Best Medical Device Development Companies

Lemberg Solutions vs Product Creation Studio: full comparison for 2026

Quick verdict

Lemberg Solutions (4.8/5) edges ahead of Product Creation Studio (4.0/5) overall. Lemberg Solutions is the better choice for connected and smart medical devices, one engineering team. Product Creation Studio is the stronger option for pacific Northwest startups and lab instruments. The right choice depends on your project size, budget, and required tech stack.

Lemberg Solutions vs Product Creation Studio: head-to-head summary

Criterion Lemberg Solutions Product Creation Studio
Founded 2007 1999
HQ Lviv, Ukraine (offices in Hamburg, Germany; London, UK; Kraków, Poland) Seattle, WA, USA
Team size 200+ Not published
Rating 4.8 / 5 4.0 / 5
Primary differentiator Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together Small ISO 13485 studio that can follow its own quality system or the client's
Pricing model Fixed project, time and materials, dedicated team Time and materials, phased fixed project
Min. engagement Not published Not disclosed
Primary tech stack Embedded Linux, RTOS, FPGA SolidWorks, Embedded C/C++, PCB design
Industries served Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics Diagnostics & lab devices, Wearables & remote monitoring, Consumer products

Lemberg Solutions vs Product Creation Studio: 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.

Product Creation Studio

Product Creation Studio is a full-service product design and development firm in Seattle, Washington. It marked 20 years in 2019, which puts its founding around 1999. In 2017 it received ISO 13485:2016 certification after a BSI assessment, and it says it is the only ISO 13485-certified product development firm in the Pacific Northwest (per company website; independently unverifiable). It works on medical devices and lab and test instruments, and can work within a client's QMS. Headcount is not published.

Services and capabilities: Lemberg Solutions vs Product Creation Studio

Capability Lemberg Solutions Product Creation Studio
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 Product Creation Studio

Framework / platform Lemberg Solutions Product Creation Studio
Embedded C/C++ 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 Product Creation Studio

Criterion Lemberg Solutions Product Creation Studio
Minimum engagement Not published Not disclosed
Engagement models Consulting, Dedicated team, Fixed project, Time & materials Fixed project, Time & materials
Rate transparency Not public Not public
Price tier Mid-market Mid-market

Target audience comparison: Lemberg Solutions vs Product Creation Studio

Dimension Lemberg Solutions Product Creation Studio
Best company size Startup to mid-market Startup to mid-market
Best industries Wearables & remote monitoring, Diagnostics & lab devices, Digital health Diagnostics & lab devices, Wearables & remote monitoring, Consumer products
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 Building a benchtop lab instrument prototype, Early prototypes for a Seattle medtech startup
Typical project type Consulting Fixed project

Lemberg Solutions vs Product Creation Studio: 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
Product Creation Studio
+ ISO 13485 certification assessed by BSI
+ Flexible about using its own QMS or the client's
+ Covers mechanical, electrical and firmware work in one studio
+ Accessible for early-stage companies
- Small, with no published headcount
- No volume manufacturing
- Fewer public medical case studies than larger firms

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 Product Creation Studio?

A typical fit: building a benchtop lab instrument prototype.

Small ISO 13485 studio that can follow its own quality system or the client's. Minimum engagement is not publicly disclosed. Works best with clients in Diagnostics & lab devices, Wearables & remote monitoring, Consumer products.

Decision matrix: Lemberg Solutions vs Product Creation Studio

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 Product Creation Studio (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 Product Creation Studio

Use case Lemberg Solutions fit Product Creation Studio fit Winner
Building a connected wearable or home-monitoring device with a companion app and cloud backend Strong Strong Both equally
Adding edge AI or computer vision to an existing diagnostic instrument Strong Limited Lemberg Solutions
Building a benchtop lab instrument prototype Strong Strong Both equally
Early prototypes for a Seattle medtech startup Limited Strong Product Creation Studio

Verdict: Lemberg Solutions vs Product Creation Studio

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.

Product Creation Studio (4.0/5) is worth a look if you need early prototypes for a Seattle medtech startup. If your situation matches that, Product Creation Studio is a competitive option.

Related comparisons

Lemberg Solutions vs Product Creation Studio FAQ

Is Lemberg Solutions better than Product Creation Studio?

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. Product Creation Studio's strongest advantage: ISO 13485 certification assessed by BSI.

How do Lemberg Solutions and Product Creation Studio differ in pricing?

Lemberg Solutions uses fixed project, time and materials, dedicated team pricing. Product Creation Studio uses time and materials, phased fixed project 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 Product Creation Studio?

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 Product Creation Studio?

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. Product Creation Studio's primary differentiator is: small ISO 13485 studio that can follow its own quality system or the client's. They also differ in team size (200+ vs Not published), minimum engagement (Not published vs Not disclosed), and primary industries served (Wearables & remote monitoring, Diagnostics & lab devices vs Diagnostics & lab devices, Wearables & remote monitoring).

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