's been an incredible ride. I hope to be here for many more years, because I'm not done yet. And I, this is this is the type of thing I love to do. Now I love to just share experience and share knowledge, and just any opportunity I get to do it. I I love to. So thanks, Sean.
And I am Angelina Lisandrelli. I see some familiar faces on here. I'm glad to see you guys again. I like Monica, said her, and I shared actually worked under Monica's leadership several years ago. And you know she is a mentor to me. So I always looked up to and acknowledged how her leadership skills have shaped my leadership skills at Medtronic. Prior to that I'll start from the beginning. I graduated as a chemistry major went into a lab started doing formulations for dow pharmaceuticals. Then, you know, went from R&D. To Medtronic, and I stayed at Medtronic for majority of my career at least 13 years.
and I worked my way up from going into a Gmp lab developing analytical test methods, then kind of having a quality role, then getting into validations. And then someone's like you got ahead for regulatory. And I was like, Okay, what is this? And that's how I went into regulatory. And ever since then I love regulatory. But what developed out of there is a belief of helping grow people and telling kind of people that they have this potential inside of them. And so I did go into people management. When Monica and I met I was an individual contributor. But when Monica left the Pbh organization. You know, she had a role that was a people leader, and so no better person to go into people leadership under her guidance there. And I don't say this with lip service. I say this as someone who admires Monica, and how she emulates good leadership inside the organization.
The from then on I moved out of there into an individual contributor role. But it was not necessarily an individual contributor role here at Phillips it was the head of regulatory file reviews. So it was basically taking those learnings and then plopping myself into any business like a parachute, and helping those that had never done submissions or looking at submissions and helping bring teams together without authority, which we'll touch on. This later again, is probably harder to do then to be like with the title right. And so after that, I am now currently the director of regulatory and quality, because one business unit said, You know what we really need you as a permanent fixture here, and that's where I'm at. I'm still at Phillips, but it's called S. Protect Phillips.
That's a nutshell.
That's great. So the topic that we chose for today's discussion is team team building teams. And you know, I think that your combined experience? As well as the people on the call. This ought to be an interesting discussion. But, like, where where do? Where do we begin. What is a team, you know, like, I mean, like. And you know, I'm we have this problem in Med Tech. What is a community? You know what you know, what what is. you know. And so, yeah, hit it.
So I would like to see if everybody's definition of a team is here on the chat. So type what your definition of a team is from your perspective, is it with someone with a title? Is it an organization? What do you think is team? Monica? I'll let you go 1st and answer that, and then I can follow up.
Yeah. To me, a team is a group of people pulling toward a common goal. And that's pretty basic definition. But that's what I consider it. Yeah.
I see the same thing. I always like to bring the Eq. Aspect to it. So yes, you're at a common goal, but you share a camaraderie. You share culture, and you share a philosophy that cohesively works together. Because if you do not have that, you can have the same goal, and how many, how many of us have experienced reaching a goal? But there's dysfunction. Is that a team.
No.
So you have to kind of combine both. They have to have a defined goal. Yes, absolutely true. But do you have that collaborative cohesiveness that synergizes and meets that goal, and it doesn't have to be within. In my perspective, a person under a title. or even as you guys, majority of you are consultants. You're considered part of the team, too. There has to be some sort of cohesiveness and philosophy that works in there. Ian, I cut you off there. What were you going to say.
No, I mean, my background over the past 10 years was. has been going into as a consultant, has been going into companies of all different types and sizes, and basically auditing the quality system which should bring people together as a team and finding the ins and outs of where the system is failing, how their people are adapting to it. And just when I step into a situation like that. I want to create a team. So that's my, that's my 1st goal is to put people around the conference table and see and examine everybody's attitude towards
what a team should really be. That's just. That's just my philosophy. Without the team. You're not going to accomplish a whole heck of a lot, or if you are, it's going to be Kappa, written 483 written. You name it. So I just, I, I like to go into a company and say, Okay, I'm here as part of the team. Where do we start? You know that's that's my, that's my teacher. Aspect of being me.
Yeah, I think even, you know. Certainly. You see it in big companies, and and probably to a certain extent, smaller companies. When you are in one of those situations where you're trying to bring a team together. There are going to be different members of the team right? Some have just joined. Some have been there for a long time, and there's a lot of this going on. It wasn't me. It was them.
Yeah.
And you know I I did not make this mess. I this was before my time, or you know, or a defensiveness of this is the way we did it. And it worked then. It works now. And you know. So it that that's the complexity of a team, right? Especially in a large organization where people do move in and out. whether it's through businesses or just kind of moving to you know, between in and between companies. There are so many different personalities and no one team. I think it's very rare for a team to stay static for any length of time. And so that's that's a big challenge, right? That I think you're touching on and is.
how do you get that cohesiveness in a team?
Right? Well, I mean, 1st of all, just the main factor of having management buy in on the whole situation is key. Now I've had. I've gone into companies where I've gone into people's training records and upper management haven't been trained. So that's a whole other subject. But it is definitely management buy-in. That's the management team that's got to bring the team together. I'll be quiet now.
Great discussion, though.
I see a comment from Alan. I actually have the book right next to me.
It's so.
Relevant to this day. I think. Oh, thank you, Sean, for putting that in there but if you want to really break it down. I think at the end of the day when I come and join a team. And even in that kind of thinking of the head of regulatory file reviews role that I had. It was almost like an internal consultant coming in. How do I show up on a team? Is really how.
Then.
The ripple effects of that team is going to perform.
Leadership.
And I think everyone should have some sort of accountability, not just from a management perspective, but from how you're showing up in a team to help leverage the management's ability to turn the team. One of the harder things that and I liked. I kind of like challenges. If you tell me there's a mountain. I'm like, great. I like it. I'm gonna do it great. Let's go. So what was one of the benefits is walking into teams cold and seeing if the same sort of tactics or fundamentals would work with the team.
Okay.
And the 1st thing and foremost is building that trust. Right? So my question to you guys are, what are 3 successful ways that you have done to build trust on the team immediately coming in cold. Because, Ian to your point, you can't be just pointing out things and saying, Well, you don't have training trying to do that. You turn into public enemy number one on a team.
So.
How did people build trust with their teams? And let's see if you guys come to the same sort of aspects as what Monica and I experienced.
Sure. Yeah.
Somebody needs to mute. Thanks.
Yeah. So I would say, like one thing that I anytime I work with people, especially if I'm bringing them into a project that I'm doing is like hearing them out. Allowing them to have ideas of regard without my without too much of what I'm thinking or what I have in my head. allowing them to speak it, and then also to carry it out to some degree. So whether it's a good idea, or if it's not a critical failure. Kind of thing, you know. Obviously say something, but if it's an idea that they have, let them carry it out and see how it plays out as them inputting into the team because people. And if you give them the chance to say, Reflect, you know, we say, let's reflect on this. See how it worked, whether it was good or bad. You gave them the trust you said I actually trust you. I believe that you can do something and then usually they want to reciprocate. And then, now you you've created that exchange, that that conversation is now initiated.
Absolutely, what else?
I really actually just to to break in for a second for Amir I that what you said about listening is just so critical. It's so. Oh, so key right there. It said that there are 2 ways to listen. Right? You listen to understand, or you listen to respond. And I, whenever you're a member of a team, I don't care if you're the associate or the senior director, you should always listen to understand, because listening to respond is basically not listening at all. It's okay. Well, what am I gonna say next after this person, you know, after this person's mouth stops moving. So.
Yeah, that's that just shows ego, which I think like takes you nowhere in a team. To be honest.
Yeah, yeah, no, very good. It's a good call out.
What else? How do you guys? All that was a wonderful example. Amir. What else can show trust on a team?
Jose.
Yeah, no, I've I know. it's always helpful as a leader to think back to when you weren't in the leadership role. And one of the things I always appreciated was leadership really sharing the grand vision, sharing the overall goals so that you don't feel like you're just doing like a small thing in a very pigeonholed area, but rather that you're part of a grander objective. So you know, now, being on the leadership side, that's something I always try to do is make sure the team understands. Hey? Here's where we're trying to be in the next 5 years, you know, at the Grand level. And here's our approach to it. Here's our strategy, and then kind of at the micro level for this project. Here's what we're trying to do. So it's not just.
you know, if you're leading an engineer who's doing a embedded software for a particular system. yeah, sure, you can just give them requirements and an architecture and say, Go, build this, but there's just going to be a different level of commitment and ownership if they understand the grand vision. you know one, and and something that I saw in medical devices. One of our clients. At some point I saw they did this as a women's health company and at board meetings. They would bring one of the patients who had benefited from the from the product. and then they would also do it at like, you know, kind of staff meetings on a fairly regular basis. Just to kind of allow people to connect. What are they doing on an everyday basis
to the, you know, ultimate outcome or impact. So yeah, just generally that that sort of thing.
Leonard, you have your hand raised.
I need to change that to Leah. I don't know why it keeps coming up with Leonard.
Neil. Sorry.
Same on you, son. so a lot of our projects. People come in late to the game always wanna like Rush Rush. We're like ready to submit. We late for testing. We're having problems. So they're very reactive. So sort of writing on Jose's comment, knowing the grand scheme of where they're at what they're trying to accomplish. You know what their sort of market scheme is understanding. That helps a lot. But then, also explaining why certain requirements are there, and how they interconnect with guidances, and how the regulator is. Gonna look at it trying to explain that helps them understand what are the more critical issues. What are the lower hanging fruit that you might be able to deal with later? And also looking at the bigger picture of design?
Are you gonna design just for the Us. Or are you looking at the grander scheme of around the world in certain markets? It's better to design altogether versus piecemeal, because then you're redesigning over and over again gets expensive and more time, etc. How do you want to approach it? We ask a lot of those questions during the process.
That's an interesting point, Leo. And one thing that I've heard over and over again, and Angelina and Monica feel free to speak to this without naming names, but in larger organizations, the concept of silos and silos not communicating with one another. And they're not being a consistent thread running through product development from early stage to commercialization. And so the grand vision that Jose spoke of getting lost in the process to the minutia of each department and and their individual things. And even Monica, you know, you spoke of being in charge of different business units and the different business units can function like completely different companies.
Yeah. in in the, in the largest of manufacturers. So I'd love to hear both of you speak to that vomit that I just did.
And do you wanna go first? st I'll go after.
No, no, go ahead. Go ahead. I'm kind of gathering my thoughts about that.
Yeah, I mean, I think it. It's that that happens everywhere, right? But it definitely does happen. Happens a lot in big companies. I think silos are just sort of inevitability. In some ways right? People are focused on their function on getting the work done and getting the job done on serving the patient. And so it's almost an organic outgrowth of that on that singular focus on what they're doing. And and I there was a great mention. Oh, Arlen mentioned Balancing being a manager versus a leader, and so I think it's incumbent on leaders to help work across those silos right? We'll probably never break them down. But if we at our level are able to work with our cross, functional partners, work, those relationships, develop them, build that political capital. Then it's going to make it much
smoother when we have to move across and into those silos together, whereas a manager we have, you know, we've more. We're more boots on the ground, right? We have to be with the people, helping the people understand and and executing the work there is work to do in terms of moving silo to silo. But I have felt, as I've moved in my career from management to leadership, that if your leader doesn't help at the highest levels with the leaders of those other. You know, siloed functions. Managers can work as hard as they want, but it's got to start at the top. So I think that's 1 key thing, being manager versus a leader.
So Ange.
I think, totally agree, I think. We're I have kind of took a hot knife to butter to silos is by when I meet with one part of the team or one kind of function. I try to share the information that they've shared with me openly. and one of the things that I do is that I do that consistently. So when people work with me just to highlight on the trust, they can trust me for sharing information and breaking down silos. Sometimes I've been pulled into difficult teams to kind of not tell them directly that that's why I'm there, but more to show them how they can naturally create
collaboration across that I don't want to call them out and say you're talking in a silo, because what the what happens between people. They start closing down, and they become almost like rock, solid rock, solid silo. And you're like, Okay, I've just screwed this up. So the way you have to come into it is almost like, Okay, let me overshare now. The other thing that will happen, too, is if you overshare too much to leadership stakeholders up there you become noise. And so that kind of middle management is very difficult to learn, unless you hit every road or bump in the road to understand. When do you need to
break that silo from the top level? And one of the 1st things I like to do is actually have one on ones with the leadership and understand their communication style? When do they want to communicate, and what stakes do they need to be aware of? So if you can bridge that, you're not only breaking silos laterally, you're breaking silos above, and then you can see the cohesiveness naturally into Monica's. A point organically develop in a team, and this doesn't have to be a manager. It could be an individual contributor. It could be in a consultant, too, because consultants sometimes get pulled in meetings with leadership as well. So that's my 2 cents. There.
Thank you, Paul. I believe you had something you wanted to add.
Yeah, it did. It was too much to type. So so many years ago I took over, as I used to turn businesses around and took over the small 2022 gave me a size company that made spectrophotometers. And one thing that worked really well for me is a combination. You know, the native Americans have this thing of the talking stick I literally brought in what? What people the biggest problem they said the employees had was, they were not heard. Right. So, and I walked in acknowledging I was the consultant. Like, guys, I don't have the corporate wisdom. Let's have a conversation about reality from your perspective. And it was amazing all the wonderful things I did to grow the business. 60% came from the employees.
Right? So one is, listen. And then the other thing is trust the team and you. And what I did was I used my expertise to to put up the guardrails because I had the business perspective right of what would work to shift the whole company. But they own their space, and out of 22, 2 of them hated their jobs. and so we could they. I helped them get another job and hire and train. The next person. Move people around. One of them said, Hey, I'm in customer service if you want. I can ask, you know, in a sense of they want fries from that. My point is, fries with that, and we made customer service a profit center. I didn't come up with those with those really cool ideas.
and I've done this in it. I used to write. I've done worked with Striker in the old days we were running hyperbaric chambers when they 1st came on. 94, 95 man, I tell you what? Asking the question, how would you do this? And stepping back? And then, as a leader, or of a group, or a team, however small or big, is then take the ownership for direction, but allow people to be heard. I just thought that was something that you don't see much in here, but much in team. So.
I just wanna tack on to what you say. One of the key elements of building trust in a team, and especially from a high leadership standpoint that I think many leaders at that top level now, granted they might be busy, is going down to the lower level. The people who are on the ground and saying that I see you, I acknowledge you, and it's not just through the survey results. It's actually not even like giving a gift card, or anything like that, just acknowledging their presence, changes the momentum.
Totally.
And I've heard actually some regulatory leaders that still that have been in their roles for 2 years, and they're not at executive level. But they're almost like at the higher Level senior director that still have not connected one on one with everybody on their team. They're like we've never had a meeting with them. and I'm why would I want to work for somebody like that? Why would I want to go the extra mile on a team like that. And I think that's key, Paul, what you're calling out. There is a huge nugget that I don't know where it fits into the whole management. But I me. It's just being a good human and recognizing the work that people are doing under your.
You know, and I'd I'd like to load it. Really. Also, what comes back. You know, one is, yeah, it's socially. There's an emotional value of listening to the people, feeling heard right. But from a business standpoint. I this this conversation, you know, triggered another memory was working with the company that did heart monitors, the Irv pacemaker, just checking the heart rate sort of a medical device new product launch and all. You know, new products always have problems. The guys that were. I went and sat with the guys that were in the warehouse. I was running the supply chain. getting the returns
and unboxing the returns and looking at how things with the product made a huge difference, and then testing it on site with the product that was returned, and then bringing that feedback and their insight to the the Dev team and the and the owners of the product of the you know, the product managers was tremendously valuable that was not in any sop to listen to the guy in the warehouse who's doing the testing and receiving the returns.
Yep.
And there was no way to document his insight, his or her. So the 3 people so, anyway. So that's that listening. And and then actually, using that information and creating the metrics and the system and the processes. That's a leader's role is, how do you mind that data.
Well, you know now the word came up. Relationship building is the key. and it shouldn't happen with your executive colleagues. You can. You can schmooze all you want over there. But really, I think making yourself available to the people that are supporting the mission and the goals is is fundamental. That's your foundation.
Well, key to that is just remembering that you know you're not a leader unless you have a team. I mean doesn't matter what your title is right. If you don't have people under you doing the work and serving the mission, you're just a bunch of hot air. So yeah, I mean to to the points you know. Angelina and Paul have been making. It's critical that the leader leads. The point is not to be in the big chair, you know, and as Angelina was saying, schmoozing, although valuable relationships are built, I have to say, Angelina, at the executive level. But no, it it's it's getting down to know the team. And that's why.
no matter how large my team has been, I've always made a point of having one on ones with each one of them at least once a year, depending on the team. And if it's a smaller team, then more often than that, because that means so much right. When I was an individual contributor. I never had one on ones with my senior director or my vice President. It just didn't happen right, no company that I worked for. So for me to sit down and give. Give each person 30 min and say, What is your experience here? How are you doing? How are you feeling? And it's it's critical. It's critical. And it's it's pivotal to the team.
I think it really helps so definitely, definitely relationships matter. I think Arlen is not on anymore. But he had made a great point about psychological safety, which I think is, you know, it's in danger of becoming a buzzword. But it's very, very vitally important, particularly when you're looking at the workforce that we have now, which is intergenerational. It's diverse in all the ways, right in terms of race and sexual orientation and education, level and age, and all of these, you know, religion and all of these things. That
could really help bring out critical contributions. You know everybody has their own worldview. Everybody has their own unique contribution, and if we invite people to share who they truly are, rather than say, you know you must be a Medtronic minion or a Phillips minion, or you know you must be stamped out of this mold, if we welcome in the uniqueness of every individual, and and make it safe for them to be who they are. I I that's that's huge. Right? I have been in teams. where there was no psychological safety at any level, and nobody wants to stay there. Nobody wants to be there.
We spend so much time at work. If you're if you don't feel safe. you're not going to give a hundred percent of yourself to anything. So I love that darling brought that up. Sorry we couldn't address it while it was here.
So I've had an interesting experience. I worked for 27 years at various size companies, from Elsevier being the largest to a startup, and I have managed teams from 0 people under me to 12 people under me. As a Vp of marketing chief marketing officer, various different functions. And since I don't work at any of those places anymore. And I'm not naming names. I'm more free to talk than perhaps some others on the call and what I'm able to say is that in my experience many of the managers that considered themselves good managers were the worst.
and the ones that knew that they had room to grow as managers, the ones that understood that nobody does this perfectly, that there is no formula for managing people that is going to carry across the board. Those were the people that were more honest, open, and accessible than perhaps the people that just assumed that because they had the corner office, that they were good at their job, and those were some of the worst, and what I saw as consistent flaw among them was that they went straight to discipline and firing. Oftentimes what I saw on a lot of the smaller companies was a revolving door on sales, they would say, Oh, we're going to go out and bring in this rainmaker. And then the rainmaker never materialized right? There's no such thing, and they would get disappointed, and they would give up what they didn't.
No was that their onboarding was insufficient. Their training was insufficient, their ability to empower the person to make decisions was insufficient. And so to the point that I think somebody else made. Ask the people that work there. They know where the friction points are, but they didn't ask my opinion. They would just scream louder at the person and be like you're not doing. You're not meeting quota, you know, like something like that, you know, and so I mean to me. It's like now, owning my own business, managing my own team. I see very clearly that I am the rate limiting factor in my own company almost all of the time. Right? I am the bottleneck. I am the problem right, and it allows me a perspective on the companies that I worked for to see just how much the personality of the team leader can interfere with the growth of the team. And so that's my experience. I just wanted to add that.
I think you're completely accurate. Right it it's the tone at the top. and it goes all the way from the CEO of the company all the way all the way down to the through the managers, right? And you can change and flex things a little bit within a company culture. But yeah, it is. It's generally the leaders who wind up, setting the tone and maintaining the tone and setting the culture. And you know, I think there have been just a ton of great comments about really really perceptive things, finding the connectors within a team, and listening. And, you know, leading with intention. And
these are all. These are all key things that we all need to to keep in mind. No matter what role we have, and no matter how many people we leave, you know to your point, Shawn. Later on.
Got a question because you Monica and Angelina, you you're the wise ones on deck today. You opted in right? So a lot of consultants here. any guidance for us, because I've been in this position. So as good as that grew the company, 60%. I got fired on my way to a meeting. They didn't even let me come in, they said, you don't need to come in anymore. Right? Do you have any advice, guidance for us. Consult a lot of consultants here, and how to come into a hostile situation.
Where we asked to work with the team. But the team doesn't like the assigned project because of all the bad blood before any guidance on that.
And it just could be stories. But I got a few minutes, but I wanted to just ask that question.
Yeah, I mean, I I would love. I would love for Angelina to to pipe in here, I can tell you. I started my medical device career as a consultant helping a company through a consent decree. So I came in with 30 consultants. Literally it was a herd of consultants, and we were just pointing out right and left what what everybody was doing wrong, and the teams hated us. Of course they hated us because we're telling them their baby was ugly, essentially, and telling them, you know, we we have to fix this, and we have to fix that and all that sort of thing. And what I quickly learned. And it's something that has stuck with me throughout my career in medical device is
we are on the same team. you know, and the 1st reaction is going to be, yeah. Well, you get paid a hell of a lot more than I do. But we are not here as a consultant right. I am not here to tell you how wrong and bad and whatever you are, I am here to share the information that I have the knowledge that I have, and to help you fix the problem. It's not. There's no blame there should never be, you know, naming somebody shaming anybody. No departments, you know, just we have a problem to fix. And my number one goal is helping you fix that problem. How can I do that best for you. It's it's always, you know, making it about them, about them, about them
rather than Hey, look at me. I'm a consultant, and I'm going to tell you how badly you screwed up, and I'm going to charge you for it.
So that's my recommendation.
I I agree with that. I resonate with that. I think we're. I've had an R. And d person yell at me on a call, saying, You're coming in and ruining everything because the ras on the call they had never done a 5, 10 k. This was mandated by the FDA to do, and they were steamrolling her. And when I come onto calls I'm very quiet. I'm listening because I want to understand one who are the connectors. Who are the disruptors. I start reading the room. Now the disruptors. I take notes and go. Okay, why are they upset? What this disruptor was upset about is.
I had requested that every R. And D report goes through regulatory for review. What had happened historically, is that R. And D. Reports never went through regulatory. They were just submitted blindly before. And so that's a risk to do from a regulatory standpoint, because you don't know if the results are failing such. So when this came up that all reports will go through regulatory. this was the comment, and this man was yelling on the call. I don't match that energy when people are yelling earlier in my career, can I say that I did absolutely later in my career I talk a lot quieter and the quieter I get.
It calms the room that's already hostile. I want them at the level that I want. and 2 I am able to clearly communicate what I need from him. And so what happened was that we were all going to review the reports, and I said to him, Are you ready to sign that you will not have regulatory review, and that I'm able to share this with upper leadership. And I said this in the court team call because he had broken psychological safety with everyone. And so I had to bring some sort of psychological safety back and go from a regulatory standpoint. You're always judging risk from a consultant standpoint. You're judging risk. How can I bring a solution? Okay, if you don't want that, and you want, that's the solution. This is the risk high risk. Let's escalate to leadership and know where it stands. It's clear, transparent, and accountability is already built.
He changed his mind so regulatory, got to review all the reports, and this person who had never done a 5, 10 K. In her career. Brand, new, young, 20 year old. had no AI letter, no interactive questions on the submission, because she was able to perform and do her job correctly. You are going to deal with different personalities all the time you have to match your energy at where you want them to be. You cannot come in at full fire, and that's where I'm very focused on Eq. Here because we are very technically sound across our our respective functions. That is never a question. And when people get agitated they feel personally tact. And I want to know that I see them, and that I don't want them to feel that way.
And so that that's key is, can you measure somebody's Eq there too, and provide solutions and provide what that risk looks like. Transparency.
Thank you. Yep. Makes sense.
There's an interesting question from Julia. What is your experience as consultants and being accepted by teams? I'm gonna go ahead and say that when I go into a company with a lot of with a full fledged marketing department, I always say they don't want me in their house. you know they they do not want another marketer in their house. They resent me being there, and the way that I handle that is to let them know that I am there to provide them with additional bandwidth, that I am there to do what they don't want to do, that I am there to assist them in getting to the next level, and that I'm leaving, and that I don't want their job.
and I think it's really important as consultant to let people know. I don't want your job. I had your job for many years, and that's the reason why I'm a consultant now. I don't want it, you know.
Thank you.
I think, to tack on to what you're saying. There, too, I work with contract manufacturers. Let's just say it's just a bigger consultant, right. What I try to do from large manufacturer to any consultant is kind of give insights that help their them grow in their career. So i 1 recommendation as consultants. You guys have ability to see so many different types of medical devices, so different, many types of Qms, so bring different solutions that are easily accepted into large manufacturers, and I will guarantee teams will start taking these. I don't want to call them breadcrumbs, but they're almost a little bit amuse bushes that make people more welcoming, inviting into a team
to the point where Shawn is like, Yeah, I'm just here for a short period of time. But let me let me give you something that is gonna be worth your while. Not just a deliverable here, but something as a professional development that you can bring to the team.
I love that you said Amuse Bush. Thank you.
The taste. It's not the whole cake.
Excellent, excellent point. There was a question in the Q. And a no, I guess it went, and it was answered, how often do you recommend to have one on one with direct manager.
With a direct manager. You should have a 1 on one every week, as far as I'm concerned. That's what I always do with my direct reports. It helps keep everyone aligned to the same goal, especially in these times, which are turbulent, which are changing in every company. Right? I have friends who work in in all the major companies, medical device companies, and and they're all seeing the same thing. Budgetary limitations, upheaval, changes in leadership, reorganization of departments. And so it's key to keep your direct reports in really close alignment with with you, so that you're all, you know, saying the same thing.
Singing from the same hymn sheet, as they say, and because otherwise it can. You can drift. You know there can be a little bit of drift even in a week off course, if something critical happens. So whether it's 30 min, whether it's 45 min with direct reports I meet every week, I make that a priority.
So you touched on something really interesting to me in that you're talking about the amount of change that's happening in the world right now, both within corporations, outside corporations and with the larger issue of digital transformation, the introduction of AI and the nature of people's jobs changing and or being eliminated altogether, particularly with things that are being replaced by automation or digitalization. You know, what are you seeing at the highest level with regard to the shifts within organizations toward.
We can just get AI to do that.
Yeah, I I mean, I think that there's a lot of there's a lot of panic around that. Some of it is justified, and some of it isn't you know. I I think everyone just glancing at everyone on this call. I don't think that we'll see a complete AI takeover in our career lifetimes. I can't speak to what will happen in the future, but at at the level I am, and and my, you know friends and other companies. We are looking for AI as an aid. Right? And frankly, I think there's more risk to people from
You know, things like like offshoring, like moving jobs from the United States to other countries that are more affordable from a budgetary perspective. But that's kind of been going on for a long time, I mean in it, if you look at it, they've been offshoring forever and ever and ever. And now I think the pendulum is just swinging to medical device where people are saying, Oh, wait a minute. We could have this done for half the cost. So I'm seeing more of offshoring being like a risk than AI right now, at least across the companies. The the 4 major companies that I have contacts in. That's AI is only a help meet for us. We we are looking for the advantages of of AI helping, not replacing at this point.
I think it'll come, Panaya. So, Angelina, what have you seen? I don't know.
yeah, I was actually on a panel last week with distiller, Sr, about a tool that they have, that they use to help with literature searches, and it is so impressive. And the medical writing team that does the Cers for Mdr submissions. I mean, it really takes the edge off on their work. And again. burnout is the key here. where AI can really help with companies, I think larger companies have to unbalance the act of lowering their bottom line to Monica's Point, offshoring to different things like places like India, Costa Rica. We've seen this shift, but how can they prevent the talent that they have
from leaving a company, and the way is bringing in kind of tools like that from distiller, Sr. Where they can help with the Literature review, help with streamlining that process and taking the edge off of doing 20 cers in the next 6 months is super valuable again to Monica's point. It's not going to replace people. It's just going to take the edge off of their work right now. I don't think AI, from what we understand, AI is is sophisticated enough to replace a person. Yet you can see that, you know there's hallucinations. There's things it takes a lot of money. I was watching Nvidia earlier this week about things that they're doing. And they're saying, oh, we're here.
I want to see it. I really want to see it, because I don't think we're there yet. There's too many hiccups with AI.
Yes, so we are nearing the end of the hour. If you have questions, or would like to reach out to Angelina or Monica directly. I encourage you to do so, and I just wanted to put in a plug for next week. I put it in the chat. Elvio Grimignano is going to be speaking next week on digital marketing for oems and contract manufacturing organizations. And so really, we're deep into commercialization next week, and and in the commercialization process. And I think
that is a topic that we haven't really covered before, at least not in recent memory. I think that'll be interesting. I also wanted to point out that I have speakers for the next 6 weeks. I my sense is that there's really no point in having a call on July the 4.th I don't know if anybody agrees with me on that but Stephan, July the 4th is a big holiday in the United States, perhaps one of the biggest non Christian holidays that we have. So it's and so I'm I'm thinking of skipping that. But then on the 27, th Stefan is gonna be speaking, and he's gonna be speaking about Cr, and related topics. Stefan, you wanna say something about that.
Yeah, but not too much already. Here I am pleased that I get the chance to talk about. My topic will be that I try to. Will I try to explain you? How can I write cers for Mdr. Submission the easiest way? How can I be sure that I get enough clinical data, so that the Cr is accepted by the notified body. And how can I avoid the biggest pitfalls I will present to you the biggest pitfalls from insights, from notified bodies, and from the manufacturers, from the responses of notified bodies. And maybe this can help you to avoid these things.
Maybe this can encourage you to also market already, FDA approved products in EU, and I'm looking forward very much to this, and thank you, Sean, for getting this chance.
Wonderful. So then we have the next 3 speakers after that lined up. I would like to point out that I will be doing a masterclass next Wednesday. On, really the managing where we are. But really taking your expertise to the next level, the main focus of this conversation is that we need to help each other. And so that ties in nicely with today's theme of working as a team, and that even though we're all individuals, and that we all come from different organizations. I think that there is something to be said for working together, so I hope that those of you that are able to will join me.
and if you would like to be a speaker, please reach out to me and propose topic, and anyone who has already joined Medtech leading voice exchange. We sent out an email yesterday. I hope that you got it introducing the new community manager and the new publication that we're going to be launching. If you would like to publish in the new publication, please send me or the editor a message. and let us know what you would like to publish on this publication will reach over 10,000 people. And so this is an opportunity for you to showcase your expertise in front of a larger audience. I encourage you to take advantage of this opportunity. We'll be publishing every month going forward. This is a crowdsourced publication. So that means that I'm relying on all of you
to get your acts together, and not just think about writing an article, but write an article and submit it. 800 to 1,500 words is great, but you can also write shorter ones. I'm also planning on doing a Qms. Top 17 or whatever number we come up with, and this is going to be a crowdsource article that I'm going to request contributions to From from the members. So it's there are a lot of speaking publishing opportunities coming your way. And yeah, just the goal is to make your expertise shine. With that. We're 2 min over, and I would like to thank our speakers again. Monica and Angelina. Thank you so much. Clap, clap, clap, clap.
Thank you. Guys.
Thank you.
Thank you. All appreciate it. It's a great time.
Better run. Thank you again.
Take care!
Take care bye.
Bye.
Alright!
Smith S., McDole-Russell M., Lisandrelli A. Global Team Building Lessons from Top MedTech Manufacturers Featuring Angelina Lisandrelli and Monika McDole-Russell. MedTech Leading Voice, Friday In-Focus, 13 June 2025.