Carpenter Technology's, Gaurav Lalwani, Medical Applications Engineer, and Brent Marini, Medical Strategic Business Developer, sit down with Chip Tomonto, Engineering Fellow at Johnson & Johnson, the world’s largest and most broadly based healthcare company. In this episode, we take a deep dive into AM topics for the medical market, exploring how additive manufacturing is positively impacting patient outcomes.
You can read the transcript or listen to the full episode below.
Intro (00:00):
Hi everyone. And welcome back to PowderHeads, a Carpenter Additive podcast. With each episode of PowderHeads, we bring you the minds of industry experts and delve into topics that are defining how additive manufacturing is making an impact on our world. We've got a special episode today with a deep dive in the additive manufacturing topics for the medical market and how its use is growing and positively impacting patient outcomes. Today's guest is Chip Tomonto an engineering fellow of 3d printing metals and ceramics at Johnson & Johnson. Chip joins two from Carpenter Technology, Gaurav Lalwani, Global Medical Applications Engineering Lead, and Brent Marini, Strategic Business Developer for the Medical Market. Many in the industry believe that additive manufacturing is transforming the medical and healthcare markets and Chip's experience and knowledge in this space, as well as his ability to speak on the topic is super informative. Thanks for listening and enjoy the conversation.
Gaurav Lalwani (01:25):
So today I have the pleasure of introducing Chip Tomonto. Uh, Chip is the engineering fellow, uh, for 3d metals and 3d printing metals and ceramics at Johnson & Johnson. Uh, he currently works on the front end material development and process development, uh, for 3d printing medical devices, uh, for, for Johnson and Johnson companies. Uh, previously, uh, Chip was a part of several J&J franchisees and he has a master's and a PhD in material engineering, uh, from Rensselaer Polytechnic Chip is a known and recognized leader in the medical 3d printing space. And we are glad to have Chip on our podcast today. How are you doing chip?
Chip Tomonto (02:13):
Good morning, Gaurav.
Gaurav Lalwani (02:17):
Great. Great. So Chip thank you for, for taking the time out and speaking with us today. Uh, I wanted to start by asking you about your additive journey. So when I look at, you know, your profile, you have a strong background of materials engineering. Uh, so would you be able to share a little bit about what you worked on, uh, previously and how your material science experience led you to the 3d printing space, especially for medical devices.
Chip Tomonto (02:57):
I've been working in and medical device industry for the last 36 years. Um, and so my, my pathway has taken me from implantable pacemakers into interventional cardiology, uh, where I was dealing with catheters and stents and wretcom, stent delivery systems and, uh, everything you would need to do for cutaneous, uh, surgical procedures into a J and J corporate role in technical operations. Uh, always working in process development, pretty much always working in metal, metal, and ceramic processing. Um, and, uh, and then, uh, J&J a number of years ago now I'm guessing it's about six years ago now decided that they needed to get into the 3d printing, um, uh, space. And so put together a team subject matter experts within J&J, uh, and started to develop, uh, the 3d printing center of excellence for J&J and, um, where that went is, uh, we've developed labs. I have a lab at the university of Miami where I do collaborate search, uh, and I have, I have three laser powder bed, fusion systems here of different vintages. Uh, I, and I have full capability to measure powder and full capability of measuring finished output, um, here. Um, and what we do here is develop process parameters, uh, and we roll them out to all of our enterprises within J&J I, and some of the strong players are orthopedics, our orthopedic space, our trauma space, uh, our two, two major areas, uh, where, uh, added manufacturing has already started to go. Um, and, uh, we're now looking at, uh, endovascular if some of the particular applications, uh, and some of the really fine, uh, parts that we make today. Why, why are we in it? Why are we in this business? It gives us the ability to, um, to make parts rapidly, to make custom parts for people. So product specific custom design, uh, is, uh, in the plans for the future. Uh, it also gives us the ability to take advantage of some of the 3d printing capability, uh, to develop products that are very difficult to build other ways, um, do not, um, 3d printing for everything, but we certainly know where its advantages are and we're targeting those advantages with our product developments.
Gaurav Lalwani (05:40):
Great. Great. Uh, so Chip you, you mentioned, you know, you've been, uh, in the 3d printing space when you transition, uh, from, uh, from, from your background in material science and metals, uh, to, 3d, printing about five years ago. Uh, and since then, you know, you're, you've been involved with process development, Parameter development, uh, for, for a lot of different applications across, uh, across the industry. Right. Uh, so my question is, uh, when you talk about advantages of 3d printing, right, uh, what specific advantages you would, you, you foresee, uh, have really played a significant role in, in getting additive manufacturing really in the limelight for, for medical, you know, we, we keep hearing about, uh, you know, 3d printing of some automotive parts and fuel nozzles. Uh, but what about medical makes it so exciting and so interesting according to you?
Chip Tomonto (06:39):
Okay. I think, again, there's two answers to that question. The ask commercial app application is the ability to put a porous structure anywhere we want to on a product design without having to do secondary processing, uh, to use a course or a porous code type of an approach. Um, so we can put a porous structure, uh, on the outside. We've also got the ability to design the inside of a part along with the outside of the part. So now I have the ability, for example, um, moving forward where I can make, uh, implants that emulate bone do not create, um, the, um, the, uh, supports that causes bone to die. Uh, fundamentally you have to have, um, you know, stress on bone to keep bones alive. Um, so that's another application. Um, and then obviously the third is I can make you a product that matches your anatomy exactly. Um, as with a sample size of one as compared to mass production, and then having parts that are close to fitting, but not, not perfect.
Gaurav Lalwani (08:00):
Hmm. Right. So following up on that Chip, uh, you know, talking about porous structures and porous integration, uh, is really a key value proposition for, for additive, uh, in medical. Uh, but if we touch a little more on patient specific devices that you just alluded to, uh, one
Chip Tomonto (08:26):
Comment I'll make at this point is Gaurav we also believe that additive will become competitive with traditional manufacturing processes, price wise. It has to go there. Um, we have to get the price of the standard part down to the point where it's competitive with traditional manufacturing, when that happens, sky's the limit. And that's true in all of the industries that you would be doing, uh, 3d printing with. Uh, and so I talked with Carpenter. The key statement to me is how do we get the costs down? What do we do to cost down?
Gaurav Lalwani (09:12):
Yeah. And that was, that was something that I wanted to also, you know, elude to, right. Uh, when we talk about patient specific implants and you mentioned, you know, an equal to one, and, you know, with that, you would expect the implant to be extremely costly. Uh, you know, it does not have economies of scale, uh, working in its favor as it would for traditional manufacturing. So in that case, when you combine that with all the pressure of reimbursements that you're seeing in the medical space, uh, how is that, How is that still a viable solution?
Chip Tomonto (09:47):
Is that, um, the additional there'll be additional cost on custom design. We're working on the work that needs to be done to bracket design so that we can rapidly turn design. We expect back the manufacturing process for will, will come down in price to offset the cost of the initial design work. And we expect that the mass production capability will be designed in a fashion that we have the ability to produce custom parts, sample size of one on a mass production scale.
Gaurav Lalwani (10:38):
How far, how far do you think chip, uh, are we in, in that journey to reach to that state? Uh, and, and if, if we are there already, uh, you know, when do we see custom patient specific implants going mainstream? And if you are not, how long do you think it's going to take for us to get to that Stage?
Chip Tomonto (11:01):
We have, we have product out today that fits in that definition.
Gaurav Lalwani (11:08):
Uh, Chip. I wanted to ask you another question. So, you know, we talk about additive manufacturing and 3d printing and patient-specific implants, right. Uh, in, in, in this situation, um, what kind of devices are we looking at? I mean, we, as you probably mentioned a little while ago, we cannot print everything. Uh, but if we just have to take a step back and look at the entire additive industry for medical as a whole, what are some of the key, major applications that have really made an impact?
Chip Tomonto (11:41):
Okay. I there's first thing, we were looking at medical instruments and we're looking at implants. Those are the two, two spaces, the medical instruments space, um, the work that's a lot of the work right now is being done in other robotic surgical space right now, uh, where we, you know, robotic surgery is going to be the, the direction of the future for, for most surgeries, uh, fundamentally three holes, one hole being a business hole, one being a hole to inflate the space so that we've got to work. And then one hole to be able to, for the borescope to follow, uh, all run off a robotic system. Um, with that being said, the precision of the end effectors that will be used in that are very high precision and small. So that's one area of great interest, uh, in the instrument space, in the orthopedic instrument space. Uh, there is a large amount of parts produced that we're open to look at 3d printing with in the inch, in the implant space. There's, uh, principally, uh, devices today in both the orthopedic trauma space, uh, that we're typically looking at for 3d printing. And those are typically done with laser powder bed fusion. We do have a belief though that we should be able to move to a binder jet, uh, with these technology would be as this technology develops stronger. And with that comes more volume at lower costs.
Gaurav Lalwani (13:27):
So we need and follow up on that. You're just building on that conversation. Uh, so when you talk about instrumentation, um, what kind of instrumentation examples would you be able to share, uh, that are 3d printed right now, uh, which will not 3d printed before, you know, and, and what kind of examples for orthopedic implants, uh, would you be able to share, uh, that are actually 3d printed now, uh, you know, versus being conventionally manufactured, you know, maybe five years ago, 10 years ago.
Chip Tomonto (14:04):
Yeah. What I, I'm not sure I can share in that space right now, because all of it is in some early stage four, we are coming out with a product hopefully this year that will go public at that time. And I can't jump the gun on that. And it does virtual manufacturing. It has full manufacturing pathway at this point, but we've what I want to tell you. For example, on the design side, early stage product development is all being done with 3d printing. And the reason we get faster design very, very rapidly with 3d printing, I'll use an example. Um, I'm not sure how this design works in a portion of the design. So I have the ability to make that portion five, five different ways at the same time and try it out. Um, and so we're, we're seeing absolute acceleration, um, product design coming out of 3d printing, and this will also launch it ultimately ended up being a commercial production. Like I said, there is verticals right now working on the product designs. There is a manufacturing pathway already set up, both in us and Europe to produce 3d printed parts. Um, and there, and there are programs, like I said, I really can't share.
Gaurav Lalwani (15:49):
So, you know, chip, I understand that, you know, 3d printing has made a lot of impact. And, you know, you talk about patient specific devices. You talk about instrumentation, you talk about implants. Uh, the question I have is what kind of material systems have really been used for 3d printing, uh, because when you look at the traditional, uh, medical instrumentation and device space, you know, uh, stainless steel, cobalt, chromes, titanium, and ceramics are some of the major material systems that have traditionally been used. Uh, what, what, what kind of materials are, are being used for 3d printing these medical devices?
Chip Tomonto (16:38):
Cool. Well, first comment I want to make is that we've pretty much proven that we can match right properties in most of those systems, uh, with 3d printing. So that's first day currently we are doing work in stainless, steels and titanium. Uh, we are not working in cobalt Chrome. And the reason being is the ISO mandate that you got to put a big label on the parts that say that they're potential cancer causing agent on anything that's cobalt based. So this is moving away from cobalt pro, um, with the, um, stainless is we've, we, one of our dominant materials, 17 four pH we do 360. It's not that big, a business for us. Um, 17 four pH is our big player there, uh, on the titanium side, it's high six for [inaudible], um, where we've done work in CP. Great too. We've done a work in time, Molly. Um, but the key biggest business is in 5, 6, 4.
Gaurav Lalwani (17:59):
Let's see. Brent, do you have any questions for Chip?
Brent Marini (18:03):
Yeah. Just On the materials side, maybe if you could wave your magic wand and develop, you know, the best material for additive manufacturing, what would, what would that kind of look like to you?
Chip Tomonto (18:17):
Well, I, again, I think there's two answers or two spaces that we are most interested when we look at, uh, additive there's direct energy deposition. There's a binder jet is on the metal side there's binder jet. And, uh, there is, um, laser powder bed fusion, the laser powder bed fusion powder as a whole is expensive. Uh, and I know it's got a lot of requirements, um, but the key is to get that price down. Uh, we have done work to look at the particle size distribution and how we can work with bigger particle size ranges, and that has helped some, but, uh, we still need to get that price down. Um, when you look at a binder jet again, um, this puts us into the metal injection molding powder, and this is the, um, you know, we're out of the 15, 50, 53 micron range into the material.
Chip Tomonto (19:18):
That's a little slower, uh, 15, right, right. And smaller varying seems to be more volume there. So it's so interesting looking at that as a potential way to get the price down. Um, but with it comes all of the issues associated with having a binder and having to get that binder out of the process and get a part in the sound. And so, but so I, so I think in the long haul, the industry's going to drive us to binder jet because that's, if it have the right price point in the long haul, I think LinkedIn, unfortunately, laser powder bed fusion, which is very good for the implant material, um, is, um, is expensive, expensive process. It's time and material is one of the biggest cost drivers of upstate across on any of these products.
Gaurav Lalwani (20:20):
Right. So, you know, chip, we know that there's, you know, you, you spoke about some of the model systems that are being used right now, uh, you know, with, with, uh, with titanium six, four, uh, being a ma uh, major, uh, workhorse of the 3d printing industry for medical right now, if you look in your crystal ball, uh, say, you know, five years down, 10 years down the road, uh, what kind of material systems do you expect to still be significant? And, and what new material systems do you expect? Uh, that will come at the fall?
Chip Tomonto (21:00):
Yeah. Okay. Well, first comment is the orthopedic space is a very, very conservative business. And so they, they don't like change. Um, and so when they find the formula that works, they keep that formula. So tactics for business and that 17 four pH space. I think you're going to see them around consistent for more than five years, what we are looking at in other materials. And if, you know, we did work with you on 4 24 55, 4 65, those are all targeted at, uh, implant on instrument side of the business, which is a little more dynamic space. And so, and all of those alloys we use in rock form, John work, uh, within the company. So, uh, that knows that introduction space I think will grow. Um, the stainless is on the instrument side of the business. Now on the implant side of the business, I think you're going to find the data to be extremely conservative, and it's not going to change an awful lot. One for cost is a submission, then the cost of clinical now the cost of the actual cost of introducing new materials.
Gaurav Lalwani (22:20):
So, okay. So let's, let's touch upon that point, right. So when you, when you say that, uh, you know, on the implant side, uh, you would still see some of the traditional models that are currently being used, still continue to be used in the future, just because of the barriers, uh, of, of introducing the new material in this space. Right. Uh, what kind of barriers are we looking at and how much effort and how much, uh, expense does that entail in terms of money and time? I know it's, uh, it's, it's extremely cumbersome, uh, to, to get a new material approved for an implantable use by the FDA, but in your experience being involved in this industry, uh, it would be great to hear it from you.
Chip Tomonto (23:09):
Yeah, here's the key, the key expenses is associated with clinicals. So how, how, you know, they, this would be what's called a PMA file. And so that wires that you demonstrate that the product meets the form, the fit, the function, uh, the FDA will want you before that even let you approve it, demonstrate that your new product is superior to what's out in the marketplace. Um, and then, so under the forklift function definitions, we're actually going after, uh, can I produce it as possible? What is the output? Does it meet the clinical performance for dynamic and static? Is it, does it mean to corrosion requirements? Uh, fatigue is on the dynamic side is very important to us. Um, and then, uh, you know, how easily can I produce it? Can I get a process? That's, that's got a CBK greater than 1.3, three, um, meeting all the dimensional requirements of the pitch finished product.
Chip Tomonto (24:13):
Um, what do I need in the way of post-processing? Is there something that would, would, uh, give us the ability in 3d printing to reduce the amount of post-processing? Because I can there say that that's a big that's. Um, and then ultimately we have to file, uh, for clinicals and clinicals can three, four years, three years CC. And, uh, there were over a million dollars each class. And so typically we would file something in, uh, in Europe, in Europe, which is a shorter pathway. Uh, we could get an approval in Europe and that we would release the product in Europe, uh, while continuing the clinical in the U S um, and ultimately put both the European data and the U S data together and get a formal approval from the food drug administration. So it's a long haul. Um, and, um, and so it's a, it's a huge investment to make that call. And they're terribly receptive to make that change unless you've got some, uh, significant benefits on the implant side. Now I didn't get to the five, 10 K filing, um, which is a cheesier filing. There's no clinicals required. Um, and there, and doctors are technologists. And so they're always looking for new and better. It's a much easier point of entry. Um, and, uh, and so they, you know, I, I think you'll see changes on the instrument, uh, medical instrument side, a lot more rapid than you'll see on the implant side. I
Brent Marini (25:52):
Wanted to ask you, you mentioned some materials like 455, 465, 420, that I don't think have industry standards yet for medical devices. So is that a challenge, you know, with defining what is an acceptable property for an additive manufacturing device made out of materials that don't have an am specific industry standard? Like some of the implantable materials that you had mentioned?
Chip Tomonto (26:19):
Yeah, those, those three alloys, we knew we use technical readiness levels here, like the military we've already executed through TRL three on all three of those alloys here, we have an internal material spec each of, um, so are we concerned that the market that, uh, there is no ACM standard for them in the edited form? No, not at all. Um, and truth be known that we can meet, uh, the rock standard ESPN rock standards for each of those in 3d printing today.
Brent Marini (26:53):
Very cool. Thank you.
Gaurav Lalwani (26:55):
So chip, I have, I have another question for you. Uh, you know, you've been involved with medical devices for a good portion of three decades, right. And you've been with the additive industry for, uh, for almost a decade closing in on a decade, uh, in your experience. Uh, you know, you've, you've, you've seen the evolution of the medical industry, uh, especially in the additive space, since it, since its inception pretty much. So, so according to you, uh, you know, what, what is the stuff in, in 3d printing right now that is the most exciting to you going down five years, 10 years, uh, something that's out there right now that you think is, is extremely exciting, innovative and interesting to you, uh, on the application side, on the material side, uh, maybe on, on, on the technology side of, of, of, uh, of equipment, uh, anything that you can share, something that really excites you about this industry as a whole right now.
Chip Tomonto (27:59):
Yeah. Um, what I can tell you, number one, uh, Adam has been around 30 plus years. It was a prototype tool. And, and with that being said, each, each machine worked differently than the next machine even blocks from the same company. The biggest benefit that's come out is that the actual additive space has started to grow into a manufacturing capability. And now all of a sudden the standards are starting to come out and the machines are starting to function the same way that a factory that has like 20 of one design machine in it. When we initially got them, they, they all work different. Now, they all work the same. Um, and that while we do, but, um, that's a, that's a big, big reason why additive is moving when the price comes down. And when, when the material, the cost gets into the range of traditional manufacturing, which is, I believe it will, you're going to very few people going to a traditional manufacturing pathway.
Chip Tomonto (29:10):
It's got a lot of flexibility. It has a lot of, uh, it's very, uh, re uh, active. I can set up a single line. I can make multiple products off that same line. Um, so you're going to see that, that the marketplace is going to drive us towards an additive solution for everything. I believe that to do that, there's going to have to be machine improvement, equipment improvement. Um, I can tell you, there's a couple of companies out there starting to develop very high speed laser systems, a higher power, high speed laser systems that can produce at least kind of infusion parts of comparable costs. What fighter infusion is today. I can see that happen. Um, I can see, uh, I was kind of excited about the new Xerox printer that came out, that they're doing aluminum work on where they're actually using wire as the feed stock into that printer.
Chip Tomonto (30:11):
And it makes very fine particles and you'll get directed energy deposition, the CIP systems and things like that. You'll realize that they are very rough finishes. Well, that's not your access getting on these new parts. These parts are starting to look like they're falling in the range of surface, finish that you see something like a laser powder bed fusion system. And that's kind of exciting because now all of a sudden we can start to buy precision wire, um, and that should be cheaper than powder. Uh, and so, and like I said, if the price you can get the price point down on powder, um, we're going to go for the cheapest option that gets us the better.
Gaurav Lalwani (30:52):
Now, what about from the application side chip? Now we see a lot of adoption in the orthopedic space, a lot of adoption and instrumentation space, but in the next 10 years, do you see that landscape changing, uh, any new applications that excite you, right? Yeah.
Chip Tomonto (31:09):
Um, I can tell you that smaller parts will happen. There is a limitation today on the conventional laser federated fusion systems on the size of the part you can produce. Um, but there are much, uh, there are new systems out there that have a smaller beam size and worked with finer powder and make very small parts, which opens up a big segment of the medical space.
Gaurav Lalwani (31:37):
Okay. Yeah, that's, uh, that's, that's great information ship. Uh, so, you know, thank you for, uh, for taking the time out and speaking with us today, uh, you know, about the additive industry in general, about J and J about your personal journey in the space. Uh, we really appreciate that.
Chip Tomonto (37:09):
I understand. Okay. Well, thank you for that. Perfect.
Gaurav Lalwani (37:15):
No chip. I appreciate you taking the time out.
Outro (37:20):
Thanks to Chip Tomonto for joining us on a PowderHeads. Chip shares his additive journey from medical implants to his current operational role tells a real story about the larger AM industry, as well as how Johnson and Johnson have supported. If you have questions or comments about what we discussed in this podcast PowderHeads, send them to powderheads@carpenteradditive.com or visit our podcast page at www.carpenteradditive.com/powderheads. We continue to build an archive of all of our interviews there as well as additional material that provides insight and perspective on modern day additive manufacturing. PowderHeads is managed by Carpenter Additive and its parent company Carpenter Technology, a global leader in specialty alloys for over 130 years. Our goal is to help solve their most challenging material process problems. Learn more at CarpenterTechnology.com. Thanks again for listening and keep building!
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