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What is a reasonable consulting fee for preparation of a complete traditional 510k?


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consultants and consulting, 510(k)
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  Post Number #1  
Old 9th December 2014, 10:12 PM
Dramirez

 
 
Total Posts: 10
Question What is a reasonable consulting fee for preparation of a complete traditional 510k?

Hello:
This is more of a question. Hopefully belongs here. The thing goes like this:
What is a reasonable consulting fee for complete preparation of a complete traditional 510k, including SE discussion, clinical data analysis (including statistical analysis and clinical discussion) + writing clinical performance report + review, assembly +re-writing (as needed) of some documentation.
PS.: It is for a moderate risk medical device to be use in pediatric population

Thanks

Daniel

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  Post Number #2  
Old 10th December 2014, 12:27 AM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,066
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

Just curious, Daniel. Are you intending to be on the paying side or receiving side of the transaction?

I tend to use different criteria depending whether I am receiving or paying the fee. Tell us which side so we c an be more on point in response.
Thank You to Wes Bucey for your informative Post and/or Attachment!
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  Post Number #3  
Old 10th December 2014, 12:37 AM
Dramirez

 
 
Total Posts: 10
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

On the receiving side..

Thanks
  Post Number #4  
Old 10th December 2014, 01:44 AM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,066
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

Quote:
In Reply to Parent Post by Dramirez View Post

On the receiving side..

Thanks
I know you posted a near duplicate of your thread starter in another thread where my answer appears as post number 4.

You should re-read my answer there AND be sure to read through the two referenced threads in my post.

The essence of my answer is that consulting is a BUSINESS, not a job. The practitioner needs to take in the expenses of running the business as part of the fees he charges.

Frankly, the task you outline seems more of a "technical writer" contract job than a consulting job, since you are not directing the clinical analysis, merely "polishing" it for presentation.
  Post Number #5  
Old 10th December 2014, 03:55 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,726
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

Getting back to the original question - Re: Reasonable Consultant Fees

What are expert medical device consultants charging these days, folks? Any specific numbers?

Clarification(s) needed:

1. What is your location (country)?
2. What is your device (at least, what class)?

I know local consultants in southern Ohio that do a US$125/hr. rate, for example, for certain medical device related consulting. Not knowing where you are located, for example, makes it difficult to reply.

You *can* put that information in your Profile which would show up in your post. We want to help but we do need to have as many details as possible.
  Post Number #6  
Old 10th December 2014, 07:40 AM
Dramirez

 
 
Total Posts: 10
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

I read your other post and now I'm like you just added a new job to my own description cause I'm being asked to find and decide the SE device and choose the route (type of 510K de novo vs traditional) and so on, on top of the clinical discussion and all the rest.
thanks, again. Your post have helped frame this situation better.
  Post Number #7  
Old 10th December 2014, 07:45 AM
Dramirez

 
 
Total Posts: 10
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

Quote:
In Reply to Parent Post by Marc View Post

Getting back to the original question - Re: Reasonable Consultant Fees

What are expert medical device consultants charging these days, folks? Any specific numbers?

Clarification(s) needed:

1. What is your location (country)?
2. What is your device (at least, what class)?

I know local consultants in southern Ohio that do a US$125/hr. rate, for example, for certain medical device related consulting. Not knowing where you are located, for example, makes it difficult to reply.

You *can* put that information in your Profile which would show up in your post. We want to help but we do need to have as many details as possible.
Marc:

I'm currently based in Montreal, Canada. The work is to be done for a large corporation, and will be for a Class II device on the Neurology panel (882.1400). Is a completely new device intended for neonatal population.

Thanks
  Post Number #8  
Old 10th December 2014, 10:26 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

Quote:
In Reply to Parent Post by Marc View Post

What are expert medical device consultants charging these days, folks?
It's important to qualify the size of job for which an hourly rate is applicable. A relatively smaller job typically has a lower hourly rate than a really big, longer-term one.
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