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The Journal Gazette

  • Rachel Bennett Steury, an Auburn resident, is a field coordinator with the Alliance for American Manufacturing. She donated a kidney to a Pennsylvania man in 2012 through a good Samaritan program. 

Wednesday, March 16, 2016 2:19 pm

We're manufacturing a healthier population

Rachel Bennett Steury

Often, when we hear about a new cure or breakthrough in the field of medicine, it’s vaccines or pills that come to mind. But medical developments aren’t limited to the pharmaceutical field alone.

Fascinating advancements are happening across the country that soon will lead to one of the most pivotal moments in medical history, and American manufacturing is poised to be at the forefront.

To understand how close to home such developments will be felt, look no further than your driver’s license. That’s where many of us are identified as organ donors. And there’s an urgent need for more of us.

According to the Organ Procurement and Transplantation Network, nearly 124,000 people are waiting for a donor and a new lease on life, but supply isn’t keeping up with demand. On a daily basis, 144 people are added to the waiting list while 21 people die waiting for a donation to come through.

This is not a manufactured crisis. But medical experts are turning to cutting-edge manufacturing processes to solve it.

Here’s how: ASAIO (formerly known as the American Society for Artificial Internal Organs) has been working for half a century to "save lives one medical device at a time." Its members are doing groundbreaking research and development to change the way we address the national shortage of organs – with science, medicine and industry joining forces.

And because there aren’t enough people filling the need for organs, ASAIO and others are exploring how to manufacture new ones.

This is a mind-boggling idea, and there’s already been real progress.

The SynCardia Heart – the world’s first artificial heart to meet approval by the Food and Drug Administration, Health Canada and Conformite Europeenne – has been implanted in more than 1,350 patients around the world, extending their chances of survival while waiting for a transplant. This revolutionary product started as an idea hatched in Ohio in the 1950s. Decades of R&D later, coupled with funding through the National Institutes of Health and the ingenuity of numerous scholars across the country, a brilliant medical device is now made in Tucson, Arizona. Future development could allow for the SynCardia to replace a human heart in transplants.

But that’s only one organ. The process of creating an artificial kidney by building it from the cells of an intended recipient is something scientists, surgeons and engineers are doing now at many research centers across the globe. Researchers led by professor Jennifer Lewis at Harvard University’s Wyss Institute, for instance, are looking at innovative manufacturing processes such as 3-D printing to make enough kidneys to fill the growing need for transplants. And it’s all taking place in America.

Innovation of this caliber has been nurtured through our universities and evolved from America’s entrepreneurial spirit and deep-seated drive to solve the world’s biggest problems. But will the medical device industry be the key to eliminating the organ transplant waiting list? This will depend, in part, on the amount of support our nation is willing to provide.

In Washington, the House Energy and Commerce Committee recently unveiled its 21st Century Cures initiative to examine how Congress can help accelerate promising new treatments to patients, "from the discovery of clues in basic science, to streamlining the drug and device development process."

Committee co-chairs Rep. Fred Upton, R-Mich., and Rep. Diana DeGette, D-Colo., will unveil draft legislation this year covering six areas for reform, including incentivizing the development of new drugs and devices for unmet medical needs, and investing in advancing research. This is promising news for medicine and manufacturing.

With bipartisan support for efforts like the 21st Century Cures Initiative, the medical device industry could see real support to keep innovation at all phases of a product’s life cycle American-made. As Congress develops its legislative agenda for this session, saving lives must be a top priority, and our voices must be heard.

Increased support for R&D of this nature would revolutionize our ability to save lives.

And, coupled with commonsense tax reform that wouldn’t saddle the manufacturing sector with a higher tax burden to finance a rate cut elsewhere, the competitiveness gap America currently has with other countries could shrink. Our most progressive trading partners are accelerating innovation at record rates, in part, because of their commitments to national manufacturing strategies – a commitment the United States does without.

Between January and October 2014, fewer than 25,000 organ transplants were performed, fulfilling just 10 percent of the need. American ingenuity and industry have proven to be up to the challenge of developing life-saving cures that could one day end the organ transplant waiting list, but they can’t do it alone. The question is: Will Congress do its part to ensure that saving lives is "Made in America?"