The 501(k) Waiting Game

The 510(k) Waiting Game

Here’s some helpful advice on how to maximize the value of your wait

Picture this: your team has worked tirelessly on your new medical device to ensure a smooth 510(k) premarket notification submission—you’ve dotted your I’s, crossed your T’s, reviewed, updated, and finally hit ‘send.’ Excitement takes over, and your device is ready to hit the market, yet you must overcome one last obstacle. Welcome to the 510(k) Waiting Game.

As you are probably aware, a 510(k) submission is required to get FDA market clearance for most Class II medical devices. The FDA has 90 days to review your submission; however, those of us in the medical device world know that most submissions take at minimum six months, and in most cases, 9–12 months. During those months, the FDA may have some questions for you and issues for you to address, but the bulk of your time is spent waiting. And waiting. And waiting. At this stage in the game, you may be asking yourself, “now what?”

Here are two things you can do while you wait:

1) Read that nice, thick, classic that’s collecting dust on your bookshelf.
2) Implement a service design strategy.

Service design can be defined as the process of creating the best possible experience for your customer as they engage in a transaction with your company. For medical device manufacturers, this might entail device installations, integration projects, or ongoing technical support.

While you may have perfected the engineering in your medical device, how much time have you put into engineering your customer experience? It’s no longer acceptable to drop your product off at your customer’s doorstep. You need to work in concert with your client to properly integrate your product to their HIS. Your solution must deliver on the promises made during the sales process. By using service design, you can architect procedures that speed up delivery, lower implementation costs, and increase customer satisfaction.

“Service design is like a lollipop wrapper. A good one comes off effortlessly, revealing a perfect lollipop. You are pleased and satisfied with your experience. With a bad wrapper, it shreds, it sticks, but most importantly—it frustrates you. Unhappy, you hastily hand it over to your mom to complete.” – Steve Krueger, Director of Quality Assurance and Regulatory Affairs, True Process.

You don’t have to be impatiently waiting on your 510(k) approval—you could dive into that old dusty classic or better yet, implement a successful service design. We recommend option two. So, what are you waiting for?


Learn More about Medical Device Service Design with our Free E-Book!

Learn the basics of service design philosophy and how you can implement a program to increase the quality and efficiency of your medical device’s implementation, integration, and support services.
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