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 and hearing test and to safely perform ear wax removal with microsuction. Within 15 months we achieved the industrialisation and CE marking of this Class I medical device, compliant with the MDR.

At a glance

Client
TympaHealth

Sector
MedTech

Services
Industrial design
Human factors
Optical
Electronics
Mechanical
Quality
Design for manufacture
Project management
Manufacturer management

Team staff on project
10

Smart hearing health

View of the digital otoscope phone attachment & accompanying app

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 health 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.

Team’s initial project helped TympaHealth optimise their smart-phone cradle and speculum concept and develop a 1st generation pilot device suitable for use in clinical trials. It was successfully CE marked as a Class I medical device and has been used on more than 15,000 patients. This gave TympaHealth early confidence in the viability of the system and delivered valuable insights into what was required for a successful commercial device. We then went on to develop a 2nd generation ‘commercial’ device with enhanced handling, usability and image resolution.

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.

Illustration of someone using the digital otoscope phone attachment

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 options and push the boundaries of what is possible.

Steven McLellan, Senior Consultant, Team Consulting.

Optics

View of the digital otoscope design process

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.

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.
view of the digital otoscope optics rendering

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.

View of the digital otoscope electronics being assembled

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.

Adrian Horrell, Senior Engineering 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.

View of the digital otoscope manufacturing process

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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