OEM Solutions

OEM Solutions

Integrate the BEP™ compression module into your devices

A modular, patent-pending biomechanical technology designed for integration into wearable medical devices, abdominal support systems, medical textiles, and metabolic health platforms.

Modular design CE pathway support ISO 13485 manufacturing Patent pending
01 — The BEP™ module

A self-contained compression assembly ready for integration

The Extra-Parietal Balloon (BEP™) is not just a component — it is a complete compression sub-assembly that can be embedded into a host device. It includes the inflatable structure, the compressive shield with reinforcement blades, the inflation system (manual pump + flexible tube), and the deflation valve.

The module is designed to be removable or permanently integrated, depending on the host device architecture. It can be housed in an internal pocket, bonded to the inner surface, or integrated into the textile structure itself.

The BEP™ module delivers targeted, adjustable, and reproducible extra-parietal compression to the epigastric region. It is the functional core of the GASTER control® platform — ready to be adapted to your form factor.
02 — Technical specifications

Engineering parameters for integration planning

Compression assembly

Parameter Specification Notes
Active surface 80 – 160 cm² Triangular or flattened ovoid geometry
Upper angle 60° – 90° Aligned with xiphoid process
Lower angles 45° – 60° Following costal margins
Operating pressure 0 – 20 Torr User-adjustable via manual pump
Useful volume 300 – 1,500 cm³ Extra-large variant available on OEM specification
Width 8 – 25 cm Depending on size variant
Height 4 – 20 cm Depending on size variant

Reinforcement system

Parameter Specification Notes
Compressive shield Semi-rigid (polycarbonate or polyurethane) Molded, covers inflatable element
Reinforcement blades 5 – 7 segmented blades Aluminum or composite, removable
Blade housing Textile sleeves, stitched or sealed Replaceable configuration
Optional annular ring Polycarbonate / polyurethane molded Vertical grooving for controlled flexibility

Inflation system

Parameter Specification Notes
Pump Manual, integrated No external power source required
Conduit Flexible watertight tube Medical-grade, low-deformation
Deflation Manual valve Controlled, progressive release
Safety Optional pressure-limiting valve Prevents over-inflation
Max pumps by size ~35 / ~45 / ~55 Mechanical limit, not usage target
03 — Integration options

Multiple form factors, one compression principle

The BEP™ module is designed for adaptation across different host architectures. Key integration decisions involve the attachment method, the textile interface, and the level of modularity required.

Option A
Internal pocket (removable)

The BEP™ assembly is housed in a dedicated internal pocket on the host garment. It can be inserted, removed, and replaced independently. Attachment via hook-and-loop (Velcro) or equivalent system. Easiest integration path.

Option B
Bonded integration (permanent)

The BEP™ is permanently attached to the inner surface of the host device. The compression assembly becomes an integral part of the garment structure. Suitable for dedicated medical devices.

Option C
Solid cushion variant

Replace the inflatable balloon with a thermoformed or injection-molded foam cushion (EVA, PE, or expanded PP). Fixed compression, no inflation system needed. Simplified manufacturing for high-volume applications.

Option D
Hydraulic variant

The inflatable pocket filled with liquid instead of air, enabling compression through fluid pressure. Alternative tactile properties and pressure distribution. For specialized clinical applications.

04 — Host textile requirements

Textile architecture for optimal compression transfer

The effectiveness of the BEP™ module depends on the mechanical properties of the host garment. GASTER control® provides detailed textile engineering guidelines for OEM partners to ensure optimal compression transfer and patient comfort.

Differentiated zone architecture

Frontal zone (compression plane): Low-extensibility materials forming a stable backing for the BEP™ assembly. Recommended: laminated PVC, reinforced nylon, or equivalent technical textiles with minimal stretch under load.

Lateral and dorsal zones (mobility): Elastic materials (elastane, mesh, stretch textile) allowing trunk mobility, respiratory comfort, and adaptation to body movements during daily activities.

Tension system interface

The host device should accommodate a mechanical pulley tension system (palan) — semi-rigid straps passing through dorsal loops and returning to the front. This enables progressive, user-adjustable peripheral rigidity. A locking mechanism (hook-and-loop, adjustable buckle, or magnetic system) maintains the set tension.

Materials reference

PVC laminated Nylon Cotton Elastane Mesh Non-slip liners Hypoallergenic coating

Biocompatibility

All skin-contact materials are evaluated per ISO 10993-1 for prolonged intact-skin contact. Key endpoints: cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10). The device is designed to be worn over a thin garment, not directly on skin.

05 — Target applications

Where the BEP™ platform creates value

Abdominal support belts

Add a compression function to existing CSA-class devices for appetite regulation support

Compression garments

Bodysuits, undergarments, or medical textiles with integrated epigastric compression

Post-bariatric devices

Post-operative support combining abdominal protection with satiety-perception function

Connected health

Pairing with companion apps for usage tracking, pressure logging, and behavioral guidance

06 — Engagement process

From first contact to integrated product

GASTER Technology provides end-to-end support for OEM integration — from initial feasibility assessment through regulatory pathway to production transfer.

01
Technical scoping Joint assessment of your device architecture, target application, and integration constraints. NDA and mutual evaluation.
02
Module specification Customization of BEP™ geometry, materials, inflation system, and attachment method for your host device. Technical documentation package.
03
Prototyping and validation Functional prototypes, fit testing, and usability evaluation. Performance verification aligned with your quality system.
04
Regulatory alignment Support for CE marking, clinical evaluation report integration, risk management file adaptation, and labeling compliance for the combined device.
05
Production transfer Manufacturing setup with ISO 13485-certified production partner. Quality controls, batch release protocols, and post-market surveillance framework.

Let's discuss your integration project

Share your device concept or technical requirements. Our engineering team will assess feasibility and propose a customized integration pathway.

GASTER control® and the BEP™ technology are proprietary. Patent pending. All technical specifications are indicative and subject to customization for OEM applications. Integration projects are subject to mutual evaluation, NDA, and technical feasibility assessment.
GASTER control® — GASTER Technology Limited, 5/1 Merchants Street, Valletta VLT 1171, Malta.