A $1.9 million order from multinational consumer healthcare giant Johnson & Johnson is the best evidence yet that Sciemetric Instruments Inc.’s quality measurement and process management platform is a compelling new way for medical device manufacturers to meet rigorous quality assurance standards, the company said on April 20.
Using Sciemetric technology that for 15 years has been proven by some of the world’s largest manufacturers in the automotive and industrial sectors, medical device manufacturers can gain complete visibility into their manufacturing processes, eliminate destructive testing, prove compliance and move away from traditional testing methodologies that decrease yield while often failing to determine that each individual device is actually free of defects.
The size of the J&J deal validates the company’s decision a few years ago to start addressing the medical device market, where some of the strictest manufacturing process and quality assurance requirements are suggested and increasingly regulated by the U.S. Food and Drug Administration and other regulators. CEO and founder Nathan Sheaff is excited by the opportunity he sees to bring better technology to an industry where quality assurance can often be a matter of life and death.
“Adoption of Sciemetric’s Process Signature Technology lets manufacturers improve quality, achieve compliance and reduce cost by eliminating destructive testing and replacing it with a more scientific approach in which all processes critical to quality are measured for every single device made,” said Sheaff. “Simply put, Sciemetric tools allow medical device manufacturers to make better products for less money.”
In the main, medical device manufacturers currently use batch testing, wherein a sample population of parts – usually a significant percentage of the manufactured output – is tested to failure. Sciemetric’s Process Signature Technology approach is more comprehensive and cost-effective because it measures each essential element of the manufacturing process, ensuring that each device meets required input criteria and so can be expected to perform as required. Where competitive solutions may measure some of the inputs, only Sciemetric can offer the precise signature of the manufacturing process that allows manufacturers to easily determine root causes. If a defective product makes it into circulation and the FDA shuts down production lines, Sciemetric users can quickly find and fix the problem and prove how it has been corrected.
Given its history in the automotive and industrial sectors, Sciemetric recognizes the opportunity for these same principles to help achieve success for manufacturers of medical devices and in other highly regulated industries like food production.
About Sciemetric Instruments
Since 1981, Sciemetric’s process-monitoring and quality-management systems and software have enabled some of the world’s largest automotive, medical and industrial manufacturers to gain visibility into, and control over, their manufacturing processes. On the production floor, process signature verification (PSV) technology provides the most accurate determination of process health and part quality while collecting all data. Manufacturing managers use Sciemetric’s analytic tools to transform the data into actionable information to reduce costs, manage quality and maximize yield while providing proof of process compliance and complete line-wide traceability.
