UltraEzAir®️ is a medical device intended to eliminate the reflex gagging and coughing caused by inhaling liquid-lidocaine anesthesia during examinations of the larynx. This innovation delivers lidocaine as a mist that is quickly absorbed by throat tissue, resulting in a safer, more comfortable patient experience.
Dr. Blake Simpson is gearing up for a laryngeal exam, but there’s one part he’s not looking forward to – the anesthesia phase, also known as “the drip.” He knows that this step usually comes with discomfort, coughing, and the patient’s reflexive gagging, making it a less than pleasant experience.
The exam itself involves inserting a slim 5mm tube through the patient’s nose and down their throat, allowing a fiber-optic camera to capture a view of the larynx. However, this seemingly routine procedure can be a source of stress, discomfort, and potential harm to the delicate throat tissue.
Unfortunately, Dr. Simpson’s patient and friend, John Houston, has had his fair share of tough examinations. Despite the challenges, Dr. Simpson’s empathy for his patients and his desire to push the boundaries of medical knowledge have led to a unique partnership with John Houston. Their joint efforts are focused on making patient care better and tackling the issues head-on.
In this collaboration, Dr. Simpson and Houston are driven by a blend of compassion and a practical determination to improve the way things are done. Their journey highlights how shared experiences can foster innovation. Together, they’re taking steps to address the discomfort patients like Houston face, with the goal of making medical procedures a bit more bearable for everyone.
With help from The Realtime Group, John built a prototype that would revolutionize the exam. Would it work as well as they both hoped it would? Upon its first trial run with John, Dr. Simpson could tell this prototype had promise. Immediately in the first few moments of the exam, he saw something was different. The once ineffective, gag-causing drip of Lidocaine was replaced with the muscle-soothing continual mist emitting from the odd-looking device. Gone was the coughing and pain, present was an exam that was painless, comfortable, and thorough. He envisioned all of the previously pained faces of his patients, replaced with joy by this new machine. With relief he blurted out “That’s Bad Ass!” …And it is.
Each year, over 30 million Americans experience a problem with their voice. Before a medical professional can diagnose the issue by conducting an endoscopic examination, what follows is what many patients liken to a sense of drowning―dripping Lidocaine down their throat to numb the area. It leaves patients choking, gagging, and coughing. What’s worse, it often prevents them from seeking additional treatment and poor utilization using the drip method can often cause patients to require multiple appointments or be subject to general anesthesia to receive a thorough exam or treatment.
Enter AirKor’s UltraEzAir, a medical device intended to eliminate the reflex gagging and coughing caused by inhaling liquid-lidocaine anesthesia during examinations of the larynx. This device delivers Lidocaine as a mist that’s quickly absorbed by throat tissue, resulting in a safer, more comfortable patient experience.
Realtime took the vision of inventor, John Houston, from a sketch and prototype to a valuable final product within just a few months – thus creating a device that works with existing laryngoscopic instruments to deliver a radically better patient experience.
Realtime’s full spectrum of product-design specialties and experience was leveraged to ensure product functionality and rapid time-to-market.
Solutions provided include:
The development process included assessing the medical and electrical systems for the original prototype as well as the assembly and other modifications. Realtime engineers worked on mounting components as well as modifications to the circuit boards and cable assembly for UltraEzAir to properly function. The biggest component in the development phase was the delivery method of Lidocaine from the UltraEzAir system. It was critical the proper amount of nebulized Lidocaine is distributed to the patient to ensure ease of pain during the procedure.
Realtime provided the mechanical prototype of the UltraEzAir system including all electronics, injection molded plastics parts, internal working components, performance test records, and regulatory guidance for providing all documentation for the FDA 510(k) submission.
Because the device must work with >95% of laryngoscopes on the market, it was important to craft the correct disposable component configurations in testing. These testing developments included airflow, environmental testing, mist quality, nebulization, the effectiveness of stream, and FDA testing.
Several tests were performed for full functionality to confirm UltraEzAir met all customer-defined requirements. These tests included EMI/EMC testing, environmental testing, mist quality testing, labeling/packaging, and usability.
This project is a huge success for our team here at Realtime, however, it wasn’t easy getting here. Realtime faced a couple of challenges including programmatic issues, technical difficulties, and ensuring every usability test was in compliance.
Since AirKor is a medical device startup, funding has been tight from the beginning, so developing a 510(k) ready device within the available funding profile has been the biggest challenge. It was crucial to Realtime and AirKor to make sure funding was secured during the process, all while minimizing the impact on the schedule. This forced very high efficiency within the team in the completion of development tasks but also greatly extended the timeline to completion.
Crafting an attractive design that meets all of the design and compliance requirements within a particular COGS (Cost of Goods Sold) was a major challenge. This project was completed during the COVID-19 pandemic era, so vendor support and supply chain issues greatly affected our ability to complete the design and development and build the devices. Clinical advisors were exceptionally difficult to coordinate meetings with due to their high demand on the front lines of the COVID-19 battle.
Realtime executed over 30 Usability Studies with actual potential customers in their clinical use environment to ensure the Industrial Design and performance of the UltraEzAir is intuitive, easy to use, and meets the user’s needs in a clinical environment. Our usability experts crafted protocols, moderated study sessions and reported on the final Human Factors Validation testing, ensuring the final deliverables were compliant to IEC 62366 and FDA regulations.
Realtime is passionate about engineering solutions that enhance people’s lives. With its ability to improve the experience and outcomes for medical patients, the AirKor concept invoked Realtime’s dedication to that mission. Currently, doctors sometimes forego laryngoscopic exams when they believe their patient won’t tolerate the procedure, which then forces them to rely on alternative – and often less-reliable — methods. By improving the patient experience and eliminating discomfort in the larynx, UltraEzAir will increase the frequency that today’s most-reliable laryngoscopic procedure is chosen. Patients will be able to have a comfortable procedure while shortening exam times.
No other laryngoscopic devices exist that transform lidocaine from liquid to mist in real time, making UltraEzAir a true innovation and disruptive technology in its field. The result is an affordable, producible device that will qualify for insurance reimbursement and has high FDA-approval potential!
Realtime’s UltraEzAir design was hailed as a top medical innovation at the 2017 Fall Voice Conference, an annual event focused on the clinical care of patients with voice-related difficulties. Since then, over 10 medical institutions and university systems have volunteered for clinical trial testing. The prototypes have been rigorously tested at The University of Texas Health Science Center for the last 14 months and have performed flawlessly. AirKor’s 510(k) filing for the FDA is on-track and approval to market the UltraEzAir is expected to be received in late-2023. It is also on track for initial availability in Q1 2024, with full-rate production by mid-2024.
The UltraEzAir system will continue on its development path by completing the FDA 510(k) submission and continuing the production of units for sale in the medical US market. New ideas are already being considered for the next revision of the UltraEzAir system.
UltraEzAir is an Edison Award-winner for patient examinations and assessments. Realtime leveraged our full spectrum of product-design specialties and experience to ensure product functionality and rapid time-to-market for this revolutionary medical device.