Medical Device New Product Design & Development- How long does this process take you?

lboll

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#1
We are a medical device manufacturer of FDA Class I and 2 devices -all low risk, non-life supporting or sustaining. Most are single use sterile disposables.

Our product development process follows all FDA, MDD, Health Canada guidelines.

The new (to us) products that we design and launch are all 'me-too' versions of devices already on the market.
Our typical timeline from start of development to launch of a sterile, 510(k)-required device is a little under 3 years. We have detailed project plans in Microsoft Project and this time frame is as short as we could make a design process that involves manufacturing process validation, product validation (included accelerated aging), sterilization/packaging validation, and submission/clearance of a 510(k).

My question is: How long does the design development process take at your company? My boss feels like we are taking too long from start to finish, yet we can't seem to shave off any more time that this.
 
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Ronen E

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#2
Re: Medical Device New Product Design & Development- How long does this process take

We are a medical device manufacturer of FDA Class I and 2 devices -all low risk, non-life supporting or sustaining. Most are single use sterile disposables.

Our product development process follows all FDA, MDD, Health Canada guidelines.

The new (to us) products that we design and launch are all 'me-too' versions of devices already on the market.
Our typical timeline from start of development to launch of a sterile, 510(k)-required device is a little under 3 years. We have detailed project plans in Microsoft Project and this time frame is as short as we could make a design process that involves manufacturing process validation, product validation (included accelerated aging), sterilization/packaging validation, and submission/clearance of a 510(k).

My question is: How long does the design development process take at your company? My boss feels like we are taking too long from start to finish, yet we can't seem to shave off any more time that this.
Hi,

It really depends on what the devices are. It also depends on your resourcing levels to an extent.

from my experience with similar devices - R&D and QA/RA - your timeline may be a bit excessive but not that much. A very simple device (1-3 parts, known technologies, "linear" behaviour) could take 18-24 months. If it's more complicated then maybe 30 months or more. Shelf life validation (accelerated ageing) is a big component and its length is affected by the actual shelf life requirement and the ability to accelerate the aging.

Please feel free to send the specifics in a PM so maybe I can work with you on improving.

Cheers,
Ronen.
 
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