3D Printing : Medical Industry

What is 3D printing?

Technology has become a key factor to affect recent human history probably more than any other industries. These technologies such as light bulb, cars and airplanes have made us live in a better way, and also brought us new opportunities and possibilities, in general, it will take us a long time to see the result, sometimes even decades. And now, most people believe that 3D printing or additive manufacturing (AM) has the great potential to become a great invention like these technologies we mentioned before. 3D printing has now been conducted vigorous propaganda by social media, we could access those information from TV, newspapers and websites. In another word, 3D printing actually is an additive manufacturing process and it is indeed the key because 3D printing is a radically different manufacturing method based on advanced technology that builds up parts, additively, in layers at the sub mm scale. This is the most basic distinction compared with the rest of existing traditional manufacturing techniques. There are many limitations and restrictions to traditional manufacturing techniques, so the world of manufacturing has to be changed, therefore we have automated processes now such as machining, casting, forming and molding, and for complex processes, those are require machines, computers and robot technology.

These technologies all need minimum material from a larger block whether to achieve the end product itself or to produce a way for casting or molding processes and it’s a severe restriction within the whole manufacturing process. In order to impose a number of unacceptable constraints to many applications traditional design and production processes, including the expensive tooling as mentioned above, fixtures, and the need for assembly for complex parts. In addition, the subtractive manufacturing processes, like machining, could be raised by 90% of the original block of material being wasted.

On the contrast, 3D printing is a process for creating objects directly, by adding material layer by layer in a variety of ways, depending on the technology used. At a word for anyone to know better what is the definition of 3D printing, you could think about the process like building something with LEGO blocks.

3D printing is an enabling technology that encourages and drives innovation with unprecedented design freedom while being a tool-less process that reduces prohibitive costs and lead times. Objects would be designed specifically to avoid fitting requirements with complex geometry and created with no waste as the meantime. 3D printing is an energy conservation technology which could help to improve efficiencies according to both fully utilizing raw materials, and lighter and stronger design.

In recent years, 3D printing has become more available for small firms and even individuals, smaller 3D printers could be owned around $1000. This lead the technology to face more audience than before and as the exponential adoption rate rapidly goes up, more and more systems, materials, applications, services and ancillaries are emerging.

History:

In the 1986, Rapid Prototyping technologies appeared, Charles (Chuck) Hull who invented Stereo Lighography Apparatus (SLA) machine in 1983 owned the first patent that issued for SLA, and that is the earliest 3D printing technologies first became visible. The processes were originally designed to be a method to improve the efficiency of creating prototypes for product development. Hull went on to co-found 3D Systems Corporation that already become one of the largest and most prolific organizations operating in the 3D printing sector today.

In 1987, SLA-1, the first commercial RP system of 3D Systems was introduced and following strict testing process, then this system was sold in the following year. Carl Deckard was working at the University of Texas in 1987, applied a patent in the US for the Selective Laser Sintering (SLS) RP process. In 1989, this patent was issued and SLS was licensed to DTM Inc, it was acquired by 3D Systems later on. In 1989, Scott Crump, a co-founder of Stratasys Inc. filed a patent for Fused Deposition Modelling (FDM). In Germany, Hans Langer also had the formation of EOS GmbH at the same time. Today, the EOS systems are recognized around the world for their quality output for industrial prototyping and production applications of 3D printing. And in 1990, EOS sold its first ‘Stereos’ system. At the meantime, there are also some other 3D printing technologies emerging during these years, like Ballistic Particle Manufacturing (BPM) originally patented by William Masters, Laminated Object Manufacturing (LOM) originally patented by Michael Feygin, Solid Ground Curing (SGC) originally patented by Itzchak Pomerantz et al and ‘three dimensional printing’ (3DP) originally patented by Emanuel Sachs et al.

For commercial operations, Sanders Prototype and ZCorporation were set up in 1996, Arcam was established in the next year, Objet Geometries launched in 1998, MCP Technologies (an established vacuum casting OEM) introduced the SLM technology in 2000, EnvisionTec was founded in 2002, ExOne was established in 2005 as a spin off from the Extrude Hone Corporation and Sciaky Inc was pioneering its own additive process based on its proprietary electron beam welding technology. These companies all served to swell the ranks of Western companies operating across a global market.

In 2005, this area began to show signs of unique diversities with two specific sectors of emphasis that are much more clearly defined today. In the first place, 3D printing is a very expensive systems, Secondly, although this is still ongoing and growing, we could only see the results in few such as aerospace, automotive, medical and fine jewelry sectors.

In 2007, the market saw the first system under $10,000 from 3D Systems, for example, Holy Grail got a 3D printer with less than $5000, it may because the system itself, and the market trend. But anyway, this was regard as the key to bring this technology to a much wider customers.

Since 2009, deposition printers have emerged with marginal unique selling points (USPs) and they continue to do so. The interesting dichotomy here is that, while the RepRap phenomenon has given rise to a whole new sector of commercial, entry-level 3D printers, the ethos of the RepRap community is all about Open Source developments for 3D printing and keeping commercialization at bay.

In 2012,  alternative 3D printing processes were introduced at the entry level of the market. 2013 was a year of significant growth and consolidation. Acquisition of Makerbot was one of the most notable moves. Heralded as the 2nd, 3rd and, sometimes even, 4th Industrial Revolution by some, what cannot be denied is the impact that 3D printing is having on the industrial sector and the huge potential that 3D printing is demonstrating for the future of consumers. 

Time Line of 3D Printing:

3D Printing in Medical Industry:

There is no denying that 3D printing has exerted a far-reaching influence on various fields. However, one of the most emerging and potential areas is the medical industry. 3D printing is just the solution, which the medical industry calls for. 3D printing technology can be applied to solve many medical difficulties, such as replacement bones, teeth and prosthetics. Nowadays, people are still studying 3D printing and explore more possible uses in diverse areas, including prototyping, architecture and manufacturing. Many universities keep close collaboration with each other to enable 3D printing to be a revolutionary technology in the medical industry. 3D printing has already become a very significant helper, which can build models for practice for dentist, to finish a more successful surgery. Meanwhile, 3D printing plays a vital role in artificial bones area. Tokyo University has used this technology to rebuild bones for facial reconstruction. It is amazing that there are a lot of similarities between real bones and the artificial bones, which are designed to integrate with the real bones.

At the current stage, 3D printing can be used to create models to help the doctors to have a more accurate diagnose and successful operations. In fact, the requirements of these artificial bones, replacements and teeth are so high that people have to improve the current levels to meet the increasing standard. Thus, scientists, doctors and the relevant researchers are supposed to work together to develop new materials with various properties including density, weight and strength. If the new materials and the new 3D printing ways can be perfectly combined together, the use of the technology will greatly accelerate the development of the medical industry.

Orthopedics

One important sector of medical industry is orthopedics, which makes up 3% of the health care spending. According to the American Board of Orthopedic Surgery there are 20,400 actively practicing orthopedic surgeons in the USA with 650 completing orthopedic residencies each year. There are many advantages of using 3DP in orthopedics. For example, the traditional fabricating orthopedic implants must be customized individually to each patient and this involves a long process with relatively high cost. However, the use of 3DP can greatly reduce the cost and the time for the reason that the technology allows a quick manufacturing process.

Prosthetics

Producing the replacements for some missing parts of the body is another very important area of 3DP. The outstanding influence of the technology is that 3DP can create highly customized and specific parts of the body at a very low cost. There is a lot of evidence that a wide range of materials can be used with 3DP, which can provide more products to both patients and doctors.

Regenerative Medicine

Regenerative medicine is a vital practice of organ generation and tissue engineering. However, it is still a small sub-sector compared to the total spending of the medical industry. There are more than 150 small and middle-sized companies all over the world, which mainly locate in Asian and USA. Till now, only a small number of companies use 3DP to layer the living cells onto the compounds to produce the synthetic organs. 

Technology Development & Industry Trends:

The global medical equipment industry was estimated at USD 280 billion in 2009, which is forecasted to grow by more than 8% annually for the next 7 years to exceed USD 490 billion in 2016. In coming section we will highlight the several reasons as to why the medical industry is expected to grow so much in the coming years. As people wants to live longer and healthier lives, it is ensured that there will be a constantly increasing demand for medical equipment and healthcare services. Huge opportunities lie in the awareness, affordability and improving health infrastructure in emerging economies. And this is fact that most demand for healthcare is not linked to discretionary consumer spending will ensure that the medical industry will continue to grow. The below given graph shows how the number of patents in the medical device industry has grown since 1995.

3D printing is a new technology, which yet has to disrupt the medical device industry. The figure below illustrates this; as the medical devices industry continues to grow 3D printing is still in the developmental stage. While the other traditional device users have another 20-30 years before this technology is developed. 3D printing is sure to progress from only an emerging technology to a disruptive technology as it promises to be a cheaper, safer, and quicker alternative.

Key Industry Players:

The key players relating to our topic can be divided into two groups:

1.      3D Printing players

2.      Medical industry players

Each group is acting in different ways to create an impact on the medical industry in going forward: 3DP players are engaged in advancing the base technology and on the other hand medical players are engaged by leveraging the technology and adapting into their particular uses. The most prominent players in 3DP area are MIT and the 6 3DP licensees, most importantly Z Corp and Integra. MIT is clearly main player because of its initial development of the technology and continued research in 3DP. It also play a fundamental and prominent role in the commercialization of 3D technology as it holds the base IP for which businesses will either need to license or invent around. Z Corp is also one of the few companies, which has turned MIT’s 3DP technology into an efficient, cost effective, and highly functional package device. Integra is a spinal implant devices company by having license for the production of implants from 3DP technology. They implants for several spinal conditions from implantable screws to synthetic vertebrae.

In medical field 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 Bio-Tech firms like Regeneron, Osiris and Genetech would have keen interests in the potential aspects of 3DP. It is expected that these firms have affect on the start-ups of the regenerative medicine to do basic R&D and concept testing and then acquire them for their technology. Top firms such as Stryker, DePuy, Medtronic, and Synthes will play pivotal role in moving 3DP into the mainstream than their Bio-Tech counterparts do with organ printing because 3DP will allow these firms to produce more specific, customizable solutions to generic operations such as hip and knee replacements. 3DP will also give chance to smaller firms to start to compete with big manufacturers in orthopedics which will force large firms to either innovate faster or evaoprate faster.

Value Chain Analysis:

The value chains for each three mentioned sector will be defined in terms of their current state and then analyzed based on possible changes due to the advent of 3DP.

Orthopedics is known by a very large value contribution by the manufacturers, surgeons, and finally hospitals for post implant services. Most of the ‘primary activities’ are done by implant manufacturers while secondary activities are the responsibility of hospitals, private practices and surgeons. Apparently the largest value is created with the production of the device then the eventual implantation/surgery. Hospitals and private practices have the potential to backward integrate and change their suppliers by utilizing cheap 3DP technology. Instead of ordering a base amount of e.g hip replacement implants, the other option is that hospitals can purchase a set of 3DP machines which could on a per-patient basis produce customized hip replacement implants. By adopting this approach new departments will be developed within hospital and practices to 3DP scanning and production. Manufacturers can adopt 3DP as a custom service provider to hospitals in the case of extraordinary parts needed would still producing generic orthopedic implants, in second case. A third case could be to involve a whole new set of implant manufacturers in the form of small regional firms. Firms can work with local hospitals in order to create per-patient implants.

Prosthetics has a similar structure to orthopedic implants and thus would be have similar disruptions and potential scenarios. As prosthetics have a tendency to become more personalized and 3DP allows them to be exponentially. Let’s suppose a person who is replacing a missing leg with work with their orthopedic doctor and a decided a third party firm to design a specific prosthetic custom to them. It is possibly that a small segment of orthopedic physicians will move into producing prosthetics and make that their specialized practice however on the whole it seems more likely that small to medium sized fabrication labs will service the specialized needs of orthopedic doctors.

In case of regenerative medicine and organ printing there is no set value chain so far. The Bio-Tech firms and hospitals all have their role in advancing the technology and there is no clear mechanism for distribution. The establishment of a standard mechanism will heavily depend on the legal precedents and regulations in relation to organ printing. To speculate though it seems likely that two situations arise.

1.      Firstly Bio-Tech firms could master the process and be allowed to widely supply hospitals with needed organs for transplants and various surgeries.

2.      Secondly hospitals could bring the technology in house and print organs in house on an as needed basis. As stated above the final model will heavily depend on government regulation and the finalized standard practices of the technology/methodology.

BARRIERS AND CONTROVERSIES

Unrealistic Expectations and Hype

Despite that the 3D printing industry provide much light of hope to the medical industry. However, what can not be missing is that there are a lot of unrealistic expectations and hopes that have given by the media, governments and even researchers themselves. Especially for how to realize those exciting organs printing.

Safety and Security

3D printing technology has already caused some serious and considerable security problems. 3D printers have already been brought into some criminal use of guns. In some theories, 3D printing tech can also be used to produce some medical facilities. Despite of forbidden the tech for all, there should need some laws and monitors.

Patent and Copyright Concerns

3D printing manufacturer will always face the problem of the copyright, manufacture design since the time the technology has developed. There are always disguises of how should 3D printing deal with the copyright problems.

Industry Transformation Analysis:

While it is likely that 3D printing will have a large impact on a variety of industries, we feel that it shows the most potential in the medical realm. The first step and opportunity to transforming this area will most likely be within the dental field. There are a variety of industries directly tied to the dental field including Surgical, Medical and Dental Instruments and Supplies, Dental Equipment and Supplies, Medical, Dental and Hospital Equipment and Supplies, Medical and Dental Laboratories, and Dental Laboratories. From the industry prospective, we feel that 3D printing will have the greatest impact on Dental Laboratories. 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 least partially to the dental offices themselves, allowing them to retain 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 second segment of the medical market which 3DP will have a large impact on is prosthetic devices related to orthopedic surgery. As discussed previously there are a small number of firms in this space who are producing 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. 3DP systems can drastically reduce this cost in many ways. Implants and bone replacements which are now specially crafted by labs out of a variety of materials can instead produce within the orthopedic professionals own practice with relatively low-cost 3DP machines which are currently available. Injured soldiers, for example, can get customized limbs in a much shorter term regardless of the complexity even making only one unit.

3DP will also change the way of preparing a prosthetic surgery, the previous procedure for facial prosthetic surgery involved putting plaster on the patient's face to make a mask. Now, with 3DP technology, doctors can use an imaging device, essentially a 3D camera, along with software that creates a map of the person's face with the corresponding prosthetic. The 3D printer can then print out a mask that surgeons can use as a guide for reconstructive surgery.

3DP can also be used in orthopedic private practices with existing technology. CAT scans, bone scans, and available 3D scanning software can be used to give an accurate representation of the model needed and then fabricated on site with a 3DP machine. The largest costs incurred by the practicing surgeon would be the upfront capital expenditure on the machine anywhere from $7-20k depending on the model the machine, materials costs, and servicing. Another alternative scenario would be that existing implant fabrication labs would begin to offer 3DP services as a fabrication alternative to their existing clientele. In the first scenario mentioned a significant movement in the value chain takes place where practicing surgeons are able to provide more value on their own without dealing with a 3rd party fabrication lab. The second scenario remains consistent with the current value chain but disrupts fabrication labs existing technology and services, in which case they would need to adapt and adopt new 3DP methods.

As mentioned previously there are a small number of firms currently operating in this space and it is certainly growing. The main concern is as with many medical practices is the approval process from the FDA. Aside from this hurdle the majority of resources and services are in place in order to facilitate the shift from current fabrication techniques to 3DP fabrication. The major ‘chasm’ if you will for majority adoption is educating practicing surgeons, fabrication labs, and hospitals. Surgeons need to understand the benefits of the technologies, how it is used and the impact it will have on their skills as a surgeon, labs need to understand 3DP’s 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 last sub-section of the medical industry, which will be affected by the advent of 3DP technology, is regenerative medicine. This is a new filed which encompasses things like stem cell research, tissue engineering, and organ generation. 3DP offers a unique advantage to this field, the possibility of one of a kind artificially generated organ replacements. 3DP allows for living cells to be ‘printed’ onto successive layers of gel composites in a specific shape upon which they grow 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 being used and researched by firms and universities it is certainly much further from widespread acceptance than dental and prosthetic applications.

There are a variety of hurdles for majority adoption, which are much more wide spread than those of prosthetics. The first would be a solidified and proven technology. Organ printing is still in development and there are a variety of practices involved all of which would need to be refined in order to provide any type of widespread adoption. The major issue associated with organ printing now and even after the technology is solidified are the ethical concerns it raises. Stem cell research is extremely polarizing and synthetic organs are certainly as controversial. People are concerned not only with how stem cells are harvested, but also the bio cyborg issues that something like printed organs represent. The other concerns could be

• Is it our place to generate organs?
• How is putting a synthetic organ in me different than a computer chip?
• Who gets priority over the supply of synthetic organs?
•  The needy?
• Those who can pay?
•  How long can we use synthetic organs to prolong our lives?
• Do I lose my humanity through the implant of synthetic organs?

The list goes on and on. These concerns do not only affect those who would wish to have or potentially use the technology but the regulatory environment around it. Society’s sentiments on these issues will determine the laws and governance around the technology, its availability and eventual implementation. Organ printing has an uncertain future and although it promises an application, which could dramatically revolutionize the medical field, its ethical implications threaten to change the fabric of our society as a whole.

Conclusion:

3DP offers users the most flexibility in printing from a diverse range of materials (it can print with any material available as a powder) to full color rendering. This technology has distinct ramifications for the medical industry and more specifically: orthopedics, prosthetics and regenerative medicine. Currently orthopedic implants compose roughly 40% of the cost of an orthopedic operation; 3DP can not only reduce this cost, but also improve the quality of the implant. Implants can be printed on a per-patient basis and customized easily to the patient’s needs. Similarly prosthetics’ costs can be reduced while customized not only to patient’s needs but also potentially patient’s style. The future of 3DP in medical field is very vast and it can revolutionized the medical industry especially organ replacement and surgical processes.

  

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Websites:

http://www.zdnet.com/article/the-history-of-3d-printing-a-timeline/  Accessed on 10 April 2015

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