Best Medical Device Development Companies

Lemberg Solutions vs Flex Health Solutions: full comparison for 2026

Quick verdict

Lemberg Solutions (4.8/5) edges ahead of Flex Health Solutions (3.8/5) overall. Lemberg Solutions is the better choice for connected and smart medical devices, one engineering team. 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.

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

Criterion Lemberg Solutions Flex Health Solutions
Founded 2007 1969
HQ Lviv, Ukraine (offices in Hamburg, Germany; London, UK; Kraków, Poland) Austin, TX, USA / Singapore
Team size 200+ Large (Flex Ltd.)
Rating 4.8 / 5 3.8 / 5
Primary differentiator Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network
Pricing model Fixed project, time and materials, dedicated team Manufacturing supply agreement, NPI contract
Min. engagement Not published Not disclosed
Primary tech stack Embedded Linux, RTOS, FPGA PCB assembly, Injection molding, Automated assembly
Industries served Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices

Lemberg Solutions vs Flex Health Solutions: overview

Lemberg Solutions

Founded in 2007, Lemberg Solutions builds both hardware and software, and has offices in Lviv, Hamburg, London and Kraków. For medical device teams it covers electrical engineering, firmware, RTOS and embedded Linux development, FPGA programming, GUI work, connectivity and IoT, edge AI and cybersecurity, so one vendor can own the device electronics, its embedded code and the cloud or mobile side that talks to it. Healthcare is one of its core industries alongside automotive, energy and logistics, and named clients include Astronics, Caltech, Ferno, Cellink and Bosch Rexroth. The company holds ISO 27001 and ISO 9001 certification and runs its own hardware lab. It does not manufacture finished devices at volume and does not obtain regulatory clearance on a client's behalf; it supplies the engineering documentation the client's regulatory team needs.

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: Lemberg Solutions vs Flex Health Solutions

Capability Lemberg Solutions 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: Lemberg Solutions vs Flex Health Solutions

Framework / platform Lemberg Solutions Flex Health Solutions
Embedded C/C++ N/A N/A
Embedded Linux ✓ N/A
RTOS ✓ N/A
BLE ✓ N/A
Cloud (AWS/Azure) ✓ N/A
IEC 62304 N/A N/A
ISO 14971 N/A N/A
ISO 13485 QMS N/A ✓
Qt N/A N/A

Pricing comparison: Lemberg Solutions vs Flex Health Solutions

Criterion Lemberg Solutions Flex Health Solutions
Minimum engagement Not published 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: Lemberg Solutions vs Flex Health Solutions

Dimension Lemberg Solutions Flex Health Solutions
Best company size Startup to mid-market Startup to mid-market
Best industries Wearables & remote monitoring, Diagnostics & lab devices, Digital health Drug delivery, Diagnostics & lab devices, Surgical & therapeutic devices
Best use cases Building a connected wearable or home-monitoring device with a companion app and cloud backend, Adding edge AI or computer vision to an existing diagnostic instrument Transferring a verified design into volume production, Pre-clinical and design verification builds
Typical project type Consulting Fixed project

Lemberg Solutions vs Flex Health Solutions: pros and cons

Lemberg Solutions
+ A single team covers electronics, firmware, cloud, data and AI, which cuts the hand-offs that usually slow connected-device programs
+ Partnerships with NXP, Microchip and STMicroelectronics give early access to silicon support and reference designs
+ ISO 27001 and ISO 9001 certified, with security designed into the product rather than bolted on before release
+ In-house electronics lab shortens prototype loops and lowers R&D risk before a design freeze
+ All intellectual property transfers to the client, and the cooperation model can be consulting, team extension or full product development
+ Practical edge AI and computer vision experience for devices that need on-board inference
- No in-house mass production, so a separate contract manufacturer is needed once the design is ready to scale
- Does not obtain FDA or CE certification for clients; it provides technical documentation and engineering support for the client's own submission
- Not ISO 13485 certified per the information reviewed, so buyers should confirm how it works inside their own medical QMS
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 Lemberg Solutions?

A typical fit: building a connected wearable or home-monitoring device with a companion app and cloud backend.

Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together. Minimum engagement is not publicly disclosed. Works best with clients in Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics.

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: Lemberg Solutions vs Flex Health Solutions

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

Use case Lemberg Solutions fit Flex Health Solutions fit Winner
Building a connected wearable or home-monitoring device with a companion app and cloud backend Strong Limited Lemberg Solutions
Adding edge AI or computer vision to an existing diagnostic instrument Strong Limited Lemberg Solutions
Transferring a verified design into volume production Limited Strong Flex Health Solutions
Pre-clinical and design verification builds Limited Strong Flex Health Solutions

Verdict: Lemberg Solutions vs Flex Health Solutions

Lemberg Solutions (4.8/5) is the stronger overall choice for most Medical Device Development projects. Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together.

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

Lemberg Solutions vs Flex Health Solutions FAQ

Is Lemberg Solutions better than Flex Health Solutions?

Lemberg Solutions (4.8/5) scores higher overall, but "better" depends on your use case. Lemberg Solutions's strongest advantage: a single team covers electronics, firmware, cloud, data and AI, which cuts the hand-offs that usually slow connected-device programs. Flex Health Solutions's strongest advantage: large global network of ISO 13485 and FDA-registered sites.

How do Lemberg Solutions and Flex Health Solutions differ in pricing?

Lemberg Solutions uses fixed project, time and materials, dedicated team 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: Lemberg Solutions or Flex Health Solutions?

Lemberg Solutions 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 Lemberg Solutions and Flex Health Solutions?

Lemberg Solutions's primary differentiator is: owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together. 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 (200+ vs Large (Flex Ltd.)), minimum engagement (Not published vs Not disclosed), and primary industries served (Wearables & remote monitoring, Diagnostics & lab devices vs Drug delivery, Diagnostics & lab devices).

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