Medtech complaint handling: Is there something to complain about?


medtech complaint handling unhappy frown face angry

[Image from Andre Hunter on Unsplash]

Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey.

The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process.

Only 18% planned to increase their complaint handling budget, and 13% actually planned to cut it, according to the report from Sparta Systems (Hamilton Township, N.J.). (The full report is available on the company’s website.)

Placing quality management on the back burner can come back to haunt a company. In fact, more than 90% of respondents indicated that up to a tenth of their complaint records were escalated to regulatory agencies.

“Our report indicates that many organizations within highly-regulated industries are continuing to fight an uphill battle in order to overcome a number of complaint handling challenges,” Joe Humm, VP of sales operations at Sparta Systems, said in a news release.

“In the long run, improving these processes and effectively leveraging customer complaint and quality management data will have a significant impact on a company’s bottom line by minimizing the risk of compliance issues and faulty products while quickly escalating key issues to development teams and regulatory bodies,” Humm said.

Other report findings included:

  • Nearly half of respondents still use antiquated point solutions, paper-based systems, Excel or Access for complaint handling. Among those deploying a point solution or centralized platform, only 10% are leveraging cloud infrastructure.
  • Nearly a third have never used complaint handling data to optimize their complaint handling process.
  • Companies were nearly evenly split when it came to using complaint handling data: 27% use it for improving manufacturing processes, 23% for escalating key issues to regulatory bodies, 24% for looking for data signals, and 23% for discovering product innovation or improvement opportunities.
  • Complaint management challenges include producing actionable insights out of it, designing sytems to capture appropriate data, transposing data from reporter to complaint professional, and employee training.

Sparta Systems is a provider of cloud and on-premise quality management software.

(Learn from some of the medical device industry’s top executives and experts at DeviceTalks Boston on Oct. 2.)

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