Does Regulatory Affairs put the "no" in innovation?
- Thread starter Watchcat
- Start date
blackholequasar
The Cheerful Diabetic
LOL I mean, the idealist in my hopes that it provides a safety structure but... I mean, maybe I laugh because if I don't I'll cry? Seems pretty accurate to me 
Our innovation can make life difficult for our competitors especially if it encourages regulators to tighten their requirements.
Likewise, our competitor’s innovation can make life difficult for us.
Likewise, our competitor’s innovation can make life difficult for us.
Seems to me that innovation always brings new risks to be assessed, while RA would like to "eliminate" risks, for obvious reasons. Progress is impossible without some level of risk taking.
It is a balancing act. I'll give a personal experience with a RA saying "no" to innovation.
As a Navy officer, I was assigned to a Torpedo Maintenance Facility. A new type of torpedo had come out. We had a lot of problems with the maintenance procedures not being very specific, full of "if applicable" clauses, and changes affecting previous changes in some procedures not others. And the Navy shipping us faulty parts and incomplete torpedoes. But if a mistake was made, the RA (in this case "NUSC") said the enlisted sailors "knew what to do" and every failure was the sailor's faults. Another officer and I started documenting issues, and even circulated a sarcastic cartoon about the parts and incomplete issues. We submitted many procedure changes. But the very same NUSC that inspected us was the procedure writers. They claimed they got dinged for "making too many procedure changes" so refused to allow ours.
In the end, the other officer and I prevailed, I even got an award from the Navy, but it was an uphill battle the whole way.
By the way, for those familiar with military history, consider we went into World War II with faulty torpedoes that would not work, but the Navy RA accepted them, would not listen to the users who fired dud after dud, and inadequately tested them
As a Navy officer, I was assigned to a Torpedo Maintenance Facility. A new type of torpedo had come out. We had a lot of problems with the maintenance procedures not being very specific, full of "if applicable" clauses, and changes affecting previous changes in some procedures not others. And the Navy shipping us faulty parts and incomplete torpedoes. But if a mistake was made, the RA (in this case "NUSC") said the enlisted sailors "knew what to do" and every failure was the sailor's faults. Another officer and I started documenting issues, and even circulated a sarcastic cartoon about the parts and incomplete issues. We submitted many procedure changes. But the very same NUSC that inspected us was the procedure writers. They claimed they got dinged for "making too many procedure changes" so refused to allow ours.
In the end, the other officer and I prevailed, I even got an award from the Navy, but it was an uphill battle the whole way.
By the way, for those familiar with military history, consider we went into World War II with faulty torpedoes that would not work, but the Navy RA accepted them, would not listen to the users who fired dud after dud, and inadequately tested them
Watchcat
Trusted Information Resource
An interesting story, one I think pretty much everyone who has worked with any large organization can relate to. However, within the medical device world, "innovation" means developing a new medical device. The role of "Regulatory" is also very different from other environments, including that it has nothing to do with acceptance of incoming materials. That's a Quality function.
Watchcat
Trusted Information Resource
To quibble, one way I describe the difference between Legal and Regulatory is that Legal wants to avoid risk, while RA wants to manage it. Avoid risk avoid reward. This is why in Big Pharma's heyday, RA had a lot more clout than Legal. The huge reward associated with a blockbuster drug gave Big Pharma a high tolerance for risk.
When someone starts talking about reducing risk "as low as possible," I think the lawyers are in charge. Assuring that risk is lower than warranted by benefits is a better fit for the RA mindset, IMO.
