Orthogonal vs Bluefruit Software: full comparison for 2026
Quick verdict
Orthogonal (4.2/5) edges ahead of Bluefruit Software (4.1/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Bluefruit Software is the stronger option for UK device makers outsourcing firmware and testing. The right choice depends on your project size, budget, and required tech stack.
Orthogonal vs Bluefruit Software: head-to-head summary
| Criterion | Orthogonal | Bluefruit Software |
|---|---|---|
| Founded | 1998 | 2000 |
| HQ | Chicago, IL, USA | Redruth, Cornwall, UK |
| Team size | 11–60 | 70–90 |
| Rating | 4.2 / 5 | 4.1 / 5 |
| Primary differentiator | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices | Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture |
| Pricing model | Time and materials, dedicated team | Time and materials, fixed project |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | iOS, Android, Cloud (AWS/Azure) | Embedded C/C++, RTOS, Test automation |
| Industries served | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Diagnostics & lab devices, Surgical & therapeutic devices, Industrial |
Orthogonal vs Bluefruit Software: overview
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.
Bluefruit Software
Bluefruit Software has written embedded software from Redruth, Cornwall, since 2000 and is employee-owned. A Plymouth University partnership case study reports that medical devices grew from 10% to 60% of its work. It handles embedded software development, testing, some hardware development and edge AI integration, plus support for regulatory compliance and quality assurance. Its team is roughly 70 to 90 people.
Services and capabilities: Orthogonal vs Bluefruit Software
| Capability | Orthogonal | Bluefruit Software |
|---|---|---|
| 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: Orthogonal vs Bluefruit Software
| Framework / platform | Orthogonal | Bluefruit Software |
|---|---|---|
| Embedded C/C++ | N/A | ✓ |
| Embedded Linux | N/A | N/A |
| RTOS | N/A | ✓ |
| BLE | ✓ | N/A |
| Cloud (AWS/Azure) | ✓ | N/A |
| IEC 62304 | ✓ | ✓ |
| ISO 14971 | ✓ | N/A |
| ISO 13485 QMS | N/A | N/A |
| Qt | N/A | N/A |
Pricing comparison: Orthogonal vs Bluefruit Software
| Criterion | Orthogonal | Bluefruit Software |
|---|---|---|
| Minimum engagement | Not disclosed | Not disclosed |
| Engagement models | Dedicated team, Time & materials | Fixed project, Time & materials |
| Rate transparency | Not public | Not public |
| Price tier | Mid-market | Mid-market |
Target audience comparison: Orthogonal vs Bluefruit Software
| Dimension | Orthogonal | Bluefruit Software |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Diagnostics & lab devices, Surgical & therapeutic devices, Industrial |
| Best use cases | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance | Writing IEC 62304 firmware for a UK device startup, Independent verification of an existing device's embedded software |
| Typical project type | Dedicated team | Fixed project |
Orthogonal vs Bluefruit Software: pros and cons
| 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 |
| Bluefruit Software | |
|---|---|
| + | Medical devices make up most of its work, so regulated firmware practice is routine |
| + | Strong emphasis on testing and test automation |
| + | Lower rates than Cambridge or London consultancies |
| + | Employee ownership |
| - | Limited hardware design compared with full product development firms |
| - | Small team; large multi-year programs may need extra partners |
| - | No industrial design, mechanical engineering or manufacturing |
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.
Who should choose Bluefruit Software?
A typical fit: writing IEC 62304 firmware for a UK device startup.
Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture. Minimum engagement is not publicly disclosed. Works best with clients in Diagnostics & lab devices, Surgical & therapeutic devices, Industrial.
Decision matrix: Orthogonal vs Bluefruit Software
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Bluefruit Software |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: Orthogonal (Not disclosed) vs Bluefruit Software (Not disclosed) |
| You need specialist depth in a specific vertical | Orthogonal |
| 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: Orthogonal vs Bluefruit Software
| Use case | Orthogonal fit | Bluefruit Software fit | Winner |
|---|---|---|---|
| Building a mobile app that controls a Class II device | Strong | Limited | Orthogonal |
| Developing a digital therapeutic for FDA clearance | Strong | Limited | Orthogonal |
| Writing IEC 62304 firmware for a UK device startup | Limited | Strong | Bluefruit Software |
| Independent verification of an existing device's embedded software | Limited | Strong | Bluefruit Software |
Verdict: Orthogonal vs Bluefruit Software
Orthogonal (4.2/5) is the stronger overall choice for most Medical Device Development projects. Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices.
Bluefruit Software (4.1/5) is worth a look if you need independent verification of an existing device's embedded software. If your situation matches that, Bluefruit Software is a competitive option.
Related comparisons
Orthogonal vs Bluefruit Software FAQ
Is Orthogonal better than Bluefruit Software?
Orthogonal (4.2/5) scores higher overall, but "better" depends on your use case. Orthogonal's strongest advantage: focused on regulated medical software for more than a decade. Bluefruit Software's strongest advantage: medical devices make up most of its work, so regulated firmware practice is routine.
How do Orthogonal and Bluefruit Software differ in pricing?
Orthogonal uses time and materials, dedicated team pricing. Bluefruit Software uses time and materials, fixed project pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.
Which is better for enterprise: Orthogonal or Bluefruit Software?
Bluefruit Software 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 Orthogonal and Bluefruit Software?
Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Bluefruit Software's primary differentiator is: Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture. They also differ in team size (11–60 vs 70–90), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Diagnostics & lab devices, Surgical & therapeutic devices).
Verify all details directly with each company before making a decision.