Lisa M. Tonder

Summary

I began working at Medtronic, Inc. in 1991 after finishing my master's degree. Medtronic is a medical-device company with seven different divisions. The division that I work for provides products (pacemakers and leads) that help to speed up a slowly beating heart, a condition called Bradycardia. I have learned quite a bit about physiology working at Medtronic, through courses provided internally and from those with whom I work. An important part of providing statistical support and determining study design is to understand the problems that one faces.

Before products can be sold in the United States, they must receive approval from the Food and Drug Administration (FDA). Careful evaluation of Medtronic device implants through follow-up visits and provocative testing is used to gather data, and statistics are applied to determine product safety and efficacy. My responsibilities are quite varied, starting with the design of a study, designing data forms, writing SAS (computer) code, conducting data analysis, reporting the results, and defending this information to the FDA. I have been part of Medtronic teams that meet with FDA reviewers.

Recently I worked with those who had developed a new generation of pacemaker. The approval of a new type of product is a slightly different process and more thorough than that required for products that are merely modifications of previously approved designs. This newly designed pacemaker had to be presented and defended to an FDA panel of physicians, and the panel members were permitted to ask any questions that concerned them.