ARMI’s mission is to make practical the large-scale manufacturing of engineered tissues and tissue related technologies, to benefit existing industries and grow new ones. Some have said that engineered organs and tissues remain science fiction.
Michael Hill, Ph.D., vice president of corporate science, technology and clinical affairs at Medtronic, disagrees. “It’s not science fiction,” said Hill. “Regenerative medicine will play an incredibly important role in the future of medical technology to meet unmet medical needs and Medtronic intends to be a leader in it.” Proof of concept in humans has been demonstrated in several areas such as cartilage replacement, vascular vessels for bypass surgery, trachea reconstruction, and others.
“The task at hand is to develop the capability to move from creating one vascular vessel to producing hundreds of thousands of these each year in a consistent high quality and reliable manner and transport these all over the world in sterile and functional condition. This capability stills needs to be created," Hill continued.
That’s why Medtronic agreed to a seven-year strategic partnership with ARMI|BioFabUSA. The collaborative effort is intended to figure out how to create and manufacture on a large-scale, patient-specific tissue and perhaps someday even working organs.
“It’s pretty obvious that with advances in stem cell technology, computer science, engineering and 3D printing, we will one day be able to create bioartificial tissue and implantable organs,” said Markus Reiterer, senior principal scientist at Medtronic. “It’s been proven on a small scale. Then the question becomes how to get that work out of the lab and mass-produced to help the most people. That’s where the ARMI partnership will be critical.”
Reiterer and Hill agree the first devices from regenerative medicine (also known as biofabrication) could be products such as ligaments and cartilage for knees, bio-fabricated skin, bone or spine devices such as discs or vertebrae. And many of these devices may someday be custom-made for individual patients, to specifically match the needs of their anatomy or pathophysiology. Functioning organs, such as hearts or pancreases, are much further down the road.
“There are all kinds of miracles that exist in roller bottles and petri dishes at universities and medical schools all over the country. ARMI|BioFabUSA sought out the best universities and biggest companies that do automation, controls, and sensors and who understand the manufacturing process to be able to work together to reach a goal where solutions come from the ARMI members’ collaboration,” said Gray Chynoweth, Chief Membership Officer at ARMI|BioFabUSA, adding, “We are very pleased that Medtronic has chosen to become a member of this pioneering community.”
“This work is going to take many years,” Hill said. “This partnership is an important step in that long journey. The vision and potential are there, and now we need to develop the regulatory sciences needed to demonstrating safety and efficacy of individualized manufactured products; manufacturing capability, technology and standards; and distribution capability to realize it.”