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 compression garments.

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

A self-contained compression sub-assembly, ready to integrate

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

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

The BEP™ module delivers targeted, adjustable and immediately reversible extra-parietal compression over 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 the xiphoid process
Lower angles 45° – 60° Following the costal margins
Operating pressure 0 – 20 Torr User-adjustable via manual pump
Working volume 300 – 1 500 cm³ Up to 3,000 cm³ for extreme morphotypes
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) Moulded, covers the inflatable element
Reinforcement blades 5 – 7 segmented blades Aluminium or composite, removable
Blade housings Textile sleeves, sewn or sealed Replaceable configuration
Peripheral ring (optional) Moulded polycarbonate / polyurethane Vertical grooving for controlled flexibility

Inflation system

Parameter Specification Notes
Pump Manual, integrated No external power source required
Tubing Sealed flexible tube Medical grade, low deformation
Deflation Manual valve Controlled, progressive release
Safety Pressure-limiting valve (optional) Over-inflation prevention
Max. pump strokes per size ~35 / ~45 / ~55 Mechanical limit, not a target for use
03 — Integration options

Multiple form factors, one compression principle

The BEP™ module is designed to suit a range of host device architectures. The key integration decisions concern 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 of the host garment. It can be inserted, removed and replaced independently. Hook-and-loop or equivalent fastening. The simplest integration route.

Option B
Bonded integration (permanent)

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

Option C
Solid cushion variant

The inflatable balloon is replaced by a thermoformed or injection-moulded foam cushion (EVA, expanded PE or PP). Fixed compression, no inflation system required. Simplified manufacturing for high-volume applications.

Option D
Hydraulic variant

The inflatable pocket is filled with liquid rather than air, providing compression through hydrostatic pressure. Alternative tactile properties and pressure distribution. For specialised clinical applications.

04 — Host device textile requirements

Textile architecture for optimal compression transfer

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

Differentiated zone architecture

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

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

Tension system interface

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

Reference materials

Laminated PVC Nylon Cotton Elastane Mesh Non-slip coatings Hypoallergenic coating

Biocompatibility

All materials in contact with the skin are evaluated in accordance with ISO 10993-1 for prolonged contact with intact skin. Endpoints covered: cytotoxicity (ISO 10993-5), sensitisation (ISO 10993-10) and irritation (ISO 10993-23). The device is designed to be worn over a thin garment, not directly on the skin.

05 — Target applications

Where the BEP™ platform creates value

Abdominal support belts

Adding a localised, adjustable compression function to existing abdominal support devices

Compression garments

Bodysuits, undergarments or medical textiles with integrated epigastric compression

Post-operative garments

Abdominal wall support devices requiring a localised compression zone

Orthoses and technical textiles

Orthosis and medical textile ranges seeking to add a reversible compression function

06 — Collaboration process

From first contact to integrated product

GASTER Technology provides end-to-end support for OEM integration — from initial feasibility assessment through the 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 Customisation of BEP™ geometry, materials, inflation system and attachment method for your host device. Technical documentation package.
03
Prototyping and validation Functional prototypes, fitting trials and usability assessment. Performance verification aligned with your quality system.
04
Regulatory alignment Support for CE marking, adaptation of the risk management file and labelling conformity for the combined device. The partner placing the finished device on the market under its own name assumes the responsibilities of legal manufacturer under Regulation (EU) 2017/745.
05
Production transfer Manufacturing set-up with an ISO 13485-certified production partner. Quality controls, batch release protocols and post-market surveillance framework.
07 — Regulatory framework

What the partner takes on, and what we provide

Under Regulation (EU) 2017/745, the party placing a finished device on the market under its own name assumes the responsibilities of legal manufacturer: technical documentation, conformity assessment, CE marking, risk management, instructions for use and post-market surveillance.

Our role is to supply the compression module, the associated technical documentation and the engineering support required for integration. The partner retains its brand, its distribution channels and control of the intended purpose it declares for its device.

The declared intended purpose determines classification, clinical evaluation and permitted claims. Any claim relating to the finished device must correspond to that intended purpose and to the evidence supporting it.

Let's discuss your integration project

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

GASTER control® and the BEP™ technology are proprietary. Patent pending. All technical specifications are indicative and subject to customisation for OEM applications. Integration projects are subject to mutual evaluation, NDA and technical feasibility analysis. Any claim relating to a finished device incorporating the BEP™ module falls within the responsibility of its legal manufacturer and must correspond to the intended purpose declared for that device.
GASTER control® — GASTER Technology Limited, 5/1 Merchants Street, Valletta VLT 1171, Malta.