Specializations

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

Specializations

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

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.

Devices that incorporate conventional microelectronic parts as well as specialized components requiring highly unique assembly processes? Combining integrated circuit technology with non-electronic 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

A fully integrated cGMP manufacturer of FDA compliant Class II/III assemblies for medical & surgical devices, implantables & wearables.

Promex is ISO 13485:16 & ISO 9001 certified & California FDB registered for Medical Device Manufacturing.

 

Biotech Instruments

Optical chains for PCR platforms, NGS flow cell fabrication, qPCR consumable modules, microfluidics modules, genomic assemblies.

Promex can do prototype to high-volume assemblies requiring Class-1000 cleanroom fabrication.

Clinical Diagnostics

FDA compliant cGMP fabrication of complex components for diagnostics 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 in 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, 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 
    Requiring manufacturing processes that eliminate particle contamination, i.e., processing in low-particulate environments, storage of work-in-process in controlled environments and careful packaging of finished products

     

  • Diagnostic Devices 
    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, blood sugar, etc. that combine 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
    U
    tilizing imaging, energy delivery, and sensors integrated into extremely compact packages
      
  • Personal Health Devices/Wearables 
    Requiring low-volume mixed assembly, tolerance for extreme temperatures, water immersion, organic contamination, ruggedized design and a small form factor.
“We engineer the build”

Some Unique Processes Developed for Customers

Medical & biotech devices demand unique and complex assembly processes.

This process of heterogeneous assembly often starts with a conventional SMT process or assembly on a 300 mm wafer. The resulting sub-assembly can be used as a platform on which standard or custom die are attached and connected specialized parts are added.

Below are a few specific examples of heterogeneous assembly processes Promex has developed for past clients.

  • Hexagonal-shaped die
  • Light pipes optically connected to sources and detectors
  • Low-temperature gold wire bonding to avoid damaging chemistry
  • Highly controlled ESD environment to enable packaging die that do not have ESD protection
  • Storage in refrigerator and processing at room temperature to avoid aging chemistry on devices
  • Adding a protective coating to prevent water during sawing from damaging chemistry on wafers
  • Developing a method of placing lids on 300 mm wafer sites with a fluid-tight channel
  • Thermocompression bonding of 100’s of bumps on large thin (75 micron) die

Typical Clients

Intuitive Surgical
Illumina
Cepheid
Boston Scientific
St. Jude Medical
Paramit
Cianna Medical
Merit Medical
Teledyne Rad-Icon
Integrated Nano-Technologies
Incube Labs
SacraMed
Spinal Modulation
*These are examples of clients that Promex has worked with on various programs from startups to Fortune 500 companies. Due to confidentiality agreements were are not able to disclose actual customer names.

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.

 

Getting Started

Concept to Commercialization

Whether you need short-run proof-of-concept prototypes, high-volume production, or a second-source manufacturer, Promex can help. Reach out to us and let's have a no-pressure conversation about how we might help advance your project to success.

  • How Can We Help?

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