MedAcuity vs Orthogonal: full comparison for 2026
Quick verdict
MedAcuity (4.3/5) edges ahead of Orthogonal (4.2/5) overall. MedAcuity is the better choice for device makers with hardware but no software 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.
MedAcuity vs Orthogonal: head-to-head summary
| Criterion | MedAcuity | Orthogonal |
|---|---|---|
| Founded | 2007 | 1998 |
| HQ | Westford, MA, USA | Chicago, IL, USA |
| Team size | 100–130 | 11–60 |
| Rating | 4.3 / 5 | 4.2 / 5 |
| Primary differentiator | US-based, ISO 13485 certified team that does nothing but regulated device software | 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++, C#/.NET, Qt | iOS, Android, Cloud (AWS/Azure) |
| Industries served | Surgical & robotics, Diagnostics & lab devices, Digital health, Implantables & neuromodulation | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
MedAcuity vs Orthogonal: overview
MedAcuity
MedAcuity was founded in 2007 by software engineers and is based in Westford, Massachusetts. It concentrates on medical technology software: architecture, embedded and application development, risk management and the technical documentation behind FDA submissions, with experience across Class I, II and III and PMA devices. It is ISO 13485:2016 certified, and listings put its team at about 119 people. In 2021 it partnered with Fathom Consulting to add human factors engineering.
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: MedAcuity vs Orthogonal
| Capability | MedAcuity | 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: MedAcuity vs Orthogonal
| Framework / platform | MedAcuity | Orthogonal |
|---|---|---|
| Embedded C/C++ | ✓ | N/A |
| Embedded Linux | N/A | N/A |
| RTOS | N/A | N/A |
| BLE | N/A | ✓ |
| Cloud (AWS/Azure) | ✓ | ✓ |
| IEC 62304 | ✓ | ✓ |
| ISO 14971 | ✓ | ✓ |
| ISO 13485 QMS | N/A | N/A |
| Qt | ✓ | N/A |
Pricing comparison: MedAcuity vs Orthogonal
| Criterion | MedAcuity | Orthogonal |
|---|---|---|
| Minimum engagement | Not disclosed | Not disclosed |
| Engagement models | Fixed project, Time & materials | Dedicated team, Time & materials |
| Rate transparency | Not public | Not public |
| Price tier | Mid-market | Mid-market |
Target audience comparison: MedAcuity vs Orthogonal
| Dimension | MedAcuity | Orthogonal |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Surgical & robotics, Diagnostics & lab devices, Digital health | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
| Best use cases | Writing and documenting the control software for a surgical system, Remediating software documentation gaps before an FDA submission | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance |
| Typical project type | Fixed project | Dedicated team |
MedAcuity vs Orthogonal: pros and cons
| MedAcuity | |
|---|---|
| + | Software-only focus means IEC 62304 documentation and traceability are part of every project |
| + | Experience with PMA-level Class III software |
| + | US onshore team helps with data access and IP-sensitive programs |
| + | Secure lab space for testing with client hardware |
| - | Does not design hardware, so you need another partner for electronics and mechanics |
| - | US onshore rates are higher than nearshore software teams |
| - | Human factors work is handled through the Fathom partnership instead of an in-house group |
| 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 MedAcuity?
A typical fit: writing and documenting the control software for a surgical system.
US-based, ISO 13485 certified team that does nothing but regulated device software. Minimum engagement is not publicly disclosed. Works best with clients in Surgical & robotics, Diagnostics & lab devices, Digital health, Implantables & neuromodulation.
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: MedAcuity vs Orthogonal
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | MedAcuity |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: MedAcuity (Not disclosed) vs Orthogonal (Not disclosed) |
| You need specialist depth in a specific vertical | MedAcuity |
| 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: MedAcuity vs Orthogonal
| Use case | MedAcuity fit | Orthogonal fit | Winner |
|---|---|---|---|
| Writing and documenting the control software for a surgical system | Strong | Limited | MedAcuity |
| Remediating software documentation gaps before an FDA submission | Strong | Limited | MedAcuity |
| 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: MedAcuity vs Orthogonal
MedAcuity (4.3/5) is the stronger overall choice for most Medical Device Development projects. US-based, ISO 13485 certified team that does nothing but regulated device software.
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
MedAcuity vs Orthogonal FAQ
Is MedAcuity better than Orthogonal?
MedAcuity (4.3/5) scores higher overall, but "better" depends on your use case. MedAcuity's strongest advantage: software-only focus means IEC 62304 documentation and traceability are part of every project. Orthogonal's strongest advantage: focused on regulated medical software for more than a decade.
How do MedAcuity and Orthogonal differ in pricing?
MedAcuity 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: MedAcuity or Orthogonal?
MedAcuity 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 MedAcuity and Orthogonal?
MedAcuity's primary differentiator is: US-based, ISO 13485 certified team that does nothing but regulated device software. 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 (100–130 vs 11–60), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Surgical & robotics, Diagnostics & lab devices vs Digital health, Wearables & remote monitoring).
Verify all details directly with each company before making a decision.