Medical device quality management system (MDQMS) software platform Greenlight Guru, has announced findings from the “State of Medical Device Product Development & Quality Management Report 2021.”

The research report reveals new insights from survey findings of over 300 medical device product development and quality professionals from around the world, providing the global medical device community with insights into current strategies, tactics, and technologies being used to accelerate product development, ensure compliance, and prioritise quality.

One of the more striking findings of this study is the gap between executives and front-line managers on the risks their organisation faces related to quality. Executives are far more likely than managers and individual contributors to give their company high marks for quality management and are less concerned about the risks posed by poor quality management. Behind the scenes, however, their front-line workers are feeling growing concerns over key regulations as well as their company's quality improvement plans for the coming year.

The current health crisis revealed insights that suggest a new catalyst for quality improvement has emerged despite the many obstacles organisations are facing. Findings show that two thirds of respondents work for companies that don’t share a uniform commitment to prioritising quality as a strategic asset, resulting in core misalignment across departmental roles.

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.”

Additional findings from the report identified varying responses by organizations in dealing with the COVID-19 pandemic, which has buoyed revenue growth for medical device companies (79%) due to spikes in demand, while it has threatened financial viability for other organisations (39%) and wreaked havoc on supply chain systems.

Some other statistics from the report include:

• Non-competitive companies are 71% more likely to struggle to keep up with regulatory changes than more competitive organisations.
• Medical device companies who leverage an industry-specific QMS are 67% more likely to be able to demonstrate closed loop traceability than those who use general-purpose tools for quality management.
• Highly-competitive organisations are twice as likely to increase their investment in quality management in 2021 than their less competitive counterparts.

Results from the State of Medical Device Product Development & Quality Management Report 2021 were driven from an online survey that was fielded between October 6 and October 20, 2020. Survey respondents consisted of 311 participants, of whom are employed in engineering, quality, regulatory, and operational roles by device organisations ranging in size from small to enterprise level that are located in various regions around the world.

To download the full State of Medical Device Product Development & Quality Management Report 2021, please visit https://www.greenlight.guru/state-of-medical-device.