Envisioning the future of regenerative medicine elicits images of an operating room that also is a manufacturing facility. Patients undergoing surgery could have immediate access to products biomanufactured within the operating room or even within their own bodies. Products such as tissue engineered for targeted healing or 3D-printed scaffolds that repair diseased organs, bones or cartilage could be customized to address individual needs.

This health care vision at the crossroads of biomanufacturing, engineering and regenerative medicine earned Mayo Clinic top honors at the National Science Foundation Manufacturing Blue Sky Competition. The David Dornfeld Manufacturing Vision Award is based on ideas described as radical, transformational, breakthrough, convergent and unconventional that could influence the future of manufacturing research. Michael McPhail, Ph.D., a biomedical engineer and research associate at Mayo Clinic in Arizona, proposed the award-winning concept of surgical manufacturing at a Society of Manufacturing Engineers conference.

"The goal of this competition is to introduce ideas that address grand challenges in manufacturing engineering and have a transformative effect," says Dr. McPhail. "Our team envisions products produced both in the operating room and in the patient to regenerate multiple tissue types to support reconstructive surgeries."

Juergen Neubauer, Ph.D., a Mayo Clinic research scientist, and David Lott, M.D., an otolaryngologist and head and neck surgeon at Mayo Clinic, are co-authors of the proposal. Dr. Lott is also associate director of Mayo Clinic's Center for Regenerative Medicine in Arizona.

The Center for Regenerative Medicine is leading a new biomanufacturing strategy across Mayo Clinic to provide next-generation therapeutics based on biologics such as cells, genes or genetically engineered cells that provide new cures for the practice.

Bringing together tissue engineering, biomaterials, regenerative medicine, robotics, 3D printing and imaging could have a transformative effect on the entire practice, according to Dr. McPhail.

"As an example, a jaw defect would have a bone regeneration template 3D-printed into the defect. The composition of the template would be designed to promote bone regeneration while providing required structural stability. The structure of the manufactured bone would be guided by medical imaging and real-time optical sensors," says Dr. McPhail. "We expect this suite of tools will enable less invasive surgeries while improving outcomes."

No longer science fiction

Dr. McPhail is part of Dr. Lott's team, which is working collaboratively to advance this vision from what may seem like science fiction to reality in daily clinical care. The research is investigating ways of applying 3D printing to address unmet patient needs.

For example, the Cosmetic Center at Mayo Clinic in Arizona uses 3D printed models to rebuild facial features after debilitating effects of disease, cancer or traumatic injury. These 3D models provide the tools for surgeons such as Brittany Howard, M.D., to precisely shape a nose, cheek or chin and let the patient try it on for size before surgery. Dr. McPhail and his colleagues envision taking 3D printing a step further to engineer intricate facial features in the operating room and in the patient.

"When it comes to reshaping a nose after cancer or injury, we need to have the aesthetics just right," says Dr. McPhail. "So maybe we move the 3D printer to the operating room to generate an exact fit for the nasal cartilage defect to assist in perfectly rebuilding the nose."

Mayo Clinic in Arizona is using 3D printing to repair the larynx for some laryngeal cancer patients. Dr. Lott and his team discovered a way to remove the diseased part of the larynx while preserving healthy tissue. Using CT scans, Mayo Clinic can create a 3D replica of the diseased portion of the larynx with exact dimensions of the section that was removed. A scaffold is molded with a 3D-printed tool and implanted within the larynx. After the scaffold is implanted, Richard Hayden, M.D., another otolaryngologist and head and neck surgeon, uses a muscle flap to cover the implant. Over time, soft tissue grows into the scaffold, regenerating the portion of the voice box lost to cancer.

While 3D printing is being introduced to facial reconstruction and laryngeal repair, further innovations, research and collaboration are needed to meet strict regulatory and quality criteria. That is crucial to bring this engineering vision of regenerative medicine to patients at Mayo Clinic and around the world.

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