OEM Dental Kit for a Saudi Hospital Group

An 18-instrument private-label dental procedure kit, manufactured under the hospital group’s own brand, FDA + ISO 13485 paperwork bundled with every shipment. From signed prototype to first 1,000-kit production run in 90 days — and a recurring quarterly draw-down since.

The challenge

The hospital group operates 14 outpatient dental clinics across Riyadh, Jeddah, and the Eastern Province. Their previous procedure kit was assembled in-house from three suppliers — a Japanese explorer set, a German scaler line, and a Pakistani forceps batch — which meant clinical staff opened three different sterilisation pouches before every procedure, and patient-facing branding was inconsistent across clinics.

The brief was specific:

• A single 18-instrument kit, all from one supplier, all to a common stainless-steel grade
• Custom-branded sterilisation pouches and outer cartons in the hospital’s livery
• FDA registration paperwork and ISO 13485 documentation packaged with every kit (the group’s compliance team had previously been chasing paperwork batch-by-batch)
• Prototype to production in under 100 days — they had a clinic relaunch tied to the rollout

Our approach

We split the project into three overlapping tracks rather than running them sequentially.

1. Specification + prototype (days 0–35)

Working from the group’s existing kit photos, we produced a single-pass spec sheet covering all 18 instruments. The clinical lead approved 16 of them as-is from our standard catalog; two required minor handle modifications (longer working ends on the periodontal scaler; matte-bead-blast finish on the explorer set to reduce procedural glare under LED dental lights). Two prototype kits shipped on day 28 — one for clinical evaluation, one for sterilisation validation.

2. Brand & packaging (days 20–60, parallel)

Their in-house design team supplied the brand assets in week three. We produced packaging proofs at our partner print house in Sialkot, with the hospital group approving final art on day 52. Production tooling for the carton dies was complete by day 60.

3. Compliance documentation (days 0–80, parallel)

The group’s compliance lead worked directly with our QA team. Each kit ships with: FDA 510(k) listing reference for the relevant instrument classes, ISO 13485:2016 quality-system certificate, per-batch material certificates, sterilisation validation summary, and a single-sheet kit-level declaration of conformity. The compliance team can now stage a regulatory audit in minutes instead of days.

The outcome

Prototype-to-production

90 days (target: 100)

Initial production

1,000 kits (18,000 instruments)

Recurring volume

~8,000 kits/year

Clinical staff prep time

−65% per procedure

The group is now on its third annual renewal. The kit has been extended with two specialty add-on packs (endodontic + paediatric) and the hospital procurement lead has referred two affiliated GCC hospital groups to us. One of them — a private hospital network in the UAE — completed their own kit programme in 2025.

What the procurement lead told us at signing: “You were not the cheapest quote. You were the only one who said ‘yes’ to all four constraints — and the only one who put the compliance paperwork in writing on day one.”