Medical research indicates that nearly 93% of children in America suffer at least one middle ear infection, which is severe enough to see a doctor. Most will suffer repeat occurrences, up to a dozen or more in childhood. These painful episodes are difficult for children, parents, and caregivers. Accurate diagnosis of middle ear infections (Otitis Media) in infants and young children may be difficult. Besides, a middle ear infection is the main reason behind surgery in children and for which antibiotics are prescribed to children. Clinical studies show diagnostic error rates averaging 50 percent, particularly in the key differentiation of whether or not to prescribe an antibiotic.
Taking this dilemma into consideration, a medical device company, OtoNexus Medical Technologies came into existence to improve the diagnosis and treatment of infections of the middle ear (Otitis Media), by developing the world’s first medical device to provide objective diagnostic data for children and adults.
Headquartered in Seattle, WA, OtoNexus is a technology innovator developing the first ultrasound-based medical device to allow clinicians to instantly assess middle ear infections and determine when and when not to prescribe antibiotics. It was started with a goal to decrease the unnecessary prescription of antibiotics for middle ear infections by 50%. With its simple and elegant device, the medical technology leads to better outcomes in differentiating when and when not to prescribe antibiotics and significantly reduced healthcare costs.
A Complete Novel Idea behind Inception
The ingenious minds behind OtoNexus are Dr. George Gates, Chief Medical Officer, and Dr. Mark Moehring, Chief Science Officer. After caring for children for over 40 years, Dr. George Gates was determined to find a better way to diagnose the problem of middle ear infection and treat these children. He was frustrated with the lack of accurate tools for the diagnoses and the resulting over-prescription of antibiotics. He met Dr. Mark Moehring, the inventor of transcranial Doppler ultrasound. They thought ultrasound technology was a potential solution, given it is a highly accurate, well-known, and safe technology.
To make this a reality, they had to overcome a significant technical challenge: using ultrasound technology without gel coupling. This had never been achieved before, but in the case of middle ear assessment, it was critical to success. You can imagine, it is entirely impractical to put ultrasound gel into a child’s ear and then remove it when the examination is complete.
It took several years of research to achieve this breakthrough. This success is significant because it creates a technology platform for other applications in medicine and industrial applications. As a result of the vision of Dr. George Gates and Dr. Mark Moehring, OtoNexus has created the first and only device to identify both the presence and type of effusion behind the eardrum. This gives physicians the data they need to determine when antibiotic therapy is appropriate.
Solving the Problem of Unnecessary Antibacterial Therapy
Current tools for assessing acute otitis media are decades old and only provide an accuracy of 50%. As a result, patients are often given ineffective treatment and are referred to specialists more often than necessary. Another concern is that unnecessary antibiotic use can cause side effects and drive the development of antibiotic-resistant strains of bacteria. The inexpensive, handheld OtoNexus device is designed for primary care and looks like an otoscope. But that is where the similarities end. The OtoNexus device analyzes the presence and type of fluid behind the eardrum within 2 seconds. It provides data that can be shared with patients and parents to communicate appropriate antimicrobial therapy.
Moreover, the OtoNexus device will provide clinicians around the globe with the information they need to accurately identify when antibacterial therapy is appropriate and when it is not. Its goal is to reduce the prescription rate of antibiotics for middle ear infections by 50%. It has a shared purpose with the stakeholders to improve clinical outcomes, decrease healthcare costs, and advance antimicrobial stewardship through the appropriate use of antibiotics to combat the development of drug-resistant bacteria or super-bugs, which benefits humanity.
A Customer-Oriented Approach
OtoNexus’ novel technology is heavily patented and protected. It provides critical data for the customers that is unobtainable by other technologies or tools. The organization developed this device after listening to its customers’ needs and designing it to fit perfectly into their workflow, creating a highly desirable and easy-to-use tool.
The company will continue to develop products that leverage this unique technology for other medical applications to expand its product and patent portfolio. In addition, it also believes that providing the best customer experience possible is the key for any company to strive and thrive in the world of business. It succeeds when its customers succeed. The organization will continue to seek customer feedback to expand its products and provide excellent customer satisfaction.
Driven By Values
The OtoNexus leadership team has created strong company values that inform and direct everything it does. The company values responsibility to doctors, patients, and parents to develop innovative products that make a difference in care for humankind; a commitment to solving complex problems to find the best solution.
Its goal is to create a simple, affordable, portable, lightweight, non-invasive tool that provides data in 1-2 seconds so clinicians may accurately assess and responsibly treat middle ear infections. By doing so, it can improve patient outcomes, reduce unnecessary antibiotic prescriptions and surgeries, and reduce healthcare costs. Following that, it will create additional medical devices utilizing this unique, fully patented technology.
A Proven Leadership
One of the leading lights of OtoNexus is Caitlin Cameron, its Chair of the Board and Chief Executive Officer. Caitlin is a highly accomplished senior executive with 30 years’ cross-industry expertise in the life sciences, biotech, technology, and IT industries. She is a specialist in building high-performing start-up companies. Previously, she held Chair and CEO positions at several life sciences and IT companies, building successful businesses and organizations, creating value, and maximizing potential in a very short period of time. In addition, she has built organizations known for employee satisfaction, including being selected for the 100 best places to work in Washington.
When advising emerging healthcare leaders and startups, Caitlin states that innovation is occurring at a breakneck speed, and there are many great ideas out there, but a great idea is not enough. She advises, “Start with your customer to thoroughly understand the problem you are trying to solve from their perspective. Understand their concerns and priorities. Your product should solve a problem, provide a better solution, and improve clinical outcomes while reducing healthcare costs. Unless you have all of those elements, it is tough to drive adoption into the healthcare system. If you improve outcomes but increase costs to the healthcare system, you will not achieve adoption. Improving outcomes while decreasing costs is a more attractive option for a healthcare system to consider.”
Creating New Opportunities for Medical Applications
Caitlin notes that it is important that diagnosis and treatment align with many stakeholders, including physicians, hospitals, patients, parents, and insurance companies. Everyone benefits when the diagnosis of viral versus bacterial infection is determined quickly, antibiotic use is minimized, time to diagnosis is reduced, clinical outcomes are improved, and unnecessary referrals to specialists are minimized.
In addition to OtoNexus’ first breakthrough device, the company expects that its technology will create new opportunities for additional medical applications. Its unique, miniaturized ultrasound transducer technology provides data without requiring ultrasound gel. This novel approach can be leveraged to create new medical devices that dramatically improve patient care and reduce costs.
A Take on the Impact of the Pandemic on Medical Devices
Talking about the impact of the pandemic on the medical device industry, Caitlin shares that one area that had an immediate impact on development was the loss of access to both clinicians and patients for clinical studies. She believes that access is critical for product development because realworld feedback is essential to create highly accurate products that integrate seamlessly into clinicians’ workflow. OtoNexus overcame this issue by working with its clinical partners to develop enhanced cleaning and disinfection measures so that clinical work could continue.
From a product development perspective, it also saw disruptions to the materials supply chain. To minimize this issue, it focused on qualifying multiple materials vendors to meet the long-term manufacturing needs, and ordering key items well in advance. This approach ensures it has supply on hand and numerous sources to supplement the supply chain for future demand.
Telehealth is the Future
When asked about the future of personal care post the COVID-19 pandemic, Caitlin mentions that Telehealth has been available for many years. However, it was not routinely used. The pandemic precautions highlighted the convenience and effectiveness of this tool for both patients and physicians. Minimizing trips to the doctor’s office or urgent care center is highly desirable for worried, busy parents. When your children are suffering in the middle of the night with a middle ear infection, you want to know the best treatment quickly. Providing patients and parents with practical tools they can use at home to share information with their physicians saves both time and costs. OtoNexus plans to simplify its device so parents can use its novel ultrasound technology at home and share the unique data it gathers electronically with their physicians.
Testament to Excellence
Dr. John Germiller – “Dr. Gates’ work in developing this technology will make a huge difference in diagnosis and management of middle ear infections.”
Dr. Richard Rosenfeld – “The availability of a device to improve the diagnostic accuracy of middle ear effusion would greatly benefit children.”
Dr. Jerome Klein – “Dr. Gates is a physician who thinks outside the box. The bottom line is we need a sensitive and specific instrument for diagnosing middle ear infections.”