Orthogonal vs Flex Health Solutions: full comparison for 2026
Quick verdict
Orthogonal (4.2/5) edges ahead of Flex Health Solutions (3.8/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Flex Health Solutions is the stronger option for design transfer into global contract manufacturing. The right choice depends on your project size, budget, and required tech stack.
Orthogonal vs Flex Health Solutions: head-to-head summary
| Criterion | Orthogonal | Flex Health Solutions |
|---|---|---|
| Founded | 1998 | 1969 |
| HQ | Chicago, IL, USA | Austin, TX, USA / Singapore |
| Team size | 11–60 | Large (Flex Ltd.) |
| Rating | 4.2 / 5 | 3.8 / 5 |
| Primary differentiator | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices | Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network |
| Pricing model | Time and materials, dedicated team | Manufacturing supply agreement, NPI contract |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | iOS, Android, Cloud (AWS/Azure) | PCB assembly, Injection molding, Automated assembly |
| Industries served | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices |
Orthogonal vs Flex Health Solutions: 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.
Flex Health Solutions
Flex Health Solutions is the healthcare division of Flex Ltd. and operates as a contract development and manufacturing organization (CDMO) for medical devices and pharma. Flex lists 26 manufacturing sites, six design and engineering sites, 16 FDA-registered entities and 21 ISO 13485 sites for health (per company website; independently unverifiable). In 2025 it opened a North American new product introduction (NPI) center for healthcare customers, and it shared a 2025 PDA Drug Delivery Innovation Award with Merck KGaA for an autoinjector.
Services and capabilities: Orthogonal vs Flex Health Solutions
| Capability | Orthogonal | Flex Health Solutions |
|---|---|---|
| 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 Flex Health Solutions
| Framework / platform | Orthogonal | Flex Health Solutions |
|---|---|---|
| Embedded C/C++ | N/A | 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 Flex Health Solutions
| Criterion | Orthogonal | Flex Health Solutions |
|---|---|---|
| Minimum engagement | Not disclosed | Not disclosed |
| Engagement models | Dedicated team, Time & materials | Fixed project, Manufacturing contract |
| Rate transparency | Not public | Not public |
| Price tier | Mid-market | Mid-market |
Target audience comparison: Orthogonal vs Flex Health Solutions
| Dimension | Orthogonal | Flex Health Solutions |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices |
| Best use cases | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance | Transferring a verified design into volume production, Pre-clinical and design verification builds |
| Typical project type | Dedicated team | Fixed project |
Orthogonal vs Flex Health Solutions: 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 |
| Flex Health Solutions | |
|---|---|
| + | Large global network of ISO 13485 and FDA-registered sites |
| + | New NPI center supports prototype builds, design verification and production transfer |
| + | Award-winning drug delivery work with Merck KGaA |
| + | Handles sterilization and packaging in-house |
| - | Development work mainly exists to feed programs into Flex factories |
| - | Better for funded programs with a clear path to volume |
| - | Site counts are company-reported and differ across Flex pages |
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 Flex Health Solutions?
A typical fit: transferring a verified design into volume production.
Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network. Minimum engagement is not publicly disclosed. Works best with clients in Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices.
Decision matrix: Orthogonal vs Flex Health Solutions
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Flex Health Solutions |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: Orthogonal (Not disclosed) vs Flex Health Solutions (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 Flex Health Solutions
| Use case | Orthogonal fit | Flex Health Solutions 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 |
| Transferring a verified design into volume production | Limited | Strong | Flex Health Solutions |
| Pre-clinical and design verification builds | Limited | Strong | Flex Health Solutions |
Verdict: Orthogonal vs Flex Health Solutions
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.
Flex Health Solutions (3.8/5) is worth a look if you need pre-clinical and design verification builds. If your situation matches that, Flex Health Solutions is a competitive option.
Related comparisons
Orthogonal vs Flex Health Solutions FAQ
Is Orthogonal better than Flex Health Solutions?
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. Flex Health Solutions's strongest advantage: large global network of ISO 13485 and FDA-registered sites.
How do Orthogonal and Flex Health Solutions differ in pricing?
Orthogonal uses time and materials, dedicated team pricing. Flex Health Solutions uses manufacturing supply agreement, npi contract pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.
Which is better for enterprise: Orthogonal or Flex Health Solutions?
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 Flex Health Solutions?
Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Flex Health Solutions's primary differentiator is: dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network. They also differ in team size (11–60 vs Large (Flex Ltd.)), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Drug delivery, Diagnostics & lab devices).
Verify all details directly with each company before making a decision.