ADD Regulatory Compliance and Cost (Rev A)

DESCRIPTION (provided by applicant): The objective of this project is to reduce the cost, complete government regulatory compliance tests, obtain FDA classification, and establish FDA quality system standards for producing a new and innovative assistive technology (AT) that permits individuals, who otherwise cannot feed themselves, to do so without assistance from another person after they are provided with food. The lack of ability to self-feed currently affects many thousands of people in the United States, alone. A more normalized mealtime environment and many of the other known psychological benefits associated with greater independence, such as improved dignity and self-esteem, result from the ability to self-feed. Over the last 25 to 30 years there have been a variety of technologies studied and devices constructed in an attempt to ameliorate this problem. At this time, only three devices are on the market, worldwide, and they can only serve the needs of a very small percentage of people who cannot eat independently because they are physically and cognitively demanding to use and place difficult positioning requirements on the user. Also, they do not control the amount of food placed on the spoon, often presenting large clumps of food stuck to the spoon (or no food at all), to the user. This has led to user frustration causing high rates of device abandonment. Supported by NICHD SBIR Phase II funding, an assistive dining device (ADD) was developed that overcomes the problems of the other devices. An ADD has three important advantages over the other devices: the ability to reliably form a controlled spoonful of food, a flexible mounting/positioning system to reach users with non-standard seating and/or posture, and a very versatile control system. However, to commercialize an ADD, several other expensive tasks must be accomplished: 1) pass governmental regulatory requirements for electrical safety and electromagnetic compatibility; 2) reduce the cost of production by acquiring expensive injection molds; 3) obtain FDA classification and an HCPCS code; and, 4) establish FDA approved quality system standards for manufacturing. At the end of this project, the ADD will be ready for Phase III, commercialization.