The 2022 study found that a majority of companies are not yet leveraging purpose-driven tools made for the medical device industry.
In fact, a notable portion of companies are still using paper and spreadsheets to manage their eQMS.
Pre-market and commercialized medical device companies recognize a need for quality improvement related to product management. While the two critical processes go hand in hand, there are often disconnects seen between them that can ultimately lead to costly downstream impacts.
Measuring quality initiatives is still a developing skill in 75% of pre-market companies. This brings to light a need for more professional education around those topics.
Competence with CAPA is critical in being able to deal with systemic problems found during manufacturing.
Finding, addressing, and managing those problems long-term and understanding what documentation is required to overcome them is easier said than done.
say their supplier management process is average or below average
Of that group, a majority are still using spreadsheets to manage their supplier information, storing their product management data in disconnected systems.
of those who were issued a warning letter took
over 3 years to fully resolve.
Despite the pandemic’s continuous effect on supply chain processes across the globe, many medical device companies haven’t taken sufficient steps to mitigate the risks associated with suppliers.
THE POSITIVES AND THE NEGATIVES
The medical device industry is evolving faster than ever and it can be difficult to keep up.
This report brings the secrets of success to light.
So, what are the 5 things that leaders in the medical device industry doing differently?