Medical Device Product Development & DFM Services
Hochuen Medical provides turnkey medical product development services, including DFM, manufacturing, and proof of concept validation.
Challenges in Medical Device Product Development
When businesses need to produce medical devices within a short time frame, it is essential that they have the right partner in place to ensure the project is completed efficiently and effectively.
Businesses without the right manufacturing partner early on may spend money unnecessarily, compromise on quality, and delay the medical device development process. Hochuen ensures manufacturers are prepared and confident during pre-production, optimizing the entire process – get in touch to learn more about our services.
Did You Know?
Approximately 70% of product manufacturing costs stem from design decisions made in the early production stages, such as materials used or methods of manufacturing.
Partner with Hochuen for Medtech Product Development to Reduce Costs
Medical device companies and Medical design houses approach Hochuen with conceptual designs, looking for services for DFM (design for manufacturability).
Hochuen’s DFM process involves taking conceptual and/or prototype designs and suggesting changes for Medtech product development. Our manufacturing development strategies focus on simplifying designs to cut down on cost and optimize the design for fabrication that is most likely to succeed.
Hochuen’s strategy involves a close communication loop with the client to minimize design complexity while maintaining the device’s most important features. We help the client choose suitable materials to reduce supply chain delays and bring costs down. Hochuen’s approach to DFM considers all the key factors required to deliver a high-quality medical device, including materials, processes, and assembly.
Our DFM service is the best solution for effective manufacturing thanks to factors including:
Experienced design teams in DFM and Mold Flow Analysis.
Onsite vertical integration to perform design, mold fabrication, injection molding, inspection, and more in one facility.
Established manufacturing in Malaysia and China.
FDA-registered and ISO 13485-certified facilities.
Interested in Learning More?
Consider Hochuen’s Advanced DFM Process
Hochuen offers a detailed DFM practice for medical device production at any scale, helping companies streamline operations and get to market faster with a better-manufactured product. Below are the steps we follow to ensure you receive the highest quality product each time.
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Client reaches out to Hochuen with interest in partnership for their product development.
Client signs a non-disclosure agreement (NDA) before the first meeting is scheduled.
Both parties meet to discuss the client’s needs and Hochuen’s service capabilities to determine the complexity and maturity of the design, timeline, and volume.
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Client provides Hochuen with 3D STEP (CAD) files and 2D drawings with tolerances and material specifications.
Hochuen reviews files within 1-3 days and offers multiple rounds of feedback and suggested CAD modifications.
An initial quote is sent to the client that may include 1) tooling costs, 2) NRE costs, 3) unit prices at various volume estimates and 4) lead times required to ship the finished product. This initial quote is subject to additional revision required by updated design features, volumes, etc.
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Following approval of the quote, the client sends the purchase order which initiates production.
Hochuen then proceeds with the mold fabrication and develops T0 and T1 samples along with FAI reports so clients can confirm the product meets their exact specifications.
Modifications requested by the client are then completed within a few days as needed.
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Once clients are satisfied with the initial production sample, Hochuen can begin scaling up production to advance the process.
Depending on the production volume requested, Hochuen may use various molds with fewer or more cavities to meet specification requirements.
Among our other capabilities, Hochuen can also integrate printed circuit board (PCBA) and flexible printed circuit board (FPCBA) while working with local global vendors to source electronic components.
For high-volume productions, Hochuen automates processes including:
Material dispensing and product filling
Surface treatment (Plasma and Hydrophobicity)
Parts assembly (bonding, capping, lamination)
Blister packing
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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.
If the client does not have OQ/PQ procedures drafted, Hochuen can draft a procedure for approval on the client’s behalf.
Sterilization
Hochuen can facilitate Gamma or EO/ETO sterilization of the developed products – 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 ready for shipment to users.
Experience Benefits with Proof of Concept Validation
Take your design idea and make your product the new medical standard with Hochuen.
Quick Lead Time
DFM feedback can be provided in a matter of days, with prototype molds within 1-2 weeks at a more cost-effective price.
Cost-Effective
Hochuen has the expertise and resources to boost production from zero to 2 million units within months and ensure each product meets high industry standards.
Quality Assurance
Hochuen has the expertise and resources to boost production from zero to 2 million units within months and ensure each product meets high industry standards.
Get in Touch to Request a Quote
Hochuen Medical has the experience and expertise to help businesses streamline their medical device development. Our DFM is designed to save your company time, effort, and money and ensure the highest quality results.
Contact Hochuen today to request a free quote for manufacturing your medical device design.