Engineers at Biosense Webster, a Johnson and Johnson medical device company that specializes in diagnosing and treating cardiac arrhythmias, write multiple test reports to comply with FDA regulatory standards. These intricate reports require 36 hours of an engineer’s time on average, constraining the engineers from completing investigations and studies in a timely matter. Writing scripts in R that create reproducible reports can significantly reduce the time spent by an engineer creating these reports allowing them to do a much thorough investigation with a larger scope. Through Shiny, engineers could conveniently have their parameters and recorded data processed and stored in a database by accessing a web link and filling out the required information within a user-friendly interface. Upon the generation of the report, accurate and properly formatted test reports, compliant to both the company and FDA regulatory standards, are produced through Rmarkdown and knitr knitting all the outputs with complete data analysis tools such as normality plots and process capability measurements to a word document that follows company required headers, footers, and headings. The reproducible report creation shown in this report can be extended to other types of test reports and protocols. The pilot phase that has been conducted has shown that complete report production has been decreased from 36 hours to an hour.
Ana Alyeska Santos works as an Engineer I in Biosense Webster, Inc. (BWI), a medical device company under Johnson & Johnson. At BWI, she is using R in conducting projects within Quality Engineering. Yeska received her bachelor's degree in Industrial Engineering from Cal Poly Pomona in May 2019.