Strength verification of surgical instruments

N

nantmel

#1
Hi All,


New poster here, but I've been hanging around for a while and been helped hugely by the wisdom shared on this forum!


I'm a design engineer at a medical device company currently developing plastic surgical instruments for general surgery. I've reached a bit of a mental block around how to create a measurable design input for the strength of the instruments. They are very strong, and in my mind strong enough, but their strength will not match that of the metal instruments so an equivalence justification isn't really an option. Beyond that, how can I justify any design input for what is strong enough to be safe and effective? They may be used in a variety of surgical settings so simulating an operation wouldn't really prove anything either.


There are similar (but not identical) products on the market already, so other companies must have found a way round this, but it's really left me scratching my head.


Any advice appreciated!


Thanks
 
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N

nantmel

#2
Also, not sure if this would be better posted in the 'design and development of products and processes' section?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Your post should be OK here. My Thanks in advance to anyone who can help with this question.
 

Al Rosen

Staff member
Super Moderator
#4
Hi All,


New poster here, but I've been hanging around for a while and been helped hugely by the wisdom shared on this forum!


I'm a design engineer at a medical device company currently developing plastic surgical instruments for general surgery. I've reached a bit of a mental block around how to create a measurable design input for the strength of the instruments. They are very strong, and in my mind strong enough, but their strength will not match that of the metal instruments so an equivalence justification isn't really an option. Beyond that, how can I justify any design input for what is strong enough to be safe and effective? They may be used in a variety of surgical settings so simulating an operation wouldn't really prove anything either.


There are similar (but not identical) products on the market already, so other companies must have found a way round this, but it's really left me scratching my head.


Any advice appreciated!


Thanks
Have you looked at the FDA consensus standards database where you can search by product code or regulation number for the relevant standards.
 
N

nantmel

#5
Thanks for the link, Al! That is a helpful resource. I've done a fair few keyword searches but can't seem to find anything that pertains to this application, however.
 

FoGia

Involved In Discussions
#6
What you could do is inspire yourself from existing standards to come up with a test of your own, with adapted methods and acceptance criteria.
Another option is to look at the worst use case scenario's inducing the biggest mechanical stress on the device (pressure in a certain area/direction), and taking into account your risk analysis (e.g. what if the box falls on the ground?).
As for the amplitude of the stresses, you can base your test on the maximum force a human/other device can exert on the device, and add a healthy margin to it.


I hope this helps.
 
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