Gaurav Manchanda, Formlabs - Spotlight Interview | LSI USA ‘23

Transcription

Nick Talamantes  0:15  

Thank you so much for joining me at LSI in the studio. 

Gaurav Manchanda  0:18  

Nick, my pleasure

Nick Talamantes  0:19  

Why don't you tell me a little bit about the things you're doing over at Formlabs? 

Gaurav Manchanda  0:22  

Sure. So a bit of background on the organization first, I think so Formlabs is a roughly 10 year old company, founded by a few engineers, out of the MIT Media Lab, back in 2011 2012. We have a mission to make digital fabrication accessible to anyone so they can make anything that they would like. We started with core focus in traditional engineering industries. So product design, consumer electronics, aerospace, automotive, we entered the healthcare space in 2016. With through the dental market, and at this point, we've deployed over 100,000 machines globally, including 30,000 machines to the healthcare space. We manufacture the 3d printers and materials and provide those, that technology stack to Medtech OEMs of all sizes, biotech companies have very, and startups of you know, of all sizes as well, what we call a point of care manufacture. So those are hospitals using patient imaging to create patient specific devices within the walls of the hospital. And in some, in some cases, replacing devices that they would have otherwise purchased from medtech OEMs. And then we have a lot of university based and other resources, research institutions using our machines for next gen, and next gen research in the healthcare space.

Nick Talamantes  1:40  

That's brilliant. You guys have come a really long way in just seven years or so by my math there. You mentioned something interesting about the hospital owning it at the point of care. I'm curious, who owns that process? What is why don't you kind of walk through what a hospital can do once they have your technology in the in their facility?

Gaurav Manchanda  2:01  

Sure. Yeah. And I'll maybe one level level before that is, you know, 3d printing, historically, I think is has this connotation tied to only for prototyping only for r&d purposes. As time has gone on, and technology has gotten better, and our regulatory team is has been built up. And we do have FDA registered 3045 manufacturing facilities. So those materials can be used to produce and use devices at the point of care, or biometric OEMs, or the other parties that I mentioned previously. And that's unlock this can of worms, if you will, that's leading leading to this question. So if they were only printing, you know, tchotchkes or r&d parts, so it'd be a different conversation, but because they're now printing, based on patient imaging, converting that imaging into printable files of patient's anatomy, so they can prepare for the surgery more effectively, or size and implant on that patient's anatomy before opening the patient up, or designing a patient map surgical guide. So you know, essentially a stencil for the surgery. So they know to remove the entire tumor, but without any without removing any excess tissue or bone, for example, these are all these are materials that are that can be sterilized that are biocompatible. And using the or, and the process is essentially CT or Mr. third party software to convert that that DICOM set into what's what we call an STL file or an OBJ file. Our software opens that up helps you with orientation with, you know, some some print previews sort of functions, and we provide the instructions for sterilization and all of the data points for or the endpoints for biocompatibility as well. So we provide enough information for our customers to have confidence to use materials for any number of ways and we don't have any. On the medical side, we don't have any specific indications for use or recommended applications. We just say, here's a material that's been tested to be safe for bone tissue dentin contact, which is a official classification with biochem testing. Meaning you could consider using this for a surgical instrument or surgical device or surgical guide or implant sizing device. It's a it's a it's up to you to just determine how to make that and you know, we have what we call workflow partners. So I mentioned before the interview started, we work with Greenlight guru and other LSI sponsor we also work with GE Healthcare on the imaging side we work with saris on a sterilization side so we work with these third parties to ensure that the whole the whole process is safe and validated to some extent, right. So it provides enough comfort for folks to adopt our machines at the end of the day.

Nick Talamantes  4:46  

That's fascinating. You know, I'm definitely unenlightened. When it comes to the 3d printing world. What does it look like in terms of how many hospitals how many medtech companies OEMs how many any of them are utilizing 3d printing today.

Gaurav Manchanda  5:02  

Sure. So I'll maybe I'll think about it by use case. So I'll say it's, you know, we're fortunate to be the market leader and have high market percentage of market share. We and because of our unique view or approach is Extreme Affordability, and combined with the quality regulatory and, and performance that you would expect from a much more expensive machine. So, in practical terms, our machines are $6,000. And up right where the competition might be 100k and up. So we're a fraction of the costs, which leads to a lot more adoption, and adoption by smaller companies as well, they don't have the budget for a quarter million dollar machine from a competitor of ours. So we have, you know, we have solo founders, we have physicians working on the side in their basements or in their innovation departments or in incubators, and what have you. So we have very small companies who have adopted us, you know, 1000s of them have adopted our machines, from everything from for r&d, of course, and then manufacturing aids, jigs, fixtures to you know, injection molding, tooling, etc. And and use these unused devices I'm mentioning, on the larger end of the spectrum, you know, that the big, the big, medtech, OEMs, are a bit because of their size, or a bit slower moving or a bit more risk averse. And as a result, I think, you know, they're still leveraging us primarily for r&d. But we have a few confidential projects right now for bringing them over the line to end use, and use devices as well. So

Nick Talamantes  6:36  

that's exciting. We can't wait to hear more about that, then

Gaurav Manchanda  6:39  

hopefully, hopefully, everyone will hear about it when it happens, or when a few of these happen.

Nick Talamantes  6:44  

Sure. Can you indulge my intellectual curiosity a bit about the biocompatibility of 3d printed materials? How do you go about determining what to use? What's safe to be put in a body? If you're making an implant? Is there a lot of intensive clinical research that goes into that? Are you working with known quantities here for 3d printing? Why don't you talk about that a little bit?

Gaurav Manchanda  7:08  

Sure. Yeah. So I'll say that, thankfully, we have a very strong material science and regulatory and quality team, I'm not on those teams, I'm market development. So I'm building this market, but I know enough to be dangerous, you could say so with that disclaimer. So there are ISO standards for biocompatibility. Right? 10993 is a common one, there are various endpoints, so is it skin contact? Is it bone tissue, dentin, contact mucosal contact, and then there's so there's that those those columns, if you will, or those rows on the table, and then the other? The other variable is duration, right? So skin tone, skin contact for less than 24 hours for up to 30 days or for greater than 30 days. So essentially, the way you break those down, and that that applies to in the body or any other, you know, classification, if you will, right. So bone tissue dentin, how long do you need that device to be used for and then there's, there is an endpoint that has to essentially so what we do is, because we have many machines I mentioned previously, you know, 10s, of 1000s of machines in the healthcare space, we have a pretty good understanding from a different current current install base, about where the requests are coming from, we wish we could make this sort of device. Do you have Viacom testing for that? And, you know, over 10 years of receiving those requests, I would say we have a good some good market intelligence of our own to pull from and say, you know, people see people doing certain type of applications seem to be asking for these requirements, right? Should we convert that into a new product or a new material? Or do we have an existing material that would meet those needs if we just do the biochem testing. So one example I mentioned, you know, skin bone tissue dentin, mucosal. one outlier was ISO 18562 testing, which is specifically for gas pathway applications in healthcare. It's a mouthful, but we never thought about testing for that until the COVID pandemic broke out. And if you recall, you know, there was a shortage of NP, swabs of masks, etc, etc. There's also a shortage of ventilators and sort of necessity is the mother of innovation, right? And we had a number of our point of care manufacturers or hospital based customers, coming up with ideas on how to convert, you know, one ventilator to serve multiple patients with similar conditions or to convert other similar CPAP machines or BiPAP machines which were readily available and not utilized. And to the same degree that ventilators were so looking for ways to convert those into minimal minimally invasive ventilators. And one essentially one piece of plastic printed with our device was was needed to make that conversion happen, basically a connector for tubing from the BiPAP machine to make it a ventilator. But we didn't have this gas pathway application or this got gas pathway biocompatibility testing done. So that that one request came in, it was a pretty dire circumstance, obviously. And when that we'd hoped doesn't happen again. But that then triggered us to say, Okay, here's the material that we have in our library that will likely meet those needs. We did the testing to our to the international standards, received the data back and shared it with the world. And then, you know, adoption happened afterwards. So we're sort of in this, I would say, interesting chicken and egg situation as a manufacturer, and that, you know, the more data points we share, the more ideas come in, right? Sure. And it's always it's always a fun balance to say, you know, what, to wonder what question might be what people might be doing with our machines, if we had implant bio comp testing, for example, we haven't done that testing yet. And we're, you know, we might we might get there sometime soon. But I think the technology is sound, it's a matter of, you know, the regulatory environment, about compatibility requirements, etc, that we're now working on,

Nick Talamantes  11:06  

you know, you mentioned applications, and that got me thinking, Where are you seeing this? You know, three year 3d printing capabilities really being applied in orthopedics, cardio, which, which sort of market of are you noticing with your market intelligence? 

Gaurav Manchanda  11:21  

Sure, yeah. 

Nick Talamantes  11:22  

Are you seeing your technology applied?

Gaurav Manchanda  11:24  

Yeah, I think within the within the realm of, of surgery, I mean, surgical oncology, as you know, resection guides are or devices used to support surgeons and removing tumors is is quite common. So orthopedic oncology, imagine any complex surgery across various specialties. So, pediatrics is cross cutting, right? So pediatric spine, pediatric neuro. These are cases that we see quite quite often. You know, we, we have some visibility, if we're allowed to, we don't have a full picture in terms of HIPAA compliance and things of that nature. We don't, we don't sort of pry into what our customers are doing. But we, we certainly hear about it when they need our help or with orientation or printing support, things of that nature. So our data in our dataset is vast. And we're, I would say, orthopedics, vascular surgery. Surgical Oncology I mentioned previously, spine, CMF is very common as well. So there's a mandibular free flap operation is quite common. We have groups like Mayo Clinic, doing 500 500 Plus cases a year, where they using the same material of ours print a surgical cutting guide for the fibula, remove that fibula, that portion of the fibula bone. Use that to replace missing missing bone on the mandible. Imagine there's a tumor on your mandible, you need that removed. What do you do here? Well, turns out there's an excess bone in your fibula that you don't need. And you can look up the clinical data here. They'll use the cutting guide, size the the entire implant configuration with the fibula with titanium plate, in some cases on a model of a patient's mandible or what's remaining. So they can pre size that and then place the entire thing, the entire configuration on immediately as opposed to doing all of that while the patients could open and the or. Right. And so these are you can just have one CMS surgeon but you need a full team to work together and that sort of case.

Nick Talamantes  13:33  

That's really interesting. So as far as the materials go, I'm curious. Are you just working with plastics? What type of materials are you working with? 

Gaurav Manchanda  13:42  

Sure. So we have an SLA printer. So stereo lithography printer which prints liquid resin. And then we have a powder printer, SLS stereo, sorry, laser sintering or SLS, which prints nylon powders and the like. These are effectively plastics made in two different ways. So you we have nylon, nylon, 11 and 12 are most commonly used for surgical instruments. And then we have what we call our biomed materials. So those are made in our QMS made in the in the FDA registered facility, tested tall, the biocompatible or the ISO standard, as I was mentioning previously, and and they're locked. So our customers know that what they buy today in that material will be the same in six months or in three years, right. And we have FDA master files as well. So there's additional visibility into what's going into their devices because at this point we're serving our regulatory team is is serving our customers and supporting them with their own 510 ks for surgical instruments or other wide range of other devices that have been cleared in the market. And they need a level of compliance and traceability and sure quality control in order to in order to do that.

Nick Talamantes  14:57  

Well that's a great value proposition for when you're bringing on new A new companies to work with, they can just come to you for everything. Yeah, be assured that you guys have definitely dotted your I's and cross your t's.

Gaurav Manchanda  15:10  

Yeah. And one thing that comes to mind is, as we're talking about this as the this is across multiple technologies, and how healthcare and technology innovation, but typically you'll see teaching hospitals who have the budgets and the innovation labs and the r&d facilities and a mandate to push the limits and what's coming in healthcare right. Now that they have machines of their own. We're seeing them publishing very interesting research about the cases I was talking about previously, and many other types of applications with our machines. they'll publish that. And then two or three years later, and we'll get a phone call from a med tech startup or a larger company saying, Hey, we saw that we've been working on that for a while following the publication. We're hoping to commercialize that sort of process or that sort of device, can you help us with, with our submission, right, and it's is this interesting, sort of Gantt chart or diffusion curve where we're seeing point of care manufacturers or hospitals have, you know, testing things out or being the proof of concept, publishing their proof of concept results, and then a medtech startup or medtech company will bring it to market? Right. So the hospitals are typically not commercializing anything, they're just doing it, you know, within the walls of their hospital, and publishing, and then they're happy. And maybe the tech transfer office gets involved in what license the process or the IP or what have you to accompany. But in many cases, it's just a company saying, Okay, we see that, you know, there's there's no legal risks to taking this on. And we'll, we'll see what we can do on the on the public market. So it's, it's this, in some ways, they compete with each other, but in many ways, I would say point of care also supports the medtech space in that way.

Nick Talamantes  16:58  

So how quickly can your device produce something needed at the point of care? Are you waiting a couple hours? What is the process look like?

Gaurav Manchanda  17:07  

Sure, yeah, so the two main variables for that affects speed are size and density, right. So in other words, the more material you need, the longer it takes. That's what our current technology. You know, we are commonly used for trauma surgery cases, and bone cement or PMMA, molds, things of that nature are emergency emergency surgery cases. So certainly, within 24 hours at the at the high end, most geometries, you know, typically, you don't need a surgical guide to be extremely large. So I would say in most cases, we're looking talking about less than 12 hours. And in some cases, I'm trying to think about a small geometry, you could do a mandible model, and four or five hours, for example. And there are techniques you can use to, you know, to hollow it out if you need to be a physics previsualization, for example, but there are plenty of tips and tricks that we share, to get that speed to be an investor. But certainly same that same day.

Nick Talamantes  18:06  

That's, that's great. I mean, that's such a helpful resource, especially when you can produce customizable solutions, as you mentioned, for surgery, or to address an on demand need and within the hospital due to material shortages. That's, that's fantastic.

Gaurav Manchanda  18:22  

And I'll add there and say, you know, if you're thinking about Production Production cases, during COVID, again, let's talk about I think we're all burned out from that from the pandemic. But just one example, you know, we have machines that are the size of a microwave, let's say, for ease of ease of reference, machines that size produce globally, over 70 million swabs was stocked out during the pandemic. So researchers at USF Health and Northwell Health in Florida and New York, work together with us to create a 3d printed version of the swab. And all of our point of care manufacturers and government agencies and even some medtech OEMs, and dental labs even all pivoted during the pandemic to print these swabs and 70 million printed in a handful of months, it's quite a quite a number. So it's really a matter of, you know, think about one machine has a certain amount of horsepower. If you need more than that you add to your fleet, and then you can peruse millions of devices and you know, in a limited time, so it's, you know, there's a one to one ratio, but it's also very modular and scale, scalable in that way,

Nick Talamantes  19:27  

what's the rate limiting factor or variable that can increase or yet really increase? How fast these devices are able to print out parts and implants?

Gaurav Manchanda  19:40  

Yeah. So I mean, we're, we're in a in a, I think, a unique position because we want to make sure that these machines are affordable at the end of the day. And I mentioned I think at the beginning of the interview, some of our competitors have similar or identical technology, but it can cost 10 20 30 50x in some cases. is, I mean, they might be bigger, they might be 5%, faster things of that nature. But they're not accessible, right. And our whole mission is to get more machines out there and enable innovation across the board no matter what size company you are. So rate limiting factors might be laser power, for example, or more build sides. Right, the more we're getting heavily involved in the, the orthotics and prosthetics market and corrective insoles, right, if you have diabetic foot ulceration, or if you have some sort of pathology that requires correction of your gait, people are printing insoles in the 10s of 1000s per week, this is a function of how many machines they have, right, so one machine can do a few 100 in a week, whereas if you have a larger farm, you can do quite a bit more. So I mean, really, our approach is more akin to, to, you know, just just servers, right, you can have one, one device, but then as you stack them, your bandwidth grows and your resources grow. So

Nick Talamantes  21:03  

That'sa fascinating approach to deal with the sort of how many devices the volume of devices you need to be able to produce.

Gaurav Manchanda  21:10  

And I will point out, it's, we know, we have 40 40 plus materials available today across those two print engines. So one machine can be swapped out to use any one of those materials. So you don't need to, it's not just a one to one, so you have some flexibility in that supply chain, as well. So you can have elastomeric materials that can that can bend and flex, you can have rigid materials that are used in the or, you know, getting hammered in the or, for example without breaking. So depending on the properties you're looking for, and the color and the performance that you need, you can use one machine for the full spectrum of mechanical properties, as opposed to needing an entire changing your entire production line over. And that sense. So,

Nick Talamantes  21:54  

Gaurav, what are you looking to achieve here at LSI?

Gaurav Manchanda  21:57  

Oh, good question. So it really be because we serve. We serve biotech companies across the life sciences, we serve medtech companies, of all sizes. There. I think this is uniquely positioned to get us in front of both audiences. It's hard, you know, we can all name the top 10 metric OEMs and their accounts of ours. But it's a different thing to to get in front of startups are promising startups and they promising is the key word there. Because, you know, anyone with an LLC can go to any trade show that they want, and get a business card printed for free, and that sort of thing. But because of the due diligence, and LSI does, all the presenting companies, we know, these are budding companies with either funding or revenue, or both. Maybe they have our technology already. Maybe they are considering it. If they're making any sort of physical product, IoT or otherwise, they need to prototype they need to think about their manufacturing line. They could consider additive for their final use products as well, or components of the of the final use products. And we have examples of that our booth, you know, across the prosthetics, the surgical arenas and others. And we're here to ensure that they know they can consider us not just or us meaning the 3d printing as a whole, not just for prototyping, but as they go from that concept to compliance to commercial commercialization. So we're really just here to, you know, hear from hear from all of them, meet and greet some existing customers and then raise awareness with would be customers.

Nick Talamantes  23:42  

Well, I wish you the best of luck spreading the word. I will definitely be swinging by your booth later today to see what you guys are doing. Check out some of those examples of implants and things you got like that. Thank you so much for joining me in the studio.

Gaurav Manchanda  23:55  

My pleasure. Thanks, Nick. Appreciate it.