When does Medical Device New Product R&D stop and Design start?

[Lbrager]

When developing a new medical device intended for FDA approval and CE marking, when does R&D stop and Design Engineering start? In particular, for Design Control purposes at what point are you officially designing and developing and no longer in R&D? We are developing an IVD product shared by 3 different business units (assay, instrument, software) and it is difficult to delineate tasks by department (R&D vs. Engineering). It seems there is a lot of overlap. I am trying to determine a clear milestone for determining when design control would begin - after feasibility in theory, but again what activities are truly feasibility vs. actual design and development?

 

[Marcelo]

Design controls really start in the initial phase of the medical device lifecycle. You need to develop a plan to control the entire design process - in fact, by today standards, a device design process is a lifecycle activity so you need to keetp the design process wo=rking during the whole device/technology lifecycle.

Anyway, the first step is design planning. You need to perform this in the beginning to make sure that your process is controlled. Just remember
- plans are expected to be update as needed.

The next step in design controls, design input, depends on your device design process.

For example, if you have a conceptual phase, you still do not have a defined device for design and development, you only have concepts. R&D is usually related to this stage (and maybe an informational phase before that).

When you decide which concept to design and develop, you need to continue with the design controls requirements. In the example, the end of the conceptual stage (where you defined the requirements for the device after selecting a concept) is in fact your design inputs.

Then detailed design and develop, design output (device parameters and characteristics), and the rest.

 

[Sidney Vianna]

When developing a new medical device intended for FDA approval and CE marking, when does R&D stop and Design Engineering start?

Have a look at this FDA presentation by Kimberly A. Trautman, Associate Director for International Affairs in the Office of the Center Director, CDRH. Pay closer attention to slides 23 and 24.

 

[Marcelo]

Have a look at this FDA presentation by Kimberly A. Trautman, Associate Director for International Affairs in the Office of the Center Director, CDRH. Pay closer attention to slides 23 and 24.

The FDA position is that research in general is not under design controls (although this really depends, as I mentioned, on the design process implemented by the manufacturer as the type of design process affects what research is), so in the FDA case you could begin planning, in the example I mentioned, after the end of the conceptual phase.

However, for CE - ISO 13485, there's a more general requirement for planning of product realization which requires lifecycle planning.

If using a design process based on NPD or something like that (which is lifecycle, also) the only way to meet both would be to plan before the expectations of the FDA. And then you could begin design input after your research phase (this would be as expected).

 

[yodon]

All good replies so far but let me add one thing.

When does it make sense for your business to put things under control? Look at a simple example: department A provides an artifact (drawing, etc.) to department B who relies on the artifact to do their work. If department A changes the artifact without department B knowing, you end up with chaos.

In general, the design controls per regulation are just good business practices. If you follow good business practices, you have met a large part of the regulations.

 

[Marcelo]

All good replies so far but let me add one thing.

When does it make sense for your business to put things under control? Look at a simple example: department A provides an artifact (drawing, etc.) to department B who relies on the artifact to do their work. If department A changes the artifact without department B knowing, you end up with chaos.

In general, the design controls per regulation are just good business practices. If you follow good business practices, you have met a large part of the regulations.

You are correct, however, all regulations and standards are just good practices.

The problem is applying the good practices systematically. That´s one of the reasons regulations and standards have requirements for those good practices.

I think the main problem here is - what do the standards and regulations do not tell?

The requirements are controls for some points, however, it´s not possible to arrive at that points if some control (not required by the regulation but necessary from a business standpoint, as you mentioned) is not used before that.

 

[sagai]

For me R&D is a superset of Design Engineering actually.

The line I would draw is more like a line between manufacturing and R&D.

However, I think I understand what you are saying, what is the latest time whilst I can let this uncontrolled wondering to keep happening.

At the time of product approval, what is really happening in the organization is not obvious for regulators, because the documents you submit is a snapshot of your product to be marketed.
So in an extreme case basically you can be okay, even with a cleared product, as long as you do not have external auditor to uncover any non conformities.
I am not encouraging you to do so, it is simple inherited into the way we have for product clearance.

So, for me most activities in R&D is subject to design control actually, and as long as manufacturing does not take place it does subject to design control.

Cheers!