Design development for a Neonatal Photo-therapy Device to treat jaundice in premature and full-term babies.
I worked as a design lead on various aspects of the development process for this device from conception to user testing to obtaining regulatory approvals.
6 out of 10 babies in the world get jaundice on the third day after birth. Infant jaundice is treatable with blue-light photo-therapy. Places in Southeast Asia and Africa lack affordable medical infrastructure to treat this condition resulting in higher infant mortality.
Neolight LLC. is a start-up medical device company created by 4 engineering and management students from Arizona State University after receiving a grant for their idea through the ASU Student Entrepreneur Initiative. Neolight’s mission was to develop a highly efficient and reliable photo-therapy device to treat infants in hospitals (or at home) at a fraction of the cost of current devices.
Design development activities for version 1.0 included: collaborating with external design firm and in-house engineers to test, modify and prototype design iterations for the device bed, recommending manufacturing processes for various parts, and conducting human factors analysis and risk mitigation activities for in-home use and hospital use.
Supporting the team with designing product assembly process, collaborating vendors and manufacturing partners, creating promotional/marketing materials for pitch presentations, etc.
Research and Usability Tests conducted during development for understanding user needs, desired experience and identifying possible hazards. Developed research protocol for Usability Engineering File according to FDA standards for usability testing. Trained research team to conduct observations with participants. For the final design validation, conducted research sessions with ~15 NICU nurses and doctors for hospital use of the device and performed observations with ~30 parents or caregivers for in-home use. Quantitative and qualitative assessment of data to analyze overall user experience and risk factors/failure modes.
This project involved regular contact with doctors, nurses, lab equipment managers and other healthcare professionals at Phoenix Children’s Hospital and St. Joseph’s Hospital and Medical Center and few other hospitals in Phoenix, AZ.
Controller keypad design through iterative prototypes and testing. Working with electrical engineers and programmers to develop manufacturing samples for the membrane keypad.
Wire-framing interface workflow with a team of programmers to ensure intended user experience. Designing for optimum performance, troubleshooting modes and developer settings for trained technicians to perform service procedures.
Designing labels, based on medical device standards, to inform the user about certifications, use, storage and transport conditions, caution and warnings, and service, repair or disposal procedures. Finding vendors and printing label samples to test them for usability, hazardous conditions and bio-compatibility as required b FDA.
Creating user manuals, according to FDA guidelines, for in-home and hospital use detailing: operating instructions, information about parts, warnings and precautions, maintenance and service procedure and technical specifications. For ease of access to instructions, a quick reference card was designed to be attached to the device power cord or hung by the patient bed.
Concept development for Version 2.0 - ideation, prototyping and testing the next version of the product with additional functionality, specifically designed for in-home use by new parents/caregivers.
Facilitated a 3-day Design Sprint with internal team, advisors, stakeholders and industry experts to identify opportunities for future products and services in Neonatal Jaundice Treatment. The Sprint was also intended to educate the team about Design Thinking process and application, and to lay the foundation of a design and innovation strategy for the company.
Next: Neonatal Jaundice Testing (click to continue)
After this project, I worked on developing a bilirubin testing device + software application to help detect neonatal jaundice at the point-of-care. Click here to continue to the Bilirubin Testing Kit.