An excerpt from The Physician Inventor: The Doctor’s Handbook to Patenting Medical Devices and Methods.
Recent New York Times articles document the growing concern that the United States will not have enough ventilators to fight the coronavirus pandemic. In one article, it is estimated that the state of New York may be thousands of ventilators short.
At the outset, let’s agree that no one really knows what will happen. We don’t know whether social distancing efforts will be enough to flatten the curve and keep the number of patients at a manageable level. We also don’t know whether increased testing will be enough. There is also a lot of speculation on how temperature and humidity will affect the infection rate. I wish to offer a word of encouragement and place my bet, so to speak.
I believe the breakthroughs are coming. I will use the example of ventilators to make my point, but the breakthrough could happen in other unexpected ways. Perhaps the breakthroughs will happen in a different field altogether that will reduce the number of hospitalizations or ventilators needed. I speak as a layman on this subject, but I will note three observations that I see in my field of expertise—medical device innovation.
First, breakthroughs are made when there is no other way. In trying to understand the ventilator shortage, I came across an old story of a 25-year old Chinese man who was paralyzed from the neck down in a motorbike accident and left unable to breathe unassisted. His family kept him alive for five years by taking turns squeezing a homemade resuscitator bag hundreds of times a day. That is 18 times per minute every minute for years. Their hands were deformed from the efforts. Eventually, his younger brother built a homemade DIY ventilator, which they used when they could afford the electricity. Finally, a large company heard the story and donated a ventilator to the family.
Second, breakthroughs are made when specialists share their experience with one another. An emergency medicine doctor shared an article with me about a way to split a ventilator to provide titrated support to multiple patients. There is also a YouTube video by doctor Charlene Babcock in which she discusses how to do this should the need arise, and the factors to consider when attempting to do this in an emergency. The rapid exchange of information of the past few days is unlike anything else we have ever seen.
Third, breakthroughs are made when hobbyists, amateurs, and technicians of different disciplines converge on a single problem. There are multiple open-source projects aimed at 3D-printing all or parts of a ventilator. When Italian doctors recently ran out of a certain $11,000 valve, volunteers printed replicas for $1. There are attempts to jerry-rig continuous positive airway pressure (CPAP) machines. It may not be pretty, but simple solutions can get us through the bottleneck and lay the foundation for future technologies.
Because all three factors are present, I believe that breakthroughs will be made in the coming weeks. Some will pray for a divine miracle. Others will place their hope in human ingenuity. I believe that human ingenuity is itself the miracle, and I bet we see it soon.
Peter D. Sleman is an attorney. He is the author of The Physician Inventor: The Doctor’s Handbook to Patenting Medical Devices and Methods. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
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