product development articles

Beyond the Risk Management File


When we work with medical device companies we find that the Risk Management File (required by regulatory bodies and specific to user and patient safety) is integrated into the product development process. However, project risk is often ignored or is a one-off risk exercise that is rarely revisited throughout the project. 

If you don’t manage project risks, a lot of unfortunate things can happen, including the following:

• Products that are not commercially viable
• Products the salesforce will not sell
• Unproven technology feasibility
• Projects that are rarely killed
• Cost overruns
• Suppliers that can’t meet the project’s needs
• Schedule delays
• Constant firefighting mode

The list goes on…

How do you go beyond?

To assist in eliminating the events above, we suggest that you measure risk beyond the Risk Management File. If you have a new product development process, integrate your risk/assumptions within your process activities. Work as a cross-functional team to identify, prioritize, and resolve the risk.

Begin early, when the project may only be a preliminary idea, to start capturing risk around market viability or new technologies. For example, early on within the process one of the first things you want to do is determine if there is a viable value proposition. If there isn’t one, you probably want to kill the project quickly. The key here is to optimize your resources in order to work on the most valuable projects.

As you move through the process, continue to review, add new risks including technical and operational risks that were not foreseen at the beginning of the project, and actively manage them.

While there will always be something that pops-up in a project, actively managing the project risks can prevent or mitigate most of the surprises and allow the team to proactively manage the risks instead of constantly reacting to them.

Part of our ‘In the trenches of new product development series’