Orthogonal vs Veranex: full comparison for 2026
Quick verdict
Orthogonal (4.2/5) edges ahead of Veranex (4.2/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Veranex is the stronger option for device design plus clinical trials and reimbursement. The right choice depends on your project size, budget, and required tech stack.
Orthogonal vs Veranex: head-to-head summary
| Criterion | Orthogonal | Veranex |
|---|---|---|
| Founded | 1998 | 2021 |
| HQ | Chicago, IL, USA | Raleigh, NC, USA |
| Team size | 11–60 | 800+ |
| Rating | 4.2 / 5 | 4.2 / 5 |
| Primary differentiator | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices | One contract can cover engineering, clinical studies, regulatory strategy and reimbursement |
| Pricing model | Time and materials, dedicated team | Fixed project, time and materials |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | iOS, Android, Cloud (AWS/Azure) | ISO 13485 QMS, SolidWorks, Embedded C/C++ |
| Industries served | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Surgical & therapeutic devices, Diagnostics & lab devices, Drug delivery, Digital health |
Orthogonal vs Veranex: 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.
Veranex
Veranex was formed in 2021 by Summit Partners, which combined Providence-based device developer Ximedica (founded 1985) with Quartesian and Boston Healthcare Associates. It has since acquired Experien Group, IMM Recherche, the healthcare design firm Worrell, Fusion Biotec and Horus Scientific. Headquartered in Raleigh, North Carolina, it reports more than 800 staff and offers product design and engineering, clinical research (CRO) services, regulatory work and market access consulting.
Services and capabilities: Orthogonal vs Veranex
| Capability | Orthogonal | Veranex |
|---|---|---|
| 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 Veranex
| Framework / platform | Orthogonal | Veranex |
|---|---|---|
| Embedded C/C++ | N/A | ✓ |
| Embedded Linux | N/A | N/A |
| RTOS | N/A | N/A |
| BLE | ✓ | N/A |
| Cloud (AWS/Azure) | ✓ | N/A |
| IEC 62304 | ✓ | N/A |
| ISO 14971 | ✓ | N/A |
| ISO 13485 QMS | N/A | ✓ |
| Qt | N/A | N/A |
Pricing comparison: Orthogonal vs Veranex
| Criterion | Orthogonal | Veranex |
|---|---|---|
| Minimum engagement | Not disclosed | Not disclosed |
| Engagement models | Dedicated team, Time & materials | Consulting, Fixed project, Time & materials |
| Rate transparency | Not public | Not public |
| Price tier | Mid-market | Mid-market |
Target audience comparison: Orthogonal vs Veranex
| Dimension | Orthogonal | Veranex |
|---|---|---|
| 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, Drug delivery |
| Best use cases | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance | Startup that needs design, a clinical study and an FDA strategy from one partner, Human-centered redesign of a surgical instrument |
| Typical project type | Dedicated team | Consulting |
Orthogonal vs Veranex: 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 |
| Veranex | |
|---|---|
| + | Rare combination of engineering with CRO, regulatory and market access services |
| + | Ximedica brings decades of ISO 13485 device development experience |
| + | Worrell adds human-centered design for healthcare |
| + | Large enough to run several workstreams at once |
| - | Built from many acquisitions since 2021, so teams and processes are still being joined up |
| - | Private-equity ownership by Summit Partners |
| - | Buyers who only need engineering may pay for a broader structure than they use |
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 Veranex?
A typical fit: startup that needs design, a clinical study and an FDA strategy from one partner.
One contract can cover engineering, clinical studies, regulatory strategy and reimbursement. Minimum engagement is not publicly disclosed. Works best with clients in Surgical & therapeutic devices, Diagnostics & lab devices, Drug delivery, Digital health.
Decision matrix: Orthogonal vs Veranex
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Veranex |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: Orthogonal (Not disclosed) vs Veranex (Not disclosed) |
| You need specialist depth in a specific vertical | Veranex |
| 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 Veranex
| Use case | Orthogonal fit | Veranex 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 |
| Startup that needs design, a clinical study and an FDA strategy from one partner | Limited | Strong | Veranex |
| Human-centered redesign of a surgical instrument | Limited | Strong | Veranex |
Verdict: Orthogonal vs Veranex
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.
Veranex (4.2/5) is worth a look if you need human-centered redesign of a surgical instrument. If your situation matches that, Veranex is a competitive option.
Related comparisons
Orthogonal vs Veranex FAQ
Is Orthogonal better than Veranex?
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. Veranex's strongest advantage: rare combination of engineering with CRO, regulatory and market access services.
How do Orthogonal and Veranex differ in pricing?
Orthogonal uses time and materials, dedicated team pricing. Veranex uses fixed project, time and materials pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.
Which is better for enterprise: Orthogonal or Veranex?
Orthogonal 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 Veranex?
Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Veranex's primary differentiator is: one contract can cover engineering, clinical studies, regulatory strategy and reimbursement. They also differ in team size (11–60 vs 800+), 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.