The recently published Greenlight Guru 2021 Risk Management Benchmark Study uncovered some rather troubling findings about medical device risk management. The results in the report are from an online survey that was fielded from April 19 to May 9, 2021. A total of 363 global respondents completed the survey.
Here are some of the more startling findings noted within the report:
- For industry professionals who work in medical device risk management day-to-day, there’s frustration that some don’t treat the discipline with the care it requires. "The design and development team are not taking on board that risk is intrinsically linked to the process, and it has to be accounted for and documented, to ensure we can fully evaluate the device we will be selling in the future," one survey respondent said, according to Greenlight Guru. Another respondent complained that others in the organization do not engage in activities aimed at facilitating an open and ongoing dialogue around risks, which makes it difficult for them as a compliance officer to be proactive.
While most (53%) respondents view medical device risk management as a strategic asset, 33% said that risk management adds value, but is not a strategic asset. Most troubling, however, is that 12% of respondents said risk management is viewed as a "checkbox" activity at their organization, meeting only the minimum requirements. "Risk management is a check-the-box activity. The question is in our post-production review to review the risk management file, but there is a copy-and-paste statement that is being used and nobody actually reviews the risk management file," one respondent admitted. Another said they worry that their organization won't adequately capture data to assess post-market risk prior to putting the product on the market, which could ultimately harm patients.
Some of the survey respondents said they find it difficult to create and define the risk matrix, and/or have difficulty tying risk mitigation to design controls. The report noted that for some, the challenge is a lack of high-quality data to tie back to design controls. Still, others say it's a lack of proper tools to ensure all the required documents get updated.
Greenlight Guru reported that of those surveyed, 42% say they worry about issues related to product risk outside of their work days, and 29% say it has a moderate or serious impact on their quality of life.
The report also noted that many survey respondents spoke of fragmented processes for capturing post-production information and feeding it back into the risk management file. Less than half say that feedback loop is effective, according to the report. When asked what challenges they face integrating post-production information back into their risk management file, one respondent said the problem is the terminology because post-market feedback is typically from a patient or medical device user while most companies review the feedback from a scientific or technical perspective, so the definition of terms is often different between the feedback originator and the internal reviewer.