Reg-ready protocol portal for the FlexBFR BFR device

We unblocked the shipment of 3,200 devices worth €600,000, cut protocol publishing from 5 days to 4 minutes, and closed the CE audit in a single sprint — through roles, approval workflows, and an immutable change log.

Saas

Portal

MVP development

B2B

Healthcare

Directus CMS

Role-Based Access

Back-Office Development

Admin Panel

About the project

A portal of rehabilitation protocols that accompanies a medical BFR device and is required for distribution into different countries. Clinician users create and update protocols with exercises, media, and warnings, while designated roles approve each release. Distributors and partners access the latest approved versions of protocols for a specific language and market. Separately, the system stores complete version and event history so an auditor can see who made changes, when, and who approved them.

About Customer

FlexBFR is a medtech startup founded by two engineers from sports science — Joel and Philip. Their flagship BFR device is already certified and in use with physiotherapists, but sales growth depends on entering new countries quickly through multilingual treatment protocols. The company runs on device sales and small R&D grants, so every week of shipping delay hits cash flow directly.

Revenue frozen in inventory

3,200 devices worth €600,000 couldn't be shipped because the Spanish and German protocols hadn't been published.

CE compliance risk

The inspector flagged missing version history and approval roles, creating a risk of fines and regulatory restrictions.

Engineering time lost to content

Any content edit consumed up to 8 hours of engineering time. The budget went into maintenance, and releases slowed down.

Hard deadline

The portal had to be live before ISPO; otherwise distributors could cancel their purchase orders.

Controlled publishing

Clinicians needed a protocol builder, while compliance needed step-by-step control, signatures, and an immutable log.

Proposed solution

We built a modular protocol-management system on a headless approach. Directus handles the back-office with roles, statuses, and revisions, while the public-facing layer consumes content through the API and updates automatically after changes. To support expansion into new markets, we added translation automation and country-level view analytics.

Modular protocol builder

We created collections for exercises, media, warnings, and protocols, so each protocol is assembled from blocks. We configured the fields so a clinician could fill them in without technical involvement. We set the target scenario for entering a protocol as a KPI of under 5 minutes.

Roles, approvals, and change log

We implemented an approval chain of clinician → medical director → compliance. Every step records the author, timestamp, status, and the changes captured in revisions — so the auditor could see the complete version history without manual evidence-gathering.

Headless content delivery

We connected Directus to the public interface through the API. After any content change, the site or portal updates automatically, with no manual deployments.

Translations and market analytics

To automate translations, we chose to integrate DeepL API for generating language copies and speeding up localization. We connected GA4 events so the team could see protocol views by country and language.

Compliance tooling

We implemented revision exports in a format suitable for regulatory inspections. We confirmed the need to prepare a complete evidence package for the inspector — without manual compilation from disparate sources.

On day one we ran a session with the founders and the regulatory advisor and defined 12 compliance gaps. We prioritized the revenue blockers preventing inventory shipment. We aligned on a 6-week roadmap with clear checkpoints tied to ISPO. We also agreed upfront on which artifacts the auditor would need and how we would generate them technically.