FAQs | Focus – Product Engineering

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FAQs

All you need to know about Focus

Find answers to common questions about Focus, our engineering services, industries, technologies, and how we work with clients to bring products from concept to production.

About Focus

What does Focus do?

Focus is a full-stack engineering partner with a team of 80+ engineers and experience across 250+ projects. Since 2015, we've helped businesses design, build, and launch innovative products across MedTech, Robotics, and Consumer Electronics. By bringing hardware, firmware, software, and automated testing together under one roof, we help clients turn ambitious ideas into reliable, market-ready products.

What engineering services does Focus provide?

From early architecture and prototyping through verification and manufacturing, our multidisciplinary teams bring hardware, firmware, software, and testing together to build products that are ready for the real world:

Hardware: Electronics and PCB design, system architecture, ultra-low-power design, and production-ready hardware built with scalability and manufacturability in mind.
Firmware: Robust, maintainable real-time firmware for embedded and connected systems, with expertise in C/C++, bare-metal, FreeRTOS, and Zephyr.
Software: Desktop tools, iOS/Android mobile apps, factory applications, cloud services, and backend systems tightly integrated with hardware and embedded platforms.
Prototyping: Rapid hardware, firmware, and software prototyping to validate concepts, reduce technical risk, and accelerate iteration.
Testing & Verification: Automated functional testing, manufacturing test systems, DFM reviews, test fixture design, and Hardware-in-the-Loop (HIL) validation.
Regulatory & Quality: ISO 13485 certified, with experience across IEC 60601-1, IEC 62304, and ISO 14971, plus verification documentation and FDA 510(k)/PMA submission support.
Manufacturing Support: Design-for-manufacture (DFM), manufacturability and test strategy, EMC/certification support, and contract manufacturer (CM) coordination from prototype through production.

What industries does Focus specialize in?

Focus operates through three specialized studios:

Medical, focused on regulated active implantable and wearable devices — primarily neuromodulation, cardiac rhythm management, and wearable monitors
Robotics, supporting companies building autonomous systems, from electronics and firmware through ROS2 and AI systems
Consumer Electronics, for companies building complex connected devices for the mass market

Where is Focus located?

Focus is headquartered in Uruguay, with engineering talent across Uruguay and Argentina. We work in US-aligned time zones, making close collaboration with clients across North America and Europe easy.

Why do companies choose Focus over other engineering partners?

Because we combine deep technical expertise across hardware, firmware, software, and testing with a strong understanding of the products we help build. We take ownership of our work, collaborate closely with internal teams, and stay focused on delivering reliable, production-ready products—not just completing engineering tasks. Our deep expertise in regulated devices, backed by ISO 13485 certification, means that same rigor carries into everything we build.

Engineering Services

What types of engineering projects do you take on?

We help companies develop innovative products from concept to commercialization. Whether you need support designing electronics, developing embedded firmware, building software, creating automated test systems, or scaling an existing product, our multidisciplinary team can integrate with your engineering organization or take ownership of complete project deliverables. We primarily work with clients in MedTech, Robotics, and Consumer Electronics.

What stages of product development can you support?

We can support any stage of the product development lifecycle, from concept and feasibility studies to architecture, design, implementation, verification, validation, and production support.

Can you develop an entire product or only specific components?

Both. We can develop an entire product from concept to production or support specific parts of your engineering effort.

Do you work with startups as well as enterprise companies?

Yes! We work with early-stage startups navigating their first prototype or funding milestone, as well as established companies and enterprises scaling teams up or down as the engagement demands.

Can you modernize or redesign an existing product?

Yes. We regularly step into projects with an existing codebase, inherited contractor artifacts, or legacy hardware that needs remediation, and bring it up to current standards, whether that means improving architecture, closing regulatory documentation gaps, or rebuilding for manufacturability at scale. We also take on scope expansions and technical debt that outgrew a client's original team or vendor.

Can you help after product launch?

Yes. Most of our engagements continue well past launch, supporting ongoing feature development.

Medical Devices

What medical devices does Focus develop?

Focus specializes in active implantable medical devices (AIMDs) and wearable devices (monitoring and external stimulation), with primary depth in:

Neuromodulation
Cardiac rhythm management

Beyond these core areas, we support a broad range of other regulated medical devices, including diagnostic instruments, hardware (IEC 60601-1), firmware and embedded software (IEC 62304), companion software (IPG programmers, patient and physician apps), automated testing and HIL, and the technical documentation required for our clients' FDA submissions.

Is Focus ISO 13485 certified?

Yes, Focus is ISO 13485:2016 certified for the design and development of hardware and software for medical devices, and related technical services.

What medical device regulations and standards Focus works with?

Focus is ISO 13485 certified, and works across the standards and regulatory frameworks that govern active implantable and wearable medical devices:ISO 13485 — Quality Management Systems for medical devices

ISO 14971 — Risk management
IEC 60601-1 — Electrical medical equipment safety
IEC 62304 — Medical device software lifecycle
IEC 81001-5-1 — Health software and IT systems cybersecurity
FDA QMSR / 21 CFR Part 820

Design controls, traceability, and technical documentation aligned with FDA 510(k)/PMA and other regulatory pathways are built into our development process, not an afterthought.

Can you help with FDA, EU or any other international regulatory submissions?

Focus doesn't file regulatory submissions directly, that responsibility belongs to the legal manufacturer. What we do is build the technical foundation your submission needs from day one: Medical Device File documentation (called DHF in QSR), requirements traceability, and design verification evidence structured to align with FDA and international regulatory expectations, so your regulatory team isn't scrambling for documentation late in the process.

How does Focus approach cybersecurity for medical devices?

Cybersecurity is integrated throughout our development lifecycle via a Secure Product Development Framework (SPDF) aligned with IEC 81001-5-1 and current FDA cybersecurity guidance, covering both premarket and postmarket requirements. This includes threat modeling, security requirements and risk controls, and verification of implemented security controls during development, with release-ready artifacts such as an SBOM and cybersecurity documentation. We also support postmarket activities, including vulnerability monitoring. Our engineers are trained in secure development practices and stay current through ongoing cybersecurity training as the threat landscape evolves.

What's Focus's role in verification and validation (V&V)?

Focus owns design verification end-to-end, confirming that every output meets its input requirements through structured testing, automated frameworks, and HIL infrastructure, fully documented and traceable within your Medical Device File.

Final device validation is performed by the legal manufacturer on the finished, market-ready product. Our verification work is what makes that step faster and better-informed, not a late-stage scramble, but a natural continuation of documentation we've already built.

What device classifications and risk levels does Focus work with?

Our quality management system is built and certified to support the full range of medical device risk classes (Class I, II, and III), as well as all IEC 62304 software safety classes (A, B, and C), which covers the safety-critical firmware found in active implantable devices. This is where Focus has its deepest technical roots: our core focus areas are neuromodulation and cardiac rhythm management systems, both high-risk, high-scrutiny device categories.

Robotics

What robotics engineering services does Focus provide?

Focus offers full-stack robotics engineering, from power electronics and control boards to firmware, ROS2 integration, and cloud connectivity. Our services span drivers and actuator control, state estimation, functional safety and compliance, HiL continuous integration, DFM/DFT for production transition, and fleet management and telemetry once robots are deployed.

What types of robots do you develop?

We work with any kind of robot. Our recent projects span autonomous ground vehicles, agricultural and off-road autonomy platforms, and legged and humanoid robots — including autonomous yard trucks for logistics, an autonomous tractor ECU for specialty farming, and SLAM-based navigation on a robotic quadruped.

Get a glimpse of our work in our case studies.

What communication protocols and technologies do you support?

We work with ROS2-based systems, gigabit networking (including PoE), CAN, and mixed-signal circuit design, alongside the broader connectivity stack we support across our studios: BLE, NFC, UWB, LoRa, and cellular IoT. We also build the data flow layer connecting different buses and gateways, and IoT integration for cloud connectivity, remote updates, and telemetry streaming.

Can you help bring an existing robotic prototype to production?

Yes. This is a core part of how we work with clients: taking a working prototype through more robust and extensible SW/FW/HW implementation, then through DFM/DFT to transition to production without surprises.

Do you work with NVIDIA platforms?

Yes. We work across the NVIDIA robotics stack: Jetson platform work including custom L4T images, kernel and BSP customization, containerized deployment, and GPU benchmarking, plus Isaac Sim and Isaac Lab for simulation. We also optimize perception and SLAM workloads to fit embedded GPU compute and memory budgets.

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Do you develop AI, SLAM, and autonomous navigation for robots?

Yes. SLAM and autonomous navigation are core strengths of our robotics team, which includes PhDs with published research in visual and visual-inertial SLAM. We've deployed SLAM-based mapping and click-to-goal autonomous navigation on quadruped robots, optimized SLAM stacks for tight compute and memory budgets on embedded platforms, and built vehicle-mounted mapping rigs fusing LiDAR, cameras, and GNSS/INS. We also support perception and state estimation for more intelligent robot behavior, using simulation and ROS2 to accelerate development and validation.

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Can you build safety-critical robotic systems?

Yes. We work on certification-bound autonomous vehicle platforms, building safety mechanisms and the evidence behind them: HIL test coverage of safety functions, safety performance indicators, SOTIF-style instrumentation and analysis, and requirements-to-implementation traceability. Combined with our medical-device heritage and ISO 13485 certification, safety assurance and documentation discipline is standard practice for us, not an add-on.

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Consumer Electronics

What consumer electronics products does Focus develop?

Our customers range from startups building fitness devices to enterprises developing drone delivery technology and advanced lab equipment. We've built devices that run for over a decade on a single battery cell, and others that stream video across hundreds of kilometers — spanning collars and wearables, e-bike systems, and other whole-system products with companion apps. We're a certified Nordic Semiconductor design partner, reflecting the depth of our hardware expertise.

See more in our case studies.

Can you help take a product from concept to manufacturing?

Yes. We take full ownership of a product's development from concept through mass manufacturing, or embed alongside your existing team if you need targeted support. That includes early architecture and silicon decisions, design for manufacture, manufacturing test, and coordination with your contract manufacturer all the way to volume production.

What wireless technologies do you support?

We cover the full connectivity stack: BLE, NFC, UWB, LoRa, cellular IoT, and Amazon Sidewalk. We're a Nordic Semiconductor design partner with deep Zephyr RTOS experience, and we shipped the first commercial product to run Amazon Sidewalk on Nordic silicon — including helping Amazon build its own validation firmware.

Can you optimize products for cost, size, or battery life?

Yes. Ultra-low-power hardware design is core to what we do — we've built devices that operate for over a decade on a single battery cell. We also work to hit aggressive BOM cost and size targets at volume, balancing power, connectivity, and manufacturability from the earliest design decisions.

Can you develop companion mobile or desktop applications?

Yes. We build companion apps and cloud integration as part of our full-stack offering, so the hardware, firmware, and software are designed to work together as one system rather than being handed off between separate teams.

Technologies

Which embedded platforms do you support?

We work across a broad range of embedded hardware platforms, with particular depth as a certified Nordic Semiconductor design partner. Our teams are comfortable with ARM Cortex-M-based microcontrollers generally, and we adapt to the silicon each project requires — whether that means an ultra-low-power wireless SoC or a higher-performance applications processor for compute-heavy edge workloads.

Do you develop Bluetooth Low Energy (BLE) products?

Yes. BLE is core to our connectivity work, alongside NFC, UWB, LoRa, and cellular IoT, and we bring deep experience getting BLE products to hold up on battery life and range in real-world field conditions, not just on the bench.

Do you work with Nordic Semiconductor, STM32, NXP, ESP32, or TI platforms?

We're a certified Nordic Semiconductor design partner with deep Zephyr RTOS experience. Beyond Nordic, we adapt to whichever microcontroller platform best fits a project's requirements, cost targets, and existing investments.

Do you develop Linux-based embedded systems?

Yes. We develop embedded Linux systems, including experience with Yocto and Buildroot, alongside real-time and bare-metal firmware where the application demands it.

Do you work with RTOS and bare-metal firmware?

Yes. We have deep Zephyr RTOS experience and build hard real-time and bare-metal firmware, including custom firmware stacks in C/C++17.

Process

How does a typical engineering project work?

We meet clients wherever they are in the product lifecycle — from early prototyping through PoC validation, full implementation, and on to production and fleet deployment. We can engage as a full end-to-end partner, take ownership of specific components, or embed as team augmentation alongside your existing engineers. We work with Agile methodologies, keeping clients actively involved in the process so feedback gets incorporated quickly rather than at the end of a long cycle.

How do you communicate during a project?

We maintain clear roadmaps, regular updates, and an iterative process that keeps clients in control and on track, with no surprises. We also believe in direct, honest communication — we tell clients when we think something won't work, because their long-term trust matters more to us than short-term approval.

How do you ensure product quality?

Quality is built into how we work, not added at the end. We are ISO 13485 certified, and disciplined validation, traceability, and automated and hardware-in-the-loop (HIL) testing are standard practice across our projects.

What happens after the project is completed?

We don't disappear once a project wraps. Depending on your needs, we can provide ongoing support, updates, and maintenance, and stay involved in future phases of the product's life — from iterating on the next version to supporting new features, production improvements, or additional products.

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