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3D–Printing and its application in Medical Care Submitted to Prof. Carlton Crabtree IS 601- Foundations of Information Systems

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3D–Printing and itsapplication inMedical Care

Submitted to

Prof. Carlton CrabtreeIS 601- Foundations of Information Systems

3D–Printing and its application in Medical Care 2013

Submitted by:-

AOA Team

Anusha Kanuri

Orville Pinto

Alejandro Jaramillo

Index1. Introduction

1.1 What is 3D –printing?

1.2 Origin of 3D-Printing

1.3 How 3D-Printing is ‘Emerging Technology’ today?

1.4 3D-Printing in Medicine

2. 3D-Printing Technology

2.1 How 3D-Printing Works?

2.2 Different Methods of 3D-Printing

2.2.1 Stereolithography

2.2.2 Fused Deposition Modeling

2.2.3 Selective Laser Sintering

2.2.4 Inkjet Printing

2.3 Medical Application of 3D-Printing

3. Potential Impacts of 3D- Printing on Medicine

4. Challenges for 3D-Printing in Medicine

5. Risks of 3D-Printing

6. Recommendations

7. References

3D–Printing and its application in Medical Care 2013

1.IntroductionImagination gives birth to new ideas and innovation to technologies that would change the world. Imagine if you had a technology or any device that could transform your idea into a tangible object that you can hold in your hand giving the accurate physical shape as thought. It can be a consumer good, a critical component of an industrial machine, even an early physical prototype that unveils your new idea to the world or an organ that can save human life. This has been made possible by the innovative technology “3D–Printing”. It is one of the most exciting innovations to emerge in recent times, 3D-Printing offers the realistic possibility that anyone, anywhere in the world can produce any object they need on demand. 

1.1 What is 3D-Printing? 3D-Printing, also known as additive manufacturing (AM) or direct digital manufacturing (DDM), is a process that makes it possible to create an three-dimensional solid object by creating a digitalfile and printing it from the 3D-printer. In the 3D-Printing process, this digital blueprint, created using computer-aided design (CAD) software, is sliced into 2-dimensional representations which are fed through to a printer that starts building up an object layer by layer from its base. Layers of

3D–Printing and its application in Medical Care 2013

material (in liquid, powder or filament form) are deposited onto a “build area” and fused together. This additive process, which minimizes waste because it only uses the amount of material required to make the component (and its support), is distinct from traditional “subtractive” manufacturing processes where materials are cut away to produce a desired form.[1]

1.2 History of 3D-PrintingThe inception of 3D- printing can be traced back to 1976, when the inkjet printer was invented. In 1984, adaptations and advances on the inkjet concept morphed the technology from printing with ink to printing with materials.

In late 1980s and 1990s the earliest use of additive manufacturing was used in rapid prototyping. A physical prototypeis an object that is realized in shape, texture and color which could be beyond the drawing or computer models to communicate your vision in more interactive way. This empowers the observer or manufacturer to examine the product or interact with it ratherthan making assumptions before producing the final product. Rapidprototyping allowed manufactures to produce those prototypes muchfaster than before, often within days or sometimes hours of conceiving the design. In RP, designers create models using computer-aided design (CAD) software, and then machines follow that software model to determine how to construct the object. The process of building that object by "printing" its cross-sections layer by layer became known as 3D- printing. [2]

Charles Hull, co-founder of 3D- Systems developed the first 3D- printing technology for printing physical 3D objects from digitaldata in 1984. In 1986, the invention of 3D printing technology was introduced as an additive print process that uses a techniquecalled stereolithography to build models and prototypes [3].  In this technique, a UV laser is shined into a vat of ultraviolet-sensitive photopolymer, tracing the object to be created on its surface. The polymer solidifies wherever the beam touches it, andthe beam "prints" the object layer by layer per the instructions in the CAD/CAM (computer-aided design/computer-aided manufacturing) file it's working from. As soon as this printing technique was introduced, Hull started the company 3D- Systems

3D–Printing and its application in Medical Care 2013

and it developed the first commercial 3D-Printing machine which was called as Stereolithiography Apparatus (SLA). Soon after, 3D-Printing based on inkjet principles was developed and patented bythe Massachusetts Institute of Technology (MIT) in 1993. In the early 1990s, MIT developed a procedure it trademarked with the name 3D-Printing, which it officially abbreviated as 3DP. As of February 2011, MIT has granted licenses to six companies to use and promote the 3DP process in its products [4].

3D Systems, has pioneered and used a variety of 3D-Printing approaches since its founding in 1986. It has even trademarked some of its technologies, such as the stereolithography apparatus (SLA) and selective laser sintering (SLS).While MIT and3D Systems remain leaders in the field of 3D-Printing, other companies such as Z Corporation, Objet Geometries and Stratasys have also brought innovative new products to market, building on these AM technologies. They saw this technology as a growing new development that could take off in many industries.

In 1999, the first lab grown organ was implanted into human, using a synthetic 2d scaffold covered with their own cells. This paved for more ways of producing human organs, including printingthem.[5]

In 2006, the 3D-Printing systems and material providers created amachine capable of printing in multiple materials, including elastomers and polymers with the help of SLS (selective laser sintering) 3D-Printing technique in variety of densities and material properties.[5]

In 2008, the first self-replicating printer was released by RepRap project that print the majority of its own components, allowing users who already have one to make more printers for their friends.[5]

In 2011, Engineers at the University of Southampton designed and fly the world’s first 3D-printed aircraft. This unmanned aircraftis built in seven days for a budget of £5,000. 3D printing allowsthe plane to be built with elliptical wings, a normally expensivefeature that helps improve aerodynamic efficiency and minimizes induced drag. [5]

3D–Printing and its application in Medical Care 2013

1.3 How 3D-Printing is ‘Emerging Technology’ today?

3D-Printing technology, though it has been available almost threedecades ago it was long used by the manufacturers for creating asingle or two prototype models in their offices that was mass produced in factories. With the advancement in the printing technology’s accuracy and speed, as well as in the quality of materials used for printing, the 3D –printing has developed so big that it has changed its single advantage of just prototyping to print anything on demand with many advantages and has become arevolution today.

3D-Printing has numerous advantages over traditional manufacturing that make it very difficult to not see it as the de-facto manufacturing technology of the future. The following are some of advantages of 3D-Printing

Manufacturing complexity is free: In traditional manufacturing, the more complicated an object's shape, the more it costs to make. On a 3D printer, complexity costs thesame as simplicity. Free complexity will disrupt traditionalpricing models and change how we calculate the cost of manufacturing things.

New Structures and Shapes: Objects produced by traditional manufacturing are limited by the finite number of shapes that are able to be produced through cutting and molding technologies available to the user. This can severely hamper the possible end product a user wants to create. On the other hand, the shape and structure of objects create by3D-Printing are only limited by the users imagination. Thisis because the nozzle of a 3D printer can create any complexshape or structure.

No Assembly required: 3D printing forms interlocked parts. Mass manufacturing is built on the backbone of the assembly line. Generally in factories, machines make identical objects that are later assembled by robots or human workers.The more parts a product contains, the longer it takes to assemble and the more expensive it becomes to make. By making objects in layers, a 3D printer could print

3D–Printing and its application in Medical Care 2013

everything at the same time, no assembly required. Less assembly will shorten supply chains, saving money on labor and transportation; shorter supply chains will be less polluting.

Zero lead time: A 3D printer can print when an object is needed. The capacity for on-the-spot manufacturing reduces the need for companies to stockpile physical inventory. New types of business services become possible as 3D printers enable a business to make specialty or custom objects on demand in response to customer orders. Zero-lead-time manufacturing could minimize the cost of long-distance shipping if printed goods are made when they are needed and near where they are needed.

Cost: 3D- printers are available to develop any object with different materials, for example, printing of human organ that are actually implanted to the person and also 3D-printers will be owned and used by final consumers, just like traditional desktop laser printers at affordable cost. Initially, 3D technology was costly, retailing for nearly $20,000 before 2010 but the prices have changed since then. Due to free and open source software licensing, 3D printers have become more affordable for smaller companies and average consumers. In today’s markets, a 3D printer can be bought for as little as $500, though the prices keep shooting upwards from there.[6]

Compact, portable manufacturing. Traditional manufacturing requires long production lines, high human labor costs, and high prototyping costs. 3D-Printing on the other hand removes all those costs and allows for the complex production of a newly designed object by only one human and only one 3D printer. 3D-Printing allow for the design and production of a newly thought object to all take place in a location as crude as your garage and all on your schedule.

Precise physical replication: A digital music file can be endlessly copied with no loss of audio quality. In the future, 3D printing will extend this digital precision to the world of physical objects. Scanning technology and 3D printing will together introduce high resolution shapeshifting between the physical and digital worlds. We

3D–Printing and its application in Medical Care 2013

will scan, edit, and duplicate physical objects to create exact replicas or to improve on the original.

In society today, many methods of 3D-Printing are being used thathas improved capabilities of manufacturing. They produce high quality prints in a fast and efficient manner. It is integrating itself into the print world with its advanced technology and versatility, which can be applied to many diverse fields. With promising technology support, 3D printing has a bright future andhas got applications in various fields like manufacturing of manykinds of plastic and metal objects, in medicine, in the arts, andin outer space etc.

1.4 3D-Printing in MedicineMedicine is perhaps one of the most exciting areas of application. If there is one sector where we want to see the growth of technology, it is in the field of medicine. We all haveour wishes for a technology in the medical field that could save human life. 3D printing is by far one of the most impressive technological developments in the history of medicine. This technology has the ability to make real objects based off of 3D models of the object. The speed and accuracy of 3D-Printing are the main reasons that it is being implemented into the diverse fields of medicine such as dentistry, prosthetic development and high-risk surgery etc. 3D printing is used to help people who mayhave lost a limb by creating prosthetic leg, people who can’t hear by creating custom hearing aids, deployed to treat challenging medical conditions, and also in advance medical research, including in the area of regenerative medicine.

2.3D-Printing Technology

2.1 How 3D-Printing WorksThe process any 3D printer takes from the conception of an objectidea to the finished printed product may vary a little bit from printer to printer but in general all 3D printers follow the sameeight steps from start to end.[8]

3D–Printing and its application in Medical Care 2013

1) CAD: All objects to be created by a 3D printer must be created first from a software model that fully describes theexternal geometry. This can be done with any professional CAD solid modeling software but the output must be a solid or surface representation.

2) Conversion to STL: This step requires the CAD file made in step one to be converted to an STL (standard tessellation language) file. This is important because just about every 3D printer can accept a STL file and nearly all CAD softwarecan convert its files into STL format. The STL file essentially describes to the computer connected to the 3D printer the dimensions of the object and forms the basis forcalculation of the slices.

3) Transfer to AM Machine and STL File Manipulation: This stepis analogous to print setting properties found on a regular 2-D printer used anywhere. So in this step with a 3D printer a user can define the size and orientation of the printing, much like a user of a 2-D printer would pick 2-sided printing or landscape or portrait.

4) Machine Setup: The 3D printer to be in use needs to be properly prepared prior to the build. Such settings includeenergy source, layer thickness, and material constraints.

5) Build: This is the step when the actual printing of the desired object occurs. This step is almost all automated and requires little, if any supervision.

6) Removal: After the desired object has been completely printed, it needs to be removed from the printer.

7) Post-processing: Once the printed object has been removed from the printer, many time it is still not ready for use and requires some form of post-processing. Post-processing step may consist of additional clean up by brushing off any remaining powder or allowing the object to stand still so itcan fully cure.

8) Application: This step is simple and only requires the final product to be used in the desired manner.

3D–Printing and its application in Medical Care 2013

Process of 3D- Printing

2.2 Different Methods of 3D-Printing2.2.1 Stereolithography

Stereolithography (SLA) is the most widely used rapid prototypingtechnology. It works by using a low-power, highly focused UV laser to trace out repeated cross-sections of a three-dimensionalobject in a vat of liquid photosensitive polymer. As the laser traces the layer, the polymer begins to form shape, solidify, andthe excess areas are left as liquid. When a layer of the three-dimensional object is completed, a leveling blade is moved acrossthe surface to give it an even finish it before depositing the next layer.  The platform which is hoisting the object is then lowered by a distance that is equal to the layer thickness, usually in the range of 0.003-0.002 in, and a consecutive layer is formed on top of the previously finished layers. The process described above, consisting of tracing and evening the surface isrepeated until the object is finally completed. Once complete, the object is elevated above the vat and drained. Excess polymer is swabbed or lightly washed away from the surfaces. Many times the object is not completely solidified and is given a final cure

3D–Printing and its application in Medical Care 2013

is given by placing it in a UV oven. After the final cure, supports are cut off the object and surfaces are polished, sandedor otherwise finished.

Stereolithography

2.2.2 Fused Deposition Modeling (FDM)

Fused Deposition Modeling (FDM) was developed by Stratasys in Eden Prairie, Minnesota. FDM works by having a piece of plastic or wax material which is extruded through a nozzle that traces the objects cross sectional geometry layer by layer until it is completed. The material which the object will be constructed fromis usually supplied in filament form, but some setups use plasticpellets fed from a hopper instead. The nozzle contains resistive heaters that keep the plastic at a temperature just above its melting point.  This allows the plastic to flows easily through the nozzle and form consecutive layers and finally build a final object.  The plastic hardens immediately after flowing from the nozzle and forms to the layer below. Once a layer is constructed,the platform lowers, and the extrusion nozzle deposits another layer.  This process is continued until the object is completed.  The layer thickness and vertical dimensional accuracyis determined by the extruder die diameter, which ranges from 0.013 to 0.005 inches.  One of the strongest benefits to using

3D–Printing and its application in Medical Care 2013

FDM is the amount of different materials available used to construct an object.  Some of the most widely used materials are ABS, polyamide, polycarbonate, polyethylene, polypropylene, and investment casting wax.

2.2.3 Selective Laser Sintering

Selective Laser Sintering (SLS) was developed at the University of Texas in Austin, by Carl Deckard and colleagues. The technology was patented in 1989 and was originally sold by DTM Corporation. DTM was acquired by 3D Systems in 2001. SLS most closely resembles SLA in the way it is conceptualized and functions.  It uses a moving laser beam to trace and selectively sinter powdered polymer and/or metal composite materials into successive cross-sections of a three-dimensional part.  This is very much like the way SLA traces the ad forms the different cross-sections of an object. Just like the previous two techniques presented, the parts are built on a platform that adjusts in height equal to the thickness of the layer being built.  To help the binding and curing process, additional powderis added on top of each solidified layer and sintered. The powderis then rolled onto the platform from a bin before building the layer. The powder is maintained at an elevated temperature so that it fuses easily upon exposure to the laser.

3D–Printing and its application in Medical Care 2013

The build process with metal composite materials is a little bit different than that of polymers.  When working with metal composite materials, the SLS process solidifies a polymer binder material around steel powder one slice at a time, forming the objet. The part is then placed in a furnace, with temperatures over 900 °C, where the polymer binder is burned off.  To help improve its density and structural integrity the part is infused with bronze.  This previously described process usually takes roughly one day to complete.  SLS, like FDM, also allows for a wide range of materials that can be used to create objects.  For example some of the materials are nylon, glass-filled nylon, SOMOS (rubber-like), Truform (investment casting), and the previously discussed metal composite.

Selective Laser Sintering

2.2.4 Inkjet Printing

The additive manufacturing technique of inkjet printing is based on the 2D printer technique of using a jet to deposit tiny drops of ink onto paper. Where the two processes differ is in the additive process, the ink is replaced with thermoplastic and wax materials, which are held in a melted state. When printed, liquiddrops of these materials instantly cool and solidify to form a layer of the part.  Inkjet printing offers the advantages of excellent accuracy and polished finishes.  On the downside, Inkjet printing has the disadvantages of slow build speeds, few

3D–Printing and its application in Medical Care 2013

material options, and fragile parts. Consequently, inkjet printing is most widely used for building prototypes of objects which are used for form and fit testing. Other applications include jewelry, medical devices, and high-precisions products.  

The inkjet printing process begins with the build material (thermoplastic) and support material (wax) being held in a meltedstate inside two heated reservoirs. The materials are then each fed to an inkjet print head which moves in the X-Y plane and deposits tiny droplets to the specified area to form one layer ofthe object. Both materials instantly cool and solidify. After a layer has been finished, a milling head moves across the layer tosmooth the surface and give it a finished look. The particles resulting from this cutting operation are vacuumed away by the particle collector. Much like the previous techniques described previous, once the layer is completed, the elevator then lowers the build platform and object so that the next layer can be constructed. This process is repeated over again until the objectis completed.   Once the object is completed, it can be removed and the wax support material can be melted away.

Inkjet printing

2.3 Medical Applications of 3D-Printing

3D–Printing and its application in Medical Care 2013

3D-Printing can fabricate parts of almost any geometrical complexity in relatively lower time and with reduced cost and without significant requirements in technical expertise. This kind of geometric flexibility, which is mostly a consequence of their additive nature, is the main reason that 3D-Printing technologies are increasingly used or tested in non-industrial applications like medicine. The global 3D-Printing medical applications can be categorized as follows

1.3D printing in Medical Applications Market, by Applications

Surgical Guides Orthopedic Dental Crani-maxillofacial

Implants Orthopedic Dental Cranio-maxillofacial

Surgical Instruments Bioengineering

2.3D printing in Medical Applications Market, by Technologies

Selective Laser Sintering Photopolymerization Stereolithography Droplet Deposition Manufacturing Inkjet Printing Fused Deposition Modeling

3.3D Printing in Medical Applications, by Raw Materials

Metals Polymers Ceramics Biological Cells

4.3D printing in Medical Applications, by Geography

North America Europe

3D–Printing and its application in Medical Care 2013

Asia Pacific Rest of the World

Below are some real time applications of 3D- Printing made in medicine

Using “Bio-ink” to create living tissue: Scottish scientistshave invented a cell printer that squirts out living embryonic stem cells using 3D-Printing, a technology that could be a boon to regenerative medicine by allowing doctorsto create tissues to test new drugs or even grow organs. Stem cells have the unique ability to develop into any type of cells, from skin to muscle, bone or organs.

3D “magic arms” allow a disabled child to hug and play: Four-year-old Emma was unable to move her arms freely due to a muscular disorder, until researchers built “magic arms” for her, with the aid of a 3D printer.  More than a dozen other disabled children have also benefitted from thistechnology. Cleveland Clinic is looking into using 3D laser melt printers to create custom, patient-specific orthopedic devices. “Currently, if you get a hip replacement surgery, the device is adjusted to fit you by removing material, but 3D-Printing would work in reverse, by building an implant that precisely matched your anatomy.”

Printing a human ear: Researchers from Cornell used a 3D printer to craft a human ear that looks and feels like a real one. The ear wasn’t printed with “bio-ink.” Instead, the ears of normal children were scanned and digitized. The images were used to create a mold that was filled with animal collagen, followed by cartilage. The collagen acted as a framework for the cartilage cells to grow. After three months, the flexible ears steadily grew cartilage to replacethe collagen. An ear replacement like this would also help individuals who have lost part or all of their external ear in an accident or from cancer.

Patching a broken heart: An international team of scientistsare developing a heart patch using 3D laser printing and human stem cells, collected from the blood vessel lining inside an umbilical cord. The heart patch was tested on ratsthat had suffered heart attacks, with significant

3D–Printing and its application in Medical Care 2013

improvement in heart function after the treatment. The researchers believe that such patches, which are like livingbandages, could ultimately improve healing in human heart-attack survivor. 3D-Printing can also help doctors customizeblood vessel devices, such as stents (used to prop clogged arteries open).

Safer surgery: At Cleveland Clinic, surgeons performing complex liver or kidney transplant operations are using 3D- printing technology to construct a 3D-model of the patients.In the operating room, the surgeons can see the inner vasculature without the patient being exposed to the ionizing radiation of a CT scanner. 3D printers are giving doctors a new tool to see inside the body, both during surgery and while they’re planning the procedure beforehand.

3.Impacts of 3D-Printing in Medicine

3D printing allows for patient specific implants to be customizable and quickly produced in a way not currently available. Orthopedics is characterized by a large value contribution by the manufacturers, surgeons, and finally hospitals for post implant services in medical industry. Themajority of ‘primary activities’ are completed by implant while support activities are the responsibility of hospitals, private practices and surgeons. Clearly the largest value is created with the production of the device (firms) then the eventual implantation/surgery (surgeons/hospitals) and then continued maintenance of the device (hospitals/doctors/private practices).By utilizing 3DP technology hospitals and private practices have the potential to backward integrate and replace their suppliers.Instead of ordering a base amount of say hip replacement implants, hospitals could instead purchase a set of 3DP machines which could on a per-patient basis produce customized hip replacement implants. This will however call for the development of new departments within hospitals and practices dedicated to 3DP scanning and production. Manufacturers could simply adopt 3DP as a custom service provided to hospitals in the case of extraordinary parts

3D–Printing and its application in Medical Care 2013

needed will still producing generic orthopedic implants. Also Firms could work with local hospitals in order to create per-patient implants.

Prosthetics involves the development and production of replacements for missing body parts. 3DP’s largest impact onprosthetics will be the ability to create highly customized and detailed parts at a much lower cost. 3DP also allows forthe use of a much wider variety of materials in the production of prosthetics giving doctors a wider variety of products to choose from. Prosthetics have a tendency to be more personalized and 3DP allows them to be exponentially so, patients will most likely work with their doctor and a contracted third party in the creation of new prosthetics. There are a small number of firms who produce custom prosthetic devices and some also producing bone replacements. This is clearly an extremely large market which can be considerably impacted by the availability of new efficient and low costs methods of producing implants, prosthetics and supports. It is estimated that roughly 40% of the cost of a hip or knee replacement is the actual cost of the implant itself. 3D printing can drastically reduce this cost in many ways. Implants and bone replacements whichare now specially crafted by labs out of a variety of materials (mostly composite ceramics) can instead produce within the orthopedic professionals own practice with relatively low-cost 3DP machines which are currently available.

Regenerative Medicine is a new filed in medical industry which encompasses things like stem cell research, tissue engineering, and organ generation. 3D-Printing offers a unique advantage to this field, the possibility of one-of-a-kind artificially generated organ replacements. 3D-Printing allows for living cells to be ‘printed’ onto successive layers of gel composites in a specific shape upon which theygrow and eventually form a specific organ. This may also be used not only to grow synthetic organs but also specialized cartilage based body parts such as ears and noses. Even though this application of 3DP technology is currently beingused and researched by firms and universities it is

3D–Printing and its application in Medical Care 2013

certainly much further from widespread acceptance than dental and prosthetic applications.

3D printing will have the greatest impact on Dentistry sector. According to the Gale Encyclopedia of American Industries, in the late 2000s, there were about 12,100 dental laboratories in the US employing some 56,750 people.These labs produced custom-made prosthetic appliances for the dental profession and typically were within 50 miles of the dental offices they serviced. They were responsible for almost $3.1 billion in service in the late 2000s. With 3D printing, this portion of the value-chain may shift at leastpartially to the dental offices themselves, allowing them toretain more profits. Additional value will shift to the producers, resellers and servicers of the printing devices as well as those firms producing and selling the printing materials. According to the Bureau of Labor Statistics in 2008 there were 120,200 dentists in the U.S. most of which worked as solo practitioners, making about 90,150 dental practices. This represents a substantial potential market for dental prosthetic capable 3D printers.  At a projected price tag of $10,000, and an estimated lifespan of 5 years, this represents potential sales of about $180 million per year.

The global medical equipment industry was valued at USD 280 billion in 2009, and is forecasted to grow by more than 8% annually for the next seven years to exceed USD 490 billion in 2016. There are several reasons as to why the medical industry is expected to grow so much in the coming years. With promises to be a cheaper, safer, and quicker alternative, 3D-Printing is sure to progress from only an emerging technology to a disruptive technology in the medical industry and would lead to division of medical growth between traditional medical device providers and 3D printer’s providers.

The key industry players are divided into two groups: 3D Printing players and medical industry players. Each group isacting in distinct ways to create an impact on the industry landscape going forward: 3DP players by advancing the base technology and medical players by leveraging the technology

3D–Printing and its application in Medical Care 2013

and adapting into their specific uses. The most key players within the 3DP section are MIT and the 6 3DP licensees, mostimportantly Z Corp and Integra. Within the medical field there are a number of firms who could be identified as key players based on the trajectory of 3DP in health care going forward. Top biotechnology and orthopedics firms will most likely be the most affected and pivotal as 3DP becomes more prevalent in the field of medicine. In the field of Bio-Techfirms like Regeneron, Osiris and Genetech will have keen interests in the potential aspects of 3DP in regards to organ printing. In regards to prosthetics and orthopedic implants, top firms such as Stryker, DePuy, Medtronic, and Synthes will play a more direct role in moving 3DP into the mainstream than their Bio-Tech counterparts do with organ printing. 3DP will allow these firms to produce more specific, customizable solutions to generic operations such as hip and knee replacements. 3DP will also allow smaller firms to begin to compete with large manufacturers in orthopedics which will force large firms to either innovate faster or adopt technology faster.

3D printing in medical applications is expected to grow at asignificant CAGR of 15.4% from 2013 to 2019. This growth is attributed to an increase in demand of quick and cheap solutions for medical problems. In addition, the market would also grow owing to an increase in investment in R&D for the technologies of 3D printing. Geographically, although the North American region constituted the largest market for 3D printing in medical applications in year 2012,Europe is expected to witness the highest growth rate of more than 15% from 2013 to 2019. This growth is mainly due to the increase in government funding in this market along with various small and big mergers and acquisitions of companies for technological advancement coupled with enhancement in application areas. Favorable reimbursement policies in the region will also provide the required impetus for the growth of the market.

4.Challenges for 3D-Printing in Medicine

3D–Printing and its application in Medical Care 2013

While the future promises of 3D-Printing are hopeful,currently 3D-Printing only works with a limited number ofmaterials, the most common being plastics. Until 3D printertechnology is further researched and developed, the 3D-Printing of complex objects that require mixed materials,such as computers, will not be possible. In the medicalworld, 3D printer biomaterial selections are even morelimited. Although there are a few “FDA friendly”—i.e.,biocompatible materials—that are starting to be used, wewould be hard-pressed to find an actual “bio-friendly”material. Until these material selection limitations arebetter addressed, it will be difficult for both medicaldevice designers as well as packaging professionals to bestutilize the true potential of this technology.

3D printing can only be applied to structure not exceedingcertain dimension as 3D printers are not able to produceextremely large, e.g., whole body, models. It is currentlyovercome by producing a miniature version of large structureby post-processing or by dividing the whole model intosmaller parts which can be combined after printing.

The major challenge associated with organ printing now andeven after the technology is solidified are the ethicalconcerns it raises. These concerns do not only affect thosewho would wish to have or potentially use the technology butthe regulatory environment around it. Society’s sentimentson these issues will determine the laws and governancearound the technology, its availability and eventualimplementation.

5.Risks of 3D-Printing in Medicine

The upholding of intellectual property and copyright laws are one the most important to a developed society. As 3D-Printing becomes more common, the printing of copyrighted products to create counterfeit items will become more commonand nearly impossible to determine. New intellectual property and copyright laws will have to be put in place in

3D–Printing and its application in Medical Care 2013

order to ensure 3D-Printing does allow for counterfeit itemsto become rampant in society. There are risks that a doctorcan use a bio-printer without approval of FDA to print illegal organs from a patient stem cells which could be a ethical concern.

The human body is very vulnerable to disease and injury. This is why we have to take medications when we get sick andwear helmets and pads when we play sports. With widespread bio-printing, however, injury becomes less of a concern because we know that injured body parts can simply be boughtand replaced. Many people will see this as an opportunity toengage more frequently in riskier behaviors such as smoking,drinking, doing drugs, fighting, playing very physical sports and more.

The material used for the implants might be a risk for the patient as there are very less biomaterial that are developed as of now.

6.Recommendations: Surgeons need to understand the benefits of the 3D

technologies, how it’s used and the impact it will have on their skills as a surgeon, labs need to understand 3D-Printing impact on their place in the value chain and hospitals need to understand both the benefits of the technology and the cost savings it offers.

The 3D-Printers used in the medical industry should be patented and must have an approval from FDA.

The 3D-Printer companies should develop printers with great accuracy and that are compatible with biomaterials so that they could provide much more advantages to the industry and also benefit them in the competitive medical device industry.

Develop specialized method of 3D-printing for regenerative medicine.

7.Future of 3D-Printing

3D–Printing and its application in Medical Care 2013

IEEE Computer Society has marked 3D-Printing as one of the top 10 technology trends for 2014.New 3D printing tools and techniques are empowering everyone from global corporations to do-it-yourselfers to create new devices and realize new concepts more quickly, cheaply, and easily than ever—from car parts, batteries, prosthetics, and computer chips to jewelry, clothing, firearms, and even pizza.

According to MarketsandMarkets, the 3D Printing Market is expected to grow at a CAGR of 23% from 2013 to 2020, and reach $8.41 billion in 2020.

References:1. Catherine Jewell, Communications Division (April 2013). 3D-Printing and the future of stuff WIPO. Retrieved October 26, 2013 from http://www.wipo.int/wipo_magazine/en/2013/02/article_0004.html

2. Stephanie Crawford (n.d). How 3D-Printing Works. Howstuffswork. Retrieved October 26, 2013 from http://computer.howstuffworks.com/3D-printing.htm

3. 3Ders.org (n.d.). 3Ders.org - The history of 3D printer. Retrieved December 6, 2013 from http://www.3Ders.org/3D-Printing/3D-Printing-history.html

4. MIT (n.d.). See who is licensing 3DP technology. Retrieved December 6, 2013 from http://web.mit.edu/tdp/www/licensees.html

5. T.Rowe Price (n.d.). Brief History of 3D Printing - T.Rowe Price. Retrieved October 26, 2013, from http://individual.troweprice.com/public/Retail/Planning-&-Research/Connections/3D-Printing/Infographic

6. Farooq Baloch/The Express Tribune (2013, December 1). 3D: The future is printed – The Express Tribune. Retrieved December 6,

3D–Printing and its application in Medical Care 2013

2013, from http://tribune.com.pk/story/637748/3D-the-future-is-printed/

7. Barry Berman (March–April 2012). 3D-Printing: The new industrial revolution. Business Horizons, Volume 55, Issue 2, Pages 155-162.

8. Gibson, I., Rosen, D. W., & Stucker, B. (2010). Introduction and Basic Principles. In Additive manufacturing technologies: Rapid prototyping to direct digital manufacturing. New York: Springer.

9. Customerpart.net (n.d.). Rapid Prototyping - Stereolithography(SLA). Retrieved October 26, 2013, from http://www.custompartnet.com/wu/stereolithography

10. J. Giannatsis &V. Dedoussis (January 2009). Additive fabrication technologies applied to medicine and health care: a review. The International Journal of Advanced Manufacturing Technology , Volume 40, Issue 1-2, pp 116-127.

11. J. Giannatsis &V. Dedoussis (January 2009). Additive fabrication technologies applied to medicine and health care: a review. The International Journal of Advanced Manufacturing Technology , Volume 40, Issue 1-2, pp 116-127.

12. Steven Leckart (August 2013). How 3D-Printing Body Parts Will Revolutionize Medicine. Popsci. Retrieved October 26, 2013from http://www.popsci.com/science/article/2013-07/how-3D-printing-body-parts-will-revolutionize-medicine

13. PRWEB (September 2013). Global 3D printing in Medical Applications Market is Expected to Reach USD 965.5 Million in 2019: Transparency Market Research. PRWEB. Retrieved October 26, 2013 from http://www.prweb.com/releases/2013/9/prweb11177452.htm

14. Lisa Collier Cool (2013, May). Amazing Medical Uses of 3D Printing | Yahoo Health. Retrieved October 26, 2013, from http://health.yahoo.net/experts/dayinhealth/amazing-medical-uses-three-d-printing

3D–Printing and its application in Medical Care 2013

15. PartneringNews (n.d.). Emerging trends in the medical equipment industry. partneringNEWS. Retrieved October 26, 2013, from http://ebdgroup.com/partneringnews/2010/05/emerging-trends-in-the-medical-equipment-industry/

16. Bureau of Labor Statistics (n.d.). Dentists : Occupational Outlook Handbook : U.S. Bureau of Labor Statistics. Retrieved November 28, 2013,from http://www.bls.gov/ooh/Healthcare/Dentists.htm

17. Top 10 tech trends for 2014: the revolution will be 3D | B3dgeable. (n.d.). Retrieved December 1, 2013, from http://www.b3dgeable.com/2013/11/25/top-10-tech-trends-for-2014-the-revolution-will-be-3d/

18. Andrew Nusca (n.d.). 3D printing: The hype, the hopes, the hurdles | Cutting Edge - CNET News. Retrieved October 26, 2013, from http://news.cnet.com/8301-11386_3-57549959-76/3d-printing-the-hype-the-hopes-the-hurdles/