Smart hearing health

Challenge

The commercialisation of a start-up company’s smartphone-enabled otoscope.

Approach

We advanced the client’s initial product vision through two stages of development by applying user feedback gained during use of a first generation ‘pilot’ system. We identified and introduced new features whilst optimising usability and handling for a second generation ‘commercial’ system. These iterations involved our designers and engineers working seamlessly with a Singapore-based manufacturing partner selected by Team Consulting for TympaHealth.

Outcome

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.

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Project background

Smart hearing health

Almost half a billion people in the world currently suffer from hearing loss. Unfortunately, whilst hearing can often be improved by simple ear wax removal, access to hearing services is disjointed. Patients often go back and forth between ear wax removal services and hearing test/aid providers.

Our client, TympaHealth, an investor-funded start-up company, had a vision for a portable all-in-one hearing assessment system, which allows health professionals to deliver the whole ‘ear clinic’ in the community. This vision required the commercialisation of a smartphone-enabled otoscope device and accompanying app.

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The device

The TympaHealth device comprises an ergonomically designed handle, cradle and speculum. Using smartphone technology and a custom designed lens system to capture and share images, the design allows healthcare associates to conduct a high-definition assessment of the ear with ease.

Usability and ergonomics

Feedback from clinical studies informed our critical decision to reconfigure the handle design to improve usability and ergonomics. 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.

Ergonomics

As a designer, it’s been a privilege to be part of TympaHealth’s journey, helping them develop their initial concept through two generations of devices 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 appreciate the challenges of medical device development and allow the design team the flexibility to explore different design solutions and push the boundaries of what is possible.

Steven McLellan, Senior Consultant, Team Consulting
Smart hearing health

Optics

The system uses a smartphone camera to capture and record images of the ear canal. By introducing a custom-designed optical system in the device, we were able to improve image quality to meet the needs specified by healthcare professionals. The design of the optics evolved through a series of functional engineering prototypes. These prototypes varied in fidelity, from early rigs set-up on an optical bench to fully functional handheld prototypes with replaceable lenses.

Optics

Following user feedback, we fined-tuned the optical system to ensure a commercially viable product which provides high image quality, usability and appropriate cost of manufacture. The feedback from healthcare professionals was crucial to the development of the device. We established a program of work early on and developed representative prototypes which were critical to enable optimisation of the optical system.

Steven Fowler, Senior Consultant, Team Consulting

Electronics

Outer ear illumination was another key component necessary to creating a clear image. The 1st generation device used the integrated flash of the smartphone. However, to enhance image quality, the outer ear required higher intensity illumination. To achieve this, we incorporated battery-powered LED illumination into the base of the speculum, fitting components within the handle to ensure suitable weight distribution. In addition, we developed a charging base to provide power to both the phone and cradle between uses.

Electronics

Including electrical components in the 2nd generation device meant that we had to conform to the IEC 60601-1 standard. This introduced multiple design constraints, which we carefully negotiated to preserve the device’s look and feel without compromising its functionality.

Steven Fowler, Senior Consultant, Team Consulting

Manufacture

We helped TympaHealth select ISO 13485 accredited manufacturing partners based in Singapore, and worked with them to optimise the design for manufacture. Because of the relatively low production volumes, the device was designed for hand-assembly. Components were produced using methods including die casting, machining and injection moulding. We managed the fabrication and assembly of printed circuit boards at a subcontractor level.

Quality checking

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 key optical performance of the device was not compromised.

Charlie Dean, Engineering Consultant, Team Consulting

Team’s ability to understand TympaHealth’s technical requirements, 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.

Dr. Krishan Ramdoo, Founder and CEO, TympaHealth

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