Zühlke vs Orthogonal: full comparison for 2026
Quick verdict
Zühlke (4.4/5) edges ahead of Orthogonal (4.2/5) overall. Zühlke is the better choice for european medtech firms modernizing device software. Orthogonal is the stronger option for SaMD and device companion apps. The right choice depends on your project size, budget, and required tech stack.
Zühlke vs Orthogonal: head-to-head summary
| Criterion | Zühlke | Orthogonal |
|---|---|---|
| Founded | 1968 | 1998 |
| HQ | Schlieren, Switzerland | Chicago, IL, USA |
| Team size | 1,500–2,000 | 11–60 |
| Rating | 4.4 / 5 | 4.2 / 5 |
| Primary differentiator | A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices |
| Pricing model | Time and materials, fixed project | Time and materials, dedicated team |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | Embedded C/C++, Embedded Linux, Cloud (AWS/Azure) | iOS, Android, Cloud (AWS/Azure) |
| Industries served | Digital health, Diagnostics & lab devices, Surgical & therapeutic devices, Financial services | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
Zühlke vs Orthogonal: overview
Zühlke
Partner-owned since its 1968 founding in Switzerland, Zühlke is headquartered in Schlieren near Zurich, with teams in Germany, Austria, the UK, Serbia and Asia. Its headcount is somewhere between 1,500 and 2,000 depending on the source. In healthcare it covers regulated device and systems engineering, connected-device software and the cloud and analytics platforms around devices, and it states more than 50 years of medtech experience (per company website; independently unverifiable).
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: Zühlke vs Orthogonal
| Capability | Zühlke | 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: Zühlke vs Orthogonal
| Framework / platform | Zühlke | Orthogonal |
|---|---|---|
| Embedded C/C++ | ✓ | N/A |
| Embedded Linux | ✓ | N/A |
| RTOS | N/A | N/A |
| BLE | N/A | ✓ |
| Cloud (AWS/Azure) | ✓ | ✓ |
| IEC 62304 | ✓ | ✓ |
| ISO 14971 | N/A | ✓ |
| ISO 13485 QMS | N/A | N/A |
| Qt | ✓ | N/A |
Pricing comparison: Zühlke vs Orthogonal
| Criterion | Zühlke | Orthogonal |
|---|---|---|
| Minimum engagement | Not disclosed | 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: Zühlke vs Orthogonal
| Dimension | Zühlke | Orthogonal |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Digital health, Diagnostics & lab devices, Surgical & therapeutic devices | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
| Best use cases | Rebuilding the embedded and cloud software of an established diagnostics platform, EU MDR remediation of legacy device software | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance |
| Typical project type | Consulting | Dedicated team |
Zühlke vs Orthogonal: pros and cons
| Zühlke | |
|---|---|
| + | Partner ownership keeps the firm independent of a large holding group |
| + | Large enough to staff hardware, embedded, cloud and data roles at the same time |
| + | Delivery centres in Serbia and Asia give some cost flexibility compared with all-Swiss teams |
| + | Experience with EU MDR environments in German-speaking markets |
| - | Much of the firm works outside healthcare, so check that the proposed team is from the medtech practice |
| - | Swiss and German rates are high for the onshore part of a team |
| - | Industrial design and manufacturing are not core offerings |
| 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 Zühlke?
A typical fit: rebuilding the embedded and cloud software of an established diagnostics platform.
A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program. Minimum engagement is not publicly disclosed. Works best with clients in Digital health, Diagnostics & lab devices, Surgical & therapeutic devices, Financial services.
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: Zühlke vs Orthogonal
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Zühlke |
| You need a large dedicated team for an ongoing programme | Zühlke |
| Your budget is at the lower end | Compare: Zühlke (Not disclosed) vs Orthogonal (Not disclosed) |
| You need specialist depth in a specific vertical | Zühlke |
| 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: Zühlke vs Orthogonal
| Use case | Zühlke fit | Orthogonal fit | Winner |
|---|---|---|---|
| Rebuilding the embedded and cloud software of an established diagnostics platform | Strong | Limited | Zühlke |
| EU MDR remediation of legacy device software | Strong | Strong | Both equally |
| 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: Zühlke vs Orthogonal
Zühlke (4.4/5) is the stronger overall choice for most Medical Device Development projects. A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program.
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
Zühlke vs Orthogonal FAQ
Is Zühlke better than Orthogonal?
Zühlke (4.4/5) scores higher overall, but "better" depends on your use case. Zühlke's strongest advantage: partner ownership keeps the firm independent of a large holding group. Orthogonal's strongest advantage: focused on regulated medical software for more than a decade.
How do Zühlke and Orthogonal differ in pricing?
Zühlke uses time and materials, fixed project 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: Zühlke or Orthogonal?
Zühlke 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 Zühlke and Orthogonal?
Zühlke's primary differentiator is: a device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program. 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 (1,500–2,000 vs 11–60), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Diagnostics & lab devices vs Digital health, Wearables & remote monitoring).
Verify all details directly with each company before making a decision.