The Real Role of Regulatory Affairs

Our next video in our Enable Wearable Delivery executive video series features Russ Pagano, Vice President of Regulatory Affairs & Quality. Tune in to learn more about how regulatory departments act as salespeople for a company!


Transcript below:

Hi, I’m Russ Pagano. I’m the VP of Regulatory and Quality here at Enable Injections, and I’m here today to talk a little bit about regulatory and the regulatory pathway for our products.

When people think of regulatory, typically they think of something restrictive, something binding where we say no a lot. We tell people you can’t do this, you can’t do that. However, I look at us as being salesmen. We’re really the first line of salespeople for the company. And why do I say that? Well, because when you think about it, Enable’s goal is to really treat and help patients as much as we possibly can. But in order to get a product to patients, we have to go through a number of customers. A number of customers have to buy off on our technology. They have to agree that it’s safe and effective.

So, who’s our first customer? Our first customer is obviously ourselves. We need to make sure that we are perfectly comfortable with the product, that the product is going to be safe, effective, it’s going to work, it’s going to do what it says it does, and it’s going to really help people. Otherwise, what’s the point of doing what we do?

The next couple of customers are slightly different than you would think. They’re not really hospitals, it’s not doctors. Those are the end customers, if you will, who then treat their patients and work with their patients, with the product. Your initial customers are really the big drug companies and the regulatory authorities.

So the big drug companies, we have to convince them that we’re safe and effective, otherwise they’re not going to partner with us. They’re not going to want to use our product with their drug. Obviously these drugs are worth billions of dollars, some of them, and they want to make sure that they’re being able to apply that and send that to customers in a manner that is going to be an improvement over what they’ve currently done. So, we need to sell that. What’s the first question that big drug companies to ask us: Are you approved? Can you sell your product in the market? And right now, our answer is no, but we are rapidly on our way heading towards approval.

And how does that work? Well, that works through the company, with regulatory taking some of the lead as selling to the FDA, the Food & Drug Administration, to the European market, the European Medicines Agency, we need to sell our product and convince them that we’re safe and effective. All the work we do behind the scenes, all the testing, all the design development, all of that comes out and has to be presented in a manner such that an intelligent, scientific person who knows nothing about the product can now take it, see it, and say yes, this is something that the American people or the European folks, or the rest of the world, should have. Through that, once they are okay and once they approve us, then we turn it over to the sales and marketing force and others who then go out and sell to hospitals, etc. and convince the hospitals that this is a good thing for your patients. And hopefully at the end of the day, we have a bunch of happy patients. Thank you.


The investigational enFuse system has not been approved for use by any Regulatory agency and is currently not approved for commercial use.