MedicalMedical Prototyping & Testing
Prototypes accurate enough to be evidence, not just illustrations
Read moreMedical Product Development & Design
Concept to final production, with the regulator in the room from the start
Sanpin Medical · since 2019
Overview
Development that covers every stage from initial concept through to final production, aimed at designs that are functional, innovative and actually manufacturable. In medical work the last of those three is where most programmes fail, because the design was signed off before anyone asked what it would take to mould it in a controlled environment.
Problems
What This Fixes
- Concepts that cannot be manufactured as drawn, discovered at tooling stage
- Design handovers where the manufacturer inherits decisions they cannot change
- Regulatory requirements considered after the design is frozen
- Development split across a design house and a factory that never speak
Benefits
What You Get
- Comprehensive support at every stage, from conceptualisation to production
- Designs assessed for functionality, innovation and manufacturability together
- Market needs, feasibility and regulatory requirements weighed at the concept stage
- The team that designs it is inside the business that will make it
Who For
Suited To
- Companies taking a medical device from concept to market for the first time
- Teams whose design partner cannot manufacture and whose factory cannot design
- Brand owners commissioning a device around a clinical need
Scenarios
Typical Jobs
- A device moving from clinical concept into a manufacturable design
- A redesign forced by a change in material availability or regulation
- Design transfer from an in-house team into production
Technical
How It Runs
- Development covering conceptualisation, design, prototyping, testing and production
- Designs evaluated against manufacturability inside our own facility
- Regulatory requirements factored into the concept phase
- Rigorous testing and validation before the product is committed
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 Product Development & Design |
|---|---|
| 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 Product Development & Design
Where does your involvement usually start?
It can start at conceptualisation, where market needs, feasibility and regulatory requirements are weighed together, or at any later stage.
Do you handle testing and validation?
Rigorous testing and validation are carried out to confirm the product meets the necessary safety and performance standards.
How is this different from your general product development service?
This runs inside Sanpin Medical, under its ISO 13485 system, with the regulatory pathway treated as a design input rather than a later hurdle.
Related
Often Quoted Together
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One-Stop Service
MedicalRegulatory Compliance Support
The manufacturing evidence your submission is going to ask for
Read moreFurther Reading
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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.