In medical product development, correctly identifying and committing to your FDA approval process or pathway can make or break many new projects. It’s not as simple as, “I have an idea,” “I’ve made a prototype”, or “does the device work?” Project success is dependent upon careful planning and consideration across all functional dimensions – regulatory, technological, clinical, commercial, legal, etc.

In a process we define as “Phase Zero,” we ask and answer the following questions to better understand a technology’s development pathway.

  • Is there a market for the product? Will someone pay for it?
  • How will your device improve outcomes compared to the current standard of care?
  • What is the product’s FDA approval pathway?
  • Can you protect your technology with Intellectual Property (IP)? Who are your competitors?
  • What are the critical design elements, specifications, and user needs that make your device work?

At the end of Phase Zero, an innovator will better understand what makes their technology function, what makes their concept unique, and what they need to do in a methodical, objective, stepwise manner to get that product through successive “phase gates” into the hands of end-users.

Asking the right questions and getting objective answers will define future work streams and funding. Here are six critical items to know about the FDA pathway at Phase Zero.

  1. How much does your FDA approval pathway selection matter?

510K, PMA or Class 1 (no regulatory)? This is a high dollar decision that will define future work streams, timelines and funding. Adding features or claims for reimbursement capability can result in a more valuable product with modest work adds. An FDA 510k project may be comparatively more expensive  to accomplish compared to a Class 1 product, but can double valuation. The goal: make a knowing decision on your landscape (payer, IP, etc.), and move forward fully informed about what you’re doing and how.

  1. What is your competitive landscape and how are those competitors regulated?

If there is an FDA approved predicate device? How is it compared to what is currently on the market? What are its indications for use, and what testing has it undergone? Knowing this information early-on in the process can help point your efforts in the right direction, and ensure that you haven’t missed any critical workstreams required for approval. This will also inform your marketing. More on that in a minute.

  1. What does the FDA care about?

Having a patent is good, but the FDA cares deeply about several other variables.

Does the product perform correctly, and as expected? Is it safe and effective? How, and with what controls, will your device be manufactured? These variables can have huge implications on your development process. To avoid costly and frustrating surprises, predict how your device is going to be regulated before you get deep in the development process!

  1. The FDA won’t ask about your reimbursement strategy.

Reimbursement from insurers like Medicare is tied to claims and objective evidence generated. 510K products are constrained on what the makers can say about their device and charge for it. There are also established valuations for products that solve similar problems. Because this is critical to medtech entrepreneurs, Phase Zero examines reimbursement closely. The FDA won’t ask what your reimbursement strategy is. Yet the value of a product and the ability to get it paid for is closely tied to your labels and marketing claims about which they care deeply.

The claims your product makes, directly affects its marketability. Failing to give marketing claims the attention they need early can have significant adverse effects on a product’s time to market, reimbursement and profitability.

  1. How long it takes for your FDA submission varies.

How long it takes to submit for and receive FDA approval varies based upon device classification. An efficiently executed FDA 510K-project can take between 12 and 18 months to complete. Our team made the journey from the back of the napkin to 510K application in 11 months with a highly motivated entrepreneur and young company, NFANT Labs. For products requiring preclinical testing, that time can vary drastically depending upon the study requirements.This variability points to the importance of knowing your devices regulatory requirements as early as possible in your development process!

  1. Your third party service providers matter to the FDA.

The FDA will absolutely concern themselves with product design engineers, project engineers and third party testing labs for items like packaging, biocompatibility and preclinical testing. Always hire experts to do this on your behalf. GCMI maintains a pre-vetted approved supplier list complete with ISO certifications, test lab certifications or accreditations, test lab standards and have audited against those standards or measures of compliance.

If you need help evaluating your medical product’s market landscape, regulatory pathway and whether or not it warrants further investment, email GCMI at , visit our website or fill out our online inquiry form.