Lemberg Solutions vs Orthogonal: full comparison for 2026
Quick verdict
Lemberg Solutions (4.8/5) edges ahead of Orthogonal (4.2/5) overall. Lemberg Solutions is the better choice for connected and smart medical devices, one engineering team. Orthogonal is the stronger option for SaMD and device companion apps. The right choice depends on your project size, budget, and required tech stack.
Lemberg Solutions vs Orthogonal: head-to-head summary
| Criterion | Lemberg Solutions | Orthogonal |
|---|---|---|
| Founded | 2007 | 1998 |
| HQ | Lviv, Ukraine (offices in Hamburg, Germany; London, UK; Kraków, Poland) | Chicago, IL, USA |
| Team size | 200+ | 11–60 |
| Rating | 4.8 / 5 | 4.2 / 5 |
| Primary differentiator | Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices |
| Pricing model | Fixed project, time and materials, dedicated team | Time and materials, dedicated team |
| Min. engagement | Not published | Not disclosed |
| Primary tech stack | Embedded Linux, RTOS, FPGA | iOS, Android, Cloud (AWS/Azure) |
| Industries served | Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
Lemberg Solutions vs Orthogonal: overview
Lemberg Solutions
Founded in 2007, Lemberg Solutions builds both hardware and software, and has offices in Lviv, Hamburg, London and Kraków. For medical device teams it covers electrical engineering, firmware, RTOS and embedded Linux development, FPGA programming, GUI work, connectivity and IoT, edge AI and cybersecurity, so one vendor can own the device electronics, its embedded code and the cloud or mobile side that talks to it. Healthcare is one of its core industries alongside automotive, energy and logistics, and named clients include Astronics, Caltech, Ferno, Cellink and Bosch Rexroth. The company holds ISO 27001 and ISO 9001 certification and runs its own hardware lab. It does not manufacture finished devices at volume and does not obtain regulatory clearance on a client's behalf; it supplies the engineering documentation the client's regulatory team needs.
Orthogonal
Orthogonal is a Chicago software company founded in 1998 and led by founder and CEO Bernhard Kappe, with its office in the Merchandise Mart. It builds Software as a Medical Device (SaMD), digital therapeutics and the mobile and cloud software that connects to medical devices, working with venture-backed startups as well as established medtech and pharma companies. Directory listings describe ISO 13485 and HIPAA compliance and Class I–III experience. Team size estimates vary widely, from about 11 to 60 people.
Services and capabilities: Lemberg Solutions vs Orthogonal
| Capability | Lemberg Solutions | Orthogonal |
|---|---|---|
| Electronics & PCB design | ✓ | ✗ |
| Firmware & embedded software | ✓ | ✗ |
| SaMD & companion apps | ✗ | ✓ |
| Connected devices & IoT | ✓ | ✓ |
| Industrial design & human factors | ✗ | ✗ |
| Mechanical engineering | ✗ | ✗ |
| Device cybersecurity | ✓ | ✓ |
| Regulatory & QMS support | ✗ | ✓ |
| Manufacturing & scale-up | ✗ | ✗ |
Tech stack comparison: Lemberg Solutions vs Orthogonal
| Framework / platform | Lemberg Solutions | Orthogonal |
|---|---|---|
| Embedded C/C++ | N/A | N/A |
| Embedded Linux | ✓ | N/A |
| RTOS | ✓ | N/A |
| BLE | ✓ | ✓ |
| Cloud (AWS/Azure) | ✓ | ✓ |
| IEC 62304 | N/A | ✓ |
| ISO 14971 | N/A | ✓ |
| ISO 13485 QMS | N/A | N/A |
| Qt | N/A | N/A |
Pricing comparison: Lemberg Solutions vs Orthogonal
| Criterion | Lemberg Solutions | Orthogonal |
|---|---|---|
| Minimum engagement | Not published | Not disclosed |
| Engagement models | Consulting, Dedicated team, Fixed project, Time & materials | Dedicated team, Time & materials |
| Rate transparency | Not public | Not public |
| Price tier | Mid-market | Mid-market |
Target audience comparison: Lemberg Solutions vs Orthogonal
| Dimension | Lemberg Solutions | Orthogonal |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Wearables & remote monitoring, Diagnostics & lab devices, Digital health | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
| Best use cases | Building a connected wearable or home-monitoring device with a companion app and cloud backend, Adding edge AI or computer vision to an existing diagnostic instrument | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance |
| Typical project type | Consulting | Dedicated team |
Lemberg Solutions vs Orthogonal: pros and cons
| Lemberg Solutions | |
|---|---|
| + | A single team covers electronics, firmware, cloud, data and AI, which cuts the hand-offs that usually slow connected-device programs |
| + | Partnerships with NXP, Microchip and STMicroelectronics give early access to silicon support and reference designs |
| + | ISO 27001 and ISO 9001 certified, with security designed into the product rather than bolted on before release |
| + | In-house electronics lab shortens prototype loops and lowers R&D risk before a design freeze |
| + | All intellectual property transfers to the client, and the cooperation model can be consulting, team extension or full product development |
| + | Practical edge AI and computer vision experience for devices that need on-board inference |
| - | No in-house mass production, so a separate contract manufacturer is needed once the design is ready to scale |
| - | Does not obtain FDA or CE certification for clients; it provides technical documentation and engineering support for the client's own submission |
| - | Not ISO 13485 certified per the information reviewed, so buyers should confirm how it works inside their own medical QMS |
| Orthogonal | |
|---|---|
| + | Focused on regulated medical software for more than a decade |
| + | Publishes practical guidance on agile methods under FDA rules, a sign of real process experience |
| + | Strong on mobile apps that talk to devices over BLE |
| + | Small enough for direct access to senior people |
| - | No hardware or firmware design |
| - | Small team limits how many parallel workstreams it can staff |
| - | Team size data is inconsistent across sources |
Who should choose Lemberg Solutions?
A typical fit: building a connected wearable or home-monitoring device with a companion app and cloud backend.
Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together. Minimum engagement is not publicly disclosed. Works best with clients in Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics.
Who should choose Orthogonal?
A typical fit: building a mobile app that controls a Class II device.
Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Minimum engagement is not publicly disclosed. Works best with clients in Digital health, Wearables & remote monitoring, Diagnostics & lab devices.
Decision matrix: Lemberg Solutions vs Orthogonal
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Lemberg Solutions |
| You need a large dedicated team for an ongoing programme | Lemberg Solutions |
| Your budget is at the lower end | Compare: Lemberg Solutions (Not published) vs Orthogonal (Not disclosed) |
| You need specialist depth in a specific vertical | Lemberg Solutions |
| You need staff augmentation or team extension | Neither; consider alternatives that offer staff aug |
| You need consulting before committing to a build | Both may offer discovery engagements |
Use case fit: Lemberg Solutions vs Orthogonal
| Use case | Lemberg Solutions fit | Orthogonal fit | Winner |
|---|---|---|---|
| Building a connected wearable or home-monitoring device with a companion app and cloud backend | Strong | Strong | Both equally |
| Adding edge AI or computer vision to an existing diagnostic instrument | Strong | Limited | Lemberg Solutions |
| Building a mobile app that controls a Class II device | Strong | Strong | Both equally |
| Developing a digital therapeutic for FDA clearance | Limited | Strong | Orthogonal |
Verdict: Lemberg Solutions vs Orthogonal
Lemberg Solutions (4.8/5) is the stronger overall choice for most Medical Device Development projects. Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together.
Orthogonal (4.2/5) is worth a look if you need developing a digital therapeutic for FDA clearance. If your situation matches that, Orthogonal is a competitive option.
Related comparisons
Lemberg Solutions vs Orthogonal FAQ
Is Lemberg Solutions better than Orthogonal?
Lemberg Solutions (4.8/5) scores higher overall, but "better" depends on your use case. Lemberg Solutions's strongest advantage: a single team covers electronics, firmware, cloud, data and AI, which cuts the hand-offs that usually slow connected-device programs. Orthogonal's strongest advantage: focused on regulated medical software for more than a decade.
How do Lemberg Solutions and Orthogonal differ in pricing?
Lemberg Solutions uses fixed project, time and materials, dedicated team pricing. Orthogonal uses time and materials, dedicated team pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.
Which is better for enterprise: Lemberg Solutions or Orthogonal?
Orthogonal is the larger team and typically the better enterprise-scale choice. For very large programmes, verify team size and compliance coverage directly with each company before shortlisting.
What are the main differences between Lemberg Solutions and Orthogonal?
Lemberg Solutions's primary differentiator is: owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together. Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. They also differ in team size (200+ vs 11–60), minimum engagement (Not published vs Not disclosed), and primary industries served (Wearables & remote monitoring, Diagnostics & lab devices vs Digital health, Wearables & remote monitoring).
Verify all details directly with each company before making a decision.