Howard Samuels: Once you are granted regulatory approval, what affects the amount of time between the approval date and when the product becomes available?
Tracey Kruger: There are a lot of things that can affect that. We always try to be prepared so that commercial launch can take place quickly following an approval; however, sometimes we need extra time for things such as operational readiness. We need to ensure that we have built a sufficient quantity of all components of a product to be able to satisfy the demand. For a product such as Neptune, this included new headpieces, multiple cable lengths in several colors, color caps and covers, not to mention the processors themselves! We always try to avoid any issues related to insufficient product availability to avoid backorder situations.
Other examples of things that can cause delays are completion of all necessary documentation, availability of supporting materials or even something as simple as updated product order forms. Of course, we know these things are needed and do our best to ensure that we have completed all necessary work prior to receiving regulatory approval but on occasion unexpected issues can arise that cause delays. We just do whatever we can to minimize this – having a great team really helps!
Finally, another reason for a delay in release of a product is actually more to do with strategic planning. There may sometimes be good reasons to delay the launch of a product in some regions of the world in order to introduce it at the most optimal time rather than solely based on when it receives regulatory approval.
Cedric Navarro: And sometimes it is a regulatory strategy. How you bring a product to market in the US is very complex. Because there are a lot of concerns in the medical world today, the FDA is an agency that is predicated on protecting patient safety at all costs. Sometimes that means it’s that one in a million concern that they have for that patient that delays an approval. To mitigate this risk, we may develop a regulatory strategy for approval of only a portion or feature of a new product that we may not intend to bring to market on its own. This approach gives the agency a chance to thoroughly review the data so that they are comfortable that there are no safety issues. Once you have completed that, then you will submit the more significant change that you intend to put into the market. And the purpose of breaking the submission up in phases is kind of like that old joke, how do you get down off an elephant? Well you don’t, it’s just too big. So if you split a large new system in portions, it can make it easier to get through the review cycle because that allows you to get a portion of the system approved that the agency is now confident with. Then you can focus on the next portion.
HS: Back to the operational aspect, are you in communication with the FDA during the approval process?
CN: We are, however, by law, one thing the FDA is not allowed to do, is to provide any company with a proposed approval date of when they think it will happen. So what happens is, once you get to about the 100-day point in the cycle, the FDA tries to respond to all applicants within 100-120 days. If we haven’t heard anything by the end of those 120 days, usually we are feeling pretty confident.
HS: Just prior to the end of the approval cycle, you really don’t know if the FDA is going to come back and say, ‘you know, this may potentially cause a sore on the back of the ear.’ So you don’t want to manufacture a bunch of product that you may have to discard.
TK: We sometimes manufacture prior to receiving approval if we are very confident that nothing like that will happen. This is actually quite common when it comes to things like user guides, which are often susceptible to late changes by regulatory bodies. It is another one of those things that can definitely hold up a product launch. It often takes a great deal of time to implement such changes, go through approvals of the changes and then produce the product with the change incorporated.
HS: What are the differences dealing with global regulatory agencies? What additional work is involved?
CN: The nice thing about global harmonization is that there is not a lot of additional work in terms of the testing and the type of work that is done. However the regulatory pathway is different. Some countries require a different regulatory pathway depending on where the product is manufactured. For example, some countries require U.S. approval before we can submit to their country. Other countries have their own regulations that we need to follow.
HS: What are you allowed to say publicly about new products at various points in the approval process?
CN: That’s actually very limited, and again the US is the most restrictive market. It’s not only what can we say, it’s what can we show. Before a product is approved, we are not allowed to make any commitments about potential dates of launch or product claims.
We have to wait until we have a product in a submission before we can show a product. And then it has to be clarified that this product is under development. If we decide to show a product while it is under regulatory review, we can’t talk about its performance or its features and we must state that it is pending regulatory approval.
TK: Outside of the US, the rules are different. In Europe, for instance, we could talk about an unapproved product, and even take orders for it before it is commercially available if we wanted to, without regulatory approval so long as we state that it is still pending regulatory approval.