User-Centered Design & Stakeholders

The design was grounded in ethnographic research including literature review, shadowing of OR and clinic procedures, and multiple interviews with pediatric otolaryngologists. Surgeons highlighted anesthesia cost, workflow disruption, and limited adoption of current in-office systems (e.g., Hummingbird, Tula) due to expense, waste, and the need for new capital equipment.

Key stakeholders include pediatric patients and families, ENT physicians, hospitals, payers, and investors, with value propositions centered on lower cost, less anxiety and pain, easier workflow integration, and reduced OR utilization.

Prototyping & Materials

Development began with 10× scale prototypes in Fusion 360 to explore flange geometry, compression mechanics, and tip design before scaling down. The team used 3D-printed thermoplastic elastomer/TPU to simulate a flexible, expandable tube and polyvinyl alcohol (PVA) or BVOH for early dissolvable tip concepts.

Multiple candidate tip materials were then evaluated for manufacturability, sharpness, and dissolvability, including rock candy, sugar cubes, salt tablets, PVA, and BVOH. Salt tablets emerged as the best-performing material conceptually, while BVOH was favored as a practical, 3D-printable option for current prototype iterations.

Benchtop Testing & Key Results

Three main verification tests were conducted: sharpness (puncture force), dissolvability, and tube retention within a simulated tympanic membrane. Puncture testing used a plastic-wrap “eardrum” stretched over a beaker with a force gauge, while dissolvability was assessed in phosphate-buffered saline at 37 °C; retention was demonstrated by placing a TPU tube through the membrane using a 10× scale introducer.

Salt tablet tips required roughly 250 g of force to puncture—well under the 500 g design threshold—while dissolving in about 19 minutes, satisfying both mechanical and timing requirements for the intended clinical use. Sugar dissolved much faster but lacked structural integrity, and PVA/BVOH provided good strength but dissolved too slowly, guiding a dual-track path forward (BVOH for rapid prototyping, optimized salt for eventual clinical translation).

Regulatory Outlook & Future Directions

MicroTymp is envisioned as a Class II device combining a tympanostomy tube and a manual ENT surgical instrument, following a 510(k) pathway with existing tympanostomy tubes and in-office systems as predicates. Planned work includes material optimization and micro-manufacturing for salt-based tips, benchtop and animal studies for safety and function, ISO 10993 biocompatibility testing, and eventual clinical feasibility trials.

Beyond technical validation, the team has initiated an invention disclosure and is preparing a provisional patent, while exploring partnerships with established device manufacturers to support scale-up, distribution, and equitable pricing strategies.