>> jim walde our next speaker i would liketo introduce is andy christensen. i've known andy for a number of years and he was trulyone of the pioneers in using additive manufacturing for medical purposes so i'm looking forwardto hearing this speech as well. so welcome, andy.>> christensen: good, thank you. thanks everybody. it's a pleasure for me to be here today. ifeel like i will definitely walk away knowing
3d printed cast with ultrasound to heal bones faster, much more than i give but hopefully to kindof take what you've--what we've learn already this morning and put a different spin on it.so i think did a great job of kind of elaborating all the technologies. and i think for me thatmakes it easier. i'm not going to talk about much of the details of those technologiesbut show some of the applications specifically
for medical purposes. i come from a companyin colorado, a medical modeling doing additive manufacturing for medical. so this is reallyall we--all we as a company are doing. so typical, i'll go back up and just you showcouple things to--that are more interesting to look at for what we do and then we'll kindof back-in to some of the, you know, the details of how we get from one place to another andwhere the applications are today that are kind of driving some quantities in this areaand where things go tomorrow in terms of additive manufacturing application to medical technology.and specifically, i think we've seen some applications actually talking about alignersfor dental and orthodontics. i mean, there's some really cool applications in dental thatare pushing forward all of these. and i'm--most
are going to stay away from dental specificallybecause it's not my--we're more focus as a company on medical technologies. so reallysurgical planning and people are getting hips and knees, and you know parts of their jawsreconstructed after tumors and such. so this are you know typical applications of past,a big, you know, big surgeries--big surgeries where we're seeing much, you know, large defectsand surgeons really need something physical. so a lot of the historical use of additivemanufacturing in medicine has been creating these facsimile models of patient data. sotaking a ct scan and creating a model to be used in surgery to physically allow the surgeonto plan surgery and do surgery on a model before they do surgery on a patient. i thinkwe all would agree, we would rather the surgeon
practice on the model before practicing onus and especially in things that are very non-routine and a lot of things in the headand neck are kind of non-routine. everybody is a little different, we all--they want toreconstruct the patients so they look right or symmetrical. beginning in the hip and inthe knee, things are very similar, you know. we all have difference but they want to achievecertain angles and geometries. so many times in the head and neck is where we've seen alot of these are done. and applications where, you know, where you're making a model or makingguides, you know. so implant supportive guides are really key use and this is kind of a pseudosurgical dental technology but--moving through i mean, all kinds of other things where, youknow, you're making models that they come
from some form of medical image data or pseudomedical image data in the form of 3d kind of facial scan technology. and i'll put inanother way that will allow the surgeon to either plan the procedure better, executeit more efficiently time wise or create custom prosthetics that really there's no other wayto do except to do in a--in a [indistinct] that would use additive manufacturing. andsome form of the--of the technique whether it be just for the planning model or whetherthat should for the prosthetic itself by some additive metal or other technique. many differentkinds of things, you've seen the technologies so you know, many of them are used and historicallyour industry in the medical side has secured about the materials as much. so we just heardabout really the extreme, you know, more the
extreme of materials in aerospace. and youthink the medical typically is pretty heavy regulated by the fda in the us and by other,you know by other agencies in different parts of the world. and theirs a lot to be saidabout the materials in terms of their biocompatible use but not as much on, you know, on thatwidget and whether it's going to get beat up, you know, by flying it at such g forcesand whatever. and it--not lets us to use the full extent of a lot of the additive manufacturingtechnologies to do the different things for color, for transparency, for whatever. then,i think you'd see--you'd see a lot of that. you'd see some of them that would make thenews. we as a company spend our time working on conjoined twins--this is a hubby really.never made any money but just donating services
to those cases you'd see on the news. everycouple of years that made a lot--made a lot of splash. in this cases, they use these physicalmodels to really take a very complex procedure and try to bring it down to a level that thewhole surgical team, you know, of what could be 20 or 30 or 50 people could understandto try to make this procedures not only time efficient in the best way they can, you knowtaking a procedure that might be a hundred hours and trying to turn it in to fifty hoursbut as well, you know trying to save lives. other things that are less--i throw this upas an interesting piece. there's a--there's an exhibit [indistinct] actually right nowshowing a lot of additive manufacturing technology and parts. so if you're in d.c., the naturalhistory museum is great. and there are many
other applications that kind of pseudo--i'dsay pseudo related to medical using additive manufacturing for models that aren't necessarilyto be used clinically but this is a model of a mummy that still i believe is on displayhere in the san francisco area at a museum called the rosa christian museum. so to showyou some images just to--of some of what's going on. i want to back up and talk aboutwhat makes, you know, what it takes to kind of get some of these things done and the keyguiding technologies that allow us to do what we do that are facilitating more and moresurgeons [indistinct]how you interact with the dataand what you do with it and how you change that raw data into a plan that is surgeoncan use to actually guide surgeries so not
just pretty pictures but really guiding picturesthat end up guiding treatment. and then, how do you get to that treatment so we'll talkabout really where additive manufacturing comes in is really what we call clinical transfer.so if you've got a surgical plan in a computer how do you take that and apply it to the surgery,you know without just taking it in your head and saying "okay. i cut this bone and i moveit around a little bit." but actually having something physical to take that to--to takethat to surgery. sorry. metals and plastics, so we'll talked about both of those a littlebit. i think for plastics we're mostly talking about, you know, models, and guides, and templatesand other things for surgery. instruments as well and i'm not going to focus too muchon that but there's a lot of really standardized
instruments that are being created and usedin both the additive metals and plastics. but metals, we'll focus a little bit on direct,you know, production of implant which is really a key area that will continue to grow in themedical field in the manufacturing side which is really converting what--whether typicallyall the old techniques, you know, the same in aerospace, you know, so casting, forgingmachinery. they are all used and they are all very typical in the medical. but moreand more are the things we can do additively that you just--you can't do, you know, sothose things are clear indications for moving to additive metal. but there are also thingsthat you can do better or faster, cheaper additively than you can with other techniques.sorry, the last piece. you know, you still
need a skilled surgeon so this is kind ofcommon, you know, is it a mean in his last week and we're talking about all these greatphysical and his implements for taking surgery and making it more accurate and more timeefficient and you know in the end you still need a surgeon. it doesn't plummet down tothe level where you don't need the surgeon there, you know, doing what he does or shedoes very well and being trained and having the clinical experience behind them. but youdo make it so that you kind of level off the learning curve a little bit. so you take theleast experience surgeon and you allow them to move up maybe a little faster than theycould otherwise because they can kind of see things in a different light. so moving ahead.in medical imaging, there's a lot of a--there's
a lot of movement going on medical imagingand much of what you see--just in regular hospital-based imaging, everything is movingto being higher quality, better resolution, faster. cheaper? probably not. i mean, cheaperin some ways but medical imaging actually turns out a bit fairly costly so if you goin, you know, if you've had--going to get your knee scan and had an mri. you know, typicallythose procedure are still costing a couple of thousand dollars you know from mr scanwhich is--which is very costly. so there is a push to try making that--try to make thatcheaper and in ct the same way there's been--there's been a push really to reduce radiation hasbeen a big part of it. so making machines that are faster that can acquire more imagesfaster both gets the patient in and out of
the hospital faster but is as well a toolthat they can use to try to reduced radiation by using more, you know smarter techniquesfor acquiring the data. and i don't know if many of would see but on the--in the mainstream media there's been quite a bit on the last year on radiation dosage things. thingson the new york times and other couple of high profile articles about radiation anda few things that have really, you know, kind of stunned that industry and i think there'sa lot going on right now there that will continue to push forward to get better quality datawith less radiation. the other big push is in dental imaging so this scanners, you know,i don't know how many of you have been to the dentist lately but more and more they'llstart to implement this in-office scanners
like this one. its basically an in-officect scanner so much like you'd go to the hospital [indistinct] and lay down on the couch andget shoved in and out of regular ct. you go to the dentist office and then a 22nd accusationthere accentually imaging your whole head and imaging all your teeth and imaging thebone and the soft tissue and all that. and it kind of takes the place of you know, evenrecently i had to go in and get you know the series of little x-rays, you know, that they'vecalled bite rings x-rays historically but 20 of those things that they're shoving inand out of your mouth and its just--its painful and its time consuming and its just inefficient,in general. so here these machines that are relatively cheap, many of them going belowa 100 k but say a 100 to 300 k machines of
what used to be three of four million dollarmachines that were only, you know, based in the hospital setting. so this is pushing thingsa lot and really imaging as well in the dental specialties there's even, you know, surfacescanning a whole lot going on for teeth. so if we again look at the aligner, you knowkind of product where you're just moving around teeth and you need aligners to kind of fitand move teeth around. the ability to take a scan of the mouth in digitally is a hugepush and their technologies are already there now kind of moving that way. and its stillkind of its infancy but it's a--it's a big business many billions of dollars have beenspent on the research surrounding that to try to get away from the fact where they haveto take and put [indistinct] in your mouth
and i'm sure many of you had to do that youknow getting orthodontics or whatever. historically, you know like take impressions which are againnot so pleasant for the patient. so medical imaging is moving a lot which is guiding theneed to do you know manipulations. so the next step for what were doing, will tell youabout many different things kind of a minute of different applications of these but inthe end you've got to take data, you know for ct that might look something like this,you know. and you've got to extract only what you really need to see out of that, you knowso here we're seeing all kinds of things from the spine and the ribs and all the internalorgans and the soft tissue and for this particular case, you know, maybe all we only need tosee, you know, the kidney or maybe only see
this vessel, you know or this nerve as itenters the spine at this level you know or this part of the skull, you know relatingsomething else. so extracting out of this, the useful information that will form thebasis in 3d of what you need to simulate turns out to be a big--is a big step, is a verytime consuming step. so kind of the experts system for the automation for doing this arenot yet were they need to be. to kind of make this as efficient as it needs to be so itreally is one of the most laborious you know steps in the process and really what i mentionedearlier about the in-office imaging system for dental. they've actually taken a stepbackwards a little bit. the image quality want more resolute is actually less accuratein a ways that allow for automation of dealing
with it. so what ends up, you put more informationand the harder to deal with information that turns into more time. so there's been someforward steps and some backwards steps there but automation is definitely part of the futurefor where that's going and keeping time to a minimum are really the key to a lot of thistechnologies is that their too time intensive and that's too expensive. surgical planningwould be the next step and we'll talk about the case which really kind of show what thismeans and guides a lot of our work is a company's spent in an orthopedics and the head-neck.and the head-neck historically, where a lot of applications are very specific. but surgicalplanning you know is done--once you've got the data, you know the 3d simulation thatdata that you either gather from a ct or mr
scan you need to do something to it to kindof facilitate them to surgical procedures. and a lot of what's done now is a big pushand i'll show some of it but the big push within in knees, you know for standard totaljoint replacement in knees which are done to the tune of, you know million plus casea year. there are--there's a big push to try to make that more efficient and more efficientby customizing the way that knee fits you or me by use of kind of simple guided injectionsand the--will tell you that in minute. on the right, there is an actual case i'll showin a second as well. but the next step, once you've--once you've planned out the surgeryand a lot of times we're involved in moving bones around. bones easier to simulate thereare a lot of reconstructive, you know, areas
in the body that are--that relate to movingbone around or fixing things from either trauma or congenital problems or joint replacement.and a lot of what we're focusing on today is joint replacement-based because its wherethe--it's where the market is. so things like knees you know, once you've got a digitalplan for creating cuts in a knee, for instance you need to take that to the patient. so youuse--you'll used guides and jigs and different things to guide that. and other times theguide, you know the guide and what the end product of the planning is really the reconstructionof a defect so patients that has a defect like this or this is going to be surgicallycreated design and implement that will fit that perfectly and an associated--a associatedinstrumentation for doing those things as
well. and again most of the--most of the toolstoday are plastic, most of the implants are metallic they're many plastic implantablematerials that are used many of those are not available yet in additive manufacturingbasis but many of them--many of them, i think to come. so for plastics, we've seen manyof the technologies earlier i'm glad i don't have to go through you know showing you thatbut if you can think of any those--many of those are perfect for this complicated shapesthat are custom for every person. you know, so well--well each of us may only be a littlebit different from each other, were all completely different, and, you know, the way that instrumentor guide is going to fit you and me is different. so this is a perfect fit for additive manufacturingwhere you can have 20 objects in a build.
and that 20 objects can be slightly differentand the machine doesn't care at all. and the complexity part of it again--you know, youkind of get the complexity for free. so there's--there's the ability there to not really worry aboutit. again, a lot size of one works well and that one can be produced in a series of 500at a time, you know, if it fits. that one can also be produced by itself when time isan issue. and then, you know, materials--there's a lot of materials and many of those thatare--that are made using the techniques we saw earlier have been tested so this chartisn't all encompassing but, you know, many things to look at for kind of applicationsof the main technologies and some of this terms aren't the standardized terms that brentwas talking about but, you know, historically[indistinct]
lithography and laser centering and fusedtheir position modeling in 3d printing. and some of the newer techniques like polyjetwhich is one of the first it going to multi material, you know, you'd look for all kindsof different factors. so you'd have materials that are better for certain things and--youknow, their flexible so you need something that's--you know, you can simulate flexibility.so you pick a material there. you also look for, you know, biocompatibility. so many ofthe application are needing kind of limited biocompatibilities. so these are parts thatare going to go in, be using surgery, maybe for--just for your surgery. and after that,they're going to be thrown in the trash. so they just need the ability to be sterilizedand used in that case for limited contact
with your body tissues. and then they goingbe tossed so depending on the materials there's some--you know, many of the processes havematerials that had been tested to certain standards. there are kind of set--you know[indistinct]standardize from materials but, if you look at that, the same way in metals. so if youlook out metals--you know, a couple of two main technology are kind of driving to usesome metals specifically for implants. so, you know, i'm not talking about instrumentsbut, talking about implants that are directly fabricated without [indistinct] manufacturing.and most all of it is driven by this desire to get to something that the bone likes. somany orthopedic implants, you know are made of--i'll show some photos in a minute but,you know, you've got an implant that is going
into your hip. and really--in a couple keys,it's got to be strong enough to kind withstand the forces. it's got to have an articulatingsurface to function into something else but, where it interacts with your bone. that bone--youneed that--you need that to be a really strong fit. and if that fit is isn't strong, andthen, the potential for the immediate fixation there isn't good, that implant will loosenand fail. and loosening of those implants is the number one cause of failure loose implants.so, the tighter and the more connected, kind of mechanically you can fit that implant,the better. many times today, the way [indistinct] you have a solid component and you led herea porous component or you'll spray on a porous surface to the back of that component to getthe bone in growth. an additive to many fraction,
you can create it all at once so you can makea solid component where you going to need solid and you can make, you know, porous componentwhere you need porous. and you can actually do things that are, again not possible withtraditional techniques, you know? and the products, you know, in the market, this isan example or some of the, you know, the spongy bone inside the tubercular bone inside thebody. one of the leading products in the markets is not made with that additive technology.it kind of produces shapes that look like this. and many companies in the market wantsomething that very uniquely porous. and the body, you know, especially titanium, the body'sloves titanium. so the bone and titanium really like each other. you know, a titanium bonewill go right up to right up against titanium
and form this bond that's great. so if youget something that's very porous and kind a tortuously porous, bone will mechanicallylock to it which is a--which is good. so kind of getting back to, you know, how is additivemanufacturing changing surgery, well look a little bit that, you know, something goingon. so as i mentioned, joint replacements--about three million joint-replacements done in 2010.and that's a world wide number but three million cases is a lot. and the--in the industry hereis, you know, i think around $50 billion for the--just the hardware part of it. so that'sjust implants and those types of things. you know, hips and knees are the primary--shoulders,ankles, and other things--you know, kind of [indistinct]the u.s. market though is an interestingpart. historically the u.s. market is been
about half the global market. and that's growingespecially things like knees which are projected to grow a lot over the next five and ten,and twenty years. and there's a lot of it today so we'll talk about the technology forguidance in knees. and this number, you know, it turns out--my guess is that they we'reprobably on the range of some 10s of thousands. forty thousand is pretty good guess. for howmany knees are done today, their additively manufacturing guided procedures. and maybewere it--you know something like three percent of that which is actually pretty good consideringit just only been, you know, a3 few years. traditionally, you know--traditionally intotal joints, one size fits all has been mostly, you know, has pretty much been the standard.so maybe there's a small, medium, and large,
or there's a small, medium and large for theright and a small, medium, large for the left. but they're going to make those implants fityou by carving you, you know, they're going to take you, and they make you fit the implantas opposed to the other way around. so we're really kind of taking that and turning itin a different way. would you say that we're going--we know what's on the shelf, you know,and this is a--we're talking about this in a sec, but we know what's on the shelf. weknow we've got size one through eight, you know, but how do we know exactly which oneof those will fit you, and exactly which way it'll fit you best to get the most longevityout of that implant. so for the--the traditional thinking, you know, it's very dependent onyou being normal, you know, which we're all
normal in some way, you know. so we're allwithin the normative pair, but it's very dependent on the skill level of the surgeon, and thetime that it takes to make the decisions about how to fit that implant to you are taken duringsurgery. so you're in surgery, and you're under the knife, and it's going to take another15 minutes or 3 hours depending on what you're doing for the surgeon to figure out exactlyhow to do that the best for you. so we can take that time, and then push it to--pushit to happening before surgery. that's i think we, as the patient, would all see that's great.you now, the surgeon as well would find some unique reason to find that, you know, what'sintended for them is to do better. so that surgery really needs to be personalized. andthat's--a lot of what's going on in medicine
with the use of additive manufacture relatingto personalization--we'll talk a lot about custom implants versus custom kind of guidesto fit implants. the concept is for a custom implant, you go through a series of stepsthat ends up giving you, in most times, a metallic implant, so that takes awhile. andit's very--it's time and labor intensive, and in the end that implant that's custommay cost five or ten times more than the standard implant's equivalent. so what was $2000 maybeturns into $10000 or $20000 which in the scheme of things is--turns out to be a lot. the alternativeis to take the standard implants that are off the shelf and plan out before hand howto fit that standard implant to you, using medical image data for you. and in the end,make guides to guide insertion of that implant,
and those guides can be made within a numberof days, and shipped, you know, some fraction of the cost, you know, hundreds of dollarsinstead of thousands of dollars. so taking you know, what is fairly standard proceduresfor doing a knee replacement which involve, you know, taking and cutting pieces of boneto fit these implants and working backwards from the implant to create the osteotomy,the bone cuts that are needed, and using plastic guides and sometimes metal inserted plasticguides guiding those perfectly positioned pre-planned movements during surgery. thiscan not only save time, but more so than saving time, make something like a knee last longer,which really is the big--the big cost. you know, the head-neck, in a typical patient--thisis actually a guy that has obstructive sleep
apnea. so this is somebody that has a realchallenge with sleeping, has episodes of not--well, not getting sleep, but severe oxygen deficiencies.some of these patients have it and really life threatening over time. and it may getthe point where it really could, you know, cause some majors issues. so in this case,you know, in the computer, we're planning out, moving things around to a new position,and guiding those things with templates. now i purposely did not include a lot of bloodyimages today, so you're thankful because there are--in the field, there are a lot of thingsthat are--there are really hard to look at. but in the end, you know, we're guiding that--thesemovements of bone around using templates and models and plates and jigs and different waysof kind of fitting things together. and these
are typical--and these are, you know, moving--theseare things that are still in hundreds and little thousands of cases. but we can takesomething like this, and predictably help the surgeon to get this kind of a result whichnot only there's a cosmetic element but there is as well a major functional element. andthe other you know, interesting piece of all this, if we look at the knee or things inthe head-neck is related to assessing surgical outcomes which is historically have--are veryhard to do. you know, on a given patient population. if you put people into a group and you said"look, we've got, you know, 18 people with the same problem." you can say "by large 30took an hour, and we did this and this and this." but for you specifically, there's no--ifthere's no plan, there's no way to asses how
the surgeon did the plan. here, we now havea baseline for 3d comparison to asses how they did. so if they have a very specificplan that's accurate to what they're going to do in surgery, we can now compare how theydid against what they did, which is pretty powerful. and things like, you know, overlaysare here, you know, in blue maybe as what we planned, and green is actually what theygot by imaging the patient afterwards. and you say "why, you know, why didn't blue andgreen, you know, why didn't blue and green even up?" in other ways, while looking atpoints, and looking at planes, and doing things that really are fairly interesting for thesurgeons to watch because they've never been really actually know how close they were gettingto a plan because the truly didn't have a
plan. and their plan was to just look at afew images and walk into surgery. so take a look a little bit about metals. these areparts--these are parts--some of these are in the market in the us for additively createdmetallic implants that are long term implants. this is a european part as mentioned earlier.this is a part that, you know, has gone into maybe 15,000 or 20,000 patients, and somethinglike 30 to 40,000 parts have been created over time. so there's a lot of work in metals.and, you know, the ability to do that on off the shelf employments is one thing, but theability as well to do that on a custom basis is a super, you know, just a great fit foradditive manufacturing. we can take a patient with a failed hip prosthesis, design exactlywhat the surgery needs to be to replace that
prosthesis with something that fits better.and tell the surgeon exactly where to take out bone, and then guide the whole thing throughthe instrumentation, and the screws, and the rest of it all in one place. so, in a minuteor so, the--where does this go in the future? there's a lot, you know, a lot in medicine,you'll hear--you'll hear robotics thrown out quite a bit. i think most of us will hearrobotics, and think "god, i don't want to go in and have a, you know, have surgery,have some big, you know, a hip or a knee or something fairly common, and have a robotdoing the surgery because i'm just a little worried about, you know, what if that robotdoesn't screw up much but they happen to screw up on me. so there's a lot of--the interimstep between now and full automation of surgery
is actually kind of robotic assistance. sotwo main technologies, one related to, you know, an actual robots, this is called theda vinci system. so this is fairly widely publicized. but surgeons sitting in the corneryou know, basically guiding small hands that can go in and do things in very tight spacesin the patient. so this robot sitting over here actually working in the patient withdifferent tools, surgeon sitting in the corner, drinking a cup of coffee, and guiding thisthing like a video game. the other is for--is for kind of robotic assistance as well. it'sfor creating very freeform and custom bone cuts using a ha pick enable device to actuallyshow them where to go in surgery with a guide, you know, guiding the bone cuts in the bottom,helping the surgeon perform the surgery with
some kind of built in stops. so if he pushestoo far, the machine's pushing back. and then i think where it, you know, where it goesfrom there, design matching functions, i talked a little bit about this in the papers, soi won't go through it here. but really to take what today is over-engineered, and reallydefine it, make it more really personally engineered to that patient for structuralpurposes. and the same thing here for, you know, for functional elements to really makethose fit to you. this is an example actually form a company in uk called within. you know,the very interesting company--but taking, you know, finding all that information, andputting that in the design, and making it way complex. and based on that--being ableto--being able to push forward and do some
things that haven't been done. and the samething for materials, this is actually a peck part. peak and peck are really moving on to,you know, high fashioned within the medical area. and peck, specifically additively manufactured,should be--should be where things come. so my final thoughts, today, we're already seeingmany thousands of patients benefiting in medical and dental, the same way. and the trend towardmore personalization is a good fit with where things are on. i think that, you know, inthe future, the trick is making it--making it more cost effective. and that still iswhere a lot of these technologies falter is that they cost a thousand dollars or two thousanddollars a case, and it's too much. so thanks for your time. happy to entertain maybe aquestion now.
>>all right. questions?>>jim wilde of the university of southern california, have you seen better patient outcomes,you know, not you personally, but the field wit am parts versus the standard parts?>>christensen: yeah. so it's a good question. i mean, typically the standard parts--forsome of these things, the standard parts don't exist. all right? so guidance doesn't exist.but in terms of doing the traditional way of doing surgery versus the guided way ofdoing surgery, yeah, we're finding--we're finding surgeons talking about patients thatare leaving the hospital sooner, you know. they're able to do procedures faster. so historically,you know, we'd people say on average--just using a model, so if we go back to the earliestbeginnings of just taking a ct scan and printing
bone model. by seeing that model, and kindof moving bone around, and seeing what they're going to do in surgery, the surgeon wouldsay, on average they can save twenty percent of the operating time per a given case. so20% of time you know, at anywhere from a hundred to three hundred dollars a minute per operatingroom time turns out to be major, you know, savings. and we'll have surgeons tell us onfairly routine procedures, they can save an hour to two hours, which turns out to be justa major, not only cost savings, but the less time you are under anesthesia, the betterfor outcomes. so the quicker you can go home, the less likely you are to have other issuesthat kind of come along with being out and sitting in a hospital.>>your question, sir?
>> yeah hi. my name is eric luther. and i'mactually a neurosurgeon at the washington university. one thing, you know, that i foundwas kind of these models is that, you know, certainly i think for kind of, you know, costumateimplants such as kind of a bone de facto, they're very good. you know but one thingis that in terms of planning is that your head is or your spine, for instance, is morethan your bony anatomy. and i think one of the challenges, you know, for kind of pre-surgicalplanning with models is not just the hard tissue, the bones we also knowing for instance,you know, because of this brain anatomy is quite different. you know, and the soft tissuenow obviously with a tumor that's involving complex vasculature. it would be great tohave the ability to have an almost a tissue-consistency
matched model of that as well because that,you know, can allow you to have plan for, you know, if there's tumors involving a majorvessel, or major nerve, or a major part of the brain. how do i deal with that beyondjust kind of say reconstructing a jawbone... >> yeah.>> ...or just reconstructing a bony defect? >> yeah. now, this is a good observation...>> [indistinct] >> yeah. and i know in neural surgery theirare challenge, some of the traditional ways of guiding surgery, you know, you can usephysical templates to guide surgery but you can always use surgical navigation, you know,so... >> great. and that's limited, you know, imean like because the brain shifts and moves
around with, you know, surgical navigation.that's why it is always planning prior to is always been a challenge either with modelsor with the computer rendered version because... >> yeah.>> ...you just can't get the sense of it. >> yeah. they both suffer from the same technologicalissue that you have to mimic those things very well either digitally or physically.>> right. >> and as a challenge, there is a bit--thereis a bit of a push. i think getting into neurosurgery maybe even further down the road. but formajor joint replacement, there's a posture trying to get away from cadaver work or, youknow, so learning by cadavers and creating not only digital cadavers which is, you know,is useful and there are ways to use that.
but physical, you know, kind of cadaver replacementsof models that mimic the tissues and increasing complexity for different types of tissuesand different types of situations where you can do that. and i think that there's a bitof a push there because the cadaveric work is so expensive that we'll see more from materialshopefully going forward. and some of those will be directly output by adding the manufacturingalthough the flexible kind of materials are still somewhat limited today...>> i mean, that would be the thing if you could use additive manufacturing to createalmost kind of gelatin-like consistencies of tissues that would be extraordinarily helpful.>> yeah. >> yeah. okay. thanks.>> i'm chris luz [indistinct] biosciences,
for the companies doing this work or the fda,how do they plan to regulate the design window that's used to make sure as people are doingcostumed designs? they're not getting close to the risk of mechanical failure or for instanceparticularly where they could form during [indistinct]>> yeah. that's a good question. i mean, historically, in the us, when you go back 10 to 15 yearsago. custom-made thing--custom-made devices kind of fit an exemption of the fda. so thatyou can--you could sell--if you had a standard product, you could sell a customed product,you say it's customed and follow whatever your internal procedures are. but in the last10 to 15 years, many of those products that are kind of common products you say a hip,or a knee, or something like that, or cranial
plate are all--have all moved into being approvedby the fda. as custom, you know, kind of patient-specific products with certain design windows. so forsome of those--for some of those it's easier. you know, surgeries looking--it's the thingabout cranial cranial plate. you know, there would be a certain minimum thickness, there'dbe a certain, you know, way it kind of interacts with the edge of the bone. but a lot of therest of it would be either have a fairly large window. so i think you are right. when youstart getting into things like knees, you know, functional joints, i think, is whereyou'd see more of, you know, useful. and how i've seen the fda relate to that sometimesis that they want to see a standard component that you are kind of basing your work against.so the interface say between the knee, you
know, the femur, and the tibia, they wouldwant to make sure that you aren't changing some geometry there that's not proven already.and if really what you're doing is just customizing the fit of the bone interface and not customizingactually the way the interface happens from a wear stand point. so i think they lockedthat down. it's the general answer that the interface for an articulating surface, theyreally try to lock down both materials as well as, you know, surface.>> great talk by the way. i have a more basic question. has the industry look at prosthetics?i mean, coming from a third world country, land mines have created more problems forlost limbs and lost body parts. and i was just curious if the industry has at all, haslooked at the--at the manufacturing for prosthetic
limbs or...>> sure, hans. sure. yeah. yeah. the answer is yes. there's a bit of that being done now.it--there's been a--it's been a bit of a step. i don't know if too many that are directlyfabricated. so has been some work of the past actually make strong enough components thatyou could use is the socket itself. say, for a lower limb prosthetic. but many of themtoday are using techniques that are kind of hybrid. so they're scanning, you know, takinga--taking a residual limb, either scanning it digitally or taking a cast of it and scanningthat digitally, designing the prosthetic kind of interphase. maybe looking at--taking itas far as looking at the bone structure of knees or maybe scanning the patient as well,looking at the loads and how to design that
socket so that, you know, when it feels goodand is functionally at the right place. but using at it to manufacturing itself to manufactureit hasn't yet kind of reach a great--hasn't done a lot. it's the same in prosthetics forlike ears and noses and eyes which were done quite a bit, you know, quite of--there's anindustry surrounding for it, you know, many of them congenital deformities. but, you know,missing ears and they're still, even though we can get to some materials that are fairlypliable, they're fairly--they go through--it's pretty rigorous, you know. so the materialsneed to be very strong. in the same way for prosthetic limbs, there's a lot of wear andtear and directly manufacturable parts just aren't commonly used yet.>> one more question [indistinct] i'm nathan
corial with the motorola solutions. and myquestion is if you can come in on the state of the art using this type of techniques forexample for tissue and in organ growth and things like that. where do you see the feasibilityof that? >> yeah. so there's a--there's a lot goingon there. and groups focusing a lot on that and i think others in the room actually mayknow little bit more about that than i do. but a lot of what is safer kind of a tissueregeneration, so in the future, you know, one of the slide i--at the end skipped overkind of briefly but, you know, the way things go today the materials are either plasticsor metals. and they're either put in and they stay in the same way forever or in some ofthe case here for the plastics, you know,
and in neural surgeries just quite a bit.plastics are the resorbing, you know, plastics that they'll stay there a while and give somestrength and go away. neither one of those really solved the issue of replacing a pieceof anatomy whether it'd be hard tissue like bone or soft tissue like some part of an organwith that--with a like tissue. so there's a lot of work on using things that will turninto that specific tissue. and then in the future many of those who are using additivetechniques, at least, to make the scaffold to them impregnate with something, some ofthe material that will, you know, either attract or promote growth of those different typesof cells. i think in the future, you know, much of what you'd see if you, you know, yougoogle an organ growing or something like
that you'd find videos, i mean, there's a--thereare few well known groups out there doing this work. and you'd see, you know, the conceptualway to make a kidney, you know, for instance it would--you've got all kinds of differenttissues working together in very complicated ways. so it makes sense to most that additivemanufacturing is the way to create those because in one given cross-section you can have, youknow, 30 different things going on. you can build that three-dimensionally which is--doesn'texist in many other techniques. so there is
a lot going on there. they are therapies ormany therapies on the market. there is some work, i think, for a skin graft actually atsome point. i think there's very few commercial applications yet but much research going on.>> thank you very much.
>> thank you very much, andy.>> *applauses*
