A new 2022 medical device industry benchmark found that fewer than 3% of pre-market medical device companies are very effective at measuring the results of quality initiatives, revealing the need to focus on these initiatives, gaps between processes and priorities, and more.
Medical Device Success Platform (MDSP) developer Greenlight Guru announced these findings in 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,” says 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 two out of three 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 three in four 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 eight 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 through the month of November 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.