Key Tech vs Orthogonal: full comparison for 2026
Quick verdict
Key Tech (4.3/5) edges ahead of Orthogonal (4.2/5) overall. Key Tech is the better choice for IVD instruments with consumables. Orthogonal is the stronger option for SaMD and device companion apps. The right choice depends on your project size, budget, and required tech stack.
Key Tech vs Orthogonal: head-to-head summary
| Criterion | Key Tech | Orthogonal |
|---|---|---|
| Founded | 1998 | 1998 |
| HQ | Baltimore, MD, USA | Chicago, IL, USA |
| Team size | 75–150 | 11–60 |
| Rating | 4.3 / 5 | 4.2 / 5 |
| Primary differentiator | Designs the diagnostic instrument and its cartridge together, with human factors in the same studio | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices |
| Pricing model | Time and materials, phased fixed project | Time and materials, dedicated team |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | Embedded C/C++, Microfluidics, SolidWorks | iOS, Android, Cloud (AWS/Azure) |
| Industries served | Diagnostics & lab devices, Drug delivery, Surgical & therapeutic devices | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
Key Tech vs Orthogonal: overview
Key Tech
Key Tech (Key Technologies Inc.) was founded in 1998 in Baltimore, Maryland. It is ISO 13485 certified and works on medical device development, in vitro diagnostic instruments and consumables, drug delivery systems and human factors engineering, with an earlier client list that includes Becton Dickinson, GE, Thermo Fisher and Abiomed. Co-founder Jenny Regan handed the CEO role to Alex Flamm. The most recent public headcount we found was around 75 designers and engineers, which may now be higher.
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: Key Tech vs Orthogonal
| Capability | Key Tech | 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: Key Tech vs Orthogonal
| Framework / platform | Key Tech | Orthogonal |
|---|---|---|
| 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: Key Tech vs Orthogonal
| Criterion | Key Tech | 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: Key Tech vs Orthogonal
| Dimension | Key Tech | Orthogonal |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Diagnostics & lab devices, Drug delivery, Surgical & therapeutic devices | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
| Best use cases | Developing a point-of-care molecular diagnostic instrument and cartridge, Usability testing for a drug delivery device | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance |
| Typical project type | Fixed project | Dedicated team |
Key Tech vs Orthogonal: pros and cons
| Key Tech | |
|---|---|
| + | Strong record in diagnostics where instrument, consumable and assay have to be developed together |
| + | ISO 13485 certified quality system |
| + | Human factors and usability engineering are in-house |
| + | Named work with large medtech and life science companies |
| - | Public headcount data is dated, so confirm team capacity for large programs |
| - | No volume manufacturing |
| - | Little public evidence of SaMD or cloud platform work |
| 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 Key Tech?
A typical fit: developing a point-of-care molecular diagnostic instrument and cartridge.
Designs the diagnostic instrument and its cartridge together, with human factors in the same studio. Minimum engagement is not publicly disclosed. Works best with clients in Diagnostics & lab devices, Drug delivery, Surgical & therapeutic devices.
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: Key Tech vs Orthogonal
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Key Tech |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: Key Tech (Not disclosed) vs Orthogonal (Not disclosed) |
| You need specialist depth in a specific vertical | Key Tech |
| 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: Key Tech vs Orthogonal
| Use case | Key Tech fit | Orthogonal fit | Winner |
|---|---|---|---|
| Developing a point-of-care molecular diagnostic instrument and cartridge | Strong | Strong | Both equally |
| Usability testing for a drug delivery device | Strong | Limited | Key Tech |
| Building a mobile app that controls a Class II device | Limited | Strong | Orthogonal |
| Developing a digital therapeutic for FDA clearance | Strong | Strong | Both equally |
Verdict: Key Tech vs Orthogonal
Key Tech (4.3/5) is the stronger overall choice for most Medical Device Development projects. Designs the diagnostic instrument and its cartridge together, with human factors in the same studio.
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
Key Tech vs Orthogonal FAQ
Is Key Tech better than Orthogonal?
Key Tech (4.3/5) scores higher overall, but "better" depends on your use case. Key Tech's strongest advantage: strong record in diagnostics where instrument, consumable and assay have to be developed together. Orthogonal's strongest advantage: focused on regulated medical software for more than a decade.
How do Key Tech and Orthogonal differ in pricing?
Key Tech uses time and materials, phased 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: Key Tech or Orthogonal?
Key Tech 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 Key Tech and Orthogonal?
Key Tech's primary differentiator is: designs the diagnostic instrument and its cartridge together, with human factors in the same studio. 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 (75–150 vs 11–60), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Diagnostics & lab devices, Drug delivery vs Digital health, Wearables & remote monitoring).
Verify all details directly with each company before making a decision.