Survey Finds Fewer Than 3% of Pre-Market Medical Device Companies Are Very Effective at Measuring the Results of Quality Initiatives

Findings from the Greenlight Guru 2022 Medical Device industry benchmark survey reveal a need to focus on quality initiatives, gaps between processes and priorities, and more

INDIANAPOLIS — February 17, 2022 — Greenlight Guru, pioneer of the only dedicated Medical Device Success Platform (MDSP), today announced findings from its 2022 benchmark study on product development, quality management, and commercialization efforts in the medical device industry. This original research report provides the medical device community with insights into key benchmarks, industry challenges, quality management preparedness, and what leading companies are doing differently.

With three years of data to compare, the 2022 report shows year-over-year declines in the use of general purpose tools for product development and quality activities. Despite these year-over-year improvements, a third of pre-market companies still attempt to get by with these general purpose tools.

This report also reveals that use of general purpose tools correlates with lower performance. Furthermore, companies that are unwilling to invest in purpose built tools put themselves at risk for significant and expensive consequences — from silent inefficiencies to missed performance signals and compliance threats.

“We found that more companies are instituting feedback loops for quality problems, but a significant number of medical device companies still struggle to leverage quality as an asset to accelerate their development,” said David DeRam, CEO of Greenlight Guru. “High-performing companies stand out by viewing quality as more than a compliance effort and injecting quality into product development and supplier management processes. This is why 81% of high-performing market leaders maintain a strong feedback loop between these teams.”

Survey data also revealed that accelerating product development is a critical priority for companies in 2022, with nearly 2 out of 3 executives (63%) citing it. This represents a 37 point jump in just 12 months.

Despite the anticipated growth, the COVID-19 pandemic still exposed defects in important processes like supplier management that previously lay dormant. More than 3 in 4 respondents say their supplier quality management program is average or below average. “COVID really revealed how risky we were behaving with very little supplier qualification,” shared one survey respondent. “We found many of our suppliers were also in much riskier positions than we thought.”

Additional findings from the report include:

• While 8 in 10 predict growth for the year ahead, only 8% report feeling very well equipped to meet objectives in 2022.

• 80% of high-performing market leaders in the field say they have processes in place to connect quality issues to R&D and management.

• Speeding product development and approvals is a priority for executives while management sees a critical need to upgrade systems and processes to stay audit-ready.

• Just 28% say they have achieved “high visibility” into quality data — meaning the people who need to access quality information can readily consult it.

Results from the 2022 benchmark study were driven from an online survey that was fielded between November 4 and November 30, 2021. Survey respondents consisted of 519 participants, of whom are employed in quality, product development, and executive management positions by device organizations ranging in size from small to enterprise-level that are located in various regions around the world. Click here to download the full report.

To get a deeper dive into the report findings, register for the upcoming 2022 State Of Medical Device True Quality Virtual Summit Series and attend engaging panel discussions from industry experts. Discover what high-performing companies do differently and gain actionable insights to take your organization to the next level.

This release follows the announcement of True Quality 2022, the must-attend conference hosted by Greenlight Guru for medical device executives, quality, and regulatory professionals who drive innovation in the most high-performing medical device companies. To learn more about sponsorship opportunities click here, or to register for True Quality 2022 visit https://www.greenlight.guru/true-quality.