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3D printing of body parts is coming fast – but regulations are not ready
Today, a quickly emerging set of technologies known as bioprinting is poised to push the boundaries further.
In the last few years, the use of 3D printing has exploded in medicine. Engineers and medical professionals now routinely 3D print prosthetic hands and surgical tools. But 3D printing has only just begun to transform the field.
Today, a quickly emerging set of technologies known as bioprinting is poised to push the boundaries further. Bioprinting uses 3D printers and techniques to fabricate the three-dimensional structures of biological materials, from cells to biochemicals, through precise layer-by-layer positioning. The ultimate goal is to replicate functioning tissue and material, such as organs, which can then be transplanted into human beings.
We have been mapping the adoption of 3D printing technologies in the field of health care, and particularly bioprinting, in a collaboration between the law schools of Bournemouth University in the United Kingdom and Saint Louis University in the United States. While the future looks promising from a technical and scientific perspective, it's far from clear how bioprinting and its products will be regulated. Such uncertainty can be problematic for manufacturers and patients alike, and could prevent bioprinting from living up to its promise.
From 3D printing to bioprinting
Bioprinting has its origins in 3D printing. Generally, 3D printing refers to all technologies that use a process of joining materials, usually layer upon layer, to make objects from data described in a digital 3D model. Though the technology initially had limited applications, it is now a widely recognized manufacturing system that is used across a broad range of industrial sectors. Companies are now 3D printing car parts, education tools like frog dissection kits and even 3D-printed houses. Both the United States Air Force and British Airways are developing ways of 3D printing airplane parts.
The NIH in the U.S. has a program to develop bioprinted tissue that's similar to human tissue to speed up drug screening. (Paige Derr and Kristy Derr, National Center for Advancing Translational Sciences)
In medicine, doctors and researchers use 3D printing for several purposes. It can be used to generate accurate replicas of a patient's body part. In reconstructive and plastic surgeries, implants can be specifically customized for patients using "biomodels" made possible by special software tools. Human heart valves, for instance, are now being 3D printed through several different processes although none have been transplanted into people yet. And there have been significant advances in 3D print methods in areas like dentistry over the past few years.
Bioprinting's rapid emergence is built on recent advances in 3D printing techniques to engineer different types of products involving biological components, including human tissue and, more recently, vaccines.
While bioprinting is not entirely a new field because it is derived from general 3D printing principles, it is a novel concept for legal and regulatory purposes. And that is where the field could get tripped up if regulators cannot decide how to approach it.
State of the art in bioprinting
Scientists are still far from accomplishing 3D-printed organs because it's incredibly difficult to connect printed structures to the vascular systems that carry life-sustaining blood and lymph throughout our bodies. But they have been successful in printing nonvascularized tissue like certain types of cartilage. They have also been able to produce ceramic and metal scaffolds that support bone tissue by using different types of bioprintable materials, such as gels and certain nanomaterials. A number of promising animal studies, some involving cardiac tissue, blood vessels and skin, suggest that the field is getting closer to its ultimate goal of transplantable organs.
Researchers explain ongoing work to make 3d-printed tissue that could one day be transplanted into a human body.
We expect that advancements in bioprinting will increase at a steady pace, even with current technological limitations, potentially improving the lives of many patients. In 2019 alone, several research teams reported a number of breakthroughs. Bioengineers at Rice and Washington Universities, for example, used hydrogels to successfully print the first series of complex vascular networks. Scientists at Tel Aviv University managed to produce the first 3D-printed heart. It included “cells, blood vessels, ventricles and chambers" and used cells and biological materials from a human patient. In the United Kingdom, a team from Swansea University developed a bioprinting process to create an artificial bone matrix, using durable, regenerative biomaterial.
Though the future looks promising from a technical and scientific perspective, current regulations around bioprinting pose some hurdles. From a conceptual point of view, it is hard to determine what bioprinting effectively is.
Consider the case of a 3D-printed heart: Is it best described as an organ or a product? Or should regulators look at it more like a medical device?
Regulators have a number of questions to answer. To begin with, they need to decide whether bioprinting should be regulated under new or existing frameworks, and if the latter, which ones. For instance, should they apply regulations for biologics, a class of complex pharmaceuticals that includes treatments for cancer and rheumatoid arthritis, because biologic materials are involved, as is the case with 3D-printed vaccines? Or should there be a regulatory framework for medical devices better suited to the task of customizing 3D-printed products like splints for newborns suffering from life-threatening medical conditions?
In Europe and the U.S., scholars and commentators have questioned whether bioprinted materials should enjoy patent protection because of the moral issues they raise. An analogy can be drawn from the famed Dolly the sheep over 20 years ago. In this case, it was held by the U.S. Court of Appeals for the Federal Circuit that cloned sheep cannot be patented because they were identical copies of naturally occurring sheep. This is a clear example of the parallels that exist between cloning and bioprinting. Some people speculate in the future there will be 'cloneprinting,' which has the potential for reviving extinct species or solving the organ transplant shortage.
Dolly the sheep's example illustrates the court's reluctance to traverse this path. Therefore, if, at some point in the future, bioprinters or indeed cloneprinters can be used to replicate not simply organs but also human beings using cloning technologies, a patent application of this nature could potentially fail, based on the current law. A study funded by the European Commission, led by Bournemouth University and due for completion in early 2020 aims to provide legal guidance on the various intellectual property and regulatory issues surrounding such issues, among others.
On the other hand, if European regulators classify the product of bioprinting as a medical device, there will be at least some degree of legal clarity, as a regulatory regime for medical devices has long been in place. In the United States, the FDA has issued guidance on 3D-printed medical devices, but not on the specifics of bioprinting. More important, such guidance is not binding and only represents the thinking of a particular agency at a point in time.
Cloudy regulatory outlook
Those are not the only uncertainties that are racking the field. Consider the recent progress surrounding 3D-printed organs, particularly the example of a 3D-printed heart. If a functioning 3D-printed heart becomes available, which body of law should apply beyond the realm of FDA regulations? In the United States, should the National Organ Transplant Act, which was written with human organs in mind, apply? Or do we need to amend the law, or even create a separate set of rules for 3D-printed organs?
We have no doubt that 3D printing in general, and bioprinting specifically, will advance rapidly in the coming years. Policymakers should be paying closer attention to the field to ensure that its progress does not outstrip their capacity to safely and effectively regulate it. If they succeed, it could usher in a new era in medicine that could improve the lives of countless patients.
Dinusha Mendis, Professor of Intellectual Property and Innovation Law and Co-Director of the Jean Monet Centre of Excellence for European Intellectual Property and Information Rights, Bournemouth University and Ana Santos Rutschman, Assistant Professor of Law, Saint Louis University.
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A man's skeleton, found facedown with his hands bound, was unearthed near an ancient ceremonial circle during a high speed rail excavation project.
- A skeleton representing a man who was tossed face down into a ditch nearly 2,500 years ago with his hands bound in front of his hips was dug up during an excavation outside of London.
- The discovery was made during a high speed rail project that has been a bonanza for archaeology, as the area is home to more than 60 ancient sites along the planned route.
- An ornate grave of a high status individual from the Roman period and an ancient ceremonial circle were also discovered during the excavations.
Foul play?<p>A skeleton representing a man who was tossed face down into a ditch nearly 2,500 years ago with his hands bound in front of his hips was dug up during a high speed rail excavation.</p><p>The positioning of the remains have led archaeologists to suspect that the man may have been a victim of an ancient murder or execution. Though any bindings have since decomposed, his hands were positioned together and pinned under his pelvis. There was also no sign of a grave or coffin. </p><p>"He seems to have had his hands tied, and he was face-down in the bottom of the ditch," <a href="https://www.livescience.com/iron-age-murder-victim-england.html" target="_blank">said archaeologist Rachel Wood</a>, who led the excavation. "There are not many ways that you end up that way."</p><p>Currently, archaeologists are examining the skeleton to uncover more information about the circumstances of the man's death. Fragments of pottery found in the ditch may offer some clues as to exactly when the man died. </p><p>"If he was struck across the head with a heavy object, you could find a mark of that on the back of the skull," Wood said to <a href="https://www.livescience.com/iron-age-murder-victim-england.html" target="_blank">Live Science</a>. "If he was stabbed, you could find blade marks on the ribs. So we're hoping to find something like that, to tell us how he died."</p>
Other discoveries at Wellwick Farm<p>The grim discovery was made at Wellwick Farm near Wendover. That is about 15 miles north-west of the outskirts of London, where <a href="https://www.hs2.org.uk/building-hs2/hs2-green-corridor/" target="_blank">a tunnel</a> is going to be built as part of a HS2 high-speed rail project due to open between London and several northern cities sometime after 2028. The infrastructure project has been something of a bonanza for archaeology as the area is home to more than 60 ancient sites along the planned route that are now being excavated before construction begins. </p><p>The farm sits less than a mile away from the ancient highway <a href="http://web.stanford.edu/group/texttechnologies/cgi-bin/stanfordnottingham/places/?icknield" target="_blank">Icknield Way</a> that runs along the tops of the Chiltern Hills. The route (now mostly trails) has been used since prehistoric times. Evidence at Wellwick Farm indicates that from the Neolithic to the Medieval eras, humans have occupied the region for more than 4,000 years, making it a rich area for archaeological finds. </p><p>Wood and her colleagues found some evidence of an ancient village occupied from the late Bronze Age (more than 3,000 years ago) until the Roman Empire's invasion of southern England about 2,000 years ago. At the site were the remains of animal pens, pits for disposing food, and a roundhouse — a standard British dwelling during the Bronze Age constructed with a circular plan made of stone or wood topped with a conical thatched roof.</p>
Ceremonial burial site<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzUzMTk0Ni9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0NDgwNTIyMX0.I49n1-j8WVhKjIZS_wVWZissnk3W1583yYXB7qaGtN8/img.jpg?width=1245&coordinates=0%2C82%2C0%2C83&height=700" id="44da7" class="rm-shortcode" data-rm-shortcode-id="46cfc8ca1c64fc404b32014542221275" data-rm-shortcode-name="rebelmouse-image" alt="top down view of coffin" data-width="1245" data-height="700" />
A high status burial in a lead-lined coffin dating back to Roman times.
Photo Credit: HS2<p>While these ancient people moved away from Wellwick Farm before the Romans invaded, a large portion of the area was still used for ritual burials for high-status members of society, Wood told Live Science. The ceremonial burial site included a circular ditch (about 60 feet across) at the center, and was a bit of a distance away from the ditch where the (suspected) murder victim was uncovered. Additionally, archaeologists found an ornately detailed grave near the sacred burial site that dates back to the Roman period, hundreds of years later when the original Bronze Age burial site would have been overgrown.</p><p>The newer grave from the Roman period encapsulated an adult skeleton contained in a lead-lined coffin. It's likely that the outer coffin had been made of wood that rotted away. Since it was clearly an ornate burial, the occupant of the grave was probably a person of high status who could afford such a lavish burial. However, according to Wood, no treasures or tokens had been discovered. </p>
Sacred timber circle<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzUzMTk0Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2MDAwOTQ4Mn0.eVJAUcD0uBUkVMFuMOPSgH8EssGkfLf_MjwUv0zGCI8/img.jpg?width=1245&coordinates=0%2C149%2C0%2C149&height=700" id="9de6a" class="rm-shortcode" data-rm-shortcode-id="ee66520d470b26f5c055eaef0b95ec06" data-rm-shortcode-name="rebelmouse-image" alt="An aerial view of the sacred circular monument." data-width="1245" data-height="700" />
An aerial view of the sacred circular monument.
Photo Credit: HS2<p>One of the most compelling archaeological discoveries at Wellwick Farm are the indications of a huge ceremonial circle once circumscribed by timber posts lying south of the Bronze Age burial site. Though the wooden posts have rotted away, signs of the post holes remain. It's thought to date from the Neolithic period to 5,000 years ago, according to Wood.</p><p>This circle would have had a diameter stretching 210 feet across and consisted of two rings of hundreds of posts. There would have been an entry gap to the south-west. Five posts in the very center of the circle aligned with that same gap, which, according to Wood, appeared to have been in the direction of the rising sun on the day of the midwinter solstice. </p><p>Similar Neolithic timber circles have been discovered around Great Britain, such as one near <a href="https://bigthink.com/culture-religion/stonehenge-sarsens" target="_blank">Stonehenge</a> that is considered to date back to around the same time. </p>
Research reveals a new evolutionary feature that separates humans from other primates.
- Researchers find a new feature of human evolution.
- Humans have evolved to use less water per day than other primates.
- The nose is one of the factors that allows humans to be water efficient.
A model of water turnover for humans and chimpanzees who have similar fat free mass and body water pools.
Credit: Current Biology
Being skeptical isn't just about being contrarian. It's about asking the right questions of ourselves and others to gain understanding.
- It's not always easy to tell the difference between objective truth and what we believe to be true. Separating facts from opinions, according to skeptic Michael Shermer, theoretical physicist Lawrence Krauss, and others, requires research, self-reflection, and time.
- Recognizing your own biases and those of others, avoiding echo chambers, actively seeking out opposing voices, and asking smart, testable questions are a few of the ways that skepticism can be a useful tool for learning and growth.
- As Derren Brown points out, being "skeptical of skepticism" can also lead to interesting revelations and teach us new things about ourselves and our psychology.