In 1968, Medtronic annual sales skyrocketed to more than $12 million, with the company reporting net income in excess of $1 million. The staff grew as well, from 36 in 1962 to 348, and so did the St. Anthony, Minnesota facility.

One addition, which anticipated U.S. Food and Drug Administration (FDA) requirements, included a clean room for assembling implantable products. By installing a filtration system to purify the air, and controls to strictly regulate temperature and humidity, the company significantly enhanced quality standards and increased production capacity.