How to qualify a medical device or IVD distributor

Identification gives you a shortlist. Qualification decides which name on it you sign. It is the half that gets compressed, usually because the first candidate is keen and the launch date is already fixed.

Qualification is not the first call

The common sequence is: meet a candidate, like them, ask for references, sign. The references are supplied by the candidate, so they are positive. Nothing in that sequence is wrong, but almost none of it is independent.

A better sequence separates three things that usually happen at once:

Going into a call already knowing the answer to the first group is what makes the second group useful. Otherwise you spend the call collecting facts a candidate has every reason to present favourably.

The commercial questions that separate candidates

Regulatory standing tells you whether a partner can get your product into the market. It does not tell you whether they will sell it. These questions get at the second part:

Who do they actually sell to?

Ask for the split between private hospitals, public tender, and sub-distributors. A partner who reaches most of the country through sub-distributors they do not control is offering you less than the map suggests, and your pricing has another margin in it that you will not see.

Who will own your product internally?

A named product manager with a target is a different commitment from "the team will handle it." Ask how many lines each salesperson carries. A rep with forty products has no time for a new one that needs clinical explanation.

What are they expecting from you?

Training, demo units, marketing support, tender documentation, clinical papers in the local language, a person on the ground for the first cases. These are reasonable asks. They are also costs, and a candidate who names them early is easier to work with than one who discovers them after signing.

What does the first year look like in their numbers?

Not the forecast they think you want. The units, the accounts they expect to open, and when. A partner who cannot describe the first five hospitals by name has not thought about your product specifically.

What happens if it does not work?

Exit terms, notice periods, stock buy-back, and above all what happens to the registration. Settle this while everyone is optimistic. Renegotiating it later, from a position where they hold market access and you do not, is a different conversation.

Qualify a shortlist properly

We do this work with clients as part of market entry, or as a standalone assessment. Tell us the market and the candidates.

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Red flags

None of these disqualify a candidate on their own. Each one is a question you should have a good answer to before you sign.

Comparing candidates without fooling yourself

By the third conversation the candidates blur together, and the one you spoke to most recently — or liked most — starts to lead. Two habits help:

When the answer is that none of them are right

It is a legitimate outcome, and it is more common than the process usually allows for. A market where no suitable partner exists yet is worth knowing about before you have committed a registration budget to it. Sometimes the right sequence is to enter a neighbouring market first, build a reference base, and come back when you are a more attractive line to carry.

We will tell you when we think that is the case. A shortlist that ends in a signature is not the goal — a market that works in three years is.

Related resources

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Most companies come to us with one of these four questions. Each one is a conversation, not a form.

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