Best Medical Device Development Companies

Zühlke vs Flex Health Solutions: full comparison for 2026

Quick verdict

Zühlke (4.4/5) edges ahead of Flex Health Solutions (3.8/5) overall. Zühlke is the better choice for european medtech firms modernizing device software. 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.

Zühlke vs Flex Health Solutions: head-to-head summary

Criterion Zühlke Flex Health Solutions
Founded 1968 1969
HQ Schlieren, Switzerland Austin, TX, USA / Singapore
Team size 1,500–2,000 Large (Flex Ltd.)
Rating 4.4 / 5 3.8 / 5
Primary differentiator A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program 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++, Embedded Linux, Cloud (AWS/Azure) PCB assembly, Injection molding, Automated assembly
Industries served Digital health, Diagnostics & lab devices, Surgical & therapeutic devices, Financial services Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices

Zühlke vs Flex Health Solutions: overview

Zühlke

Partner-owned since its 1968 founding in Switzerland, Zühlke is headquartered in Schlieren near Zurich, with teams in Germany, Austria, the UK, Serbia and Asia. Its headcount is somewhere between 1,500 and 2,000 depending on the source. In healthcare it covers regulated device and systems engineering, connected-device software and the cloud and analytics platforms around devices, and it states more than 50 years of medtech experience (per company website; independently unverifiable).

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: Zühlke vs Flex Health Solutions

Capability Zühlke 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: Zühlke vs Flex Health Solutions

Framework / platform Zühlke Flex Health Solutions
Embedded C/C++ ✓ N/A
Embedded Linux ✓ 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

Pricing comparison: Zühlke vs Flex Health Solutions

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

Target audience comparison: Zühlke vs Flex Health Solutions

Dimension Zühlke Flex Health Solutions
Best company size Startup to mid-market Startup to mid-market
Best industries Digital health, Diagnostics & lab devices, Surgical & therapeutic devices Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices
Best use cases Rebuilding the embedded and cloud software of an established diagnostics platform, EU MDR remediation of legacy device software Transferring a verified design into volume production, Pre-clinical and design verification builds
Typical project type Consulting Fixed project

Zühlke vs Flex Health Solutions: pros and cons

Zühlke
+ Partner ownership keeps the firm independent of a large holding group
+ Large enough to staff hardware, embedded, cloud and data roles at the same time
+ Delivery centres in Serbia and Asia give some cost flexibility compared with all-Swiss teams
+ Experience with EU MDR environments in German-speaking markets
- Much of the firm works outside healthcare, so check that the proposed team is from the medtech practice
- Swiss and German rates are high for the onshore part of a team
- Industrial design and manufacturing are not core offerings
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 Zühlke?

A typical fit: rebuilding the embedded and cloud software of an established diagnostics platform.

A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program. Minimum engagement is not publicly disclosed. Works best with clients in Digital health, Diagnostics & lab devices, Surgical & therapeutic devices, Financial services.

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: Zühlke vs Flex Health Solutions

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

Use case Zühlke fit Flex Health Solutions fit Winner
Rebuilding the embedded and cloud software of an established diagnostics platform Strong Limited Zühlke
EU MDR remediation of legacy device software Strong Limited Zühlke
Transferring a verified design into volume production Limited Strong Flex Health Solutions
Pre-clinical and design verification builds Limited Strong Flex Health Solutions

Verdict: Zühlke vs Flex Health Solutions

Zühlke (4.4/5) is the stronger overall choice for most Medical Device Development projects. A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program.

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

Zühlke vs Flex Health Solutions FAQ

Is Zühlke better than Flex Health Solutions?

Zühlke (4.4/5) scores higher overall, but "better" depends on your use case. Zühlke's strongest advantage: partner ownership keeps the firm independent of a large holding group. Flex Health Solutions's strongest advantage: large global network of ISO 13485 and FDA-registered sites.

How do Zühlke and Flex Health Solutions differ in pricing?

Zühlke 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: Zühlke or Flex Health Solutions?

Zühlke 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 Zühlke and Flex Health Solutions?

Zühlke's primary differentiator is: a device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program. 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 (1,500–2,000 vs Large (Flex Ltd.)), minimum engagement (Not disclosed vs Not disclosed), and primary industries served (Digital health, Diagnostics & lab devices vs Drug delivery, Diagnostics & lab devices).

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