StarFish Medical vs Orthogonal: full comparison for 2026
Quick verdict
StarFish Medical (4.6/5) edges ahead of Orthogonal (4.2/5) overall. StarFish Medical is the better choice for startups needing design plus pilot manufacturing. Orthogonal is the stronger option for SaMD and device companion apps. The right choice depends on your project size, budget, and required tech stack.
StarFish Medical vs Orthogonal: head-to-head summary
| Criterion | StarFish Medical | Orthogonal |
|---|---|---|
| Founded | 1999 | 1998 |
| HQ | Victoria, BC, Canada | Chicago, IL, USA |
| Team size | 201–250 | 11–60 |
| Rating | 4.6 / 5 | 4.2 / 5 |
| Primary differentiator | Medtech-only practice that can build clinical and early commercial units in its own certified clean room | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices |
| Pricing model | Phased fixed project, time and materials | Time and materials, dedicated team |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | ISO 13485 QMS, IEC 62304, ISO 14971 | iOS, Android, Cloud (AWS/Azure) |
| Industries served | Diagnostics & lab devices, Surgical & therapeutic devices, Wearables & remote monitoring, Drug delivery | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
StarFish Medical vs Orthogonal: overview
StarFish Medical
StarFish Medical was founded in Victoria, British Columbia, by Scott Phillips (the company gives 1999; some directories list 1998). It works only on medical devices, covering design, development and low-volume manufacturing in ISO 13485 certified facilities, and reports around 230 staff across Victoria, Toronto and Irvine (per company website; independently unverifiable). In November 2024 it acquired Omnica Corporation, a California medical device design firm, which added a larger US West Coast presence. Victoria remains the headquarters and its largest site.
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: StarFish Medical vs Orthogonal
| Capability | StarFish Medical | 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: StarFish Medical vs Orthogonal
| Framework / platform | StarFish Medical | 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 | ✓ | ✓ |
| ISO 14971 | ✓ | ✓ |
| ISO 13485 QMS | ✓ | N/A |
| Qt | N/A | N/A |
Pricing comparison: StarFish Medical vs Orthogonal
| Criterion | StarFish Medical | 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: StarFish Medical vs Orthogonal
| Dimension | StarFish Medical | Orthogonal |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Diagnostics & lab devices, Surgical & therapeutic devices, Wearables & remote monitoring | Digital health, Wearables & remote monitoring, Diagnostics & lab devices |
| Best use cases | Taking a venture-backed device from proof of concept to clinical-trial units, Designing an optical diagnostic instrument with its consumable | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance |
| Typical project type | Fixed project | Dedicated team |
StarFish Medical vs Orthogonal: pros and cons
| StarFish Medical | |
|---|---|
| + | Every project is a medical device, so design reviews, risk files and documentation follow medtech practice by default |
| + | Prototype and pilot production happen in its own ISO 13485 facility, avoiding an early transfer to a contract manufacturer |
| + | The Omnica acquisition adds Southern California capacity for US clients |
| + | Multidisciplinary teams cover industrial design, mechanics, electronics, software and human factors |
| - | Volume manufacturing beyond pilot quantities still needs a larger contract manufacturer |
| - | North American cost base makes it more expensive than Eastern European or Asian engineering teams |
| - | The Omnica integration is recent, so cross-site processes are still settling |
| 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 StarFish Medical?
A typical fit: taking a venture-backed device from proof of concept to clinical-trial units.
Medtech-only practice that can build clinical and early commercial units in its own certified clean room. Minimum engagement is not publicly disclosed. Works best with clients in Diagnostics & lab devices, Surgical & therapeutic devices, Wearables & remote monitoring, Drug delivery.
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: StarFish Medical vs Orthogonal
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | StarFish Medical |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: StarFish Medical (Not disclosed) vs Orthogonal (Not disclosed) |
| You need specialist depth in a specific vertical | StarFish Medical |
| 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: StarFish Medical vs Orthogonal
| Use case | StarFish Medical fit | Orthogonal fit | Winner |
|---|---|---|---|
| Taking a venture-backed device from proof of concept to clinical-trial units | Strong | Limited | StarFish Medical |
| Designing an optical diagnostic instrument with its consumable | Strong | Limited | StarFish Medical |
| Building a mobile app that controls a Class II device | Limited | Strong | Orthogonal |
| Developing a digital therapeutic for FDA clearance | Limited | Strong | Orthogonal |
Verdict: StarFish Medical vs Orthogonal
StarFish Medical (4.6/5) is the stronger overall choice for most Medical Device Development projects. Medtech-only practice that can build clinical and early commercial units in its own certified clean room.
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
StarFish Medical vs Orthogonal FAQ
Is StarFish Medical better than Orthogonal?
StarFish Medical (4.6/5) scores higher overall, but "better" depends on your use case. StarFish Medical's strongest advantage: every project is a medical device, so design reviews, risk files and documentation follow medtech practice by default. Orthogonal's strongest advantage: focused on regulated medical software for more than a decade.
How do StarFish Medical and Orthogonal differ in pricing?
StarFish Medical uses phased fixed project, time and materials 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: StarFish Medical or Orthogonal?
StarFish Medical 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 StarFish Medical and Orthogonal?
StarFish Medical's primary differentiator is: medtech-only practice that can build clinical and early commercial units in its own certified clean room. 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 (201–250 vs 11–60), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Diagnostics & lab devices, Surgical & therapeutic devices vs Digital health, Wearables & remote monitoring).
Verify all details directly with each company before making a decision.