The Current State of Manufacturing Human Organs

The Department of Defense has been interested in engineering organs, tissues and limbs for decades as a means of treating its wounded soldiers. The number of veterans in need of tissue repair and limb replacement has skyrocketed in the 21st century.
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Thirteen. The number of people that die each day waiting for a life-saving kidney transplant.

$5 billion. The cost to create a new drug.

$3 billion plus. The amount invested in engineered tissue and organ research by the Federal government in a three year period.

Zero. The number of organs currently being manufactured by US industries for transplant.

322,762,018. The number of Americans in 2016 that could benefit from the Department of Defense's new Advanced Tissue Biofabrication Manufacturing Innovation Institute (ATB-MII).

The Department of Defense has been interested in engineering organs, tissues and limbs for decades as a means of treating its wounded soldiers. The number of veterans in need of tissue repair and limb replacement has skyrocketed in the 21st century, due primarily to the recent and pervasive use of improvised explosive devices, coupled with dramatic improvements in body armor that save lives but not without sacrifice. Meanwhile, the need is equally as strong in the civilian world, where hundreds of thousands of Americans wait on organ transplant lists living day-by-day in fear of what the future holds.

Many wonder: "Why can't we manufacture organs TODAY?" The charge is not new, nor will it fade in the coming years. It rises from the halls of Congress. It mingles with tears in homes across our nation. It echoes down hospital hallways and lingers in operating rooms. As a DoD scientist working in the field of biofabrication and tissue engineering for over 15 years, I wake up every morning trying to answer that same question; trying to explain to my children, my colleagues, my friend whose husband is on his second and final kidney transplant--why can't we make faster and more substantive progress?

The answer, as is often the case in the world of science, is not so simple. The world is full of promising technologies. Stem cells. Bioprinters. Gels that simulate the biological and structural properties of human tissue. Sophisticated imaging and computer-aided design technologies. Why, then, do we not have manufacturing plants that churn out organs? We should be able to use these starting materials just as Henry Ford used steel, rubber, and assembly lines to create the first automobiles, right? Answers like "Biology is really complicated" and "Soft, living materials are just more difficult to build than computer chips and iPhones", don't resonate too well, especially when the need is so high.

Despite these challenges, progress is being made on all fronts. After decades of research, these technologies are maturing to the point where manufactured tissue is almost within reach. All that is needed is one big push.

Enter the Government's most recent investment, bringing at least $160 million to the table to accelerate tissue and organ development: the Advanced Tissue Biofabrication Manufacturing Innovation Institute, or the ATB-MII for short, sponsored by the Manufacturing Technology Program within the Office of the Secretary of Defense for Acquisition, Technology and Logistics. The ATB-MII will pull emerging technologies into the industrial world--the world of manufacturing, automation and standardization. It will convene the best and brightest minds in the country across universities, small and large businesses, as well as local, state and federal governments, to identify, elevate, and synergize technologies. It will enable disruptive biofabrication tools, currently isolated in specialized laboratories across the country, to be inserted into manufacturing processes throughout diverse biotechnology sectors. It will enable biological starting materials and biofabrication tools to be standardized to the small- and mid-sized companies looking for a competitive edge. Ultimately, the ATB-MII will evolve into an enduring ecosystem that will accelerate the development to manufacture tissues, organs, and organ-based products.

Short-term products will emerge from the institute such as miniature tissues or organs, coined "organs-on-a-chip," that can be used to eliminate poorly performing drug candidates before they enter costly animal and human trials. These organs-on-a-chip will translate test results into the world of personalized medicine, helping speed up decision-making by clinicians looking to determine the most effective and least dangerous treatments for critically-ill patients.The industry is poised to revolutionize the way new drugs are discovered, as well as the way we engineer tissues and organs.

The ATB-MII is the path to create definable tools, products and standards that will have tangible outcomes--real products that can change lives.


Dr. Ringeisen will serve as the DoD's Chief Technology Officer for the Advanced Tissue Biofabrication MII, which is currently under solicitation. He also serves as the Head of the Bioenergy and Biofabrication Section at the Naval Research Laboratory in Washington, DC.

This post is part of a series produced by The Huffington Post and ORGANIZE, a non-profit looking to end the organ donation crisis by identifying and building on opportunities for improvement through technology, advocacy, and policy. Learn more at ORGANIZE.org.

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