Define the intended workflow, users, environment, core problem and success criteria.
- Use-case definition
- System assumptions
- Feasibility risks
Medical Devices & Embedded Systems
Build the idea first. Engineer the product next.
Medical-device development should start with the right destination. Codexter Labs offers two deliberately different pathways — one for proving an idea quickly, and one for engineering a product toward medical-grade development.
Two pathways under one engineering team.
SERVICES @ CODEXTER LABS
Choose your development path.
The biggest mistake in early medical device development is treating every prototype as if it were already a regulated product, or treating a serious product as if a quick prototype were enough. We separate the two pathways so the engineering effort matches the objective.
Prove that the idea works.
Designed for founders, researchers, innovators and organizations that need to demonstrate technical feasibility, test a clinical or operational workflow, attract investment, or establish what should be built next.
Typical target: a functional prototype or proof-of-concept — not a claim that the system is ready for clinical deployment or regulatory submission.
Our approach.
We compress the uncertainty before expanding the engineering. The objective is to answer the highest-risk technical questions early, build the minimum system needed to demonstrate the concept, and document what is required for the next stage.
01. DISCOVER
Problem & use case
02. ARCHITECT
Concept architecture
Translate the idea into a practical hardware, firmware, software, sensor and connectivity architecture.
- System block diagram
- Component strategy
- Technology selection
03. PROTOTYPE
Build the core
Develop the minimum hardware/software combination needed to prove the key technical assumptions.
- Embedded logic
- Sensor integration
- Application layer
04. VALIDATE
Test the concept
Run structured functional tests against agreed proof-of-concept criteria and capture limitations.
- Bench testing
- Workflow testing
- Issue log
05. HANDOFF
Define next step
Turn prototype learning into a clear productization roadmap.
- Technical findings
- Open risks
- Productization plan
What you receive.
Deliverables are shaped around proving the concept rather than prematurely creating a full regulated development package.
01
Product / system concept
Defined use case, functional requirements, system assumptions and development objectives.
02
Technical architecture
Hardware/software architecture, component selection and integration approach.
03
Functional prototype
Working proof-of-concept covering the agreed critical functions and workflow.
04
Prototype test results
Test scenarios, observations, known limitations and technical findings.
05
Prototype documentation
Relevant source code, configuration information, architecture documentation and build notes.
06
Productization roadmap
Recommended next-stage engineering, regulatory considerations, risks and development priorities.
Expected timeline.
Indicative timelines for a focused proof-of-concept. Complex sensing, custom electronics, mechanical development or specialized algorithms can extend the schedule.
Week 1-2
Discovery & architecture
Use case, requirements, feasibility analysis and technical architecture.
Week 3-6
Prototype build
Core hardware/software development and integration.
Week 7-8
Testing & refinement
Functional testing, issue resolution and demonstration preparation.
Week 9-10
Handoff & roadmap
Documentation, findings and medical-grade productization plan.
Engineer for the product lifecycle.
Designed for organizations that are moving beyond demonstration and need a structured engineering program for a product intended for medical-device development, verification, quality and regulatory progression.
Important: development toward medical-grade requirements does not by itself constitute regulatory clearance, approval, certification or authorization. The exact pathway depends on intended use, device characteristics, jurisdiction and the applicable regulatory strategy.
Our approach.
Medical-grade development starts with product definition and risk-aware architecture, then carries requirements, design decisions, implementation, verification and traceability through the development lifecycle.
01. DEFINE
Product & intended use
Establish the product purpose, users, operating environment, interfaces and development objectives.
- Intended-use inputs
- Product requirements
- Regulatory pathway inputs
02. ARCHITECT
System engineering
Design the complete product architecture across electronics, embedded software, application software, connectivity and data.
- System architecture
- Safety/security considerations
- Interface definitions
03. DEVELOP
Build the product
Implement hardware, firmware and software using a controlled development process with documented requirements and design decisions.
- Embedded/firmware
- Device software
- Connectivity & cloud
04. VERIFY
Verify & refine
Build a structured verification approach around requirements, interfaces, functions and system behavior.
- Verification planning
- Test protocols
- Defect management
05. PRODUCTIZE
Prepare for scale
Move from engineering prototype toward a maintainable, documented and production-oriented product baseline.
- Traceability
- Release baseline
- Regulatory readiness inputs
Development workstreams.
A medical-grade product is not simply a more polished prototype. The engineering program must connect product requirements, risk, hardware, software, verification, security and documentation.
Product / system concept
Defined use case, functional requirements, system assumptions and development objectives.
Technical architecture
Hardware/software architecture, component selection and integration approach.
Functional prototype
Working proof-of-concept covering the agreed critical functions and workflow.
Prototype test results
Test scenarios, observations, known limitations and technical findings.
Prototype documentation
Relevant source code, configuration information, architecture documentation and build notes.
Productization roadmap
Recommended next-stage engineering, regulatory considerations, risks and development priorities.
Core Deliverables.
The exact documentation set is tailored to the product, development stage and regulatory strategy. Typical engineering outputs include:
01
Product requirements
Structured product and system requirements connected to intended functions and operating conditions.
02
System architecture
Hardware, embedded, software, communication and data architecture with defined interfaces.
03
Engineering implementation
Electronics/embedded/software implementation, integration and controlled technical releases.
04
Risk & design inputs
Engineering inputs that support risk-aware design decisions and the broader quality/regulatory process.
05
Verification evidence
Test plans, protocols, results, defect records and supporting evidence appropriate to the development stage.
06
Productization baseline
Release documentation, traceability inputs, technical files/supporting artifacts and roadmap toward the next stage.
Which pathway?
The right path depends on what you need to prove & what you need to build.
| Consideration | MVP / Proof of Concept | Medical-Grade Product Development | ||
|---|---|---|---|---|
|
Primary Objective |
Prove technical feasibility and demonstrate the concept. |
Develop a structured product baseline suitable for progression through medical-device development. |
||
|
Best for |
Early-stage ideas, research concepts, investor demonstrations and technical validation. |
Products moving toward formal productization, verification, quality and regulatory activities. |
||
|
Engineering depth |
Focused on the highest-risk functions and minimum viable architecture. |
System-level engineering across requirements, architecture, implementation, verification and lifecycle. |
||
|
Documentation |
Practical prototype documentation and findings. |
Structured engineering documentation and traceability appropriate to the development stage. |
||
|
Typical duration |
Approximately 6–10 weeks for a focused scope. |
Approximately 4–6+ months for a focused product program; complex products can require substantially longer. |
||
|
Regulatory Posture |
Regulatory considerations inform the roadmap; prototype is not assumed to be submission-ready. |
Regulatory and quality considerations are incorporated into the engineering lifecycle from the beginning. |
||
Core Services
From prototype thinking to medical-device thinking.
Where applicable, our engineering programs can be aligned with the broader requirements and standards landscape relevant to the product and target market, including US FDA, EU MDR/CE and SFDA considerations, as well as ISO 13485, ISO 27001, IEC 62304 and IEC 60601-related engineering contexts.
US FDA
EU MDR / CE
SFDA
ISO 14971
ISO 13485
ISO 27001
IEC 62304
IEC 60601
SaMD
SiMD
Let's convert your imagination into a commercial reality.
Tell us what you are building, where the concept stands today and what you need to achieve next. We can help map the appropriate development pathway, technical scope and engineering milestones.