Best Medical Device Development Companies

Orthogonal vs Kaleidoscope Innovation: full comparison for 2026

Quick verdict

Orthogonal (4.2/5) edges ahead of Kaleidoscope Innovation (4.0/5) overall. Orthogonal is the better choice for SaMD and device companion apps. Kaleidoscope Innovation is the stronger option for enterprises already working with Infosys. The right choice depends on your project size, budget, and required tech stack.

Orthogonal vs Kaleidoscope Innovation: head-to-head summary

Criterion Orthogonal Kaleidoscope Innovation
Founded 1998 1989
HQ Chicago, IL, USA Cincinnati, OH, USA
Team size 11–60 100–250
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 US medical design studio with access to Infosys engineering and digital capacity
Pricing model Time and materials, dedicated team Time and materials, fixed project
Min. engagement Not disclosed Not disclosed
Primary tech stack iOS, Android, Cloud (AWS/Azure) SolidWorks, Usability engineering, ISO 13485 QMS
Industries served Digital health, Wearables & remote monitoring, Diagnostics & lab devices Surgical & therapeutic devices, Diagnostics & lab devices, Consumer products

Orthogonal vs Kaleidoscope Innovation: 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.

Kaleidoscope Innovation

Kaleidoscope Innovation was founded in Cincinnati, Ohio, in 1989. Infosys acquired it in September 2020, and the deal coverage described its services as focused mainly on medical devices. It is listed as ISO 13485 certified and FDA compliant, and runs product development labs that it has expanded for healthcare clients. Headcount estimates range from about 100 to 250.

Services and capabilities: Orthogonal vs Kaleidoscope Innovation

Capability Orthogonal Kaleidoscope Innovation
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 Kaleidoscope Innovation

Framework / platform Orthogonal Kaleidoscope Innovation
Embedded C/C++ N/A 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 Kaleidoscope Innovation

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

Target audience comparison: Orthogonal vs Kaleidoscope Innovation

Dimension Orthogonal Kaleidoscope Innovation
Best company size Startup to mid-market Startup to mid-market
Best industries Digital health, Wearables & remote monitoring, Diagnostics & lab devices Surgical & therapeutic devices, Diagnostics & lab devices, Consumer products
Best use cases Building a mobile app that controls a Class II device, Developing a digital therapeutic for FDA clearance Industrial and mechanical design for a surgical instrument, Device testing in an accredited lab environment
Typical project type Dedicated team Fixed project

Orthogonal vs Kaleidoscope Innovation: 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
Kaleidoscope Innovation
+ ISO 13485 certified, with medical devices as its main focus
+ In-house test and prototyping labs
+ Infosys ownership adds software and digital scale
+ Over 30 years of product design work
- Owned by Infosys since 2020, so pricing and contracts may follow a large IT services model
- Electronics and embedded software depth is less visible than its design work
- Team size data comes only from third-party estimates

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 Kaleidoscope Innovation?

A typical fit: industrial and mechanical design for a surgical instrument.

US medical design studio with access to Infosys engineering and digital capacity. Minimum engagement is not publicly disclosed. Works best with clients in Surgical & therapeutic devices, Diagnostics & lab devices, Consumer products.

Decision matrix: Orthogonal vs Kaleidoscope Innovation

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

Use case Orthogonal fit Kaleidoscope Innovation 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 and mechanical design for a surgical instrument Limited Strong Kaleidoscope Innovation
Device testing in an accredited lab environment Strong Strong Both equally

Verdict: Orthogonal vs Kaleidoscope Innovation

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.

Kaleidoscope Innovation (4.0/5) is worth a look if you need device testing in an accredited lab environment. If your situation matches that, Kaleidoscope Innovation is a competitive option.

Related comparisons

Orthogonal vs Kaleidoscope Innovation FAQ

Is Orthogonal better than Kaleidoscope Innovation?

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. Kaleidoscope Innovation's strongest advantage: ISO 13485 certified, with medical devices as its main focus.

How do Orthogonal and Kaleidoscope Innovation differ in pricing?

Orthogonal uses time and materials, dedicated team pricing. Kaleidoscope Innovation 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: Orthogonal or Kaleidoscope Innovation?

Kaleidoscope Innovation 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 Kaleidoscope Innovation?

Orthogonal's primary differentiator is: agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices. Kaleidoscope Innovation's primary differentiator is: US medical design studio with access to Infosys engineering and digital capacity. They also differ in team size (11–60 vs 100–250), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Wearables & remote monitoring vs Surgical & therapeutic devices, Diagnostics & lab devices).

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