Focus
Cal MedTech's primary production expertise is in the assembly and testing of complex medical devices and laboratory instruments. This includes the fabrication and testing of printed circuit boards, wire harnesses, sheet metal, custom metal and plastic parts, laser systems, macro /microfluidics (pumps, tubing, valves, sensors), precision electromechanical and electro-optical assemblies, molded parts, user interfaces and custom enclosures.

Certifications
Cal MedTech is licensed by the State of California as a manufacturer of medical devices and laboratory instruments. We are also registered with the FDA as a manufacturer of Class I, II and III medical devices. We maintain ISO-9001 and ISO-13485 certification for design, manufacturing and service of medical devices and laboratory instruments, and we are FDA/QSR compliant.

ERP System
We recently implemented a fully-integrated ERP system that encompasses manufacturing management, accounting & finance, BOM management, engineering change control, productivity monitoring and sales support. This system helps us ensure that we have the right parts in the right place at the right time in order to meet your delivery expectations.

Volumes
We manufacture as few as one and as many as ten thousand units per year. New projects are evaluated based primarily on their long-term revenue potential and the strategic fit with Cal MedTech's competencies. We accomodate low volume projects during clinical trials and pilot launch phases if there is a significant chance of higher-volume production after the first year. Most projects fall within the range of several hundred to several thousand units per year for the first few years. We have a three-tiered manufacturing organization, as described below, which enables us to move projects from more expensive pilot production resources to lower-cost, higher-volume production as projects mature.

Pricing Policy
Cal MedTech operates on an open book pricing policy. Typically, we build a small number of units, either jointly or independently, in order to establish baseline costs for materials, labor and yield. Then we add industry-standard margins for materials and labor, resulting in our transfer price. If a warranty is offered on the product, we also add an allowance for warranty repairs.

Fulfillment Services
Once your product is ready for production ramp-up, we can provide full logistics support to your organization. Specifically, we can manufacture units to a certain finished goods inventory level, then ship directly to your customers, all under your control. Finished goods inventory data, as well as tracking information for shipments, is available to you through a secure online site.

Service Depot
Cal MedTech’s in-house service department handles warranty repairs, periodic maintenance and refurbishment. Products can be directly shipped to us from your end-users, since we have full decontamination capability. If desired, we can maintain a loaner pool and provide 24-hour hot swapping, so your customers have no down-time. Field service repair may also be provided as needed for equipment which is difficult to ship.



Facilities and Locations

San Diego
Cal MedTech headquarters are located in the Rancho Bernardo area of San Diego, roughly forty-five minutes south of Orange County and forty-five minutes north of Mexico. Within our 25,000 square foot headquarters facility, we have a complete machine shop with multiple 3-axis and 4-axis CNC milling stations, production floor, warehouse, finished goods storage area, and service area with decontamination capability.

SF Bay Area
Our Bay Area Design Center houses a Silicon Valley design team with prototyping and pilot production capabilities. Once designs are fully tested and validated in this facility, they are transferred to the San Diego location, or directly to one of our offshore affiliates.

Mexico
Cal MedTech's affiliate in Tijuana, Mexico, has the capability of PCB assembly, wire harness fabrication, sub-assembly production and testing, as well as finished goods manufacturing. When certain product lines in our San Diego facility reach high enough volumes (typically over one thousand units per year), we consider transferring some labor-intensive portions of the product to our Mexico location, in order to lower the overall product cost. This facility employees approximately eighty workers and is ISO-13485 certified.

China
Our affiliate in Xiamen, China, employs over eight hundred workers, and has the capability to assemble PCBs, wire harnesses, sheet metal, thermoformed parts, machined parts, injection molded parts, sub-assemblies and finished goods. In addition to assembly services, our affiliate can also produce injection mold tooling at very significant savings relative to domestic resources. This facility is ISO-9001 and ISO-13485 certified.