The Ability to Zig Zag Through Medical Device Product Development

If you have been a part of medical device product development, there is a good chance you are somewhat familiar with the image below:

Most refer to this as the FDA Design Control waterfall diagram (the origin is actually Health Canada) and is referenced in FDA Design Control Guidance document.

Since starting my career as a product development engineer for a medical device company and my first exposure to this image, I have been fascinated by it. In many respects, the image is pretty good at showing the progression of Design Controls during product development. Many interpret and infer that Design Controls = Product Development. There is definitely a dependent relationship of sorts. Design Controls are generally part–albeit a huge part–of medical device product development. Many companies have implemented a phase approach to product development. Often times these phases coincide with the Design Control diagram shown above.

What I continue to find interesting about medical device product development and Design Controls is that we continue to express this process as a linear progression. Yes, when I write procedures for product development and Design Controls, I use phases to describe the process. But do phases really make sense?

Let’s use the image above to evaluate a little more. I interpret that in order to establish Design Inputs, I first need to establish User Needs (and so on). By a strict interpretation, you cannot finalize Design Inputs until you have first finalized User Needs.

Is this how medical device product development works in your organization? I speculate that the answer is no.

In practice, you likely have a fuzzy list of User Needs. The list is rarely complete before you start to define Design Inputs. In fact, you might even begin creating Design Outputs before you have even officially finalized the list of all User Needs.

Doesn’t it make more sense to get as much as of your medical device to Design Verification and Design Validation as quickly as possible? I speculate yes.

This type of approach is more logical but complicated by a few things, including:

  • Your procedures dictate product development phases
  • Your organization may require you to complete one phase before proceeding to the next
  • You likely do not have good tools in place to allow you to effectively manage this type of approach

But what if you did have a tool that would allow you to manage the more natural way of product development? What if you have a software solution to capture all Design Controls which provided clear, easy to follow linkage for each element in one place? Do you think this tool exists? In my experience and research, not really. At least not until now.

This is why Creo Quality is launching UniDoc. UniDoc is the collaborative way to manage design history for all your medical device projects.

It’s time to use a tool to help you manage your Design Controls and product development efforts in a more logical, efficient way. Contact us to put UniDoc in place at your company.

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