Pro-Dex » Powerful Solutions

Design & Manufacturing

Manufacturing Capabilities
Quite simply if it can be built we can build it. From surgical implantables (screws, fixation systems), devices with electronics, custom software development, complex assemblies and sub-assemblies, sterilization, complex materials, and injection molding.

  • Implantable fusion devices
  • Sterilized screws and fixation systems
  • External fixation systems for trauma
  • Surgical tools and instruments
  • Powered devices with smart technologies
  • Disposable adapters (cutters, shavers, drivers)
  • Injection molding for drug delivery
  • High precision highly complex assemblies
  • Custom design projects

Competitive Advantages
Pro-Dex is a big step ahead of the pack. From our location, to our industry experience and comprehensive suite of
services we lead the contract manufacturing industry for good reason.

location for contract manufacturers 2Strategic Location
30,000 manufacturing square feet in the heart of Irvine, CA.
location for contract manufacturers 2Regulatory Compliance
510(k) filings to device history files let us manage your documentation needs.
location for contract manufacturers 2ISO 13485 Certified
Our facility is registered with the FDA and CA Department of Public Health Food & Drug Branch.
location for contract manufacturers 2Industry Leader
We have extensive experience precision manufacturing for the world’s largest companies.
location for contract manufacturers 2Long Manufacturing History
Pro-dex was established in 1978 and has delivered over 40,000 powered devices.
location for contract manufacturers 2Manufacturing Assembly
Our assembly model utilizes cells with extensive cross training and testing.
location for contract manufacturers 2Testing Solutions
Standalone service. Let us design your testing protocols. Quality is our DNA.
location for contract manufacturers 2Fully Transparent
Pro-dex is a public company and trades under the symbol “PDEX.”
location for contract manufacturers 2Engineering & Staffing Solutions
Our Engineers will design your product for manufacture. Need additional resources? We’ve got them.

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How it works:
Our Design & Manufacturing Solutions
Prodex offers turnkey manufacturing solutions for a wide variety of industries. From prototyping to engineering to manufacturing and assembly to validating your suppliers and supply chain management to meeting regulatory and compliance needs we have solutions for every aspect of your project and manufacturing needs. Bringing products to market is our specialty. Schedule a facility visit today!

We invite you to come see our six phase development process in action; we begin with proof of design and product feasibility testing, leveraging our in house engineering talent and long history of manufacturing experience. We then develop designs for manufacturability and concurrently develop processes for manufacture and assembly. Prior to product transfer and release all of our products go through a rigorous verification and validation process. Finally we conduct post production evaluations, continually optimizing and making process improvements.

1. Design. Most of our manufacturing opportunities start with the signing of a non-disclosure agreement (“NDA”) and a discussion amongst our engineering teams about the particulars of the product or part of interest. Our engineering team can review your drawings for manufacturability or create a design from scratch given your product specifications. We will leverage our manufacturing expertise and offer suggestions for amendments where we see potential for improvements. We often create working prototypes and 3D prints of product concepts to validate the designs and proof of concept. The convenience of our location allows us to work closely with your development team. We also offer engineering contractor services if more bandwidth is needed.

2. Manufacture. Our versatile high precision manufacturing facilities are able to produce on a low volume quick turnaround basis as well as on a high volume cost effective basis. From high precision injection molding and tooling to ultrasonic welding or precision motion control to machining at extremely tight tolerances we excel at speed to market, high quality, on-time deliveries and reduced manufacturing costs. Our engineering team will work to help every step of the way, working hard to avoid problems before they happen and suggesting alternatives to reduce the cost of tools, use of parts, and optimize the manufacturing so that it is lean and well within your specifications. We are one of only a few local FDA registered and ISO 13485 certified facilities with decades of experience manufacturing finished medical devices. Our employee base is extremely loyal with five of our key machine shop employees having almost a century of experience between them.

3. Assembly. Our assembly facilities are equally versatile. We assemble in stages with regular testing intervals to increase efficiency and virtually eliminate any fully assembled performance failures. Testing is built into the culture of our assembly team. Open channels of communication between our inventory, manufacturing and assembly teams with strong management oversight (meet our Director of Operations Mr. Rick Boyd) allows for a culture of continuous improvement. Assembly is an important aspect of our turnkey product/compent concept to market strategy. We aren’t simply a contract manufacturer. We are capable of driving your project from beginning to end.

4. Testing. Rigorous testing is a key aspect of our Quality Management System. We are so recognized for the quality of our testing that some customers outsource their finished product testing to our facilities for our team to test on their behalf. Our engineering is involved every step of the way, monitoring testing outcomes and constantly looking for product design enhancements. Our product testing capabilities serve as a standalone capability for Pro-dex and are another way that we set ourselves apart from the pack, offering solutions at every stop of the manufacturing process.



5 Documentation of medical device maufacturing35. Documentation & Compliance. These are critical aspects of the manufacturing in many industries. In the manufacture of medical devices manufacturers are required to file 510(k) Clearances notifying the intent to market a medical device. Quality System Regulations, Design History Files, and strong and effective documentation controls are essential to proper development and manufacturing. With Pro-dex you can outsource your documentation and compliance needs or leverage the expertise of our in house team. We have been qualified by some of the largest medical device distributors in the world and are more than capable of handling your documentation and filing requirements (meet our Director of QA and Regulatory Affairs Angel Domingo)

6 Delivery of medical device maufacturing36. Delivery. Pro-dex offers multi-directional logistics and fulfillment. We not only drop ship finished and laser etched products globally but we receive finished devices for repairs and refurbishments. Our job is to not only manage every aspect of the product design, manufacture, assembly, and testing, but to also provide the backup and repair services needed for you and your customers to use our products with the peace of mind that we can service them. Our ERP system keeps us on top of inventory and delivery times and ensures that we deliver your products exactly when you need them.

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Pro-dex in house manufacturing capabilities
Pro-Dex is a big step ahead of the pack. From our location, to our industry experience and comprehensive suite of
services we lead the contract manufacturing industry for good reason.

location for contract manufacturers 2Design & Technical Drafting
Experience drawing detailed design specifications with hardware/software interfaces, tolerance analyses & manufacturing feasibility.
location for contract manufacturers 2Electronics & Software
Experts in embedded systems and solutions (battery powered, torque limiting software, led displays, etc).
location for contract manufacturers 2Mechanical Engineering & Design
Specialize in transforming ideas and concepts into functional prototypes ready for manufacturing.
location for contract manufacturers 2Precision Machining & Assembly
Decades of experience with tight tolerances and flexible & high mix manufacturing.
location for contract manufacturers 2Quality & Compliance
At our regularly audited ISO 13485 certified facilities good manufacturing practices are embedded in our culture.
location for contract manufacturers 2Testing & Other Capabilities
Circuit and PCB design, programming (C++, Java, Visual Basic, etc), display sub-systems for instrumentation.
location for contract manufacturers 2Prototyping & Validation
We have seen a lot of product ideas and can help you successfully develop your concept for manufacture.
location for contract manufacturers 2Precision Injection Molding
Extensive track record of manufacturing high precision injection molding tooling for a blue chip customer base.

1. Design & Technical Drafting.We specialize in transforming ideas and concepts into functional prototypes ready for manufacturing. Our engineering professionals have the innovative skills to give your project its competitive edge.

2. Electronics & Software. Our team is knowledgeable in embedded systems and solutions; enabling your products to have the intelligence they need. Our portfolio of product development includes low power, battery operated hand-held devices; precision motion control and positioning devices; control functions with unique patient safety technology.

A. Embedded Systems:

* Motion control, including console and battery operated systems
* Physiologic signal processing, display and analysis
* Rotary drive systems including handheld “smart” power screwdrivers
* Data acquisition for low signal/high noise environments

It is our job to be analytical and methodological to ensure the toughest of problems are solved correctly. Our engineers specialize in writing, designing, and developing effective and efficient algorithms.

B. Engineering Solutions:

  • Motion & Object Detection
  • Feature Extraction/ Signal Trending
  • Imaging & Image Enhancement
  • Optical Character Recognition
  • Decoding of 2D Barcodes
  • Temperature Control

3. Mechanical Engineering & Design. We specialize in transforming ideas and concepts into functional prototypes ready for manufacturing. Our engineering professionals have the innovative skills to give your project its competitive edge.

  • Conceptual models through to designs ready for manufacture
  • Variety of materials- plastics and composites, steel, aluminum, alloys
  • Machined, cast and molding processes
  • High reliability- harsh environment, autoclave, dishwasher
  • Surface treatments, finishing, coatings, anodize
  • Thermal, mechanical- vibration, shock, load and stress analysis
  • Powered or manual devices for orthopedics, CMF, dental, ENT
  • Enclosures, housings, components, sub-assemblies
  • Disposable and reusable devices



4. Precision Machining & Assembly. Your experience at Pro-Dex as a customer is important to us which is why we are dedicated in meeting your expectations while fulfilling regulatory requirements. With our experienced work force and in-house specialized equipment we are in the business to support a variety of industries and product lines.

  • Precision Machining
  • Flexible & High Mix Manufacturing
  • Components to Finished Products
  • Assembly Capabilities
  • Historical On-time Delivery of 98%
  • Rapid Prototyping
  • Lot Tracking
  • Speed to Market
  • Material Certification
  • EProcess Validations
  • Lean Manufacturing



5. Quality & Compliance. We have over 15 years experience providing quality and compliance assurance in conformance to FDA and ISO 13485, Medical Device Directive and other standards. At Pro-Dex, our reputation is on the line, as is yours; it is therefore our goal to ensure your product is safe and effective. Good manufacturing practices are apart of our culture. Our facilities are regularly audited to ensure continued adequacy and compliance. We can offer a range of solutions tailored to your specific needs.

  • Risk Management- Services, Templates, Forms
  • Quality System Services – Procedures, Work Instructions, Forms, Technical Writing, System and Process Audits
  • Validations – Creation of Protocol, Execution, Report Writing
  • Inspection Services – Capabilities include CMM, Optical, Electronic and Mechanical
  • Control Plans – Master, Process and Inspection
  • Process Mapping



6. Testing & Other Capabilities.

  • Circuit and PCB design for virtually any application and form factor
  • Electronics design from low level, low frequency analog through RF and high clock rate DSP applications
  • PCB layout and design
  • Full prototyping and board/bench debug
  • Detailed design specifications including hardware/software interfaces, tolerance analyses
  • Programming languages including C/C ++/Java/Visual Basic/Forth/LISP/UML
  • Operating systems including Kadak / VxWorks / ThreadX / SEGGER emboss / PowerPack / Micrium II, III/Free RTOS
  • Drivers and support for SPI, IIC, UART, ADC, GPIO, RTC
  • Superb documentation of software from top level graphical architecture through extensive source code commenting
  • Display sub-systems for instrumentation, monitors



7. Prototyping & Validation. At Pro-dex we are experts at taking your back of the napkin ideas and creating product prototypes. With our in house 3D printing capabilities and superb engineering team we have everything needed for quick turnarounds. Our Engineers have expertise in metallurgy, mechanical engineering, aerospace, industrial and manufacturing. Prototyping is a huge part of what we do and the starting block for every aspect of our engineering and design process. Our state of the art product development equipment allows us to quickly manufacture a working prototype for validation and conceptualization of your product ideas.


8. Precision Injection Molding. Our precision injection molding capabilities are just another example of how Pro-dex offers fully vertically integrated manufacturing solutions for our partners. Read more about our precision injection molding here.

Pro-dex stands alone in the marketplace for the range of services we provide. If it can be built, our team can build it!
Take a virtual tour of our ISO 13485 certified 30,000 square foot Irvine facility in this video!

Still not sure how our business works or what our manufacturing capabilities are? Don’t hesitate to contact us! We pride ourselves
at being extremely responsive and chances are that our engineering team has already built what you need.