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Medical Device Design Control Auditor Recommentations

Ronen E

Problem Solver
Staff member
Super Moderator
#11
design controls are simply a name created by regulators to specific certain milestones that any good design process should have anyway
Spot on (only I would have used "tools and milestones" rather than "milestones" only).

I like to think of (good) MD regulations as grounding established best practices.
 
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Watchcat

Quite Involved in Discussions
#12
I will have to think more about this. You are outside my scope of expertise on some of it.

(what is called "design controls" by regulators should be already part of any good design practice).
Agreed. This would seem to dictate that design controls do exist outside the regulatory world, just not the term? Seems to me that it's either that, or good design practice does not exist outside the regulatory world.
 
#13
I will have to think more about this. You are outside my scope of expertise on some of it.

Agreed. This would seem to dictate that design controls do exist outside the regulatory world, just not the term? Seems to me that it's either that, or good design practice does not exist outside the regulatory world.
The need to control the design process always existed, but the concept did not have a name (it was not called "design controls").

Maybe the problem is the focus on the "regulatory world". Regulations (and standards) are simply a collection of good practices from the several fields of science, they do not create anything new. In the case of engineering design, what happened is that the best practices of engineering design from the engineering design literature were evaluated, and the some were included as requirements in the regulations.

What is very common is that they invent some new names for things (for example, you won't find the term "risk management file" in risk management literature, outside the medical device standards and regulatory world because it was created to provide a way to verify the related process by regulators.

This is the same for design controls.
 

Watchcat

Quite Involved in Discussions
#14
Marcelo, agree and agree and agree. Many people seem to think FDA invented...well, a lot of things, but I don't think regulators ever invent much of anything. They tend to be collectors, which they formalize by incorporating them into regulations and guidelines and giving them labels.

Speaking of labels, your reference to "engineering design" got me to wondering if by this you mean the same thing as "device design," or if you think there is potentially a distinction between the two?
 
#15
Speaking of labels, your reference to "engineering design" got me to wondering if by this you mean the same thing as "device design," or if you think there is potentially a distinction between the two?
Medical device design (as the design of almost everything) is a subpart of engineering design (surely, you do not need to be an engineering to design anything, but the best practice design process is called engineering design, so even if you are not en engineering, it would be good to use this anyway).

See this for very generic information: Engineering design process - Wikipedia.

The most know book on the subject (by Pahl and Beitz) also is called Engineering Design - https://www.amazon.com/Engineering-...g+design+pahl&qid=1569252677&s=gateway&sr=8-1
 

Watchcat

Quite Involved in Discussions
#16
is a subpart of engineering design

See this for very generic information: Engineering design process - Wikipedia.
The most know book on the subject (by Pahl and Beitz) also is called Engineering Design - https://www.amazon.com/Engineering-...g+design+pahl&qid=1569252677&s=gateway&sr=8-1
And engineering design is also a subpart of medical device design. At least, in the way I think of medical device design, which involves more than engineers. I don't know if that's meaningful, though. Will have to think about it.

Thanks for the references. I look forward to reading them. Is there a book specifically on medical device design that you would recommend?
 
#17
And engineering design is also a subpart of medical device design. At least, in the way I think of medical device design, which involves more than engineers. I don't know if that's meaningful, though. Will have to think about it.
Sure, engineering only exists for medical devices :p Not sure if you are kidding or not, sorry.

To be clear, it's obvious that any system design includes more than only engineers, but designing systems and processes (including medical devices) is an engineering discipline, that's why it's called engineering design.
 
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#18
Regarding books specifically for medical device design, there are several, but I do not like most of them, unfortunately. Right now, the one that I think is the best of the bunch is Medical Device Design: Innovation from Concept to Market, from Peter J. Ogrodnik. But even this one has several problems (for example, as all other books on the topic, it makes a mess of medical device risk management).
 

Watchcat

Quite Involved in Discussions
#19
Not sure if you are kidding or not, sorry.
No, not kidding, but perhaps not clear/misunderstood. To me, a complete medical device design team includes design engineer(s), marketing, regulatory, quality, and manufacturing. It is the role of the design engineer(s) to do the engineering design, but that's along way from being the entire medical design process.

This could be a matter of semantics, since I have left off "...and development." Perhaps your perspective is that all the other bits as development, not design? If so, that works, too. Just not how I think of it.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#20
I think of it this way.
You start off with design, which splits into the technical side (which I refer to as engineering design) and the artistic/conceptual/psychological side, which is many times termed "industrial design".
That's generic. Under engineering design you can find, among other fields, medical devices engineering design. Similarly, under industrial design you can find medical devices industrial design.

Development is the process from identifying a need to the provision of a solution to satisfy this need. Engineering design and industrial design of a product may be parts of this process. Marketing, regulatory, quality, manufacturing - they all should feed into that process as well, where applicable. And this whole lovely bunch of course interact with each other in multiple ways...
 
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