Velentium vs Orthogonal: full comparison for 2026
Quick verdict
Velentium (4.5/5) edges ahead of Orthogonal (4.2/5) overall. Velentium is the better choice for implantables and FDA cybersecurity submissions. Orthogonal is the stronger option for SaMD and device companion apps. The right choice depends on your project size, budget, and required tech stack.
Velentium vs Orthogonal: head-to-head summary
| Criterion | Velentium | Orthogonal |
|---|---|---|
| Founded | 2012 | 1998 |
| HQ | Katy, TX, USA | Chicago, IL, USA |
| Team size | 51–250 | 11–60 |
| Rating | 4.5 / 5 | 4.2 / 5 |
| Primary differentiator | Combines active-implantable engineering with a dedicated device cybersecurity team that prepares FDA premarket security documentation | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices |
| Pricing model | Fixed project, time and materials, manufacturing contract | Time and materials, dedicated team |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | Embedded C/C++, RTOS, BLE | iOS, Android, Cloud (AWS/Azure) |
| Industries served | Implantables & neuromodulation, Surgical & therapeutic devices, Wearables & remote monitoring | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
Velentium vs Orthogonal: overview
Velentium
Velentium was founded in 2012 and is based in Katy, near Houston, Texas. It designs, develops and manufactures active medical devices, including implantables and their programmers, and offers systems engineering, firmware, software, cybersecurity and CGMP manufacturing. Great Point Partners completed a growth recapitalization in 2021, the company sold its oil and gas division in 2023 to focus fully on medtech, and it took $15M in growth financing from Trinity Capital in 2024. Headcount estimates range from 51 to 250.
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: Velentium vs Orthogonal
| Capability | Velentium | 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: Velentium vs Orthogonal
| Framework / platform | Velentium | Orthogonal |
|---|---|---|
| Embedded C/C++ | ✓ | N/A |
| Embedded Linux | N/A | N/A |
| RTOS | ✓ | N/A |
| BLE | ✓ | ✓ |
| Cloud (AWS/Azure) | N/A | ✓ |
| IEC 62304 | ✓ | ✓ |
| ISO 14971 | ✓ | ✓ |
| ISO 13485 QMS | N/A | N/A |
| Qt | N/A | N/A |
Pricing comparison: Velentium vs Orthogonal
| Criterion | Velentium | Orthogonal |
|---|---|---|
| Minimum engagement | Not disclosed | Not disclosed |
| Engagement models | Fixed project, Manufacturing contract, Time & materials | Dedicated team, Time & materials |
| Rate transparency | Not public | Not public |
| Price tier | Mid-market | Mid-market |
Target audience comparison: Velentium vs Orthogonal
| Dimension | Velentium | Orthogonal |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Implantables & neuromodulation, Surgical & therapeutic devices, Wearables & remote monitoring | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
| Best use cases | Building a neurostimulator and its clinician programmer, Preparing the cybersecurity section of an FDA 510(k) or PMA | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance |
| Typical project type | Fixed project | Dedicated team |
Velentium vs Orthogonal: pros and cons
| Velentium | |
|---|---|
| + | Cybersecurity is a full practice here, covering threat modeling, SBOMs, testing and postmarket monitoring |
| + | Experience with active implantable devices, one of the hardest device categories to engineer and certify |
| + | Can manufacture Class II and III devices after development, reducing transfer risk |
| + | Offers training on device cybersecurity, which helps client teams keep up after hand-off |
| - | Private-equity recapitalization and debt financing mean ownership priorities may shift over time |
| - | Smaller than the large consultancies, so very broad programs may stretch the team |
| - | Industrial design and human factors are not its main strength |
| 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 Velentium?
A typical fit: building a neurostimulator and its clinician programmer.
Combines active-implantable engineering with a dedicated device cybersecurity team that prepares FDA premarket security documentation. Minimum engagement is not publicly disclosed. Works best with clients in Implantables & neuromodulation, Surgical & therapeutic devices, Wearables & remote monitoring.
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: Velentium vs Orthogonal
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Velentium |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: Velentium (Not disclosed) vs Orthogonal (Not disclosed) |
| You need specialist depth in a specific vertical | Velentium |
| 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: Velentium vs Orthogonal
| Use case | Velentium fit | Orthogonal fit | Winner |
|---|---|---|---|
| Building a neurostimulator and its clinician programmer | Strong | Strong | Both equally |
| Preparing the cybersecurity section of an FDA 510(k) or PMA | Strong | Limited | Velentium |
| 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: Velentium vs Orthogonal
Velentium (4.5/5) is the stronger overall choice for most Medical Device Development projects. Combines active-implantable engineering with a dedicated device cybersecurity team that prepares FDA premarket security documentation.
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
Velentium vs Orthogonal FAQ
Is Velentium better than Orthogonal?
Velentium (4.5/5) scores higher overall, but "better" depends on your use case. Velentium's strongest advantage: cybersecurity is a full practice here, covering threat modeling, SBOMs, testing and postmarket monitoring. Orthogonal's strongest advantage: focused on regulated medical software for more than a decade.
How do Velentium and Orthogonal differ in pricing?
Velentium uses fixed project, time and materials, manufacturing contract 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: Velentium or Orthogonal?
Velentium 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 Velentium and Orthogonal?
Velentium's primary differentiator is: combines active-implantable engineering with a dedicated device cybersecurity team that prepares FDA premarket security documentation. 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 (51–250 vs 11–60), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Implantables & neuromodulation, Surgical & therapeutic devices vs Digital health, Wearables & remote monitoring).
Verify all details directly with each company before making a decision.