The act of coughing may seem annoying, but for those who can no longer cough on their own because of a medical condition, it's a matter of life and death. Today, more people are surviving brain/spinal cord injuries caused by stroke and automobile accidents. Many of these individuals are unable to cough on their own, leaving them susceptible to infection and a collapsed lung.
Defense against germs, viruses
Coughing is a critical defense mechanism which keeps our respiratory system clear of germs, allergens, viruses, mold and mucus. For those in good health, a contraction of muscles in the chest and abdomen results in a cough: a burst of about 1.5 liters of air shot out of our lungs at a high rate of speed – nearly 50 mph.
If patients, like those with a neuromuscular disease, can't clear their lungs naturally with a cough, devices are available to assist. However, many of the cough assist devices on the market today are large, costly and require electricity.
Beaumont doctor has an idea
Bassel Salman, M.D., knows a thing or two about the importance of a cough. A pediatrician with Beaumont Children's specializing in critical care, he had an idea – he would create an affordable, economical, portable device to help people unable to cough. He envisioned a simple cough assist device that required no power – meaning it could be used in both developed and underdeveloped countries. A device that could improve the quality of life for patients with a neuromuscular weakness.
"I'm a clinician, teacher and mentor, I didn't really think of myself as an inventor, but I saw a need," said Dr. Salman, a native of Syria. "Life takes you in different directions."
From concept to prototype
Dr. Salman took his cough assist device idea to the Beaumont Commercialization Center. The center, part of Beaumont Health's Research Institute, assists employees with the development of new medical products, devices and processes.
Explained, Jaideep Rajput, director, Beaumont Commercialization Center, "We oversee the development and patenting of new technologies created by our employees with the goal of bringing medical technology from idea to market to improve patient lives as quickly and effectively as possible."
The role of the Commercialization Center, housed within Beaumont Research Institute in Royal Oak, is to identify, protect, commercialize and manage intellectual property across all eight hospitals at Beaumont Health.
Examples of medical innovations developed and patented by Beaumont inventors include cone beam technology and automatic breathing control technology, both used in treating cancer.
GVSU engineering students collaborate
Rajput assisted Dr. Salman with product development, the patent process and marketing his technology. Thanks to a relationship with engineering students at Grand Valley State University in West Michigan, they collaborated to produce a prototype of a cough assist device that was affordable and portable. With input from Dr. Salman and the guidance of John Farris, Ph.D., professor of Engineering at GVSU, four undergraduate students produced a prototype that was mechanical, economical, effective and easy to use.
"The students – all juniors, in our Product Design class learned the importance of starting with ideas. They worked as a team to problem-solve and did extensive research," explained Dr. Farris. "Working with Dr. Salman, the group was able to apply what they learned from materials and books from a wide range of courses."
The students studied cough assist devices currently on the market – most cost between $6,000 and $12,000 and require a power source. They succeeded in creating a device that was low cost, powered by a foot pump with the equivalent therapy to current devices. Foot pressure replicated inhaling and exhaling. The entire project, including 3-D printing, cost just under $800. The prototype cost under $300.
How does it work? After the tubing and mask are fitted to the patient and connected to the device, the caregiver places their foot on the top of the machine and like a bellows foot pump steps or pushes down to generate positive pressure. This is done while watching the pressure manometer to assure a safe pressure. The caregiver then releases their foot, creating negative pressure which dislodges and removes secretions from the respiratory tract much like a cough.
Said Dr. Farris. "The collaboration with Beaumont is a big deal – both for Grand Valley State University and our students."
Patent, licensing agreement
The Beaumont Commercialization Center's Rajput worked with a market research company to identify potential commercialization routes and a patent analysis followed. Rajput then filed for a patent on Dr. Salman's device in August 2017.
Rajput also helped negotiate and execute a license with TechBank Medical, a Shanghai-based medical commercialization organization.
"This device is especially attractive to us, as it falls precisely into our strategy," said Brad Yang, founder and CEO of TechBank Medical. "We think the market potential for COPD is huge along with the opportunity to dramatically improve the quality of life for those with COPD. For developed markets, like the U.S., this technology will provide a truly portable device that is small, lightweight and does not require electrical power. For developing markets, like China and India, the design allows for those previously unable to afford a cough assist device to finally get relief from their disease, as the technology has a simple and low-cost design."
Yang said TechBank Medical recently completed their first prototype of the device in China. Next, they will work on product refinements, then conduct clinical research to study the effectiveness of the device.
"If everything works well, we look to get CFDA approval by the end of 2019 and introduce the product throughout China," explained Yang. "We will move quickly to secure CE and Food and Drug Administration approval and bring the device to the global market."
Potential to improve patient care
Rajput emphasized there is always an element of risk in developing new medical devices. The Beaumont/GVSU device has the potential to improve patient care, advance innovation, impact patient lives and address clinical needs.
Now seniors, three students – Jake Stephens, Jordan Vanderham and Sam Oostendorp shared their thoughts about developing the prototype.
Jake: "It's incredibly gratifying to see your hard work turn into something that has the potential to change the lives of people fighting a broad range of diseases around the world."
Jordan: "This project makes me look forward to a long career of solving problems that make a positive difference. The experience was a 10 out of 10."
Sam: I was thrilled to have the opportunity to work with such a talented team in solving this problem. It is very rare for a student's project to receive a patent, let alone seeing it go onto becoming licensed."
Thinking globally and inventing locally
The cough assist device has the potential to improve patient care – an example of Beaumont innovators thinking globally and inventing locally.
Said Dr. Salman, "I am hopeful this device will impact patient care by offering patients worldwide a better quality of life by decreasing the cost of more intensive therapy."