Krish Ramdoo, ENT surgeon for the NHS, had an idea that could help accelerate access to hearing healthcare for thousands of patients. Could a smartphone together with a novel otoscope device, provide a full hearing health solution outside of the hospital?
Within 15 months, Team Consulting worked hand in hand with TympaHealth to develop Krish’s idea. Through an iterative process with Team’s designers and engineers, we progressed this prototype device to a pilot medical device suitable for clinical trials. It was quickly and successfully CE marked as a Class I medical device.
In May 2012, I was told I had cirrhosis of the liver and without a transplant I had an estimated 12 to 18 months to live. I was placed on the waiting list but I was told there were about 12 to 18 months to wait for a liver of my type. I was very worried it was cutting it a bit too fine and I wouldn’t get a transplant. The waiting is horrible. You’re waiting for the phone to ring, wondering: ‘Are they ever going to call me?’
I took part in the trial because if the device can help more people in my situation in the future, it’s my duty to help. I feel better than I’ve felt for 10 to 15 years, even allowing for the pain and wound that’s got to heal. I’m getting better day by day. I just feel so alive!
The TympaHealth device is a unique portable smartphone-enabled otoscope with an accompanying smartphone app.
Almost half a billion people in the world currently suffer from hearing loss. While hearing can often be improved by simple ear wax removal, patients often go back and forth between ear wax removal services and hearing test/aid providers, a process that can take 12-16 weeks.
The TympaHealth device is made of an ergonomically designed handle, cradle and ear speculum. Using smartphone technology combined with a custom designed lens system, it captures images of the ear canal. Pharmacists canconduct a high-definition assessment of the ear with ease and send those images to an audiologist or ENT specialist via cloud technology for further review.
We needed to make the handle easy to use and as ergonomic as possible. To do this, we relied on user feedback from clinical studies to inform the handle design. By building the handle at an angle, the device can be held more comfortably for longer periods of time by both left and right-handed users, without compromising grip or control
As a designer, it’s been a privilege to be part of TympaHealth’s journey, helping them develop their initial concept and realising their vision to bring their product to market. This is a dream project for any designer or engineer: working with a start-up company who appreciates the challenges of medical device development and allows the design team the flexibility to explore different design solutions, pushing the boundaries of what is possible.
The all-in-one hearing health assessment system uses a smartphone camera to capture and record images of the ear canal. We listened to feedback from healthcare professionals to increase the image quality to meet their standards by introducing a custom-designed optical system in the device. We then fined-tuned this system for both usability and cost efficiency of manufacture.
We developed a series of functional engineering prototypes early on in the process which varied in fidelity. This was critical to enable optimisation of the optical system and ensure the product would be commercially viable.
Outer ear illumination was another key component necessary to create a clear image. We had to produce high image quality of the outer ear. To do this, we required a higher intensity illumination than the native smartphone torch.
We incorporated battery-powered LED illumination into the base of the speculum, fitting components within the handle to ensure a good weight distribution. In addition, we developed a charging base to provide power to both the phone and cradle between uses.
We had to conform to the IEC 60601-1 standard which introduced multiple design constraints.
Designing and building working prototypes for device development was an intricate process. But detailing the design to be compatible for production of thousands of devices was the real challenge. Fine control of the manufacturing tolerances was necessary to ensure that we did not compromise on the key optical performance of the device.
Working with our network of manufacturing partners
We helped TympaHealth select ISO 13485 accredited manufacturing partners based in Singapore.
Together with these partners, we produced components using methods including die casting, machining and injection moulding.
The TympaHealth device is a portable smartphone-enabled otoscope with accompanying smartphone app; the world’s first all-in-one hearing health assessment system. It allows trained staff to carry out a full ear examination, a hearing test and to safely perform ear wax removal with microsuction,
improving the patient pathway. Within 15 months we achieved the industrialisation and CE marking of this Class I medical device, compliant with the MDR.
The multifunctionality of the TympaHealth device is revolutionising the delivery of ear care services. It drastically improves the patient healthcare pathway, particularly benefiting communities where accessing such services can be difficult
The TympaHealth hearing health assessment system has been awarded with a Good Design Award, iF Design Award and a gold UX Design Award recognising its design, easy of use and patient impact.
The multifunctionality of the TympaHealth device is revolutionising the delivery of ear care services. It drastically improves the patient healthcare pathway, particularly benefiting communities where accessing such services can be difficult
The TympaHealth hearing health assessment system has been awarded with a Good Design Award, iF Design Award and a gold UX Design Award recognising its design, easy of use and patient impact.
