Product Creation Studio
Seattle product development firm with BSI-assessed ISO 13485 certification
Founded 1999 | Seattle, WA, USA | Not published employees
industrial-designmechanicalelectronicsfirmwarediagnostics
What is 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.
Product Creation Studio works primarily with clients in Diagnostics & lab devices, Wearables & remote monitoring, Consumer products sectors. Its primary differentiator is: Small ISO 13485 studio that can follow its own quality system or the client's.
Product Creation Studio tech stack and services
SolidWorksEmbedded C/C++PCB designISO 13485 QMSRapid prototyping
| Service area |
|---|
| Industrial Design & Human Factors |
| Mechanical Engineering |
| Electronics & PCB Design |
| Firmware & Embedded Software |
| Diagnostics & Lab Instruments |
Product Creation Studio pricing
Short answer: Product Creation Studio uses a time and materials, phased fixed project pricing approach. Minimum engagement is not publicly disclosed; a discovery call is required.
| Engagement model | Typical range | Best for |
|---|---|---|
| Fixed project | From not disclosed | Well-defined scope |
| Time & materials | Variable; depends on team size | Large programmes or team augmentation |
Product Creation Studio does not publish a public rate card. Contact them directly via their website to get project-specific pricing.
Product Creation Studio pros and cons
| Advantages | Things to consider |
|---|---|
| +ISO 13485 certification assessed by BSI | -Small, with no published headcount |
| +Flexible about using its own QMS or the client's | -No volume manufacturing |
| +Covers mechanical, electrical and firmware work in one studio | -Fewer public medical case studies than larger firms |
| +Accessible for early-stage companies |
Product Creation Studio vs alternatives
How Product Creation Studio compares to the other top Medical Device Development companies.
| Company | Best for | Key difference | Rating | Compare |
|---|---|---|---|---|
| Lemberg Solutions | Connected and smart medical devices, one engineering team. | Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together | 4.8 | Full comparison |
| StarFish Medical | Startups needing design plus pilot manufacturing. | Medtech-only practice that can build clinical and early commercial units in its own certified clean room | 4.6 | Full comparison |
| Sunrise Labs | Electromechanical devices, fluidics and infusion. | Three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled | 4.5 | Full comparison |
| Velentium | Implantables and FDA cybersecurity submissions. | Combines active-implantable engineering with a dedicated device cybersecurity team that prepares FDA premarket security documentation | 4.5 | Full comparison |
| Cambridge Consultants | Novel technology with high technical risk. | Physicists, chemists and engineers working in one building on problems no off-the-shelf design can solve | 4.4 | Full comparison |
| TTP | Pharma device programs, inhalers and injectors. | Employee ownership plus long-running drug delivery and surgical device work for large pharma and medtech clients | 4.4 | Full comparison |
| Zühlke | European medtech firms modernizing device software. | A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program | 4.4 | Full comparison |
| MedAcuity | Device makers with hardware but no software team. | US-based, ISO 13485 certified team that does nothing but regulated device software | 4.3 | Full comparison |
| Key Tech | IVD instruments with consumables. | Designs the diagnostic instrument and its cartridge together, with human factors in the same studio | 4.3 | Full comparison |
| Team Consulting | Inhalers, injectors and human-factors-heavy devices. | Three decades of medical-only industrial design and human factors, especially for drug delivery | 4.3 | Full comparison |
| Minnetronix Medical | Electronic devices from design into US production. | Develops and then manufactures electronic medical devices in the same Minnesota medtech cluster | 4.3 | Full comparison |
| Planet Innovation | Diagnostics companies in Asia-Pacific and the US. | Diagnostics roots plus product and commercialization experience in Australia and the US | 4.2 | Full comparison |
| Orthogonal | SaMD and device companion apps. | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices | 4.2 | Full comparison |
| S3 Connected Health | Pharma companies adding connectivity to drug delivery. | Combines embedded wireless engineering with patient-facing apps and data platforms for pharma programs | 4.2 | Full comparison |
| Veranex | Device design plus clinical trials and reimbursement. | One contract can cover engineering, clinical studies, regulatory strategy and reimbursement | 4.2 | Full comparison |
| Sagentia Innovation | Surgical robotics and combination products. | Medical development backed by a listed science group that also runs a regulatory consultancy | 4.1 | Full comparison |
| Bluefruit Software | UK device makers outsourcing firmware and testing. | Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture | 4.1 | Full comparison |
| Promenade Software | Small device makers needing software and security. | Pairs contract device software with its own medical cybersecurity tooling and information-sharing service | 4.1 | Full comparison |
| Integrated Computer Solutions (ICS) | Touchscreen user interfaces on medical devices. | Qt and embedded UI depth applied to regulated device software, including on QNX | 4.0 | Full comparison |
| Delve | User research and industrial design for medtech. | Design research and industrial design depth from two long-established US studios | 4.0 | Full comparison |
| Kaleidoscope Innovation | Enterprises already working with Infosys. | US medical design studio with access to Infosys engineering and digital capacity | 4.0 | Full comparison |
| Simbex | Sensor wearables and biomechanics research. | Biomechanics and sensor research background applied to wearable health devices | 3.9 | Full comparison |
| Softeq | Connected devices needing hardware plus apps. | Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place | 3.9 | Full comparison |
| ScienceSoft | SaMD and device software on a budget. | Large, ISO 13485 certified software team with healthcare analytics and testing services | 3.9 | Full comparison |
| Tata Elxsi | Large medtech firms offshoring sustaining engineering. | Offshore scale for verification, documentation and sustaining work on existing device portfolios | 3.9 | Full comparison |
| Phillips-Medisize | Drug delivery devices needing high-volume production. | Design, molding and assembly of drug delivery devices under one global quality system | 3.9 | Full comparison |
| Jabil Healthcare | Global production capacity for cleared devices. | Global scale, supply chain and FDA-registered production for established medical device brands | 3.8 | Full comparison |
| Flex Health Solutions | Design transfer into global contract manufacturing. | Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network | 3.8 | Full comparison |
| Plexus | Complex capital equipment needing build and sustaining. | Engineering, NPI and sustaining services for low-to-mid volume, high-complexity medical equipment | 3.8 | Full comparison |
Product Creation Studio FAQ
What is Product Creation Studio?
Seattle product development firm with BSI-assessed ISO 13485 certification
How much does Product Creation Studio charge?
Product Creation Studio uses time and materials, phased fixed project pricing. Minimum engagement is not publicly disclosed. A discovery call is required to get project-specific quotes.
What tech stack does Product Creation Studio use?
Product Creation Studio works with SolidWorks, Embedded C/C++, PCB design, ISO 13485 QMS, Rapid prototyping. Primary industries served include Diagnostics & lab devices, Wearables & remote monitoring, Consumer products.
Is Product Creation Studio right for enterprise?
Pacific Northwest startups and lab instruments. Not published team size. Key consideration: Small, with no published headcount.
What are the best Product Creation Studio alternatives?
The best alternatives to Product Creation Studio depend on your use case. Top options are:
- Lemberg Solutions: owns pcb design, firmware, embedded linux, iot backend and edge ai under one roof, so device and cloud are designed together
- StarFish Medical: medtech-only practice that can build clinical and early commercial units in its own certified clean room
- Sunrise Labs: three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled
Compare Product Creation Studio with other Medical Device Development companies
Product Creation Studio vs Lemberg Solutions Product Creation Studio vs StarFish Medical Product Creation Studio vs Sunrise Labs Product Creation Studio vs Velentium Product Creation Studio vs Cambridge Consultants Product Creation Studio vs TTP Product Creation Studio vs Zühlke Product Creation Studio vs MedAcuity Product Creation Studio vs Key Tech Product Creation Studio vs Team Consulting Product Creation Studio vs Minnetronix Medical Product Creation Studio vs Planet Innovation Product Creation Studio vs Orthogonal Product Creation Studio vs S3 Connected Health Product Creation Studio vs Veranex Product Creation Studio vs Sagentia Innovation Product Creation Studio vs Bluefruit Software Product Creation Studio vs Promenade Software Product Creation Studio vs Integrated Computer Solutions (ICS) Product Creation Studio vs Delve Product Creation Studio vs Kaleidoscope Innovation Product Creation Studio vs Simbex Product Creation Studio vs Softeq Product Creation Studio vs ScienceSoft Product Creation Studio vs Tata Elxsi Product Creation Studio vs Phillips-Medisize Product Creation Studio vs Jabil Healthcare Product Creation Studio vs Flex Health Solutions Product Creation Studio vs Plexus
Verify all details directly with Product Creation Studio before making a decision.