IVD & POCT Device Manufacturing
Hochuen Medical has robust manufacturing & automation capabilities that help your IVD or Point of Care testing device get to market faster & at a lower cost.
Point of Care Testing Device Manufacturing
Point of care testing (POCT) provides timely and accurate test results that can guide therapeutic decisions and improve patient outcomes. POCT device manufacturers must understand that the need for POCT devices is growing at a rapid rate as a result of COVID-19. Hochuen Medical is uniquely positioned to meet this need.
Our advanced manufacturing facility is capable of producing large quantities of POCT devices quickly and efficiently. We source all of our materials locally, which helps to keep costs down and ensures that our products are of the highest quality. As an FDA-Approved POCT manufacturer, we provide clients with POCT devices that are both affordable and reliable.
IVD (In Vitro Diagnostics) Device Manufacturing
In vitro diagnostics (IVDs) are tests performed in glass, test tubes, or similar equipment to detect disease, conditions, and various infections in the body. Hochuen Medical is proud to offer rapid production of in vitro diagnostic devices (IVD). Our advanced manufacturing process allows us to scale up production quickly and efficiently.
Our team of experts works hard to ensure that your products are of the highest quality, while also keeping costs low. Contact us today to learn more about our IVD device manufacturing services.
Hochuen’s Manufacturing Process
Hochuen Medical is a full-service medical device development and manufacturing company. We offer complete design, engineering, and manufacturing services for a large range of medical devices, including IVD and POCT devices. We have extensive experience in all aspects of medical device development, from concept through production. Hochuen follows a strict process for each of our clients to ensure that your medical devices are of the highest quality.
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We start each manufacturing process with a non-disclosure agreement (NDA). This ensures that your ideas are protected as we move forward. Once the NDA is in place, we'll schedule a call to introduce ourselves and our capabilities. We'll also discuss your timeline, production volume, and design status.
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We 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. This process takes 1-3 days and once the design is finalized, we provide a quote that 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. Depending on the capability needed, the prototype fabrication process can take between 1-5 weeks to fabricate. Hochuen can provide T0 and T1 samples alongside a first article inspection (FAI) report to ensure we are meeting the tolerances that you specify. Following your feedback from the T0 and T1 samples, Hochuen will make the necessary mold modifications for your POCT and IVD product development.
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If you’re satisfied with the initial fabrication, we can begin scaling up production. Hochuen can formulate reagents on-site; we also have clients who directly send us reagents. While we can integrate Printed Circuit Board Assembly (PCBA) and Flexible Printed Circuit Board Assembly (FPCBA) onto devices, 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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In this phase, we will review any existing operational qualification or performance qualification (OQ/PQ) procedures, and provide suggestions for improvement. If you do not have procedures in place, we will draft a procedure based on our experience and expertise.
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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 during the manufacturing process.
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As our production volumes increase, we are able to integrate automation into more of our processes, including dispensing and content filling automation, surface treatment (Plasma and Hydrophobicity) automation, parts assembly (Bonding, Capping, Lamination) automation, and blister pack automation.
Why Choose Hochuen Medical?
Quick Turnaround Time
Our production molds take 4-6 weeks to complete, and we can handle large volume orders with ease. In addition, we offer a complete supply chain solution, ensuring that your molds are designed and distributed according to your specific needs.
Cost-Effective Manufacturing
Hochuen is committed to using locally-sourced materials for each of its productions. This commitment helps to ensure that the materials used meet the stringent quality standards required for medical devices. In addition, sourcing locally also supports local communities.
Dedicated Support Team
We have significant experience in the industry and are confident that we can meet your needs. Hochuen Medical is committed to providing the highest level of customer service possible – our team of highly skilled professionals is always happy to provide you with the best manufacturing experience possible.
Contact Hochuen Medical for a Custom Solution
At Hochuen Medical, we understand that getting a new medical device to market quickly and efficiently is crucial. That's why we offer a complete range of services to support your product, from prototype to production. Our team is always available to answer any questions or concerns you may have, and we offer competitive pricing and quick turnaround times, so you can be confident that your product will be completed on time and within budget.
Request a quote from Hochuen Medical today to learn how our team can help you bring your new medical device to market quickly and efficiently.