The News Room

A new webinar from the Association for the Advancement of Medical Instrumentation (AAMI) aims to give medical device manufacturers the statistical tools and methods they need to succeed.

“Introduction to Statistical Methods and Tools for a Quality System”—which will take place Sept. 22 — is designed to provide attendees with a solid understanding of the statistical methods and tools needed to support a quality system, and offer recommendations on guidance documents from the U.S. Food and Drug Administration (FDA) and other agencies.

FDA’s Quality System Regulations (QSR) calls for the use of appropriate scientific methodology in the design process. These rules are often applied to acceptance sampling plans, says Peter Knepell, PhD, president of Peak Quality Services and webinar speaker.

“Let’s say you have an automated process. Inspecting everything will drive you crazy,” Knepell says in explaining an acceptance sampling plan. “So what you do is take a sample, and based on that sample you try to draw a conclusion on how the process will do in the future. An acceptance sampling plan helps to draw that conclusion and quantify the risk in that decision from a statistical point of view.”

The webinar introduces and explains various statistical tools and methods, such as design of experiments. “The most important thing to understand is you can’t experiment forever and can’t sample forever,” Knepell says. “The point of design of experiments is to be efficient, and to come up with the measure of risk in your decision for the samples that you have taken.”

Another tool highlighted in the webinar is graphics. “We transform raw data into information using graphics, and then based on that information we start asking profound questions,” Knepell says. “We don’t just throw data on the wall. We talk about it, understand it, ask questions to understand it even more, and understand the process and the product.”

The webinar will also summarize guidance documents and recommendations from FDA and other agencies such as the Global Harmonization Task Force (GHTF).
           
The goal of the webinar is to offer tools for medical device manufacturers to quantify risk using statistics. “All decisions involve risk,” Knepell says. “The idea is to quantify your risk. That is what statistics does.”