Building a Partnership with your Regulatory Consultant

In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector.

From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.

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Key Timestamps

• [00:02:30] Christine's journey from biochemistry to medical device innovation
• [00:15:00] Insights on starting a medtech startup and the early failures
• [00:30:45] Effective collaboration with regulatory consultants
• [00:45:10] Handling FDA interactions and strategic submissions
• [01:00:20] Advice for medtech startups on navigating regulatory environments

Key Takeaways

1. Engage with local medtech communities and resources, such as accelerators or innovation hubs.
2. Early interactions with the FDA can significantly influence your device’s regulatory pathway.
3. Thorough documentation and clear communication with consultants are essential for effective project management.

Links: 

• Texas Medical Center Innovation Institute
• Proxima Clinical Research
• Christine Luk on LinkedIn
• Etienne Nichols on LinkedIn

Memorable quotes:

• "You're pitching all these awesome capabilities of your device, meanwhile on the FDA side, we're asking, who are you most like?" – Christine Luk
• "Every meeting is money. Making sure everybody is aligned and on the same page is crucial when dealing with consultants." – Christine Luk

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Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Sponsor:

This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed specifically for medical device companies. Streamline your processes and stay compliant with Greenlight Guru.

Transcript

Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host of today's podcast. With me is Christine Luck from Proxima. She is the associate regulatory affairs manager, and she has an interest.

She kind of came to medical devices, I guess, head on. Do you want to tell us a little bit about your background?

Christine Luk: Yeah. Thanks so much for having me today, Etienne. My name is Christine Locke. My background is in. Let's see here. My journey started with biochemistry. I thought I would be pre-med.

I was not. And so, I thought I would take a gap year and do a master's in biomedical engineering. It was not a gap year. And so, I. My background, I did my master's at Rice University in the global medical innovations program, which is very similar to the name of your podcast.

But basically, the focus of that program was the design and development of medical devices.

And I just. I just fell in love with it. And a big focus of the program was doing things like developing very early stage, from concept to prototype, and meeting with clinicians and gaining their feedback.

Part of that focus was startups, how to develop business plans, how to really validate that value proposition. And so right out of the gate, I joined. I founded a startup in the women's health space.

It fizzled kind of immediately, but leading up to that fizzle point, it was a fantastic experience. Gained a lot of insights, especially being in the Houston area, you know, with all the energy from the TMC innovation space, JLabs, all that stuff at the cookie factory, and formed a great network down there with lots of great people, lots of support in the space. And so, from there, I joined a medical device and drug therapeutics studio that basically focused on the commercialization of early-stage assets, supporting it through.

And so, I wore all of the hats in the hat store. I wore the engineering hat, I wore the project manager hat, the business, the sometimes patents and lots of grants, fundraising, all of the above.

And so, as my regulatory hat was kind of a flimsy little paper origami hat at the time, I needed somebody to help me out, and so that was my first time, you know, working with Proxima.

I, they were part of our grant, and so I worked closely with them to, from the very early stages for the project I worked on, and from informational meeting through pre sub and strategies for what our final submissions would be. And so, I knew nothing at the time, and so it was great. And so, I wanted to share with everybody today kind of what that transition was like and tips and tricks.

If you are in the same shoes as me, of, I've never worked with a consultant before, how do I get the most out of this relationship?

And now I work at Proxima.

Etienne Nichols: I love that introduction, and I love the multi varied background that you gave. And there's so many things that I kind of want to ask questions about, but I still want to go more into your background, if that's okay.

Christine Luk: Go for it.

Etienne Nichols: One of the things that especially stood out to me, two things, I guess. The Texas Medical center for Innovation, TMCI. Is that all right?

Christine Luk: I think it's TMCI at the time. They rebranded a bunch, I think they call it the TMC innovation factory now.

Etienne Nichols: Okay, was it a Nabisco factory? I don't remember. Yes. Yeah, we were there earlier in the Bisco cookie factory.

Christine Luk: Yeah. Did you see the little, the original signages they've got? And I think they used to have little Oreo cookie things on the floor to just kind of get that nod to it.

If you breathe in real deep, you can still smell Oreo. I'm just kidding. No, you can't.

Etienne Nichols: It was a great space, and, man, if I was in the Houston area, I would be there.

Christine Luk: It was great, you know, and whenever new startups come to me and ask, like, hey, how do I, how do I learn more? What are resources I can tap into? I always tell them, sign up for all the newsletters you can.

There's so much going on from JLabs to BioHouston to TMC innovation. And everybody in these groups is just so great to just talk to. They're very open. They don't, if they don't know, they know somebody who they can introduce you to.

And so, it's fantastic energy, and it's always growing, and it's grown so much, just even the last, like, four or five years. And another thing, I have to give a shout out to them. I help out with the Southwest Pediatric Device Innovation Consortium, the SWPDC, with Dr. Chester Koh at Texas Children's Hospital.

And so, it's an FDA sponsored program to help the development and getting pediatric devices through the FDA. And so, got to give a shout out that that's a resource for all of you pediatric device companies listening, you know?

Etienne Nichols: Absolutely. They need. It's close to my heart when I see people doing that, helping pediatrics. So, if we zoomed out just a little bit, some people may be saying, well, I don't.

I don't live in Houston, you know, but you could still apply that, because almost anywhere you are, there's. Well, not anywhere you are, but most metropolitan areas, there's some medical device community that you can get involved in.

So, I definitely recommend that. What are your thoughts?

Christine Luk: Mm hmm. Yeah, there's a lot of, not just like, there's a lot of great accelerator programs that are popping up in major cities as well. As, well, a lot of virtual opportunities as well.

So, if you are in a city innovating where there's not as robust of a network, maybe there's something virtual that you can join, especially, you know, in this post work from home COVID era. A lot of these have popped up exponentially in the last couple of years.

So, if you found yourself to this podcast, you're in a great. You're doing. You're doing the right thing, right?

Etienne Nichols: Yeah, absolutely. Okay. So, one of the other things I wanted to ask about was your failed definition. You said you failed early. What does that mean? What does that look like?

And how did you know for sure?

Christine Luk: Yeah, I mean, that's the thing about the med devices life sciences industry is it is. There’re so many things that could go wrong in all of the stages, from concept through commercialization.

But I think what kind of happened with us was, I mean, it was a straight out of a graduate program, and we all found our own full-time careers and took different directions.

It was just as simple as that. And it happens. And there were probably other technical things that we could have spent some more time on. It could have worked out, but at the time, some of us, or at least I in particular, wasn't quite ready to take that risk yet.

And many of my co-founders are now off doing incredible founding companies of their own and absolutely killing it.

Etienne Nichols: So, yeah, General magic from Houston, Texas. I don't know if you've heard of General magic or not, the little group.

I don't remember why this came up in my mind today, but just the group of people who got together before the iPhone, before the iPod. But these are the people who invented all these different things.

It was the most important company in Silicon Valley that no one nobody's ever heard of. But anyway, they failed. Everybody went their different directions. One guy started Android, one started.

Anyway, it doesn't matter.

Christine Luk: Oh, wow.

Etienne Nichols: General magic. It's an interesting story, but in ten years, we'll be looking back at yours. What was the name of your startup?

Christine Luk: Lily Speck. So, you might have heard Joanna Nathan, Caitlin Cherry. They've got parathoracic coda health now, so. Yeah. Oh, yeah.

Etienne Nichols: Awesome. Okay. Anyway, that's not what you wanted to talk about, so thank you for indulging me and going down that pathway anytime. So, working with the consultant. So, let's. Let's pretend you're at a certain point in the company, and I'll let you decide at what point you want to be in the company, whether you own the company, whether you're just working with as product developer, or where do you want to be in the company, and who do you think this story might pertain the most to?

And then how do you work with a consultant that you worked with and. And to get the most out of it?

Christine Luk: Depending on how you want to structure company, you know, you could have all this in house. You can hire in the expertise, or if you want to keep your team lean and just have consultants for different subject matter, expert areas, you can certainly do that.

Etienne Nichols: Well, let's talk about your criteria for deciding that. How did you determine what you're going to keep in house? What you were going to outsource? What was some of the criteria you went through?

Christine Luk: Yeah, well, it's kind of weird because the structure of the company that I was at, we were, we had a kind of our core team, and then for each project, if we needed, we had partners in different spaces. Like, for example, we were partnered with Texas Children's A&M for engineering and clinical.

And so, we wanted to keep that kind of central point of contact project manager as our in house, as sort of like the business expert, the CEO, but shared across different key people within the company sort of thing. And then as we grew, then eventually would spin out into its own standalone company. But at the time, you know, very early stage, and like I said earlier, med devices, startups, very, very risky.

And so, you wanted to de risk as much as you could in the very beginning instead of putting all of your eggs in a basket. At least that was the model that we took.

So that was kind of a rationale behind that, we had grant funding to support it, and that way we could just go deliverable and buy deliverable at a time to see what we really need in the future.

Because if you build all this out and you have to pivot, you know, then you got to change a lot of things around.

Etienne Nichols: I'm sure you had a lot of different consultants then that you were working with.

Was it difficult to juggle those? Or.

And maybe one of the things that I think about from a medical device perspective is I've got to make sure that whatever they're doing is quality driven. And so that might have been one of the difficulties.

You can correct me if I'm wrong, but how are you able to juggle those different things? And what recommendations do you have for companies to get the best relationship?

Christine Luk: Yeah. And, yeah, especially as you start getting somebody for regulatory reimbursement, quality subject matters, and also, like, groups to run your biocomp testing or animal studies, you know, the list grows really, really fast.

And so, it was definitely a big learning experience for me, juggling all of the ringmaster of the circus, so to say, making sure everybody is aligned. Who do I invite to every meeting?

What is everybody doing? And what happens if there are conflicts between consultants with different opinions? How do you resolve that? And how do you keep things under control in one meeting where these discussions are happening?

Because, you know, it's time and materials based, and so every meeting is money. And that was something that I learned pretty fast and something that I think everybody who starts working with consultants should be cognizant of.

And that's why it's extra important. How do I get the most, and how do I get the most out of these very knowledgeable people that I enlist?

Etienne Nichols: Yeah. If we take a specific example, one of the things that I think about that people probably aren't very familiar with is the actual interaction with the FDA.

What would you say are some things you wish you would have known, you know, before they approached the FDA on your behalf, or were you with them? What did that look like?

Christine Luk: Yeah. Oh, man. So, I interacted with the FDA twice at an informational meeting, and I did a pre submission meeting. Proxima took the lead on both, but I still was, like, part of the team that presented, responded to questions, things like that.

And so it was a lot of preparation and learning of the lingo to and but less so lingo, more so just being comfortable and making sure everyone who is talking was, like, on the same page of what you wanted to present and what you weren't ready to present yet because it would be, you know, bound into your file and written in permanent marker on your record, you know, things like that. And the most, like, appropriate way to structure a question was a big one for me, because the FDA is, you know, it's better to do a yes or no sort of thing.

Does the FDA concur versus a open ended question and then suddenly you do like it, 2 billion people, clinical trial, and you don't want to do that.

Yeah. So, it was a lot of strategy that I wasn't aware of, first off, and that's probably how I fell in love with doing regulatory work. And why I'm at Proxima now is because of that strategy of how to best approach showing your device to the FDA, what's the best pathway to take? And there's so many nuances that, and I get, I get a lot of companies, especially whenever they talk to me through the SWPDC, of like, there's a lot going on here.

How do I start? What are resources that I could go to to at least like, get a crash course of, what's a 510(k), what is a De Novo, what's a PMA? What am I hiding on? And then the extra central spirally crisis. And so, I love that so many people are putting out these resources of, because I learned these in my master's program as a PowerPoint in one lecture.

And then throughout my career, I just kind of grew and grew as a knowledge base, you know?

Etienne Nichols: Are there any things that you really wish you had known a little bit more, even even from your master's program? I mean, just one course might depend on how much you absorb if you're a sponge versus not being a sponge.

But are there any things you really wish you'd known before embarking on that journey from a quality regulatory perspective?

Christine Luk: I wish I knew a little bit more about. And I'm not just saying that's because Greenlight Guru is a QMS system, but I wish I knew more about the QMS system and how to actually use it.

You know, like, I got an idea of what the design history file looks like, but what about things like the quality manual and needing to vet your, your vendors? Didn't know I need to do that, but also, like, how to juggle that.

Oh, I'm doing R&D, and I don't. And I don't know if I want to start doing my risk. And what am I ready for this? Do I need to, like, cart before the horse?

You know, write down all of my design inputs because I already have a working prototype or like vice versa, and it's slowing me down and kind of figuring out how that fits into a real working.

Etienne Nichols: Yeah, you know, so what, what, at what point did you start doing design controls or did you make it to.

Christine Luk: That point for a lot of the. So, we started doing design controls for one of my projects, but we already had a functioning prototype. It just wasn't quite ready for animals.

So basically, when we were starting to design freeze, when we were starting to reach our design freeze and really iterating, and we have the general gist of it that we knew what we were developing our risk assessment for.

It wasn't just an idea in a cloud. We had a tangible prototype, and then we needed to fine tune it is when we started really digging deep, was a constant iteration of, oh, we need to add more details, but this is what we've learned, what we learned in our usability, what we learned in our bench, in our cadavers, stuff like that.

And so, I think what's really important when you start off a relationship with a client, even before you hire them in, as you start vetting different consultants and getting different proposals, like reflect, take a step back and realize what is it that I'm looking for first off, because things should be kind of deliverable, focused instead of a general thing.

What's your first goal that you're going to have to get? What do you have any time constraints? What is your, what do you have right now? Do you have a design freeze? Are you ready for this? Or do you just have a concept and your regulatory pathway is going to define or at least guide, what else?

How many bells and whistles you're going to put into your prototype? Basically, yeah. And so, getting that figured out, because then you're going to have to present that idea to the consultant and the consultant's going to be like, what are you explaining to me?

I want to make sure I get a grasp on it before I build a proposal for you, because otherwise I don't want to build something that's not going to be accurate to what you really need.

So, getting a firm understanding of that, and then whenever you're ready to start, like, what does the consultant need from me? I keep saying me and I interchangeable. I'll try to make this clearer.

Etienne Nichols: No, no, it's good.

Christine Luk: So, what would the, I'll say, okay, me as a client, what would the consultant need from me to best understand the device? What sort of documentation, what level of detail is it design inputs?

Is it just general specifications, user needs or published documentation that shows how this works?

That's going to be something that both the client and the consultant are going to want to discuss on, is what level of detail and also what level of communication is going to be had during the drafting of that deliverable.

Is there going to be intermediate inter, is there going to be meetings in the middle? Is there going to be rapid back and forth of emails? What level of communication we're going to have? Or am I just going to hand you a package and you're going to ghost me for a couple of weeks and then you're going to come back with something that's totally wrong.

So, I think that partnership of open line, of communication is super important. And especially, you know, especially if you're in these early stages, you're moving rapidly. Things are changing all the time.

Etienne Nichols: Yeah.

Christine Luk: That being said, being on the consultant side now, please version history and date your designs. I really appreciate it because that way I want to integrate something that's in an old version of a drawing that's no longer the case and so we can have the most accurate snapshot of your technology.

Etienne Nichols: Yeah, that's incredibly important. Absolutely.

Christine Luk: Doesn't have to be super formal, but at minimum a date and version of some sort. Awesome. Love it.

Also getting an idea of not just the current deliverable, but kind of what's your roadmap? What's coming up next? How much might that cost? What will you need? What will I need to be ready for that stage?

And so, kind of that high level overview of like, what are we working towards? What's the overall goal and then what's the upcoming goal? So that alignment's really important for that partnership.

Etienne Nichols: That makes sense. And there's a couple different perspectives. I can see a company or a company leader looking at this through. So, you might be thinking, okay, I need to know where my company is, what is my quality management system set up?

Or am I working towards ISIL 1345 certification, whatever the case may be, or am I just working for towards a submission? Maybe I already have those other things done. Just depending on who you're working with and what you're working towards, it makes sense.

Christine Luk: Do you have other indications that you want to add in the future? That if we find anything relevant, we can put that in our pocket for later, or if we want to start with a broader scope, if we want to start with a narrower scope, if you wanted to start pediatric and go to full adult in the future, future plans, what are things that. But then also being clear, what is your first FDA submission going to include? Is that going to be all the way to the end of the scope or is it just going to be the minimum viable intended use, so to.

Etienne Nichols: Say, crawl, walk, run? Yeah, yeah. And now that you are on the.

Christine Luk: Other side, crawl, walk, run to market first.

Etienne Nichols: Yeah. Right. One of my favorite questions to ask is, do you have a favorite failure story? Can you look back and say, man, you know, I really messed it up with this vendor or whatever, you know, this client relationship.

Christine Luk: Let me think. Because, yes.

Etienne Nichols: Change the names to protect the guilty, and you could be as me, I'm guilty. Just change, change the facts if you like. No, it's all good. But, yeah, just a general idea just to present the gist would be great if, if possible.

But.

Christine Luk: Yeah, no, I mean, I think one of my biggest things that, one of my biggest fails that I want to learn from is handling. Like you mentioned earlier, you have all of these different consultants making sure they're all on the same page and making sure the budget is being cared for and understanding what all of your payment cycles are and keeping an eye on what everyone's working on, what everyone will work on, and how that Runway looks for the next couple of months, next couple of weeks, especially if you're working on a constrained budget, like a grant or some sort of award from an accelerator or something, just paying extra close attention to that. And that's something that I also really value with any partnership is transparency from both parties of, hey, we're running low on money, or, hey, you're getting close to your.

What was proposed in this, in the scope of work, do we need an amendment? What's your, and just being very, like, what are, what are things being spent on stuff like that? You know, it's from a, more of a project management stand, client management standpoint that goes from, that's a, that's a communication from both parties.

And so that's, that's very critical to any, especially if you're early-stage startup. That's bootstrap for money.

Etienne Nichols: Yeah. So, are, are there ways or tactics you can suggest to have a smoother conversation when that comes up? Because I know a lot of people, they start talking about, they're not getting it done, and they need to get done.

You wait until you get to a certain threshold with an emotionally, you, you now may be emotionally charged when you have that conversation, or maybe not. I don't know. Did you experience anything like that?

And are there any tips you have in really facilitating that conversation?

Christine Luk: Yeah, I mean, that's the thing. Converse conversation is key. I think both parties, client and consultants, should not be afraid to nudge. If you're missing something or if you need something from me, don't wait.

Nudge. Because longer you wait, the more assumptions are made or, you know, your timelines get pushed back for, you know, FDA submissions take a while for the FDA to review, and then that pushes your pre sub, and then that pushes your minutes, and then they'll push blah, blah, blah.

And then you can't start your testing into, you know, it's snowballs. And so, communication early often. Don't be afraid to bother. It's fine.

It's not like I'm getting a team's message ping every 10 seconds. It's an email and I will respond. And, you know, I think it's important for clients to realize, and consultants to realize that the goal is the same for both parties. We want to get a successful, safe and effective device, or therapeutic, or combination, or RVD through the market, through the FDA, in an efficient manner with a strategy that makes sense. So just the goal is same, and so we will drive the same level of energy.

Etienne Nichols: Yeah. So as a founder, were you ever presented with the option to use equity to pay for some of these services, or did that ever come up in a situation? I'm always curious about that.

Christine Luk: Yeah. For the program or for the projects that I worked on, the startups that I, that I worked on, we focused on non-dilutive funding, so I didn't utilize equity at the time.

So, I don't have a good answer for that.

Etienne Nichols: Okay, no worries. No, that sounds good. Okay. What other, what other piece of advice do you have for companies who are facing these, these overwhelming requirements, you know, whether they're used to it or not.

What other pieces of advice do you have for companies who are starting to.

Christine Luk: Utilize consultants when you're doing your early-stage vetting? I love a good spreadsheet that lists every category you need and what, make sure that whoever you're vetting has that level of experience specific to the product that you're working on.

Let's see.

Yeah. And that way you can also use that spreadsheet to help track what level of community, what stage you're at with them, or if they've set your proposal yet. If you need a ping.

Again, just kind of having all those lined up in one place was really helpful for me. Who my point of contact is, when does my contract need to be updated, things like that? Kind of. From a more administrative management standpoint, I think that was really helpful because it gets really overwhelming when there's just so many different things that you need, and you, especially if you need to present it to the rest of your team, just to have those as an easy comparison is nice.

Etienne Nichols: Yeah. So, I'm curious more about that spreadsheet. I wonder if you can go into more detail about.

And I'm assuming we're taking this from the person who is getting a consultant. They're building out a spreadsheet of their needs that they want to receive from the consultant. Is that accurate?

Christine Luk: Yeah. Like, what. What are. What are the questions that you need answered? What are the gaps that you need to fill by a consultant? So, like, if you need a contract manufacturer to build out this component, what kind of machining do they need to do? What are materials? What is their expertise? And are they compliant with *** standards? You know?

Etienne Nichols: Okay. So, if we were to talk about that specifically from a regulatory standpoint, what are some things you typically see? And I'm sure you probably get this type of list from people before, and then you go down the road working with them for a little bit, and you realize, man, I wish they'd had this, this and this, but they didn't include it because they didn't even know that they needed that.

Anything come to mind like that?

Christine Luk: Hmm. Yeah. Like, if something pivots and suddenly you have a new magical material that you.

Etienne Nichols: Yeah. If something pivots or, you know, a lot of times, I mean, let's just. We're going to use the. I, like you were. I'm going to make the same. Go down the same road.

Let's say I, as a medical device company, I put together what I believe is a comprehensive list of needs for this consultant, and then two or three months go by, and that list of needs has doubled.

Nothing's really changed. It's just that I've realized so much more, and I don't know.

Christine Luk: You don't know until you know.

Etienne Nichols: Yeah. Are there common things that people leave out, or. Or is it just case by case? I mean, it could be either one. I don't know. If I'm relatively new to the medical device industry, I might not think about Iqoku.

PQS for machines, for a CMO.

Christine Luk: Yeah.

Etienne Nichols: From a regulatory standpoint, I might not be thinking about certain aspects of reimbursement, maybe.

Christine Luk: Ooh. Especially if you dive into clinical. There's a lot of stuff you don't think about as well. Starting off, I'm thinking about because I wrote a lot of grants in the past.

What were things that I didn't think about until I walked through the steps of my Gantt chart and then as I built out this Gantt chart of. Okay, well, now we're in this step.

My device now has such and such components that I didn't think about. I need a QMS system, or I need a.

I need to.

Etienne Nichols: And that's a good point. You actually went to a place you had the grant filled out, and that probably revealed that. Unearthed some things, I'm guessing. Probably.

Christine Luk: Oh, yeah, I wrote the grant.

Etienne Nichols: So.

Okay, that makes sense. Well, where I was going to is like, something like eastar, you know, where you look through and. And you're going to fill this out. So, you know, there's probably all of these different needs.

Different things like that are always helpful to me, I think. To think about what could unearth some unknown need.

Christine Luk: Definitely. Like getting an idea of what standards and guidances your device might comply with. Yeah, that's a really good point, and I'm starting to think about it now. Like, if I'm going to have to seek out a different lab separate from what I already have on hand to do this particular thing, or if that's covered by this wheelhouse, or if I could overlap this with another study going on, will I need sterilization?

What will that look like? Can my current contract manufacturer connect me with somebody?

Etienne Nichols: Yeah. Can it be gamma or ETo and all these different things? You just go down the rabbit hole? That's probably a good question. Maybe. And you tell me what you think.

But seems like that would be a good question in that conversation early on with your regulatory consultant. Tell me. My unknowns evaluate me, and you tell me what, I don't know if there's any way to give me a gap analysis on my own thinking about my device.

Is that accurate or a fair statement?

Christine Luk: Yeah. Like, as the client, I'm the expert in what I have so far. I'm the expert in the value prop. I'm the expert in how the device works and what goes into it. But for the next steps after that, it's. If I give that to you, what will the.

What will I need to do for the FDA? What will the FDA want to see to prove that it's a safe and effective device based on this, my baby, that I have spent so many years developing.

Etienne Nichols: Yeah.

Christine Luk: And I just so desperately want to get to market.

Etienne Nichols: Robert, what. What about personality differences? Because I could see that being something that would play into this partnership or this relationship between a client and a regulatory consultant. And I'll give you an example of what I'm thinking is if, if I care so much and I believe in my product,

I've pitched it to so many people, you know, it's going to work, and it is this and it's safe and it's effective and so forth.

I'm going to have to have a regulatory consultant who can say, hammer me home and say, no, you got to do these different tests because it's not truly safe until we know this is safe.

What are your thoughts?

Christine Luk: Oh, side tangent. That's something I wish I knew as a client. What am I allowed to put on my website? I can't say I'm FDA approved. If I'm not that allowed, what's some verbiage that I can or cannot put on my website legally?

That's a big thing.

And I sometimes see these on people with websites. I'm like, uh oh, you can't have that there.

Etienne Nichols: Marketing and labeling. Absolutely.

Christine Luk: Marketing and labeling is a big one that, you know, as a startup, you don't learn these things out of thin air. You learn by, unfortunately, learning the hard way usually. Hopefully not, but it happens. Back to your question, it's, you know, it's so funny because as a founder and you're pitching all these awesome things that your device is going to be able to do all of its capabilities, all of its capabilities it'll be able to do down the road.

It's safe, it works.

And it's funny because you want to show that you are groundbreaking, pivotal, disruptive. That's the term. That's the word. Disruptive technology. Meanwhile, I am over here on the FDA side going, okay, who are you most like?

Because that would be a 510(k) predicate. That would be. Then we could leverage their testing. But thankfully, now there's the De Novo pathway that you can kind of have that you don't have the full burden of a PMA, but you still have that novelty and that edge on your competition of being the first to market in that space, but still being able to leverage testing designs, at least by other groups, and be like, it's kind of like this, and it's kind of like this, too. Yeah, but, yeah, so it's just kind of those two different hats of, no, I don't want to change it.

Or I, you know, like, if it's justifiable, you, you've got buy in from your end users. You know, I think that's one of the most important things. And especially in early stages and throughout the design process, is getting that buy in from your end users, from your buyers, your.

Who's going to use it? Who's going to buy it? Who's going to pay for it?

Etienne Nichols: Okay.

Christine Luk: You know, yeah. What do they want? And if that's justifiable, that's a really.

Etienne Nichols: Good point that you bring up, too, about the. I think I'm novel, and maybe I haven't done a whole lot of competitive research, but I'm certain that I'm the only one out there when in reality, maybe I have a predicate and that could get me to market faster.

And the regulatory consultant, they're going to expect some legit market and competitive analysis so that they can actually make that comparison. That makes sense.

Christine Luk: That is a strategy you could take. You can. You can get clearance for so that you can at least, like, show that this, this part of the device is safe and then adding on new features that might affect the safety later on, but at least you have your base device that you could start marketing.

Etienne Nichols: Yeah.

Christine Luk: That is a strategy you can do.

Etienne Nichols: That's a good conversation to have, though. I. Those are. Those are interesting things. That's, you know, I want it to do any and everything, but like you said, maybe we can get to market faster if we just.

Christine Luk: Yeah. Do you want to do this as a tier, or do you want to do this all in one? You know, it's. It's a choice that you have to make as a founder, and maybe your advisors can help guide you with that as well.

Etienne Nichols: Very cool. Any other thing your investors want?

Yeah. Any other things that were missing or that you wanted to cover or thought about with this relationship or.

It's really interesting talking, I'm sure. You know, it's funny. We talk about, I was in this program; I founded this company. I failed. I did this. And between every one of those sentences, there's a whole lot of stories, I'm sure. And I don't know if you had any additional ones you wanted to tell, but let's me bind you some time here.

I'll tell you one that I experienced one time. So, as a project manager, I didn't really give you a lot of my detail, but I was working with one distributor, or one not distributor, manufacturer.

I was trying to get a component in, and I found out that there was an issue. Their tolerance was not measured the same that we were measuring our tolerances. And so, there was a big problem there.

Well, I didn't realize it was going to be a six-month process to get things changed and updated. So, my timelines were extended beyond, way beyond what I thought. So, one of the things that I think I would have done differently if I could go back is to have a better relationship to understand what their process was in updating the way they inspected that product versus the way we inspect it or whatever.

Christine Luk: All right, I've got one for you.

Etienne Nichols: Okay.

Christine Luk: This is actually with Proxima.

I if I were to go back and, you know, I talked so much about making sure you know what your goals are. And that's because when I started hiring Proxima as a consultant, I didn't know what I wanted.

I just assumed that, okay, I got to check a box. We got to get regulatory consulting going. Don't know what this entails, but we're going to do it.

Didn't know what was expected of me, what information I needed to provide to paint a full picture. We might have been too early even just because we didn't have those specific design inputs of how long did this device last for in the body, how was this deployed?

And there were still a lot of prototype changes that needed to happen. How might, and also really getting an idea of what our patient population was, those things that you want to make sure you have a story at least before you go in, or at least different ways that it could go mapped out clearly because that could impact your regulatory strategy upfront.

I flirted with 510(k). I even looked down the HDE pathway with this. And if it was qualifiable or not, I think a lot of time money could have been saved upfront if not only had we had a clearer pathway of kind of what our goals and timeline was, what we wanted to, if I could have a better idea of what we wanted to get out of the FDA, like what questions do we want answered in the informational meeting for clarifying for our next steps?

Now, granted, in an informational meeting, the FDA's responses to your question are kind of like, not as like, they're not tied to those answers, but at least it serves some guidance.

And I wish that also, as we went through, I wish I had logged those carefully of why we made those decisions, because then later on, a couple a year down the road, we look back at, oh, why didn't we check this out?

No, this is what we decided on at the time. So being I wish I kept a log of why we made those decisions.

Etienne Nichols: Yeah, that makes sense. That is something that we probably all struggle with a little bit. Every company I've ever worked at, how we got to where we are is a difficult story to tell.

And so that's really good to be cognizant of that early, because otherwise you're.

Christine Luk: Going to have a little deja vu. Moment of. Did we talk about this before?

Etienne Nichols: Yeah.

Christine Luk: Oh, let's look at this again. No, let's look at this again. A hand back.

Etienne Nichols: You know, and if the company goes long enough, the guy who made that decision and actually knows might have left. So.

Christine Luk: Yeah, that's why documentation is so valuable. Good note taking, good project handoff. That's. That's a lesson that I learned right there. Making sure that's all clear. Oh, my goodness. Yes.

Etienne Nichols: It's exciting to hear your story and how excited you are to hear even to talk about it. When even you use the word failure, it's still, you learn so much. And it's probably,

you know, it's funny how we think they're setbacks, but sometimes they're just setups for comebacks. So, I'm excited for.

Christine Luk: Oh, yeah.

Etienne Nichols: Where your future may take you.

Christine Luk: Yeah. I mean, when you, when you. When you. You have to fail in med devices, because as you fail, you uncover new things that you should have found out about. If you pretend like you're, you're succeeding and you're.

You're sugar coating, something could seriously go wrong. Someone could seriously get hurt.

Etienne Nichols: Yeah.

Christine Luk: Um, so it's so important to be brutally honest and just be real that so much can go wrong, and it'll be okay. There’re things you can do. There’re resources you can call upon.

Etienne Nichols: Yeah. Where can people find you to reach out more, to talk more about this if they're interested in doing so?

Christine Luk: Yeah, you can reach out to me on LinkedIn, just Christine Luk I'm on there. Or you can email me at my proximate email christineluk@proximacro.com. Thanks for listening to me.

Ramble. Thanks for listening to me at two x speed. I see you. Don't worry. This is for you. I was kidding.

Etienne Nichols: Very cool. Yeah. And we'll include the links in the show notes to her email and so forth so that you can easily get a hold of her. But very cool. Thank you so much for being on the podcast.

Christine Luk: Thanks so much for having me. This was a blast. Appreciate it.

Etienne Nichols: All right, we'll see you all next time. Take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone. Look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps others find us, and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening, and we'll see you next time.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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