Best Medical Device Development Companies

Sunrise Labs vs MedAcuity: full comparison for 2026

Quick verdict

Sunrise Labs (4.5/5) edges ahead of MedAcuity (4.3/5) overall. Sunrise Labs is the better choice for electromechanical devices, fluidics and infusion. MedAcuity is the stronger option for device makers with hardware but no software team. The right choice depends on your project size, budget, and required tech stack.

Sunrise Labs vs MedAcuity: head-to-head summary

Criterion Sunrise Labs MedAcuity
Founded 1992 2007
HQ Bedford, NH, USA Westford, MA, USA
Team size 90–110 100–130
Rating 4.5 / 5 4.3 / 5
Primary differentiator Three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled US-based, ISO 13485 certified team that does nothing but regulated device software
Pricing model Time and materials, phased fixed project Time and materials, fixed project
Min. engagement Not disclosed Not disclosed
Primary tech stack Embedded C/C++, RTOS, IEC 60601 Embedded C/C++, C#/.NET, Qt
Industries served Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices Surgical & robotics, Diagnostics & lab devices, Digital health, Implantables & neuromodulation

Sunrise Labs vs MedAcuity: 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.

MedAcuity

MedAcuity was founded in 2007 by software engineers and is based in Westford, Massachusetts. It concentrates on medical technology software: architecture, embedded and application development, risk management and the technical documentation behind FDA submissions, with experience across Class I, II and III and PMA devices. It is ISO 13485:2016 certified, and listings put its team at about 119 people. In 2021 it partnered with Fathom Consulting to add human factors engineering.

Services and capabilities: Sunrise Labs vs MedAcuity

Capability Sunrise Labs MedAcuity
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 MedAcuity

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

Pricing comparison: Sunrise Labs vs MedAcuity

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

Target audience comparison: Sunrise Labs vs MedAcuity

Dimension Sunrise Labs MedAcuity
Best company size Startup to mid-market Startup to mid-market
Best industries Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices Surgical & robotics, Diagnostics & lab devices, Digital health
Best use cases Developing an infusion pump or fluid management system, Rescuing a stalled electromechanical device program before verification Writing and documenting the control software for a surgical system, Remediating software documentation gaps before an FDA submission
Typical project type Fixed project Fixed project

Sunrise Labs vs MedAcuity: 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
MedAcuity
+ Software-only focus means IEC 62304 documentation and traceability are part of every project
+ Experience with PMA-level Class III software
+ US onshore team helps with data access and IP-sensitive programs
+ Secure lab space for testing with client hardware
- Does not design hardware, so you need another partner for electronics and mechanics
- US onshore rates are higher than nearshore software teams
- Human factors work is handled through the Fathom partnership instead of an in-house group

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 MedAcuity?

A typical fit: writing and documenting the control software for a surgical system.

US-based, ISO 13485 certified team that does nothing but regulated device software. Minimum engagement is not publicly disclosed. Works best with clients in Surgical & robotics, Diagnostics & lab devices, Digital health, Implantables & neuromodulation.

Decision matrix: Sunrise Labs vs MedAcuity

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 Check each company's engagement model
Your budget is at the lower end Compare: Sunrise Labs (Not disclosed) vs MedAcuity (Not disclosed)
You need specialist depth in a specific vertical MedAcuity
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 MedAcuity

Use case Sunrise Labs fit MedAcuity fit Winner
Developing an infusion pump or fluid management system Strong Limited Sunrise Labs
Rescuing a stalled electromechanical device program before verification Strong Limited Sunrise Labs
Writing and documenting the control software for a surgical system Limited Strong MedAcuity
Remediating software documentation gaps before an FDA submission Limited Strong MedAcuity

Verdict: Sunrise Labs vs MedAcuity

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.

MedAcuity (4.3/5) is worth a look if you need remediating software documentation gaps before an FDA submission. If your situation matches that, MedAcuity is a competitive option.

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Sunrise Labs vs MedAcuity FAQ

Is Sunrise Labs better than MedAcuity?

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. MedAcuity's strongest advantage: software-only focus means IEC 62304 documentation and traceability are part of every project.

How do Sunrise Labs and MedAcuity differ in pricing?

Sunrise Labs uses time and materials, phased fixed project pricing. MedAcuity 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: Sunrise Labs or MedAcuity?

MedAcuity 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 MedAcuity?

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. MedAcuity's primary differentiator is: US-based, ISO 13485 certified team that does nothing but regulated device software. They also differ in team size (90–110 vs 100–130), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Drug delivery, Diagnostics & lab devices vs Surgical & robotics, Diagnostics & lab devices).

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