A recent report suggests there is room for improvement for quality management systems for medical device manufacturers.
The survey from the “State of Medical Device Product Development & Quality Management Report 2020” report, undertaken by Greenlight Guru, indicates that 81% of medical device companies are not using tools designed for the industry in their quality management processes.
The report provides insights on survey findings from more than 500 medical device product development and quality professionals from across the world, giving a look into the strategies, tactics, and technologies they are using to accelerate product development, ensure compliance and promote quality.
Key findings from the report identified several organisationally-inflicted challenges to improving product development processes, with a shortage of resources (55%), insufficient budget (37%) and lack of management buy-in (29%) cited as leading issues. Additionally, more than half of the respondents shared that their organisations are utilising tools that are not specifically designed for the medical device industry as it relates to design controls and risk management of their device(s).
David DeRam, CEO of Greenlight Guru, said: “To find that more than 80% of organisations are asking their quality and engineering teams to ‘make do’ with legacy tools and solutions is as an eye-opener. 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% of respondents identified access to adequate risk information for device design and development as a top challenge in risk management.
Jon Speer, VP of QA/RA at Greenlight Guru, commented: “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. 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% 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%) said they are currently ready for an EU MDR audit.
● Of the organisations that say they use legacy products such as Excel or paper-based record-keeping systems, less than half (41%) agree that quality is woven into the organisation’s culture (compared to 56% using best-in-class tools).
● 71% report the data collected by their company’s quality system is not easily accessible in real-time. And nearly 60% indicated the data generated by their quality system was not consistently reliable.
Results from the “State of Medical Device Product Development & Quality Management Report 2020” were developed from an online survey fielded between September 11th and September 27th, 2019. Survey respondents consisted of 524 participants, 93% of whom represented quality, regulatory, engineering and operations professionals from small and enterprise-size device makers.