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At any given time, 33 percent of patients in hospital intensive care units and 9 percent of all others are physically unable to use a standard nurse call button.
In addition, many cannot speak because of a breathing tube and/or paralysis.
This lack of communication can lead to costly common medical complications such as adverse reactions to medications, aspiration pneumonia or pressure ulcers.
A Coralville company, Voxello, has developed the 'noddle,' a device that enables patients, doctors, nurses and other caregivers to communicate using sensors, a tablet-size computer screen and text-to-speech software.
'With just a tongue click, a patient can call a nurse and communicate what they need,' said Rives Bird, Voxello CEO. 'A tongue click is a very typical response that a patient who is paralyzed or unable to speak will use to get someone's attention.'
The noddle, which a patient can use to control up to three devices, received U.S. Food and Drug Administration clearance last month.
A typical medical device clearance can take up to 120 days. Voxello's submission was reviewed and cleared by the FDA in 78 days.
The FDA action paves the way for a soft product launch in Chicago and Philadelphia in advance of making the system commercially available to hospitals and patients.
Voxello was founded under the Iowa Medical Innovations Group program at the University of Iowa. The program brings together students in medicine, business, law and engineering to 'commercialize solutions to medical problems identified by clinical staff and faculty,' Bird said.
The noddle began with professor Richard Hurtig, who as chairman of the UI Speech and Communications Disorders Laboratory was selected to mentor an Iowa Medical Innovations Group team.
'The noddle is really his brainchild and led us to what Voxello is today,' Bird said.
'Plug and play'
Hurtig was approached in 2013, after he had been developing individual custom patient communication devices at the request of doctors and nurses at the UI Hospitals and Clinics.
'In order for this kind of technology to work, it has to effectively be plug and play,' Hurtig said. 'It has to be something that is not difficult for patients to learn and use.
'You also don't want something that requires all sorts of fiddling and calibration because that would provide extra work for nurses setting it up.'
Hurtig said the noddle 'learns' the tongue click, slight finger movement, eye blink or other voluntary patient gestures and adjusts for sensitivity.
'The noddle knows what kind of sensor has been plugged in and applies the correct signal processing strategy to detect the sound or gesture,' Hurtig said. 'An intensive care unit can be somewhat noisy at times with alarms going off, a door closing or people talking. The code in the noddle is designed to detect the correct sound in the background of that noise and ignore everything else.'
For short-term stays
Bird said the noddle system uses text-to-speech software created by Saltillo Corp., a Millersburg, Ohio, developer of assistive technology for adults and children with communication disabilities.
'We took one of Saltillo's products, NOVA Chat, and now it's Noddle Chat,' he said. 'NOVA Chat is designed for long-term care patients. We have stripped it down and reduced the number of features for someone who typically will be a patient in an ICU for three or four days.
'If we have a patient with a spinal cord injury who is going to be in rehabilitation for months, we can graduate them to the additional features of NOVA Chat.'
Hurtig also is working on a bilingual version that will use the patient's language on the tablet display and 'speak' to caregivers in English. When a nurse, lab technician or doctor needs to communicate with the patient, their request in English will be translated into the patient's language.
A ready market for Voxello's noddle system — manufactured in Mankato, Minn. — was created in 2012 when the Joint Commission, the not-for-profit accreditation and certification body for the health care industry, mandated that care facilities provide an effective means of communication for patients who cannot verbally communicate.
Bird, a 20-year veteran of the medical device industry, said the noddle system is expected to sell for about $3,000 per unit to hospitals.
The sensors, which are designed for single patient use, will cost about $100 apiece.
In 2008, the federal Centers for Medicare and Medicaid Services ruled hospitals cannot bill patients or seek reimbursement from their insurer for the higher costs of treatment when preventable adverse events occur.
'We already have statistically significant feedback that the noddle improves patient satisfaction,' Bird said. 'We also are collecting preventable adverse-event data, which requires a lot more patients to reach statistical significance.
'So far, we have had no preventable adverse events.'
Bird said Voxello will gather additional information from clinical trials at Thomas Jefferson University Hospital in Philadelphia that treats many spinal cord injuries and has a 900-bed ICU, the University of Wisconsin, New York University and a consortium of Washington University, Barnes-Jewish and St. Louis Children's Hospital in St. Louis.
Company to expand
Founded as Iowa Adaptive Technologies, the company changed its name to Voxello in June 2015. It signed an exclusive licensing agreement with the UI Research Foundation that same year.
Voxello has raised $500,000 in grants and $800,000 from private equity investments. Bird said the company expects to open a $5 million round of equity financing as early as this month.
It employs a staff of five, but Bird noted that number is expected to grow fairly rapidly as the company adds administrative, engineering and sales employees. With headquarters in the UI BioVentures Center at 2500 Crosspark Rd. in Coralville, Voxello also will need to expand into larger quarters in the near future.
You can watch a video demonstration of the Voxello device at http://urltrim.co/2caooc.