Which Came First, the Regulatory Chicken or the Egg?

Please…without further ado, let me introduce to you a member of the McCormick LifeScience Consultants Team, Diane C. Tiernan, M.S., RAC, a Device Regulatory professional possessing >25 years industry experience. Diane has worked in large and small device companies, and is currently a private medical device consultant.


Take it Away Diane!

So…imagine that your favorite salesperson has brought a new product idea for a medical device to the marketing manager and upper management’s attention. Dr. Famous is a renowned healthcare provider and a new customer who presented the idea to the rep at a recent meeting. You are eager to keep Dr. Famous as a top customer and enhance your current product line. This may be the product to do it!

Who are you? You are a member of the Research and Development (R&D) team. You have a great reputation, and it is critical to keep Dr. Famous as a key customer. You have a number of questions and you need answers, namely:

  1. What is your first course of action for this device? Design a prototype?
  2. When do other departments need to know about this new idea? Whom do you need to speak?
  3. What are marketing and sales planning on saying about the product? What and when is their launch plan? Will they promote the product at trade shows?

Hmm … Better get started. However, aren’t you forgetting something? The product is a medical device-most likely used to treat a specific population, and therefore will require some sort of regulatory affairs effort. Ugh! Just when you thought you had it all covered, you have a “regulatory process” to deal with.

The Regulatory Process

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 so many questions to answer!

What we do know is whom the product is intended for, and what it is intended to do. In addition, we have a videotape of the MD discussing the idea (as filmed by our top salesperson).

Is this information sufficient to market and sell the product and comply with the regulations? What type 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 materials we use to manufacture the product? Who will manufacture 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: Regulatory Affairs can begin a plan of action, save you time and money, and answer many of your questions including the biggie …

What are the indications for use?

The answer seems self-explanatory; however, often times the indications for use are not clear. It is important to confirm this information as soon as possible. If not, there can be significant consequences. Like what, you ask? Delays in clinical trials and ultimately the lack of FDA approval! Worse still, you may not realize the need for additional data to support the indication until you are well into the clinical trials process and possibly the regulatory review process. Now you are faced with work effort that potentially wastes time, resources, and money! Finally, the more definitive you are with the answer to the question of intended use, the easier it will be to answer additional key items about your medical device and, create a development and launch strategy that is both timely and cost effective. What other questions should you and your team think about NOW from a regulatory perspective? Visit Toto’s tips for more!

Toto's Tips

What Regulatory questions should you have answered as early on in your products lifecycle as possible? Tell us Toto!

(Can’t answer all of these? “Eh–hem”…hire yourself a snazzy, top-notch regulatory consultant [I won’t mention any names, MLC, LLC’s, Diane Tiernan])

Is it really a medical device? What Class is it? Is it a combination product? Will clinical trials be required? What testing will be necessary? Are there guidance documents outlining what are necessary to satisfy the regulatory requirements? What group at FDA will review the regulatory documents you send to the Agency? What is required with respect to the Quality System Regulation (QSR)? Are you ready to comply with design control requirements? What documents will you supply in support of the design control elements of the QSR? Will the device manufacturer be inside or outside the United States? If outside the US, are they a registered medical device establishment? Who will take responsibility for the QSR requirements? Are the documents in the country of manufacture in the country’s native tongue? If so, who will translate the documents for FDA review? What can you legally say about the product (with respect to the sales and marketing effort) and at what point in development can you say it without jeopardizing the product approval process? Will post approval clinical trials be necessary?

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, so add this piece to your plan early on!