Medical and Biotech Products

Located in the heart of Silicon Valley, Promex is a fully integrated cGMP manufacturer of FDA-compliant Class II/III medical device and biotech assemblies that offers complex assembly unique to the specialized requirements of these clients.

Medical Devices

Medical and Biotech Products

Located in the heart of Silicon Valley, Promex is a fully integrated cGMP manufacturer of FDA-compliant Class II/III medical device and biotech assemblies that offers complex assembly unique to the specialized requirements of these clients.

Medical Devices

Promex specializes in the assembly and fabrication of complex medical devices and biotech instruments and consumables.

Do you need customized assembly processes for physically small devices? Promex specializes in customizing assembly processes.

Do you need devices that incorporate conventional microelectronic parts as well as specialized components requiring highly unique assembly processes? Promex combines IC technology with nonelectronic elements such as optical components, acoustic devices, piezoelectrics, microfluidics, and MEMS with electronic parts into an integrated heterogeneous assembly.

We have the skills to develop and provide these unique, customized, and controlled assembly processes that such unconventional components require. Promex understands the unique demands of medical device and biotech companies, reducing both your developmental risk and time to production while working within rigorous cost requirements.

Medical Devices

As a fully integrated cGMP manufacturer of FDA-compliant Class II/III assemblies for medical and surgical devices, implantables, and wearables, Promex is ISO 13485:16 and ISO 9001 certified and is registered with the California Department of Public Health’s Food and Drug Branch (FDB) for Medical Device Manufacturing.

Biotech Instruments

Whether it’s optical chains for PCR platforms, NGS flow cell fabrication, qPCR consumable modules, microfluidics modules, or genomic assemblies, Promex can handle prototype to high-volume assemblies requiring Class 1000 cleanroom fabrication.

Clinical Diagnostics

Promex provides FDA-compliant cGMP fabrication of complex components for diagnostic devices such as stereoscopic endoscope camera assemblies, ultrasound imaging sensors, 1200-µm RF tissue markers, and PCR cartridges for molecular diagnostics.

We Build the Hard Parts

A Full Range of Medical & Biotech Assemblies

Are you responsible for fast-tracking Class III device development? Designing microfluidic instruments? Incorporating more sensors into a smaller package? We can help you with that, and more. We’ll meet your requirements for the use of FDA-approved Class III materials and manufacturing processes.

Promex can provide documentation packages that include material traceability (incoming inspection and documentation) along with part/substrate serialization. No matter whether you need to assemble a few beta units in low volumes of less than 100 units a year or are ready to scale to high volumes, we have the engineering experience and specialized equipment to get it done.

  • Image sensors 
    Require manufacturing processes that eliminate particle contamination – processing in low-particulate environments, storage of work-in-process in controlled environments, and careful packaging of finished products 
  • Diagnostic Devices 
    Used for detection and analysis of samples using a mix of small-format optical, thermal, or electrical detection mechanisms, many are primarily fluidic assemblies requiring fluid sealing, electrical isolation, cleanliness, particle control, optical transparency, and long-term stability
  • Disposable Diagnostic Devices 
    Used for a single run of a medical or biologic sample to detect DNA, bacteria, blood chemistry, lactose, and other testing that combines wet sample handling with electronics and sensors
  • Implantable Devices
    Driven by size and compatibility with the human body and surgical practices, with reliability requirements well beyond standard
  • Instruments, cameras, diagnostic equipment
    Utilize imaging, energy delivery, and sensors integrated into extremely compact packages 
  • Personal Health Devices/Wearables 
    Require low-volume mixed assembly and tolerance for extreme temperatures, water immersion, and organic contamination, combined with ruggedized design and a small form factor

Specialized Assemblies

Project Case Studies

Here are two short (3-4 minute) case studies of specific projects where Promex has been able to develop unique heterogeneous assembly process to solve difficult component assembly challenges and go to full-scale production.

Endoscope Camera Assembly

Just 4 x 8 mm in size, a full-color high-definition stereoscopic camera capable of autoclave sterilization requiring cleanroom assembly.

 

Radio-Frequency (RF) Tissue Marker

Cylindrical with protruding biocompatible antennas, just 0.05-inches in diameter and capable of being injected through a hypodermic needle.