Budny 4:00 L13 3D PRINTERS: THE ETHICS BEHIND THIS REVOLUTIONARY TECHNOLOGY Ashley Dacosta (asd63@pitt.edu) 3D PRINTERS, THE FUTURE OF THE MEDICAL INDUSTRY In the span of five years, three dimensional printers (3D printers) have become one of the main bioengineering and chemical engineering tools used for experimentations and surgeries involving tissue and cartilage implants, as well as cellular reproduction and development. Currently, the 3D printer is saving thousands of lives and is providing people with the care they need. From printing food from synthesized cells to printing a whole new graft of skin, 3D printing is making a large impact on society, and this is just the beginning. Research is continuously going on with this technology to better improve the printers and to offer more services to a wider range of people. In the near future, scientists will be able to use a patient’s cells to manufacture organs for the use of transplants, along with better care for those who need cartilage, bone fragments, tissues and muscles. If this new development proves to be successful, then that would make it possible for thousands of people to get the required surgeries that they need to better their health. Three dimensional printers will revolutionize medical care practices and will possibly become the next biggest thing in the health care industry. With the new advancements and the imposing possibilities for the usage of this technology comes grand responsibility. As an engineer, we must make hard decisions regarding possible breakthroughs in this industry. In specific, engineers are required to follow an ethical code of conduct that ensures the continued presence of morals and ethical behavior in a field that is mainly concerned with the innovations rather than the moral implications. TO RELEASE OR NOT TO RELEASE: AN ETHICAL DILEMMA At Organovo, I am one of the head chemical engineers involved in the new development of manufactured organs for human use. Organovo is a company that “designs and creates multi-cellular, dynamic and functional human tissues for use in drug discovery and medical research.” [1] I have my master’s degree in chemical engineering with a focus in cellular and bioprocess engineering, and a minor in software engineering. My team is composed of software, biomedical, and chemical engineers with one common goal: the successful use of a 3D printed organ. We are at the breakthrough of our research, and after years of development University of Pittsburgh-Swanson School of Engineering 2015-11-02 1 and experimentation, have designed a kidney that would be used for human organ transplants. Previously, organs were printed on a small scale and were only used for the testing of drug usage and passage. Now, our research has enabled us to print a kidney on a larger scale with the proper vascularized channels to allow for the passage of nutrients throughout the organ. This innovation of 3D printed technologies would amplify the company as a whole and would change the medical field forever. As a result of our outstanding advancements, we decide as a team to showcase the results of our findings and discuss how we will immediately start the use of such organ designs for transplant usage. Two weeks pass by, and it is the night before the big press conference with the news to present the results of our research. The team and I are going over the schematics one more time and further analyzing our research to make sure everything is in order. As I am reviewing the chemical processes conclusions and data outputs one final time, I realize that there is an error in the organ’s outlines. The design is not sufficient enough to support the flow of blood and nutrients throughout the organ once implanted in the human body. Also, I notice that the calculations show that the organ would not be able to sustain the stresses put on it by the body. The cell regeneration processes would not create a strong enough tissue to hold the structure together to fully function in the patient. These problems cause me to rethink our decision on revealing our data to the world, and I am forced to make a decision on whether or not to tell my team about my discoveries. THE ETHICAL PROBLEM The problem here is that we have already contacted over a dozen news casters to broadcast our findings to the nation and across the globe. This is a huge accomplishment for Organovo, and if I were to disclaim such information to the head manager, that could cause problems for our company and possible publication issues. That could result in our company being put in the press for rushing into such a complex invention and not thoroughly evaluating our research, but would also allow the team to make corrections and better the previous inquiries. If I choose not to present my findings, then our information shall go global, and the company would be elevated in its position and credibility. Though this is the case, once we actually start printing organs and undergoing transplants, there could be a problem. If a patient were to experience complications after surgery and it is found that the possible injuries and deaths were caused by miscalculations and failures in our research, then Ashley Dacosta Organovo would be sued and everyone who was working on this project would be fired. This would cause a national epidemic and would cause 3D printing to be looked down upon and many might argue that it should be banned from human use. objective criticism of the work of others. [4] By considering both codes of ethics, I can make a moral and ethical decision as to what is the best thing to do in this situation. I am posed with a multitude of questions that need to be thoroughly evaluated and must take into account the possible actions that could occur following the press release and actual implementation of this new technology. THE “IDEAL” ANSWER CASE STUDIES INTERPRETED The use of three-dimensional printing equipment has grown significantly over the past few years due to the increasing availability of inexpensive computing and electronics technologies. This technology could have such a positive impact on society, especially with the use of 3D printed organs. Many people are getting sick and even dying because they cannot get the medical attention they need right away [2]. That is something that is out of the control of the medical professionals because organs and medicines are on a first come, first serve basis, and these things cannot be distributed to everyone. With the new discoveries made, us as scientists can reduce these factors, and provide a greater of care for patients who are in dire need. With organs being facilitated in a laboratory, this will cut the down the risk of a patient rejecting the organ, and will be more cost efficient. With all these risks being cut down and the amount of people whose lives could be saved by these facts, it is safe to say that it would be the best thing to go ahead, unveil the research, and immediately implement this knowledge in the medical field. There is one particular case study that relates to the problem I am faced with, and brings up ethical questions that would be applicable in this situation. A certain medical device company, XMed, has successfully launched a new product. However, the Lead Product Development Engineer has discovered that he has not signed off on the final phase review, so the final review of the product was never approved of and technically never happened. After reviewing this specific case study, one could ask the question of whether or not there would be any consequences to the product’s malfunction [5]. If the product were to malfunction, this would cause the patients to have complications, as well as the company and the engineers who were in charge of the product, specifically those who were to ensure that a final inspection happened. This could be connected back to my situation because as engineers, my group and I are to do everything in our power to make sure that our technologies function properly and pose no dangers to its consumers. After comparing this case to my current situation, we could ask the same questions to him and his employer, as it is unknown as to what would happen with the products after they are put to use in the medical field. Although the product proves to have great potential in revolutionizing the health care industry, it cannot be put out on the market knowing that there are errors in the calculations. By not admitting to the fact that I found a flaw in the data from our inquiries, that is a violation of the code of ethics on my part. I am not adhering to the fact that I need to put the health of the public first regarding the new innovations and technologies for human use. Two similar cases that I have also reviewed talk about honesty and integrity, which relates to the third rule of practice provided by the NSPE code of ethics, which states that “Engineers shall issue public statements only in an objective and truthful manner.” [3] In the first case study provided titled “Honesty’s Always the Best Policy,” a high school boy named Raj tweaked his resume so that he could get a summer internship at a famous research institute. [6] In the second case study titled “The Cost of Integrity,” an engineer is notified of their fault in a civil structure which may cause harm if strong winds were to hit the structure. Fixing the problem would be difficult and may hurt the engineer’s reputation [7]. Looking into this case study, we can see that people would be put in danger stress was applied to the building. Although it would become detrimental to the reputation of the engineer, the health and CONSIDERING THE CODE OF ETHICS Though this sounds like an ideal plan, there are certain ethical codes that I as an engineer must follow and consider when I am faced with hard hitting decisions regarding technological and medical breakthroughs. This ethical code of conduct ensures the continued presence of morals and ethical behavior in a field that is mainly concerned with the innovations rather than the moral implications. There are a multitude of constituents of not just the Code of Ethics for Engineers as provided by the National Society of Professional Engineers (NSPE), but the American Institute of Chemical Engineers (AIChE) Code of Ethics as well. As stated in the preamble of the code of ethics provided by NSPE, “the services provided by engineers require honesty, impartiality, fairness and equity, and must be dedicated to the protection of the public health, safety, and welfare.” [3] The code of ethics continues on with a multitude of canons, which would be considered fundamental by any engineer. As an engineer, I have the responsibility of looking out for the well-being of the public, avoiding deceptive acts, work as a faithful employee, and conduct myself honorably, ethically and lawfully. [3] Similar things are stated in the code of ethics for chemical engineers by the AIChE. In particular, I as a chemical engineer must accept responsibility for my actions, seek and heed critical review of my work and offer 2 Ashley Dacosta lives of those within and around the building come first and the right course of action would be to inform the building owner so that they could potentially fix the problem. Relating both of these case studies back to my situation, I see the importance of honesty and integrity in the workforce. If I were to leave the schematics alone and allow for the organs to be printed using that data, and someone were to get a transplant with one of these faulty printed organs, then there could be a chance that the organ fails due to a lack of nutrients to the kidney or an excess of pressure on the organ. That would cause the person to have health issues, and I would feel guilty for such problems because I could have prevented such a thing from happening. moral thing to do, I was able to make an ethical decision. As to not violate the code of ethics provided by the NSPE and the AIChE, I decided that it would be the right thing to be honest and reveal my findings to my team and the heads of the company. Though that would mean ruining the possible fame and recognition that we would gain from our breakthrough research, it would also mean protecting the lives of the general public by looking out for their health. I would be honoring the code by being honest and responsible for the information found. As was mentioned before, part of the problem was that the organ would not be sustainable enough to handle the pressures done by the body and for the passage of nutrients through the organ. In order to correct this, I could make modifications on the chemical processes that are involved in synthesizing the cells required for making the organ in order to make a stronger and more efficient organ. By doing so, this would not hurt my integrity as an engineer and would allow me to continue research on 3D printing and further advancing the synthetic manufacturing of structures. ETHICAL DEBATE Currently, there are debates going on about the benefits of 3D printing and the possible ethical issues the advancements of this technology could pose. In the article published by Nanalyze, the authors reason why three dimensional printing should be supported and continued to be improved upon because of the previous successes and the future possibilities to come. From 3D printed cartilages to a small working kidney that lasted four months being printed by the Hangzhou Dianzi University in China, the 3D printer has proved to be successful and continues to excel in its complexity and capabilities. [8] Nanalyze argues that research should increase in this area of expertise because by just taking a small sample of a person’s cells, scientists can do remarkable things, from printing a new layer of skin cells for a burned patient, to creating new cartilage for the ear or knee joint, and soon, to manufacture organs for patients waiting for transplants. Though this is true, they predict that global debates will soon start against the ethical issues that could arise from organ manufacturing. Lucas Mearian, author of Bio-printing Human Parts will Spark Ethical, Regulatory Debate says that “laying out living cells is one thing, but creating the vascular structure to support tissue with oxygen and nutrients is yet another challenge,” causing an ethical issue that could arise for companies. [9] In another article, Rhiannon Williams says that 3D printing will advance faster that we, as scientists, would be able to comprehend due to the raised popularity and prospects of the technology. [10] There are multiple ethical questions that arise from this technology and these quick advancements could violate such things. Being ethical isn’t always about cut and dry answers, but about getting yourself to actually consider the possibilities and consequences of actions. By doing this, one can actually realize how they can make an impact and the effects their actions can have on a society. RECOMMENDATIONS FOR FUTURE ENGINEERS Engineering is a field that impacts the lives of everyone in the world by offering services to everyone and providing technology to help improve everyday life. By abusing the power that we have as engineers, it would hinder us from helping those who truly need it. By making decisions that are influenced by monetary values or popularity that shields an individual’s judgement of what is morally right and wrong. The fastest way to see if you are doing the right thing easily lies within your conscience. Some of the easiest decisions could be made by just by going with your gut feeling. Other ways to check if your decisions are ethically correct is to possibly consult a close family member or a friend, or consulting with case studies that contain similar ethical situations that you are dealing with. Case studies provide ethical questions regarding a wide variety of situations that allow for you to go even more in depth as to deciding whether a certain decision is ethical or not. Once engineers realize the impacts that their innovations have on the world, it is crucial that they put themselves second and act in the best interest of the society as a whole. REFERENCES [1] “Organovo-Bio printing Functional Human Tissue”. Organovo. (online website). http://www.organovo.com/ [2]L. Binder (n.d.). “The Five Biggest Problems in Health Care Today.” Forbes (online article). http://www.forbes.com/sites/leahbinder/2013/02/21/the-fivebiggest-problems-in-health-care-today/ FINAL DECISION After considering all the codes of ethics and looking into situations similar to mine, as well as those that speak of the 3 Ashley Dacosta [3] (2015). “NSPE Code of Ethics for Engineers.” National Society of Professional Engineers. (online journal). http://www.nspe.org/resources/ethics/code-ethics [4] "Code of Ethics." Code of Ethics. American Institute of Chemical Engineers, n.d. Web. 03 Nov. 2015. (website) http://www.aiche.org/about/code-ethics [5] “To Release, or Not to Release: An Engineer’s Perspective.” Stanford University. (Case Study). http://biodesign.stanford.edu/bdn/ethicscases/21releasequesti on.jsp [6] “Honesty is Always the Best Policy.” Northeastern University. (Case Study) http://www.webguru.neu.edu/professionalism/casestudies/honestys-always-best-policy [7]“The Cost of Integrity.” Northeastern University. (Case Study). http://www.webguru.neu.edu/professionalism/ casestudies/cost-integrity [8] "Investing in 3D Bioprinting." Nanalyze. Nanalyze, n.d. Web. 03 Nov. 2015. (online article) http://www.nanalyze.com/2014/02/investing-in-3dbioprinting/ [9] Mearian, Lucas. "Bio-printing Human Parts Will Spark Ethical, Regulatory Debate." Computerworld. N.p., n.d. Web. 03 Nov. 2015. (Online Article) http://www.computerworld.com/article/2486998/emergingtechnology/bio-printing-human-parts-will-spark-ethical-regulatory-debate.html [10] Cooney, Michael. "Gartner: Top 10 Future Strategic IT Predictions." Network World. N.p., n.d. Web. 03 Nov. 2015. (online article) http://www.networkworld.com/article/2225521/malwarecybercrime/gartner--top-10-future-strategic-itpredictions.html like to thank the friends in my study group who kept me on track for this assignment and offered to help when I needed it. ADDITIONAL SOURCES [11]Butterman, Eric. "Ethics in Engineering." Ethics in Engineering. N.p., n.d. Web. 03 Nov. 2015. (website) https://www.asme.org/engineeringtopics/articles/engineering-ethics/ethics-in-engineering [12] "Ethics Cases." Ethics Cases. N.p., n.d. Web. 03 Nov. 2015. (case study) http://www.depts.ttu.edu/murdoughcenter/products/cases.ph p [13]Williams, Rhiannon. “3D printing human tissue and organs to 'spark ethics debate' ” (Article) http://www.illinoisjltp.com/sources/Park/8_Rhiannon%20W illiams,%203D%20Pri.pdf ACKNOWLEDGEMENTS I would like to thank Julianna Said for taking the time to read my paper and provide feedback on it. I would also like to thank Jennifer Chickola, my little seminar leader, for helping me to select a topic for my paper. Finally, I would 2