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.