Best Medical Device Development Companies

Promenade Software vs Flex Health Solutions: full comparison for 2026

Quick verdict

Promenade Software (4.1/5) edges ahead of Flex Health Solutions (3.8/5) overall. Promenade Software is the better choice for small device makers needing software and security. Flex Health Solutions is the stronger option for design transfer into global contract manufacturing. The right choice depends on your project size, budget, and required tech stack.

Promenade Software vs Flex Health Solutions: head-to-head summary

Criterion Promenade Software Flex Health Solutions
Founded 2013 1969
HQ Irvine, CA, USA Austin, TX, USA / Singapore
Team size 11–50 Large (Flex Ltd.)
Rating 4.1 / 5 3.8 / 5
Primary differentiator Pairs contract device software with its own medical cybersecurity tooling and information-sharing service Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network
Pricing model Time and materials, fixed project Manufacturing supply agreement, NPI contract
Min. engagement Not disclosed Not disclosed
Primary tech stack Embedded C/C++, Cloud (AWS/Azure), IEC 62304 PCB assembly, Injection molding, Automated assembly
Industries served Surgical & therapeutic devices, Digital health, Diagnostics & lab devices Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices

Promenade Software vs Flex Health Solutions: overview

Promenade Software

Since 2013 this Irvine, California, company has developed software for medical devices, from low-level firmware to cloud services, along with postmarket support. Directory listings say it follows IEC 62304 and holds ISO 13485:2016 and ISO 9001:2015 certification. It has also built cybersecurity products for the industry, including CyberMed Cloud and the MedISAO information-sharing service. The team is small, with estimates of 11 to 50 people.

Flex Health Solutions

Flex Health Solutions is the healthcare division of Flex Ltd. and operates as a contract development and manufacturing organization (CDMO) for medical devices and pharma. Flex lists 26 manufacturing sites, six design and engineering sites, 16 FDA-registered entities and 21 ISO 13485 sites for health (per company website; independently unverifiable). In 2025 it opened a North American new product introduction (NPI) center for healthcare customers, and it shared a 2025 PDA Drug Delivery Innovation Award with Merck KGaA for an autoinjector.

Services and capabilities: Promenade Software vs Flex Health Solutions

Capability Promenade Software Flex Health Solutions
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: Promenade Software vs Flex Health Solutions

Framework / platform Promenade Software Flex Health Solutions
Embedded C/C++ ✓ N/A
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 N/A
ISO 13485 QMS N/A ✓
Qt N/A N/A

Pricing comparison: Promenade Software vs Flex Health Solutions

Criterion Promenade Software Flex Health Solutions
Minimum engagement Not disclosed Not disclosed
Engagement models Fixed project, Time & materials Fixed project, Manufacturing contract
Rate transparency Not public Not public
Price tier Mid-market Mid-market

Target audience comparison: Promenade Software vs Flex Health Solutions

Dimension Promenade Software Flex Health Solutions
Best company size Startup to mid-market Startup to mid-market
Best industries Surgical & therapeutic devices, Digital health, Diagnostics & lab devices Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices
Best use cases Firmware and cloud software for an early-stage device, Building SBOM and vulnerability monitoring for a cleared device Transferring a verified design into volume production, Pre-clinical and design verification builds
Typical project type Fixed project Fixed project

Promenade Software vs Flex Health Solutions: pros and cons

Promenade Software
+ Software-only, ISO 13485 certified team that knows FDA expectations
+ Owns cybersecurity products, so security work comes with tooling
+ Small team keeps costs and overhead down for startups
+ Southern California location close to the Orange County medtech cluster
- Very small, so capacity for large programs is limited
- No hardware or mechanical design
- Certifications come from directory listings and should be confirmed with the company
Flex Health Solutions
+ Large global network of ISO 13485 and FDA-registered sites
+ New NPI center supports prototype builds, design verification and production transfer
+ Award-winning drug delivery work with Merck KGaA
+ Handles sterilization and packaging in-house
- Development work mainly exists to feed programs into Flex factories
- Better for funded programs with a clear path to volume
- Site counts are company-reported and differ across Flex pages

Who should choose Promenade Software?

A typical fit: firmware and cloud software for an early-stage device.

Pairs contract device software with its own medical cybersecurity tooling and information-sharing service. Minimum engagement is not publicly disclosed. Works best with clients in Surgical & therapeutic devices, Digital health, Diagnostics & lab devices.

Who should choose Flex Health Solutions?

A typical fit: transferring a verified design into volume production.

Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network. Minimum engagement is not publicly disclosed. Works best with clients in Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices.

Decision matrix: Promenade Software vs Flex Health Solutions

Your situation Recommended choice
You need full-ownership delivery on a defined project scope Promenade Software
You need a large dedicated team for an ongoing programme Check each company's engagement model
Your budget is at the lower end Compare: Promenade Software (Not disclosed) vs Flex Health Solutions (Not disclosed)
You need specialist depth in a specific vertical Promenade Software
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: Promenade Software vs Flex Health Solutions

Use case Promenade Software fit Flex Health Solutions fit Winner
Firmware and cloud software for an early-stage device Strong Limited Promenade Software
Building SBOM and vulnerability monitoring for a cleared device Strong Limited Promenade Software
Transferring a verified design into volume production Limited Strong Flex Health Solutions
Pre-clinical and design verification builds Limited Strong Flex Health Solutions

Verdict: Promenade Software vs Flex Health Solutions

Promenade Software (4.1/5) is the stronger overall choice for most Medical Device Development projects. Pairs contract device software with its own medical cybersecurity tooling and information-sharing service.

Flex Health Solutions (3.8/5) is worth a look if you need pre-clinical and design verification builds. If your situation matches that, Flex Health Solutions is a competitive option.

Related comparisons

Promenade Software vs Flex Health Solutions FAQ

Is Promenade Software better than Flex Health Solutions?

Promenade Software (4.1/5) scores higher overall, but "better" depends on your use case. Promenade Software's strongest advantage: Software-only, ISO 13485 certified team that knows FDA expectations. Flex Health Solutions's strongest advantage: large global network of ISO 13485 and FDA-registered sites.

How do Promenade Software and Flex Health Solutions differ in pricing?

Promenade Software uses time and materials, fixed project pricing. Flex Health Solutions uses manufacturing supply agreement, npi contract pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.

Which is better for enterprise: Promenade Software or Flex Health Solutions?

Promenade Software 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 Promenade Software and Flex Health Solutions?

Promenade Software's primary differentiator is: pairs contract device software with its own medical cybersecurity tooling and information-sharing service. Flex Health Solutions's primary differentiator is: dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network. They also differ in team size (11–50 vs Large (Flex Ltd.)), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Surgical & therapeutic devices, Digital health vs Drug delivery, Diagnostics & lab devices).

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