Most medical device companies want to “Do it right”.
They typically do the right things when developing a world class device. They take all the right steps. No shortcuts.
As a matter of fact, some of the most successful companies ” work closely with the enemy” (i.e. the FDA) and even seek advice from the meanest plaintiffs attorneys they can find….you know the ones.
I’m Kidding, Right? No!
Think about it: this kind of preparation may actually help create the barrier for problems down the road. Set another hurdle for plaintiff attorneys to jump over if you have a bad claim.
One of my good friends tells a story of the very proud CEO on the witness stand who boasts about how he followed every FDA guideline when developing their product….only to hear the plaintiff attorney ask “so, you only did the minimum that was required of you?” Not a good outcome.
Will it Be Expensive? What Will This Cost Me?
Then of course, its the age old question of “how do I measure the ROI?” Its similar to how do you predict the stock market or how many fish you will catch.
We think it is about the skill level of risk takers more than the risk itself. Those that get it seem to have an inherent understanding of the presence of risk and recognize there is ROI already in play; they just cannot measure it as accurately as other costs or revenue.
One way of quantifying ROI is to demonstrate that there are historical patterns to claims. While they can never be completely controlled, damages from exposures can be lessened by knowing what to avoid and how to mitigate once arrived.
You do this through identifying cost drivers to your business and applying techniques and processes to eliminate cost and inefficiency.
Contact me to discuss further.