Biomedical device innovation methodology: applications in biophotonics.

The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs. This process has been applied to the field of biophotonics with many notable successes. Device innovation begins with identifying an unmet clinical need and evaluating this need through a variety of lenses, including currently existing solutions for the need, stakeholders who are interested in the need, and the market that will support an innovative solution. Only once the clinical need is understood in detail can the invention process begin. The ideation phase often involves multiple levels of brainstorming and prototyping with the aim of addressing technical and clinical questions early and in a cost-efficient manner. Once potential solutions are found, they are tested against a number of known translational factors, including intellectual property, regulatory, and reimbursement landscapes. Only when the solution matches the clinical need, the next phase of building a "to market" strategy should begin. Most aspects of the innovation process can be conducted relatively quickly and without significant capital expense. This white paper focuses on key points of the medical device innovation method and how the field of biophotonics has been applied within this framework to generate clinical and commercial success.

Temporal-Bone Measurements of the Maximum Equivalent Pressure Output and Maximum Stable Gain of a Light-Driven Hearing System That Mechanically Stimulates the Umbo.

HYPOTHESIS: That maximum equivalent pressure output (MEPO) and maximum stable gain (MSG) measurements demonstrate high output and high gain margins in a light-driven hearing system (Earlens). BACKGROUND: The nonsurgical Earlens consists of a light-activated balanced-armature transducer placed on the tympanic membrane (Lens) to drive the middle ear through direct umbo contact. The Lens is driven and powered by encoded pulses of light. In comparison to conventional hearing aids, the Earlens is designed to provide higher levels of output over a broader frequency range, with a significantly higher MSG. MEPO provides an important fitting guideline. METHODS: Four fresh human cadaveric temporal bones were used to measure MEPO directly. To calculate MEPO and MSG, we measured the pressure close to the eardrum and the stapes velocity, for sound drive and light drive using the Earlens. RESULTS: The baseline sound-driven measurements are consistent with previous reports. The average MEPO (n = 4) varies from 116 to 128 dB SPL in the 0.7 to 10 kHz range, with the peak occurring at 7.6 kHz. From 0.1 to 0.7 kHz, it varies from 83 to 121 dB SPL. For the average MSG, a broad minimum of about 10 dB occurs in the 1 to 4 kHz range, above which it rises as high as 42 dB at 7.6 kHz. From 0.2 to 1 kHz, the MSG decreases linearly from approximately 40 dB to 10 dB. CONCLUSION: With high output and high gain margins, the Earlens may offer broader-spectrum amplification for treatment of mild-to-severe hearing impairment.