Our friends at Direct Dimensions in Owings Mills, Maryland, will be "creating a 3D CAD model" of the Roberto Clemente Bridge in our hometown of Pittsburgh, Pennsylvania. The resulting files will then be used to create 3D prints of the bridge for an upcoming RAPID + TCT show being held in Pittsburgh in May.
Pittsburgh, long recognized for its sports accomplishments, is becoming well known as a Center of Excellence in Additive Manufacturing as well.
Development model shown to Portland city council for project approval.
RapidMade gets to work on many cool new product ideas. Given our love of dogs - we have a dog-friendly workplace, this project has been a favorite...
"OMDOG performance canine headgear started as a simple idea — to build a custom helmet for Charlie the Dog, who rides around Portland, Oregon in a cargo bicycle. When the decision was made to duplicate and improve the design, we contacted Rapid Made. They were responsive and excited about the project. They quickly 3D scanned our prototype, reverse engineered it, and made it easy for us to review and approve the CAD model before printing. Rapid Made helped us take an idea that started as a cardboard model made from a pizza box turn it into a viable product design. They're providing us with manufacturing options within our budget and well suited for our target market. We are extraordinarily grateful to have found Rapid Made!"
Click image to read case study.
One of the juicier projects we've had involved 3D scanning real 10-lb crabs to recreate life-like replicas for Bering Sea Crab Fisherman's Tour. The captain and his crew take tourists out on the high seas in the summer to watch them work. Unfortunately, they were losing much of their inventory recreating their catches - this was both costly and unsustainable.
Once we 3D scanned the real thing, we 3D printed a master pattern which was used to create a mold. The mold allowed RapidMade to cast the crab look alikes in urethane rubber. See the results here.
My traditional cast for my broken right wrist
I am now 3 weeks into my cast-restricted convalescence. And yes, it is as annoying, smelly and uncomfortable as everyone says. So when my accident occurred (a large dog was desperate to greet Luke and I was in its way), I toyed with getting our team to scan and 3D print a cast. The doctors were not keen, and since traditional casts are reliable, cheap and quick, I didn't argue.
If I had gone that route, what would have been involved? Well, as in the traditional approach, we would have waited a week for the swelling to go down. Then I would have had a 3D scan to get an exact image of my arm. The resulting file would then be modified to 3D print the lattice-like open "exo-skeleton" cast which would snap into place. Oh, to be able to scratch and shower undeterred! But I'm under no illusions; it could have been a pricey and time-consuming project - the design would have to withstand use and be printed in a non-toxic material, so while I was in a traditional cast 1 week after my fracture, it would likely have taken longer for a high-tech alternative.
But there are times when I'd give almost anything to scratch that itch.
Photo Credit: Joe Shearer/The Daily Nonpareil via AP
Iowans have 3D scanned the historic Dark Angel Statue in Council Bluff, IA in an effort to preserve this piece of art. The statue, officially a memorial to the wife of a local Civil War general, is 96 years old and was sculpted by Daniel Chester French, who is better known for another work of his-the Lincoln Memorial in Washington, D.C. The people of Council Bluffs raised enough money to get the statue scanned so that if any parts break off or if it falls into disrepair, it can be easily replicated with the exact dimensions of the original design. The community is happy with its investment in the preservation of the local landmark and historic work of art.
If only ancient Egyptians had had the technology, we would know what the Sphinx’s nose looked like.
Photo Credit: NewHistorian.com
We've written before about using 3D printing to create artwork and artifacts. These stories are especially interesting to us given that RapidMade has been privileged to 3D print both originals and replicas. And apparently we are in good company...
In another brilliant example of this approach, Cambridge University is 3D scanning and printing reproductions of Ox bones. During the Shang Dynasty in China, roughly 1339 BCE-1112 BCE, oracles would inscribe their writings on Ox bones which are being recreated for research and educational purposes. These bones provide insight into the way of life during the Shang Dynasty. Archaeologists, anthropologists, and historians alike can now safely continue to learn from the information contained in these bones while ensuring their preservation. The university’s collection contains over 600 bones (that is a lot of scanning and printing) which will now be more readily available for study due to these replicas.
Credit: Andy Wood
We've posted before about artists using 3D Scanning and Printing to recreate antiquities damaged by ISIS and to digitally catalog priceless exhibits. Another effort is being undertaken by an Iranian artist in Mosul, Iraq.
Morrehshin Allhyari is working on an exhibition of 3D printed replicas of artifacts destroyed at the Nineveh Museum in Mosul, Iraq by ISIS. Taking images and 3D scans of the museum’s collection, Morrehshin is able to replicate the lost artifacts with 3D printers: “The more files that are saved on people's computers, even if they’re never printed, the number of PDF files that are read or kept, the more that history that was initially removed by ISIS will be saved.” The exhibition is titled “Material Speculation” and is widely seen as an act of historic preservation, political activism, and art, simultaneously. It also makes a great point of the pragmatism of using 3D scanning and printing technology for museum collections and historic exhibitions.
Photo Credit: 3Dprintingindustry.com
One popular application of 3D printing is creating exact reproductions of antiquities. As is often the case, museums want to display artifacts but face challenges making priceless objects available to the public. The latest example of this technique is the recreation of the Iceman.
Ötzi - the Iceman, the oldest European mummy, was replicated by Additive Manufacturing. Two 3D replicas have been made for display at the South Tyrol Museum in Italy. Using CAT scans taken of Ötzi, the models were rendered and printed using 3D engineering and manufacturing techniques. Once printed and assembled, a rubber mold was applied to the replicas, which were then sculpted and painted. Because Ötzi needs to be preserved, he will be stored in stable conditions while visitors of the museum can see these identical models.
3D print by RapidMade for Decimate Mesh Art
Since ISIS began destroying priceless artifacts in territory it controls, archaeologists and artists around the world have been scrambling to salvage and, or recreate the objects being annihilated. Recently RapidMade worked on one of these projects: Ryan Woodring's Decimate Mesh Art Exhibit.
Closer to the tragedy, in a bold and proactive counter offensive,
“Archaeologists at Oxford and Harvard have launched a high-tech offensive against Isis by creating a full digital record of threatened ancient sites and artefacts in the Middle East by Islamic State.”
Using 3D cameras, the academics who've partnered with Unesco, plan to collect millions of digital images that will enable them to capture and reconstruct any piece that is destroyed. Their plan involves positioning "hundreds of the internet-enabled 3D cameras around important sites where they will take full photographic records from several different angles before uploading them to an open-source database online.
Given the wide-scale destruction wrought on the area to date, the project team recognizes that it is literally "up against the gun" to save as many antiquities as it can.
For years, museums like the Smithsonian have been creating digital libraries of their collections to catalog, study and share. But this effort is one of the first geared specifically to safeguard artifacts from defacement or destruction.
Here's a great white paper written by RapidMade Co-Founder and Advisor Mark Eaton:
Investing in 3-D printing technology can provide significant business advantages. Product development, customer value, manufacturing costs and product life cycle management can all be positively impacted by this technology. Determining where to make the investment requires careful consideration of the expected outcomes and thorough analysis of the business, processes or products that will be impacted by the investment.
For companies considering investing in 3-D printing, outsourcing to a reputable service bureau is a viable, cost-effective alternative that is less susceptible to changes in technology and materials than in-house ownership. The benefits derive from eliminating the initial capital cost of the equipment and the infrastructure setup cost to avoiding the operating costs of ownership and obsolescence issues relating to the rapid development of 3-D technology.
The technology for 3-D printing, also known as additive manufacturing, has existed since the 1980s. Although the additive manufacturing market took approximately 20 years to reach $1 billion, five years later in 2012, it had reached $2 billion. By 2013, consensus estimates by Gartner and Wohlers indicate it had reached $2.5 billion. A significant portion of this revenue was derived from 3-D printer sales, but estimates by PwC and ZPryme indicate that by February 2014, 67 percent of manufacturers who responded were already testing or using 3-D printing.
Despite advances in speed, reliability and material availability, 3-D printing has to this point still been largely used for prototyping, testing and tooling. Although rapid prototyping remains important, the pivot to printing more fully functional finished products and components is the direction that analysts see the sector heading.
For example, GE plans to mass produce 25,000 LEAP engine nozzles using additive manufacturing and already has $22 billion in commitments, said Dr. Mark Cotteleer of Deloitte Services in October 2014. Medical, dental and automotive are other sectors that report increasing use of 3-D printing to create fully functional parts.
Yet, in a recent December 2014 Gartner worldwide study, 60 percent of respondents cited the high acquisition and startup costs as delaying their investment in 3-D printers. Of those surveyed, 37 percent had just one 3-D printer within their organizations, with 18 percent owning 10 or more.
The average number of printers per organization was 5.4. One interesting finding was that respondents felt overwhelmingly that using a 3-D printer as part of their supply chain generally reduces the cost of existing processes, especially research and product development costs. The study concluded that those companies who were using the technology for product development were seeing a 4 percent improvement in costs.
Despite the widely held mistaken belief that 3-D printers can "print anything," commercial manufacturers and product developers are still faced with the reality that there are many types of 3-D printing processes. Each process has speed, part tolerance and quality-related factors to consider.
Similarly, each 3-D printer is designed to work with a select set of materials. Most commercially available 3-D printers (often called professional or production printers) are designed to work with either plastic or metal. However in the case of plastic, the material or polymer will vary depending on the 3-D printing process, as will the mechanical, aesthetic and functional properties of the finished part.
UV-cured polymers behave differently to laser-sintered nylons. In the case of metals, parts printed on a laser-sintered machine will have different properties to those produced on an electron-beam or laser-melt style printer. Complexity further increases when the user has to consider ceramic, biomaterials and/or materials needing regulatory approval, which may require not only specialized materials, but printers with unique attributes.
Most materials, often termed feedstock, are pre-processed to create the liquid or powder that is ultimately reformed as a printed part. The cost of materials is a significant factor in the adoption of 3-D printing. Depending on the material type, prices can range from $35 to $600 per kilogram; specialty materials that have unique applications can be much higher.
In many cases, companies that supply 3-D printers try to control the material supply using, for example, prefilled cartridges or other means. Of late, this practice is beginging to change as new 3-D printer manufacturers enter the market, alternate material suppliers emerge and machine owners determine how to override printer settings. In fact, the study conducted by Roland Berger showed that experienced 3-D printer owners had effectively created their own supply chain, and this was driving down material costs.
Three-dimensional printing is still in the early adoption phase when it comes to the production of finished components and products. Speed of printing has yet to match the rates of typical mass production techniques. Companies such as GE, Siemens and Autodesk envisage 3-D printing being used in conjunction with or alongside traditional manufacturing techniques.
The rate at which 3-D printing will supplant traditional manufacturing techniques, such as CNC machining, injection molding or casting, is openly debated and will largely depend on advances in technology, materials and software.
But according to a recent Siemens report by Sandra Zistl, "Even though analysts at WohlersAssociates expect the rapid prototyping market to grow to more than $5 billion by 2020, 'Money will be made with manufacturing, not with prototypes,' forecasts Tim Caffrey, a consultant at Wohlers." This assessment is shared by Bernhard Langefeld, a machine construction expert at Roland Berger Strategy Consultants and one of the authors of the study titled "Additive Manufacturing – A Game Changer for the Industry?"
What is also often a source of debate is the degree to which commercial manufacturers and product developers should own or outsource 3-D printing technology. Here we have to turn to traditional methods for evaluating capital investment and make-buy decisions. At the same time, we have to consider the risks of obsolescene, premature adoption of new technology, and the true cost of ownership.
In order to asses the capital investment or make-buy decision, we first must understand the expected financial and commercial returns from the decision, and to do that, we have to carefully consider the benefits of 3-D printing technology and where to apply it.
The capital cost of acquiring a professional or production 3-D printer varies tremendously. UV polymer printers vary from the mid-$30,000 range to $200,000 for the more complex machines. Metal-laser sintering machines will cost anywhere from $500,000 to $1 million-plus. It is also important to realize that just like traditional manufacturing, there will be additional costs for cleaning systems, dust collection, chamber gas-delivery and recovery systems, and for more sophisticated printers, complex material handling systems will be needed. Similarly, space and building requirements have to be considered, as do machine layout, material flow and cell design.
Three-dimensional printing is able to create a part directly from a digital file. However, this creates additional considerations because the ability to create an effective part is a function of the quality of the file; for example, is it an accurate representation of the desired finished part? Software that can manipulate the file to change the structure of the part or that can adapt the file to more effectively print the product is also available.
For each printer type, there is often a need for different types of software. The costs of this software must also be conisdered as part of the capital investment. Workflow software is also required when managing multiple files and parts if the production of these parts is to be efficient.
As this white paper indicates, there are many potential applications and markets for 3-D printing technology. In general, these can be
characterized into four primary categories; marketing and promotion, product development and design; production elements such as tooling, fixtures, products and components; and business services.
When considering an investment in 3-D printing, determining the application or intended purpose requires the investors to make a careful assessment of their existing business, process or product. Secondly, it requires a clear understanding of the expected outcomes from the investment; reduction in product development time, increased customization, lower supply chain costs, improved quality, new commercial opportunities and added customer value are some of the examples often cited for investment.
For example, the United States Postal Service estimates turning postal processing centers into 3-D printing hubs could generate $646 million in commercial packaging revenue. However, reaching such a conclusion requires analysis and investigation of multiple factors as well as a thorough understanding of available technology, materials and software. In these cases, businesses are turning to existing 3-D printing companies such as Stratasys, RapidMade and Baker 3D Solutions to help them navigate the decision process.
Having identified the need for investment in 3-D printing, the business leader is most often faced with the make-buy decision (or in-house vs. outsource). A number of factors must be considered.
Traditional factors such as the protection of intellectual property and the critical nature of the product or component remain important. Of additional importance is the degree to which the 3-D printing technology itself is evolving. In 2009, the FDM patents expired, which led to the launch of many low-cost desktop copies. Similarly, in 2014, the SLS sintering patents expired, and this is expected to impact the cost of these printer types. Three-dimensional printer speeds are expected to increase fourfold over the next five years with companies such as Siemens stating that material feed rates will improve from 10 cm3/hr to 80 cm3/hr.
While many 3-D printing manufacturers market and advertise the simplicity of these machines, the reality is that print builds fail and need to be reprinted. Similar to traditional manufacturing processes, there are usually post-processes required to finish the product. There are waste streams that have to be managed; support material often has to be removed, and production has to be planned to ensure the printers run efficiently. Labor operating costs are similar to modern CNC machines, although these can be automated if volumes dictate.
For a typical commercial manufacturer or product developer who is producing products constructed of multiple materials and components, multiple 3-D printer types will be required. It is not uncommon to require multiples of the same machine because print rates sometimes result in daylong builds. The Gartner survey from December 2014 found that, for those owning 3-D printers, the average number of machines owned was 5.4. For a simple product development, for example, it is not uncommon to need three different types of 3-D printers.
This total cost of ownership analysis and the recommendation to buy versus make is very similar to the analysis that would been done for a traditional machine tool. What is the labor cost to operate; what are the waste factors; what are the utilization rates; what are the utility and space considerations; what are the maintenance costs, etc. Factors that will also need to be considered are the material limitations of each 3-D printer type, the software and the pre-processing that is required along with the associated costs.
In most cases, there will be fixed engineering and operating support costs that will have to be applied over the planned usage hours. Consumable costs will include materials as well as print heads, UV lamps, lasers, build plates, support material, part-cleaning solutions, chamber gas, etc.
For many situations, the option to buy from a "service bureau" will be more cost-effective than owning the technology. As with traditional manufacturing, a service bureau can specialize by using one type of 3-D printer or by better leveraging costs over aggregated production volumes.
As a cautionary note, it is important to select a reputable service bureau. Not all 3-D printers are built to the same quality and their ability to maintain build tolerance or part strength will vary. So it is important to understand how the part will be printed.
As with traditional manufacturing, service bureaus can be differentiated by those that have engineering expertise, a quality management system, a maintenance program and certified technicians compared to those that do not. Just like traditional manufacturing, there are print tolerance limitations that have to be considered in the design, and a service bureau with embedded engineering capabilities will be able to address these issues.
Consider also the importance of ensuring that the material supply chain is robust. Whether the decision is made to print In-house or through a service bureau, control of the material supply chain, both from a traceability and a material compliance viewpoint, is a consideration.
For mission critical or complex materials, organizations such as the Lawrence Livermore National Laboratory can provide independent certification of the material. In general, because these are essentially created materials, their properties will approximate but not always replicate traditional materials. Having access to knowledgeable resources will help avoid common pitfalls.
Middle School students from Catlin Gabel 3D printing camp enjoy RapidMade tour
RapidMade recently hosted 13 middle school students and 2 chaperones from Catlin Gabel's 3D printing summer camp. The group learned how we scan objects and prep files and then watched prints being made on our Objet30 Pro, Fortus mc250 and Zprinter 650. Later they were shown how 3D prints are post processed and finished.
Today, it is too easy for firms to become dangerously dependent upon their suppliers. Imagine that a key distributor goes out of business or a critical supplier stops making spare parts. What happens when your supplier has your tooling, and you need to modify it? When your machine breaks down, and you need to replace the part, you don’t want to learn repairs are no longer possible - orders are backing up; production is at a standstill, and you are stuck scrambling to find an alternative. Even if you find another supplier or new equipment, you’ve already spent considerable time and money, something every business and entrepreneur has little to spare.
Now imagine an insurance policy that guarantees that no matter how old the part or obscure the producer, you know that the part can be made and the job can get done with little delay. How? Scanning and converting parts and products into digital 3D images reduces your dependence on unresponsive suppliers.
Digitization allows companies to:
Create a catalog library or parts inventory.
Find spare or obsolete parts.
Reverse engineer an existing product or part.
Replicate a new product.
Rapidmade, renowned for its 3D printing, scanning services and engineering capabilities, efficiently and effectively renders these services for Fortune 50 and small start ups alike.
Why use us?
Professional 3D laser scanners are able to capture fine details and are not susceptible to issues with reflection, thickness, and color.
Our software can accurately smooth and sculpt the part allowing you to have consistent quality.
We ensure that there are no errors and can often print the part for assurance.
Rapidmade offers cost effective and competitive pricing schemes that include a quantity discount: having multiple parts scanned at the same time allows us to offer an inexpensive 3d scanning option.
Having a digital parts catalog liberates you from unresponsive suppliers. You insure your assets; why not ensure that your business is safe by digitizing critical parts?
Contact us to learn more.
Reconstructive Scientist scans son's face to 3D print a prosthesis for his dad (Photo Credit: 3Dprint.com)
Anyone who has experienced facial scarring can appreciate the pain and embarrassment that often accompanies the disfigurement, no matter how minor. After four relatively simple surgeries to reduce the scarring and improve the shape of my nose, I am still sensitive about how it looks - but then I read the following story in 3dprint.com which described the medical miracle of a man who got a new face - and lease on life - through 3D printing. To say it put things into perspective would be an understatement...
“Every year, thousands of individuals are left with terrible deformities due to their courageous battles against cancer. This was the case for a 74-year-old man named Keith Londsdale who had started his battle again cancer all the way back in 1990, undergoing 45 different procedures to save his life against a very aggressive form of basal cell carcinoma.
When all was said and done Londsdale’s life was spared. However, he was left without an upper jaw bone, cheekbones, his nose, and his palate, and in their place was a gaping hole. Without the ability to properly speak, eat or drink, doctors sought out a solution to make this brave man’s life as normal as possible.”
Until recently, most prostheses have been functionally or cosmetically lacking. (I remember a patient who had lost her lower jaw to disease, and she had a basic plastic cup that just sat where her jaw had been). Now, 3D scanning, modeling and printing are achieving lifelike results that closely match the recipient's existing features.
Keith Londsdale is one such beneficiary of medical additive manufacturing. His son, Scott, worked with Jason Watson, a Reconstructive Scientist at Nottinghams' Queen's Medical Center, to create a prosthetic that incorporated Scott's features to ensure a familial likeness.
“Watson had Scott come into the hospital where they 3D scanned his face. From the scans, a sophisticated computer algorithm created a 3D printable model, which the team at Queen’s Medical Centre was able to print out. Basically doctors now had a 3D printed physical replica of a portion of Scott’s face they then were able to copy in wax and create a mold from. From that mold they then created a silcone mask from Scott, which fit Keith’s face nearly perfectly.”
Imagine the day when such prostheses are bio printed using living skin cells.
RapidMade is participating in the FedEx Small Business Grant Contest. We are hoping to use the proceeds to buy another 3D printer... Please help us!
This week, I graduated from a soft cast to a hand splint, custom made from low-temperature thermoplastic and Velcro. The process was an interesting mix of art and science. My Occupational Therapist, who specializes in hand injuries, regularly creates them "while you wait."
The procedure began with a gross sizing using a paper pattern placed against my arm to determine how much thermoplastic material would be needed. After the two sheets were cut down, each was heated in a hot water bath and then carefully molded against my arm to obtain a form fit - a snug, protective shield whose edges roll away from the skin to prevent chafing. Later the two splints were joined by a series of strategically placed Velcro strips. Unfortunately, I encountered pinch points which prompted a return visit this morning... alas, as I type this post, I suspect there will be more tweaking needed.
So I find myself debating whether the fitting process could be improved using a 3D scanner and printer. Theoretically, a doctor's staff could quickly scan the patient's hand in the office to create a model that could then be used to make the splints. The final fitting would then be completed during the first OT appointment, allowing the patient to begin therapy during the initial visit instead.
But would the additive manufacturing approach be much more accurate than the current in-office process? I suspect it might be more expensive (but I won't know until I get the bill) and since the splints are only worn (hopefully) for about four weeks, insurance companies might not approve. But given how tender the injured body part can be, anything that minimizes the amount of handling required during the fitting would be welcomed.
Screws and plate used to repair a hip fracture (image credit 3Dprint.com
I wish RapidMade's recent blogging silence was due to the holidays. Alas, I was sidelined by a bad fall down a steep flight of stairs. Shortly after I broke my foot, shattered my wrist, and learned I needed surgery, I remembered a conversation I had with an NIH representative at the FDA's meeting on 3D printing. He expressed frustration that, despite additive manufacturing being more widely adopted in medicine, many procedures were not benefitting from its customization. Ironically, he specifically mentioned the screws used in orthopedic surgery, saying it was frightening that patients' bones were modified to accommodate the screws and not vise versa.
I was in too much pain to think to ask my surgeon if my standard-issued screws and plate matched my bones well enough or ask how often fit is a problem, so I will have to speculate on what factors have slowed its adoption.
First, I suspect screws could quickly and easily be cut to fit. But if that is true then why would surgeons ever alter the recipient's bones instead?
I also wonder if the simple screw and plate designs make 3D printing them more expensive and time consuming than traditional manufacturing, especially if custom fittings are rarely required. Interestingly, I just read about a hip surgery where Dr. Bagaria repaired a hip fracture by taking CT scans to create a 3D print that allowed him to plan the surgery and customize his approach.
“Using the model, Dr. Bagaria was able to create a 7-hole reconstruction plate that was pre-contured. They then used the model to carry out a surgical simulation prior to taking part in the real thing. The surgeons were able to drill the screw trajectories, measure the screw lengths required, and confirm the positions of the plate, all with the help of the model” (3Dprint.com).”
Perhaps a major reason 3D printed screws aren't in great demand is that surgeons don't often have CT scans of the broken bones and are therefore less likely to know fit will be an issue until the patient is on the operating table. Honestly, fixing most broken bones is fairly straight foward - and truthfully the xrays were painful enough, I don't know if I'd have welcomed getting CT scans as well. Having said this, I was told my wrist was worse than expected, requiring more work than expected, so who knows?
I won't know my outcome until Monday when the cast comes off, but I'm guessing screw size won't be a problem. I'll just be happy to type with two hands.
Image Credit: http://www.cockeysvilledentist.net/
Recently, I broke yet another tooth which required - of course - another crown. But this time was different. Today, after my dentist did the standard tooth preparation, a licensed technician scanned my tooth using a hand-held 3D scanner and then downloaded the CAD file onto the computer right next to my chair. I got to watch her manipulate the 3D model - the dental office knew I have a 3D printing company, so they humored me. She explained how she first determines the borders and then calculates the bite (using a scan of the tooth's chewing mate). She then proceeded to determine the best tooth shape to ensure a proper rough fit.
The procedure used was a great example of a hybrid manufacturing process because once the file was ready, the tooth was made using subtractive instead of additive manufacturing. A block was milled to the correct size and then further reduced by hand through successive mouth fittings. Once the ideal fit was achieved, the uncured porcelain crown was baked for a mere 20 minutes and then glued permanently (hopefully) into my mouth.
It would have been really cool if it had been 3D printed, but honestly, this process took less time, so for now, that's good enough for me.
Image Credit: 3dprintingindustry.com
Weeks before the Egyptian Revolution, I had the opportunity of a lifetime to visit Cairo. When I visited the pyramids, I was shocked to see so many people climbing all over them. I had imagined we wouldn't be allowed to touch, let alone scale, something so ancient and valuable.
Such access has taken a toll on another Egyptian site: the burial chamber of the Pharaoh Tutankhamun.
"It was the constant changes, caused by the humidity of the breath and temperature of the visitors that had started to make the paint on the walls crack, and the plaster to fail.
It was decided that if something wasn't done, the chamber would deteriorate to the point where valuable artifacts would be lost."
Fortunately, 3D printing has come to its rescue. A Spanish-based 3D printing company undertook a five-year project to thoroughly 3D scan the tomb's interior and 3D print an exact replica.
Perhaps one of the most extensive examples of using additive manufacturing to preserve history, the Egyptian project is just one of many such efforts. For years, the Smithsonian Institution has also been scanning and printing a number of its artifacts: Smithsonian X 3D allows individuals to remotely "navigate, explore and manipulate 3D collection objects" And other museums have begun to reproduce valuables to make exhibits more interactive and accessible.
Patient-specific printed splints are used to treat life-threatening thoracic constrictions. Work done at the University of Michigan involves laser sintering bio compatible, bio absorbable materials.
The official purpose of this week's FDA-sponsored workshop was "to provide a forum for FDA, medical device manufacturers, additive manufacturing companies and academia to discuss technical challenges and solutions of 3D printing." In other words, the FDA wants "input to help it determine technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions."
The FDA is trying to stay current with advanced manufacturing technologies that are revolutionizing patient care and, in some cases, democratizing its availability... When a next-door neighbor can print a medical device in his or her basement, that clearly has many positive and negative implications that need to be considered.
Ignoring the regulatory implications for a moment (I'll get to those shortly), the presentations were fascinating. In particular, I was intrigued and inspired by the Post-Printing speakers and Clinical Perspectives projects.
STERIS representative Dr. Brodbeck cautioned that the complex designs and materials now being created with additive manufacturing make sterilization practices challenging. How will the manufacturer know if the implant is sterile or if the agent has been adequately removed or if it is suitable? Some materials and designs, for example, cannot tolerate acids, heat or pressure.
Wake Forest Presenter Dr. Yoo shares his institution's research on bioprinting
Dr Boland from the University of Texas El Paso shared his team's work on 3D printed tissues. Using inkjet technology, the researchers are evaluating the variables involved in successfully printing skin. Another bio-printing project being undertaken at Wake Forest by Dr. Yoo involves constructing bladder-shaped prints using bladder cell biopsies and scaffolding. And Dr. Liacouras at Walter Reed discussed his institution's practice of using 3D printing to create surgical guides and custom implants.
Since RapidMade creates anatomical models, one project, near and dear to my heart - pun intended - is work done at Children's National Hospital by Drs. Krieger and Olivieri. The physicians use printed cardiac models to "inform clinical decisions" ie. evaluate conditions, plan surgeries, and reduce operating time.
As interesting as the presentations were, the subsequent discussions were arguably more important. In an attempt to identify and address all significant impacts of additive manufacturing on medical device production, the subject was organized into pre-printing (input), printing (process) and post-printing (output) considerations. Panelists and other stakeholders shared their concerns and viewpoints on each topic in an attempt to inform and persuade FDA decision makers.
An interesting (but expected) outcome was the relative positions of the various stakeholders. Well establish and large manufacturers proposed validation procedures: material testing, process operating guidelines, quality control, traceability programs, etc. Independent makers argued that this approach would impede, if not eliminate, their ability to provide low-cost prosthetic devices.
Coming from the highly regulated food industry, I completely understand and accept the need to adopt similar measures for some additively manufactured medical devices. An implant is going into someone's body, so the manufacturer needs to evaluate and assure the quality of raw materials, processing procedures and finished product. But this means, as in the food industry, the manufacturer needs to know the composition of materials. Suppliers cannot hide behind proprietary formulations. If manufacturers are expected to certify that a device is safe, they need to know what ingredients are in the materials they are using.
Hopefully, the FDA will also agree with the GE representative who suggested that manufacturers should be expected to certify the components and not the process. What matters is whether or not the device is safe, not what process was used to make it. Another distinction should be the product's risk level. Devices should continue to be classified as I, II or III and that classification, not the process used, should determine its level of regulation.
If you are interested in submitting comments to the FDA on this topic, email them to http://www.regulations.gov .
