Best Medical Device Development Companies

Orthogonal vs ScienceSoft: full comparison for 2026

Quick verdict

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

Orthogonal vs ScienceSoft: head-to-head summary

Criterion Orthogonal ScienceSoft
Founded 1998 1989
HQ Chicago, IL, USA McKinney, TX, USA
Team size 11–60 700–800
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 Large, ISO 13485 certified software team with healthcare analytics and testing services
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) .NET, Java, iOS
Industries served Digital health, Wearables & remote monitoring, Diagnostics & lab devices Digital health, Diagnostics & lab devices, Wearables & remote monitoring, Financial services

Orthogonal vs ScienceSoft: 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.

ScienceSoft

Healthcare IT has been a ScienceSoft practice since 2005, inside a McKinney, Texas, software company that dates to 1989. The company holds ISO 13485:2016 certification for medical device software and SaMD, and it states experience preparing software for FDA clearance and CE marking (per company website; independently unverifiable). Its team is about 750. Its medical work is mostly software: SaMD, device companion apps, data analytics and medical device software testing.

Services and capabilities: Orthogonal vs ScienceSoft

Capability Orthogonal ScienceSoft
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 ScienceSoft

Framework / platform Orthogonal ScienceSoft
Embedded C/C++ N/A 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 ScienceSoft

Criterion Orthogonal ScienceSoft
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 ScienceSoft

Dimension Orthogonal ScienceSoft
Best company size Startup to mid-market Startup to mid-market
Best industries Digital health, Wearables & remote monitoring, Diagnostics & lab devices Digital health, Diagnostics & lab devices, Wearables & remote monitoring
Best use cases Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance SaMD for clinical decision support, Mobile companion app for an existing device
Typical project type Dedicated team Dedicated team

Orthogonal vs ScienceSoft: 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
ScienceSoft
+ ISO 13485 certification covers medical device software and SaMD
+ Large team can staff software projects quickly
+ Offers medical device software testing as a separate service
+ Competitive rates compared with US onshore software firms
- Generalist IT company where healthcare is one of many practices
- No hardware, electronics or mechanical design
- FDA and CE experience claims are self-reported

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 ScienceSoft?

A typical fit: SaMD for clinical decision support.

Large, ISO 13485 certified software team with healthcare analytics and testing services. Minimum engagement is not publicly disclosed. Works best with clients in Digital health, Diagnostics & lab devices, Wearables & remote monitoring, Financial services.

Decision matrix: Orthogonal vs ScienceSoft

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

Use case Orthogonal fit ScienceSoft 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
SaMD for clinical decision support Limited Strong ScienceSoft
Mobile companion app for an existing device Strong Strong Both equally

Verdict: Orthogonal vs ScienceSoft

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.

ScienceSoft (3.9/5) is worth a look if you need mobile companion app for an existing device. If your situation matches that, ScienceSoft is a competitive option.

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Orthogonal vs ScienceSoft FAQ

Is Orthogonal better than ScienceSoft?

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. ScienceSoft's strongest advantage: ISO 13485 certification covers medical device software and SaMD.

How do Orthogonal and ScienceSoft differ in pricing?

Orthogonal uses time and materials, dedicated team pricing. ScienceSoft 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 ScienceSoft?

ScienceSoft 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 ScienceSoft?

Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. ScienceSoft's primary differentiator is: Large, ISO 13485 certified software team with healthcare analytics and testing services. They also differ in team size (11–60 vs 700–800), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Digital health, Diagnostics & lab devices).

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