Cost-Effective Medical Device Manufacturing

Hochuen Medical Device Manufacturing has the expertise and automation capabilities that help your medical device get to market faster, and at a lower cost.

Hochuen Medical is one of the leading OEM manufacturers of medical devices. Hochuen’s advanced manufacturing facilities enable us to produce a wide range of products for various clients, from simple devices to complex systems.

Hochuen has extensive experience in both large-scale and small-batch production volumes. Our turnaround time ranges between 4-6 weeks for production molds, using locally-sourced materials to positively impact your return on investment (ROI). We work directly with lead project managers to develop the highest-quality products for businesses.

The Complete Medical Device Manufacturing Solution

End-to-End Solutions for Medical Manufacturing

Hochuen simplifies the medical device manufacturing process while ensuring each product exceeds the client’s expectations.

Development & Proof of
Concept Validation

We provide design for manufacturing (DFM) feedback within a matter of days and can offer a quote within the same timeframe.

Prototypes &
Custom Molding

Hochuen sends T1 and T2 samples to the client at the beginning of production to ensure the product meets the client’s needs. Injection molding prototype tooling takes an average of 1-2 weeks while die cut tooling can take 1-3 days.

Medical Device Assembly
& Automation

Hochuen works directly with a sister company that designs medical device automation equipment to ensure the most efficient and detailed manufacturing process – no third-party sourcing needed.

Medical Device Manufacturing Capabilities

Hochuen’s advanced techniques allow for high-quality production of medical devices, such as, but not limited to:

In-Vitro Diagnostic Devices (IVD)

Microfluidics

Point of care testing (POCT) devices

Our extensive manufacturing capabilities include injection molding, die cutting, LSR, bonding (including laser welding, ultrasonic welding, heat staking, etc.), adhesives, lamination, laser machining, dry reagent handling, wet reagent blister packing, and many more. No matter what stage of development your medical device is in, we have the expertise and resources to complete it within your timeframe and budget.

Ready to Scale Your Medical Device Production?

Hochuen’s manufacturing process ensures a smooth transition from prototype to market. Learn how Hochuen can help you scale up your medical device development.

Small and High Volume Production

  1. Once clients are satisfied with the initial production sample, Hochuen can begin scaling up production to advance the process. Our experts can easily scale up your production in a timely and efficient manner, ramping up to volumes of millions of pieces per month when needed. For example, we can ramp up production from 0 to 2 MM/mo within 2 months.

  2. Depending on the production volume requested, Hochuen may use various molds with fewer or more cavities to meet specification requirements.

  3. Among our other capabilities, Hochuen can also integrate printed circuit boards (PCBA) and flexible printed circuit boards (FPCBA) while working with local global vendors to source electronic components. This can ensure a cost-effective manufacturing process for the client while meeting high-quality standards.

  4. For high-volume productions, Hochuen automates processes including:

    1. Material dispensing and product filling

    2. Surface treatment (Plasma and Hydrophobicity)

    3. Parts assembly (bonding, capping, lamination)

Quality Control

  1. Hochuen is FDA-registered and ISO 13485 certified, and we implement thorough quality control procedures for each capability, so your product is of the highest quality.

  2. If the client has the operational qualification (OQ) and performance qualification (PQ) procedures drafted, Hochuen can review and provide suggestions for the client’s approval.

  3. If the client does not have OQ/PQ procedures drafted, Hochuen can draft a OQ/PQ procedure on the client’s behalf to ensure all safety and functional requirements are met for each product.

Sterilization

Hochuen can facilitate Gamma or Ethylene Oxide (EO/ETO) sterilization of the developed products in a medical device manufacturing clean room. We have a longstanding relationship with the single sterilization vendor in Shenzhen.

Packaging

If needed, Hochuen can provide packaging products from as simple as standard Tyvek pouches to complete packaging (with printed labels & barcodes) ready for shipment to users.

Packaging typically consists of thermoformed plastic trays that are sealed with aluminum foil followed by sterilization. These packages are typically sealed to prevent contamination and exposure from air/humidity.

Why Choose Hochuen for Medical Device Manufacturing?

Hochuen offers various manufacturing services for medical devices of any kind – experience the benefits of our expert medical device manufacturing process.

Highly Cost-Effective Manufacturing Solutions

Our manufacturing process is flexible with minimum order quantities and includes locally-sourced materials, so you don’t have to worry about shipping and other unnecessary costs.

Fast Turnaround Time

Hochuen’s lead time for production molds is 4-6 weeks, compared to the average time of 8-10 weeks with other medical device manufacturers.

Hochuen has the expertise and resources to scale up production from zero to 2 million parts/month in two months, ensuring each product meets high industry standards.

Scale Up Production Quickly

Contact Hochuen Medical for a Custom Solution

As experts in medical device manufacturing, we have the resources to get your product from prototype to production quickly and efficiently. As an FDA-approved medical device OEM, Hochuen will work with you throughout the FDA-approval process to ensure your product meets industry standards.

Request a quote from Hochuen Medical to learn how our team of experts can help you bring your medical device to market faster, and at a lower cost.