Best Medical Device Development Companies

Orthogonal vs Softeq: full comparison for 2026

Quick verdict

Orthogonal (4.2/5) edges ahead of Softeq (3.9/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Softeq is the stronger option for connected devices needing hardware plus apps. The right choice depends on your project size, budget, and required tech stack.

Orthogonal vs Softeq: head-to-head summary

Criterion Orthogonal Softeq
Founded 1998 1997
HQ Chicago, IL, USA Houston, TX, USA
Team size 11–60 250–500
Rating 4.2 / 5 3.9 / 5
Primary differentiator Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place
Pricing model Time and materials, dedicated team Fixed project, time and materials, dedicated team
Min. engagement Not disclosed Not disclosed
Primary tech stack iOS, Android, Cloud (AWS/Azure) PCB design, Embedded Linux, RTOS
Industries served Digital health, Wearables & remote monitoring, Diagnostics & lab devices Wearables & remote monitoring, Digital health, Consumer electronics, Industrial

Orthogonal vs Softeq: 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.

Softeq

Houston-based Softeq Development Corporation dates to 1997 and builds hardware, embedded, mobile, web and cloud products. The company holds ISO 13485 certification, which it presents as evidence that it can build medical devices to industry rules. Medical devices are one of several markets it serves, along with consumer electronics and industrial IoT. Its team is in the 250 to 500 range.

Services and capabilities: Orthogonal vs Softeq

Capability Orthogonal Softeq
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 Softeq

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

Pricing comparison: Orthogonal vs Softeq

Criterion Orthogonal Softeq
Minimum engagement Not disclosed Not disclosed
Engagement models Dedicated team, Time & materials Dedicated team, Fixed project, Time & materials
Rate transparency Not public Not public
Price tier Mid-market Mid-market

Target audience comparison: Orthogonal vs Softeq

Dimension Orthogonal Softeq
Best company size Startup to mid-market Startup to mid-market
Best industries Digital health, Wearables & remote monitoring, Diagnostics & lab devices Wearables & remote monitoring, Digital health, Consumer electronics
Best use cases Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance Connected home-use device with a mobile app, Firmware and cloud for a remote monitoring wearable
Typical project type Dedicated team Dedicated team

Orthogonal vs Softeq: 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
Softeq
+ Covers hardware, firmware, apps and cloud for connected devices
+ ISO 13485 certification
+ Long company history since 1997
+ Flexible engagement models including dedicated teams
- Generalist firm where medical is one market among many
- Few public medical device case studies
- No industrial design or manufacturing

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 Softeq?

A typical fit: connected home-use device with a mobile app.

Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place. Minimum engagement is not publicly disclosed. Works best with clients in Wearables & remote monitoring, Digital health, Consumer electronics, Industrial.

Decision matrix: Orthogonal vs Softeq

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

Use case Orthogonal fit Softeq 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
Connected home-use device with a mobile app Limited Strong Softeq
Firmware and cloud for a remote monitoring wearable Limited Strong Softeq

Verdict: Orthogonal vs Softeq

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.

Softeq (3.9/5) is worth a look if you need firmware and cloud for a remote monitoring wearable. If your situation matches that, Softeq is a competitive option.

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Orthogonal vs Softeq FAQ

Is Orthogonal better than Softeq?

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. Softeq's strongest advantage: covers hardware, firmware, apps and cloud for connected devices.

How do Orthogonal and Softeq differ in pricing?

Orthogonal uses time and materials, dedicated team pricing. Softeq uses fixed project, 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: Orthogonal or Softeq?

Softeq 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 Softeq?

Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Softeq's primary differentiator is: Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place. They also differ in team size (11–60 vs 250–500), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Wearables & remote monitoring, Digital health).

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