A new report from Indianapolis-based Greenlight Guru says a gap remains between executives at medical device companies and front-line managers regarding the risks their companies face related to product quality. The report shows quality improvement has taken the spotlight in the industry due to the current health crisis.
Greenlight Guru, a medical device quality management system software platform, says the report surveyed more than 300 medical device produce development and quality professionals from around the world.
The “State of Medical Device Product Development & Quality Management Report” says executives are more likely than managers to “give their company high marks for quality management and are less concerned about the risks posed by poor quality management.” Additionally about two-thirds of respondents said they work for companies that “don’t share a uniform commitment to prioritizing quality as a strategic asset.”
“To find that more than 80 percent of organizations are asking their quality and engineering teams to ‘make do’ with legacy tools and solutions is an eye-opener,” David DeRam, chief executive officer of Greenlight Guru, said in a news release. “Quality isn’t a department, but a cultural mindset within a business. Quality cannot be treated as a check-the-box activity — unfortunately, even when mandated by law, we’re seeing companies do the bare minimum.”
According to the report, on-site inspections of medical device makers fell 93% as the U.S. Food and Drug Administration searches for virtual options during the pandemic.
The report says highly-competitive companies are twice as likely to increase their investment in quality management in 2021 than their less competitive counterparts.
You can view the full report by clicking here.