Interview with Mike Graffeo, CEO of Fluidform on FRESH 3D Printing Technique and Entrepreneurship

It has been almost nine months since we interviewed Mike Graffeo, CEO, and co-founder of Fluidform, a 3D printing startup out of Carnegie Mellon University focusing on key applications using Freeform Reversible Embedding of Suspended Hydrogels (FRESH) technology.  If the average lifetime of a typical startup is five years, the one-year time of a startup is equivalent to 20 human years.  Check out the recording of this episode of Instagram Live on how a bioprinting startup was founded, lessons learned, ambitions, and more. 

The video format of this interview can be found on 3dheals.com.

Instagram Live occurs every Thursday to put the innovators, artists, and founders behind impressive 3D technology Instagram shares in front of the camera.  Want to join us next Thursday? Direct message us on Instagram @3dheals.

About our guest:

Mike Graffeo
CEO and co-founder of Fluidform

A senior executive with a proven track record in the commercialization of innovative medical technology, Mike is a results-oriented, decisive leader with a track record of successfully growing new businesses in both startup and growth organizations. Throughout his career, he has gained extensive experience translating highly complex devices and clinical data into successful businesses, both in the US and globally. Mike holds a BS in Engineering Physics and an MEng in Mechanical Engineering from Cornell University, as well as an MBA from Harvard Business School.

Transcript

Jenny Chen: 0:00

hey there this is Jenny Chen i'm the founder of 3d heels welcome to the lattice podcast the official podcast for 3d heels this is where you will find fun but in depth conversations with technological game changers creative minds entrepreneurs rule breakers and more focusing on how we can use 3d technologies like 3d printing and bio printing to reinvent healthcare and even life sciences this podcast will also include ama or ask me anything sessions past instagram live interviews with influencers and other direct engagements with our tribe welcome to our episode today mike thanks for joining us i want to give a little bit introduction about who you are you had a pretty strong engineering background you have been a biomedical engineer earlier in your career and then you went to business school one of the best business schools and then you work in the medical device industry for i would say decades right for many years

Mike Graffeo: 1:09

over 20 now yeah

Jenny Chen: 1:12

and then it's almost like fairy tale you found your college friend adam feinberg and then you co founded fluid form you know it's actually a very interesting story and so why didn't you share with us how that got started

Mike Graffeo: 1:29

sure sure happy to you know it's funny when i think about it because it was almost 25 years ago that i first met adam he and i were co op engineers at a medical device company and working in r&d on you know innovative new in that case cardiac devices and we you i think at the same time we both sort of got intrigued by some of what was going on in the field of tissue engineering i can remember reading those early papers you know you know the content at lab langer lab working on some really interesting work this was in the days when you know we had no idea what tissue engineering could be but i think it was on the cover of newsweek you know we're all gonna have 3d printers or tissue engineered organs in the next five years i knew that for me industry was the way to go so i have i spent most of the last 20 years in industry in medical devices and combination drug device products and launched for different pma and bls approval products and i get really fascinated with how do we bring products to market and how do we decide what the right product and the best products are to help people and in parallel adam was you know as a terrific researcher and went off and did his phd and then a postdoc at harvard and has been carnegie mellon for over a decade now focused on these central problems of how do we do tissue engineering the way that the body does not just sort of whatever we can make up so it's been really intriguing to watch that that research process come to fruition you know their their labs published some great papers over the years and while i've been mostly a business person for the last you know 15 years i still love reading literature i still love reading papers clinical and research and so when i had reached out in 2017 beginning of 2018 as to what was going on with their research and whether you know there was any opportunity there you know adam had a few other folks in graduate students in his lab were working on putting together a business plan and so it's a you know would you would you come out and take a look you know maybe maybe you might see something that we're not and he was just a really good fit is a tremendous group of people the folks in the feinberg lab at carnegie mellon are some of the best in the world and he was a real privilege to work with them on the thoughts they were having and start to try to ask some questions and shape things so you know we had a lot of fun kicking some ideas around and ultimately decided to put a company together amongst the five of us so then really fortunate to work with some world class colleagues and put into business together and i can say you know the the ability to work with people that you you can rapidly build a relationship either have a relationship with or rapidly build a relationship with because of that it's been you know it's been a real privilege it's really exciting it's really a great group and it's just an awful lot of fun

Jenny Chen: 4:19

ya know i can't imagine sitting around with brilliant people talking about creative ideas i mean that itself it's a it's a joy but but founding a company especially a company focusing on bioprinting you know somewhat of a i guess a very unknown path it's it's ambitious and it's it's kind of scary i would say so how did you guys decide that you're going to do this something that never you know there's no really i would say well established prior business models and the technology itself is super new how did you guys like jump into airship? What's the deciding moment?

Mike Graffeo: 5:03

Well, you know, it's really interesting question, I think the answer is probably different for each of the members of the founding team and for fluid form. And the answer is probably different for you know, every entrepreneur who does it right. Because there's, there's something that makes you realize it, I knew that I wanted to be back into entrepreneurship. I'd spent six years in startups, prior to my role before fluid forum where I led business development for a mid cap med tech company called insulet. And I love startups. I love the dynamicism of it. I love the ability to sort of actually think and change and make decisions in real time as you get really better information. I'm a strategy person, by my nature, that's the part of it that I love and relate to the best. So in startups, there's always strategy questions. So I knew I wanted to be in that kind of space. And for me, the question was, well, if I want to be in a startup, what kind of startup do I want to be in? You know, the end of the day, every startup is hard. There's always challenges. There's always difficulties, nothing goes according to plan. So if I wanted to be in a startup, I wanted to be in a startup that had a chance to change the world. Yeah, that to me was what attracted to me to an opportunity like this.

Jenny Chen: 6:09

You want to join a winning team?

Mike Graffeo: 6:12

Well, you know, it's, it's really hard to pick winners in entrepreneur. So many things can go wrong from market to technology to team to just external conditions. So betting on winners is a really hard game. That's why I feel like you know, whatever you pick, you've got to be really passionate about it. And you've got to have a lot of belief that it can make a tremendous difference.

Jenny Chen: 6:35

Yeah, Mike, I want to give the audience a little context of what your company does. I know that you have a motto, or some something that you can show people. And when do

Mike Graffeo: 6:49

I do? Yeah. So you know, at its core, we are a company focused on advancing a 3d bioprinting technique called press. That technique basically allows you to overcome what we think of as a lot of the limitations of the last 15 years or so in the field of applying 3d printing to biology. As some of the folks on the on the chat may be aware, 3d printing is really hard when your materials don't stand up on their own, when they're soft, and when they deformed when they fall over. Because then you can't really predict what you're actually going to print. So a lot of the 3d printing research in the last 15 years in the field of biology has been about how do we change biomaterials to make them more printable? in fluid form, we think about the opposite question, right? How do we change how we print to work really well with the natural materials of the body. And so we've developed a technique called fresh that allows you to 3d print inside of an environment where both you control how those materials stay where you want them, and how they chemically are processed. So you can encourage biological like kind of cross linking and other chemistry to be working. And so last little bit about some of the materials. You can see here, where what you're looking at, is about an inch and a half high, that makes it easier for me to carry around and show people you can see some of the detail down to the the LCA and the RCA and the la dee they're on there, that's about as much as you get out of it out of an MRI, you can also see down into the atrial appendage, and you can even see there's a little bit of valve inside there. This is an example of the sort of thing that, you know, unlike really small structures, you know, typically, you know, centimeter or two that we often see at a bio printing, and unlike structures that really don't have a lot of height, which is what we see out of bio printing because again, bio printing in air is incredibly difficult. We are focused on bio printing, not in air, but in these environments that we create called fresh. And that allows us to build at much, much larger scale. In fact, this you know, inch and a half size heart is just, you know, a tiny example of the kinds of sizes we felt there was a paper published in November of a full size adult human heart model out of alginate. But that was you know, a full six eight inch size heart. And that's that's no different printing in fresh than printing an inch and a half model.

Jenny Chen: 9:20

Yeah. Because you know, in the air, you're working against gravity, but because of this jail suspension, actually fresh stands for freeform reversible embedding of suspended jails is almost exactly what it is the acronym. Yeah, but in it, I was, you know, I was looking through reviewing refreshes, and there's a lot of chemistries involved. And so I'm sure there's like, all kinds of different chemistries that you can play with to create this chip do that for different kind of structures you want to print or something like that.

Mike Graffeo: 9:55

That's absolutely right. Jenny, one of the things that people first see when they see fresh As they say, Oh, you know the gravity thing, right? It overcomes the forces of gravity. So my materials that don't cure very, very rapidly can still be printed, because the gel will hold it in place. One of the things that takes a little bit longer to appreciate is that in addition to overcoming gravity, you're also printing into a controlled chemical environment. So for example, when we print collagen, which is a material, we use a lot for a number of the pieces that we work on. When we print collagen, we print an acidified collagen directly into a neutralized bath. And as folks online, who might work in the tissue engineering field know, when collagen goes through pH neutralization, it forms a certain kind of isolation, that happens, right, so the collagen cross links, and becomes a solid structure. And so we can use that behavior of collagen, to cause our materials to, to gel under those conditions, we can control that duration kinetics, we can actually make it do exactly what we want it to do. And that's just one of dozens and dozens of examples of the benefit of not just printing into an environment that overcomes gravity, but also an environment where you can control the chemistry around it. Yes, we print alginate, for example, we can print alginate, into a bath that has calcium, and calcium will cause alginate to crosslink around it. And so that gives us the ability to print a number of materials. And frankly, there's really no other way to print effectively without going to things like UV light. And otherwise, you know, UV lights a great tool, don't get me wrong, but there's some really, really interesting research being done with it. But we believe that in the long run the Our goal is to make things that have the potential to translate for repair and replacement. And for repair and replacement inside the human body. We want to avoid anything that's you know, foreign or non native to the body, however possible. So we definitely want to be able to take advantage of these native properties of biomaterials that, that let us do all the things that we can do.

Jenny Chen: 11:51

I mean, maybe you won't tell us but I feel like you can have like 100 patents just out of trying to tinker or different chemistries and different materials that you can create, because of these just slight modifications of the technique. But you know, one thing I really want to enjoy, always enjoy talking to you, Mike, is because you have a very strong business background. And I think, you know, a lot of us are super fascinated with technologies. And, and they are, deservedly, deservedly so. But commercialization is a huge challenge to a lot of scientists in the lab. I mean, even to me, you know, I'm not really from a business background. So how do you how do you tackle this idea that now you've got this incredible technology? How do you find a market? If it doesn't exist? Or how do you expand it? How do you find the right product to focus on? Because you have so many ideas? And, you know, potential areas?

Mike Graffeo: 12:51

Yeah, you know, it's a great question, Jenny. And I think it's one of the real challenges in this space. I see a lot of people chasing a lot of different goals. And, and there's a lot of different directions, any technology can go. You know, classically, there's the, there's the ability to say, listen, there's a gold rush coming. So I'm going to sell picks and shovels so that the people who are coming for the Gold Rush have the right tools. And there are a lot of tools, companies. In fact, that's where the majority of the company names that we know in the bio printing space are tools, companies. I do believe that gold rush is coming. And I think tools companies have a chance to be successful. I think that the growth rate and how fast that gold rush comes is an open question. And I think that it'll be you know, we'll find out over time how that works out. I also think that it's really important as a backdrop to remember that the idea of building technology that takes hundreds of millions of dollars to develop and a decade, there's a funding mechanism for that, right biotech companies do it every single day. And so the the reason why the biotech funding model works is because everybody understands, you know, if I identify the right opportunity, here's where the need is, and identify a technology that has a chance to solve that, yes, and the pathway to get from here to there, at least I understand what the steps are, then it's worth then we can build a series of tests with a, you know, large, large amount of money at each step along the way. So there's good funding mechanisms for that. The challenge, I think, for bio printing, in general is to develop the sophistication of his business model around am I a really competent tools company, and therefore, I can tell you when the gold rush is coming and what it's going to be worth, or am I developing real applications that make me look more like a biotech? And then do I have a credible story that I know what I'm going to do with my technology and I know how to get from here to there. I do find that, you know, most early stage companies don't have a good handle on that. And that makes it really challenging for you know biotech companies to do for companies that want to be biotech like to pick an application and to do their direct all their work on that path a lot of bio printing technologies are kind of enamored with what we could do a lot of different things and becoming enamored with we can do a lot of different things tends to lead people down the tools path which is fine but on the tools path you've got to come up with your own assessment of you know when is that gold rush actually coming and how many people are going to need picks and shovels

Jenny Chen: 15:30

so who is your who's your forum current focus in terms of applications and customers perhaps

Mike Graffeo: 15:40

sure so you know we are very much the the applications oriented company we do have a product available for researchers and we believe that you know there's pressure i believe right now is the largest bio printing platform that's been cited in the literature anywhere yeah so because of that and that's largely on the backs of the paper published by my co founder andrew lee and the rest of my founders in 2019 in science because of that we want to enable researchers broadly to do research on this platform we do think that there's you know no matter how much r&d we do internally folks in the academic community will always be able to do more so we have a product available and that is something that we think of more as an opportunity to collaborate with academia that is you know the business rationale for the existence of fluid form as a business we're all about developing applications and so we're really focused on taking steps that get us from here to there i think one of the key questions for any business in this space is how do you if your applications oriented how do you not build a you know seven year$500 million tests that you only get an answer on seven years from now because you know if you're building that and you have no idea if fda will just say yeah there's no way you know no investor is going to sign themselves up for seven years and $500 million and nobody's going to develop an application for a lot less than that so you know the core question is how do you mitigate the risk along the way how do you demonstrate that you are actually making progress how do you demonstrate that you are working with you know regulators around the world how do you demonstrate that you can run clinical trials on things that have been made using your technology and how do you do all that without focusing on something that's just not very interesting as a market because a lot of folks will say well we could do you know xyz market there's a lot of markets that you could apply bioprinting towards that aren't very attractive so you know you can do things in certain bioprinting spaces where there's some money to be made but not not you know billion dollar multi billion dollar markets to be chased after and that doesn't help you either right so the core challenge and this i think is the strategic challenge for any bio printing technology is how do you figure out where's that intersection of what we can do and what is what is the market that's really attractive with how do we demonstrate steps along the way

Jenny Chen: 18:08

and survive steps along the way

Mike Graffeo: 18:12

well listen i do believe very much down to my core that if you have a game changing technology then you've got a really really big addressable market and you've got reasonable steps to get from here to there to demonstrate that there are investors out there who want to fund those there's there's no question in my mind that there's a there's a lot of money looking for technologies that can change the game the core question is have you been able to think through all of those steps a lot of bio printing technologies have one piece of those three or maybe two but very few people are able to piece together a coherent strategy that has all three

Jenny Chen: 18:51

yeah well just based on the fresh technology itself i was thinking that maybe the applications along the way that you're thinking is some kind of structures as replacing your body components

Mike Graffeo: 19:05

yeah you know listen we are you know we're really excited about a few programs that we have internally we believe that because of our technology's ability to separate what's going on we can we can build functional things that are a cellular we can build functional things that are cellular as our ability to structure collagen gives us that flexibility so you know we believe that that actually opens up a lot of things that are more medical device like that we can actually start to build the clinical trial expertise the fda regulatory perspective all independent of this the risk of cellular eyes things which we can build in parallel but not on the implantable and then the idea would be to marry those two things up to be able to start to work on tissue for repair and replacement so that's really been core to how we structure it you know we we have two active programs right now one that's an a cellular implantable device like product pro Bam, the other one that's a cellular arised, non implantable pharma toxicity model. By being able to work on both of those in parallel, we think it's sort of de risks, the questions that are being asked in the space in a really intelligent way. Yeah, I

Jenny Chen: 20:16

mean, from our research seems to be a huge area of interest from all the bio printing companies. How does fresh stand apart from the other kinds of bio printing?

Mike Graffeo: 20:29

Yeah, you know, I think this is a really important topic when it comes to, you know, pharma is the, the classic fill in, right, so you know, we can bio print for research, and then there's going to be tissue and organs. And what do we do in between, and the every slide I've seen for the last three years, I've been doing this as well, it's going to be pharma. The really important thing to recognize, I think, is that the 2d cell culture is good at a lot of things. And were to the sale culture isn't good at things like microfluidic models and organoid, models and organ on chip models have been able to step in and make a difference. So if bio printing is to bring value to the pharmaceutical discovery process, bio printing needs to do one of two things. Either it needs to make the workflow on those other things better, being used as kind of a pick and place robot for precision droplet and all the rest of it and their folks doing that. Or it needs to be focused on making things that those other techniques can't make. That gives somebody in pharma additional insight that they otherwise can't get. And that's the thing I think, is really important, right? It's not just Can I make a model of a piece of tissue? It's not Can I use my bio printer to lump a bunch of organoids. Together? There's a great paper on fresh on that last year and fresh can certainly do that. But where we focus is where does the where does the physiology, the structure and the function and how they interact? Where does that give information that you can't get any other way? And that's an area that we think, you know, there's a lot of unmet need in the pharma discovery process, oxide, as well as on the disease model side. So that's how we're thinking about it.

Jenny Chen: 22:19

So we had a conversation yesterday to prepare for this interview, and you said, You wish you knew a lot of things when you just started the company. You want to share with us some of your past mistakes, or successes, and we definitely want to hear that through of just just I think you've been with flow form for like, two, three years now. So there must be a lot of lessons throughout. Sure. Yeah.

Mike Graffeo: 22:49

You know, the, I mean, if you want to listen to mistakes, the question is, how long do you have? Right, we've made most of them. And I think we probably still making some right now that we're going to learn about, we're going to continue to try to correct and get better. When I think about, you know what I wish I could know better, or what i what i what I've learned or what I wish I could go back and do better. You know, I really think about a couple of areas. Number one. There is no signal in the market that I wish we had asked earlier, there's questions that we asked the market that we didn't ask two years ago that if we had, we would have made different decisions sooner. I really do believe that the quality of the the business outcome is directly correlated to the quality of the questions that you ask. Right? So you've got to be out talking to the market, you've got to be talking to the people who can be using your product, and you've got to understand where their pain points are. We did that. But I always feel like we could do that faster, we could do that smarter. I also think that our our ability to sort of pick these programs that we're in the process of developing working on right now. It took us a lot a little bit longer to sort of land on what we wanted to work on and why. And I think in part that was because our platform can do so many things. So we sort of delayed the let's pick a program and just work on it longer than we should have at the expense of let's talk to everybody and figure out what else they might need. And I do think you know, going back earlier, I would I would go back and just put a line in the sand and start working on something. And if we needed to change, then we'd change. I think that's probably the single biggest thing. I would say, you know, on the plus side, the one thing that that I can say that I would absolutely do again, exactly the same way with no changes is, you know, when we set out to build our seed round, we set out to find a group of investors who not just you know, had money and were willing to write a check, but were actually intrigued by what we were doing, and saw us as a group that was worth it. Kind of going on a journey with. And we've been incredibly fortunate that our investors have been behind us have had our backs have been very supportive have been working with us, they've rolled up their sleeves, and they've worked with us a lot. And I know that not every startup can say that, we're incredibly fortunate to be able to say that, and I'm, you know, to this day, incredibly appreciative of everybody who took a chance on writing a check to support what we're doing.

Jenny Chen: 25:27

So any advice for a budding entrepreneur in this space?

Mike Graffeo: 25:33

I would say, you know, the only universal advice that I can give is, dream big. Don't let fear get in your way. And, you know, be relentless, go down and go out and knock down every door, until you find folks who are kind of part of your tribe, right, your, your energy, your your, your vision will attract your tribe, go out there and and put that vision out in front of as many people as you can and that energy will attract the right tribe.

Jenny Chen: 26:03

Yeah, it's easier said than done. For sure, Mike, but you've done it.

Mike Graffeo: 26:09

No, of you, right. I mean, that's what you have is building with 3d heals for as long as we've been talking for several years now. And I think that's very much what you've been doing as part of what I admire about you and how you built this organization. So I do I think that's a universal?

Jenny Chen: 26:25

Well, I think for sure this with the heels pass, allow me to emphasize with you guys the pain that you have to go through to get the word out to convince people, you're about your ideas, and you know, not give up because they're definitely painful moments no matter what business you're in. Well, let me see if there's some questions talking about there want to know. So Adam Feinberg is the scientist behind the technology, the lab that's behind it, who's one question? Anyone else has questions? Please ask right now. Let's see. So actually, I'm happy to post the links of any publications that you want to share, along with the post that I'm gonna write with this interview. Um, let's see. Okay, I think we don't have any questions today. Thank you, Mike, for this. Were very wonderful interview. I'm hoping to do it again. And maybe when you can finally reveal to us what exact application

Mike Graffeo: 27:31

that would be great. Yeah, I'd love to do it. It's my first time on Instagram Live. Yes. It's been a fun experience. Thanks for said, Well,

Jenny Chen: 27:37

you know, this is actually Instagram room. So this is live. Yes. But now we can actually invite up to three guests. So maybe in the future, we may even have Adam on this as well. That would be fun. Yeah. Well, have a great day. Thank you. Thanks. Thank you, Mike. That's it for this episode. Be sure to follow us on Facebook, Twitter, and Instagram at 3d heroes, and check out the links in the show notes. See you next time.