MedicalMedical Product Development & Design
Concept to final production, with the regulator in the room from the start
Read moreMedical Prototyping & Testing
Prototypes accurate enough to be evidence, not just illustrations
Sanpin Medical · since 2019
Overview
Rapid, accurate prototypes for testing and validation, produced so that the results mean something when they reach a regulator or a clinician. Prototyping shortens the development cycle because problems surface while they are still cheap, and it reduces the risk of delay during the approval process by verifying compliance early.
Problems
What This Fixes
- Design issues found after design freeze, when every change is expensive
- Functional claims that cannot be tested because no physical part exists
- Regulatory delays caused by requirements verified too late
- Clinician feedback gathered from drawings rather than from something they can hold
Benefits
What You Get
- Rapid iteration, so the design team can identify and address issues early
- Physical prototypes allow functional testing against the intended performance
- Helps verify compliance with regulatory requirements before the submission
- Supports feedback from healthcare professionals and patients on a real object
Who For
Suited To
- Device developers preparing for design verification
- Regulatory teams assembling evidence ahead of a submission
- Clinical and human-factors teams running user evaluations
Scenarios
Typical Jobs
- A usability study that needs devices a clinician can actually operate
- Functional testing of a fluid path before the tool is committed
- A design review where three variants are compared as physical parts
Technical
How It Runs
- Rapid and accurate prototyping supported by the medical facility
- Prototypes produced for testing and validation, not only for appearance
- Measuring room inspection applied to prototype parts
- Path from prototype into clean room moulding within one company
At A Glance
Specification
Everything below is published because it is what an engineer checks before sending a drawing. Anything not listed is confirmed in the quotation rather than guessed at here.
| Capability | Medical Prototyping & Testing |
|---|---|
| Group company | Sanpin Medical, established 2019 |
| Category | Medical Device Manufacturing |
| Location | Shenzhen, Guangdong, China |
| Certification | ISO 9001:2015 / ISO 13485:2016 |
| Post-treatment | Plating, Anodizing, Painting, UV printing, Screen printing |
| Response time | Engineer replies within 24 hours |
Order Process
How This Job Would Run
The same eight stages apply whether the order is a single tool or a production programme.
Request A Quote
Send the part drawing or 3D file by email. An engineer comes back within 24 hours with a consultation, not an auto-reply.
DFM Report
Before any steel is cut we return a design-for-manufacture report that flags flaws and errors in the design, so they are fixed on paper.
Mould Design & Moldflow
A predictive model analyses how the molten material behaves inside the cavity. Flow analysis settles gating and cooling before tooling.
Mould Tooling Production
Tooling is cut from the steel grade chosen for the application, not from whatever is on the rack.
T1 Sample Inspection
First-trial samples go out for your inspection and review. Errors are identified on T1, before mass production is committed.
Low Volume Production
A low-volume run follows the trial phase, so precision is proven on real machines under expert surveillance before the ramp.
Strict Inspection
Parts are inspected against international tolerance standards and against the specification you supplied.
Delivery
Parts are packaged to survive the journey and released through our logistics partners on a scheduled delivery.
Questions
About Medical Prototyping & Testing
How accurate are the prototypes?
Accurate enough to be used for testing and validation, which is the standard we build to. Send the tolerance that matters and we will confirm before starting.
Does prototyping help with regulatory approval?
It helps verify that the device complies with the requirements before the submission, which reduces the risk of delays during the approval process.
Can prototypes be used for user testing?
Yes. They are commonly used to gather feedback from healthcare professionals and patients so the final product meets real user needs.
Related
Often Quoted Together
Medical
One-Stop Service
MedicalMedical Device Moulding
Intricate, high-precision moulds for parts that go into patients' care
Read moreFurther Reading
Related Articles
KnowledgePrototyping For Medical Devices: Why It Matters
Prototyping is a critical step in medical device development. It accelerates the development cycle and makes sure the final product meets every requirement it has to.
Read moreKnowledgeFrom Concept To Market: How Product Development Is Supported
Bringing a medical device from concept to market is a complex, multi-stage process. Most programmes fail at the joins between stages rather than inside them.
Read moreGet This Quoted
Attach the drawing or the 3D file and tell us the annual quantity. An engineer replies within 24 hours with a consultation.
An engineer replies within 24 hours. Attach a drawing or a 3D file and tell us the annual quantity.