Best Medical Device Development Companies

Orthogonal vs Promenade Software: full comparison for 2026

Quick verdict

Orthogonal (4.2/5) edges ahead of Promenade Software (4.1/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Promenade Software is the stronger option for small device makers needing software and security. The right choice depends on your project size, budget, and required tech stack.

Orthogonal vs Promenade Software: head-to-head summary

Criterion Orthogonal Promenade Software
Founded 1998 2013
HQ Chicago, IL, USA Irvine, CA, USA
Team size 11–60 11–50
Rating 4.2 / 5 4.1 / 5
Primary differentiator Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices Pairs contract device software with its own medical cybersecurity tooling and information-sharing service
Pricing model Time and materials, dedicated team Time and materials, fixed project
Min. engagement Not disclosed Not disclosed
Primary tech stack iOS, Android, Cloud (AWS/Azure) Embedded C/C++, Cloud (AWS/Azure), IEC 62304
Industries served Digital health, Wearables & remote monitoring, Diagnostics & lab devices Surgical & therapeutic devices, Digital health, Diagnostics & lab devices

Orthogonal vs Promenade Software: 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.

Promenade Software

Since 2013 this Irvine, California, company has developed software for medical devices, from low-level firmware to cloud services, along with postmarket support. Directory listings say it follows IEC 62304 and holds ISO 13485:2016 and ISO 9001:2015 certification. It has also built cybersecurity products for the industry, including CyberMed Cloud and the MedISAO information-sharing service. The team is small, with estimates of 11 to 50 people.

Services and capabilities: Orthogonal vs Promenade Software

Capability Orthogonal Promenade Software
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 Promenade Software

Framework / platform Orthogonal Promenade Software
Embedded C/C++ N/A ✓
Embedded Linux N/A N/A
RTOS N/A N/A
BLE ✓ N/A
Cloud (AWS/Azure) ✓ ✓
IEC 62304 ✓ ✓
ISO 14971 ✓ N/A
ISO 13485 QMS N/A N/A
Qt N/A N/A

Pricing comparison: Orthogonal vs Promenade Software

Criterion Orthogonal Promenade Software
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 Promenade Software

Dimension Orthogonal Promenade Software
Best company size Startup to mid-market Startup to mid-market
Best industries Digital health, Wearables & remote monitoring, Diagnostics & lab devices Surgical & therapeutic devices, Digital health, Diagnostics & lab devices
Best use cases Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance Firmware and cloud software for an early-stage device, Building SBOM and vulnerability monitoring for a cleared device
Typical project type Dedicated team Fixed project

Orthogonal vs Promenade Software: 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
Promenade Software
+ Software-only, ISO 13485 certified team that knows FDA expectations
+ Owns cybersecurity products, so security work comes with tooling
+ Small team keeps costs and overhead down for startups
+ Southern California location close to the Orange County medtech cluster
- Very small, so capacity for large programs is limited
- No hardware or mechanical design
- Certifications come from directory listings and should be confirmed with the company

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 Promenade Software?

A typical fit: firmware and cloud software for an early-stage device.

Pairs contract device software with its own medical cybersecurity tooling and information-sharing service. Minimum engagement is not publicly disclosed. Works best with clients in Surgical & therapeutic devices, Digital health, Diagnostics & lab devices.

Decision matrix: Orthogonal vs Promenade Software

Your situation Recommended choice
You need full-ownership delivery on a defined project scope Promenade Software
You need a large dedicated team for an ongoing programme Orthogonal
Your budget is at the lower end Compare: Orthogonal (Not disclosed) vs Promenade Software (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 Promenade Software

Use case Orthogonal fit Promenade Software 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
Firmware and cloud software for an early-stage device Limited Strong Promenade Software
Building SBOM and vulnerability monitoring for a cleared device Strong Strong Both equally

Verdict: Orthogonal vs Promenade Software

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.

Promenade Software (4.1/5) is worth a look if you need building SBOM and vulnerability monitoring for a cleared device. If your situation matches that, Promenade Software is a competitive option.

Related comparisons

Orthogonal vs Promenade Software FAQ

Is Orthogonal better than Promenade Software?

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. Promenade Software's strongest advantage: Software-only, ISO 13485 certified team that knows FDA expectations.

How do Orthogonal and Promenade Software differ in pricing?

Orthogonal uses time and materials, dedicated team pricing. Promenade Software uses time and materials, 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 Promenade Software?

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 Promenade Software?

Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Promenade Software's primary differentiator is: pairs contract device software with its own medical cybersecurity tooling and information-sharing service. They also differ in team size (11–60 vs 11–50), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Surgical & therapeutic devices, Digital health).

Verify all details directly with each company before making a decision.