Orthogonal vs Simbex: full comparison for 2026
Quick verdict
Orthogonal (4.2/5) edges ahead of Simbex (3.9/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Simbex is the stronger option for sensor wearables and biomechanics research. The right choice depends on your project size, budget, and required tech stack.
Orthogonal vs Simbex: head-to-head summary
| Criterion | Orthogonal | Simbex |
|---|---|---|
| Founded | 1998 | 2000 |
| HQ | Chicago, IL, USA | Lebanon, NH, USA |
| Team size | 11–60 | 11–100 |
| Rating | 4.2 / 5 | 3.9 / 5 |
| Primary differentiator | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices | Biomechanics and sensor research background applied to wearable health devices |
| 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) | BLE, Embedded C/C++, Sensor fusion |
| Industries served | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Wearables & remote monitoring, Sports technology, Digital health |
Orthogonal vs Simbex: 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.
Simbex
Simbex was founded in 2000 in Lebanon, New Hampshire, and works on product design, applied research and commercialization in medtech, health tech and sports technology. Riddell, the American football helmet maker and a long-time client, acquired it in April 2024. Its medical work includes RestEaze, a remote monitoring device for sleep disorder diagnosis built with Tanzen Medical, and fall-detection wearables. Team size estimates range from 11 to 100.
Services and capabilities: Orthogonal vs Simbex
| Capability | Orthogonal | Simbex |
|---|---|---|
| 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 Simbex
| Framework / platform | Orthogonal | Simbex |
|---|---|---|
| Embedded C/C++ | N/A | ✓ |
| Embedded Linux | N/A | N/A |
| RTOS | N/A | N/A |
| BLE | ✓ | ✓ |
| Cloud (AWS/Azure) | ✓ | N/A |
| IEC 62304 | ✓ | N/A |
| ISO 14971 | ✓ | N/A |
| ISO 13485 QMS | N/A | N/A |
| Qt | N/A | N/A |
Pricing comparison: Orthogonal vs Simbex
| Criterion | Orthogonal | Simbex |
|---|---|---|
| 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 Simbex
| Dimension | Orthogonal | Simbex |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Wearables & remote monitoring, Sports technology, Digital health |
| Best use cases | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance | Sensor-based wearable for remote monitoring, Biomechanics research study for a device concept |
| Typical project type | Dedicated team | Fixed project |
Orthogonal vs Simbex: 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 |
| Simbex | |
|---|---|
| + | Strong sensor and biomechanics research skills |
| + | Experience with wearable monitoring devices |
| + | Covers design through commercialization planning |
| + | Small team with direct access to principals |
| - | Owned by Riddell since April 2024, so sports technology may take priority over medical clients |
| - | Small team |
| - | Fewer regulated Class II and III device credits than medtech-only firms |
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 Simbex?
A typical fit: sensor-based wearable for remote monitoring.
Biomechanics and sensor research background applied to wearable health devices. Minimum engagement is not publicly disclosed. Works best with clients in Wearables & remote monitoring, Sports technology, Digital health.
Decision matrix: Orthogonal vs Simbex
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Simbex |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: Orthogonal (Not disclosed) vs Simbex (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 Simbex
| Use case | Orthogonal fit | Simbex 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 |
| Sensor-based wearable for remote monitoring | Limited | Strong | Simbex |
| Biomechanics research study for a device concept | Limited | Strong | Simbex |
Verdict: Orthogonal vs Simbex
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.
Simbex (3.9/5) is worth a look if you need biomechanics research study for a device concept. If your situation matches that, Simbex is a competitive option.
Related comparisons
Orthogonal vs Simbex FAQ
Is Orthogonal better than Simbex?
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. Simbex's strongest advantage: strong sensor and biomechanics research skills.
How do Orthogonal and Simbex differ in pricing?
Orthogonal uses time and materials, dedicated team pricing. Simbex 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 Simbex?
Simbex 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 Simbex?
Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Simbex's primary differentiator is: biomechanics and sensor research background applied to wearable health devices. They also differ in team size (11–60 vs 11–100), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Wearables & remote monitoring, Sports technology).
Verify all details directly with each company before making a decision.