Ultrasonic Coating Equipment Deployment for Stent & Balloon

Customer Case Study: Ultrasonic Coating Equipment Deployment for Stent & Balloon Mass Production

1. Customer Overview

This enterprise is a professional global medical device manufacturer focusing on the R&D, customized production and global distribution of interventional cardiovascular medical devices. The company boasts a complete production workshop for disposable interventional consumables, mainly engaged in the standardized manufacturing of medical-grade coronary stents and PTCA dilation balloons. Its finished stent and balloon products are supplied to medical institutions, pharmaceutical distributors and interventional therapy labs across Europe, Southeast Asia and the Middle East.

To expand its high-value drug-coated interventional device product line and meet ISO 13485 medical production coating standards, the enterprise launched equipment procurement and process upgrading projects for dedicated stent and balloon surface coating procedures in early 2025.

2. Customer Production Pain Points

Before equipment upgrading, the enterprise adopted traditional dip coating and two-fluid spray coating processes for stent and balloon surface modification and drug coating production, which brought multiple production and quality bottlenecks restricting batch delivery:

• Uneven coating consistency: Traditional spraying creates uneven film thickness, edge accumulation and missing coating on intricate laser-cut stent mesh structures and curved balloon surfaces, leading to unstable drug release performance of finished devices and high product rejection rate.
• High raw material waste: Low atomization efficiency of traditional coating equipment causes massive waste of expensive medical polymer coating liquid and antiproliferative drug reagents, raising unit production cost of drug-eluting stents and drug-coated balloons.
• Unable to support differentiated production: The old process cannot realize fixed-area targeted coating, segmented coating and adjustable micron-level film thickness, failing to develop customized stent/balloon models for clinical differentiated intervention scenarios.
• Poor production compliance: Uncontrolled spraying particle size brings workshop particulate pollution, which cannot meet the dust-free production requirements of Class 10000 medical clean workshops, increasing compliance audit risks for medical device registration.

3. Customer Demand & Equipment Consulting Requirements

After benchmarking mainstream ultrasonic coating technology for interventional devices in the global medical industry, the enterprise initiated official consultation, putting forward clear targeted equipment procurement demands:

• Procure one professional Ultrasonic Stent Coating Machine specially designed for full coverage uniform coating of bare metal stents and drug-eluting coronary stents;
• Procure one dedicated Balloon Coating Machine adaptive to semi-compliant, non-compliant PTCA balloon surface hydrophilic coating and drug coating processing;
• The two sets of equipment need to be compatible with mainstream medical coating solvents, polymer solutions and clinical antiproliferative drug liquids, supporting batch continuous production of finished balloon and stent products;
• Equipped with programmable coating control system, to realize traceable coating parameters, convenient for medical device batch filing and quality inspection;
• Compact clean-type equipment structure, adaptive to existing medical clean workshop layout, no extra large-scale workshop renovation required.

4. Customized Solution & Equipment Configuration

Combined with the enterprise’s product specifications, daily output target and medical production certification standards, our team provided a matched dual-equipment integrated coating production solution after technical docking, sample testing and process verification:

4.1 Supplied Core Equipment

• Ultrasonic Stent Coating Machine: Adopt high-frequency ultrasonic atomization technology, micron-level uniform spray particle size, support 0.01mm-0.1mm adjustable stent coating thickness, 360° rotating clamping fixture for full-surface dead-free coating of mesh stent structures
• Balloon Coating Machine: Customized curved adaptive spraying module, support whole-balloon coating and local stripe targeted coating, low-temperature atomization design to avoid denaturation of biological drugs on balloon surface

4.2 Auxiliary Supporting Service

• On-site installation, clean workshop commissioning and operator one-stop training
• Free formulation debugging for the enterprise’s existing coating drug liquid
• Provide equipment parameter report documents supporting EU medical product export audit
• Global overseas after-sales maintenance and regular process optimization service

5. Project Implementation Progress

– Demand Confirmation & Sample Test: Complete stent and balloon coating sample proofing within 7 working days, pass laboratory coating thickness, adhesion and drug dissolution testing;
– Contract Signing & Production Delivery: Confirm dual-equipment order, finish standardized medical-grade equipment assembly and factory inspection;
– On-site Commissioning: Deliver equipment to overseas production base, complete clean workshop docking, fixture calibration and batch trial production;
– Mass Production Launch: Complete staff operation training, formal put two coating machines into daily batch production of stent and balloon finished products.

6. Project Operational Results & Customer Benefits

After 3 months of stable batch operation, the two ultrasonic coating devices fully meet the enterprise’s production and R&D demands, bringing comprehensive upgrades in quality, efficiency and cost control:

• Improved finished product qualification rate: Ultrasonic atomization achieves homogeneous coating film, zero missing coating and edge overflow defects on stent mesh and balloon curved surface. The qualification rate of drug-coated stent and balloon finished products rises from 82% to 98.5%.
• Reduced coating material cost: Compared with traditional spraying process, ultrasonic coating improves drug and polymer liquid utilization rate by 37%, effectively cutting the raw material cost of each set of interventional stent and balloon.
• Realized multi-model flexible production: One-click switching of equipment parameters supports rapid production of different diameter specifications of coronary stents and interventional balloons, facilitating rapid launch of new clinical device models.
• Met global medical compliance standards: Closed ultrasonic spraying structure reduces workshop dust pollution, fully compliant with ISO 13485 medical clean production standards, accelerating the registration approval progress of new coated stent and balloon products in overseas markets.
• Stable long-run production: Integrated programmable control system ensures consistent coating effect of each production batch, complete production data traceability, lowering quality risk of terminal clinical interventional devices.

7. Customer Feedback

“We selected professional ultrasonic coating equipment to solve the long-standing coating quality pain points of our balloon and stent production lines. The Ultrasonic Stent Coating Machine and Balloon Coating Machine delivered by the team run stably, with simple operation and highly consistent coating effect. The professional overseas technical service team solved our process debugging problems efficiently. At present, our drug-coated interventional device business has expanded steadily, and we will maintain long-term strategic procurement cooperation for follow-up production line expansion.”

About Cheersonic

Cheersonic is the leading developer and manufacturer of ultrasonic coating systems for applying precise, thin film coatings to protect, strengthen or smooth surfaces on parts and components for the microelectronics/electronics, alternative energy, medical and industrial markets, including specialized glass applications in construction and automotive.

Our coating solutions are environmentally-friendly, efficient and highly reliable, and enable dramatic reductions in overspray, savings in raw material, water and energy usage and provide improved process repeatability, transfer efficiency, high uniformity and reduced emissions.

Chinese Website: Cheersonic Provides Professional Coating Solutions