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Maintaining Health Now and for the Future: The Law and Ethics of Biomedical Engineering
Analyzed
Logan Brady
1B
Abstract
BIOMEDICAL ENGINEERING & TECHNOLOGY 2
This paper examines the laws and ethics and possible issues that arise with the studies and
research within the field of biomedical engineering. Topics of this paper will include personal
experiences of the author as well as analysis of several issues and concerns involving research
done with biomedical engineering. The author analyzes the laws that are currently implemented
to deal with research done within the United States as well as globally. The purpose of this paper
is to propose solutions and new legislation ideas to complement the work of the biomedical
Biomedical engineering is a newly developed subject that has been emerging within
society for the past couple decades. The field of biomedical technology deals with all parts of the
medical field, ranging from organ transplant, mental health help, virus and disease identification,
as well as almost anything else. The field is innovative and inspiring to all medial creations and
research to come. Developments within the field of biomedical engineering are contemporary
and will allow for all people globally to be influenced by the ingenious challenges and problems
easy to get lost or caught up in everything that the field entails. An example of how people learn
about some of the more basic ideas is through television; although sometimes, the learning may
be skewed due to dramatic effects aimed toward the audience. Greys Anatomy is a show in
which the beginning developments concerning biomedical engineering and developments. This
show typically stretches the truth of the medical issues that they pursue, but the idea that
medically engineered products could be used in replacement within any medical practices was an
idea that seemed all too practical to be overlooked. This television show lead viewers to believe
After research, biomedical engineering is professional defined as, the branch of engineering that
uniquely leverages the vast knowledge base of biology and medicine to solve problems focused
According to Tom Ricci, author of How Bioengineers Are Enhancing the Quality of
Healthcare, there are nine sectors that the field of biomedical engineering breaks down into.
These sectors include but are not limited to bioinstrumentation, biomaterials, biomechanics,
BIOMEDICAL ENGINEERING & TECHNOLOGY 4
cellular and tissue genetic engineering, clinical engineering, medical imaging, orthopedic
Through careful dissection of the field, it has shown that these nine sectors are the most
important as well as capable when explaining the inner mechanics of the field. For easier
explanation and examination, these nine sectors are able to be split into two main categories.
These main categories are the physical and clinical implementation of bio medically engineered
products (what someone can actually see is happening) and theoretical development, or in other
words, the behind the scenes work that one cant see but knows is going on. Most of the sectors
fit into the physical being of the field, but the theoretical aspect is just as important. Especially,
when developing technology that must be extremely accurate and exact. Bioinstrumentation,
orthopedic engineering, and some parts of rehabilitation engineering all fit into the first physical
spectrum (Gleason, n.d.). Meanwhile, the other remaining sectors all fall into theoretical
Out of all these sectors, separation into these two main categories will help when
specifying the laws and other legal aspects and what exactly has been analyzed versus what has
not. The two sectors help to establish a common ground. Although there are several different
details that separate the works into their own categories, there are similarities that do help to
categorize them in a more composed fashion (Iltis, 2009). The physical part of biomedical
engineering is the type of innovative medical developments that more people would tend to hear
about, while the theoretical developments of biomedical engineering are less heard and thus less
discussed. Nonetheless, neither part is easier to judge and pull apart in terms of the law. Both
aspects of the biomedically engineered devices bring up issues that can be difficult to analyze
BIOMEDICAL ENGINEERING & TECHNOLOGY 5
and distinguish by one person. The field has been constantly developed, corrected, and added on
to as time has gone on. It is most important for this sort of work because there is never going to
be one case in which the researcher or research done is 100 percent correctly. For this reason,
many of the advancements within the field are a compilation of studies between various works of
researchers. Leading back into the two different aspects of the research, the physical side of the
work has the issue that there are more complications with the products and therefore more cases
of liability; So therefore, there is much more discussion concerning what parts malfunction.
Whereas, theoretical developments of the works involved are more concerned with what
methods will effectively work to implement the engineered products into a patients body. This
causes issues with explanation and reevaluation of work done and how to explain to the patient
the process that which the researchers are going through to further progress the developments
(Iltis, 2009).
The Peirce-Cottler Laboratory is named after Dr. Shayn Peirce-Cottler. Dr. Peirce-Cottler
is a professor and researcher from the University of Virginia who studies and leads developments
within the field of biomedical technology. The lab research is focused around discovery of useful
biomaterials as well as methods that can be implemented to prove beneficial with encouraging
further developments.
Morgan Lataillade was one of the undergrad students who was working in the lab.
Morgan and Dr. Peirce-Cottler had been working on the experimental stage of their research,
they were working to find materials that would be sustainable and solid enough to print tissues
and parts of organs. The bio-printing work at first seemed very simple- all that had to be done
was fill the canisters with the materials that it was set to dispense and then submit the layout into
BIOMEDICAL ENGINEERING & TECHNOLOGY 6
the computer for the product that was being printed. Wrong, to fulfill a job well done there
needed to be much more thought put into the process. Products were often times not stable
enough to be used, constructing a layout was much more difficult than it seemed, and putting the
two together seemed utterly impossible when it actually became time to do so (S. Peirce-Cottler,
Personal communication, October 26, 2016). This is where the difficulties of biomedical
Arising Issues
Lack of funding within this field is something that arises much too often. To solve the
issue that biomedical engineers faced with funding, the National Biomedical Research Act was
founded. This act ensures that half of the money that the federal government distributes to
studies goes to the National Institutes of Health and the FDA. This act ensures that the money is
being used in ways that will prove to beneficial for the majority of people. There are some
categories that are pre-set to where the money will go, but the general distribution of the funds
coming from the government should go to the interest-bearing obligations of that specific point
in time. The different areas of authorized use for the money granted includes precision medicine
research on disruptive innovation, research on diseases concerning federal health help, work by
early career scientists, research efforts that increase potential for breakthrough discoveries,
Misinterpretation between the different works of study is an issue that could prove to be
extremely problematic within the works and research of biomedical engineering. Although there
are several different sectors and fields, that is beyond the point. The point is, researchers need to
BIOMEDICAL ENGINEERING & TECHNOLOGY 7
communicate the full extent of their work to other researchers to ensure there is no
Although the works of biomedical engineering do seem to be something that will prove to
be of costly investment, it is research that will most definitely be beneficial to everyone in the
future (Rockey & Collins, 2013). The developments are something that have an infinite effect;
they are going to be long lasting and, hopefully further in the future, much more commonly
implemented. If research of these biomedical developments follows the positive innovative track
it is on right now, then the benefits the products will provide to society will far surpass the
Biomedical research is a thing that is becoming extremely beneficial and overall a good
thing within society today, except there have been times when research has been questionable
and has been brought to the attention of the government. In the case of the Willowbrook State
School Study and the Tuskegee Syphilis Study, researchers encouraged people to
intentionally become infected with the diseases so that medical testing and gene therapy could be
done to more effectively study how the diseases could be treated (Pecorino, 2002). The biggest
issue with the research was not necessarily the idea of it, but it is dealing with the idea of
vulnerable individuals. To protect these individuals, The Common Rule was established. It reads:
When some or all of the subjects are likely to be vulnerable to coercion or undue
have been included in the study to protect the rights and welfare of these subjects.
(Federal Policy for the Protection of Human Subjects (Common Rule), 2016)
BIOMEDICAL ENGINEERING & TECHNOLOGY 8
This issue is extremely important regarding biomedical studies and research. In order to
implement the studies more smoothly into society, it is imminent that people know, even if they
are not really concerned with biomedical studies at a certain point in time, that they are safe from
ever being mislead or taken advantage of when it comes to biomedical research. The Council for
In the case of Mattern v. Biomet, the issue concerning a bio medically engineered hip
replacement part became discussion when it began causing problems for the user after
implementation. Mr. Mattern originally sued the company, Biomet, in order to compensate for
the excruciating pain that came about a few weeks after he had the hip replacement surgery. The
case was handled in the United States New Jersey District Court. The prosecutor sued the
company, claiming that they were liable for the situation at hand. The defendants, Biomet, got
the case dismissed by the courts after claiming that they were not liable as a seller or
manufacturer. After examination of the product that was bringing about the issues, it was
determined that it was only one component of the entire implant that was used in the hip
replacement surgery. Therefore, the company was not held liable for the damages because it was
found that the actions of the company, putting together the implant with the parts they were told
to trust, was not the standing cause of the pain. For evidence for this trial, the defendant used the
guidelines of the Biomaterials Assurance Act. The act, allows trial courts to dismiss the
biomaterials suppliers from lawsuits prior to discovery (Mattern v. Biomet, 2013). The main
that was put into place to protect bulk manufacturers of biomaterials from being
liable for finished implants that they did not take part in making- they simply
supplied and sold a part for the implant to be made. The overarching idea of the
This act is extremely exact when explaining the liability of the biomaterial suppliers with
all sorts of biomedical engineering (Charles & Richards, 1999). Even though this one case is
dealing with an orthopedic surgery, the act still applies to all sorts of studies and research. The
biomaterial manufacturers at Biomet did not furnish raw materials or any of the components that
were the cause of the problem or ultimately failed to meet the requirements of the enforced
contract. The act specifically defines raw materials and components to show this distinction. This
clear definition is done to ensure that liability is placed correctly when something does go wrong.
The discussion concerning progress and continued research within the field of biomedical
engineering and research has been something that several countries have been concerned with for
decades now. For example, the United States and the Russian Federation created an act in 1994
concerning biomedical developments and the very basic guidelines that will govern research
done within and between the two countries (Agreement between the Government of the United
States of America and the Government of the Russian Federation on Cooperation in the Fields of
Public Health and Biomedical Research, 1994). The agreement is split up into 14 articles, and
each article of the agreement divulges into a different basis that will stand to be the driving rules
behind all the research done. By the very fact that this document existed in 1994, it shows that
the biomedical research being done then was extremely crucial to the developments within the
medical world. Adaptations to the new times, even of the 90s, was up and coming, and this
BIOMEDICAL ENGINEERING & TECHNOLOGY 10
agreement shows that many countries, as opposed to solely the United States, were beginning to
recognize that.
The current issue that stands with the topic of biomedical developments is that there are
barely any laws that currently exist to govern the work the researchers are doing. The codes of
Virginia that are dealing with biomedical engineering resemble that of the United States because
vague and mostly concerning the distribution of research funds. Additionally, many of the
Virginia codes that are in place to monitor medical research and the funds were implemented
only within the last ten years. To get more details on the specific legislation that is required
within a code concerning the research done, Virginia code section 32.1-162.23 through section
32.1-162.31 was analyzed. This chapter of the Virginia code deals with the Christopher Reeve
Stem Cell Research Fund. The specifics of the code and fund divulge into nine different sections,
all which seem to be dealing with some sort of monetary subject or the duties of the board in
entailing specifics and extent of what research can actually be done is included within the code.
The reason this proves to be extremely common when developing and dealing with legislation
concerning biomedical technology and developments is because people dont understand what
kind of limitations need to implemented. That is where the majority of the issue lies concerning
this topic; it is that there is misconception and simply misunderstanding of the topic of
biomedical engineering. For this reason, many legislators feel they should only create the
majority of their legislation surrounding the research limitations aspect because they arent
exactly sure what should be done within the field and so they may feel that it isnt their place to
put limitations on the creative process. These same factors tend to be true with federal laws as
well, just on a much larger scale. Concerning biomedical research and development, there is
BIOMEDICAL ENGINEERING & TECHNOLOGY 11
almost no legislation in the federal spectrum that outlines protocol or rules for projects being
done. The most distinct law that was found concerning actual content of the research projects
was the extent of what subjects could be used for experimentation. The extent of these guidelines
was discussed in the above section, Issues that arise, discussing the Tuskegee Syphilis Study.
Biomedical studies are an area of medical developments that can relate and be beneficial
to just about everyone that takes an interest in this prescribed solution to a medical issue.
Although the extent of what medical cases biomedically engineered products can be used for is
slimmer than other solutions, the field overtime is quickly and steadily branching out to cover
more and more area. Out of all the medical fields, it seems that biomedical developments are
some that are able to be some of the most personalized fields of study(Ricci,n.d.). This stands to
be true for two main considerations. First, most biomedically developed products are done
personalized, or in other words, using a persons own tissue to biomedical print the cells or
products they are in need of. This is important because it makes the cells and projects more
adaptable, as well as the fact that when the the products are inserted or surgically implanted into
a persons body, the body will be more accepting and less likely to reject something that is
recognizable. There is always chance of complications with the biomedical products, but the
chances are much reduced with this personalization. Second, almost all people will be influenced
by biomedical technology and developments in the near future. The world isnt far off from
having everything in its entirety be run by technology, especially all developments completed
within the medical world. For this reason, people will become more familiar with studies, and the
idea of using biomedically engineered products within the medical field will no longer be an idea
of question but simply an action of habit. An additional beneficial aspect of biomedical research
BIOMEDICAL ENGINEERING & TECHNOLOGY 12
fromCenterforBiomedicalEngineeringDescribeRecentAdvancesinBiomedicalEngineering,"
2011). All of the research that has been done thus far is able to help researches build towards
Although biomedical technology and developments are medical fields that have extended
possibilities, several questions are to arise when concerning the research. What laws can be
implemented so that the developments that are available can be of service to everyone
worldwide? It seems that currently it is mainly the United States and some countries within
Europe that dominate the research done within the field of biomedical studies and the
developments that follow this research. For this reason, this question is not as much concern for
the countries within which the research is being conducted. This question is mostly concerning
the countries that dont have as much access to these kinds of developments and these research
prohibitions and provisions. In order to be of service and inspiration to these less advanced
countries, it would prove to be beneficial to recruit researchers from other countries to these
would still be difficult to have the outspread of the actual biomedical research and developments
of these studies within the developing countries, due to cost and extenuating circumstances
concerning the availability of the products, the idea of the collaborative work is the get the ball
Within this field of research, as well as many other technological developments, the idea
of liability is a factor that cannot be taken lightly. Currently, liability is the main discussion of
BIOMEDICAL ENGINEERING & TECHNOLOGY 13
many of the court cases that deal with the subject of biomedical technologies (Shirwaiker, Tan, &
Cohen, 2013). Actually, regardless of the field of medicine, this tends to be the case for many
medical cases taken to law. For this reason, there is an increased importance for there to be a
specification of laws in place to ensure that liability is not an issue, so that people understand the
agreement they are signing into- even more so for procedures that involve biomedically
engineered parts. To implement this plan, it would be most beneficial to enhance the extent of the
waivers that people currently sign when they agree to get a procedure done. In addition to this,
there needs to be a waiver from each company that allows them to be held liable only in the case
that is the part that they contributed is malfunctioning. This piece of information is extremely
vital to the liability process, mostly for the reason that there have been times when the doctors
who implanted the part werent at fault, the manufacturers who put the product together werent
at fault, but the providers of one sole part of the product had a piece that was the source of the
malfunctions (Shirwaiker, Tan, & Cohen, 2013). For this reason, even though the inclusion of
this extra paperwork may seem extensive, it is extremely necessary in helping to find which
party is liable if something were to go wrong. It is within the best interest, and therefore
necessary, for most people to complete this extensive paperwork so correct determination of
The margin of error is something when dealing with biomedical engineering that is never
really discussed all that much. It is an idea that people want to believe barely ever happens,
because they dont want to consider that a procedure that someone chooses to provide benefits
could have a possible backlashing negative effect. The error and success rate of some of the more
complicated procedures tend to have a lower percentage than some of the easier procedures, as
obviously expected. The issue that is found is that since most of the developments are so new,
BIOMEDICAL ENGINEERING & TECHNOLOGY 14
there is an issue with deciding on how to correctly implant the products and whether or not they
are going to work (Crawford, n.d.). Noah Crawford, a prior student of Pittsburgh University, was
faced with a dilemma when given the task to construct a personalized trachea for one of the
largest benefactors for the hospital where they were working at the time. The group knew that the
chance that their project would fail was close to being almost 100 percent. The chief of surgery
where they were working put the pressure on their group because he wanted their hospital to be
ground breaking and push innovation even more forward. The group found several issues with
their model and after a long and tedious process couldnt seem to figure out what exactly they
needed to do (Crawford, n.d.). This is only one example of where the margin of error was much
wider than almost anyone would realistically expect. Of course it would almost never be
expected that the product was 100 percent perfect, but the fact that something could be just about
100 percent ineffective is simply shocking. For this reason, it is the job of current and future
researchers to come to ensure that this margin of error concerning the biomedically engineered
products is closed to a much smaller percentage before they are even thought about using the
products on patients. In essence, this process all leads back to the idea of liability. If the margin
of error with the products is much smaller, then less patients will need to worry about claiming
which party is liable because hopefully, the smaller margin of errors would lead to less
Besides the entire idea of liability and the lessened margin of error, a more solid plan
needs to be developed to help ensure that the products that biomedical engineers are working on
are being of benefit globally. It is simply unethical to completely dispose of the researchers own
personal thought and to tell them what they can and what they cannot study, but for researchers
who may be interested, and therefore qualified, there should be money federally mandated to
BIOMEDICAL ENGINEERING & TECHNOLOGY 15
specifically chosen researchers in each country to collaboratively work to solve the worlds most
pressing problems. Not to say that this isnt already occurring on a smaller scale, but it would be
in the best interest of all people to compose this type of research team to find the solutions the
world and its people have been searching for. Pressing diseases such as Aids, HIV, hepatitis, etc.
all are deadly diseases that have faced the world for thousands of years now. Therefore, setting
aside money for the research that can be done to benefit a much wider spectrum of people is
something that needs to be changed if the people of the world want biomedical engineering to
Conclusion
the work involving this subject is never done. The most inspiring part of all the research done
within this field is that the work is continuously building. There are constantly more and more
components that can be researched to build upon the next. Although issues do arise concerning
the funding or mechanics behind the research, there are never enough limits to stop the
innovation that is sparked with the idea of infinite possibilities for the human bodies and the
remedies found to solve the existing maladies. Solving the future problems is just as important as
solving the future problems. Biomedical engineering is without a doubt a research field within
which the world will continue to benefit. When researchers are able to find a method to more
widely spread the research and methods will be a time when the world is unstoppable. The
medical field is something that will always be of need and of service to everyone. Biomedical
engineering, and its approaches, is just the start of the beginning for what medical ventures the
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