A new medtech product development survey concludes that companies are shooting themselves in the foot when it comes to improving their product-development processes.
Medtech quality management firm Greenlight Guru said this week that it surveyed more than 500 medical device product development and quality professionals from across the world about the strategies, tactics and technologies they use to accelerate product development, ensure compliance and promote quality.
Here are some of top hindrances they reported in the report, “State of Medical Device Product Development & Quality Management Report 2020:”
- Shortage of resources — 55%.
- Insufficient budget — 37%.
- Lack of management buy-in — 29%.
More than half of the respondents also said they are using tools that are not specifically tailored to medtech design controls and device risk management.
“To find that more than 80% of organizations are asking their quality and engineering teams to ‘make do’ with legacy tools and solutions is as an eye-opener,” said Greenlight Guru CEO David DeRam 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.”
Survey data also identified risk as a significant challenge for leadership, particularly in regard to data and visibility. More than half of respondents said that risk management was not fully integrated into their quality management systems. In addition, 43% percent of respondents identified access to adequate risk information for device design and development as a top challenge.
“Medical device manufacturers are taking huge gambles with their risk management,” added Jon Speer, VP of quality assurance and regulatory affairs at Greenlight Guru. “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 those that reported using legacy products such as Excel or paper-based record-keeping systems, less than half (41%) agree that quality is woven into the organization’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. 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 11 and September 27, 2019. Survey respondents consisted of 524 participants, 93% of whom represented quality, regulatory, engineering and operations professionals from small and enterprise-size device makers.
You can download the full survey results here.
