Hoop Medical

What Hoop Medical does

Hoop Medical is an Ireland-based (Wexford) contract manufacturer founded in 2019 that produces custom medical balloons for medical device OEMs. The company operates with 11–50 employees under an owner-managed structure led by CEO Clive Hayes and Managing Director Teddy Mudge. Its primary customer segment is medical device companies that require application-specific balloons for therapeutic or diagnostic devices, with projects scoped through a combination of design services, non-recurring engineering (NRE), and custom hardware production.

The company's core technology is built around proprietary blow molding and pre-forming processes that allow it to produce non-standard balloon geometries with 2–3 week turnaround on custom units and under 1 day on new tooling. Its product portfolio spans standard compliance balloons, custom shapes, pleated and folded balloons, neck-thinned balloons, balloon testing fixtures, perforated balloons (holes/windows), high-pressure braid-reinforced balloons, sensor- and energy-effector-integrated balloons, radiopaque balloons, drug-coated balloons, and lubricity/friction-tuned balloons. The facility operates under ISO 13485:2016, the quality management standard required for medical device component suppliers.

Hoop Medical monetizes across three revenue streams: custom balloon manufacturing (hardware sales), NRE services tied to process and tooling development, and design services supporting customer balloon engineering. Commercial reach is delivered through a network of regional sales representatives covering the US West (Haldeman & Frazier), US Midwest (Betz-Tek), EU and India (Alpha Zukunft), Japan (MDS), and Israel (Saguy), in addition to listing on the Chamfr marketplace. The operating model is asset-light relative to larger balloon manufacturers but depends on highly specialized process engineering talent and a regulatory-grade quality system to remain qualified for OEM supply chains.

Name

Hoop Medical

Legal name

Hoop Medical Limited

Website

https://hoopmedical.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

Hoop Medical is an Ireland-based, ISO 13485:2016-certified manufacturer of custom medical balloons serving medical device OEMs. It uses proprietary blow molding and pre-forming processes to deliver application-specific balloons, NRE, and design services through a global rep network.

Ownership category

akta.pro rank

Product category

Medical Balloon Manufacturing

NAICS

Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Blow-Molded Medical & Laboratory Containers (IMANAGAI)

Keywords

• Medical balloon manufacturing
• Custom balloon components
• Blow moulding processes
• Medical device components
• Balloon catheter parts

Headquarters

HQ city

Ardcavan, County Wexford

HQ country

Ireland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Supply Chain, Infrastructure, Marketing or Sales

Revenue model

1. Custom Balloon Manufacturing: Revenue generated from manufacturing custom medical balloons for medical device companies. Pricing follows tiered annual order quantities (5,000 to 200,000 units per SKU) with per-unit pricing that decreases at higher volumes.
2. Non-Recurring Engineering (NRE) Services: Development phase charges including time and materials for iterative engineering, tooling creation, testing (dimensional and performance), and balloon sample production. These are one-time costs during the development phase before production pricing kicks in.
3. Design Services: Design For Manufacturability (DFM) input provided via Design Services to help projects scale faster. Customers without existing specifications can work with Hoop engineers to develop balloon specifications and drawings.

Pricing tiers

Go-to-market motion2 records

Distribution channels7 records

Marketing channels3 records

Core offering

Hoop Medical designs and manufactures custom medical balloons and balloon components for medical device companies, using proprietary blow moulding and pre-forming processes with materials such as Nylon, PET, Pebax, TPUs, and TPEs. The company delivers a full compliance range (ultra-compliant to non-compliant), custom shapes (spheres, dumbbell, donut, hemi, conical, tapered, stepped), and advanced capabilities including high-pressure braid reinforcement, flexible electronics integration, radiopaque modification, precision hole/window cutting, pleat and fold, neck thinning, and balloon testing. Complementary Design For Manufacturability (DFM), Non-Recurring Engineering (NRE), and Shortie Catheter services support medical device customers from concept through production.

Product overview

Hoop Medical is a manufacturer of next-generation medical balloons operating from a state-of-the-art ISO 13485:2016-certified facility in Wexford, Ireland. The core offering is a full spectrum of medical balloons — ultra-compliant, compliant, semi-compliant, and non-compliant — produced from high-performance materials (Nylon, PET, Pebax, TPUs, TPEs) via proprietary blow moulding and pre-forming processes. The product portfolio centres on standard and custom-shaped balloons (spheres, dumbbell, donut, hemi, conical, tapered, stepped) supplemented by a suite of advanced add-on modules: Pleat & Fold, Neck Thinning and Surface Modification, Balloon Testing, Holes and Windows in Balloons, High Pressure Braid Reinforced Balloons, Sensors and Energy Effectors on Balloons, Radiopaque Balloons, Drug Coating, and Lubricity/Friction Tuning. Complementary services include Design Services (DFM) and Shortie Catheter assembly support. Turnaround times are 2–3 weeks for custom balloons and under one day for new tooling.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Balloons (Standard Compliance Range) Hoop Medical manufactures medical balloons across a full compliance spectrum (ultra-compliant, compliant, semi-compliant, and non-compliant) using materials including Nylon, PET, Pebax, TPUs, and TPEs, with surface modifications and blends available on request. Balloons are produced via advanced blow moulding and pre-forming processes using 3-piece, 5-piece, and clam-shell tooling, intended for medical device OEMs across interventional, drug-delivery, diagnostic, and sensor-integrated applications.
• Custom Balloon Shapes Bespoke balloon geometries including spheres, dumbbell, donut, hemi balloons, conical, tapered, stepped, and other complex shapes manufactured to customer design specifications with Design For Manufacturability (DFM) input from Hoop's design services team. Intended for medical device OEMs requiring non-standard balloon geometries.
• Pleat & Fold State-of-the-art pleating and folding at component level that creates optimised balloons with minimal crossing profile and improved production yields, with each folded balloon leak tested prior to shipping to eliminate pinholes. Offered to medical device manufacturers incorporating Hoop's balloons into catheters.
• Neck Thinning and Surface Modification Secondary process that reduces balloon wall thickness in the neck region to minimise crossing profile, with tailored surface finishes to enhance adhesion, increase friction, or adjust light refraction characteristics. Offered to medical device OEMs optimising balloon deliverability and integration.
• Balloon Testing Comprehensive lot-level testing providing Dimensional Inspection Data (balloon OD, length, neck-IDs, double wall thickness) and Performance Test Data (burst pressures at 37°C, rated burst pressure, failure modes) using advanced vision systems, metrology technology, and industry inspection techniques. Provided to medical device manufacturers for quality verification.
• Holes and Windows in Balloons High-precision cutting of holes and shapes into balloons with smooth cut-edges, capable of intricate, strong patterns in ultra-thin-walled blow-molded components (10µm single wall thickness to 130µm SWT). Components are often used as thin film rather than balloons. Offered to medical device OEMs needing micro-patterned, ultra-thin components.
• High Pressure Braid Reinforced Balloons Proprietary balloon technology creating balloons with high Rated Burst Pressure (RBP) and ultra-low compliance; thermally bonded braids ensure component fixation without adhesives (example: a 6x50mm balloon bursting over 40atm with only 0.30mm growth from 2atm to 30atm). Targeted at medical device OEMs requiring high-performance balloons for demanding interventional applications.
• Sensors and Energy Effectors on Balloons Mounting of flexible electronic hardware including PCBs, sensors, transponders, antennas, energy effectors, traces, and shields to the outer surface of balloons, integrating flexible electronics with balloon components. Targeted at medical device OEMs developing sensor-integrated and next-generation balloon-based devices.
• Radiopaque Balloons Balloons modified for visibility under X-Ray and fluoroscopic imaging via deposition of thin gold metal alloy layers or addition of tungsten-loaded polymer marker elements, enabling visibility when inflated with gas or pure saline without requiring contrast-loaded saline. Targeted at medical device OEMs requiring imaging visibility during interventional procedures.
• Drug Coating Drug coating service for drug eluting balloons, enabling pharmaceutical agents to be applied to balloon surfaces. Targeted at medical device OEMs developing drug-eluting balloon devices.
• Lubricity / Friction Tuning Surface treatment service to optimise lubricity and friction characteristics of balloons for specific performance requirements. Targeted at medical device OEMs needing tailored balloon surface behaviour.
• Design Services (DFM) Design For Manufacturability input to help projects scale faster; Hoop's balloon engineers assist with developing specifications and drawings, advising on balloon design requirements to accelerate development timelines. Offered to medical device OEMs that need balloon design support or lack internal balloon specifications.
• Shortie Catheter Service Mounting of balloons to a short mock catheter shaft with luer fittings for easy inflation via syringe or Endoflator, simplifying initial evaluations of balloon components. Targeted at medical device R&D teams conducting early balloon evaluations.

Quantifiable outcome

• 2-3 weeks custom balloon turnaround vs industry standard
• +4 more outcomes

Named customers3 records

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Haldeman & FraziercoreChannel Partner/ Reseller/ DistributorRegional sales partner covering US West territory for Hoop Medical balloon products.
• Betz-TekcoreChannel Partner/ Reseller/ DistributorRegional sales partner covering US Midwest territory for Hoop Medical balloon products.
• Alpha ZukunftcoreChannel Partner/ Reseller/ DistributorRegional sales partner covering EU and India territories for Hoop Medical balloon products.
• MDScoreChannel Partner/ Reseller/ DistributorRegional sales partner covering Japan territory for Hoop Medical balloon products.
• SaguycoreChannel Partner/ Reseller/ DistributorRegional sales partner covering Israel territory for Hoop Medical balloon products.
• MER-EuropecoreChannel Partner/ Reseller/ DistributorEU-based regulatory/regional partner for Hoop Medical.
• ChamfrminorChannel Partner/ Reseller/ DistributorMedical device component marketplace where Hoop Medical products are available for purchase online.

Scale indicators7 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• TE Connectivity / Creganna Medical: TE Connectivity acquired Creganna Medical (Ireland-based) and offers balloon catheter design, development, and manufacturing as part of its medical segment. Comparable product capability and Ireland/EU footprint, but part of a much larger medical-device manufacturing platform.
• Integer Holdings (Integer Medical): Integer Holdings is a large medical device outsource manufacturer with balloon, catheter, and finished-device capabilities following acquisitions (Vention, Lake Region). Broad incumbent competing for the same OEM programs Hoop targets, particularly above certain volume thresholds.
• Confluent Medical Technologies: Confluent Medical is a large medical-device contract manufacturer offering balloons, extrusions, nitinol components, and finished catheter assembly. Overlaps Hoop on balloon components but operates at significantly greater scale and across a wider med-device CMO service portfolio.
• Nordson Medical: Nordson Medical (including the legacy Interface Biomedical line) is a large medical device component manufacturer offering medical balloons, extrusions, and assembly solutions. Broader incumbent with overlapping balloon offerings plus a wider portfolio of fluid-management and device-finishing products.

Direct peers

• Polyzen Inc. Polyzen specializes in custom polymer balloons and film-based medical components with blow-moulding and extrusion capabilities, including ultra-thin-walled, radiopaque, and drug-coated variants. Strongly comparable to Hoop's ultra-thin-wall and advanced-coating balloon product modules.
• Synecco (formerly Advanced Polymer Extrusion): Synecco is a European medical balloon and extrusions manufacturer serving minimally invasive device OEMs, with comparable capability set (custom balloon shapes, blow moulding, secondary processing) and similar customer overlap to Hoop's niche.
• Duke Extrusion: Duke Extrusion manufactures custom medical balloons and tubing via extrusion and balloon-forming processes, serving interventional catheter OEMs. Overlaps Hoop directly on custom balloon manufacturing for medical device customers.
• Putnam Plastics: Putnam Plastics (a Precision Engineered Products company) manufactures custom medical balloons, extrusions, and catheter shafts for medical device OEMs. Direct competitor in custom medical balloon components, particularly for interventional and specialty catheter programs.
• Custom Medical Balloons: Custom Medical Balloons designs and manufactures custom medical balloons (Pebax, Nylon, PET) for catheter applications using proprietary balloon forming equipment. Direct overlap with Hoop on custom medical balloon components for medical device OEMs.

Others

• Chamfr: Chamfr is a medical device component marketplace where Hoop Medical currently lists its balloons for sale. Adjacent ecosystem participant that helps surface Hoop to prospective OEM buyers rather than competing for manufacturing share.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/hoop-medical

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Hoop Medical