Dean Kamen, executive director of the Advanced Regenerative Manufacturing Institute (ARMI), president of Deka Research & Development Corp., and long-time inventor, entrepreneur and advocate for science, is on a new mission to solve the medical industry’s next big problem.
“Your next job is to create all the baseline engineering necessary to create the industry that will start, at scale, manufacturing replacement human tissues—skin, bones, cartilage—and eventually complete organs, like livers and kidneys and lungs,” Kamen said. He was talking to the audience at the Automation Fair At Home event, specifically the Perspectives Tuesday keynote address, “Define OUR Next Together.” But he was also talking to the many important partners that have joined ARMI to bring this reality to fruition, as well as the many professionals and patients it will affect in the medical field.
“I’m here to tell you why we think that is the next big thing for the whole engineering community,” Kamen said.
He developed ARMI because the problem would require many partners, including the U.S. Department of Defense which started the non-for-profit organization with a $80-million budget, and technology companies, research institutions, medical schools, scientists and manufacturers in aerospace, semiconductors, pharmaceuticals, automotive and defense.
The science and technology to do this kind of work has been around for decades, yet still no practical application of the science is being deployed large-scale. “There are many fantastic research institutes already around the country,” Kamen said. “There are a lot of great institutions that already have miracles in petri dishes in labs all over the country. What they don’t have is the expertise, the knowledge, the tools and the experience to take miracles out of the petri dishes and figure out how, at scale, to make safe reliable, high quality human replacement organs.”
Automation will be a key in bringing organ manufacturing to scale, and Rockwell Automation is one of the earliest members of ARMI. “When we were given, a couple of years ago, the opportunity to try to bring together the engineering community to create the baseline core technologies to help bring all the science and all of the miracles in all of the petri dishes around the country to scale, we couldn’t turn it down. I called a few people,” Kamen said. Very near the top of the list of people he called to make this unique coalition work was Rockwell Automation CEO and Chairman Blake Moret.
Tissue and organ manufacturing complex
The home of ARMI and Deka Inc. is in Manchester, New Hampshire, at the old home of the Amoskeag Manufacturing Company, which during the reign of water-powered textile manufacturing in New England in the 1800s was the largest industrial manufacturing complex in the world. Kamen moved from New York to New Hampshire and became passionate about rebuilding the property as his new engineering home and manufacturing complex.
When he founded ARMI a few years ago, Kamen told a group of supporters, that this entire property will become “the birth place of the next great industrial spurt in the world.” The property would be “Carbon Valley for the manufacture of human organs, what Silicon Valley is to the semiconductor industry,” he said.
An industry to reliably produce human replacement organs and deliver them to patients in need would dramatically change health care treatment and drive down the cost of health care, Kamen said. A large majority of health care is spent on the treatment of chronic conditions that don’t have a cure but require endless medicines and procedures. “Regenerative medicine” is a common term in the medical world, but Kamen was quick to point out that the “M” in ARMI, stands for “manufacturing,” not medicine.
“Regenerative medicine, it’s the future. Well, it’s been the future for decades, and the problem is it will continue to be the future until the world of engineering becomes a very visible piece of the equation,” Kamen said.
In his research, he toured medical school and research institutions, where graduate student and researchers painstakingly nurture petri dishes with no automation, where contamination is widespread and replication is difficult. “Could they do it in a way that it could be so well controlled and well documented that they could go to the Food and Drug Administration (FDA) and say I want the approval to make this tissue or organ?” Kamen asked. “How are they going to ensure to the FDA that each thing that they made met some particular standard, when the standard doesn’t even exist?”
Government was happy to fund the early research, and industry is always happy to support ventures, once the risk is low and the time frame to get product out to the market is well understood, Kamen added. “But when the industry doesn’t really exist yet,” he said, “and in an environment where we don’t even really know what the regulatory process would look like, there’s been very little time and resources spent in the middle.” Kamen decided that middle piece would be what AMRI would solve.
He reached out to companies that had the technologies that he thought could be redirected to this purpose, and many of them joined ARMI. In its third year, the organization has more than 150 members.
“We have to automate every aspect of everything we do, and besides automating it, we have to find ways to sensorize it, put all of the technology that every one of these companies is going to need into a bundled package that they can all use,” Damen said. “The baseline pre-competitive technologies that a whole industry is going to need has to be developed by a whole bunch of different companies.”
ARMI has begun this initial development work at its tissue foundry in Manchester. In an isolated, sterilized environment, they can produce a high-quality 7-cm bone-ligament-bone sample in 42 days. Manufactured replacement tissue and organs can also use genetic material from its recipient, so organs won’t be rejected and patients won’t need immunosuppressant therapies for the rest of their lives.
“If you start adding all the other costs of taking care of all the other conditions that could be completely eliminated, if we can give people replacement organs instead of other therapies, we would change the lives of all these people, and prevent this country from bankrupting itself because of health care costs,” Kamen said.
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