“I work as if I were going to be the next person to need a respirator. I share in the benefits I bestow on others, and my work has enriched my life."
~ Dr. Forrest Bird
Inventor of the world's first mechanical ventilator
Even during pandemics, I stand by my claim that 99% of the time its small, simple ideas that have the greatest capacity for growth and power to the change the world.
Simple ideas continue to shape our ordinary life, including patented inventions like the Toothpick, Toilet Purifier™, Post-it Note®, , The Coffee Sleeve®, Spanx®, Blue Jeans®, Slinky® and D-Help®, a surgical anti-fogging tool that earned my client over $100 million dollars when he sold his medical startup to a medical giant.
When Dr. Bird, quoted above, invented the patented mechanical ventilator shortly after World War II, his prototype did not consist of microprocessors, transistors, and advanced software that now power the lifesaving machines that are in perilously short supply in today’s hospital operating rooms.
Instead it was a makeshift device composed of three strawberry shortcake tins and a metering device.
It exemplified the legendary characteristics of the today’s “garage inventors” who are changing the world.
Breathing Life Into Ventilators
At first this Victorian-Era-flavored device performed poorly and received little fanfare.
Yet after several years of tinkering, his patented mechanical devices grew in sophistication and functionality until “Babybird” reached commercial maturity. It would reduce infant mortality due to respiratory problems from 70 percent to less than ten percent.
Other ventilator products, aimed at adults, would produce similar results.
He did not live long enough to witness and experience the current
COVID-19 pandemic which has put his patented technology in such high demand.
He would have been shocked and dismayed to see the terrifying impact of an airborne virus that attacks our lungs and inhibits natural breathing, especially in our older communities.
And yet I can also imagine the pride, joy and energy that would flow through his veins as he witnessed the tidal wave of creativity emerging to combat an invisible enemy.
This is happening at just about every level of American life and includes NASA, government, medical device manufacturers, titans of industry, and ordinary independent, garage inventors who form the bulk of my client base.
In many ways it mirrors the efforts put in by ordinary people and commerce during (and after) World War II, a period in which Dr. Bird pioneered breakthroughs in aviation breathing apparatus.
As Sun Tzu said in the Art of War “in the midst of chaos, there is also opportunity”, perfectly describing the revolution underway in healthcare during the COVID-19 pandemic.
Since ventilators play such a critical role in the management of patients with severe respiratory illness, such as COVID-19, there is a laser-like focus by government and industry to find solutions to mass producing a viable ventilator.
This includes President Trump invoking the Defense Production Act (DPA) to compel General Motors to switch lanes and manufacturer them on a giant scale.
NASA Enters Ventilator Space
Or the stellar news that NASA has developed a new ventilator aimed specifically at coronavirus.
Incredibly, it took the space agency just 37 days for its team of engineers to produce Ventilator Intervention Technology Accessible Locally (VITAL).
While modern ventilators are incredibly complex – less mechanical and more computer-like – the NASA team decided a more simple, elegant approach was required.
Their prototype uses one-seventh the number of parts required for a conventional ventilator harkening back to the first prototype that Dr. Bird produced decades ago.
The problem solvers at NASA hope that VITAL will decrease the likelihood patients will experience the more dangerous stages of COVID-19 and require more advanced ventilator assistance.
It also means NASA’s device will retail at no more than $3000 in the marketplace. If this sounds expensive, consider for a moment that traditional ventilators may retail for $30,000 or above.
This represents a 10x reduction in cost and complexity which should motivate all medical inventors to re-think the way medical products are built and manufactured in the United States and abroad.
Dyson Joins The Fray
If you think 37 days to build a prototype is impressive, consider Dyson’s entry into this space.
The household name typically associated with vacuum cleaners recently announced it had produced its first prototype in the space of 10 days!
Several days later, it confirmed that 10,000 new critical care ventilators would be ready shortly for local markets.
The speed of innovation described above is truly astounding, similar in feat to manufacturing planes and warships during World War II. Or the remarkable achievement of putting man on the moon during a few short years of determined innovation.
Yet it would be a mistake to think that this flurry of inventing is solely limited to the rocket scientists at NASA or the smart engineers at Dyson.
The Average Joe Inventor
Average Joes are throwing themselves into the pandemic battle, launching elegant and simple products that are not only saving lives but making blue chip companies stand up and take notice.
This includes an enterprising mom and pop operation run by Chris Austin in Texas, who is making a name for himself with helmet-style ventilation devices.
His company, Sea-Long, has drawn attention for his hoody helmets whose original purpose was to supply oxygen to patients receiving treatment in hyperbaric chambers.
Once the pandemic hit, countries like Italy repurposed the helmets to serve as simple alternatives to current mainstream ventilators.
Priced below $500, this crafty entrepreneur has outmaneuvered NASA in producing an even cheaper and simpler alternative to the expensive models that dominate the marketplace today.
Additionally, patients find the helmet more comfortable and less invasive than the oxygen mask typically associated with medical emergency ventilators.
Some studies suggest it may even offer better survival rates.
To meet demand, this tiny company is gearing up to produce 50,000 helmets per week if a second wave of COVID-19 makes its appearance.
Going Open Source
The pandemic has literally fueled a renaissance in healthcare innovation, eliminating government red tape and enticing cross-disciplinary partnerships between startups, entrepreneurs, inventors, government and big business.
While in the past huge divisions existed, a new landscape has opened up that's truly OPEN SOURCE.
In rare displays of goodwill and compassionate capitalism, companies like Medtronic, are giving full public access to the design specs and software code that make up its Puritan Bennett (PB) 560 portable ventilator hardware.
Smaller than typical ventilators and portable, it provides airway support for both adults and children. The mobile nature of the ventilator allows the device to be used at home or other non-hospital settings.
“By openly sharing the PB 560 design information, we hope to increase global production of ventilator solutions for the fight against COVID-19,” said Medtronic.
The $100 Millon Dollar Patent
By the way, Medtronic is the same company that previously purchased one of my client’s healthcare startups for over $100 million. The sale was motivated by the underlying intellectual property relating to D-Help, a surgical tool developed by my client.
Other startups are embracing the open source revolution in medical ventilators, too, including engineers and scientists in MIT, Israel and Morocco.
Their approach would surely bring a smile to Dr. Bird, since they take an even more basic and ingenious approach to solving the ventilator shortage.
Further, it expands on a product that was invented around the same time period as Dr. Bird’s ventilator: The Ambu bag®.
In 1956 Holger Hesse in partnership with an anaesthist, Henning Ruben, launched the world’s first ventilation bag, Ambu.
The patented reusable self-inflating resuscitator is still a considered a milestone in medical equipment. It allows emergency services team to manually push air into a patient’s lungs by compressing the bag.
The hand-held device includes a flexible mask and filter (and valve) to prevent backflow into the bag. It has saved millions of lives since its exception decades ago.
His tiny medical startup expanded at a rapid pace becoming one of the most dominant companies in medical care. His product line would eventually encompass other medical device areas including endoscopy, neurology and cardiology.
The current shortage in more sophisticated computer-driven ventilators has accelerated interest in automating the operations of the Ambu.
The MIT Solution
MIT first posed the question: Is it possible to safely ventilate a COVID-19 patient by automatically actuating a manual resuscitator?
Many years before the pandemic hit U.S shores, MIT had been focused on the challenge of extending the capabilities of Hesse’s Ambu bag, especially for remote locations and hospitals in developing nations.
In particular, MIT was drawn to a medical emergency that had taken place some time ago in India:
The Indian Patient
A 30-year-old farmer admitted to a local hospital developed paralysis and was unable to breathe on his own. Modern mechanical ventilators were not available, but the hospital did possess a bag-valve mask (or Ambu bag) that they could use to force air into his lungs.
Over a period of 18 days, the farmers family – including mother and brother – took turns squeezing the medical hand pump to push air into the farmers lungs until a more sophisticated ventilator became available.
Thirty days later the patient recovered fully and was sent home. .
“This is thought to be a record for the length of time a person has been kept alive by manually operated ventilation, and it underscores the need for simple, inexpensive, widely available equipment that could do the job without requiring such extraordinary and heroic efforts,” said MIT.
In 2010, MIT went to work on designing and prototyping a low-cost portable mechanical ventilator that could be used in during times of emergency, including natural disasters or pandemics. Their simple approach encased the pump in a plastic box with a battery, motor and controls, thereby replacing the manual tasks of squeezing the bag with an operator hand.
At the time, it was believed the prototype could be mass produced for less than $200, a fraction of the cost of modern mechanical ventilators retailing for around $30,000.
MIT issued a prescient comment regarding the utility of the ventilator:
It’s likely there would be millions of cases worldwide that could benefit from such a device. In addition, a U.S. government study in 2005 found that in a worst-case pandemic scenario, this country alone might need more than 700,000 mechanical ventilators, while only 100,000 are now in use.”
Unfortunately, while the team did file for a patent, further testing, development, manufacturing and licensing were put on ice for unknown reasons until COVID-19 began to infect millions across the globe several years later.
The shortage of ventilators again prompted MIT to revisit the original project and formed a team called MIT E-Vent (for emergency ventilator) to deal with the huge influx of inquiries relating to the original design.
Like Medtronic, they adopted an open source approach to mass production and published all clinical and design specifications online for anyone to use. MIT hopes the creative sharing of technology will support rapid scale-up of device production to alleviate hospital shortages.
The 10-Day Israeli Prototype
Another startup in Israel has followed a similar approach.
Inspired by the bag-valve mask ventilators used extensively by paramedics, an Israeli group made up of Air Force electronics experts, robotics specialists, and medical professionals have launched an emergency ventilation system called Ambo-Vent-1690-108.
Incredibly, it took the team only 10 days to build the first prototype using the motor of a snowblower as a central lynchpin to drive the device. They then released the $500 device to open source platform, GitHub, to allow anyone universal access to the device schematics and source code.
It also included instructions on how to assemble the ventilator. Around 20 prototypes were produced which have been sent to national regulators around the world in an effort to fast-track approval.
Morocco's Ventilator Project
A similar project is underway in Morocco where the startup, STM Loop, has built a custom automated ventilator. In tandem, a local company called OK Design is also collaborating with the inventors to manufacture the device on a mass scale.
The cost to produce one device is said to be around $200 again highlighting the accelerated pace of innovation that’s driving down prices for rudimentary-to-intermediate ventilators across the planet.
The pandemic is compelling society to become problem solvers in record time. In some instances, devices have been crafted in less than two weeks, a feat that seems impossible in our typical slow-moving healthcare environments.
The prototypes are simple in nature, using less parts and offer huge potential for scalability.
In fact, they all seem to borrow an insight from Leonardo Da Vinci who once stated that “Simplicity is the ultimate form of sophistication.”
This approach is not limited to ventilators – entrepreneurs from non-related sectors are racing into the field to disrupt traditional approaches to Personal Protective Equipment (PPE).
A Simple Shield
This includes a print labelling company in Grand Rapids, Meta, who used their experience in the lamination, die-cutting and 3D printing sector to launch a new startup, called Simple Shields®.
The patent-pending face shields gives healthcare workers 360-degree protection, covering the eyes and neck and shielding the wearer from air particles and droplets.
After a few hiccups using 3D printing to produce traditional shields, the inventors decided to simplify the process and make the design mimic the contours of a lamp shade.
It's a simple, sleek design!
They claim to able to print over 60 face shields per second making their PPE solution repeatable and mass producible.
The company hopes that local groceries stores will one day carry the product and plan to donate 50,000 shields to local hospitals over the coming months.
If a second wave of COVID-19 hits the United States, outreach efforts like this will become invaluable to local healthcare institutions and businesses.
The Golden Age of Inventing
While the pandemic has darkened our health and economy, it has not killed the entrepreneurial light of ordinary Americans who work in large medical companies, small healthcare operations, government, regulatory bodies and space agencies.
Or those small, independent inventors work out of their garages late at night as they tinker with new ideas that could change the world.
Or the startups that are brainstorming new ways to build ventilators more simply and cheaply.
In many respects, there has never been a better time to be a medical inventor. COVID-19 and the pandemic has forced governments to cut red tape and fast-track new ideas to the marketplace.
Additional financing opportunities have also been lined up for smaller inventors.
Famous ventilator product lines are being open sourced, allowing entrepreneurs to find new ways build these lifesaving machines more quickly at lower prices.
There is a cross-disciplinary spirit emerging in the marketplace sucking in a new generation of inventors itching to transform the healthcare space.
Old ideas are being revisited, reshaped and re-imagined.
They are being turned into novel and non-obvious incantations which will find favor with the United States Patent Office.
Even if the pandemic subsides, we all need to prepare for the next one.
Since the coronavirus emerged, a wildfire has spread through the American entrepreneurial landscape burning down stale ideas and replacing them with bold new innovations that are disrupting slow-moving medical arenas, including emergency ventilators.
It’s a landscape that would have excited Dr. Bird.
Without doubt, had he been a medical entrepreneur during this pandemic era, his first ventilator machine would have been produced in days, not years.
Take inspiration from his journey and the ones described further above: America needs YOU, the small, independent inventor to throw yourself into the fray and contribute your world-changing PATENTED idea to help win the fight against this global pandemic.
John Rizvi, Esq.
The Patent Professor®
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