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Nordson MEDICAL Team Works Double Time to Help Save a Life

 

A major medical device manufacturer recently approached our Nordson MEDICAL team in Sunnyvale, California, with an urgent request: deliver a product that was in the development phase within just two weeks to try to save an individual's life, when all other options had been exhausted.

"They got approval from the FDA for what's called compassionate use," said Tom Testa, Vice President and General Manager of Nordson MEDICAL. "This is a situation where the physicians go to the FDA and say, this patient doesn't have a good path towards being treated appropriately with anything that's currently on the market. Even though this is experimental and it's not an approved medical device yet, we'd like to use this experimental device on a patient because it's the only way to save his or her life."

While compassionate use cases are not unheard of for our medical teams, each one presents unique challenges and requires intense focus on collaboration and innovation to speed up our development process and meet the customer's need in very little time.

In this case, a patient needed a very specialized heart valve repair but wasn't a candidate for open-heart surgery due to the amount of strain the invasive procedure would place on the patient's body. This can be a challenge with patients who are advanced in age, or who can't go under anesthesia.

Rick Newhauser, General Manager of the Western Region, explained that the system that is being developed allows for a much less invasive procedure than usual for a valve replacement.

"The catheter enters through a blood vessel in a patient's leg, then goes up through the heart and deploys the valve inside the heart. Your heart doesn't have to be put on bypass, your chest doesn't have to be open and your heart doesn't have to be cut open," he said. "It really takes it down to one relatively small hole in your vein in your leg, then one small hole in your heart."

Completing the prototype device was no simple task. It would typically take four to five weeks to turn around such a request and the team had just two weeks until delivery. Andrea Leung, Senior Program Manager, led the initiative.

"The team had an awesome attitude about it, to do their best to hit the date," Andrea said. "Everyone understood the importance."

The team had a lot to do, and fast. They had to conduct test runs, release engineering drawings and manufacturing documentation, assess and determine quality requirements to ensure the device would be safe for human use, build and then deliver the product. When it came time for delivery, our Nordson team personally hand- delivered the device to the customer's location rather than shipping it to make sure the patient would receive it in time.

"I was really excited by how the team was able to hit the ground running," Rick said. "I was excited by how well the team worked together. Not just the team executing, but also the extended team working with the client and the quality management team to really come up with a good holistic solution to provide the client what they wanted."

Tom Testa also shared his pride in the Sunnyvale team for their outstanding teamwork, innovation and – most importantly – their commitment to quality. Their efforts helped a patient at their time of need, and also deepened our relationship with our customer by instilling confidence in our technical capabilities and our customer service.

"We're not just building highly-engineered plastic parts. These are going into devices that save patients' lives," Tom said.