Medical Product Development & Manufacturing

Developing innovative medical devices with wide-ranging experience and industry-leading expertise.

Bring your medical technology to market.

We offer comprehensive and robust development services for medical devices and consumables to reduce risk and shorten your time to market. Our quality team is integrated into all steps along the way to assure we're meeting your ISO 13485 requirements.

We are seasoned in bringing innovative medical devices to market and our engineering, design and manufacturing teams are tenured in user experience, design for manufacturability, and reliability. Our strengths in manufacturing include extensive prototyping abilities and offer flexibility and customizability, supplemented by a team of skilled manufacturing, assembly, and engineering level technicians.

CP1A9642

3,000+ successful medical device projects.

CP1A9005

Engineering

SymbientPD-LoctJan21-64

Prototyping

CP1A1924_1

Manufacturing

Medical Device Product Segments

Whether you need instrumentation such as a molecular point of care (POC) diagnostic device or a more complex system such as a radiation oncology, or imaging, our staff of engineers, scientists, and designers can meet your medical device needs.

We are proud to be at the front end of breakthrough diagnostic and molecular point of care (POC) product development including in vitro diagnostics (IVD), molecular point of lab and point of care and immunohistochemistry devices. Our additional specialties include diagnostic imaging devices, laser systems, therapeutic equipment, surgical hardware and other complex instrumentation.

Our engineering strengths are extensive in the areas of driving fluidics and optics based detection.

Through our subsidiary Symbient facility is focused and highly skilled in medical consumable product development. Our deep expertise is in Point of Care (POC) microfluidic cartridge development along with general clinical products and more advanced omics devices.

If you're looking for CLIA waivable product development, we have you covered. Iteration is key when developing plastic consumable devices and SLA and 3D printing can only get you so far.

With our rapid plastics injection molding capabilities, we can iterate on actual part designs using commercial-ready materials. We are your fastest solution to market.

With capital equipment comes complexity. Whether your device is for therapeutics, imaging, or testing in a lab, we have the team and expertise to integrate your core technology into a system with a great user experience or we can go deeper to help develop any optics or imaging systems to meet your technical requirements.

Alongside development, we execute your capital equipment manufacturing. With over 50,000ft² of operations space we're ideally suited to commercialize your product.

We're proud to highlight a few additional Medical Development and Manufacturing Capabilities.

noun_hazmat suit_3511328

Complete assembly & quality control testing

noun_Gauge_3659287

Controlled environments for class 100, 1000, & 10000

noun_Plastics Ethylene_952429

Injection molding & plastics processing

noun_checkmark_788137

We follow ISO 13485 quality standards

noun_Reagent Bottle_550550

Reagent filling in our dry-room space

noun_regulation_839072

Regulatory support

ISO 13485 Quality Management System

Group 674
Group 631 (1)