Which Came First, the Regulatory Chicken or Egg?

So…Imagine that you have a product that your favorite salesperson has brought to the attention of the marketing manager and upper management. The idea was brought to the sales rep's attention by one of his customers, Dr. Famous, who is a new customer and is a renowned healthcare provider. You very much want to keep Dr. Famous as a top customer, and this may be the product to do it.

Who are you? As a member of the R&D department, you've got a great reputation and it is critical to keep Dr. Famous as a key customer. What's your first course of action? Design a prototype? Who do you need to speak with in other departments? Who needs to know? When do they need to know? What do marketing and sales plan on saying about the product?

Are they telling management about the date that they plan on launching the product? Which trade shows will they use to promote the product? When do they plan on showing the product?

Hmm…Better get started. But aren't you forgetting something? This is a medical device, and depending on the condition it will treat and the treatment population, this device will require some sort of regulatory affairs effort with whichever country your company is interested in marketing it to. Ugh! Just when you thought you had it all covered, you have a "regulatory process" to deal with.

How will this regulatory process affect what sales, marketing, and upper management wants? We won't know until we talk to regulatory, but when? We haven't built the prototype, and we're not exactly sure how we're going to make the specific parts and pieces work. There's all of these questions to answer!

What we do know is who the product will be used on, and what it is intended to do. What we do have is a videotape of the MD who came up with the idea (as filmed by our top salesperson).

OK, we do have some information, and wouldn't it be helpful to know what we'll need to sell this product? What kind of testing will FDA require? Will clinical trials be necessary? If we use untried materials, will we have to do a lengthy set of tests on the biocompatibility of the material?

Who is going to make this product? Do we have a manufacturing site that will produce this? Will it be produced sterile?

The Big Question: When do I notify Regulatory Affairs? At what point in the development process does it make sense to let them in on the project?

The Answer: When you have the semblance of a product that you believe you can sell for a specific indication(s).

Here's Why:

The regulatory path can be incorporated in to the timeline for future planning and can give investors a reality check with respect to how long it will take to get the product on the market

The Advantage:
If you are small and don't have a regulatory affairs professional on staff, you need to look for one, and keep them in the loop; they will be your liaison with the FDA, and can certainly work with you on strategizing the best plan of action for notifying the FDA, and then...? 

Diane C. Tiernan, RAC, Principal, DCT Ltd.