Best Medical Device Development Companies

Sunrise Labs vs Orthogonal: full comparison for 2026

Quick verdict

Sunrise Labs (4.5/5) edges ahead of Orthogonal (4.2/5) overall. Sunrise Labs is the better choice for electromechanical devices, fluidics and infusion. Orthogonal is the stronger option for SaMD and device companion apps. The right choice depends on your project size, budget, and required tech stack.

Sunrise Labs vs Orthogonal: head-to-head summary

Criterion Sunrise Labs Orthogonal
Founded 1992 1998
HQ Bedford, NH, USA Chicago, IL, USA
Team size 90–110 11–60
Rating 4.5 / 5 4.2 / 5
Primary differentiator Three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices
Pricing model Time and materials, phased fixed project Time and materials, dedicated team
Min. engagement Not disclosed Not disclosed
Primary tech stack Embedded C/C++, RTOS, IEC 60601 iOS, Android, Cloud (AWS/Azure)
Industries served Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices Digital health, Wearables & remote monitoring, Diagnostics & lab devices

Sunrise Labs vs Orthogonal: overview

Sunrise Labs

Founded in 1992 by MIT-trained engineers, Sunrise Labs is a privately held product development firm that now operates from Bedford, New Hampshire, with a Boston-area office added in 2022. Its work concentrates on electromechanical medical devices: infusion and fluid handling, diagnostics instruments and therapeutic systems that combine motors, sensors, electronics and embedded software. Directory listings put the team at roughly 90 to 100 people. Sunrise Labs handles development and design transfer and does not run its own volume manufacturing.

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: Sunrise Labs vs Orthogonal

Capability Sunrise Labs 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: Sunrise Labs vs Orthogonal

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

Pricing comparison: Sunrise Labs vs Orthogonal

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

Target audience comparison: Sunrise Labs vs Orthogonal

Dimension Sunrise Labs Orthogonal
Best company size Startup to mid-market Startup to mid-market
Best industries Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices Digital health, Wearables & remote monitoring, Diagnostics & lab devices
Best use cases Developing an infusion pump or fluid management system, Rescuing a stalled electromechanical device program before verification Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance
Typical project type Fixed project Dedicated team

Sunrise Labs vs Orthogonal: pros and cons

Sunrise Labs
+ Deep experience with infusion, fluid handling and other electromechanical systems that most software-led firms avoid
+ Engineers who own mechanics, electronics and firmware sit on the same team, which helps with system-level risk analysis
+ Long track record with US medtech clients and FDA submission support
+ Mid-sized team means senior engineers stay visible on projects
- No in-house volume manufacturing; design transfer to a CM is part of every plan
- US-only footprint and Northeast US rates put it at the higher end on cost
- Less suited to software-only or SaMD projects
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 Sunrise Labs?

A typical fit: developing an infusion pump or fluid management system.

Three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled. Minimum engagement is not publicly disclosed. Works best with clients in Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices.

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: Sunrise Labs vs Orthogonal

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

Use case Sunrise Labs fit Orthogonal fit Winner
Developing an infusion pump or fluid management system Strong Strong Both equally
Rescuing a stalled electromechanical device program before verification Strong Limited Sunrise Labs
Building a mobile app that controls a Class II device Limited Strong Orthogonal
Developing a digital therapeutic for FDA clearance Strong Strong Both equally

Verdict: Sunrise Labs vs Orthogonal

Sunrise Labs (4.5/5) is the stronger overall choice for most Medical Device Development projects. Three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled.

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.

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Sunrise Labs vs Orthogonal FAQ

Is Sunrise Labs better than Orthogonal?

Sunrise Labs (4.5/5) scores higher overall, but "better" depends on your use case. Sunrise Labs's strongest advantage: deep experience with infusion, fluid handling and other electromechanical systems that most software-led firms avoid. Orthogonal's strongest advantage: focused on regulated medical software for more than a decade.

How do Sunrise Labs and Orthogonal differ in pricing?

Sunrise Labs uses time and materials, phased fixed project 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: Sunrise Labs or Orthogonal?

Sunrise Labs 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 Sunrise Labs and Orthogonal?

Sunrise Labs's primary differentiator is: three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled. 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 (90–110 vs 11–60), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Drug delivery, Diagnostics & lab devices vs Digital health, Wearables & remote monitoring).

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