Orthogonal vs Product Creation Studio: full comparison for 2026
Quick verdict
Orthogonal (4.2/5) edges ahead of Product Creation Studio (4.0/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Product Creation Studio is the stronger option for pacific Northwest startups and lab instruments. The right choice depends on your project size, budget, and required tech stack.
Orthogonal vs Product Creation Studio: head-to-head summary
| Criterion | Orthogonal | Product Creation Studio |
|---|---|---|
| Founded | 1998 | 1999 |
| HQ | Chicago, IL, USA | Seattle, WA, USA |
| Team size | 11–60 | Not published |
| Rating | 4.2 / 5 | 4.0 / 5 |
| Primary differentiator | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices | Small ISO 13485 studio that can follow its own quality system or the client's |
| Pricing model | Time and materials, dedicated team | Time and materials, phased fixed project |
| Min. engagement | Not disclosed | Not disclosed |
| Primary tech stack | iOS, Android, Cloud (AWS/Azure) | SolidWorks, Embedded C/C++, PCB design |
| Industries served | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Diagnostics & lab devices, Wearables & remote monitoring, Consumer products |
Orthogonal vs Product Creation Studio: 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.
Product Creation Studio
Product Creation Studio is a full-service product design and development firm in Seattle, Washington. It marked 20 years in 2019, which puts its founding around 1999. In 2017 it received ISO 13485:2016 certification after a BSI assessment, and it says it is the only ISO 13485-certified product development firm in the Pacific Northwest (per company website; independently unverifiable). It works on medical devices and lab and test instruments, and can work within a client's QMS. Headcount is not published.
Services and capabilities: Orthogonal vs Product Creation Studio
| Capability | Orthogonal | Product Creation Studio |
|---|---|---|
| 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 Product Creation Studio
| Framework / platform | Orthogonal | Product Creation Studio |
|---|---|---|
| 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 Product Creation Studio
| Criterion | Orthogonal | Product Creation Studio |
|---|---|---|
| Minimum engagement | Not disclosed | Not disclosed |
| Engagement models | Dedicated team, Time & materials | Fixed project, Time & materials |
| Rate transparency | Not public | Not public |
| Price tier | Mid-market | Mid-market |
Target audience comparison: Orthogonal vs Product Creation Studio
| Dimension | Orthogonal | Product Creation Studio |
|---|---|---|
| Best company size | Startup to mid-market | Startup to mid-market |
| Best industries | Digital health, Wearables & remote monitoring, Diagnostics & lab devices | Diagnostics & lab devices, Wearables & remote monitoring, Consumer products |
| Best use cases | Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance | Building a benchtop lab instrument prototype, Early prototypes for a Seattle medtech startup |
| Typical project type | Dedicated team | Fixed project |
Orthogonal vs Product Creation Studio: 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 |
| Product Creation Studio | |
|---|---|
| + | ISO 13485 certification assessed by BSI |
| + | Flexible about using its own QMS or the client's |
| + | Covers mechanical, electrical and firmware work in one studio |
| + | Accessible for early-stage companies |
| - | Small, with no published headcount |
| - | No volume manufacturing |
| - | Fewer public medical case studies than larger firms |
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 Product Creation Studio?
A typical fit: building a benchtop lab instrument prototype.
Small ISO 13485 studio that can follow its own quality system or the client's. Minimum engagement is not publicly disclosed. Works best with clients in Diagnostics & lab devices, Wearables & remote monitoring, Consumer products.
Decision matrix: Orthogonal vs Product Creation Studio
| Your situation | Recommended choice |
|---|---|
| You need full-ownership delivery on a defined project scope | Product Creation Studio |
| You need a large dedicated team for an ongoing programme | Orthogonal |
| Your budget is at the lower end | Compare: Orthogonal (Not disclosed) vs Product Creation Studio (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 Product Creation Studio
| Use case | Orthogonal fit | Product Creation Studio fit | Winner |
|---|---|---|---|
| Building a mobile app that controls a Class II device | Strong | Strong | Both equally |
| Developing a digital therapeutic for FDA clearance | Strong | Limited | Orthogonal |
| Building a benchtop lab instrument prototype | Strong | Strong | Both equally |
| Early prototypes for a Seattle medtech startup | Limited | Strong | Product Creation Studio |
Verdict: Orthogonal vs Product Creation Studio
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.
Product Creation Studio (4.0/5) is worth a look if you need early prototypes for a Seattle medtech startup. If your situation matches that, Product Creation Studio is a competitive option.
Related comparisons
Orthogonal vs Product Creation Studio FAQ
Is Orthogonal better than Product Creation Studio?
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. Product Creation Studio's strongest advantage: ISO 13485 certification assessed by BSI.
How do Orthogonal and Product Creation Studio differ in pricing?
Orthogonal uses time and materials, dedicated team pricing. Product Creation Studio uses time and materials, phased fixed project pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.
Which is better for enterprise: Orthogonal or Product Creation Studio?
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 Product Creation Studio?
Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Product Creation Studio's primary differentiator is: small ISO 13485 studio that can follow its own quality system or the client's. They also differ in team size (11–60 vs Not published), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Diagnostics & lab devices, Wearables & remote monitoring).
Verify all details directly with each company before making a decision.