The Advanced Engineering Innovation Lab is at the forefront of medical device prototyping, transforming innovative concepts into high-performance prototypes with precision micro-manufacturing and cutting-edge capabilities.
Rapid Medical Device Prototyping
Simple Micro Machined Parts
Ship as fast as 2 weeks.
Complex Parts & Assemblies
Typically ship in 6–8 weeks.
Relentless Iteration for Breakthrough Results
Successful medical device prototyping is achieved through a process of continuous iteration. Each prototype undergoes advanced pilot manufacturing followed by rigorous inspection. Subsequently, prototypes are refined and optimized to meet your exact specifications. This process ultimately drives innovation and redefines what’s possible.
Manufacturability
Designs are refined to ensure they can transition seamlessly from prototype to production.
Quality
Components are meticulously developed to meet the highest standards of reliability and performance.
Performance
Features are fine-tuned for functionality in real-world medical applications.
We’ll take on the most audacious projects however, please understand that this process takes time.
Average lead times are 6–8 weeks, as this accounts for multiple iterations. However, some projects may require fewer iterations, whereas others may need further optimization. Moreover, with each iteration, every drawing dimension and general requirement is checked until your specifications are met. Collaboration is at the heart of this journey—working together ensures the final product meets all expectations, no matter the challenges.
Flexible and Scalable Medical Device Prototyping Solutions
Quote Tip
Quoting multiple quantities such as 5, 10, 25, or 50 units helps clarify costs and scalability.
Prototyping efforts requires flexibility to meet the unique demands of every project. With no minimum order quantities (MOQs) for most inquiries, you can refine your designs without committing to large-scale production.
Quoting multiple quantities—like 5, 10, 25, or 50 units—is recommended to provide a clearer understanding of costs and scalability. Scalable options ensure seamless transitions from initial prototypes to production-ready solutions.
Quality Assurance for Medical Device Prototyping Labs
ISO-7 cleanroom environments are available to support manufacturing processes that require the strictest quality controls, ensuring compliance with medical device standards. Prototype builds undergo ultrasonic cleaning and inspection protocols as needed to meet the high quality and reliability requirements of the medical device industry.
All processes align with ISO 13485 design and development standards, ensuring prototypes adhere to regulatory and functional expectations. This commitment to quality is essential for applications where compliance and precision are non-negotiable.
Precision Capabilities Beyond Conventional Limits
The advanced pilot line has state-of-the-art technologies to meet the most demanding medical device requirements. This isn’t just about manufacturing—it’s about exploring what’s truly possible and bringing your vision to life.
In need of Medical Device Prototyping? Let us help!
We manufacture micro components and assemblies in accordance with Medical Device and ISO regulations.
- Extensive Quality Management Systems
- ISO 13485:2016 Certified
- Class ISO-7 Clean Room