Q: What’s in store for the medical device sector in the coming year? What news, technologies, regulations, or companies will capture the spotlight in 2016?
One of the most important trends in the medical device industry today is a reliance on data. Medical insurers have told the device makers wanting to prove the superiority of their implants; let’s see the numbers. At Lowell, Inc. a fifty year old precision machining contract manufacturer of complex implants, we see data as a cornerstone of our business. Starting with our 450 SF climate controlled test lab that houses three robotically tended CMMs to our use of statistical software analysis packages Minitab and JMP, Lowell is well schooled in the importance of data.
Quality is the number one job at Lowell and quality is measured with data. We are working with customers on design for manufacture (DFM), design verification and validation. Our team is working hard to lead the industry in the capture and analysis of data. This includes compiling a detailed feature level assessment (FLA) for each component. Starting with the machining center, we run down a list of activities that make up a part’s complexity and create a capability matrix. With this formalized historical process knowledge, Lowell expects to trim the amount of features inspected by 90%, making quality with speed (QWS) and shorter lead times possible for our customers.