Orthogonal vs Tata Elxsi: full comparison for 2026
Quick verdict
Orthogonal (4.2/5) edges ahead of Tata Elxsi (3.9/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Tata Elxsi is the stronger option for large medtech firms offshoring sustaining engineering. The right choice depends on your project size, budget, and required tech stack.
Orthogonal vs Tata Elxsi: head-to-head summary
| Criterion | Orthogonal | Tata Elxsi |
|---|---|---|
| Founded | 1998 | 1989 |
| HQ | Chicago, IL, USA | Bengaluru, India |
| Team size | 11–60 | 13,000+ |
| 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 | Offshore scale for verification, documentation and sustaining work on existing device portfolios |
| Pricing model | Time and materials, dedicated team | Time and materials, dedicated team, fixed project |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | iOS, Android, Cloud (AWS/Azure) | Embedded C/C++, Embedded Linux, Test automation |
| Industries served | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Surgical & therapeutic devices, Diagnostics & lab devices, Digital health, Automotive |
Orthogonal vs Tata Elxsi: 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.
Tata Elxsi
Tata Elxsi is a Tata Group engineering and design company founded in 1989 and headquartered in Bengaluru, with more than 13,000 employees across automotive, media and healthcare. Its medical device practice covers hardware, firmware, mechanical engineering, verification and validation and lifecycle management under an ISO 13485:2016 compliant QMS, and it offers pre-submission support for 510(k) and PMA filings. In 2026 it opened an offshore development center for Terumo in Pune and launched AnaTel, an AI tool for preparing regulatory documents.
Services and capabilities: Orthogonal vs Tata Elxsi
| Capability | Orthogonal | Tata Elxsi |
|---|---|---|
| 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 Tata Elxsi
| Framework / platform | Orthogonal | Tata Elxsi |
|---|---|---|
| Embedded C/C++ | N/A | ✓ |
| Embedded Linux | 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 | N/A |
Pricing comparison: Orthogonal vs Tata Elxsi
| Criterion | Orthogonal | Tata Elxsi |
|---|---|---|
| Minimum engagement | Not disclosed | Not disclosed |
| Engagement models | Dedicated team, Time & materials | Dedicated team, Fixed project, Time & materials |
| Rate transparency | Not public | Not public |
| Price tier | Mid-market | Mid-market |
Target audience comparison: Orthogonal vs Tata Elxsi
| Dimension | Orthogonal | Tata Elxsi |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Surgical & therapeutic devices, Diagnostics & lab devices, Digital health |
| Best use cases | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance | Sustaining engineering for a portfolio of cleared devices, EU MDR technical file remediation |
| Typical project type | Dedicated team | Dedicated team |
Orthogonal vs Tata Elxsi: 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 |
| Tata Elxsi | |
|---|---|
| + | Can staff large verification, documentation and sustaining teams |
| + | Offshore development centers for major medtech clients such as Terumo |
| + | Supports 510(k) and PMA preparation |
| + | Lower cost per engineer than Western firms |
| - | Large generalist where healthcare competes with automotive and media for attention |
| - | Better suited to established portfolios than to early-stage invention |
| - | Offshore delivery needs strong client-side technical ownership |
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 Tata Elxsi?
A typical fit: sustaining engineering for a portfolio of cleared devices.
Offshore scale for verification, documentation and sustaining work on existing device portfolios. Minimum engagement is not publicly disclosed. Works best with clients in Surgical & therapeutic devices, Diagnostics & lab devices, Digital health, Automotive.
Decision matrix: Orthogonal vs Tata Elxsi
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Tata Elxsi |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: Orthogonal (Not disclosed) vs Tata Elxsi (Not disclosed) |
| You need specialist depth in a specific vertical | Tata Elxsi |
| 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 Tata Elxsi
| Use case | Orthogonal fit | Tata Elxsi 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 |
| Sustaining engineering for a portfolio of cleared devices | Limited | Strong | Tata Elxsi |
| EU MDR technical file remediation | Strong | Strong | Both equally |
Verdict: Orthogonal vs Tata Elxsi
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.
Tata Elxsi (3.9/5) is worth a look if you need EU MDR technical file remediation. If your situation matches that, Tata Elxsi is a competitive option.
Related comparisons
Orthogonal vs Tata Elxsi FAQ
Is Orthogonal better than Tata Elxsi?
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. Tata Elxsi's strongest advantage: can staff large verification, documentation and sustaining teams.
How do Orthogonal and Tata Elxsi differ in pricing?
Orthogonal uses time and materials, dedicated team pricing. Tata Elxsi uses time and materials, dedicated team, 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 Tata Elxsi?
Tata Elxsi 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 Tata Elxsi?
Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Tata Elxsi's primary differentiator is: offshore scale for verification, documentation and sustaining work on existing device portfolios. They also differ in team size (11–60 vs 13,000+), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Surgical & therapeutic devices, Diagnostics & lab devices).
Verify all details directly with each company before making a decision.