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

Dramirez

Starting to get Involved
#1
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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Wes Bucey

Quite Involved in Discussions
#2
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.
 

Dramirez

Starting to get Involved
#3
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

On the receiving side..

Thanks
 

Wes Bucey

Quite Involved in Discussions
#4
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

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.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
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.
 

Dramirez

Starting to get Involved
#6
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 :rolleyes: 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.
 

Dramirez

Starting to get Involved
#7
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.
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
 
M

MIREGMGR

#8
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

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.
 

Wes Bucey

Quite Involved in Discussions
#9
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

There are a few more variables which contribute to rate or gross fee. Chief among them are:
Expertise and experience of the consultant (some medical device specialists of my acquaintance are "super experts" and could generate a complete 510 application which would sail through regulatory concerns in a single draft; others might need to go through numerous rewrites to feel confident in the submission) would determine the total elapsed time before delivery of a finished project. If time is a critical factor, the shorter time would deserve a substantial fee increase of the total fee.

As a consultant, I charge by the assignment, NOT by the hour. Doing a good job in short time results in happy customers, repeat business, and strong referrals. Almost always, the total fee is immaterial to the customer if the job is done right the first time.

Value of the completed project to the client/customer.
An experienced consultant would determine this by judicious questioning during the discussion concerning critical "deliverables." Probably not best to lead off with fee until the true scope and importance of the assignment is determined.

Reason an outsider is considered for the task. Why aren't the folks who actually designed and conducted the testing deemed "good enough" to write the finished 510K? (Are they looking for someone to put lipstick on the pig?)

 

Marc

Hunkered Down for the Duration
Staff member
Admin
#10
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

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
I'm not in regulatory affairs so I personally don't know what they are charging. As others have pointed out, it depends upon the job.

For work I do I charge anywhere from US$50/hr. for small local jobs to US$1450 a day for larger jobs with larger companies. I quote each job differently using a "quote" spreadsheet I made up some years ago to approximate aspects such as travel expenses and such.

My hope here was that someone who is in regulatory affairs might be able to give some ball park figures for regulatory affairs consulting.

As an aside, while size of job and such are factors, a big factor will be who - That is, an individual will typically be less expensive than a big consulting company.
 
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