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How Lazurite Scored Rapid FDA Approval for Their Wireless Surgical Camera · StartUp Health NOW Podcast

• 0:00
  [ on-hold music] Welcome to Startup Health Now, the podcast where we celebrate the entrepreneurs and innovators reimagining the future of health. I'm your host, Logan Plaster.
• 0:16
  In health innovation, sometimes the eureka moment that sparks a business is subtle.
• 0:21
  Maybe you're a doctor clicking away on an electronic health record, and it dawns on you that you could do the same thing with fewer clicks. An idea is born. At other times, inspiration smacks you in the face.
• 0:32
  Or in the case of Eugene Malinsky, the co-founder and CEO of Lazrite, smacks someone else. [on-hold music] I was in an operating room, and they were about to start a surgery.
• 0:46
  They had the patient prepped, um, and if you can sort of visualize this, right? There's a patient on the table, staff all over the place.
• 0:54
  The patient's already intubated, and, uh, everything is getting ready to start the, the procedure.
• 1:02
  And a PA walks by the table and unfortunately trips over the cables from the camera and falls, takes a really hard fall. And that's supposed to never have happened, right?
• 1:18
  Like that, that sort of just like blew my mind. They had to cancel the surgery. I heard later that, uh, the PA was, uh, actually o- out for a while because of that. Sort of saw, my God, this is, this is crazy.
• 1:32
  How can this be happening? At this point, this was, uh, seven years ago. I was like, there's nothing technological preventing wireless camera technology. The hurdle was it's really, really hard.
• 1:45
  Nothing in physics was stopping it. It doesn't mean it was easy.
• 1:50
  [on-hold music] That fateful day in the operating room set Malinsky on a multi-year journey of creating the world's first wireless, minimally invasive camera system for use in the operating room.
• 2:03
  The big challenge, as he'll explain, was getting a powerful enough light system into the unit.
• 2:08
  This month, Malinsky and his team celebrated the milestone of receiving FDA clearance for their camera, so we caught up with them to hear the latest.
• 2:16
  We also hit Malinsky up for some practical advice on navigating the FDA process. One tip: find and invest in an experienced regulatory partner early in the process.
• 2:27
  Without further ado, here's my conversation with Eugene Malinsky from Lazrite. [on-hold music] Give us a quick overview of your company, what you're building, and what your mission is.
• 2:45
  Wonderful. Um, and once again, thank you for having me on the show. Um, it's always a pleasure to participate with the Startup Health community.
• 2:56
  So, uh, Lazrite is, uh, really a, a very forward-looking company, uh, where we're looking to change how the operating room, uh, performs for the people in the operating room.
• 3:11
  So that's both the patients as well as the physicians and the staff, and really even the, the people behind the operating room, the administration and, and the facilities where they're at.
• 3:23
  Um, and, uh, we're looking at this as a multi-year, multi-product, uh, sort of, uh, journey.
• 3:36
  And as the first, uh, big part of that journey, as you alluded to, uh, we've actually, uh, just sort of hit a major milestone on, and that is we got FDA approval on our first product, which is called Arthur Free.
• 3:54
  And Arthur Free is the world's, uh, first fully wireless, uh, minimally invasive camera system for use in the operating room.
• 4:06
  [clears throat] So that was a lot of words to really say that we made, uh, a wireless camera that a physician can now replace their wired cameras, and the only thing they have is wired cameras, right?
• 4:21
  There are no other wireless cameras. We're really first to market.
• 4:25
  Um, and they can perform the surgeries that they've already been performing, uh, uh, arthroscopies, endoscopies, uh, GI surgeries, a- and a whole slew of other, um, minimally invasive surgeries that they're already doing.
• 4:45
  They can come in, and they can replace the camera that they have with our wireless camera and make their lives easier, uh, potentially make the, the o- operation faster, make the room safer, right?
• 5:01
  You, you don't have the cords. You don't have to be tripping patients up. You don't have,
• 5:07
  uh, uh, surgical fire risk because of the, uh, operating room fires from the current wired cameras, um, and a whole other, uh, benefits. But we can sort of get into that later. Yeah.
• 5:19
  The idea here is this is the first product
• 5:22
  in what we're expecting to be a number of products down the, the line, um, where we're coming in, and we really are trying to make a, a better operating room, a better life for the patients, the, the physicians, the staff, and the facility.
• 5:39
  Eugene, what led you to this problem? Um, what, what's your background a- a- and why the operating room? Y- yeah. So, so my personal background is, um, I'm a, quote, quote, "serial entrepreneur."
• 5:54
  Uh, this is company number five, um, depending on how you count. I've had an exits in the IT space. I had a number of companies in the IT space.
• 6:04
  Um, but this is actually my second company in the medical space.And I've always had sort of this interest in medicine. I've worked in the medical field as an EMT. I did some work at one of the Cleveland Clinic hospitals.
• 6:21
  Um, i- but I've also always had this engineering background as well. And so I found a way to sort of marry those together, the, the...
• 6:32
  my passion for medicine, my engineering background, um, in what was actually my prior company, and it was a, a medical device consulting company. Okay. And, uh, at that company, uh, called Dragon ID,
• 6:47
  which I also, uh, ran and founded and ran, um, the patient prepped, um... And if you can sort of visualize this, right? There's a patient on the table, um, staff all over the place.
• 7:00
  The patient's already, uh, uh, intubated, and, uh, everything is getting ready to start the, the procedure. And the PA walks by the table and unfortunately trips
• 7:17
  over the cables that are right there, um, from the camera and falls, takes a really hard fall, and that sort of was... That's supposed to be a never event, right? Like, that, that sort of just, like, blew my mind.
• 7:35
  Um, they had to cancel the surgery. I heard later that, uh, the PA was, uh, actually o- out for a while because of that. But I sort of... And in that moment- Yeah... I sort of saw, my God, this is, this is crazy.
• 7:52
  Um, how can this be happening? At this point, this was, uh, seven years ago. I was like, there's nothing technological preventing wireless camera technology, and- So what was the hurdle?
• 8:08
  The hurdle was it's really, really hard. [laughs] It turned out to be- Why? It turned out that there's- Why is it so hard? Nothing in physics was stopping it. It doesn't mean- Yeah... it was easy. Yeah.
• 8:20
  So, um, couple quick, uh, hits there. So, uh, number one, um, we ended up having to invent our own light engine technology. So we use a non-LED light. It is called the Meridium Light Engine.
• 8:36
  Um, and, uh, a whole lot of our base technology is actually based just around the light engine.
• 8:43
  Um, to put this in context, uh, currently in an operating room, if you're doing surgery, virtually any surgery, and you need some sort of a light in the body or near the body, you use l- a light box, right?
• 8:58
  They're universal. They're, they're available pretty much from every vendor. And these light boxes are something like 300 to 400 watts, and they're LED. Uh, they have a long cable that goes from there to the site, and
• 9:15
  that cable is very expensive, gets damaged all the time. And that's sort of what is the status quo. And here's us coming in with our light engine, and the Meridium Light Engine is able to produce that
• 9:33
  light that we need for the surgery in under four watts. Wow. That is two orders of magnitude less than what is currently used in the operating room.
• 9:48
  And you had to- And we can do it- And you had to invent that more or less in order to- We had to invent that more... No, no, not more or less. Yeah. We had to invent that. Got it. Okay. So [laughs] we had to invent that.
• 9:56
  So we have a non-LED lighting technology. Um, I mentioned earlier that we have a pipeline of products. A lot of our products are actually based on this. We have a tremendous amount of IP around just the light.
• 10:10
  We see a lot of uses for it in both the operating room, the larger healthcare and hospital environment, but also even outside of the medical field, right? Uh,
• 10:21
  w- was the statistic something like one-sixth of all global power usage goes towards lighting? Um, if we can make lighting more efficient, that's a huge sort of green boost, um- Mm... overall.
• 10:38
  Yeah. Interesting. So that- So part of the reason, part of the reason why we're having this conversation is because of the Ar- Arthofree, uh, camera, uh, came to market, uh, was FDA approved how long ago?
• 10:51
  Uh, just a couple weeks ago. Couple weeks ago. Congratulations. Thank you. I understand that you, that you got that approval in 90 days, and that that is, if not a record, very fast for getting FDA approval.
• 11:03
  So i- is that true? Yes. It is very, very fast. Um, we are very thankful to both our internal team and our partners.
• 11:12
  Um, I, I think what that really speaks to is the quality of the application that we put together, um, and really were able to show to the FDA are
• 11:29
  sort of the fact that how safe we are as a product and that we are, um, very similar to what our predicate is, but while also having all these improvements.
• 11:39
  So I, I think all that really does is just speak, um, well to the team that, th- that was able to put that together. Yeah. Uh, all the tests that we did and all the prep work that we spent years, um, creating. Yeah.
• 11:55
  Let's spend a little time on that idea because there's, there's a lot of folks who are gonna listen to this who are in the health tech space for whom FDA clearance is, uh, e- either a black box or just a giant hurdle, uh, something very scary they assume is gonna take two to three years, whatever, and it could.
• 12:13
  So I, I wanna hear from you some concrete sort of rules of the road for a successful FDA application.
• 12:22
  A- absolutely.So number one, um, rule of the road, and this is something we followed, is you probably are not gonna be able to do it alone. Um, we partnered-- In our case, we partnered with Micra.
• 12:38
  Um, Micra is, [clears throat] uh, one of the strongest, if not the strongest, um, regulatory advisor in the orthopedic space, but also a number of other spaces.
• 12:53
  And we partnered with them almost since day one of starting the company. [lip smack] I put together, uh, actually a plan. [clears throat] Um, here's how I think we can get through the FDA. Here's our 510[k]
• 13:11
  potential submission. I wrote that long before ninety-nine percent of the work had actually been done on the product itself.
• 13:22
  And by doing that, I was able to sort of set guardrails for us on what we had to hit.
• 13:30
  Micra then was able to take my work, um, updated it, cleaned it up, made sure that I really was following all the right rules, I really was, uh, on track, and we've partnered with them hand-in-hand the entire time, and they were actually the ones who put our submission in on our behalf to the FDA.
• 13:53
  And so seven years' worth of partnerships, regular conversations, and then obviously the closer we got to the submission, the more, the, the more we worked with them.
• 14:04
  Um, but it really is one of those things where getting the right partner at the top, at the start, is absolutely crucial. One. Number two, write your FDA plan, right?
• 14:18
  I don't care how light it is, but write your FDA plan at the start, and then- Mm... follow that FDA plan, right?
• 14:25
  So once we had that FDA plan, when we would do our, uh, internal development, when we would do our compliance testing, whatever it was that we were doing, wherever we were in the process, we would always reference back to the plan and make sure that we were still on track, and we were- Mm-hmm...
• 14:44
  doing the things that we were advised would be what the FDA was always going to look for. So that's- Gotcha. So that's, that's sort of two key elements. The third, obviously- But-...
• 14:56
  key element is you have to have the people internally. I, um, regulatory was one of my first hires. Um, and I have a, a fantastic team, um,
• 15:09
  uh, Patrick Burrito and Danielle Filkowski, uh, who have been with the company almost since the start, and, uh, really again, on the internal side, made sure that our internal team was doing what they needed to, keeping all of us in check, working with Micra, and then at the end, having spent a tremendous [chuckles] amount of time getting ready for the FDA.
• 15:33
  What I hear you saying is that that ninety days to approval is kinda misleading because you said for seven years you've been working on a roadmap, and you had- Mm-hmm...
• 15:43
  to sort of build the plan and then be ready and double ready and triple ready before you started the process, versus someone who starts before they have the plan and has to revise, revise another year, another year.
• 15:57
  You did the work ahead of time. Correct. Do the work ahead of time, and then h-honestly just stick to it, because we had many opportunities to...
• 16:08
  let's call false opportunities to sort of go a different way or, or go under a different sort of code than we were thinking about. A-and honestly, at the end, we, we pretty much stuck with almost exactly how
• 16:25
  I had written it up at the top. It, it's- Yeah... it's, it's almost eerie. Like, you can even, uh, some of the stuff changed because obviously at-- seven years had passed, but it, it was almost eerie.
• 16:35
  Like, here's what the device is doing, here's how we're putting it through, and here's why the FDA is gonna find that this is a good candidate for a 510[k].
• 16:46
  What's the most challenging aspect of applying for FDA or succeeding in getting FDA clearance? [clears throat] Um, all the work you have to do ahead of time.
• 16:57
  [chuckles] The submission is-- So putting the package together is daunting and took a long time, uh, both for us and our partners. But being able to
• 17:12
  know what you're doing, have a plan in place, at that point, you're just executing on the plan. So I- Mm-hmm... I'd say honestly for all the listeners here who, who are concerned about the FDA,
• 17:28
  the FDA is very much a critical path item. You have to get through it. It, it, in every circumstance it's different, in every circumstance it's unique.
• 17:39
  That being said, putting the plan ahead of time together, sticking to it, um,
• 17:48
  and then just really executing on all the tests and all the things that you said you have to do or that the FDA told you that you have to do, that's key and crucial.
• 18:02
  Um, and then honestly, just answer their questions, uh, when you do have the conversations with them. Yeah. A-any words of wisdom about kinda the financing of this?
• 18:13
  'Cause I think there's al-al-often struggles of how much should I outsource to an outside agency.
• 18:19
  You, you mentioned working with Micra, you said, early on, um, kind of-I'm sure that's expensive, paying the, paying the money necessary to have the right people on the bus early.
• 18:29
  But any words of wisdom around what to really invest in financially versus trying to do it yourself if you're really bootstrapping on a tight budget? Yeah. That's a great question. So I think
• 18:47
  our story that we told our financial backers, right? And we are venture and private funded, so just, just to be clear.
• 19:01
  Um, but the story that we told the folks who have trusted us with their money was only made better by the early onboarding of Mikra,
• 19:18
  um, as a strong partner to the company. Yeah. Mikra is a well-known name in the industry. They're an incredibly... Beyond being a good name, they're an incredibly strong partner. Um,
• 19:33
  working with them, putting that plan together was something I could show during a funding round, and that took a number of questions sort of away- Mm... from how are you guys going to be able to make this happen?
• 19:51
  What is the FDA gonna say? When honestly I can be like, "We're working with Mikra. We have a plan. Here's a short blurb of the plan. Here's our timeline," and that was it. And that was it, right?
• 20:04
  And for 99% of our investors, that gave them the certainty to continue doing their due diligence and eventually put their money into the company, um, because that was such a locked down part of the story.
• 20:23
  Interesting. No, that's a really interesting thought. I wanna switch gears a little bit and talk about the future of Lazrite.
• 20:30
  Um, you said this is really just the first of many, a suite of products centered around improving the operating room, both for the patient as well as for the provider. Um, so that can go in so many different directions.
• 20:44
  You have a background in medical devices. You're an engineer.
• 20:48
  Um, really you could attempt to solve any of a myriad challenges, and so I kinda wanna get at your philosophy of problem solving because y- you know, with Arthra Free, you had to, you know, invent this new way of, of lighting.
• 21:04
  And, uh, a- as you move to new devices, you're gonna have to decide, okay, what challenges are we going to try to solve, and how are we gonna create something that's never existed before?
• 21:15
  So as an engineer, I'm just curious, kinda what is your philosophy around, uh, this kind of problem solving? Yeah. Great question. So I think this even goes back to sort of the idea here that, look, we saw this incident.
• 21:30
  That sort of led to the development of the idea, then the company, and everything else that followed. [coughs] Our pipeline of products is very much a reflection...
• 21:47
  And I'm saying this both, both as an engineer but also as a CEO a- and all that. Um, it's very much a reflection of us working with our partners, physicians, surgeons, nurses, hospitals, facilities, um,
• 22:05
  to understand what their needs are, what is solvable, what makes sense to solve. You have to sort of triangulate a little bit. Um, but really once you start... I'll give you an example.
• 22:20
  Once you put Arthra Free into the hands of surgeons, right, the instant response is, "Oh my God, I love this. Where has this been all my life? I've been talking about this for the last 10 or 15 years. This is amazing."
• 22:32
  [coughs] And then they say, "Hey, could you also solve XYZ?" Mm. So we listen to that. We write it down.
• 22:42
  We then sort of have these conversations over, and over, and over again, and you start to see patterns emerge on what is a problem, what isn't a problem, what do people think is a problem but maybe really isn't a problem.
• 22:56
  So you start to sort of triangulate around where do people have these fundamental issues. You then look at the physics. You look at the engineering. You look at obviously money. You look at the time.
• 23:15
  Um, you look at the market, and you sort of try to figure out, okay, what, what of this is solvable? 'Cause like you said, there's a million problems that could be solved.
• 23:23
  And you then choose, okay, if I solve this problem, then this likely leads me to an innovation around something else that leads me to then solve this other problem that was identified.
• 23:35
  So you start building out, just like we've started, you start building out, um, a portfolio of both IP as well as products and engineering knowhow that you can then build on in order to solve these other pro- uh, problems that you've heard about or that you know about, um, and that you've tested and made sure that they are real problems with real market demand behind them.
• 24:04
  Interesting. Have you ever been in situations where the real innovation that you want to apply is to enable surgeons to actually use less technology?
• 24:14
  I was just working with one of our companies, uh, that uses virtual reality, uh, to distract patients during hand surgeries, and they're doing it in order to utilize fewer operating room hours and less general anesthesia.
• 24:30
  So they're using one piece of technology to actually do less, uh, and actually kinda dial down the complexity of he- the healthcare experience. Has that ever been your experience? Yeah.
• 24:40
  [coughs] So-I haven't spent all that much time on Arthafree, but that is really what Arthafree is doing, right?
• 24:48
  By eliminating wires, eliminating a number of boxes that are actually in the operating room, um, simplifying things, we're enabling the surgeon and the staff to perform better, safer, potentially even more efficiently
• 25:08
  with a piece of technology, you're right, but that, that eliminates other pieces of technology, that, uh, simplifies other stuff. So we are...
• 25:18
  A number of products that we are actually considering that we have in the pipeline are actually exactly that, which is there's, there's a lot to be said for
• 25:29
  decluttering, um, removing overhead, taking away some of the things that are being done right now that probably aren't necessary, but nobody's really created a better way of solving a certain problem.
• 25:49
  So we're... There is very much a niche there, and it's a very lucrative niche.
• 25:55
  Um, uh, that's getting to the end of our time here, but any final words of wisdom for a, a founder or an entrepreneur who's maybe earlier in their journey than you're at right now, maybe thinking about FDA, uh, and the process, thinking about bringing a device to market?
• 26:12
  Um, a- any, any sort of hard-won wisdom? Uh, yeah. Whether it's a device, uh, software, anything that you have to do with the FDA, um, uh, I'm gonna sort of repeat it.
• 26:26
  Engage either internally or externally with people who know what they're doing, who have done the work with the FDA, who have the experience. Um, even if you have the experience, rely on somebody else to back that up.
• 26:43
  Mm-hmm. Um, because it's, it's almost invaluable, right? Every single situation is unique, and if you don't
• 26:54
  set that plan up, if you don't consider what you're doing, um, you're probably just gonna take a lot of time to get where you're going, if you get there at all. Yeah. Uh, Eugene, that's great, great stuff.
• 27:08
  I love this idea that, you know, while it only took you 90 days to get FDA clearance, you spent seven years doing the, the hard legwork. It's like you were a seven-year overnight success like so many startups, uh, say.
• 27:22
  And- That's how that works... you, yeah, you did the hard work. You, you, you did that roadmap from the beginning.
• 27:27
  You, you established the right partnerships from the beginning, and when the time came for that important, uh, flip to be switched, you were ready. So, uh, exciting to celebrate that news with you.
• 27:38
  Um, congrats on the FDA clearance. Thanks for sharing your thoughts with us today, and I can't wait to see what you build next. Thank you. All right. Have a good one. All right. Bye.
• 27:49
  [upbeat music] Thanks for listening to Startup Health NOW. Startup Health invests in health transformers from around the world who are committed to achieving audacious health moonshots.
• 28:00
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• 28:08
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