Main Reasons for Design Control and Risk Management Failures (Part 1)

I have been asked numerous times what I believe are the biggest challenges to great design control execution.  Design Control when done correctly consistently ensures that the right device is designed with the patient’s health and safety in mind.  


There is a great article by Jon Speer titled 8 Reasons Design Controls And Risk Management Processes Fail by Jon Speer, founder & VP of QA/RA, greenlight.guru. It highlights some of the key issues that repeatedly plague Design Controls and Risk Management execution. 

I think this article is on point. However, I would add to these reasons the following:

• not having the right resources at the right time on projects, 
• focus on timelines above patient needs throughout development,
• focus on short term project cost instead of total lifecycle costs of the device.   

These show up as deficiencies in design inputs, risk management and design review that cascade further and are the root drivers of numerous execution mishaps.  I have mentioned in the past organizations need to re-evaluate the way they do business.  They must assess Quality Systems to look for opportunities to help stay ahead of the changes effectively and efficiently.  This is a key area that impacts the entire product lifecycle and must be addressed to survive in the future.  

I will dive further on this take and explain why these are key in a series of upcoming posts.