Best Medical Device Development Companies

Orthogonal vs Plexus: full comparison for 2026

Quick verdict

Orthogonal (4.2/5) edges ahead of Plexus (3.8/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Plexus is the stronger option for complex capital equipment needing build and sustaining. The right choice depends on your project size, budget, and required tech stack.

Orthogonal vs Plexus: head-to-head summary

Criterion Orthogonal Plexus
Founded 1998 1979
HQ Chicago, IL, USA Neenah, WI, USA
Team size 11–60 ~20,000
Rating 4.2 / 5 3.8 / 5
Primary differentiator Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices Engineering, NPI and sustaining services for low-to-mid volume, high-complexity medical equipment
Pricing model Time and materials, dedicated team NPI contract, manufacturing supply agreement
Min. engagement Not disclosed Not disclosed
Primary tech stack iOS, Android, Cloud (AWS/Azure) PCB design, PCB assembly, Embedded C/C++
Industries served Digital health, Wearables & remote monitoring, Diagnostics & lab devices Surgical & robotics, Diagnostics & lab devices, Aerospace, Industrial

Orthogonal vs Plexus: 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.

Plexus

Plexus Corp. is a NASDAQ-listed company headquartered in Neenah, Wisconsin, that offers design and development, supply chain, new product introduction, manufacturing and sustaining services. Healthcare and life sciences is one of its three markets alongside aerospace and defense and industrial. Its healthcare work includes surgical equipment, imaging equipment and diagnostic instruments. The company has around 20,000 employees in total, though only part of that is healthcare.

Services and capabilities: Orthogonal vs Plexus

Capability Orthogonal Plexus
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 Plexus

Framework / platform Orthogonal Plexus
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 ✓
Qt N/A N/A

Pricing comparison: Orthogonal vs Plexus

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

Target audience comparison: Orthogonal vs Plexus

Dimension Orthogonal Plexus
Best company size Startup to mid-market Startup to mid-market
Best industries Digital health, Wearables & remote monitoring, Diagnostics & lab devices Surgical & robotics, Diagnostics & lab devices, Aerospace
Best use cases Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance Building and sustaining a diagnostic imaging subsystem, Electronics redesign for component obsolescence
Typical project type Dedicated team Fixed project

Orthogonal vs Plexus: 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
Plexus
+ Strong with complex, lower-volume capital equipment such as imaging and surgical systems
+ Offers product engineering as well as manufacturing
+ Sustaining engineering over long product lives
+ Public company with transparent financial reporting
- Generalist manufacturer; healthcare competes with aerospace and industrial for capacity
- Not a fit for early-stage concept work
- Most engineering engagements lead toward a manufacturing contract

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 Plexus?

A typical fit: building and sustaining a diagnostic imaging subsystem.

Engineering, NPI and sustaining services for low-to-mid volume, high-complexity medical equipment. Minimum engagement is not publicly disclosed. Works best with clients in Surgical & robotics, Diagnostics & lab devices, Aerospace, Industrial.

Decision matrix: Orthogonal vs Plexus

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

Use case Orthogonal fit Plexus fit Winner
Building a mobile app that controls a Class II device Strong Strong Both equally
Developing a digital therapeutic for FDA clearance Strong Limited Orthogonal
Building and sustaining a diagnostic imaging subsystem Strong Strong Both equally
Electronics redesign for component obsolescence Limited Strong Plexus

Verdict: Orthogonal vs Plexus

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.

Plexus (3.8/5) is worth a look if you need electronics redesign for component obsolescence. If your situation matches that, Plexus is a competitive option.

Related comparisons

Orthogonal vs Plexus FAQ

Is Orthogonal better than Plexus?

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. Plexus's strongest advantage: strong with complex, lower-volume capital equipment such as imaging and surgical systems.

How do Orthogonal and Plexus differ in pricing?

Orthogonal uses time and materials, dedicated team pricing. Plexus uses npi contract, manufacturing supply agreement pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.

Which is better for enterprise: Orthogonal or Plexus?

Plexus 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 Plexus?

Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Plexus's primary differentiator is: Engineering, NPI and sustaining services for low-to-mid volume, high-complexity medical equipment. They also differ in team size (11–60 vs ~20,000), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Surgical & robotics, Diagnostics & lab devices).

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