Episode Transcript
How do I get FDA approval for a medical device? How do I get funding? How do I sell a medical device? How do I? How do I? How do I? I'm Kayleen Brown, managing editor for DeviceTalks. We are on a mission to unravel the complexities of the medical device product development cycle. In each episode, we take a deep dive into a specific stage of this journey, guided by the expertise of senior med tech leaders who have not only experienced it, but have mastered it. This is MedtechWOMEN Talks.
Christina Hawley, welcome to MedtechWOMEN Talks. We are here today at DeviceTalks West, October 18 and 19th, 2023 in Santa Clara. Really appreciate you being with us here today to have a conversation.
Thank you. It’s fantastic to be here, Kayleen and I appreciate the invitation to talk with.
You, really, pleasure is all might so what we’re trying to accomplish today is to help navigate the medical device product cycle. And I find your role in particular, difficult to understand. And it seems to me that there’s a lot of crossover and a little bit of mudding water. So I’m hoping you can help clarify a few things for us. But before doing so, I want to get to know you a little better. So medical devices is not exactly sexy.
I’ve been in Medtech for 16 years. I’ve never heard of it before I got into it and I will never, ever leave it because it is the best industry in the world. But I’m always curious, how do others find Medtech? So if you take us through your journey, why medtech?
Yeah. So I think my story might be common among other people that I’ve encountered in clinical affairs. Growing up, I had a lot of interests. I wanted to be a doctor at some point. I actually started nursing school and just decided it wasn’t the right fit for me. And at some point I made a transition over to public health and started studying epidemiology. And then pretty soon after finishing college, I randomly found a job at a medical device company, a large medical device company.
And after that, I have never stopped working in medical devices. For me, it was taking my combination of passions and experience, like science, medicine, and then the more analytical aspects of my background and bringing that into clinical research. And it’s really fit well in clinical research. And specifically, I think since my first job was in medical device, I never left. I didn’t ever move over to a CRO or pharmaceutical company, nothing against those companies by any means, but I just am really interested in medical devices. And I think the reason I’ve stayed in medical devices is a little bit more of a personal story.
Every company that I’ve worked at has been very patient focused, which I appreciate. And I think probably anybody who’s working in medicine or healthcare or biotech or medtech is very keen on doing things to help patients. And for myself, that’s been a driving factor, is being able to see the impact of what we do and how it impacts patient’s lives. And for myself personally, more recently, I became one of those patients.
I was in a really serious car accident last year, and I unfortunately, have devices in me now that I’ve worked on in the past. So it kind of came full circle, and I realized from behind things, saw the impact I was having on patients lives. But to actually turn into that patient and be like, oh, okay, I’m impacted and helped by so many of the things that either I’ve worked on or friends have worked on, colleagues have worked on that work, saved my life. And so for me now, it’s more of a personal journey, but it’s also still being able to help other people. I’m in this profession because I want to help people.
I have been interviewing for a decade and a half. I’ve never met somebody that I’m sitting down with and speaking with who have actually worked on the devices that are inside them. So this is inspiring, intriguing. Are you comfortable sharing more about that experience and maybe more backroom?
Yeah, absolutely. So, depending on how much you want. All of it. Yeah. So, last year, I was coming back from Yosemite with my family, and somebody, a distracted driver, hit my car. They ran a stop sign going very fast and hit my car. My car rolled two and a half times. Fortunately, everybody survived. I have no memory of the accident. I was driving, and I woke up a couple of times after the accident. One time, it was a very blurry memory, and I could see my car.
And then after that, I woke up in life light, and for maybe 5 seconds was awake before I woke up maybe a week later in the ICU of a local hospital.
A week later?
Yeah, a week later, I was intubated for a week. I had ended up rupturing my diaphragm. Basically, my entire pelvis was crushed in the accident. I broke my legs, my hips, my pelvis, my ribs. I had a lot of internal damage, but fortunately, the surgeons fixed me up. And I have implants. I have medical devices that put a plug out for striker. Striker. I’ve got lots of plates and screws in my body now.
And fortunately, those medical devices allowed me to almost fully recover. I mean, I walked in here, I’ve got heels on, and without the surgeons and all of the research that went into all of the things that happened for me, I had ten units of blood put in me. I mean, I was almost dead. Yeah. So it’s pretty amazing that those things, all those little parts of those different companies, different projects, different drugs, different devices, they allow me to be here today.
And so that’s why I stay in this, because I want other people to be able to. Whatever they’re dealing with in their life, to be able to not be able to keep moving on beyond that.
Well, one, I’m so grateful to everybody who helped your healing journey in the process, and I’m so grateful to be sitting with you today to hear this story that you’re here with us today. You said this was just last year.
Yeah, it was about a year and a half ago now. Yes.
You would never know. Looking at you, I got very lucky, yet. Unbelievable. I feel silly to pivot because we’ll just take a beat. Just thank you, universe. Thank you to all of the surgeons and the medtech stakeholders who have helped us take a quick beat. So you shouted out Stryker. Was that the first company that you worked?
That was the first medical device company that I worked with. Stryker, orthopedics, ironically, yeah, that was where I got my start. And honestly, at that point, I was very young. It was a job. It looked interesting to me. I didn’t know anything about medical devices. It was a job as what you call a monitor and a study manager in the orthopedic space, and I knew nothing about the industry, and it just looked like an interesting job. And they kind of set the foundation for what I became after that because they exposed me to so many different things.
And then I realized, okay, this is medical device. I didn’t really understand it before then. I didn’t even know what clinical research was going into that. And here, 20 some years later, I’m still doing it.
So, two things. One, huge fan of Stryker as well. Huge fan of all the oems. I mean, look at you by what fans, but Stryker is really known for their development of their employees and really trying to expose you to what you’re passionate about and then give you the resources that you need to advance in that passion. So you’d mentioned study monitor. What is that?
Yeah, that was actually two roles. So there’s a monitor, or more commonly known as a clinical research associate. So that’s an individual who usually travels, goes out to the research sites and verifies the data, trains the sites. Depending on the company that you’re at, there can be more or less responsibilities, but you’re really verifying the data quality and making sure what the site is reporting for the study matches the patient’s medical record.
The study manager is generally who’s responsible for making sure from a to z that the study is covered and that we’re doing all the operational things to make sure that the study achieves whatever we need it to achieve at the end, aside from the technology working, making sure that we run the study in accordance with regulations, if it’s a regulated.
Medical device study, two really sort of raised in this industry, in this space.
Yes.
So then take us maybe 40,000ft in the air here. So if you could, beyond your title, beyond your current position, how would you describe your role, sort of in the broader sense of medical device product development?
A cat herder? No. So I think for anybody who’s worked in medical device, and I think it probably varies a little bit by company and the scope of your role. But generally speaking, in clinical affairs, we are responsible for executing on a clinical study, and usually you don’t want to spend all of the money to do a clinical study if you don’t need to do it from a regulatory’s perspective. So my role is to execute the strategy that we’ve defined, actually to help define the strategy, along with all of my cross functional teammates in R&D, regulatory quality, the business team marketing, making sure that we are designing a study as a group that is going to meet the needs which is driven by the regulatory strategy generally. So we don’t do clinical studies for fun.
I mean, they can be really fun. They are a lot of work, but we do them because we’re trying to achieve a regulatory strategy and maybe that’s device approval in the US or another country. But sorry to step back for a. It’s, we are collaborating as a group and my role is to make sure that that study and my team is executing on that study in order to try to get to regulatory approval.
That’s really helpful in terms of who you’re collaborating with, and we’ll kind of dig in that in a little bit. So clinical trials, Keystone to what we do, can you explain maybe the significance of how important is it to understand clinical affairs, be prepared when it comes to that point in the development cycle? I mean, can you just sort of take us through why this is so essential?
Yeah, I’ll use the example of an investigational medical device, which most of the projects I’ve worked on have been for investigational medical devices. Meaning it doesn’t have approval with the FDA. We can only use it in people in the US or whichever country we’re studying it with as a part of an investigational study or a clinical study. So in order to get approval to sell that device, meaning anybody can have access to it, meaning somebody who’s not in a study necessarily, we have to show that the device is safe and effective for the population. So a clinical study is how we do that.
We pull out all the kind of extra variables and try to get to a very narrow focus of what we’re studying. It’s not real world. Right. Because we have inclusion criteria that patients have to meet, but we’re trying to show that a product works and is safe in a very controlled environment. And from that, we then want to get approval for it so that we can use this for other patients.
Freeze. You’re kind of talking about the. Would it be accurate to say the efficacy and validation of the product?
Yeah. So validation generally is more R&D. Yeah. So that’s like product development lifecycle. So we are trying to demonstrate, we’re assessing efficacy and safety generally depending on the phase of the study. If you’re working on early feasibility study, your design might not be locked down. But if you’re working on a pivotal trial, which I’m working on now, you don’t want to be changing the device at that stage in development because any changes you make can affect the outcomes of the study. So you want to make sure you’re running your study with a locked down design, which is a design lock, design freeze.
But in early feasibility studies, when you’re kind of iterating, you’re learning from each case that you do. It’s a different space, and sometimes design iterations happen, but that’s not a study that is used fully to support FDA approval.
So there’s different trial have. Okay, so I’m with an engineering group. We’ve developed this medical device that we’re ready to test as much as possible. At what stage does it come to early feasibility? I’m assuming not prototype. So somewhere between prototype to where it’s only iterated slightly. When do I say I’m ready for early feasibility?
Yeah, generally in device, I mean, depending on the device, you usually do some sort of preclinical testing to demonstrate ease of use and not so much, definitely not efficacy at that point. So you’re really trying to assess safety. So it’s kind of like early pharmaceutical trials. You don’t go straight to a big population of patients with your drug if you haven’t done early safety studies to make sure in healthy participants. So it’s similar. Unfortunately, with medical devices, we never go to healthy participants unless it’s like a digital wearable, which I’ve worked in. That’s a different space than implantables or more invasive devices.
So you’re going to generally start in animals or animal models in the development cycle, and then generally you’re having discussions with. That’s if you’re doing your study for us regulatory approval, you are wanting to be talking to FDA during your development so that you are going to do the right study at the right time. So, yeah, usually you’ll have a first inhuman study and then early feasibility and feasibility, it can vary depending on how you do your study, but there are not predefined phases in the device development, but generally first in human early feasibility, and then you move to a pivotal study, and that’s usually what you use to submit to get regulatory approval, and then post market studies after that. And there could be registry studies as well, which are more collecting data on real world populations.
So that’s once the device is actually in the patient, not in a controlled setting.
Right. It would be just being used per the device labeling. So once you have approval for a device, you can sell it on the market, and then physicians can use that device for the appropriate indication. And then sometimes you’ll be required to do a registry, or maybe the company just wants to do a registry to keep collecting outcomes data on durability or on other potential benefits of whatever that is, a drug or a device.
That would probably be part of what I’ve been steering at commonalities, the feedback loop. So then sort of the feedback from that goes back to many of the other stakeholders. I had the wrong impression, thinking that the medical device product development cycle was really linear, and it was one phase that is the next phase and the next phase. And what I’m understanding is there’s multiple phases really happening at the same time, where you’re preparing for one while you’re going into another, you’re working with the FDA before even going into your early feasibility, your first and human.
Now I’m understanding. So I wanted to understand sort of maybe on a different way, like how do you collaborate with some of the key stakeholders? So research and development, you mentioned the FDA. So are you involved with all of the stakeholders at every point in your influence, or kind of walk us through that collaboration?
It is a very complex environment. I think that’s why I love it so much. And I can say with all the companies that I’ve worked at, I’ve worked at large companies, small companies, I’m at a startup now. It’s never been the same job, and it’s always been a lot of figuring things out. Even though we have regulations and ways to do things, there’s always so many variables that come into play. You’re making a device, and you realize that device doesn’t work as intended.
So you go back to the drawing board, and that’s usually with R&D. So the things you learn in that early study often affect device development. And then that feedback loop of, they take that input and they adjust. That’s why you don’t want to go into a big study with an unclear device, because you don’t want to be making changes at that point in any medical device company. I think I mentioned a little bit earlier, R&D, quality, regulatory, marketing, clinical, they all intertwine.
And just because you’re doing a study and it’s not working on its own, you need to make sure that you are calling the product the appropriate thing, that you’re not making any claims when you haven’t done a study yet. And so that’s why I really rely on all of my cross functional colleagues to be bringing their expertise to the table. I look at it from a certain viewpoint. Just like with anything in life, we try very hard to look at things from an open perspective, but you always have your biases, and mine is, I look at it from a clinical focus, and so having a team is critical.
We all have to work together throughout a study, I mean, throughout the device development, and there’s kind of ebbs and flows. So maybe as a clinical study gets going, maybe R&D slows down, unless they’re working on the next iteration of the device, in which case they’re working on their thing while a clinical study is going on.
So it sounds like a lot of collaboration, which is a common theme that I’m learning. Is there an open communication channel?
So if you’re in a small company like I am, we see each other all the time. And so, yes, we are always openly communicating. I think that if you are not communicating in a company, whatever company it is, you’re not going to be successful. So I think that when you’re in a growing environment, which is, I love to work in companies that are either growing or are early and trying to figure things out, communication is so critical because you don’t want somebody intending to do something and then you didn’t get that message, and then you’re going down a different route. So communication is key to make sure that everybody’s aligned and working towards the same thing.
So I still struggle with understanding the difference between clinical affairs and regulatory affairs. Can you walk me through the difference?
Yes. So regulatory affairs is, and I have a ton of regulatory colleagues, and hopefully they go easy on me with me trying to describe their role. But regulatory affairs is really who is leading the regulatory strategy and advising on what we need to do for a study. So if we need to do a study and what type of study we need to do, and that’s based on how we intend to use the device. So regulatory knows the regulations.
They’re generally the ones, either they talk to FDA or it’s a collaboration. Again, that varies by company. So regulatories, really, they know the rules that we need to follow, and they’re going to advise on what type of study we would need to do to meet the requirements to get approval for that device. Clinical, then. So I guess what I’ll step back and say is, I think I look at this as kind of regulatory is defining the why.
Like, why do we need to do a study? Because if we don’t need to do one, we’re not going to spend millions of dollars doing a research study. So regulatory is defining that why, and that’s usually a collaboration, but there’s a regulatory reason we need to do a study, and then clinical is working with all the stakeholders to kind of say how we’re going to do that.
Thank you so much again, Christina, for taking more time out of your schedule. I had some burning questions that I needed answered, and I couldn’t think of a better way to do that than to ask for more of your time. So with that, Christina, let’s just dive right in. So one of the questions that I have been trying to navigate my way through is how do you determine the need, the scale, and the design of a clinical trial for new devices?
Yeah, this is a very big question, but it all starts with identifying a patient need for whatever treatment you have, whether that’s a drug or a device, but you don’t want to develop something that there’s no market for or in a better way to put it, is a patient need if there’s a problem, and we want to provide a solution for that or a treatment for that. So that’s where it starts. And I think that typically starts with either marketing or kind of a business development involvement in identifying some sort of therapy, and then from there, deciding what type of trial you need to do. If you need to do a trial that really heavily comes in with developing a clinical and regulatory strategy, and that’s something that, depending on the size of company that you’re working at, could be a formal document that you put together that outlines what your plans are for, what you need to do, what geographies you want to go to, and what the requirements in those geographies are, and what types of studies you need to run for each of those geographies.
Or it could be just a slide deck that you sit down with your leadership team and the working teams and figure out. So there’s different ways to come up with a strategy and a plan. What’s important is that you have one, because developing medical devices are very expensive and you want to know what you’re doing and what your plan is to get to your end result of being able to sell a medical device to patients who need it.
So that can be an informal or a formal process. And then I think the third part of that is really working with clinicians, and by that I mean physicians or whoever is working directly to take care of these patients so that you are building your protocol, your study design around.
The real world scenario.
So, for example, if you’re developing a device that you want to be used in a clinic, you need to make sure it works like the process flow works for using that device in that clinic. Do they have the patients that would benefit from this, or is that a different group that you need to go to? So it’s kind of thinking holistically. And I am a big advocate for involving physicians in the development of the study design, but also the operations of making sure that the study will work, you’ll be able to execute the study within their clinic.
So you’re talking a lot about sort of planning and preparation. So the other side of that would be KPIs and milestones. So what are the primary milestones then, for clinical validation? That process for a new medical device? Yeah.
So it really does depend on the pathway that your device needs to take. So, for example, if there’s something on the market and the device is a substantially equivalent device, you can go the 510K route. And that’s a little simpler, just from a timeline perspective and the amount of work that goes into it. If you need to do a PMA.
Which means you have to do investigational device study to get approval from FDA before you can sell the device, then usually you may have to do an early feasibility study before you can even get to that pivotal trial. And, sorry, by pivotal trial, I generally mean a randomized controlled trial. So you’re randomizing patients against a treatment and a control arm so you can really compare if the treatment is benefiting them or if there’s some kind of placebo effect going on.
Back to that. The milestones are really initially it’s figuring out which pathway you have to take for your device from a regulatory perspective, and then within that, what are the things you need to do?
So, for example, most of the studies I work on are IDE studies. So investigational device exemption studies. And for those, it’s a really good idea to do a pre submission meeting with FDA, and that is to make sure that they’re on. If this is a us study, presuming this is a us study to make sure they’re on board with your plans, because you don’t want to submit a pivotal study for approval to start the study, and they totally disagree with what you’re trying to do. So it’s important to have, I would say the early milestones are frequent or communication with the regulatory bodies, but aligned to whatever the requirements are.
But really getting that regulatory strategy down is key to doing a clinical trial. So that’s the primary milestone.
And then once you get operational, once you have approval to do the study, there are a number of milestones after that, which I’m happy to kind of talk through those. But if we’re keeping it higher level, it’s definitely more. It’s the getting the approval to do the study that is a major milestone.
If you don’t mind. I’m definitely interested in what those subsequent milestones are, and I have a feeling that a lot of people have those questions as well.
Yes, I’m actually going through this with a study now that we’re working on at the company that I’m at and so I would say there are kind of a bucket of things that are pretty standard that you have to do once you have approval to do an investigational device study.
And I’ll maybe talk a little bit.
Higher level, but try to keep it.
Specific enough so that it’s familiar for people who maybe don’t work every day in this space, but you need to select research sites to do your study. So that is what I’ve been doing for the last several months, and it’s.
A lot of work.
It’s a lot of talking to physicians.
And their research coordinators about what you’re.
Doing, seeing if they have the patient population to potentially participate see if they have the research infrastructure to do the study, to execute the study. So there’s site selection on the backside. We build databases to collect the data that the sites are entering. So the sites are collecting data about our device, about their patients, and then that data is what we’re going to ultimately submit to FDA.
But we need to get that data.
So we can analyze it with all.
Of the other patients in the study. So we have to build a database, we have to develop a lot of study documents and tools for the site. Working in a regulated study, there’s regulations that we have to follow, and the way we meet those regulations is a lot of documentation.
So we have to create that documentation.
In the first place. And then there’s other things like patient enrollment. So once you can actually get sites.
Trained to do the study, you start.
Enrolling patients, start collecting data, start supporting cases. If it’s a medical device, that has to be support. So. Sorry, by supporting cases, I mean a sponsor may send a technical expert on the device out to each of the cases or to a certain number of the cases to make sure that there aren’t any technical challenges with the procedure. So we never touch the patients or treat them, but we’re there to answer any technical questions that might come up with the device.
So I’ll pause in case there’s any questions there. But that’s kind of. I think that’s the early part of major milestones for the study. For probably the first half after you get through enrollment, and then after more, it’s getting to data analysis and figuring.
Out if your study worked and then.
Putting together a BMA submission to get to request approval from FDA to market the device.
I honestly had no idea.
I came into this series admitting that I know very little about the cycle, but this has really highlighted how little.
That I know personally. And I feel like so many members of the medical device industry just don’t know all of the different steps that go into this. I don’t know why. There’s this general feeling or concept that there is a structured process for clinical trials and you just sort of plug and play, but it doesn’t sound plug.
And play at all.
It’s very customized. There’s a lot of work that goes into it and getting middle end.
You have a heavy role.
So I’ve done this. I would say most of the companies that I’ve worked at from medical device companies I have worked in study startups, so. Meaning it was a brand new study that we needed to get up and running. It just kind of seems to be what I do for the most part, and I enjoy it because it’s familiar to some extent, but it’s always something slightly different. So even though you’re starting up a study, you have a different therapeutic area. You have to figure out how to make that study work in that different therapeutic area.
But I think it actually speaks to.
Something that I think we might have touched on previously, or maybe I avoided the question, but around AI, because I think you specifically asked me, and I.
Don’T remember if that was before we.
Were on camera or off, but I specifically remember you asking me about AI and the relevance in clinical research. And I was like, yeah, we can do it. But to that point, so much of what I do is it’s standardized, yet it’s not standardized. And I have to do the same high level things every time we start a study, but it’s like we start from scratch every time. Unless you’re working in a company that has templates for everything, usually you have to make everything from scratch anyways. I think that’s just an interesting kind of tie back to the AI. Like, maybe there is a role for.
That in what we do.
Maybe take some of the bootstrapping out.
Of the process so you can be.
More of an artist, because that’s really what it sounds like to me. I mean, there’s an art to this process. Wow.
I bet you didn’t think that you’d.
Be called an artist in a medical device.
It’s a really good point. I consider myself a creative person. And clinical research, although we are operating within regulations, sometimes the how you get to that is where you have to be creative. And I think a lot of people actually struggle in clinical research because they expect it to be very black and white. And when I try to explain, like, well, no, it could be this. If you have to be able to think through kind of all of the different scenarios and all of the different interactions and things to get to where you’re going, it’s a very complicated process, but it’s a lot of fun.
Wow.
Well, speaking of interaction, then the big question is, so how does clinical affairs interact with regulatory bodies? And then a follow up to that. You were being very specific about us, but how does that also differ across different countries or.
So, just to start, most of my experience has been that regulatory is the regulatory affairs individual is the primary conduit for communications with FDA or with another regulatory body outside the US. However, clinical often does have some role in that. I would say the direct communication is typically regulatory. So the written communication with FDA, or if there’s a live call, it’s typically regulatory. Although some other companies, it could be clinical as well.
But a lot of the written documentation that is generated to give to FDA, like study protocols, informed consents, those are developed by clinical and then reviewed cross functionally. So clinical can have, I would say, a varying interaction with regulatory bodies depending on the size of the company, the structure of the company. My experience, it’s heavily been in the regulatory group, but they rely on us for providing clinical input as well.
Okay. So I do think that what is important once you are looking at a space that’s unfamiliar to you.
So, for example, if you’re in Europe.
And you’re wanting to do a study in the US, if you’re in the US and you want to do a study in Europe or another geography, identifying experts in those areas, regulatory experts in those areas is really, really important because what you don’t want to do is to design a study and expect you’re going to get approval for that study in some other country, but you haven’t considered their requirements. In the US, with FDA, we have.
Medical device regulations that we have to follow.
And so if somebody tries to develop a study that doesn’t meet those requirements, it’s not going to get. And when you go to look at studies being done in Europe, there have been a lot of changes in regulations recently or within the past couple of years. And so I personally have not done a lot of studies in Europe recently. So it’s a big learning curve to try to get back up to speed. But if you have people that do that all the time, it can really save your company a lot of time and money and mistakes as well with submitting things that you didn’t realize didn’t meet the requirements.
So that sounds like a really big tip.
Get the right person with the right experience doing that, quote unquote, right function. Do you have any other tips for a smoother process?
Yeah, so I think definitely sometimes we have to rely on consultants, but I think from a regulatory process, this also goes back to something we talked about previously, is how important that cross functional communication is, because a lot of times people have had different experiences in different companies and they can pull on that knowledge to help figure out the current challenge. So making sure that everybody is super aligned and communicating openly is really important.
I’m in a very small company right now, so that’s pretty easy to do. I think as the companies get larger, it gets a little more challenging to do that. But it’s incredibly important to make sure that everybody is working towards the same thing, that everybody has the same expectations, and that as challenges come up, people are communicating so they can figure out those challenges and keep moving forward.
And I would say that kind of tip is relevant. From the time of conceiving of an idea of what device you want to do all the way through and probably beyond getting marketing approval, there are going to be challenges all throughout that process. And being able to make sure you’re aligned as a company on what you’re trying to achieve and then communicating as you go along is just so important.
Very well said. I have so many more questions, but I’ve already taken additional time from you that wasn’t scheduled, so I’m going to wrap it up with this very general, broad question. You already gave us a few tips, but is there anything else that you’d like to share with our audience that might help them better navigate this process?
I would say just keep asking questions. I love your curiosity and I knew.
That you want to talk more about.
Clinical research because personally I’m biased and it’s so much fun to learn about this space and it’s never the same. So I think that for people who are interested in maybe getting into a career in clinical research, it’s just network and start talking with people to learn more about it. It’s very much a job that you learn by doing. And I think that communication is very important. Strategy is very important. Planning is very important.
And then being a part of a team that is working really well together and executing really well is really important.
As well because you don’t want a.
Bunch of disjointed people kind of marching in different directions to try to get this device somewhere. Like cohesiveness is really important. I mean, there are so many really important things, but I just, personally speaking, like having a great team, being a part of a great team is so important and it makes everything so much funner and so much more fun and also makes the days easier.
I love that.
Christina, well, thank you so much for not just sharing more information on your role and this facet of the medical device product development cycle, but for sharing your story and why the medical device industry is, again, in my opinion, the best industry in the world. Thank you so much for being on medtech women talks. Really appreciate your time. And I guess I got to repeat myself one more time. Thank you.
Really, thank you.
Thank you.
Kayleen, it’s wonderful to talk to you and I love what you’re doing with this series. And just educating everybody about what we’re doing. There’s not enough information out there about everything that goes into medical devices, and.
I think it’s fantastic.
That's a wrap. Thank you so much for joining us on this episode of MedtechWOMEN Talks. Please share this episode on social media, to your co-workers, to that new hire who is overwhelmed by the nuances of medtech, and to that seasoned executive who is looking for a way to educate and inspire. Please like, follow, and subscribe to the DeviceTalks Podcast Network to never miss an episode. Our next will feature Rebecca Whitney, senior vice president and global spine president of ZimVie, from the perspective of “The Business Leader.” But before I let you go, I'd like to shout a big thank you from our figurative rooftop to our sponsors, Aptyx, Catalyze Healthcare, Confluent Medical, and Cretex Medical. It is only with their support that we've been able to create this incredible series. Want to join the best sponsors in medtech? There's still time. Connect with me on LinkedIn or reach out to our DeviceTalks editorial director Tom Salemi. Once again, I'm Kayleen Brown of DeviceTalks and we'll be back soon with Rebecca Whitney, ZimVie.
