AbStats: From Concept to Market
- Author(s): Kotite, Andrew Nicolas
- Advisor(s): Kaiser, William J
- et al.
Clinical grade electronics is a highly challenging and competitive field. Creating high volume reliable systems involves many complex design considerations. AbStats, a digestive monitor- ing system, was designed from the ground up to incorporate these design considerations to bring a clinical device to market. Built to diagnose postoperative ileus, AbStats is able to monitor symptoms and aid physicians in treating patients. Early prototypes defined system specifications, and after a proof of concept was established, a production ready version of AbStats was needed to bring the technology to market. The system comprised of two main parts, the gateway and the sensors. The gateway comprised of a user interface for the physician, as well as electronics to enable the sensors and algorithms. The sensors were designed to be noninvasive, and provide the interface to the patient. Creating high quality inexpensive sensors was the most challenging aspect of the design. Quality assurance is a critical part of the design as end of line testing is integral in any consumer facing product. Taking cues from the consumer electronics space, design considerations were made to quickly develop the system and push to production. Contract manufacturing and rapid prototyping influenced the development and enabled a rapid push to market. Currently, AbStats has received FDA 510(k) and IEC 60601-1 certifications. AbStats is currently ramping up production to satisfy the needs of many hospitals and clinics in the Los Angeles area. AbStats has created a new space in gastrointestinal monitoring and is proving to be successful in the market.