Jerry Yang was asking himself an obvious question that no one at his company seemed to be answering: What good is a lifesaving mitral valve implant if it can’t travel reliably from the lab to the patient?
Yang is an Associate Design Engineer for Caisson Interventional LLC, a medical device manufacturing company that makes mitral valve implants to replace heart valves that no longer function optimally. Think of a heart valve like a tiny door in one of the heart’s chambers, where blood is pumped and circulated throughout the body. If that door becomes too tight and won’t open properly, or too loose and won’t close properly, you’ve got big problems (infection, disease, and more). A mitral valve implant is essentially a new door that gets installed, allowing blood to come and go smoothly.
Caisson’s valve implant still has to be FDA-approved, yet it has seen high success rates in patients who have opted for it. In the meantime, Caisson’s delicate implants must continue to be shipped to hospitals, and that’s where Yang and his obvious question come in.
“There were issues with the jars and external packaging that the implants were being shipped inside of,” Yang says. “If there’s a leaky jar, you can’t put that product in a patient; you must discard the product because there’s been a sterility breach. Every time that happens, Caisson loses money.”
In every 40 jars shipped, about two or three were leaking. Yet most of Caisson’s engineers focused their attention on designing and fine-tuning the product itself, not the product packaging. When it came to packaging, a jar was simply stuffed inside a cardboard box and packed with five separate chunks of foam to stabilize it. Yang, who was finishing up his final year as a student in the Manufacturing Operations Management (MM) program, saw the packaging problem as an opportunity to earn credit for his capstone project while also fixing a red-flag issue for his employer.
Approaching the Redesign
A capstone project should do what its name implies: It should be the pinnacle of what an education has amounted to, and that’s precisely what Yang’s was. He knew from his coursework in engineering concepts and resource optimization that design decisions in manufacturing are complex. His course in medical device regulation was especially helpful in this department, as it provided a depth of knowledge about the complexity of these regulations. The designer must consider an array of risks that the product might encounter. Yang began calculating those risks and searching for packaging solutions that would withstand them.
“As I thought about the jar and the box it would go inside, I did a lot of risk analysis,” Yang says. “I asked myself, ‘If I use this jar or that jar, will it withstand pressure in an airplane? What mechanisms seal the jar? What about the packing foam that surrounds the jar inside the box?’ One question leads to another.”
What was supposed to be a six-week project turned into a year-and-a-half-long project. Yang’s research and risk-mitigation analysis paid off, though. After lots of trial and error and in-house testing, he came up with a packaging solution that Caisson and his capstone instructor at the U of M were very pleased with.
Yang’s final packaging design included a heavier jar with thicker glass, which fit neatly inside a single custom-cut styrofoam mold. This was packed tightly inside a corrugated cardboard box with a solid bleached sulfate exterior. The labels were redesigned as well, and the finished packaging looked professional and solid. Most importantly, it worked. Of the 150 jars sent using Yang’s packaging, 100 percent arrived at their destinations intact with no leaks.
Final Stages of Design
Caisson is moving forward with Yang’s packaging design. The next step is to create steel molds for fabricating the packaging materials, an expensive procedure that commits Caisson to using Yang’s design for a long time to come.
“We send out one or two mitral valve implants a month right now,” Yang says. “But once we finish all the testing required by the FDA, that number might skyrocket to 40 or 50 implants per month. We have to be ready for that.”
Thanks to Yang’s packaging remedy, they will be.
Jerry Yang is a recipient of the Osher Reentry Scholarship.