Do company sales agents/distributors need to go through supplier evaluation process?

#1
Hello,

I'm working for a medical device startup, and since we don't have our own sales force, we're signing distributors to distribute/sell our products to the physicians. Do these sales agents/distributors need to be qualified as a service supplier? They would not affect product quality in any way (not add value to product). They're measured on sales quota based on a contract.

Thank you.
 
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B

blewispunk

#2
Re: Do company sales agents/distributors need to go through supplier evaluation proce

I would say they do not need to from a quality system perspective if they are not performing product-impact activities (installation or training). However, every sales person needs good product knowledge and understanding so from a business perspective it may be wise to establish your own set of requirements for the distributor to approve them to start and establish metrics to track them over time.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: Do company sales agents/distributors need to go through supplier evaluation proce

Hello,

I'm working for a medical device startup, and since we don't have our own sales force, we're signing distributors to distribute/sell our products to the physicians. Do these sales agents/distributors need to be qualified as a service supplier? They would not affect product quality in any way (not add value to product). They're measured on sales quota based on a contract.

Thank you.
Hi and welcome to the cove :bigwave:

From a regulatory standpoint, it depends on whether you are buying from them or selling to them. If you are purchasing their distribution service, then I would say yes, they are suppliers and as such they should meet all applicable requirements documented in your SOPs. If, on the other hand, you sell them your products, then if anything I would consider them customers and not suppliers.

BTW, I do not agree that distributors don't add value to the product. If you don't have your own sales force then they are your face on the market, and also part of your product's market appeal. It's great to have a good product but it is, IMHO, at least as important (if not more important) to have good service, pre- and post-sales. Many small companies fail because they fail to understand this. Personally I know some companies who do very well although their products are average or just good-enough - simply because they have excellent distribution and customer service.

So, even if distributors don't modify the product in any physical way, they definitely have the potential to add value (and also to reduce value). There are many definitions to "quality", but my favorite is "everything that contributes to the customer's satisfaction". Customer service sure comes under that, so yes, I would say distributors definitely affect quality.

Additionally, distributors have a very practical role in your quality system if you don't have a sales force. They are one of your most important communication channels with the market. They are usually the ones that will (or won't) provide you with the post-marketing feedback, and the information and used samples in cases of customer complaints. They are also your route to tracking and recalling faulty or suspicious products already on the market.

Cheers,
Ronen.
 
Last edited by a moderator:
Y

yana prus

#4
Re: Do company sales agents/distributors need to go through supplier evaluation proce

I agree with Ronen for the important role of distributors from regulatory perspective. Ensure that the claims that they use are indeed the approved claims (and not the off label claims).

In the case of international distributors, I would suggest to verify that they obtain any necessary registrations and licences for the product and marketing for the defined Territory.
 
A

AFuenzalida

#5
Re: Do company sales agents/distributors need to go through supplier evaluation proce

I would also advise you to be very careful as in some countries in Europe or Middle East your distributors can be deemed commercial agents, which means that if you terminate them penalties and indemnification for good will is owed.
 
D

deuce64

#6
Re: Do company sales agents/distributors need to go through supplier evaluation proce

Ronen,
I'm in agreement with your opinion (re: value add and communication channel) with that, I would argue that the distributor (foreign or domestic) is a critical part of the Quality System and that there is liability at the Manufacturer's level to ensure that agreements are in place between both parties that protect traceability, storage, and adverse event reporting for the devices that the distributor sells. Additionally, a foreign distributor should be obliged to maintain and prove to the manufacture, proper registration of the products for which they have been granted distribution rights.
i'm curious, do people do supplier audits of their distributors? I'm heavily considering it.
deuce
 
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