TiNO Digital Design Project
THE CONCEPT
TiNO is a gas generator that provides a tankless, direct, cost-effective, and unlimited supply of inhaled Nitric Oxide for the treatment of Pulmonary Hypertension and other respiratory conditions in children. The device can be universally connected to and calibrated with various pediatric ventilation systems to provide limitless Nitric Oxide to kids in need. Nitric Oxide is easily produced from the air in a cutting-edge ionization chamber and does not need to be stored in tanks.
Client
Biomatic International
Duration
3 months
April 2022 - June 2022
Role
Designer
Tools
Adobe Illustrator - Procreate -
Adobe Photoshop - Pen - Paper
Original Design
Developmental Goals
The Engineering update Project will include the following primary design modifications required for the next generation of TiNO:
Redesign of control electronics and any necessary mechanical components in support of modernizing the device and enabling new features.
Redesign of the device enclosure and user interface establishing a well-defined, modern brand aesthetic.
Integrate NO sensing capability - the sensing should determine NO levels near the patient's mouth, display them to the user and regulate NO generation/output to maintain the user-set levels.
Integrate battery for up to 2 hours use without power source.
Ensure compliance with FDA consensus standards (e.g. IEC 60601-1,IEC 62304)The Heart of the Device will remain the same but Biomatic has determined that in order to address a larger market, some engineering updates are needed.
The main goals are modernization of product architectures (GUI), i mproving the device aesthetics, complying with market regulations, and focusing on reliability and ease of use.
These updates are needed in order to align or initiatives with the guidance of the FDA.
After much thought and research Biomatic has determined that the quickest, most reliable, and affordable path moving forward is partnering with medical device engineering firm Key Tech.
Key Tech is proposing to develop functional prototypes and the accompanying documentation, per ISO 13485 and FDA QSR, commensurate to a beta device/pre-validation build.
New Features
Adding a display and button user interface.
Support portable operation and integrate an uninterruptible power supply (UPS).
Integrating key code that must be updated annually for device to continue running.
Simplifying the methods for device operation and calibration.
The Vision
The device itself to be mostly white (or black) with red accents, but open to anything. The device should still be a box around current size with same round filter and yellow tube but with a much more rounded look. The front panel of the device will be a digital screen.
