A West Michigan graduate student has designed a medical device in collaboration with Spectrum Health Innovations and clinical staff to reduce risk to patients during hospital stays.
A team of representatives from Spectrum Health Innovations, Spectrum Health clinical staff and a graduate engineering student from Grand Valley State University created a patent-pending endotracheal tube holder to address the issue of patient extubation and is now working toward finalizing a prototype.
The EV Airway Innovation was designed by graduate student Eric Van Middendorp, who was recruited by Spectrum Health Innovations to work with clinical staff and the Innovations team to develop the medical device.
Scott Daigger, innovation and entrepreneurship manager at Spectrum Health Innovations, said when patients need a breathing, or endotracheal, tube while in the hospital, it is not uncommon for the patient to pull it out or for the tube to accidentally move.
“It is kind of an unnatural situation to have a tube go down your throat. Any time the tube can move or be pulled out can cause a lot of damage to the trachea,” said Daigger. “It is a really severe incident. It is one of those events you never want to have happen for patient safety.”
Nursing 2015 Critical Care, a peer-reviewed journal, published the article “Minimizing Self-Extubation” in September 2013, which indicated the premature removal of the breathing tube by a patient can cause complications such as bronchospasm, dysrhythmias and respiratory arrest, which can result in increased length of stay and health care costs.
Although the endotracheal tube is typically secured using tape or a holder, Daigger said it relies on an adhesive or clamp to keep the tube in place, which can weaken due to the plastic material, the temperature and moisture.
“That is the problem we were trying to solve. Every time you use an endotracheal tube, there are two tabs that stick out on both sides. The invention uses an improved headgear, but then there is a part that goes over those two tabs, physically blocking the tube from getting pulled out,” said Daigger. “Essentially, it kind of makes it foolproof.”
The collaborative project began after Spectrum Health Innovations, GVSU and GR Current received funding from a Michigan Initiative for Innovation and Entrepreneurship grant in 2014.
An initiative of the Presidents Council, State Universities of Michigan, the MIIE grant helps accelerate the commercialization of university research while promoting public and private collaboration between academic institutions and private businesses.
The grant prompted the partnership to pursue the potential development of three to five projects that address current issues facing health care patients by forming teams comprised of a graduate engineering student, a graduate business student and an entrepreneur to work with clinical staff and the Spectrum Health Innovations team.
Daigger said the EV Airway Innovation was one of the projects developed.
“We — meaning Spectrum Health Innovations, along with GVSU — were discussing this partnership, and Eric was suggested by some of the engineering professors,” said Daigger. “We interviewed him and decided to bring him on board as the graduate engineer for the project.”
From January to October 2014, Van Middendorp said he worked with a master of business administration student and the Spectrum Health Innovation team on developing the medical device until the conclusion of the grant funding. Van Middendorp continued to work with the Spectrum Health Innovations team on further developing the device and raising funding by entering competitions.
“Under the grant we needed to pick three to five problems. This one really jumped out at me because a couple of months before I started working with Spectrum Health Innovations, I had a nephew who was born premature who self-extubated,” said Van Middendorp. “I was really baffled a child was able to pull out his own breathing tube.”
Van Middendorp presented the project at the Accelerate Michigan Innovation Competition in November 2014 and received $7,000 for first place in the student competition, before going on to win $25,000 as the grand prize winner of the 2015 GreenLight Business Model Competition in March.
Future financial support will help send prototypes to potential medical device manufacturers and to seek FDA approval, according to Van Middendorp.
“I might also take this through clinical trials myself,” said Van Middendorp. “By adding more value to the project, it is much easier to license it out to another manufacturer.”
With the cost of developing a medical device ranging up to millions of dollars depending on the complexity of the product and necessary degree of legal protection, Daigger said the team will continue to work with community partners, seek out grant funding and enter competitions to fund the early-stage development before partnering with a medical device manufacturer to bring the product to market.
“There has been a lot of change in health care — a lot of challenges, but I think there is a lot of opportunity to do things better. As West Michigan looks to brand itself a little bit, we are not going to be the next Silicon Valley or Boston, but I think what a lot of people agree upon is there is this strong sense of trust and collaboration,” said Daigger.
“I think this is just one of those examples of many more to come of cool collaborations that lead from just a problem we were seeing in the hospital to new products that can hopefully go out and literally impact lives.”