The medical device industry faces a pivotal moment.
The industry, born in garages of the American Midwest, sorely needs a larger-than-life leader who can innovate while facing a host of headwinds in the form of globalization and the new healthcare law (whose fate now rests with the U.S. Supreme Court).
In American history, four figures have emerged to have their visages forever etched on the mountains of South Dakota. The Mount Rushmore National Memorial is not only a homage to four stalwart presidents. It is also a testament to American ingenuity.
Now imagine a Mount Rushmore Medical Device Memorial. Which Americans could replace the iconic figures of Washington, Jefferson, Lincoln and Teddy Roosevelt, and provide inspiration for generations to come?
Here’s my favorite foursome. Tweet yours to @medcitynews or comment below.
Earl Bakken
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
No tribute to the medical device industry can be complete without a nod to Bakken. Bakken (1929 – present) developed the first battery-operated, transistorized, wearable artificial pacemaker in 1957, thereby cementing his and his company’s (Medtronic) place in the annals of the medical device industry.
He and his brother-in-law founded Medtronic in a garage in northeast Minneapolis to repair medical equipment. But their interaction with Dr. Walt Lillehei at the University of Minnesota hospital led them to design an alternative to the large, external pacemakers which Lillehei used to stabilize children following corrective heart surgery.
And thus the paperback book-sized pacemaker was born.
Dr. Royal Copeland
Copeland (1868-1938) was a three-term Democratic senator from New York and the primary author and sponsor of the Federal Food, Drug and Cosmetic Act of 1938, which brought the market for medical devices under regulatory control for the very first time. (More comprehensive device regulation and definition followed in 1976.)
And love it or hate it, the bill ushered in a new era of government as gatekeeper in protecting the nation’s well-being. The U.S. Food and Drug Administration’s Center for Devices and Radiological Health through which all medical devices win clearance and market approval traces its origins to the passage of the FDCA.
It comes as no surprise that Copeland should be its sponsor. He was a physician who was acutely aware of public health issues. He was a health commissioner of New York City and the president of New York Board of Health. It was during his stint as New York City’s health commissioner that he became sympathetic to the FDA. But apparently he ended up not seeking the FDA’s input or that of the original sponsor in crafting the compromise bill that ultimately became law. He died four days after the FDCA was passed.
Copeland, who became a U.S. senator in 1922, was recognizable by a red carnation which he once described as “an emblem of therapeutic perfection.”
Willem Kolff
It’s no joke. Sausage casings can actually saves lives. That was one of the elements that Dutchman Willem Kolff (1911-2009), who immigrated to the U.S. in 1950, used to build the original kidney dialysis machine in wartime Holland.
But Kolff is not only known as being the foremost innovator in hemodialysis. He is also a pioneer in the field of artificial organs and is known as the father of artificial organs, having developed the first artificial ear and eye, and inspired the first artificial heart.
An inventor for life, he is also credited with building the the intra aortic balloon pump and making an important contribution to the development of the heart-lung machine while at Cleveland Clinic. Later he went to the University of Utah, where Kolff was a distinguished professor emeritus of bioengineering, surgery and medicine, until his death.
Kolff, who won numerous awards recognizing his contributions during his 97 years, had the quintessential trait of a visionary and innovator — in the pursuit of improving the human condition, he was able to imagine the impossible through the possible.
Dean Kamen
Nearly 26 million children and adults suffer from diabetes in the United States, and to many of them the insulin pump is indispensable.
For that handy medical device, they have to thank a prolific inventor Dean Kamen (1951 – present), popularly known for the invention of the Segway PT, an upright, single-person electronic vehicle that has become a staple tool of law enforcement.
When Kamen was an undergraduate, he invented the first wearable drug infusion pump, which became the basis for his later invention — the first wearable insulin pump for diabetics. In 2000, Kamen was awarded the National Medal of Technology.
But Kamen is not simply a tech aficionado content to be the owner of numerous patents. He has made it his life’s mission to expose children to science and engineering to inspire them to become great innovators themselves. With that aim, he founded FIRST — For Inspiration and Recognition of Science and Technology — in 1989. The organization spawned the FIRST Robotics Competition, an annual competition in which high school students are paired with mentors — teachers and engineers — and charged with designing and building robots.
