Best Medical Device Development Companies

MedAcuity vs Delve: full comparison for 2026

Quick verdict

MedAcuity (4.3/5) edges ahead of Delve (4.0/5) overall. MedAcuity is the better choice for device makers with hardware but no software team. Delve is the stronger option for user research and industrial design for medtech. The right choice depends on your project size, budget, and required tech stack.

MedAcuity vs Delve: head-to-head summary

Criterion MedAcuity Delve
Founded 2007 2021
HQ Westford, MA, USA Madison, WI, USA
Team size 100–130 200–500
Rating 4.3 / 5 4.0 / 5
Primary differentiator US-based, ISO 13485 certified team that does nothing but regulated device software Design research and industrial design depth from two long-established US studios
Pricing model Time and materials, fixed project Time and materials, phased fixed project
Min. engagement Not disclosed Not disclosed
Primary tech stack Embedded C/C++, C#/.NET, Qt SolidWorks, Usability engineering, Rapid prototyping
Industries served Surgical & robotics, Diagnostics & lab devices, Digital health, Implantables & neuromodulation Wearables & remote monitoring, Surgical & therapeutic devices, Consumer products, Industrial

MedAcuity vs Delve: overview

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.

Delve

Delve is a product design and innovation firm headquartered in Madison, Wisconsin, with studios in Boston, Philadelphia and San Francisco. Trinity Hunt Partners bought it in 2021 and merged it with Philadelphia's Bresslergroup (founded 1970), and the combined business now operates under the Delve name and later acquired digital design firm altr. Its team is estimated at 200 to 500 people. Delve says it designed and engineered the Dexcom G6 continuous glucose monitor (per company website; independently unverifiable), and medical devices are a large share of its work alongside consumer and industrial products.

Services and capabilities: MedAcuity vs Delve

Capability MedAcuity Delve
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: MedAcuity vs Delve

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

Pricing comparison: MedAcuity vs Delve

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

Target audience comparison: MedAcuity vs Delve

Dimension MedAcuity Delve
Best company size Startup to mid-market Startup to mid-market
Best industries Surgical & robotics, Diagnostics & lab devices, Digital health Wearables & remote monitoring, Surgical & therapeutic devices, Consumer products
Best use cases Writing and documenting the control software for a surgical system, Remediating software documentation gaps before an FDA submission Industrial design and user research for a wearable, Human factors work on a home-use device
Typical project type Fixed project Consulting

MedAcuity vs Delve: pros and cons

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
Delve
+ Strong user research and industrial design, important for patient-worn devices
+ Multiple US studios
+ Public wearable CGM experience
+ Bresslergroup brings a long patent and design-award record
- Private-equity owned since 2021 and built through mergers
- Medical is a large share, but consumer and industrial work compete for attention
- ISO 13485 certification was not confirmed in our research

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.

Who should choose Delve?

A typical fit: industrial design and user research for a wearable.

Design research and industrial design depth from two long-established US studios. Minimum engagement is not publicly disclosed. Works best with clients in Wearables & remote monitoring, Surgical & therapeutic devices, Consumer products, Industrial.

Decision matrix: MedAcuity vs Delve

Your situation Recommended choice
You need full-ownership delivery on a defined project scope MedAcuity
You need a large dedicated team for an ongoing programme Check each company's engagement model
Your budget is at the lower end Compare: MedAcuity (Not disclosed) vs Delve (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: MedAcuity vs Delve

Use case MedAcuity fit Delve fit Winner
Writing and documenting the control software for a surgical system Strong Limited MedAcuity
Remediating software documentation gaps before an FDA submission Strong Limited MedAcuity
Industrial design and user research for a wearable Limited Strong Delve
Human factors work on a home-use device Limited Strong Delve

Verdict: MedAcuity vs Delve

MedAcuity (4.3/5) is the stronger overall choice for most Medical Device Development projects. US-based, ISO 13485 certified team that does nothing but regulated device software.

Delve (4.0/5) is worth a look if you need human factors work on a home-use device. If your situation matches that, Delve is a competitive option.

Related comparisons

MedAcuity vs Delve FAQ

Is MedAcuity better than Delve?

MedAcuity (4.3/5) scores higher overall, but "better" depends on your use case. MedAcuity's strongest advantage: software-only focus means IEC 62304 documentation and traceability are part of every project. Delve's strongest advantage: strong user research and industrial design, important for patient-worn devices.

How do MedAcuity and Delve differ in pricing?

MedAcuity uses time and materials, fixed project pricing. Delve uses time and materials, phased fixed project pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.

Which is better for enterprise: MedAcuity or Delve?

Delve 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 MedAcuity and Delve?

MedAcuity's primary differentiator is: US-based, ISO 13485 certified team that does nothing but regulated device software. Delve's primary differentiator is: design research and industrial design depth from two long-established US studios. They also differ in team size (100–130 vs 200–500), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Surgical & robotics, Diagnostics & lab devices vs Wearables & remote monitoring, Surgical & therapeutic devices).

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