Now in a brand new 30,000 sq. ft. facility. Same trusted service, greater capacity to support your next breakthrough.
Medical Device Prototyping
Build a prototype that validates your vision.
You bring the vision. We’ll help you realize it with expert design reviews, fast, functional builds, and precision processes.
Let’s make your first build count.
Your prototype sets the direction for testing, feedback, and everything that comes next. We’re the medical device prototype manufacturer that will help you move forward quickly and clearly with hands-on design input, in-house control over every detail, and builds that reflect where you’re headed.
With Sonele, your early-stage hardware is engineered to align with downstream performance, cost, and compliance from the start.
Chris Bass, CEO
InventoRR MD
“It has been great working with Sonele. Their team has been extremely responsive and helpful in working with us to design AbClo into the great product it is today.”
What sets our medical device prototypes apart
Engineering-led prototyping
Our engineers collaborate on design, DFM, materials, and testing to de-risk your build and support downstream success.
Production-aligned builds
Prototypes are designed to flow smoothly into validation and manufacturing, allowing you to skip expensive and time-consuming rework.
In-house prototyping capabilities
Key capabilities, such as 3D printing, micro-machining, PCB integration, and final system enclosures, are handled internally to keep your build on track.
Custom tooling & fixtures
We design and build the jigs and tooling needed for alignment, consistency, and testable early iterations.
Our medical prototyping process
01
Design Review & Feasibility Analysis
We start with a collaborative review of your concept, 3D models, and specifications. Our team identifies potential risks, suggests improvements, and confirms feasibility based on your technical goals and timelines.
02
Material & Process Selection
We assist in selecting materials, adhesives, manufacturing methods, and test strategies tailored to your device’s application, balancing performance, manufacturability, and cost.
03
Custom Tooling & Fixture Development
When needed, we design and build custom tooling, jigs, and fixtures to ensure process repeatability, alignment, and precision throughout prototype assembly and testing.
04
Build Execution
Prototypes are fabricated and assembled in-house using precision manufacturing processes with competitive turnaround times and quality control throughout.
05
Functional Testing & Documentation
Your prototype is tested to verify that it meets its intended requirements. We provide test data, photos, and supporting documentation for review. We encourage collaborative feedback and validation during this phase.
06
Iteration or Design Transfer
Based on test results and stakeholder feedback, we support rapid iteration or prepare the design for scale-up, validation, and manufacturing transfer with production-ready documentation.
Frequently asked questions
The timeline depends heavily on design complexity and supply chain factors. Our in-house capabilities and collaborative approach help us move quickly without sacrificing quality, enabling faster iteration, testing, and preparation for validation.
Absolutely. You’ll work hands-on with the engineers who guide your medical device prototyping process and won’t be filtered through layers of project managers. We collaborate directly with your team to improve product designs, identify design flaws, and move your idea toward a final product that performs and gets to market faster.
Custom tooling can make a big difference if your functional prototype requires alignment, consistency, or rigorous testing. We design and build fixtures that enable multiple iterations and early usability testing, helping you refine the user interface, improve ergonomic design, and de-risk your build.
Yes. Our team supports a broad range of prototyping applications—from embedded components and enclosures to integrated systems requiring CNC machining, PCB integration, and custom assemblies. Whether you’re iterating on an initial concept or preparing for full production, we adapt to your project complexity.
Companies with new medical devices in need of a prototype aligned with regulatory compliance, material selection, and a scalable development process choose Sonele for our extensive experience in the medical industry. We focus on building functional, testable prototypes that transition seamlessly into medical manufacturing within the same facility, keeping everything under one roof. The knowledge gained during development is retained throughout validation and manufacturing, ensuring continuity, efficiency, and fewer risks during scale-up.
Contact Us
Ready to build your prototype right?
Make your first build count with expert guidance, precision processes, and real manufacturing alignment.
Fill out the form, and we’ll contact you within 3–5 days to discuss your prototyping needs.
