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?
Krish came to Team Consulting wanting to turn his idea into an award-winning commercial device, capable of bringing the whole ‘ear clinic’ to the community – pharmacies, opticians, care homes, GP’s surgeries and more.
His start-up company, TympaHealth, needed to rapidly progress this concept into a functioning device. We quickly established a multidisciplinary team to support every aspect of the device development, from front end innovation through to human factors, industrial design and manufacture.
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.
Since then, the award-winning device has been used in the United Kingdom, USA and a number of remote locations across the globe.
Team’s ability to understand TympaHealth’s technical requirements and design challenges, to make critical decisions, evolve the design and produce prototypes, quickly allowed TympaHealth to conduct numerous rounds of user studies (enhancing the design in the process) and obtain universal positive user feedback to secure funding and produce commercially viable products.
The TympaHealth device is a portable smartphone-enabled otoscope with an accompanying smartphone app. The world’s first all-in-one hearing health assessment system, it allows trained staff to carry out three tasks: a full ear examination, a hearing test and an ear wax removal using micro suction. The test results can also be sent to an ENT specialist for further review.
Almost half a billion people in the world currently suffer from hearing loss. While hearing can be improved by simple ear wax removal, patients must often go back and forth between ear wax removal services and hearing test/aid providers, a process that can take 12-16 weeks.
Our client, TympaHealth, wanted health professionals to deliver the whole ‘ear clinic’ to the community in a single 30-minute appointment.
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 can conduct 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.
To improve usability, 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, we ensured the device could 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. Listening to feedback from healthcare professionals, we increased 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.
To produce a high image quality of the outer ear, we required a higher intensity illumination than the native smartphone torch was capable of.
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.
As part of the electronics design we had to conform to the IEC 60601-1 standard, which introduced multiple design constraints. We carefully negotiated these to preserve the device’s look and feel without compromising its functionality.
Designing and building working prototypes for the 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.
We helped TympaHealth select ISO 13485 accredited manufacturing partners based in Singapore. These partners produced components using methods including die casting, machining and injection moulding.
The multifunctionality of the 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.
Team Consulting helped TympaHealth turn a concept into a commercially successful start-up with offices now in the UK and the US, and over 100 employees. The hearing health assessment system has since been awarded with a Good Design Award, iF Design Award and a gold UX Design Award recognising its design, ease of use and patient impact.
