Why Healthcare Is Like Aviation in the 1970s
Despite a bad year in 2014, the airline industry has never been safer. The medical device industry could learn a lot from the reforms that industry has made in the past several decades.
In many ways, the aviation industry in the 1970s is like the healthcare system now. Decades ago, pilots more or less had the discretion to fly as they wanted to, sometimes downplaying feedback from air traffic controllers. Consistency among pilots was uncommon then while crashes happened all too often. Then, a horrific crash on March 27, 1977 shook things up. On that day, two packed Boeing 747s slammed into each other on the runway on the remote island of Tenerife, killing 583 people. It remains the deadliest aviation disaster in history.
The catastrophe eventually paved the way for sweeping reform in the industry—in part by instituting more standardization. Pilots internationally adopted uniform protocols. Communication was standardized as well to avoid miscommunication. English began being used more extensively as a shared language. The industry adopted a protocol known as Crew Resource Management, which made it easier for more junior flight crew to question their superiors if they spotted something amiss.
Since then, increased standardization in the aviation industry, along with an improved focus on roles and responsibilities, has made the aviation industry vastly safer. Despite the press that crashes continue to get, and the uptick in airline crashes last year, the number of commercial aviation deaths globally continues to fall each decade. The field of aviation continues to refine the protocols it uses to manage safety and they continue to work well. The annual average for the first four years of this decade had half as many air accidents as the annual average in the 1970s.
Healthcare is in the throes of undergoing a similar transition. The field is becoming more systems-oriented and less hierarchical. The notion that ‘doctor knows best’ is falling out of favor as did the idea that pilots shouldn’t be question softened in the 1970s. While physicians continue to play a vital role, more emphasis is being placed on improving outcomes and making the healthcare field more efficient.
The traditional approach to medical device design is moving in the same direction; it is becoming more integrated, more team-oriented, and more systems-based. The proverbial silos are coming down.
The most innovative medical devices demonstrate this. They are not only designed to help make the healthcare industry overall more efficient—they are themselves byproducts of a systems-based approach to product development that assumes nothing and questions everything.
Take for instance, Medtronic’s tiny Micra pacemaker, whose development exemplifies this approach. Recently winning CE Mark approval, the Micra is one tenth the size of the company’s previous pacemaker. The point of the making the device so small was not only to make it less invasive but to simplify the procedure used to implant it. The device can be implanted using a catheter and has no leads.
Like the aviation industry’s reform in the late 1970s, the key to the device’s development is how its engineers focus on how its different pieces fit together. Given a mandate to make radical changes to the pacemaker and to eschew using any components used in earlier products, the group was free to build an entire system anew. “What we decided as a technology group is that in order for us to make a major breakthrough, we can no longer afford to treat everything as a component and wire it together at the end,” says Mark Phelps, senior program director, diagnostics and monitoring at Medtronic. “Prior to that, everyone focused on their area. They focused on integrated circuit design or packaging of the electronics or the design of the electronic modules or the battery technology or the casing or leads in the case of a pacemaker.”
The development of the device wouldn’t have been possible without an increase in collaboration between the members of the engineering team. “What we had to to do to miniaturize the pacemaker was to shrink all of its components. Everything now is connected to everything else,” Phelps says. “We combined the outer case of the battery to the outer case of the device because we couldn’t afford to put it into another can.”
The key driver of the Micra’s small size is its ultra low power capability, which also created a collaborative approach to pull of. “We had to partner with our integrated circuit manufacturer to redesign some of their processes so that we can make our electronics as low power as possible,” Phelps says.
“We had to partner with our integrated circuit manufacturers to redesign some of their processes so that we can make our electronics as low power as possible. The way we had to do that was to have a deep understanding of how their processes worked,” Phelps says. “We had really good models to be able to design the integrated circuits and that partnership made our suppliers better because we are down in areas that most people don’t care about. We also see variation or any problems before anyone else does. We have become sort of a canary in the coal mine in spotting variation that no one else is looking at.”
While teamwork, standards, and safety protocols are by no means new to the medical device field or healthcare industry at large, it seems clear that both are upping the ante to deal with the pressures of healthcare reform, globalization, cost pressures, and a global epidemic of chronic disease.
Medical device professionals would be wise to look to other industries to see how they are handling similar challenges.
The field of aviation already seems to be having an influence on the healthcare field. Notice the uptick in books, training courses, and journal articles seeking to apply lessons from aviation to everything from clinical practice to surgical training.
|Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6–7, 2015.|
Like what you’re reading? Subscribe to our daily e-newsletter.