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Masha Paley
Mr. Rogers
US Government
November 2, 2015
Mock Congress Research Paper
Do you need a new organ or body part? Well now with the advent of bioprinting, you can
print one out for yourself, using your own cells. Bioprinting is the process of using computer
software and 3D printers to manufacture and assemble living and nonliving bioengineered
structures. With further development of this process, scientists will ultimately be able to use a
patients own cells to assemble other living cells, tissues, and organs that can then be used to
replace problem organs in the patients body. Scientists have already successfully created living
cells, tissues, and even model organs, but the creation of vascularized organs, or organs with a
blood supply, and the bioengineering of cells with functional nerve endings are proving to be a
challenge. However, bioprinting is advancing at such a quick rate that these challenges are only
temporary the creation of bioengineered organs will soon be a reality. Since this is a new area of
development in medicine, little to no guidelines or regulations are present for the bioprinting
industry. For this reason, the 3D Printing Act of 2015 should be passed to prevent bioprinting
black markets, regulate the existing and future bioprinting industry, and to maximize the
efficiency of the industry.
Bioprinting black markets, where bioengineered products are created underground and
without regulation, exist already and without any change in legislation will continue to thrive and
pose a threat to the bioprinting industry. Bioprinting black markets have been on the rise ever
since bioprinters have become available for purchase (Lipson). This is especially dangerous

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because the amount of people willing to turn to black markets for the organs they need has also
been steadily increasing. Currently in the United States, an average of 22 people die each day
waiting for an organ transplant that cant take place (Need). Clearly, there is a great shortage of
donor organs for patients in need. This fact amplifies the threat that black markets pose because
patients on the waiting list for organ donations create a huge market for illegitimate organ sales.
Furthermore, bioprinting black markets are a problem because they churn out faulty products
while creating unfair competition for the legitimate industry of bioprinting. According to
bioprinting expert Hod Lipson, 3D printers used in black markets range in quality from sufficient
for providing medical aid to life-threatening (Lipson). This means that while some black market
organs are up to par with legitimate ones, others are completely unsafe and made so cheaply that
legitimate organs cannot compete with their pricing. Since it is inevitable that people will turn to
black markets for the organs they are unable to get legitimately, it is important to minimize black
market activity and the existence of black markets in general so that there are less opportunities
that patients have to purchase organs from them and compromise their health and safety by using
organs that do not meet the standards of quality for use in the human body. With black markets
threatening both economical and safety aspects of the developing bioprinting industry, it is
imperative that they are seen as a danger and eliminated in order to ensure the industrys further
success.
In order to further increase the safety of the bioprinting industry, it is necessary to
regulate and set guidelines for the existing and future bioprinting industry. Even though it is a
rapidly-developing industry, bioprinting is still a new practice and little to no guidelines currently
exist for its function. The bioprinting of organs is advancing at such a quick rate that medical
applications can occur as soon as 2016 (Williams). Since this expected date is less than a year

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away, guidelines need to be created for bioprinting soon so that by the time real applications
occur, regulations will already be set up for the industrys operation. Furthermore, at the rate that
developments are being made, within the next ten years it is expected that 3D printing will
become an $8.9 billion industry, $1.9 billion (21%) of which will be focused on medical
applications (Ventola). This goes to show that a sizable chunk of the huge 3D printing industry
will be devoted solely to its medical implementations, once again making regulations for
bioprinting a necessity. Rules and guidelines for bioprinting are also needed because the 3D
printing of organs can quickly lead into printing of humans if unregulated (Williams). With
scientists already almost able to print fully-functional organs, printing out an entire human is
quickly becoming a realistic concept. Such practices would be the equivalent of reproductive
cloning and would therefore pose a threat to the community by dirtying the gene pool and
leading to gene-related problems for future generations. It is imperative that the printing of
humans is prohibited in order to avoid these monumental problems that are otherwise inevitable.
It is clear that an unregulated bioprinting industry will create a multitude of problems, so it is
important that guidelines for the industry are created before real applications of bioprinting
technology occur.
The applications of the bioprinting industry come not only with a need for regulation, but
also with a great money-making capacity that can be maximized and used to the advantage of the
country. Since computer files are used to print out the bioengineered products that bioprinters
create, the sharing of these files holds great potential for increasing efficiency. In 2014, the
National Institutes of Health created 3D Print Exchange which allows for the sharing of 3D print
files for medical and anatomical models, custom labware, and replicas of proteins, viruses, and
bacteria, (Ventola). This is a program that is endorsed and utilized in the 3D Printing Act of

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2015 which greatly improves the bioprinting industry. It makes all 3D print files with medical
applications shared and available so that medical personnel do not have to create files every time
they need to print out a new organ, tissue, or other biomass. They can instead use a template that
has already been used by another member of their field and in doing so make their job easier and
faster. This will in turn bring more money to the industry and have a positive effect on the
economy. In addition, bioprinting will be able to lower the cost of drug testing and give
companies that manufacture pharmaceuticals more effective ways to test their products
(Thompson). 3D-printed tissues are much better models for real human tissues than the twodimensional models used today, so there is great financial benefit for bioprinting applications in
the pharmaceutical industry. Currently, according to a White House report for the Presidents
Council on Science and Technology, clinical trials have a $31.3 billion dollar budget, making
them the largest part of the pharmaceutical industrys budget as a whole (Holdren). With the
substantial amount of funds dedicated to clinical trials as of now that can be better conducted
with the use of 3D bioprinting, it is clear that a lot of money can be saved and made through an
efficient use of the bioprinting industry. With the development of a well-connected and efficient
bioprinting industry, it will be possible to reap the benefits of the advantages of bioprinting such
as the potential for improved product testing methods. Increasing the efficiency of bioprinting
allows for a substantial positive effect on the economy and the creation of a new source of
revenue for the country, so its development can only be an advantage.
Some may say that bioprinting cannot solve the problems of organ shortage and that the
industry is too expensive to have any kind of positive effect on technology and medicine. These
arguments stem from the idea that bioprinting doesnt have a broad enough scope to cover all of
the needs that patients currently waiting for organ and tissue transplants have and from the notion

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that bioprinting is an industry with little potential for economic success and development in the
future. The first of these arguments is untrue because the bioprinting of tissues multiple layers
thick that include multiple cell types will reap medical benefits in the fields of oncology, stem
cell biology, hepatology, and cardiology (Bioprinting). This covers a wide range of patients, and
means that a large percentage of patients waiting for organ transplants for donors will be able to
turn to bioprinting as an improved solution to their situation. Instead of having to wait or die
waiting for an organ donor and transplant, patients in the variety of medical fields that
bioprinting spans will be able to receive organs or other bioengineered products immediately
with the use of bioprinting. The second argument that the bioprinting industry is too costly is also
untrue since bioprinting is actually a less expensive method of manufacturing materials than the
methods currently in use. 3D printing is a cost-efficient alternative to traditional manufacturing
methods, especially in the case of small-sized standard implants or prosthetics, such as those
used for spinal, dental, or craniofacial disorders, (Ventola). This means that already 3D printing
is able to cut manufacturing costs in its medical applications which are predicted to make up a
sizeable part of the industry. Furthermore, no matter what is being printed or what 3D printing is
applied to, the cost does not increase as complexity of what is being produced increases (Tesla).
This is an advantage of bioprinting that is unique to the industry and outweighs any financial
setbacks that the industry may have as of right now. Even though bioprinting may seem
expensive now, no matter how complex the products that are being bioprinted become in the
future, their manufacturing cost will remain constant. This coupled with the fact that the industry
is only just now starting out and is already experiencing success prove that bioprinting is an
industry that is worth investment into.

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In conclusion, the 3D Printing Act of 2015 should be passed because it allows America to
take advantage of the new bioprinting industry by minimizing the presence of bioprinting black
markets in the United States, creating guidelines for the function of the rapidly developing 3D
organ printing practice, and reap the economical benefits from the bioprinting industry by
maximizing its efficiency. Bioprinting is just one example of how technology is advancing in
todays world. By supporting it and the other technological advancements that are being made,
America can stay in touch with the times and advance as a country while making life better for
its citizens. In order to ensure success in this endeavor, it is essential that the 3D Printing Act of
2015 is passed. Not only will it allow America to utilize and continue to develop an extremely
promising new medical technology, but it will be able to solve problems in the medical field that
already exist in the United States, making life better for all Americans.

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Works Cited
"Bioprinting Advantages." Organovo. Organovo Holdings Inc., 2015. Web. 19 Oct. 2015.
<http://www.organovo.com/science-technology/bioprinted-human-tissue/bioprintingadvantages/>.
Holdren, John P. "Report to the President on Propelling Innovation in Drug Discovery,
Development, and Evaluation." (n.d.): n. pag. White House. White House, Sept. 2012. Web.
2 Nov. 2015. <https://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-fdafinal.pdf>.
Lipson, Hod, and Melba Kurman. Fabricated: The New World of 3D Printing. Indianapolis:
John Wiley & Sons, 2013. Print.
"The Need Is Real: Data." Organdonor.gov. US Department of Health and Human Services, n.d.
Web. 02 Nov. 2015. <http://www.organdonor.gov/about/data.html>.
Tesla, Chuck. "Want a New Organ? Press Print An Introduction to the Future of 3-D
Bioprinting." Tumotech. WordPress, 28 July 2014. Web. 19 Oct. 2015.
<http://www.tumotech.com/2014/07/28/want-a-new-organ-press-print-an-introduction-to3-d-bioprinting/>.
Thompson, Cadie. "How 3D Printers Are Reshaping Medicine." CNBC. CNBC LLC, 10 Oct.
2012. Web. 19 Oct. 2015. <http://www.cnbc.com/id/49348354>.
Ventola, C. Lee. "Medical Applications for 3D Printing: Current and Projected Uses." Pharmacy
and Therapeutics. MediMedia USA, Inc., Oct. 2014. Web. 19 Oct. 2015.
<http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4189697/>.
Williams, Rhinannon. "3D Printing Human Tissue and Organs to 'spark Ethics Debate'" The
Telegraph. Telegraph Media Group, 29 Jan. 2014. Web. 19 Oct. 2015.

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<http://www.telegraph.co.uk/technology/news/10604035/3D-printing-human-tissue-andorgans-to-spark-ethics-debate.html>.