Waldo, C. (2012, September 25).
Bioprinting
Bioprinting
is a unique aspect of 3D printing in that live cells are applied to 3D printed
structures with the intent of growing replacement organs or structures to
promote healing and growth in the body. Bioprinting is more complex than even
the normal rigors of 3D printing not only because we are dealing with live
cells but because of the range of cell differentiation. Once the cells are in
place, they need to be programmed to perform a certain task by creating
structures that match their role. For example, if the intent was to bioprint an
ear then a “scaffold”, or filament structure that shapes the ear, needs to be
printed (Bhatia
& Sharma, 2014). Often living cells will be inlaid into
the scaffold in order to facilitate the uptake of the scaffold by the cells.
The normal 3D printing process of scanning the object to obtain the printing
parameters and then uploading the image into “CAD” (computer-aided design)
software to get the code for the structure design is still followed in the
bioprinting process (Bhatia
& Sharma, 2014). In the process of making bone grafts
and prosthetics, CAT scans or MRI are often used to get such detailed
information as “soft tissue, vasculature and other structures” to create truly
individualized prosthetics (Bhatia
& Sharma, 2014).
The three most common bioprinting processes are: biomimicry, autonomous self-assembly, and mini-tissues (Murphy, 2014). Biomimicry is the process of creating an identical structure to the organic tissue or organ that was damaged or lost. It is a difficult process that requires knowledge of the “complex micro-architecture of the extracellular matrix (ECM) components and multiple cell types in sufficient resolution to recapitulate biological function” (Murphy, 2014). The ECM is the organic equivalent to the 3D printed scaffold. Then multiple cells types must be programmed by placing them on specific sites of the scaffold in order for them to learn what job to do or what structure to build. In contrast, autonomous self-assembly does not use a scaffold but instead uses stem cells to grow entirely new structures with a lessened chance of rejection (Jakab, Marga, & al., 2010). This method is even more complex as it must re-educate adult stem cells to act as embryonic stem cells and grow entirely new structures up to organ systems (Jakab, Marga, & al., 2010). Mini-tissues are seemingly a by-product of the biomimicry and autonomous self-assembly process. When a complete organ, prosthetic or structure does not need to be rebuilt, but rather repaired or supplemented, portions of the necessary tissues or specifically grafted bandages can be printed as a “mini-tissue” (Murphy, 2014) . A mini-tissue could be a reprinted ligament, portion of a heart, kidney or liver, or a bandage that would hold structures together while encouraging cellular healing and growth (Murphy, 2014).
Bioprinting is a modern wonder that is fraught with ethical dilemmas. While utilizing such procedures could eliminate the need to animal testing in pharmaceutical trials, it could also lead to a dystopian immortality in individuals that can afford to have organs repaired or replaced as they wear out (Wolinsky, 2014). While some may see this attainable immortality as a blessing, it does raise further concerns. Social justice is a relevant concern in this matter as most likely, money would decide who lives and dies (Wolinsky, 2014). Furthermore bioprinting could become related to performance enhancement in professional sports by becoming a tool to repair injured tissues from playing or training or by unnaturally advancing human capabilities (Wolinsky, 2014). A bioprinted organ black market may result and replace the human organ thieves and black market bidding for donated organs. If unregulated parties are bioprinting organs to make a profit, who is to say that the organs meet quality control standards? (Wolinsky, 2014) Regulation of the organs is a multi-faceted concern. From the medical insurance perspective, would bioprinted organs or mini-tissues be considered a preventive measure or a treatment (Wolinsky, 2014)? Which costly procedures would warrant coverage by a person’s insurance? Furthermore, while copyright laws are a concern with all 3D printing, various medical professionals would benefit from a knowledge sharing networks, but should still credit and reward those who create new codes for bioprinting constructs. On a more ominous note, knowledge sharing of bioprinting practices could also be weaponized for bioterrorism by using malignant or contagious self-replicating organisms (Wolinsky, 2014). In summary, while 3D printing is a paradigm-shifting double-edged sword, bioprinting is an even more complex and possibly dangerous aspect of it.
As stated earlier, there are many ethical considerations regarding bioprinting. Utilitarianism strongly supports its use as we could improve quality of life, cure disease, and repair injury in many individuals by printing repairs or replacements with their own tissues. This also has the potential to reduce or eliminate the use of animal testing in pharmaceutical labs and product testing facilities for the benefit of many species. Duty or deontological ethics, however, creates an ethical dilemma as the rules we have are not yet expansive enough to cover the many ethical concerns regarding bioprinting. For instance, while we have rules regarding who receives organ donations and placement on waitlists, this is because organs must be donated. What happens if new organs can be bought and printed in a matter of days from one’s own tissues? How do we regulate placement in the wait list to use the printers? Do organs need to be paid out of pocket or billed by insurance to begin the ordering and printing process? For what reasons should printing a new organ be allowed? Should we allow those who can pay for it to print organs to maintain their health leading to a sort of immortality? In the entertainment industry, how will bioprinted repairs or replacements be categorized in professional sports, as a drug/doping or a legitimate treatment? Will plastic surgeons be able to bioprint more aesthetically-pleasing versions of a patient’s body to replace damaged, aging or undesirable tissues? The FDA would be concerned with how will we license and regulate organ printers; do they need to be scientists or medical professionals with certified labs? The business, legal and manufacturing industries would be considered with distribution of not only the bioprinters or kits to modify printers to bioprinters, but also the sale and storage or the cells utilized in bioprinting; medical waste disposal; intellectual property copyrights of design codes to bioprint scaffolds and lay down cells; or design structures. The government may also require authorization to use certain materials or print organs/structures for high profile persons or strictly regulate distribution and quality control as a method to combat not only illness and disease but also bioterrorism. The ethics of bioprinting will require much careful review.
It may be easier to approach the ethics of bioprinting by producing regulations and having them voted upon. Associated areas like insurance and FDA regulation already have regulations for similar areas like organ/tissue donation and replacement; these could be updated to fit with bioprinting standards and procedures. Waitlists, as well as bioprinter lab and bioengineer registration would most likely be the easiest and most straightforward way to begin deontological ethical analysis. Next, insurance industries could work with various medical professionals in order to determine rates and standards for billing and “medically necessary” prescriptions for bioprinting in the cosmetic as well as prevention and treatment medical practices. Within the rates and standards discussion, the extent of use and modifications ethical concerns could be address. Topics like sports enhancement versus necessary repair, limit of modifications for cosmetic or alternate purposes other than medically necessary, and bioprinting experimentation regulations could all fall under the guidelines and jurisdiction of the insurance companies, medical professionals, and the FDA. The FDA could also monitor quality control and licensing updates for the 3D printers and bioengineers and scientists/medical professionals that utilize them. Medical waste disposal and informed consent procedures (of both tissues utilized and disposed) may also fall under the jurisdiction of the FDA but other legal institutions or relevant service provider jobs could be created to enforce ethical practices. Finally, intellectual property copyrights and distribution could be funneled through businesses or legal agencies in order to free up the professionals writing or implementing them. Bio-printing, like 3-D printing, is a technological advancement that will widely impact current institutions so the ethical concerns need to be evaluated and valued in both a utilitarian and deontological manner in order to choose the best practices to benefit society.
The three most common bioprinting processes are: biomimicry, autonomous self-assembly, and mini-tissues (Murphy, 2014). Biomimicry is the process of creating an identical structure to the organic tissue or organ that was damaged or lost. It is a difficult process that requires knowledge of the “complex micro-architecture of the extracellular matrix (ECM) components and multiple cell types in sufficient resolution to recapitulate biological function” (Murphy, 2014). The ECM is the organic equivalent to the 3D printed scaffold. Then multiple cells types must be programmed by placing them on specific sites of the scaffold in order for them to learn what job to do or what structure to build. In contrast, autonomous self-assembly does not use a scaffold but instead uses stem cells to grow entirely new structures with a lessened chance of rejection (Jakab, Marga, & al., 2010). This method is even more complex as it must re-educate adult stem cells to act as embryonic stem cells and grow entirely new structures up to organ systems (Jakab, Marga, & al., 2010). Mini-tissues are seemingly a by-product of the biomimicry and autonomous self-assembly process. When a complete organ, prosthetic or structure does not need to be rebuilt, but rather repaired or supplemented, portions of the necessary tissues or specifically grafted bandages can be printed as a “mini-tissue” (Murphy, 2014) . A mini-tissue could be a reprinted ligament, portion of a heart, kidney or liver, or a bandage that would hold structures together while encouraging cellular healing and growth (Murphy, 2014).
Bioprinting is a modern wonder that is fraught with ethical dilemmas. While utilizing such procedures could eliminate the need to animal testing in pharmaceutical trials, it could also lead to a dystopian immortality in individuals that can afford to have organs repaired or replaced as they wear out (Wolinsky, 2014). While some may see this attainable immortality as a blessing, it does raise further concerns. Social justice is a relevant concern in this matter as most likely, money would decide who lives and dies (Wolinsky, 2014). Furthermore bioprinting could become related to performance enhancement in professional sports by becoming a tool to repair injured tissues from playing or training or by unnaturally advancing human capabilities (Wolinsky, 2014). A bioprinted organ black market may result and replace the human organ thieves and black market bidding for donated organs. If unregulated parties are bioprinting organs to make a profit, who is to say that the organs meet quality control standards? (Wolinsky, 2014) Regulation of the organs is a multi-faceted concern. From the medical insurance perspective, would bioprinted organs or mini-tissues be considered a preventive measure or a treatment (Wolinsky, 2014)? Which costly procedures would warrant coverage by a person’s insurance? Furthermore, while copyright laws are a concern with all 3D printing, various medical professionals would benefit from a knowledge sharing networks, but should still credit and reward those who create new codes for bioprinting constructs. On a more ominous note, knowledge sharing of bioprinting practices could also be weaponized for bioterrorism by using malignant or contagious self-replicating organisms (Wolinsky, 2014). In summary, while 3D printing is a paradigm-shifting double-edged sword, bioprinting is an even more complex and possibly dangerous aspect of it.
As stated earlier, there are many ethical considerations regarding bioprinting. Utilitarianism strongly supports its use as we could improve quality of life, cure disease, and repair injury in many individuals by printing repairs or replacements with their own tissues. This also has the potential to reduce or eliminate the use of animal testing in pharmaceutical labs and product testing facilities for the benefit of many species. Duty or deontological ethics, however, creates an ethical dilemma as the rules we have are not yet expansive enough to cover the many ethical concerns regarding bioprinting. For instance, while we have rules regarding who receives organ donations and placement on waitlists, this is because organs must be donated. What happens if new organs can be bought and printed in a matter of days from one’s own tissues? How do we regulate placement in the wait list to use the printers? Do organs need to be paid out of pocket or billed by insurance to begin the ordering and printing process? For what reasons should printing a new organ be allowed? Should we allow those who can pay for it to print organs to maintain their health leading to a sort of immortality? In the entertainment industry, how will bioprinted repairs or replacements be categorized in professional sports, as a drug/doping or a legitimate treatment? Will plastic surgeons be able to bioprint more aesthetically-pleasing versions of a patient’s body to replace damaged, aging or undesirable tissues? The FDA would be concerned with how will we license and regulate organ printers; do they need to be scientists or medical professionals with certified labs? The business, legal and manufacturing industries would be considered with distribution of not only the bioprinters or kits to modify printers to bioprinters, but also the sale and storage or the cells utilized in bioprinting; medical waste disposal; intellectual property copyrights of design codes to bioprint scaffolds and lay down cells; or design structures. The government may also require authorization to use certain materials or print organs/structures for high profile persons or strictly regulate distribution and quality control as a method to combat not only illness and disease but also bioterrorism. The ethics of bioprinting will require much careful review.
It may be easier to approach the ethics of bioprinting by producing regulations and having them voted upon. Associated areas like insurance and FDA regulation already have regulations for similar areas like organ/tissue donation and replacement; these could be updated to fit with bioprinting standards and procedures. Waitlists, as well as bioprinter lab and bioengineer registration would most likely be the easiest and most straightforward way to begin deontological ethical analysis. Next, insurance industries could work with various medical professionals in order to determine rates and standards for billing and “medically necessary” prescriptions for bioprinting in the cosmetic as well as prevention and treatment medical practices. Within the rates and standards discussion, the extent of use and modifications ethical concerns could be address. Topics like sports enhancement versus necessary repair, limit of modifications for cosmetic or alternate purposes other than medically necessary, and bioprinting experimentation regulations could all fall under the guidelines and jurisdiction of the insurance companies, medical professionals, and the FDA. The FDA could also monitor quality control and licensing updates for the 3D printers and bioengineers and scientists/medical professionals that utilize them. Medical waste disposal and informed consent procedures (of both tissues utilized and disposed) may also fall under the jurisdiction of the FDA but other legal institutions or relevant service provider jobs could be created to enforce ethical practices. Finally, intellectual property copyrights and distribution could be funneled through businesses or legal agencies in order to free up the professionals writing or implementing them. Bio-printing, like 3-D printing, is a technological advancement that will widely impact current institutions so the ethical concerns need to be evaluated and valued in both a utilitarian and deontological manner in order to choose the best practices to benefit society.