From Time to Time, a Little Perspective

Not too long ago, while cleaning up shelves in my office at home, I picked up a book purchased the year I graduated from college. It was a collection of short stories titled “Trying to Save Piggy Snead” by John Irving (famous for his books  “A Prayer for Owen Meany” and “The World According to Garp”). Soon, rather than continuing with my task, I began to flip through its pages—any excuse to avoid sorting out the mess that is my den. One of the essays, “Almost to Iowa,” tells the story of a grown man running away from problems at home in Vermont. He takes off (in the middle of a cocktail party) and heads west in his 1969 Volvo, which becomes the other character in the story. The protagonist has deep chats with the car during the drive. The story is brooding like most of Irving’s work, but one line jumped out at me. The driver says: “We often need to lose sight of our priorities in order to see them.”  I put the book down and got back to organizing. What does this have to do with medical technology? Not much on its own. But it came to mind after reading something else—this time much closer to the subject of medtech.

Kaiba Gionfriddo suffered from a rare disease called tracheobronchomalacia, a condition in which the windpipe collapses due to flaccid supporting cartilage. His parents discovered the condition following dinner at a restaurant where their six-month-old son turned blue and stopped breathing. On a regular basis—often daily—Kaiba’s breathing would become obstructed, and his parents would have to resuscitate him using CPR, each time not knowing if it would be the last. There are varying degrees of the condition, but Kaiba’s was particularly bad and his parents and physicians began to doubt that he could survive long-term. A 3-D printed device put an end to their doubt and gave Kaiba new life. The entire Ohio family now can breathe easy. 

A tracheal support splint, already in development by University of Michigan Associate Professor of Pediatric Otolaryngology Glenn Green, M.D., and Professor of Biomedical Engineering and Mechanical Engineering Scott Hollister, Ph.D., was the answer. Green and Hollister were contacted by Kaiba’s doctors. To make the implant, they first obtained a CT scan of the baby’s trachea/bronchus, then created a computer model of the splint based on that. A laser-based 3-D printer was used to convert the digital model into a physical object layer by layer, made from polycaprolactone (PCL), a biodegradable polyester. Information about each layer is transmitted from the computer to a laser beam, which melts the PCL into a 3-D structure. PCL has been approved by the U.S. Food and Drug Administration (FDA) for specific applications used in the human body such as a drug-delivery device, suture or adhesion barrier. It currently is being investigated as a scaffold for tissue repair via tissue engineering. But this was something vastly different, and it had never been tried in a human before as it was being proposed for Kaiba. Green and his team had to apply for an emergency-use exemption from the FDA, which they quickly got.

In February last year, the ridged tube-shaped splint was sewn around Kaiba’s airway to prop open up his bronchus and serve as a skeleton to guide the proper growth of more rigid cartilage as he matures. Most babies with tracheobronchomalacia grow out of the condition as their trachea develops in two to three years, which is about the same amount of time that it should take the biocompatible polymer to be dissolved into his body. Twenty-one days after the procedure, Kaiba was taken off ventilator support and hasn’t had any breathing problems since. He is now almost two years old.

“Even with the best treatments available, he continued to have these episodes. He was imminently going to die,” Green told UofMHealth.org. A group from the University of Michigan wrote about the experience in the May 23 edition of the New England Journal of Medicine. Green and Hollister have used the same process to build and test patient-specific ear and nose structures in pre-clinical models. Hollister also has used the method to rebuild bone structures (spine, craniofacial and long bone) in pre-clinical models.

What does this story have to do with the Irving quote? Well, we (as journalists, manufacturers, consultants, lobbyists, etc.) often get mired—particularly in this, our Top Company Report issue—in the discussion and coverage of bottom lines, market forces, market shares, international markets, speed to market, FDA shortcomings, funding shortfalls, higher taxes, taxing regulations, and the list goes on.

Perhaps a little perspective about the priorities is lost. Clearly, I realize that all of the items I just listed are critical to the health of the medical device industry. But also critical to an individual’s health—this time a toddler with little hope of survival—is pure clinical need solved by brilliant innovation. And that’s the best of what the medical device industry is all about. In this example, a problem was identified, smart people came together to solve it with innovative research and manufacturing, the FDA cleared a path, and success was achieved. Kinda cuts through the noise, doesn’t it? Let’s not lose sight of that.