Scott DeFelice is CEO and founder of Oxford Performance Materials (OPM), the first company to successfully 3D print with the high-performance poly-ether-ketone-ketone (PEKK) material. In 2013, with its cranial prosthesis, OPM also became the only company to receive FDA clearance to 3D print patient‐specific polymeric implants before obtaining a second 510(k) for patient-specific facial implants in 2014. Aside from being a pioneer in the medical 3D printing industry, OPM operates an Aerospace & Industrial division, where it has been applying its proprietary OXPEKK® materials technology for applications in commercial, defense, and space aircraft. 3DPI’s Andrew Wheeler recently had the opportunity to interview Mr. DeFelice about the company’s past, present, and future.
3D Printing Industry: Tell me a little bit about the origins of OPM, and how you transitioned from a raw materials supplier to an additive manufacturing company.
Scott DeFelice: We started working PEKK in 2000, really developing composition, application and process technologies. In 2006, two things happened: there were some SBIRs that came out of the Air Force that had a desire to have a 3D printed polyketone, and PEKK is in a family of other high-performance polymers known as polyketones. Almost simultaneously, there were a number of surgeons who approached us and said, “we love your polymers, we have implants that are machined and molded for us, but can you 3D print with it?” At that point, those two things converged. We explored this possibility within the company, and decided that there probably is a processed method that would work. It was looked at and from what we knew about the polymer, we started honing in on Selective Laser Melting. We already had a deep scientific understanding about how the molecule behaves and we also had a pretty good understanding of how the material was processed in a variety of different ways. Though it took a long time to get to a commercial product, we could see a pretty clear path to get there. Both biomedical and aerospace were industries that we had sold into as a raw material supplier for a number of years, so really our focus was two-headed from the onset.
3D Printing Industry: Could you describe what it took for you to receive FDA clearance for OsteoFab® patient-specific cranial and then facial implants?
Scott DeFelice: PEKK had a very nice history of acceptance as a medical implantable material from the FDA, CE and other notified bodies around the world. For example, there were already 50,000 spinal implants machined and molded from PEKK already in the marketplace, and there was also a lot of core regulatory work done on the raw material. So important legwork like ISO 10993 testing, where you are looking at biocompatibility and purity, was done at that time as well. Going from that foundation to validating those same aspects in a 3D printed structure involved a pretty big climb, and then going to a validating process for patient-specific implants that are enabled by 3D printing was another big climb to manage. The FDA understands how they like to get a medical device to the market. Whether it’s molded, machined or printed is in some ways is irrelevant. They don’t really care how you get to the form of the device, as long you get to the form with the right controls, processes, validations and data to support safety and efficacy.
3D Printing Industry: How did the NIH sponsored project get going?
Scott DeFelice: The NIH study is part of an overall theme by which we use the enabling capabilities of additive manufacturing to introduce new functionality such as delivering active substances into the body that address things such as infection, and cell growth for example. Additive manufacturing allows you to do things that were previously impossible from a structural point of view. This led us to what we call multi-functional structures. So, you can have a structure that just stands there and elutes something, or one that conducts electricity. We have two commercial products for our industrial side: OXFAB®-ESD and OXFAB®-N. The ESD is both a structure and is electrically conductive, which is its night job. That’s how we think of our structures, the more jobs we can give them, the more valuable they’ll be to our customers.
3D Printing Industry: How are the drugs actually delivered through the implant? Within the 3D print are there moving parts or does it slowly dissolve into the body over time?
Scott DeFelice: So, that can be catheterized to the implant. Think of it as a reservoir with little streams coming out of it – these streams lead to the tissues surrounding the implant. So it is not eluting it is really just drug delivery, which brings up an interesting point. So a lot of the drug delivery technologies around today center around sophisticated and complicated chemical methodology. Additive manufacturing gives you the ability to not worry so much about that complex chemistry. Just think of it as a catheter that is filling up a reservoir and the drug’s being pushed out through channels printed into the implant. So it’s really simple from a delivery point of view, but it’s only enabled because we can create that complex structure that allows that to happen.
3D Printing Industry: How far along are you in terms of actually allowing a functional working device a patient could use or a doctor could use on a patient?
Scott DeFelice: Yeah, I would put that into the 3-5 year realm.
3D Printing Industry: I think our readers would really want to know if you guys are still using EOS printers for your industrial stuff? Or what kind of printers do you use for your materials? Is it EOS laser sinter kind of stuff or something else?
Scott DeFelice: Yes, we are continuing to use the EOS 800 printer.
3D Printing Industry: Have you guys made parts for silicon wafer companies? Maybe you can explain how OPM’s materials are that scalable and flexible that they can actually go that kind of complex, miniaturized manufacturing…
Scott DeFelice: Polyketone, this class of high performance polymers that we are working in, all exhibit very high purity, very high chemical resistance, and very high mechanical properties. So the bulk materials themselves have found substantial favor in semiconductor processes. This means that the method by which you go from a ingot of silicon to a chip, all 4 or 5 steps in that process – slicing the wafer, polishing the wafer, etching the wafer – require a lot of purity, high mechanical properties, as well as a lot of robotics. PEKK and PEEK have some favor in that market. So what we were doing was essentially going to the market and saying hey, you know those polyketones that you love and use all throughout your process in wafer handling and polishing? Now you can get that product in a very clean manufacturing process, in any shape you like. They’re used to buying billets of PEEK or PEKK and machining it, and molding very complex structures that require lots of tooling. Now we can just can say forget all of that, we are just going to print stuff for you using PEKK (3D-printed PEEK is not an option). It’s very enabling, especially in an industry that’s moving from 300mm wafers to 450mm. They’re really big and heavy, and now it’s necessary to have robots to that move stuff around and they want light, efficient structures to do that. So, additive manufacturing combined with a material they know and love is a really powerful and enabling tool.
3D Printing Industry: That’s great. I think our readers might be interested in the white light inspection system and report that comes with that.
Scott DeFelice: Yeah, so a lot of what goes on in 3D printing especially on the side of prototypes, is that they send files to a service bureau and there are people in the back sanding the printed parts, to make them good and effective prototypes. That doesn’t work in our world, because PEKK is very hard and very abrasive – so you’d be sanding parts for the rest of your life. As a practical matter, we don’t have the opportunity to make things that aren’t right, and our customers demand high specifications. When we make a cranial implant, you know, literally some guy is lying in an OR on a table and the top of his head’s off and you know, a part comes in a box and it’s got to fit, right?
3D Printing Industry: Oh yes indeed.
Scott DeFelice: So now we’ve shipped over 600 of these implants and they’ve all fit. There are commercially available white light and structured light scanning technology systems available. We cooperated with one of the companies that developed the technology, and developed something suitable for us that was faster and more efficient. We don’t sell it, and it’s not something we’ll do, which really just speaks to the fact that we’re an additive manufacturing company. We ship a product certified to a dimension. You know, we’ll certify, say a millimeter from the source file on all dimensions. It’s just a tool you need to have when you’re making end-use functional products from additive manufacturing, not just engaging in prototyping.
3D Printing Industry: I am interested to know how industrial manufacturing or engineering companies respond to or request your material. What’s the first step you take if you a company is looking to hire OPM to create a part? Do you guys just go over there and introduce the product, or how does that work exactly?
Scott DeFelice: So there is a great deal of confusion around this within the 3D printing industry. So, say I’m a guy and I have a machine and I tell the world someday people are going to buy my machine and they are going to build parts for the aerospace community. So if you go to that guy and say “did you quantify the performance of the thing that comes off your printer?” He says, “well, that is what our customers will do.” The claim on the “someday someone is going to buy those parts and they are going to build” is completely uniformed. So the informed claim – and this isn’t anything new – is that a market for the printer is not determined by the attributes of the printer. The market for the printer is determined by the attributes of the product that comes off the printer. And to illustrate what I mean by attributes of the product that comes off the printer, let’s take the case of our aerospace products, OXFAB®-ESD and OXFAB®-N grade. Both of those products were the results of contracts with America Makes. We received contracts to quantify the performance of the product that comes off the printer in accordance with test methods and standards dictated by the end user. That’s a really big point. So, the end users in our case, Northrop Grumman and NASA said, okay, we’re going to work with you guys and we are going to quantify performance – which means quantifying mechanical properties, electrical properties, chemical resistance and so on. In fact, it is called a B-Basis, and is actually what I was reading when you came in, because it is going to be presented as a finished product at an America Makes meeting next week.
3D Printing Industry: Interesting.
Scott DeFelice: So, that’s really the gold standard if you are going to penetrate those markets. The discussion you have when you walk in and talk to the Boeings of the world, or the Airbuses of the world, begins with the quantified performance of the product. It is done in a way that is tried and true in the Aerospace industry. This isn’t something that people in additive manufacturing had to think about to convince customers in the aerospace industry to try out so that they would feel comfortable with the technology. This is a standard B-Basis Allowables test regime that has been done on every material that has ever flown.
3D Printing Industry: Okay, I think that will clear up a big misconception, because I think a lot of people just think you say hey, look we have all the right properties you need, but it has never been tested, there’s no standardized quality assurance for the part, and that’s just not the case. A lot of people think that 3D printing is wildly out of touch with regulations and standards that already exist, they see it as something that is so unorthodox that people have to be convinced from an outsider perspective, and not as someone who is just following existing standards within the industry.
Scott DeFelice: So, the end users, our customers, you know, they do have to be convinced. And the way they are going to get convinced is to see that the material has to be tested and fully validated in terms of its technical readiness level, in terms of its performance, in terms of its repeatability, in terms of all the attributes—they do this all the time. This is something they do when they want to introduce a new material. The only additive manufacturing company that has a B-Basis, which is the statistical performance of repeatability, this big study that we did with NASA and Northrop – is OPM. So honestly, when someone comes and says, you know, we’re going to develop a new machine and we are going to conquer the aerospace world with a metal machine…my first question to anyone – in fact I was on a panel recently and some new guys have some new wiz-bang machine – then the question is, “what is the quantified performance of the product that comes off of the printer?” The answer was, “well, we haven’t done that.”
So someone has invested in the machine and they are making those claims without doing that, it’s, you know, it just speaks to the state of their business. It doesn’t mean their machine is bad, it doesn’t mean that their product is bad, it just means that that it is unknown.
3D Printing Industry: How many panels and speaking engagements do you do in an average week? A lot?
Scott DeFelice: You know, we’re not really heavily on the speaking circuit. We do some stuff, we are more on the industrial additive manufacturing sort of ecosystem, really not focused on, you know, all the machine builders and all the guys getting together and the 3D Printing space. We are more focused on what’s happening really in Aerospace, what’s really happening in Biomedical, what’s really happening in semiconductors… so we tend to, we are probably not the most well-known company in the 3D Printing world – but if you talk to people in aerospace or semi-conductors and energy, they would know who we are. We are pretty well known in those industries.
3D Printing Industry: Cool, it is always a good thing for people to know, because there are tons of conferences and they are all great and everyone is trading all kinds of information. There are standard claims that seem to be out of touch with what a select few companies are actually doing. These companies don’t generally appear at these things because they are either not desktop based or they are brand new AM companies.
Have you guys heard of Senvol Database?
Scott DeFelice: Yes, I have met Annie Wang (Co-President) on a few different occasions.
3D Printing Industry: There are so many 3D printing start-ups popping up every day and they are one of the companies that are really trying to provide clarity and real analytic prowess to industrial AM, I was just curious if you guys had interacted with them.
Scott DeFelice: Yeah, I genuinely like the fact that they are thinking about the materials systems, because the material systems are the fundamental determinant of the addressable markets. The machine alone doesn’t determine the total addressable markets. The material system plus the machine results in structures that when quantified determine the addressable markets. You can hammer the hell out of that point but it’s true.
3D Printing Industry: That’s a good point to repeatedly hammer home.
Scott: The industry is suffering right now from people still making the types of claims that really undermine the industry. Someone comes out and says, we just 3D printed the first something – last night it was, the Chinese company that 3D printed the first house.
3D Printing Industry: WinSun, yeah.
Scott DeFelice: So, okay, that’s a novelty, and I think from the trade press the thing that I find very frustrating, that causes a lot of confusion in the marketplace, is that those types of stories about someone 3D printing something that will never, ever be a business shouldn’t be stories. It’s just not a story, because no one is going to go spend money to 3D print houses. And I would just hope that there would be more discipline around the idea that because someone can make a shape it a) isn’t necessarily a functional and useful shape and b) even sometimes when is a functional and useful shape is still at 100 times or 10 times the cost of an non-3D printed alternative, no one will ever buy it. When you start doing that – when these stories come in – and you hear all the neat things people can do, and you finish the story, well, it’s not functional and probably no one will ever buy it, that’s sort of the reality check.
3D Printing Industry: That’s why I tend to highlight or underline companies that I think are really valuable in terms of cutting through all of the hype surrounding 3D printing.
Scott DeFelice: So that’s one big bucket of problems in the industry, the sort of story of businesses that really aren’t businesses, and the other is the repackaging of old technology.
3D Printing Industry: Oh, yeah.
Scott DeFelice: So you got a lot of companies – and I won’t name anyone – but there is a lot of that repackaging inside those companies. It’s basically 25-year old technology being re-positioned as a “manufacturing revolution,” when neither the materials nor the processes have been quantified in a way that is suitable, or proved to be suitable. What it really comes down to at the end of the day is the quantified performance – those two words – of the thing that comes off the 3D printer. If the answer is that we don’t have the data set yet, but we’re making big claims – that’s a situation where they need their pants pulled down.
3D Printing Industry: Right. I’ve only been reporting in this industry and in this industry for 8 months and within 3-4 months I was thinking up phrases like, wow, it’s “just another RepRap printer in the witness protection program.” They just have a different face, it’s the same god damn technology, so what is really going on here?
Scott DeFelice: That’s a great line (laughing).
3D Printing Industry: It’s just running on selling the future and that is cool and it really does have something to do with the industry and the narrative of technology in general, but it also does it a disservice because people don’t want to focus on what’s actually going on in terms of the evolution of technology that fits the bill of quantified performance. It gets out too early and too soon and all that stuff, so I hear you there.
Scott DeFelice: Because what happens is once you quantify the performance then all of a sudden you go to another level. We have B-Basis, the gold standard for structured use in Aerospace, so you as the reporter have to figure out how you actually determine the value proposition? So then you find an aerospace structural engineer to interview, ask questions like: How are parts approved in your world? What does it mean to have that performance? And here is the performance set, what does that mean? And now you are really getting down to the brass tacks. You could respond to answers by asking: Well if it’s that strong and it’s that light, and how many pounds of the part is going to be on an aircraft? How many aircraft is it going to be on? And before you know it, you have a story that really stands up to the test versus, well, we are going to develop a machine and someday someone is going to quantify it and someday someone is going to buy it.
This is why we have a clear leadership position in both biomedical and aerospace industries. In both of those sectors the average time from when someone wakes up and says they have this new molecule, to the time when the molecule is inserted into production, is 15 years.
3D Printing Industry: That is a very important point. I want to be the realist when I can and say, look, this 3D printing isn’t simple, it’s not magic. It’s not that easy.
Scott DeFelice: Yeah. So PEKK, for example, was first invented by DuPont in the mid- eighties. It was first used by Boeing Aircraft in the early-nineties, so they were already were familiar with it. OPM successfully got other compositions of PEKK on the 787, which is a recent aircraft, and now we are moving towards 3D printed PEKK on commercial aircraft. So, the lineage there is 15 years of work. So, in biomedical, polykeytone first started getting used around 2000 in implants. OPM gets its first implant in the body in 2006, and here we are 3D printing cranial implants in 2015. If you go and look at any other material system, penetrating those markets, it’s 15 years. No one has done it quicker, so when someone comes up with a new formulation that is running through their RepRap and says they are going to be making implants, it just doesn’t pass the test. Why did the world change, because you figured out how to extrude a filament?
The truth is, when you are supplying into these high value markets of aerospace and biomedical, there are all of these balances of capacities one needs to have. So, just as you can buy a little desktop milling machine and put it in your garage, you know, Boeing isn’t going to buy parts from you because you can make that part. The whole rest of the situation needs to be appropriate. So I believe there is this completely unrealistic assumption that because a hospital can get a printer to make an implant and put it in their basement, that this is going to be the right thing to do. The reality is that it’s not. We are in a highly regulated industry. We have to be ISO compliant, AS 9100 C, ISO 13485, and so on – no individual would be able to reach that level of sophistication. So when people move to AM, they need to forget about that idea.