How do I take an approved medical device to market? with YJ Oh, Edwards Lifesciences

Speaker 00s - 93.82s

How do I get FDA ORG approval for a medical device? How do I get funding? How do I? How do I? How do I? How do I? How do I? I'm Kailene Brown PERSON, managing editor for device talks. 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 MedTech Women Talks ORG. YGO, thank you for joining us on MedTech Women Talks ORG, and 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 as 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 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?

Speaker 194.94s - 218.12s

I love the question, Kaylee PERSON. And 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 the med tech industry, it's interesting because I think now there is 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 GPE, it's in the heart of it all, which is Silicon Valley LOC.So when I started, my undergrad, I had a focused 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 I wasn't sure if I wanted to be a doctor. I went through the process. If everyone knows, you do the MCAT ORG, it's grueling.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 PERSON, 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 and 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, which everyone knows, Jane PERSON, Jay 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 thatwas probably the pinnacle description of my dream job was combining the opportunity of being in science, working with really incredible people, and just being able to make an impact right there and there in an operating room. So that's how I got started. And I started in sales.

Speaker 0220.14s - 259.92s

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, and that's 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 used in the number of patients who were positively affected by that was one of the privileges of the beginning of my career. And I had to echo your sentiments. It felt so much like a dream job, but a dream that I didn't know existed. I agree. Totally agree with you.

Speaker 1260.02s - 273.64s

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 that that is a line of work. So, it's a privilege. And even when I tell people, this is what I did and I still do, people are amazed that that is a line of work. So it's, I mean, it was just an amazing opportunity to start in that space.

Speaker 0274.1s - 354.26s

I think it's really interesting starting in sales too. 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 realize that the most valuable asset that I have and the other members of the community that I speak to, the valuable asset they haveis relationships and it keeps coming up over and over and over again. And in fact, I hate to take over the conversation here, but in fact, over the last two days again, we're at Devise Talks West, and this isn't about Devise Talks West ORG, but I have been lucky to lead some panel discussionsand sit in on some sessions. And a common sort of theme that I'm finding in each of these sessions is more collaboration. So getting clinicians with FDA ORG, with the OEMs all together to really talk about the devices earlier for better health outcomes. So I feel like, going back to where you're 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.

Speaker 1355.02s - 410.6s

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 med tech and i think the reason why when i did go to the big pharma space for several years you really learn a lot of interesting processes the methodology you know all the elements that are of uh of a biologic category but there's only one industry where you actually getto 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 position 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

Speaker 0410.6s - 425.06s

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, how would you describe your rule in the larger medical device product cycle or development cycle?

Speaker 1425.56s - 426.8s

So good question, Kaylee PERSON.

Speaker 0427.5s - 429.14s

I mean, my official title is Global Marketing.

Speaker 1429.88s - 435.22s

So just thematically, what that entails is I have upstream marketing, which works on product development.

Speaker 0435.98s - 439.82s

You know, that transitions to downstream marketing and define downstream marketing as anything

Speaker 1439.82s - 477.52s

that's in the commercial state. So I have, you know have 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 working with our sales organization, working with our field clinical specialist and providing the tools for them to talk about our devices in an approved format. So that would be the scope of what I do, and kind of in a nutshell, what marketing I would say consists of. Would you say just kind of how you

Speaker 0477.52s - 497.66s

defined it and then based off of your experience that your role, just even aside from Edwards, life sciences, let's go even further in the sky with that, is more sort of commercial develop or 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

Speaker 1497.66s - 525.92s

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 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

Speaker 0525.92s - 572.98s

team? Let's circle back to what 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's sort of extended as time is going on. So we talked about your role sort of as a broader sense. Now, I placed this episode sort of at the end of this series, thinking that commercialization, and that's what I'm just going to generally call it, commercialization kind of comes at the end. But over the several episodes that we've beenfilming, 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 are people reaching out and touching the commercialization side? So I'm going to say from the very beginning.

Speaker 1573.66s - 579.8s

So let me explain what that. That means in how I define that. We do voice of customer. So from an

Speaker 0579.8s - 584.74s

upstream standpoint, it's to really discern what is an unmet need and whatever therapeutic

Speaker 1584.74s - 587.78s

area that I'm focusing in. And so we start there. And I think it's important. And I think it's to really discern what is an unmet need and whatever therapeutic area that I'm focusing in.

Speaker 0587.78s - 589.34s

And so we start there.

Speaker 1589.34s - 644.5s

And I think it's important to know what the needs are, what the unmet needs are of a particular area in order to know what do we need to think about. And so those insights translate then to what I would say is the commercialization slash product development cycle. Because I think for all of our companies, whichever space you're in, you hope to commercialize something.You hope to make an impact in patient's lives or physician's lives. And so I think you 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 is a kickoff.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.

Speaker 0644.94s - 652.8s

So would you say that you have a hand in sort of maybe looking at the gaps in product portfolios? Yes. Really? One hundred percent. Can you go into that?

Speaker 1654.08s - 727.08s

I think the insights 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, both in 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 need? 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 $5? Is it worth a million? 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've got to start with the end in mind and if the end is always to commercialize what is the dollar but market potential opportunity, what is the number of patients that can be impacted, how difficult would it be from a reimbursement, all these questions get asked up front before we start any other product development. They never would have pieced that together.

Speaker 0727.08s - 737.32s

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 to work in.

Speaker 1737.32s - 743.8s

Right. Because you can't sell it. What are you doing? Right. You know, and there's nothing worse when you hear about a product shelves, you know, this

Speaker 0743.8s - 780.02s

amazing, like, intellectual property and what it could be gone forever because it just, it wasn't able to make its way to the market. Either the market wasn't ready or, you know, something else happened. So, you know, really looking at it early on, I feel like can course correct. You have more time to course correct. Right.Makes a lot of sense. So we talked about kind of stages. 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

Speaker 1780.02s - 908.24s

collaborate with and when? It's a very good question. I will say from my experience, it's all of them. But let me explain a little bit of what 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 whichever targetmarket is going to. Clinical affairs, 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 the reimbursement community for payers. Obviously, R&D. R&D left of their own devices I love because they'll come up with something.They'll create any widget, but does it have a home to your earlier comment? And that's really important to have. And so those are the key elements that I would say from a partnership. So 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 in 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 patient population, what do we thinkthat would 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 LOC is or different phase gates to know when is the decision going to be made to decide do we move forward or not, do we put more resources into this, resources meaning more people, more money to keep the next phase of development going,need to be built in and all agreed to up front. Because there's a great quote by Yogi Berra is if you don't know where you're going, how do you know that you're being successful? So it's to map that part out. And so I think that's an important part of the product development processand all the different functions play a key part to establish that.

Speaker 0909.3s - 920.54s

So it makes me think milestones, markers, as you say, like having this North Star. Would you say that your role has any influence in sort of the go-no-go decision-making as you afford?

Speaker 1921.44s - 1009.58s

I play a part along with my other counterparts. I think the biggest part that I 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 group thing because you think it's really, really, really cool. But if you don't have, you don't have to, you just emotionally fall in love with, right? And then you get into a little bit of group thing 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 the market say, what the customers say? Is this still in line with what we thought it was going to treat? If we don't have that to go back toand have a logical process, you end up going down a road because you 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 X, Y, and Z? Did we say that we're gonna get to feasibility by this stage? Do we have a clinical development plan and an easy, early feasibility plan to test, you know, in the clinic? Is it all bench top testing? All of these things factor in to 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 top of mind in these conversations.

Speaker 01011.84s - 1057.26s

From what you're saying, I'm inferring that there's some coming together of all of these roles to have these heart conversations. Do you do that and is it a regular conversation kind of every step of the way? Yes. To answer your question, yes. 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. You know, those are really hard conversations to have. So you have them and they're regular, I assume?

Speaker 11057.7s - 1058.08s

We have.

Speaker 01059.88s - 1060.56s

We have regular, I would say, phase gate.

Speaker 11065.86s - 1131.88s

Those are the probably more formal milestones to say, okay, these are the things that are required to review in a face 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. 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 and 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 best practices from a process is that there's a steering committee. I think these are the ultimate decision makers of 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 determine in the end that we want

Speaker 01131.88s - 1141.36s

to move forward with or not? 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

Speaker 11141.36s - 1204.2s

in the project scope. It's kind of like the contract, you go, okay, these are the things we're going to accomplish. At this phase gate, number one, is there feasibility that this product will actually work? So what does that look like? What are the metrics? How are you going to define that? Another phase gate may be, okay, are we ready to go into clinic?Are we ready to test this on subjects? And who are those subjects? Where are those subjects? And so we make sure that there's a safety and who are those subjects, right? Where are those subjects? And so we make sure that there's a safety and appropriate, I think efficacy of product 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 feasibility, there was a problem. We saw it in, you know, the second phase. So let's figure out what that looks like. Do we need to do different bench testing?Is there, 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 there's a natural way to step forward. And if we have to stop at whatever phase, we can go backwards and be very intentional as what we're looking for.

Speaker 01204.6s - 1225.04s

So it's the more formal process of what you've been talking about following that North Star EVENT, but we talked a lot about collaboration. I think the sistered collaboration is the feedback loop. Right. So how essential is the 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 internal team, like how is that integrated?

Speaker 11231.24s - 1238s

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.

Speaker 01238.78s - 1243.2s

Obviously, most of the devices that we create are for physicians. And it's done in a different

Speaker 11243.2s - 1335.6s

ways. So some of of it depending on the stage of development will 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 And so, you know, we look at how do their hands maybe? Is it very difficult? Where do their eyes go? Where are we seeing, you know, fatigue? What are they struggling with on thedevice? Because obviously, most MedTech ORG devices are done with physicians' hands, whatever the specialty area is. And that's a really critical part. Are they losing control? They're getting more control. 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 questions and observations from each of the functions are represented. So while my team does lead voice of customer and feedback in a, I think, bench testing or any of that, we do have medical affairs and clinical development observing because they'll be looking for potentially different things than what my team is. And I think that's the epitome of collaboration, is making sure that inthat 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

Speaker 01335.6s - 1357.46s

that feedback. A real diversity perspective. Right. That's lovely. So how do you identify a unique selling point? So you had talked at the very beginning, like finding the price point, making sure that there's space for that in the market. Right. How do you find the unique selling point? So features and benefits are always what people,

Speaker 11357.7s - 1463.78s

I'd say companies, not people, but companies go to. And so in my opinions, certain companies just focus on that. I think the early phase or early stage of MedTech ORG 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 your intended user. So an example is, how do physicians decide what product they're going to use? It's not always in the future benefit. It may be the emotional payoff that rewards the physicians.So, for example, certain physicians are much more about control than others. So is that really what you're talking about? Does your device lend 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. It allows me to be able to manage the time, you know, in whatever is an operating room or a Calphabor wherever they're doing the procedure. And so the selling point may be what the benefit payout is for that intended user, not necessarily that this is three millimeters or, you know, that that's a part of it, but that's not the selling feature. And so that's what I think is the most important part about commercialization is getting theinsights to what makes people pick products that they do. Why do 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 ORG. I mean, some people are obviously Android PRODUCT.But to me, if it was all logical, it was really easy, and everything laid out, people would all just use Apple ORG products. But they don't. There's a reason why, because there's an emotional behavioral connection

Speaker 01463.78s - 1476.2s

to why people use products. So there's so much more psychology than I expect it, because it's reading a room, reading a clinician, reading the space. Do you find another pivot

Speaker 11476.2s - 1489.36s

question? Yeah, of course. Questions on questions and questions. And I do wish our time is five hours instead of the short time that we have together. I have so many questions for you. So there's more psychology than I expected.

Speaker 01489.48s - 1505.82s

Do you find in your role that you have some team members, and maybe not specifically with Edwards Life Sciences ORG, but kind of in your experience, have a psychology background or some sort of behavioral health backgrounds, kind of help with understanding the unique selling points and that

Speaker 11505.82s - 1573.08s

strategy so interesting question Kaylee PERSON 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 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 thingsthan what a typical market research end or behind the glass scenario would look like. So I think that's probably the sophistication now of 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

Speaker 01573.08s - 1642.68s

been hearing is to be it, you know, it takes a village to build a medical device. My last episode is that it takes a village but also takes an entire country to build a medical device. So knowing you're adding in this entire this entirely different background that I never would have considered 10 years ago, 15 years ago. I never thought there would 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. 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, you know,how do you adjust your strategy for the different global markets and not just for that specific, you know, community in that market, but the regulations behind the different countries and kind of from a global scale. So how do you shift that strategy?

Speaker 11642.9s - 1842.46s

Yeah, that is, 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 LOC, it used to be, because at CE mark was a little bit easier to obtain,Europeans NORP had access to medical technology well in advance of the United States GPE. 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.Well, CE Mark was easy to achieve. Now, for a variety different reasons, and everyone's well aware that the breast implant fiasco and impact caused appropriately so more stringent regulatory requirements. I think it would be suffice to say thatmaybe it's gone too far to the other end of the guardrail now because, you know, the 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, which the intent was to come with, making sure that there was rigor behind productsthat get approved. But now the flip side of that is they 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 to be able to approve regulatory approvals in a timely fashion. But to your question about how do you look at from a global stage and where 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 markets, the United States being one of them, and Australia GPE has a private pay market where the consumer or the patient decides what they want and where they go. In the end, I think if you do 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 GPE is going to be creating a much more, I think, friendly regulatory environment to bring, you know, breakthroughtechnologies to, you know, the folks that are governed by the UK GPE regulatory ruling. And so it's how much are they willing to pay for that? And 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, in China GPE and or more developed markets. And so I think that thoughtfulness has to come up front when we think about design.

Speaker 01843.22s - 1878.88s

Very, very well said. And I had no idea just like how much this landscape has changed in such a short amount of time. Yeah. 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 educations for the clinicians or the end users, especially when those devices are more novel,

Speaker 11879.24s - 2011.36s

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. From a formal structure standpoint, professional education is under my responsibility, and their job is to create training manuals that will be used to trainphysicians 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 differentskill set into it so for a novel device as I mentioned to you we went we try to record everything that is happening when we have a physician using a device that's never been used before or in the 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? 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? What 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.

Speaker 02012.52s - 2015.3s

So it's, you spend some time on this.

Speaker 12015.8s - 2022.9s

We spend a lot of time in many years from the product development cycle to ensure that it is

Speaker 02022.9s - 2025.22s

as best as we can when we launch.

Speaker 12025.42s - 2118.32s

Now, that being said, sometimes after we launch a novel device, we will get feedback through initial product evaluation where we're very methodical and 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 determinesup front, and then all of that is digested, and we report back and go, was the initial product evaluation successful? And that might be, you know, some companies call a limited launch. And so do we go only do that with 25 centers? And once that gets all signed off, again, the steering committee then meets together and go, do we feel comfortable with where things are at? This time we include our sales organization because they've been in a critical part because the product is now commercialized and a very initial limited use in limited centers.And then if we go, yeah, this feels great, then we 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 wanna ultimately in the end, assure that number one, patients are getting the intended outcomes that 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.

Speaker 02119.24s - 2149.4s

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 just perspective in the very, very beginning would help course correct along the way. So then having this checks and balances at the end, there's that sort of final course corrections for the best health outcomes possible. Absolutely.And other outcomes, beyond health, actually, to that point. Yeah, absolutely.

Speaker 12149.5s - 2150.2s

You said that really well.

Speaker 02150.74s - 2153.68s

So I would not, if I had films this a year ago,

Speaker 12153.68s - 2157.02s

I would not ask you about AI machine learning.

Speaker 02157.48s - 2157.62s

Right.

Speaker 12157.86s - 2162.22s

But now that generative AI is everywhere and it's really democratized AI,

Speaker 02162.68s - 2177.24s

how has that today really changed your rules and responsibilities and how you see at and how you see it in the future? And I'm going to do a comma, however comma, the future could be a month from now with how

Speaker 12177.24s - 2309s

quickly this is progressing or five years from now. So however you want to interpret future. So 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 data sets, it is a great tool to help discern and kind of do whatever level of cutsthat 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 another, you know, clinical trial data. I see it 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'sinsights for sure. I think it's a matter of where and how though, because with the novel device, I think it's, there isn where and how though, because with the 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 the different test methods and the outputs, it may be able to say, you know what, for device manufactability, you need to have this machine, 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 in the product development cycle, because I think for, at least for my experience, for me personally, I've had very limited use in what my team currently does.

Speaker 02309.86s - 2345.28s

I mean, that's a very thoughtful and responsible way, I think, to think about AI. And so just jumping in, thinking about how you 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 ask 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 wayback, do you have any sort of advice or last thoughts for our audience about the medical device product development cycle considerations or

Speaker 12345.28s - 2404.06s

resources I will say it is by far the most exciting career that I've had you know and I talked about I'm going to call it my sabbatical and in biotech I think that if you are looking for impact on patients you're looking for working with incredible different colleagues, like engineers, people that have arts backgrounds, 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 med tech 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, Y.O.

Speaker 02404.18s - 2413.66s

Edwards Life Sciences, 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.

Speaker 12414.04s - 2420.66s

Thank you for having me, Kaley PERSON. It was a really great conversation, and certainly I'm very, very grateful for the opportunity.

Speaker 02421.36s - 2678.5s

And with those final words from YGO ORG, the first season of MedTech Women Talks has come to an end. I am so beyond touched when I reflect on the support from the industry around this series.We've had more than 10,000 plays of the first six episodes. This is before the episode you're listening to has even aired. So thank you for listening. I can't believe that the series is over.And I can tell you with full and complete certainty that it may be the end, but the end in this case is really just the beginning. We are going to continue on with this series with even more episodes. We're departing away from the season structureso that we can produce content as close to on-demand as possible. But before I go into the details of what's to come, I want to reflect on what we just experienced. So thank you to our incredible guests, Kirsten Carroll of Can Do Health, Dr. Catherine Rieger of intuitive, Dr. Vivian Golfan of Intuitive Ventures, Nicole Osmer of Health and Commerce ORG, Christina Holly of May Health, Rebecca Whitney of Zimbi, and of course, you just heard the incomparable YGO of Edwards ORG' life sciences. Each of those incredible female med tech leaders have helped me personally better understandthe medical device product development cycle from each of their individual perspectives. And I hope that they have helped you understand it as well. Huge thanks to our partner in this series, MedTech Women ORG. Thank you for believing in this idea when Tom PERSON and myself came to you and said we wanted to have a series that helped educate our industry, help bring our community together, and also help highlight the incredible female leadersthat we have in this space. And thank you to our sponsors. Confluent medical technologies, catalyze health care, aptics, and critics medical. The four of you allowed us to take this idea, this passion project of mine personally, and bring it out into the world. I encourage all of our audience to learn more about these sponsors. Again, we could not have done it without them. So to learn more about Confluent Medical Technologies PRODUCT, please go to confluentmedical.com. Catalyzed healthcare is at catalyzehealthcare.com ORG, and that's spelled C-A-T-A-L-Z-E health care.com.Optics, they just went through a rebrand, and it's so interesting and fascinating. You can find them at A, P, T, Y, X.com. And lastly, we have Critics Medical ORG. All four of these sponsors are the reason that we were able to go from, in our own way, ideation to market.What's next, you ask? Well, the sky is the limit. So we are absolutely going to continue developing this content. However, we are going to do it in a slightly different way. We are going to be moving the series under our sister brand medical design and outsourcing.It makes a lot of sense to take a publication that talks about developing medical devices and bring the series that talks about how to develop medical devices under that umbrella. So stay tuned. Please continue to visit Devicestalks.com to get access to season one of MetTech Women Talks and to listen to more episodes that are coming with a slightly different rebrandand a slightly different name, but the same incredible caliber of guests and the same partner MedTech Women ORG. Huge, mega, extreme thank you once again to all of the audience, our guests, MedTech ORG Women, and our sponsorsfor making season one happen, and I will reconnect with my audience, our guests, MedTech women, and our sponsors for making season one happen, and I will reconnect with my beautiful, amazing device talks audience come June with the newly rebranded series. So stay tuned for more incredible content. Thank you. Thank you.Thank you.