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Medical Device Prototyping & Manufacturing by Kaiao-RPRT

At Kaiao-RPRT, we understand the critical balance between innovation, precision, and compliance in the medical device industry. We are your dedicated partner, providing comprehensive rapid prototyping and low-volume manufacturing solutions designed to accelerate your product's journey from an initial concept to market readiness. Our expertise is rooted in bringing your medical innovations to life with unparalleled quality, rigorous regulatory adherence, and unmatched efficiency, ensuring every device meets the stringent demands of healthcare professionals and patients alike.

Why Rapid Prototyping is Indispensable for Medical Devices

The medical device landscape is characterized by its dynamic nature, demanding not just speed but also absolute reliability and safety. Rapid prototyping and advanced manufacturing techniques are not merely tools; they are foundational pillars that empower developers to navigate this complex environment successfully. Here's why they are critical
●  Accelerated Innovation Cycles: Swiftly transform concepts into tangible prototypes, allowing for quicker iteration and refinement of designs. This dramatically shortens time-to-market for life-changing devices.
●  De-risking Development: Identify and rectify design flaws, ergonomic issues, and functional limitations early in the process. This proactive approach minimizes costly rework, potential recalls, and regulatory hurdles down the line.
●  Comprehensive Validation Stages: Support crucial validation phases including:
○Proof of Concept: Confirm the fundamental viability of your design and technology.
○  Visual Presentation Prototypes: Create high-fidelity models for stakeholder buy-in, investor pitches, and early market feedback.
○  Functional Prototypes: Subject your device to rigorous performance and usability testing in simulated real-world environments.
○  Engineering Validation & Testing (EVT): Fine-tune engineering specifications, verify technical performance, and address any design challenges.
○  Design Validation & Testing (DVT): Ensure the device meets all user needs, intended use requirements, and safety standards for its specific application.
○  Production Validation & Testing (PVT): Optimize manufacturing processes to ensure consistent quality and scalability for future production runs.
●  Cost-Effectiveness: By catching errors early, rapid prototyping significantly reduces the overall cost of development and manufacturing.
●  Facilitating Regulatory Approvals: High-quality prototypes and well-documented manufacturing processes are essential for navigating complex regulatory submissions and achieving certifications.

Kaiao-RPRT's Unwavering Commitment to Medical Device Excellence

Our mission is to be more than just a manufacturer; we aim to be an extension of your development team, providing expertise and solutions that align with the highest standards of the medical industry.

Our Foundation: Quality, Compliance, and Certifications

At Kaiao-RPRT, quality and safety are non-negotiable. Our operational framework is built upon robust quality management systems designed specifically for the medical sector.
We are proud to be ISO 13485 certified, a globally recognized benchmark for quality management systems in the medical device industry. This certification is a testament to our profound commitment to:
●  Strict Regulatory Adherence: All our processes, from material sourcing to final inspection, are meticulously aligned with international medical device regulations, ensuring your products are compliant and market-ready.
●  Rigorous Quality Control: We implement comprehensive inspection protocols at every stage, including Design for Manufacturability (DFM) analysis, in-process checks, and final quality assurance using advanced tools like Coordinate Measuring Machines (CMM) where applicable.
●  Precise Material Verification: We ensure the traceability, biocompatibility, and integrity of every material used, critical for patient safety and device performance. Our supply chain is carefully vetted to meet medical-grade standards.
Beyond ISO 13485, Kaiao-RPRT holds additional certifications that further underscore our manufacturing excellence, material authentication, and technological prowess, guaranteeing that your medical devices are produced to the highest possible standards.

Comprehensive Services Tailored to Your Product Lifecycle

Kaiao-RPRT offers an end-to-end suite of services designed to support your medical device at every stage of its development:
●  Rapid Prototyping: From concept models to functional prototypes, we quickly create physical representations of your design for early testing and validation.
●  Low-Volume Manufacturing: Ideal for clinical trials, initial market launches, or specialized niche devices, our low-volume production capabilities ensure efficient and cost-effective output without compromising quality.
●  Tooling Design & Fabrication: Expertise in creating precision molds and tools for injection molding and other high-volume processes.
●  Expert Engineering Support: Our seasoned engineers, with extensive experience in medical device manufacturing, provide invaluable guidance on design optimization, material selection, and process efficiency.

Advanced Manufacturing Processes for Medical Devices

Leveraging cutting-edge technology and a team of highly skilled technicians, we employ a diverse array of manufacturing processes perfectly suited for the intricate demands of medical device components and assemblies:
●  CNC Milling: Achieve ultra-high precision for complex geometries, intricate features, and exceptionally tight tolerances crucial for surgical instruments, implantable components, and diagnostic equipment.
●  CNC Turning: Ideal for producing cylindrical and symmetrical parts with superior surface finishes and dimensional accuracy, commonly used for connectors, shafts, and specialized fluid delivery components.
●  3D Printing (Additive Manufacturing): Revolutionize your development with rapid creation of complex, customized, and patient-specific designs. We utilize advanced 3D printing technologies such as SLA (Stereolithography), SLS (Selective Laser Sintering), and FDM (Fused Deposition Modeling) to produce anatomical models, surgical guides, and intricate prototypes with diverse material properties.
●  Vacuum Casting (Urethane Casting): A cost-effective method for generating small batches of high-quality prototypes and functional parts that closely mimic the material properties of injection-molded plastics, perfect for early-stage validation.
●  Plastic Injection Molding: For scalable and high-volume production of plastic medical components, offering exceptional repeatability, consistency, and cost-efficiency. Ideal for device housings, drug delivery components, and disposables.
●  Sheet Metal Fabrication: Precision cutting, bending, and forming of metal components for robust medical device enclosures, mounting brackets, and structural elements.

Biocompatible & Medical-Grade Materials: The Foundation of Safety

The choice of material is paramount in medical device manufacturing. We work exclusively with a wide selection of high-performance, biocompatible, and medical-grade materials that meet industry standards for sterilizability, chemical resistance, and long-term durability. Our material expertise includes:
●  High-Performance Thermoplastics:
○PC (Polycarbonate): Excellent clarity, impact resistance, and sterilizability.
○PEEK (Polyether Ether Ketone): Exceptional strength-to-weight ratio, chemical resistance, and biocompatibility, ideal for implantable devices.
○PMMA (Acrylic): Optical clarity for lenses and display covers.
○POM (Acetal): High stiffness, low friction, and excellent dimensional stability for mechanical components.
○PPSU (Polyphenylsulfone) & PSU (Polysulfone): High-temperature resistance and sterilizability for repeated use applications.
○Ultem (PEI): High heat deflection, excellent strength, and chemical resistance.
○ABS (Acrylonitrile Butadiene Styrene) & PP (Polypropylene): Common for housings and non-critical components due to good processability and cost-effectiveness.
●  Medical-Grade Silicone Rubber: For flexible, soft-touch components, seals, gaskets, and biocompatible tubing.
●  Advanced Metals:
○Stainless Steel (304, 316L): Corrosion resistance and strength for surgical instruments, implants, and structural components.
○Titanium: Superior biocompatibility, strength, and corrosion resistance, widely used for implants and surgical tools.
○Aluminum: Lightweight with good strength, often used for housings and structural parts.

Precision Post-Processing & Surface Finishes

Precision Post-Processing & Surface Finishes
To further enhance the functionality, aesthetics, and performance of your medical devices, we offer a comprehensive suite of precision post-processing and finishing solutions:
●  Anodizing: Increases corrosion and wear resistance on aluminum parts, allowing for various color options and a durable finish.
●  Powder Coating: Provides a tough, chemical-resistant, and aesthetically pleasing finish for device enclosures, available in a wide range of colors.
●  Electroplating: Applies a thin metallic coating to improve corrosion resistance, wear resistance, conductivity, or aesthetic appeal.
●  Bead Blasting: Creates a uniform, non-reflective matte finish, ideal for reducing glare on surgical tools or enhancing the tactile feel of device housings.
●  Passivation: A chemical treatment for stainless steel that removes free iron and enhances corrosion resistance, crucial for medical instruments exposed to harsh environments or sterilization processes.
●  Heat Treatment: Modifies the microstructure of metals to achieve desired properties such as increased hardness, strength, or ductility, optimizing performance for specific applications.
●  Polishing & Surface Grinding: Achieve ultra-smooth surfaces for improved aesthetics, sterilization, and reduced friction.
●  Painting & Silk Screening: For custom branding, labeling, and aesthetic differentiation.

Our Professional Service

Rapid Prototyping
CNC Machining
3D Printing
Rapid Sheet Metal
Low Volume 
Manufacturing
Reaction 
Injection Molding

Medical Device Components Manufacturing Solutions

CNC Machining

Our high quality CNC Machining rapid prototyping process is able to satisfy the needs of the growing robotics sector.

Using CNC milling solution to custom produce the robotic plastic parts and robotic metal parts. We create your custom robotics parts from your design. CNC machinery robotic parts like robotic gear,camera plastic housing,and other robotic component like aluminium robotic plate, battery case as robotic parts.

 

 

Vacuum Casting

Due to low cost and short time tooling making the vacuum casting (cast urethanes) is one perfect rapid prototyping service for quality low volume manufacturing. Vacuum casting is one common process using in robotic industry to cast the plastic robotic components.We’re the reliable custom manufacturer providing vacuum casting service for your robotic parts.

 

 

 

Sheet Metal Fabrication

Our in-house sheet metal manufacturing prototyping service allows us to make the aluminium medical parts ,brass medical components, steel medical device components, combined our other solution laser cutting service, we’re no problem to fabricate the metal bracket aluminium box steel plate for your medical parts . We use the sheet metal solution to bend the metal parts in stainless steel,copper,brass, aluminium plate to shape the parts for medical device innovation.

 

 

Plastic Injection Molding​​​​​​​

Plastic injection molding is a fabrication process for low volume especially large volume production plastic parts in wide range of materials.

The plastic injection molding help industrial robotics also with competitive unit price and high quality. The robotic plastic parts with double or more separate parts where joined together it called as plastic over-molding process ,which can meet more cosmetic needs or more function. Send us a inquiry to custom made injection molded plastic robotic components and relative robotic parts.

Quality lnpection

It goes without saying that quality is vital to the success of any manufacturing project. When it comes to rapid manufacturing the importance is magnified due to the need to get it right the first time. At Kaiao, we employ many different quality control measures to ensure your rapid project not only gets done on time but also meets your stated specs. Below is a quick snapshot showing the steps involved in making your rapid parts.
 
On-Line Delivery
 
Safe And Secure
 
QA/QC Satisfied

Kaiao-RPRT: Your Partner in Medical Industry Advancements

Kaiao-RPRT stands as your steadfast medical device prototyping and production provider, accommodating a spectrum from uncomplicated to intricate medical components. Armed with a fusion of cutting-edge technologies and unparalleled manufacturing proficiency, we excel in translating your medical concepts into tangible realities. Irrespective of the complexity of the component, our arsenal of rapid prototyping, bridge tooling, and low-volume production solutions propels you toward your objectives.

Strong Capabilities

Our distinction lies in our XXX certifications, attesting to our formidable manufacturing prowess, material authentication, and technological prowess. Every medical device element originating from Kaiao-RPRT adheres resolutely to regulatory compliance prerequisites, encompassing dimensions, performance criteria, strength, and more.

Precision Parts

Crafting precision is the cornerstone of our medical device prototyping endeavours. We prepare medical components that align meticulously with tolerance and precision requisites, capably achieving tolerances of up to +/- 0.001 inches. Our mastery of machining techniques ensures that the precision of your medical device prototype remains uncompromised.

Fully Customizable

At Kaiao-RPRT, we expedite medical parts manufacturing through our bespoke design and tailor-made tooling competencies. Our collaboration hinges on meticulously analysing your product's distinctiveness, which undergoes metamorphosis through sophisticated manufacturing processes, breathing life into your visionary concepts.

Instant Quotation

Our adaptive instant quotation platform underscores our commitment to elevating the medical parts manufacturing process. By uploading your design files, you receive prompt feedback encompassing DFM analysis, pricing, and lead time, all within minutes. Empowering you further, our streamlined tracking and management systems grant you unequivocal command over your orders.

Fast delivery

With the fusion of instantaneous quotations and rapid prototyping technologies, Kaiao-RPRT excels in curbing lead times by an impressive margin—surpassing the 50% threshold. Our profound technical proficiency and adeptness work synergistically to expedite this transformation, maximizing efficiency at every juncture.

From Prototyping to Mass Production Phases in the Medical Sector

Leverage advanced solutions tailored for the development of medical products. RapidDirect presents meticulously crafted and engineered custom items known for their exceptional durability and functionality. Our offerings span across several stages, facilitating the attainment of your manufacturing objectives.

Prototyping

Fabricate prototypes of high quality using materials akin to those used in production, catering to the early phases of development. Evaluate your design thoroughly and implement pertinent alterations to the design or material to prime the medical prototypes for testing adequately.

Quality Assurance-Prototyping

After an in-depth analysis of your design file, our skilled technicians will actualize prototypes that align with your design prerequisites. The choice of materials and processes hinges on the intended application, aiming to replicate the final product's appearance. This approach empowers you to scrutinize specifications and conduct functional assessments.

Swift Material and Design Modifications

Precise Prototypes Featuring Intricate Geometries
Prototype Models Resembling Final Components

Suitable Materials for Medical Product Development

Our manufacturing proficiency aligns with a diverse spectrum of materials tailored to meet the exacting requisites of the medical sector. Our experts boast considerable familiarity and expertise in identifying the most suitable materials for advancing medical products. Collaboratively, we will pinpoint the material that impeccably aligns with your specifications. Delve into a compilation of the foremost materials frequently employed in the progression of components for medical devices.

Thermoplastics

Thermoplastics are resolute, pliable, and functional constituents in medical product fabrication. Their commendable resistance to corrosion, detergents, and chemicals bestows upon them a prolonged lifespan, surpassing that of conventional medical materials. Moreover, their robust adhesion to metals renders them invaluable for encapsulating medical prototypes, thus augmenting functionality.

Thermosets

Exhibiting an innate resistance to elevated temperatures, thermosetting plastics remain impervious to distortion or deformation in extreme thermal conditions. This attribute renders them an optimal choice for medical devices necessitating repeated sterilization. Their appreciable hardness and rigidity, coupled with impeccable dimensional stability, engender precise and accurate components.

Nylon

Steel, too, holds a pivotal role in modern automotive part production. This enduring metal thrives in performance and durability, facilitating the creation of top-tier components. Its corrosion resistance, lightweight nature, and capacity to yield aesthetically pleasing parts solidify its role. Its usage spans car brakes, engines, exhaust systems, wheels, and beyond.

Copper

Copper enhances comfort, efficiency, and safety across the automotive sector. Recognized for its outstanding electrical conductivity, ductility, and malleability, copper finds a home in various electronic components—encompassing the vehicle's wire harness, radiator, starter motor, alternator, and brake tubes.
 

Magnesium

Polyamide, distinguished by heightened tensile strength and resilience against high temperatures and chemicals, is a prerequisite for medical apparatuses. It seamlessly interfaces with various manufacturing techniques, including injection moulding, CNC machining, and 3D printing. Furthermore, nylon lends itself to fortification through amalgamation with other medical-grade substances, amplifying its robustness.

Silicone Rubber

Silicone rubber emerges as a frontrunner among thermosetting materials. Due to its elevated thermal stability and supple nature, its adherence to industry benchmarks facilitates effortless sterilization via diverse methods. Additionally, this material upholds its strength while retaining flexibility even when confronted with extreme conditions.

Titanium

Titanium boasts an unparalleled strength-to-weight ratio and superior resistance to corrosion, rendering it an optimal candidate for prototyping medical devices. Its compatibility with 3D printing allows bespoke components predicated on patients' anatomical scans. The material's inherent attributes equip it with heightened endurance against chemical agents and extremes of temperature.

Stainless Steel

As a low-carbon alloy, stainless steel is a quintessential selection for many medical components. Esteemed for its non-toxic and non-corrosive characteristics, stainless steel manifests in diverse variants, thus rendering it an asset across a comprehensive spectrum of medical applications. While inherently resilient, stainless steel can be refined to enhance its aesthetic appeal and mechanical properties.

The Kaiao-RPRT Advantage: Your Partner in Medical Innovation

Choosing Kaiao-RPRT means forging a partnership with a team that deeply understands the nuances of medical device development. We differentiate ourselves through
●Unrivaled Speed & Efficiency: Our streamlined processes and advanced technology allow for instant quotation upon design file upload, providing DFM analysis, pricing, and lead times within minutes. This efficiency can reduce your lead times by over 50%, significantly impacting your time-to-market.
●Guaranteed On-Time Delivery: We recognize the critical nature of timelines in medical development and are unwavering in our commitment to delivering your projects punctually, every single time.
●Experienced Medical Engineering Team: Our dedicated team of engineers possesses extensive experience in medical device manufacturing, offering proactive insights, problem-solving, and design optimization to ensure manufacturability and performance.
●Transparent & Well-Controlled Quality: From the initial review of your design to the final inspection, our rigorous quality control system is transparent and meticulously documented, providing you with confidence in every part we produce.
●Strict Material Verification: We maintain a robust system for material authentication and traceability, ensuring that only certified, high-quality, and biocompatible materials are used for your critical medical components.
●Client-Centric Collaboration: We believe in a collaborative approach, working closely with your team to understand your precise requirements and deliver customized solutions that consistently exceed expectations.
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