Hochuen’s Medical Device Development Process
Learn more about our full medical product development process
Our Turnkey Process
At Hochuen Medical, we pride ourselves on our ability to offer a comprehensive range of services to our clients. Hochuen has extensive experience in medical device development, tooling fabrication, prototyping, and small and high-volume production. In addition, we offer assembly, quality control, packaging, and sterilization services.
Contact Hochuen Medical today to start a conversation about your medical device development needs.
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After you get in touch with Hochuen Medical, we sign a non-disclosure agreement (NDA) before proceeding. This is to protect the confidentiality of your information. Once signed, we will have a call with you to introduce ourselves and our capabilities and discuss your design, timeline, and production volume.
Ready to get started? Get in touch with Hochuen Medical to start a conversation with our team about your needs.
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Hochuen will request 3D STEP (CAD) files and 2D drawings with tolerances and materials before starting work on a project. This way, we can develop a design for manufacturing (DFM) and propose an accurate quote. We also select the best possible materials for the job, considering your specific needs and our own experience and expertise.
Depending on design complexity, this review process can take 1-3 days. Once our engineering team has reviewed the files and provided feedback, our clients can make any necessary modifications to the CAD files. Once the design is finalized, a quote can be generated which includes tooling costs, non-recurring engineering (NRE) costs, unit prices at various volume estimates, and lead times.
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Once you’re satisfied with the quote and send the purchase order (PO), we can begin production. For Injection Molding, prototype tooling can take between 1-2 weeks to fabricate depending on complexity, whereas production tooling may take approximately 4-5 weeks to fabricate.
The tooling process can take between 1-3 days for Die Cutting. At the beginning of every production, Hochuen will send samples to confirm that the product is exactly what you’re looking for. Hochuen can provide T0 and T1 samples alongside a first article inspection (FAI) report to ensure we are meeting the tolerances that you specify. T0 samples are sent over to you to ensure that you have an opportunity to note specific changes. Following your feedback from the T0 and T1 samples, Hochuen will make the necessary mold modifications.
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If you’re satisfied with the initial fabrication, we can begin scaling up production. For Injection Molding, lower volume production will use production molds with fewer cavities and higher volume production will use production molds with a higher number of cavities. For Die Cutting, we can use Stamp Die Cutting for lower volume production and Rotary Die Cutting for higher volume production.
Hochuen can formulate reagents on-site; we also have clients who directly send us reagents. We can integrate Printed Circuit Board Assembly (PCBA) and Flexible Printed Circuit Board Assembly (FPCBA) onto devices; however, we do not design electronics nor do we manufacture them in-house. Instead, we work with reputable vendors in Shenzhen to source these electronic components.
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Hochuen works closely with you to jointly determine the best methods for testing products. If you have operational qualification or performance qualification (OQ/PQ) procedures drafted, we will review them and make suggestions for improvement. If you don’t have procedures in place, we will draft a procedure based on our experience and expertise.
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We offer a wide range of packaging options, from simple Tyvek pouches to complete packaging ready for shipment. Hochuen has a longstanding relationship with the single sterilization vendor in Shenzhen, so we can facilitate Gamma, Ethylene Oxide, or Ethylene Oxide Processing (EO/ETO) sterilization services if needed.
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As our production volumes increase, we are able to integrate automation into more of our processes. This includes dispensing and content filling automation, surface treatment (Plasma and Hydrophobicity) automation, parts assembly (Bonding, Capping, Lamination) automation, and blister pack automation.
View all Capabilities and learn more about our Contract Manufacturing Services
Why Choose Hochuen Medical?
Hochuen offers quick turnarounds and unique manufacturing capabilities that allow us to produce high-quality medical devices and components. Our experience and expertise in medical device production are unrivaled, and we are dedicated to providing our clients with the best possible products and services.
Cost-Effective Manufacturing
Hochuen will work with you to utilize locally-sourced materials when possible to cut down on costs while continuing to meet the quality standards required for medical devices.
Quick Turnaround Time
Hochuen can create prototype molds in 1-2 weeks once the design is locked. We can create production molds in 4-6 weeks, depending on design complexity.
Dedicated Support Team
Our goal is to provide you with the best possible product. We manage the entire supply chain, including everything from design to distribution.
Low-Volume to High-Volume
Hochuen is able to ramp up from 0 to 2 million parts/month in 2 months. This is a difficult feat. However, Hochuen has the experience and expertise to make this happen.
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We have the resources to get your medical device from prototype to production quickly and efficiently, and our team is always available to answer any questions or concerns you may have. In addition, we offer competitive pricing and quick turnaround times, so you can be sure that your product will be completed on time and within budget.
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.