When a new device is introduced into the market there are series of assumptions made; in research and development, in design, in risk analysis, in the performance specifications, in the instructions for use and (most importantly) in the indications for use.  Initially these assumptions are based on near-ideal conditions and in the belief that the device is safe and performs as intended. 

• How well do the assumptions hold up after a year or two?   
• After perhaps hundreds of thousands additional uses? 
• What happens when the device is used in less than ideal conditions? 
• Are your assumptions still valid?

No one knows a device better than the manufacturer, therefore you are by far in the best position to determine if the device is performing within expectations.  Manufacturers who operate a sound, systematic, ongoing process gathering and evaluating pertinent information on the performance of their devices can not only answer those questions, but also they will have several valuable advantages working for them:

1. Defects and shortcomings are identified in advance of occurrence
2. Next-generation devices are more sophisticated, robust and useful
3. Enhanced device performance
4. Improved patient outcomes
5. Indications for use are expanded
6. Potential injuries are reduced and perhaps eliminated
7. Health care providers support the continued use of your device

Regulatory agencies agree – the vast majority of defects come from insufficient design or poor manufacturing practices.   A professionally-executed post production monitoring program will help identify shortcomings and provide an array of corrective actions for your consideration.