Industry experts guide global quality-improvement project
The survey was developed by a multidisciplinary team of manufacturing executives and managers representing operations, IT, quality improvement, customer service, program and project management, and supply-chain management, according to Cambashi. Its multiple choice questions touch on various aspects of strategy, process and operations. For example, one question asks: “How significant a challenge has it been to keep quality high based on the following factors?” To this respondents choose “Significant,” “Moderate,” “Modest” or “No Challenge” for such factors as changes in regulatory-compliance requirements, challenges with the rate of innovation and issues with staff skills.
Cambashi said the guiding team, called the Industry Council, vetted the survey to make sure it identifies useful metrics. The council includes leaders from such medical-manufacturing segments as cardiovascular, radiology, plastic components, oncology, orthopedics and women's health.
“Many companies appear to lack a detailed awareness of what the regulations require,” said Larry Dube, vice president of operations at NP Medical of Tokyo and Clinton, Mass., in prepared remarks. “With the uncertainty of what needs to be done, companies often layer in far more checks and balances than they need, which drives up costs. Companies that can streamline their compliance needs are more competitive and flexible.”
Dube said he is supporting the survey “to help the industry understand what we can do to gain agility and profitability yet still be in compliance.” NP Medical makes medical fluid-delivery products.
Cambashi plans to present a preview of the findings at the Medical Device and Manufacturing East show May 21 to 24 in Philadelphia. Lead researcher Julie Fraser, Cambashi’s president of U.S. operations, will suggest best practices based on data compiled from the research, which has support from UBM Canon.
The survey is accessible via Cambashi’s homepage.