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 medtech leaders who have not only experienced it, but have mastered it. This is MedtechWOMEN Talks.
YJ Oh, thank you for joining us on MedtechWOMEN Talks. I really appreciate you taking some time today to sit with me and help me navigate the medical device product development continuum. So I'm hoping to focus on kind of now the product is done. And I say that in quotes, because I've learned over the filming the previous episodes that it's never actually done, hence the cycle part. But I'm hoping to talk about okay, we have something in hand. Now, how do we bring that product to market? So that's the goal of our conversation. But before we do that, I'm always interested in how medical, medical technology community members join the community, because it's not really a sexy industry, it's not really something that we hear a lot about. So how did you get your start?
I love the question. Kayleen. First of all, thank you so much for having me, it really is an honor to be here to just talk about my passion and what I love to do. And to your point, coming to med tech industry, it's it's interesting, because I think now there's so much noise around startups and the ability to be able to invent something and make a difference. And I think especially where device talk is held right now in Santa Clara. It's, it's in the heart of it all, which is Silicon Valley. So when I started my undergrad, I had a focus in physiology. So back then, it was all sciences, but it was really kind of a pre med pathway into medical school. And when I finished I had other interests around business and and I wasn't sure if I wanted to be a doctor, I went through the process of everyone knows you do them CAD scrolling. And while I was waiting, I had a friend of mine that was in business school. And I was looking to see what kind of work I could find. And I said, I got this offer from a company. And he said, You know what, that's a great, you know, tech company to start for, to learn about business. It was a sales job. So I thought, Okay, I'll give it a go. Shortly afterwards, my boss actually says to me, she goes yj, I have found my dream job. And I kind of looked on her and said, What's your dream job she goes, I get to be in the operating room, teaching physicians how to use products. And I looked at her I said you teach physicians in the operating room, like what kind of job is that? So it was working for a med device company. So I this one company, I'm sure everyone knows, J&J is, you know, the behemoth, it was one of the companies that they had purchased. And so I think I spent two years hounding them and going through multiple different interviews, and I finally got hired. And I think that was probably the pinnacle description of my dream job was combining the opportunity, being in science, working with really incredible people and just being able to make an impact right then and there in an operating room. So that's how I got started. And I started in sales.
There's a lot I want to dig in, but I have to share, we have a connection. So I started in sales as well, not absolutely not what I was planning on doing. And the idea of having a direct impact on clinicians teaching them educating them about the new technology that's out there and doing it in a responsible way. And then seeing when these devices were in their hands use and the number of patients who are positively affected by that. Yeah, was the privileges of the beginning of my career. And I have to echo your sentiments I, it felt so much like a dream job but a dream that I didn't know existed.
I agree. Totally agree with you. I mean, I think it and to your point, it's a privilege and even when I tell people, This is what I did, and I still do. People are amazed at that is a line of work. So it's me it was just an amazing opportunity to start in that space.
I think it's really interesting starting in sales to because you are seeing our industry from a very different perspective. And you're seeing it arguably in a broader perspective, because you're looking at every stakeholder and how the kind of the part that you play in there and from my perspective, it's been about building relationships. And now 16 years later, I realized that the most valuable asset that I have, and the the other members of the community that I speak to the valuable asset they have is relationships. And it keeps coming up over and over and over again. And in fact, you know, I hate to take over the conversation here. But in fact, over the last few days, again, we're at DeviceTalks, West. And this isn't about DeviceTalks West. But I have been lucky to lead some panel discussions and sit in on some sessions. And a common common sort of theme that I'm finding in each of these sessions is more collaboration. So getting clinicians with FDA, with the OEMs, all together to really talk about the devices earlier, for better health outcomes. So I feel like, again, going back to her saying, it's such a privilege, I feel very, very privileged. And the landscape has really evolved in a decade and a half, and I see it as less siloed, and more community focused, which is really exciting.
It's a big evolution. And I think for the longest time, probably biotech and I did get a chance to spend some time in Big Pharma with biologics, and how that operates in pharma, is very different than medtech. And I think the reason why when I did go to to the Big Pharma space for several years, he really learned a lot of interesting processes, the methodology, you know, the all the elements that are of a biologics category. But there's only one industry where you actually get to see a direct impact when you make a change on a product, right? So I know we're talking about your product development and how you you're positioning that in a commercial setting. But you can make iterations and impact to a device that will directly impact a patient immediately versus a molecule development. So there certainly is a need for both, it just meets different needs and a different process to get there.
Very well said. I mean, I think this is a perfect bridge to the broader conversation. So I want to talk about your role. So if you could help take us 40,000 feet in the air? What how would you describe your role in the larger medical device product cycle work development cycle?
So good question, Kayleen. My official title is global marketing. So just schematically, what that what that entails is I have upstream marketing, which works on product development, that transitions to downstream marketing, and defined downstream marketing is anything that's in the commercial state. So I have, you know, therapy, awareness, disease awareness, which is more direct to consumer or direct to patient marketing, I have a referral categories of physicians, and then are the actual intended user of the devices. And that is typically what I think most people would go as, you know, working with our sales organization, working with a field clinical specialist, and providing the tools for them to talk about our devices in an approved format. So that's, that would be the scope of what I do. And kind of in a nutshell, what marketing I would say it consists of.
Would you say - just kind of how you defined it and then based off of your experience - that your role, even aside from Edwards Lifesciences, let's go even further in the sky with that, is more sort of commercial developer commercialization, working marketing and sales, sort of two sides of the same coin to bring that product to market?
Yeah. So if I look at your your question about sales and marketing, I would say, that is a critical partnership for the commercial state. So how do we take a product and make sure that we either, you know, grow the category, bring awareness to physicians that use it bring awareness to patients to give them options of choices? But I would say the other half is really around the development side. So something that is not yet commercial, or yet thought about how do I work with my partners, to bring the market needs and the insights to the development team?
That circles back to we were just talking about, collaboration. How you work with the partners. And I think there's probably more of a collaboration between sales and marketing naturally, so it's nice to see that sort of extended as time is going on. So we talked about your role, sort of as a broader sense that I placed this episode sort of at the end of this series thinking that commercialization and that's what I'm just gonna generally call it commercialization kind of comes at the end. But over the several episodes that we've been filming, I'm realizing that maybe that's not accurate. So at what stage would you say the medical device product development cycle? Does your influence come in when when are people reaching out and touching the commercialization side?
So I'm going to say from the very beginning, so let me explain what that that means and how I define that we do voice of customer. So from an upstream standpoint, it's to really discern what is an unmet need and whatever therapeutic area that that I'm focusing in, and so we start there, and I think it's important to know what the needs are what the unmet needs are of a particular area. So, in order to know, what do we need to think about, and so those insights translates into what I would say is the commercialization slash product development cycle. Because I think for all of our companies, which whichever space you're in, you hope to commercialize something you hope to make an impact in patients lives or physicians lives. And so I think you'll always start with the idea that you're going to commercialize whatever idea you come up with. And I think it's how you get there and making sure that what you are developing is going to lead to that. And so along the way, that's for me as a kickoff, we, we start off as commercialization ideas, but make sure that we're first and foremost gathering the insights, market insights, customer insights, and patient insights to know what needs to be started in the development process.
Would you say that you have a hand in sort of maybe looking at the gaps in product portfolios?
Yes.
Really?
100%
Can you go into that?
I think the insights to that we feed into product portfolio would be like, if we look at the existing commercialized portfolio of products, right? I mean, obviously, they're the ones that in any company, you put a lot of resources behind from both a marketing and from a sales structure or sales resources. But it's not everything. And I think from that standpoint, from a positioning of your portfolio, is there something that we need to address? Is there enough of a market needs? So that's really where at the beginning, from an upstream marketing standpoint, we try to assess what a potential market in that area could be? Is it worth $5? Is it worth a million dollars? Is it worth more? Because at that point, then based on, you know, I would say some pretty good assumptions? Is this a space that we want to do more research into and potential product development? So you got to start with the end in mind? And if the end is always to commercialize, what is the dollar market potential opportunity? What is the number of patients that can be impacted? How difficult would it be from a reimbursement like all these questions get asked upfront, before we start any of the product development.
I never would have pieced that together. So it's very, very helpful to understand that there's a lot of influence from the stakeholders who have to find a way to get that product market, right? Because you can't sell it. What are you doing? Right? You know, and there's nothing worse than when you hear about a product shelves, you have this amazing like intellectual property and what it could be gone forever, because it just it wasn't able to make its way to market, either the market wasn't ready or something else happened. So you're really looking at it early on, I feel like course, you have more time to course. Correct. Right. Makes a lot of sense. So we talked about kind of stages. You we talked a lot about collaboration on a broader sense. But specifically in the role, who do you collaborate with? Is it R&D? Is it Clinical Affairs, regulatory, engineers? Who do you collaborate with and when?
It's a very good question. I will say, from my experience, it's all of them. But let me let me explain a little bit of what that that entails. So you know, from a product development team, I think to be successful, you need to have the right folks in the room. So definitely upstream marketing that bring the market and voice of customer insights, regulatory to understand how you're going to get something approved bid to whoever target market, going to clinical fairs, because you need to generate the data to prove feasibility or efficacy and or outcomes that are going to be important for the clinical community. But obviously for, you know, the the reimbursement community for payers, for obviously, r&d, r&d left to their own devices, I love because they'll come up with something, they'll create any widget. But But does it have a home to your earlier comment, and that's really important to have. And so those were the the key elements that I would say from a partnerships, we have marketing, we have regulatory, we have Clinical Affairs, or clinical development, which is I think, earlier on in the stage that we're looking at an r&d. And from a process standpoint, we always try to have a project scope. So all the questions or other comments I mentioned earlier around market reimbursement, Who is the intended you know, therapeutic space or the the patient population? What do we think that will look like? All of that's in scope, before we kick off so that when because as with anything, with projects that kick off, they have a tendency to move? And if you don't know where I would say your North Star is or different phase gates to know when is the decision going to be made to decide do we move forward or not to put more resources into this resources, meaning more people more money to keep the next phase of development going? thing needs to be built in and all agree to upfront, because it's, you know, there's a there's a great quote by Yogi Berra is, if you don't know where you're going, how do you know that you've been successful? So it's to map that part out. And so that's I think that's an important part of the product development process. And all the different functions play a key part to establish that.
So it makes me think milestones, markers, as you say, having this Northstar. Would you say that your role has any influence and sort of the go/no go decision making as you move forward?
I play a part, along with my other counterparts, I think the biggest part that I as a as a marketing voice, in that process is is making sure the voice of customer is very clearly top of mind. Because a lot of times, I think, and I've seen this happen, where we have devices where we just emotionally fall in love with, right? And then you get into a little bit of groupthink, because you think it's really, really, really cool. But if you don't have something to compare it to, or you don't go back to what did, what did the market say? What the customer say, is this still in line with what we thought it was going to treat? If we don't have that to go back to an abacus logical process, you end up going down a road, because you'd love it so much. Because you do spend a lot of time you do spend a lot of effort into it. And people love their projects. I mean, we all do. That's why we work on them. But we need to have a check and balance point and say, Okay, at this milestone, do we see XY and Z? Did we say that we're going to get to, you know, feasibility by this stage? Do we have, you know, a clinical development plan and easy or the feasibility plan to test, you know, in the clinic? Or is it all benchtop? Testing all of these things factor into go? Okay, are we ready? Do we feel good about where we're at, and then let's move forward. And my upstream team, that role is is a very good voice of making sure that the market voice, the voice of the customer is is top of mind in these conversations.
From what you're saying I'm inferring that there's some sort of coming together of all of these roles to have these hard conversations. Do you do that? And is it a regular conversation? It kind of every step of the way?
Yes. To answer your question. Yes. We have regular, I would say phase gate. Those are the probably the more formal milestones to say, okay, these are the things that are required to review in a phase gate review. But as far as a working process, I mean, the core team, I think they meet on a regular cadence, I mean, and they should, it's a lot of it is just more like updates, because everyone is very focused in their function. But I think it's important to just come together and see if there's any new learnings, especially depending on what stage and the speed with which innovation occurs at different companies, it can happen much quicker than you think. And so it's also early, an early time in appropriate time to talk about things that may not be going well, because that's an important thing to learn to go, Okay, do we adjust? Does this what does it mean? Is it really a meaningful impact for us? Or is it just a roadblock that we go through? And those conversations need to happen? Because I think each function has a different lens with which they look at the data. And so from a core team, I think, you know, best practices from a process is that there's a steering committee, I think these are the ultimate decision makers have those functions that go Okay, now that we know all this information, we have a recommendation from the steering, you know, the core team, what does the steering committee determined in the end that we want to move forward with or not?
That's very encouraging. From what I'm learning right now, it feels like that might be one of the most essential parts of the medical device product development cycle is those checks and balances and having those conversations, everybody has a seat at the table. And you know, having those "I know you love this, but it's not working because of this." Those are really hard conversations to have. So you have them and they're regular I assume? So then what's the difference between a steering committee, which now I understand really kind of what that means, and phase gate?
So a phase gate is in the project scope. It's kind of like the contract, you go, okay, where these are the things we're going to accomplish at this phase gate? Number one is their feasibility that this project will actually work. So what does that look like? What are the metrics? How are we going to find that, you know, another phase gate may be okay, are we ready to go into clinic? Are we ready to test this on? Subjects? So who are those subjects? Right? Where are those subjects? And so we make sure that that there's a safety and appropriate, I think efficacy of product, a built into these phase gates, so that we are appropriately moving along the process and if things don't work, we know what we go back to. So it's not like, you know, early visibility, there was a problem. We saw it and you know, the second phase so let's figure out what that looks like. Do we need to do different bench testing. Does there need to be something adjusted in the device? Whatever that may be. And then we go back to review like feasibility on that point. But if there's a natural way to step forward, if we have to stop at whatever phase we can go backwards and be very intentional is what we're looking for.
So it's the more formal process of what you've been talking about, following that Northstar? We talked a lot about collaboration, I think the sister to collaboration is the feedback loop. Right. So how essential is a feedback loop? And when you are given feedback from clinicians from your internal team, like how is that integrated?
Really good question. So it's incumbent upon my upstream team, when we do product development, to get feedback from our intended customers. So we typically pick with good physician partners, obviously, most of the devices that we create are for physicians. And it's done in in different ways. So some of it, depending on the stage of development, we'll have a hands on session. And during that session, everything is absorbed, because sometimes it's a little bit of an artificial setting. And so physicians are sometimes overthinking their answers, or focusing on things probably more than they would when they're normally in their day to day if it was a commercial product. And so, you know, we look at how do their hands may visit very difficult, where do their eyes go? Where are we seeing, you know, fatigue, what are they're struggling with on the device? Because obviously, most medtech devices are done with physicians hands, whatever this specialty area is, and that's a really critical part, are they losing control? They're getting more control? What are what are they not saying? That is a big part of the feedback. And so, you know, we have a team that discerns all that data and information. And we report that out to the cross functional team. So we make sure that information is shared, and questions and observations from each of the functions are represented. So while my team does lead voice of customer, and I have feedback in in, in a I think bench testing, or any of that we do have, you know, medical affairs and clinical development, observing, because they will be looking for potentially different things than what my team is. And I think that's the epitome of collaboration, is making sure that in that type of environment and setting that all your colleagues are there with you all with the same objective, but have a very different lens or a different eye that they're looking to get that feedback.
A real diversity perspective, right? That's lovely. So how do you identify a unique selling point? So you talked at the very beginning, like finding the price point, making sure that there's space for that in the market. How do you find the unique selling point?
So features and benefits are always what people are tech companies, on people that companies go to. And so, in my opinion, certain companies just focus on that. And I think they're the early phase or early stage of medtech. When I started was very much a feature benefit type of selling. I think as we've evolved now, it's probably more around behavioral insights of the intended user. So an example is how do physicians decide what product they're going to use? It's not always the feature benefit, it may be the emotional payoff, that that rewards the physician. So for example, certain physicians are much more about control than than others. So is that really what you're talking about district device lends itself to more control? Why is that so important? To that physician? Well, that control makes them feel like I can get my cases done in a predictable fashion. You know, it allows me to be able to manage the time, you know, in whatever is an operating room or a cath lab or wherever they're doing the procedure. And so the selling point may be what that the benefit payout is for that intended user, not necessarily that this is three millimeters, or you know that's a part of it. But that's not the selling feature. And so that's what I think the most important part about commercialization is getting the insights to what makes people pick products that they do, why did they pick, you know, device X versus device Y? And it's not always the features and benefits because if it was just the logical approach, everyone would be using, I'm going to say Apple, I mean, some people are obviously Android, but to me if it was all logical, it was really easy and everything laid out. People would all just use Apple, but they don't. There's a reason why because there's an emotional behavioral connection to why people use products.
There's so much more psychology than I expected, because it's reading the room, reading the clinician, reading the space. Do you find it - another pivot question. Questions on questions on questions. And I do wish our time was five hours, not the short time that we have together. I have so many questions for you. So there's more psychology than I expected. Do you find in your role that you have some team members, and maybe not specifically with Edwards Lifesciences, but kind of, in your experience, have a psychology background or some sort of behavioral health background to help with understanding the unique selling points and that strategy?
So interesting question, Kayleen. I think as I've been in the industry now, for over 25 years, I have seen the approach to marketing change. So now a lot of the, I would say, vendors and our partners that we work with, have a very strong psychology department and or market research personnel that have a deep, deep, deep knowledge in the psychology space. And so we do have psychologists that do market research that we partner with, because they're going to glean different insights, and different I think, emotional connections on why they do certain things, then what a typical, you know, market research and or behind the glass scenario would look like. So I think that's probably the sophistication now of, you know, marketing teams and marketing agencies. And I think those that figure that out well are going to have an edge in how they commercialize products.
One of the other common themes from this series that I've been hearing is, you know, it takes a village to build a medical device. And my last episode is that it takes a village but also takes an entire country to build a medical device. So now, you're adding in this entirely different background that I never would have considered. And years ago, 15 years ago right, I never thought there'd be this psychology crossover. So I feel like it's getting even - our community is expanding. And I think we said diversity of perspective. It's diversity of backgrounds and education as well, that's coming into our space to try to bring devices to market. And that's absolutely fascinating. I mean, this might be a good way to sort of pivot. We were talking about how the community is expanding. Let's talk about - so we went from village to country, maybe it's the globe now, as we're expanding. So when we do talk about global markets, how do you adjust your strategy for the different global markets, and not just for that specific community and market but the regulations behind the different countries and kind of from a global scale? So how do you shift that strategy?
Yeah, that's a really salient topic. Right now, I think, in light of the fact that around the world, regulatory bodies are, I would say, reassessing their role and their requirements. So for example, in Europe, it used to be because it CE mark was was a little bit easier to obtain. Europeans had access to medical technology well in advance of the United States. I mean, that's really where a lot of startups really gained a lot of traction and ability to be able to get market insights very early on. CE mark was easy to achieve. Now for very different reasons. And everyone's well aware that the the breast implant fiasco and impact caused appropriately so more stringent regulatory requirements. I think it would be suffice to say that maybe it's gone too far to the other end of the guardrail now, because, you know, in Europe, at least the MDR, which is the regulatory guidelines now are making it almost impossible to have existing products that have been in the market for decades, stay on market, and which, you know, the intent was to come with, you know, making sure that there was rigor behind products to get approved. But now, the the flip side of that is it made it so difficult, that there are patients that are not going to be able to have access to technologies because it's so restrictive, so I see the regulatory bodies and different panels now having to figure out how to adjust to get the right amount of clinical data which is required, and the needs be able to approve it, you know, regulatory approvals in a timely fashion. But to your question about how do you look at from a global stage and where do you decide where products go? I think it depends primarily on reimbursement. So we know that most markets around the world are socialized so the government pays for health care. There's a couple of markets, United States being one of them. And Australia has a private pay market where the consumer or the patient decides what what they want and where they go. In the end, I think if you do your your product scoping and project scoping out front, it will help set the stage for how much is the market going to bear for your device. And, you know, there is a lot of, I think, focus on breakthrough technology approvals. Lots of markets have it, I just saw something today that the UK is going to be creating a much more, I think friendly regulatory environment to bring your breakthrough technologies to, you know, the folks that are governed by the UK regulatory ruling. And so it's how much are they willing to pay for that. And that's, that's really the fine line. Because if a country or a government or insurance or a patient can't afford to pay for it, it could be the best device, it just won't get used. And I think that's really the fine balance to determine which markets do I go globally to? Which markets are willing to pay for that? And is that disease state a big need in that culture? Because most diseases are universal across the world. There are others that are more prevalent, obviously, as you know, you know, in China, and are more developed markets. And so I think it's that thoughtfulness has to come up front when we think about design.
Very, very well said, and I had no idea. Just like how much this landscape has changed in such a short amount of time. So you've touched about your background, and you had mentioned that you're maybe one of the people who inspired you to come into this space, their dream job was teaching clinicians. So let's talk about training clinicians on devices. So how do you prepare for training and education for the clinicians or the end users? Especially when those devices are more novel, as opposed to something that you can expect?
Yeah, that's a good question. Where I work now, currently, we are creating novel devices for the structural heart space, things that have never been done before. So this is definitely a question that we think about each and every day. You know, from a formal structure standpoint, that professional education is under my responsibility. And their job is to create training manuals, that will be used to train physicians when products do go commercial, and a part of submission for regulatory approval. So that's a really important role. And there's a definite science behind it. And so when I look at the makeup of my team, they could have nursing background, some of them have adult learning background, because the methodology for adult learning is very different than the traditional teaching, you know, of younger kids, for example. And so they bring a different skill set into it. So for novel device, as I mentioned, to you, we've tried to record everything that is happening when we have a physician using a device that's never been used before or in a therapeutic space. So we look at what are they struggling with, as I mentioned? Is there something involved with the device itself? Is it something in their hands? Is there something about the repetition of a device? Is it about placement, you know, does a placement help and so every little thing is dissected. So that in the end, with our partners for clinical development, we can create a training manual that has basically a step by step guide to what a physician needs to go through to be proficient. Where they can be officially signed off, which is typically what happens with it's a novel device is based on the history of the development process. Do they need five cases? Do they need 10 cases? Do they do they need a proctor in the room with them? In order to make sure that when they go by themselves for the very first commercial case, that they will be set up for success, that patient will have a successful outcome. And that the therapy, especially when it's novel, will continue to be accepted in the community.
So you spend some time on this.
We spend a lot of time and many years from the product development cycle to ensure that it is as best as we can when we launch. Now, that being said, sometimes after we launch a novel device we will get feedback through initial product evaluation, where we're very methodical, intentional. When we launch a product we want to make sure we take feedback after every case. And so there are certain specific questions that will ask a physician around the procedure itself, so that we're validating our assumptions in an actual commercialized setting. Whether that's 50 cases, 100 cases, 200 cases. I mean, that's something that the team determines up front, and then all of that is digested and we report back and go, was the initial product evaluations successful? And that might be, you know, some companies called a limited launch. And so do we go, do we do that with 25 centers? And once that gets all signed off, again, the steering committee then meets together and goes, do we feel comfortable with where things are at this time? We include our sales organization because they've been a critical part, because a product is now commercialized and very initial limited use and limited centers. And then if we go yes, this feels great. I'm gonna go broadly. And that launch commercially, going broadly, then make sure that the training manual and the signups are properly followed. But it's been vetted. And we want to ultimately in the end ensure that, number one, patients are getting the intended outcomes that we we we foresaw and that it was designed for. Two, physicians feel very comfortable with the support and education that they're getting. So that ultimately in the end that patient benefits. And thirdly, that we can have broad rollout so that more patients and more physicians can have access to the technology.
So it sounds like boots on the ground are sort of the final phase of that feedback loop. It makes a lot of sense. And I'm sure we were I think we had said kind of in the beginning, having this diversity of perspective in the very, very beginning with help course correct along the way. So then having this checks and balances at the end, there's a sort of final course corrections for the best health outcomes possible. And other outcomes beyond health, actually, to that point.
Yeah, absolutely. You said that really well.
So I would not, if I had filmed this a year ago, I would not ask you about AI and machine learning. But now that generative AI is everywhere and it's really democratized AI, how has that today really changed your rules and responsibilities and how you see that and, you know, how you see it in the future? And I'm going to do a however, comma, the future could be a month from now with how quickly this is progressing, or five years from now. So however you want to interpret future.
So I my caveat is I am not very familiar with AI just to be to be super upfront with you. We have limited use, I think in our organization. The value that I do see with AI, though, is when you have really large datasets, it is a great tool to help discern and kind of do whatever level of cuts that you want for the data. I think that's probably where personally I see the most value. Whether it's claims data, you know, big giant testing data to see a difference between, you know, one cutoff point versus anothe. You know, clinical trial data, I see it, I see more of a filter of data to look through than anything at this stage, you know. Where my head is going is that, will AI be able to help think, streamline and speed up the process that right now is very heavily dependent on, you know, people's brains and people's insights? For sure. I think it's a matter of where and how, though, because with a novel device, I think it's - there isn't data created. And AI needs actual data constantly being fed in to learn and to be able to discern. And when you're in a novel space or a novel therapeutic area, it's somewhat limited. But I think in more established areas and, or more established device manufacturing, it is a perfect tool to be able to take all the inputs and learnings from before to offer, you know, slight changes. I see it as from a manufacturability of new devices. I think if you have AI assessing that the different test methods and the outputs, it may be able to say you know what, for device manufacturability, you need to have this machine at this knot or at this level or this size. That will then benefit from a global supply chain, consistency of manufacturing, and reducing costs of the devices that you create. So I think there's avenues there, but I personally don't speak very intelligently on AI and the product development cycle. At least from my experience. For me personally, I've had very limited use in what my team currently does.
That's a very thoughtful and responsible way, I think, to think about AI. And so just jumping in, thinking about how you'd use it responsibly. That's so important and something that we need to be talking about right now. Which is one of the reasons why I asked the question now. It may not be something that's in your day to day, but it's here. And how can we start having those conversations, to our point at the beginning, so we can course correct along the way. So circling all the way back, do you have any advice or last thoughts for our audience about the medical device product development cycle considerations or resources?
I will say it is by far the most exciting career that I've had, you know, and I talked about, I'm gonna call it my sabbatical in biotech. I think that if you are looking for impact on patients, you're looking for working with incredible different colleagues, likeengineers. You know, people that have arts backgrounds, you know, education backgrounds, nursing backgrounds, clinicians. I think you just get this incredible wealth of opportunity to work with people that are different and unique from you with a common goal. To be able to see immediate impact is something that I think in medtech you're able to be a part of. And there's so many unmet needs, quite frankly, that I think there is a plethora of opportunity for people to seek and make a difference in. I mean, it's an industry that I feel very passionate about and would encourage anyone to look into.
Well, thank you, YJ Oh, Edwards Lifesciences for joining us and sharing your insights and helping clarify this muddy water for me. I really appreciate your time and I've thoroughly enjoyed our conversation.
Thank you for having me, Kayleen. It was really great conversation and certainly, I'm very, very grateful for the opportunity.
