Best Medical Device Development Companies

Orthogonal vs Delve: full comparison for 2026

Quick verdict

Orthogonal (4.2/5) edges ahead of Delve (4.0/5) overall. Orthogonal is the better choice for SaMD and device companion apps. 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.

Orthogonal vs Delve: head-to-head summary

Criterion Orthogonal Delve
Founded 1998 2021
HQ Chicago, IL, USA Madison, WI, USA
Team size 11–60 200–500
Rating 4.2 / 5 4.0 / 5
Primary differentiator Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices Design research and industrial design depth from two long-established US studios
Pricing model Time and materials, dedicated team Time and materials, phased fixed project
Min. engagement Not disclosed Not disclosed
Primary tech stack iOS, Android, Cloud (AWS/Azure) SolidWorks, Usability engineering, Rapid prototyping
Industries served Digital health, Wearables & remote monitoring, Diagnostics & lab devices Wearables & remote monitoring, Surgical & therapeutic devices, Consumer products, Industrial

Orthogonal vs Delve: 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.

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: Orthogonal vs Delve

Capability Orthogonal 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: Orthogonal vs Delve

Framework / platform Orthogonal Delve
Embedded C/C++ N/A ✓
Embedded Linux N/A N/A
RTOS N/A N/A
BLE ✓ 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 N/A

Pricing comparison: Orthogonal vs Delve

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

Target audience comparison: Orthogonal vs Delve

Dimension Orthogonal Delve
Best company size Startup to mid-market Startup to mid-market
Best industries Digital health, Wearables & remote monitoring, Diagnostics & lab devices Wearables & remote monitoring, Surgical & therapeutic devices, Consumer products
Best use cases Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance Industrial design and user research for a wearable, Human factors work on a home-use device
Typical project type Dedicated team Consulting

Orthogonal vs Delve: 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
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 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 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: Orthogonal vs Delve

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

Use case Orthogonal fit Delve 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
Industrial design and user research for a wearable Limited Strong Delve
Human factors work on a home-use device Limited Strong Delve

Verdict: Orthogonal vs Delve

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.

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

Orthogonal vs Delve FAQ

Is Orthogonal better than Delve?

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. Delve's strongest advantage: strong user research and industrial design, important for patient-worn devices.

How do Orthogonal and Delve differ in pricing?

Orthogonal uses time and materials, dedicated team 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: Orthogonal 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 Orthogonal and Delve?

Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Delve's primary differentiator is: design research and industrial design depth from two long-established US studios. They also differ in team size (11–60 vs 200–500), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Wearables & remote monitoring, Surgical & therapeutic devices).

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