I specialize in identifying disruptive, core technologies and strategic technology trends in early-stage startups, research universities, government sponsored laboratories and commercial companies.

In my current role, I lead sourcing of strategic technology investment opportunities and managing Dyson’s diligence and outreach processes, specifically in the U.S., Israel and China.

I write here (sporadically) on the convergence of science and engineering, with broader adopted interests in novel disruptive technologies, cognitive psychology, human-computer interaction (HCI), philosophy, linguistics and artificial intelligence (AI).

Bioprinting toward organ fabrication: ethical challenges and future trends

The just-give-them-the-Emmy-already opening credit sequence of HBO's new sci-fi drama "Westworld" features precisely stunning creation of its universe of using advanced 3D-printed technologies. From the polymorphic stages of a horse to Da Vinci's Vitruvian Man-style artificial hosts of the human varieties being brought into existence, flashbacks of early production units highlight technology to create ultra-advanced synthetic organs that mimic skin, muscle fibers, eyeballs, intestines, and hearts without actually serving the same human functions (is this close to what the Creator's office looks like?). Putting aside (but not too far) the sophisticated robotics assembly line, the organ technology is very familiar-looking and it is plausible to suggest that we are just a few upgrades far from a day when we develop synthetic human components that look and behave completely like real ones.

The concept of organ printing based on the techniques of directed deposition and sequential biological tissue self-assembly opens the possibility of being able to organize cells and molecules in three dimension with the desired local density, functionality and anatomical structure mimicking their distribution in organs. 

3D bioprinting (and ethical debate on its use) gain more and more traction in medical conferences and journals—what the specific applications are involved and how the technology development might affect the average citizen. But what if the ability to 3D print organs and other soft tissues also brings wonderful opportunities for the organs and tissues to be "enhanced" with non-human genetic material?

How it works

Bioprinting is the use of a specialized 3D printer with two print heads to produce bones, organs, and soft tissues by adding live cells (picture "bio-ink" from the cells) to a growth medium (usually stem cells) while also applying an organic polymer base (picture glue gel) to hold the cells together. Bio-ink is placed exactly where required by a moving-left-and-right-back-and-forth-up-and-down bioprint head. 

Organovo introduced the world's first commercial bioprinter, the Novogen MMX, in 2013. The University of Louisville has a six-axis tissue building machine that can produce a heart and valves, then move them around to insert the valve in the heart muscle. 

Two milestones in bioprinting occurred in 2013. Scientists at China's Hangzhou Dianzi University 3D printed a working kidney that lasted four months. Earlier in the same year a girl received a windpipe made of her own stem cells. Some people extend the concept to any use of 3D printing technology to produce a partial windpipe, a partial jaw replacement, or a blood vessel. Those applications may use soft plastics, titanium powder, ceramics, and organic materials in some combination. 

In this early stage of development, 3D bioprinting technology already has numerous medical applications. In the not-so-far future, individuals might be able to use the technology to give themselves new capabilities. For example, an athlete could order genetically identical enhanced lung or muscle tissue. This form of bioprinting raises the same legal and ethical issues as the purely organic variety.

Controlling the tech

The issue of controlling the technology is relevant in two ways: it raises legislative issues and it raises general public health challenges. Legally, the technology to create a certain type of tissue or bone currently cannot be limited nor patented, leading to pretty self-evident conclusion of unregulated Wild Wild West-type bioprinting environment. Three (for now) problems:

High Cost—Printed tissues and bones might be more expensive than transplanted tissues, though the printed replacements would be easier to get, as they can be produced on demand. However, consequently it brings questions of more broad economical costs of 3D printing in general, posing a risk to intellectual property (Gartner estimates a global loss of $100 billion a year by the end of 2018). But will we know in time if you can patent the use of a specific kind of pig cell in bioprinted kidneys or can an a specific technique for "growing" a piece of hip bone be patented? Hmm... Granting bioprinting patents can be quite intricate, a patent office may grant a patent for a method of 3D printing a kidney but not for a kidney itself because internal organs are "products of nature" and can be found in (almost) every human (or animal). But to quote Lisa Feisee, Vice President of International Affairs for Biotechnology Industry Organization:

"Biotechnology patents allow for the dissemination of potentially valuable scientific information. The availability of the information disclosed in biotechnology patents enables others in the field of science to build on earlier discoveries. Not only can other researchers use the information in a patent, but by disclosing cutting edge scientific information, the patent system avoids expensive duplication of research efforts. It is only with the patenting of biotechnology that some companies, particularly small companies, can raise capital to bring beneficial products to the market place or fund further research. In addition, this capital provides jobs that represent an immediate public benefit independent of the technological benefits. Continuing employment opportunities represent a national resource for the future because they encourage the youth of today to become the scientists and inventors of tomorrow. Thus, the patent system not only fosters benefits to our society today, but ensures our future ability to innovate and grow."

Safety—There may be undiscovered health risks with replacement tissues and organs, even if they are fully organic. The rejection risk of a 3D printed heart valve or artery is kind of self-explanatory. 

Enhancing human performance—mentioned before athletes might pay extra for 3D printed tissues that enhance their lung capacity or give their leg muscles a little more endurance. In world-class athletic competition a small advantage often pays off in more prize money and bigger endorsement deals. If enhanced muscle or lung tissue are not allowed, how can next-human cheaters be caught?

Ethical balance of safety and quality

National governments regulate drugs, medical devices, and medical procedures. A process of fabricating biological constructs is not different and they will have to draft or modify existing rules to cover 3D printed organs and tissues. 

In the United States, the Food and Drug Administration already regulates 3D printed medical devices today, so they could spearhead comprehensive regulation framework on the use of bioprinted organs and tissues. Otherwise, the European Union and member States already regulate medical implants and devices, so the extension of control on 3D printed tissues and organs should follow. Only trained approved medical professionals should access to bioprinters while the governments should regulate that access.

While most bioprinted parts would be made by experts under sterile conditions, not all of them (reality check) would be. Countries, where bioprinting is growing, need to proactively define quality standards in place parallel or equivalent to those of medical devices like hip and knee replacements to protect the public from improperly designed products. Medical professionals have to be able to perform quality analysis of a synthetic new kidney before giving to someone.

Animal-human hybrid organs

The issue can become way more complicated when the tissues contain non-human cells. Safety is harder to analyze and determine, though it cannot be assumed that using cow cells in a bioprinted liver creates a new health risk. Human liver tissue that contains cells from a pig liver might be viable and a workable replacement for a patient's liver, but is this safe? No one really knows if that hybrid liver will last as long as a regular transplanted liver, be more vulnerable to cancer or simply be rejected, causing illness and require a second transplant surgery. An unnamed university has already used human amniotic fluid, bovine cells, and canine smooth muscle cells. A hybrid with two types of non-human cells has little research about rejection and disease.

Applications of successfully implemented bioprinting technology are truly unlimited (just one example is organ transplantation that is a currently only accepted treatment modality for end-organ failure, however according to the latest data from the U.S. Department of Health and Human Services, and average of twenty-two people die daily waiting for a transplant), but so are its risks.

Based on the current standings of technology, we might not be too far from having marketable bioprinted organs with high-order functionality and we need to fulfill their ethical and legal requirements for ultimate use in humans. The extreme ends of no regulation or self-regulation seem fairly unattractive (in my humble opinion).

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