Communications is key to successful medical device manufacturing. “There are not only endless acronyms and unique terminology for each medical specialty, but also copious FDA regulations and customer quality requirements for validating both products and processes,” explains Kevin Bradley, who has been promoted to business unit director of Mack’s newly formed Medical Business Unit.
“A dedicated approach to medical manufacturing, this new business unit allows us to consolidate all medical customers and their respective account managers under one program management umbrella, where we can fine-tune our focus on their requirements,” says Bradley. “This is a team of professionals with a medical manufacturing culture that not only speaks and understands the same language, but thinks it as well.”
The Medical Business Unit manages all medical accounts, from product development through manufacturing and distribution. “We assign a program manager to each account, who is supported by a supplier engineer, quality engineer, manufacturing engineer, regulatory compliance advisor and a document control change analyst,” adds Bradley. A procurement specialist and test engineer are also added if needed.
“With this market-specific, engineering-intensive program management approach, it is our goal to provide quicker response times, greater flexibility, intensified technical support, and more accurate information and communications,” says Bradley. “The customer doesn’t have to spend time bringing us up to speed on the stringent requirements of his market. In this highly specialized business unit, we eat, sleep and breathe medical manufacturing- it is our sole focus.”
Contact: Kevin Bradley, Director, Medical Business Unit