In an earlier post, I identified ten questions that are important to answer when developing innovative medical devices. These are general questions that cover a wide variety of topics, without initially diving too deep. But, it’s also necessary to drill down and answer more specific safety-related questions.
Whitmore (2012) has identified six questions that are a good starting point for addressing potential risks associated with medical devices. They include:
- Have all the safety risks been identified for normal use of the device?
- Have all the safety risks been identified for foreseeable misuse of the device?
- To what extent are the identified risks minimized through routine design development procedures, product testing, and application of industry standards?
- To what extent will warnings and anticipated adherence to those warnings minimize the hazard?
- Could an alternative, lower-risk design be used?
- Given the identified risks of the product, do you, the manufacturer, consider the device to be reasonably safe?
Whitmore, E. (2012). Development of FDA-regulated medical products: A translational approach (2nd ed). Milwaukee, WI: ASQ Quality Press.