A Digital Design Approach to Produce an Automated and Iot-Enabled Resuscitator for Covid-19 Emergency Uses

The onset of the COVID-19 pandemic prompted an unprecedented demand for medical equipment capable of combating the effects of acute respiratory failure. Health care systems worldwide were found ill-equipped to handle the sheer volume of patients exhibiting the respiratory issues associated with this novel strand of the coronavirus, often requiring methods of assisted breathing. This project was initiated amidst the worldwide shortage of mechanical ventilators with the goal of designing, manufacturing, and testing a portable, inexpensive, and automated respiratory support device that utilizes an FDA approved bag valve mask (e.g., Ambu bag) to mechanically assist patient breathing. The foundation of this project was initialized with a mechanical understanding of the problem. The manual bag valve mask resuscitator is an alternative solution to the traditional, expensive, and complex method of mechanical ventilators. Medical personnel repeatedly provide manual compressive action on the bag to assist a patient that is exhibiting respiratory issues. To alleviate the manual requirement from this process, a mechanized compression gantry was designed to create an automated and programmable operation. The device’s contribution to the engineering and medical fields lies in the process with which it was developed. The employed design process incorporated a digital and distributed manufacturing approach that streamlined design iterations and maximized productivity. Managing the design process in the digital environment enabled the team to capture design history and relevant design decisions. The team also integrated product lifecycle management (PLM) tools to document each avenue that was pursued to achieve the final device. This process augmented traditional design and prototyping methods with an approach that conceptualizes and validates the design in the digital environment prior to manufacturing. To effectively utilize this streamlined digital design process, each custom component was run through three interconnected phases: Design, Simulation, and Optimization. Following the conceptualization of the component design, computational analysis tools were used to validate the design’s ability to handle the anticipated loads. These load cases were determined through experimentation and implemented in the digital design workflow. With the validated design, simulation results were used to identify components as candidates for optimization processes in a final refinement phase. This phase was used to uniquely produce parts that capitalized on the robust capabilities of additive manufacturing processes. Despite initiating this project on a mechanical thread, the biomedical aspects were progressively weaved into the design process. Experiments were developed around the design to test the device’s ability to meet regulatory requirements. As this is an electromechanical device, even the electrical components of the design were first assembled in CAD prior to physically purchasing the parts. The outcome of implementing this rapid digital design process was a completed and manufactured prototype that was ready for testing within a month after project launch. The design evolved with each test where multiple components were consolidated into single parts, custom components were redesigned for quicker manufacturing, and optimization tools were used to reduce the physical footprint of the device. Using computational analysis tools and creating digital assemblies reduced the number of transitions required between the digital and physical workspaces. Efforts have already been devoted to creating a second version of the device to be more compact and easier to manufacture. This project was an exercise in a deadline-enforced product design process for a real-world application. The team employed streamlined digital design techniques to design, validate, and optimize the device for efficient manufacturing and testing.