“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 as an eye-opener,” said David DeRam, CEO of Greenlight Guru. “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.”
Survey data also identified risk as a significant challenge for leadership, particularly in regard to data and visibility. More than half of respondents stated that risk management was not fully integrated into their quality management systems. On top of this, 43 percent of respondents identified access to adequate risk information for device design and development as a top challenge in risk management.
“Medical device manufacturers are taking huge gambles with their risk management; if management teams lack adequate insights into device risk, auditors lack sufficient insights, too,” said Jon Speer, VP of QA/RA at Greenlight Guru. “Revisions to ISO 14971 are coming soon, meaning issues with risk management now will create larger risk management issues in just a few months.”
Additional findings from the survey include:
- 75 percent of medical device professionals said that they would not be prepared for an unannounced audit by the FDA or other Notified Body. Of these professionals, even fewer (20 percent) said they are currently ready for an EU MDR audit.
- Of the organizations that say they use legacy products such as Excel or paper-based record-keeping systems, less than half (41 percent) agree that quality is woven into the organization’s culture (compared to 56 percent using best-in-class tools).
- 71 percent report the data collected by their company’s quality system is not easily accessible in real-time. And nearly 60 percent indicated the data generated by their quality system was not consistently reliable.
The results from the report were developed from an online survey fielded between September 11 and September 27, 2019. Survey respondents consisted of 524 participants, 93 percent of whom represented quality, regulatory, engineering and operations professionals from small and enterprise-size device makers.