Choosing an EVD Manufacturer as a Distributor: 12 Questions to Ask

A distributor choosing an EVD manufacturer should ask twelve questions, grouped around five themes: the product range, the quality system, supply reliability, clinical and documentation support, and the partnership terms. Good manufacturers answer each one with documents, specifications or named contacts. Vague answers on any of them are a warning sign worth taking seriously.

Why does the choice of manufacturer matter so much for EVD?

An EVD line ties a distributor to its manufacturer more closely than many products. The device is used emergently, managed by nurses for days, and supported by the distributor long after the sale. If the product, the supply or the support falls short, it is the distributor who faces the neuro-ICU. Choosing well at the start protects the distributor's reputation with every account it serves.

The questions below are designed to be asked of every candidate in the same way, so the answers can be compared side by side. They are also the questions DESU expects prospective partners to ask, and we answer them here for our own range where the facts allow.

Questions about the product range

1. Does the range cover the drainage needs of a typical neuro-ICU?

Look for complete systems, both drainage routes and both catheter types. DESU's EVD-010 Series includes a 31 cm ventricular catheter, a 30 cm measuring scale, a 150 ml drip chamber and an 800 ml drainage bag. The EVD-020 Series combines a pressure scale, drip chamber, drainage bag and filter, and is used with a ventricular or a lumbar catheter. The lumbar drainage catheter kit has an 80 cm silicone catheter with tantalum marks from 5 to 20 cm and 24 holes.

2. Is there an antibiotic-impregnated option, and how is it identified?

Many hospitals stock both catheter types. Ask how the antibiotic-impregnated version is made, how long the agent is released and how staff tell it apart. DESU's antibiotic-impregnated catheters are orange, with the agent released in a controlled way over 28 days, across drainage and shunt catheters.

3. Does the range extend along the patient pathway?

A manufacturer that also offers ventricular and peritoneal catheters, shunts and connectors gives the distributor more to offer each account. DESU's range includes the ventricular catheter kit, peritoneal and ventriculoperitoneal catheter kits, the Depus, Defit and Decurve shunt families, connectors and an antisiphon device, plus collagen dural grafts for the same surgeons.

Questions about the quality system

4. Which quality management system and certifications apply?

Ask for the quality system certificate and the product certifications, and check that they cover the products you will sell. DESU works under an ISO 13485 quality management system and its products carry the CE mark.

5. Where and how are the products made?

Ask whether the manufacturer designs and produces the devices itself, in its own facilities, or relies on subcontractors for key steps. DESU, founded in 2007 as an R&D company at Hacettepe Teknokent in Ankara, Türkiye, designs and manufactures in its own cleanrooms with 5,000 m² of production.

6. How are complaints handled, and how quickly do partners hear back?

Ask to see the complaint process from a partner's point of view: what information is needed, who acknowledges the report, how investigations are run and how results are communicated. A manufacturer that explains this clearly and without defensiveness is one you can stand behind in front of a hospital.

Questions about supply

7. What are the lead times, and how are delays communicated?

Ask for typical lead times for each stage, from order confirmation to shipment, and how the manufacturer warns partners of delays. Ask what happens when a distributor needs an urgent shipment. Ask, too, how the manufacturer uses partners' forecasts in production planning, and what notice it needs before a large conversion. A manufacturer that plans with its partners, rather than simply filling orders as they arrive, is easier to rely on.

8. How are lot traceability and shelf life managed?

Every shipment should come with lot and expiry information, and the manufacturer should agree on a minimum remaining shelf life at shipment. Ask how records allow lots to be traced to the distributor and from there to hospitals.

Questions about support

9. What documentation is available for hospitals, in English?

Value analysis committees, infection prevention and clinical engineering will ask for instructions for use, specifications, labeling explanations, sterility and packaging information, biocompatibility summaries and quality certificates. Ask to see the full set before signing.

10. What clinical training and in-service material is provided?

Ask what the manufacturer provides for training reps and supporting nurses: component diagrams, quick-reference material, training systems and access to product specialists. EVD conversions depend on training every shift, and the manufacturer's material should make that easier.

Questions about the partnership

11. What territory, exclusivity and product scope are offered?

Clarify the territory, whether exclusivity applies and what is expected in return, which products are included, and any accounts reserved for others. Put the answers in the agreement.

12. How does the manufacturer work with partners in new markets?

Ask how many markets the manufacturer serves and how it supports a partner entering a new one: documentation adapted to local needs, joint account planning, responsiveness across time zones and willingness to listen to feedback from the field. DESU exports to more than 50 countries and has product registrations in 34, so it is used to adapting to the market in front of it. Ask any candidate for that kind of track record, and talk to the people you would actually work with.

How should a distributor compare the answers?

Put the twelve questions in a simple table, one column per candidate, and record each answer together with the document or contact that supports it.

Weight the themes according to your business. A distributor with strong clinical teams may weight documentation and quality most heavily; one with thin inventory may care most about supply. Whatever the weighting, an answer without evidence should score lower than one with it.

Some answers should raise concern regardless of weighting:

• specifications that differ between the brochure, the label and the instructions for use;
• reluctance to share certificates or the complaint process before signing;
• lead times quoted without any explanation of how delays are communicated;
• no named technical contact, only a general sales address;
• pressure to sign quickly, before documents have been reviewed;
• claims about clinical outcomes that the manufacturer cannot support with real, published sources.

Finally, meet the team. A visit, in person or by video, to the people who handle orders, quality questions and training tells a distributor more about the partnership ahead than any presentation.

Talk to a DESU product specialist

If you are evaluating EVD manufacturers, put these twelve questions to DESU. Our product specialists will answer each one with documents and specifics, and discuss how a partnership could work in your market. Write to sales@desu.tr or use the contact page to start the conversation.