• Melita Ball

July 28, 2020 Blog Post

Emerging Medical Device Companies

An FDA Compliance Roadmap – Part 2

Welcome to Part 2 in this FDA Compliance Roadmap for Emerging Medical Device Companies.  If you missed Part 1, you can read it <<HERE>>.

If you followed the guidance for the Idea Phase, you should have a basic understanding of what it’s going to take to get your product to market and you should be grounded in a realistic approach to achieving your goal.  You are now ready to move to the Research Phase

In the Research Phase, you will refine the details for your step by step approach to a successful launch.  You will determine where you want to market your device with short-term and mid-term goals, you will refine your understanding of your product as it relates to safety and risk, you will define a development model to use, and you will identify the components of your initial Quality System. 

Let’s dive into the actionable tasks critical to the Research Phase.

  • Develop a Marketing Plan and a Regulatory Plan – A marketing plan is essential to understanding the regulatory requirements for the countries where you would like to market the device.  Without a well thought out market strategy, your regulatory plan will be woefully inadequate and will likely cause delays and rework once you begin development.  Countries have different regulatory pathways to get your product to the market.  If these aren’t accounted for early in the process, you may not have what you need when entering that particular market.  Much of the non-clinical & clinical data is the same; however, the documentation needed varies widely from country to country.  With a good plan, much of this can be set up for future implementation without undue work.  Without it, you will find yourself constantly re-producing evidence instead of leveraging what you have.

  • Define Submission Requirements – Just within the United States there are a number

of submission pathways.  If you add in other countries, it can become quite complex.  The safety and risk classification may differ from country to country along with the submission requirements.  Selecting the correct submission pathway(s) depends on a number of factors. It is of critical importance to engage knowledgeable experts here to ensure you have the correct submission pathway and any special requirements for the type of device you’re making.  Did you know that there are three (3) types of 510(k) submissions?  In addition to the 510(k)’s, there’s the PMA process and the De Novo process.  In Europe, there is a special process to obtain a “CE Mark” … without it, you cannot sell in Europe.  These are just a few of the items you will need to consider as you refine and develop the requirements for getting your product on the market.

  • Determine your Development Model – There are lots of development models to choose from.  The traditional Waterfall Model is the most common and easiest to understand for small companies; however, if your device is software, the V-Model might be a better choice.  Another popular model is called the AGILE Methodology.  Although this is a popular method for fast prototyping, it is less effective in demonstrating compliance to all of the documentation requirements for design and development.  Other models include SDM or Spiral Method, Evolutionary Prototyping Model, and Iterative and Incremental Methods similar to AGILE.  For small companies not highly skilled in some of these more complex methodologies, we usually recommend sticking with the Waterfall Model or for software, the V-Model.  These

models have a lower learning curve and are recognized by global regulatory authorities.  Regardless of which model you choose, the regulatory requirements need to be built into it.  In the US, 21 CFR Part 820.30 defines those Design Control requirements.  For the European Union, they are defined in ISO 13485:2016 Section 7.3.  In addition, the Product Risk Management Standard requirements need to be implemented as part of the full life- cycle for your device.  These requirements can be found in ISO 14971:2019.

  • Define Initial Quality Management System – At this stage, you certainly don’t have to have a fully developed and implemented Quality Management System; however, you should implement a number of foundational elements for that system to support the operations that you will have shortly.  A good way to identify which elements you need to implement now is to review the 7 Subsystems of Quality and ask yourself … which of these apply to me now?  Then, take those elements identified and implement processes and procedures around them.

  • BONUS HINT: Stay tuned for Part 3 where we will walk you through which of the sub-systems you need to implement now.

In Part 3 of this Blog series, I will lay out what you’ll need for the Development Phase.  Again, we will cover actionable steps that will propel your business forward while preparing you for operating within this highly regulated environment. As always, thanks for reading!  Stay safe and be well!

Thoughts? Please comment below …


Melita Ball

CEO and Principal Consultant

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