BIO19: Liposome Construction as an Anti-Platelet Biomolecule

Abstract

Objective: Clinician feedback on new medical device real-world experience challenges product development teams to continually innovate and often presents opportunities to improve ease of use unrelated to device performance. Product development teams can think creatively to quickly bring user experience improvements to clinicians while developing in parallel larger, generational device updates. Here we present a case study of the phased approach to improve purge system user experience with Impella 5.5 with SmartAssist temporary MCS device. Methods: A parallel phased approach addressed purge system ease of use via training, iterative adjunct device development, and Impella 5.5 with SmartAssist next generation development. Real-world user experience impact was tracked through the Impella Quality (IQ) Database from October 2019-December 2021. Results: Each phase reached users and informed iteration during development of the next-generation Impella 5.5. 4371 devices were implanted between the first-generation launch and the completion of next-generation development. The phase 1 improvement was available for 91.0% (4133/4371) and phase 2 for 47.2% (2062/4371) of the devices. The IQ Database demonstrated 52% reduction in purge system related feedback after phase 1 and 92% reduction after phase 2. Conclusions: This phased strategy brought usability improvements to market during the longer Impella 5.5 with SmartAssist development cycle. Such an approach can allow companies to quickly improve user experience while the development cycle for a complex medical device proceeds.