Hardware Prototyping for Irvine and Orange County
Prototypes and product engineering for Orange County's medical device, automotive and consumer electronics teams: boards, firmware, enclosures in materials that suit skin, wipes and sunlight, and the documentation a regulated or retail product needs. Based in Silicon Valley, serving Irvine and the whole county.
Three free tools that run in your browser, with no sign-up: a range for the engineering, a timeline from prototype to production, and what the boards themselves should cost.
Orange County hardware: devices people wear, drive and hold
Orange County's engineering economy leans toward products that touch people directly. Irvine and its neighbors hold one of the largest medical device clusters in the United States, grown around cardiovascular devices, surgical tools and patient monitoring, with UC Irvine's engineering and medical schools close by. Several automakers run their North American headquarters or design operations from Irvine, and EV companies have expanded there. Consumer electronics and computer hardware companies round out a county where the end user is usually a patient, a driver or a shopper rather than another engineer.
That end user sets the requirements: a product a patient, driver or shopper uses without a manual has to be safe and obvious, and the decisions that make it so are cheap at the prototype stage and expensive later.
Medical devices that leave the hospital
More and more medical devices are wearable, portable or used at home: monitors, sensors and therapy devices that a patient carries or operates alone. Those products bring requirements a bench prototype ignores. Materials that touch skin need a biocompatibility case under ISO 10993, so we choose enclosure plastics, adhesives and strap materials with that evaluation in mind instead of after a test fails. Housings have to survive the disinfectant wipes and alcohol used to clean them, which crack some common plastics. Home-use medical electrical equipment has its own collateral standard, IEC 60601-1-11, and usability engineering under IEC 62366-1 asks you to show that a tired patient can use the device correctly.
Connected medical devices add cybersecurity. Since 2023 the FDA has expected premarket submissions for devices that run software and can connect to the internet to include a cybersecurity plan, a software bill of materials and a way to deliver updates, so secure boot, signed firmware and an OTA update architecture belong in the first firmware, not the last. Our medtech background includes the software behind ELDA BrainTech's neurodiagnostic device; the case study has the details.
Automotive and EV hardware outside the vehicle maker
Startups in the automotive world rarely design a module for a carmaker's production line. More often they build what plugs into, charges or rides along with a vehicle: telematics units on the OBD-II port, dashcams and fleet trackers, chargers and charging accessories, battery monitors. Each has a quiet trap. A device on the OBD-II port draws from the car battery with the ignition off, so its sleep current is a requirement, not an afterthought. Charging hardware has to follow the coupler and signaling standards, SAE J1772 and increasingly SAE J3400 in North America, with safety listing under UL 2594 for supply equipment. Anything that reaches toward a safety function brings ISO 26262 functional safety into the conversation early.
The firmware matters as much as the board. Beyond the standard OBD-II data, CAN messages differ by make and model year, so a device that reads vehicle data needs a plan for what it does when a message is missing or different. We design the firmware and the cloud back end to degrade gracefully instead of going silent.
Consumer electronics that ship to a store shelf
A consumer product here is usually headed for retail or direct-to-consumer sales, which adds three tests a prototype rarely sees: a drop onto a hard floor, a lithium battery that must pass UN 38.3 before it can be shipped, and a phone app that has to pair on the first try or the product comes back as a return. We build drop testing into DVT, choose cells with their shipping paperwork in mind (see choosing a battery), and design the BLE protocol and the companion app together, so pairing is tested on real phones before EVT.
Working with us from Orange County
We have no office in Orange County. Our engineering team is in Silicon Valley, roughly 400 miles north and a little over an hour by air to John Wayne Airport, on the same Pacific clock as you. Weekly progress happens on video and in a shared repository. Hardware moves by carrier after bring-up on our bench, typically one to two days by ground or overnight when needed, and we suggest keeping a second unit on our bench while you test the first, so any bug you find can be reproduced here the same day. We come down in person for a kickoff, a usability session with real users, or a contract manufacturer visit, when a day on site saves a week of email.
What we design and build
- PCB design for low-power wearables, vehicle electronics and consumer devices, with test points and DFM from Rev A.
- Mechanical design and industrial design: housings in materials that suit skin, wipes, sunlight and drops.
- Embedded firmware with secure boot and OTA updates, and the companion app that talks to it.
- Rapid prototyping through EVT, DVT and PVT, with certification preparation and pre-compliance scans along the way.
- Transfer to manufacturing: DFM, test fixtures and documentation a contract manufacturer can build from.
How much does hardware prototyping really cost? breaks a prototyping budget down stage by stage.
Orange County hardware prototyping questions
Do you have engineers based in Irvine?
No. Our team works from one base in Silicon Valley. Working with us from Orange County means remote engineering in the same time zone, hardware delivered by carrier, and in-person visits for the meetings where being in the room changes the outcome, such as a kickoff, a usability session or a factory visit.
Can you design a wearable medical device enclosure?
Yes, together with the electronics inside it. The early decisions are materials for skin contact and cleaning agents, sealing against sweat and water, battery placement for comfort and safety, and access for charging. We pick materials with the ISO 10993 biocompatibility evaluation in mind and leave the testing itself to an accredited lab.
We are building an OBD-II device. What should the prototype prove first?
That it sleeps. A device that drains the car battery over a long weekend fails no matter how good its data is. After that: that it reads the data you need across the makes and model years you plan to support, and that it survives the electrical noise and heat of a parked car in summer. We usually test those three before anyone designs a polished enclosure.
How long does it take to go from prototype to production?
Regulation decides more than engineering does. A consumer BLE product can move from first works-like prototype to production in a matter of months; a medical device adds design controls, verification testing and an FDA pathway that can take considerably longer. The free hardware timeline planner on this site lays out EVT, DVT, PVT, certification and production for your product type.
What will the engineering cost?
Priced in engineering hours; you get a written quote with phases before any work starts. Before you call, the free project cost estimator gives a range for the engineering and the PCB cost calculator gives indicative board fabrication and assembly costs, so the first conversation starts from numbers rather than guesses.
Building hardware in Orange County?
Thirty minutes with a senior engineer, free. Bring the idea, the board or the deadline, and you will leave knowing what the first prototype should prove.