ECRI’s annual list points the finger at poor cleaning of flexible endoscopes.
Device manufacturers are concerned about data availability and security, as well as risk to their brand.
As additive manufacturing comes to the forefront as a disruptive technology, industry continues to speculate about how liability will be shared.
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.