6 Safety Questions to Ask During the Medical Device Development Lifecycle

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:

1. Have all the safety risks been identified for normal use of the device?
2. Have all the safety risks been identified for foreseeable misuse of the device?
3. To what extent are the identified risks minimized through routine design development procedures, product testing, and application of industry standards?
4. To what extent will warnings and anticipated adherence to those warnings minimize the hazard?
5. Could an alternative, lower-risk design be used?
6. Given the identified risks of the product, do you, the manufacturer, consider the device to be reasonably safe?

References

Whitmore, E. (2012). Development of FDA-regulated medical products: A translational approach (2nd ed). Milwaukee, WI: ASQ Quality Press.