Integrity is really about character and that is really all we have. A person’s character is demonstrated over a lengthy period of time. Integrity is also a huge part of how I think and operate in any work environment. Further, when I look to either hire direct reports or choose what company I would like to work for or with, I look at character, as it can be quite telling in many ways. If you hire or choose correctly, there would be little concern relative to integrity and following the rules, and focus can be shifted to goals and outcomes. 

My legal experience and background mandates that I act with integrity. We are taught and trained in law that everything we do must be done with integrity and consistent with ethics. It goes to professional liability and in making sure we advance the time-honored values of the legal profession. This is something I do take very seriously, which is why I am a rules follower. 

It is important to distinguish that ethics and integrity can be viewed as two different things (one of which is internal and the other as external). However, I view these as one in the same. If you are not doing one versus the other, clearly at some point, this can cause conflict and become quite confusing and inconsistent. The law of contradiction supports a similar line of thinking, i.e., a thing cannot be both true and false at the same time.

To make this clear, no one is perfect (I am including myself into this as well). Yet, I follow the belief system that we should strive each day to achieve the highest level of personal and professional integrity as much as possible. We do not get a special award for doing such and no one is watching us, counting how many times we are behaving within the lines. However, we should act in a way where our closest confidant would feel proud that we did the right thing. 

Let’s take procedure as an example, as this is an area where integrity meets ethics. I can provide numerous examples of attorneys, who did not follow the rules and were subsequently suspended or disbarred, which are great examples where integrity meets ethics. And these things were simple legal ethical requirements such as the ethics of client trust accounts. 

I learned early in my law school education that ‘procedure is your friend.’ I love this phrase because this is very true and applicable to virtually everything in the legal profession. The risks are simply too high to not follow the rules, as illustrated above. 

While there may be gray areas where certain procedures or rules do not have to be strictly followed, not following those procedures or rules could cause more harm and unnecessary increased risk for the client. This goes to both integrity in how the professional navigates that process and the ethics in whether to follow the rules or not. 

My regulatory experience also mandates I act with integrity. You cannot escape integrity. It is virtually everywhere in the regulatory function and must be taken seriously as the buck usually starts and stops at the regulatory professional, no matter the point in the design control process. I am a rules follower and this has been something appreciated by my employers. They have confidence in knowing I will do the right thing, as they never had to think twice on my work. 

One of the biggest responsibilities of a regulatory professional is serving as a liaison between the regulatory bodies and device manufacturer. Everything from regulatory meetings to regulatory communication (both written and oral) to regulatory submissions require ethical rigor and finesse. Not everyone can act with such. The regulatory professional may have competing interests in getting a device registered quickly and ready to place onto the market for sales and approving an efficient design that is safe and effective while keeping to regulatory and compliance standards. 
 

Though there are gray areas in the regulatory field, if the regulatory professional isn’t following the rules, it will be uncovered. There is no place to hide in the regulatory field. For instance, when a device is designed, developed, manufactured and/or registered with a regulatory body (for instance, with the FDA via a 510k, De Novo or PMA), a regulatory professional is attesting that the device complies with all applicable regulations and requirements, is safe and effective and no information has been hidden or missing from the regulatory submission. My experience successfully interacting with entities like ANVISA, FDA, COFERIS and InDRE, TGA, MHRA, Health Canada, European bodies, DIGiMED, SFDA as well as notified bodies and certifying standards organizations (ISO and MDSAP) tells me that being transparent and providing the necessary information to support regulatory requests (and not cutting corners) are tantamount to showing that the device has not only met the requisite standards but is a safe and effective device to place out into the designated market.

This goes without saying but I will not sign a regulatory submission if I believe it is either not complete and accurate, the regulatory mandates have not been fulfilled or it does not demonstrate that all regulatory mandates have been satisfied, as the device is not ready to be put into the market. It is a legal obligation and must be taken seriously. I believe in the motto of ‘measuring twice, cutting once.’ It is better to do it right the first time than put a device into the market when it is not ready, where there are known and unknown consequences, issues ranging from warranty, device safety, device security issues, brand and reputation damage, as well as various regulatory issues, the list can go on.