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Design, Development, & Testing

Design with Purpose. Develop with Speed. Test with Confidence.

Recognized as a trusted partner in device design, development, and testing, Kymanox® has supported the creation of 70+ devices in the past five years, helping MedTech move from concept to commercialization with confidence. By combining creative engineering, iterative testing at a phase-appropriate maturity level, and regulatory alignment, we deliver devices that are safe, effective, and manufacturable for clinical and commercial success.

When the path isn’t clear, we help chart it.

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Design and Innovation
Product and Device Development
Test Engineering
Human Factors Engineering
Sterilization Engineering
Quality Assurance

Design and Innovation

We turn great device concepts into market-ready solutions by blending mechanical, electrical, software, and packaging expertise with early manufacturability and usability considerations. From first sketches to Contract Manufacturing Organization (CMO) ready design packages, we create devices that meet regulatory requirements, perform reliably, and are built for efficient production.

Mechanical & Systems Engineering

  • Early concept sketches, creative engineering, and rapid prototyping using additive manufacturing, CNC machining, injection molding, and other techniques.
  • Design for Excellence (DfX) — including manufacturability (DFM), assembly (DFA), sterilization, testing, usability, and sustainability.
  • System integration to ensure seamless performance across all device components.

Primary Container & Packaging Design

  • Custom primary container and secondary packaging solutions that meet regulatory, quality, and sustainability requirements.
  • Early feasibility testing to confirm compatibility between container, closure, and device.

Electrical & Software Engineering

  • Development of custom electronics from prototype through production-ready devices.
  • Embedded software solutions that deliver full functionality while maintaining compliance with global safety standards.
  • Digital health integration to connect devices to companion apps and data systems.

Feasibility & Proof-of-Concept Development

  • Early-stage technical analyses (FEA, first principles, tolerance analyses) to guide design decisions.
  • Usability test stimuli design and production to capture meaningful feedback from real users before committing to capital investments.

WHY THIS MATTERS

Many device concepts fail late in development because manufacturability, usability, or cybersecurity weren’t addressed early. Our integrated approach brings these considerations into the earliest stages—reducing redesigns, accelerating timelines, and improving your chances of first-submission cycle approval.

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Product and Device Development

Bringing a product from concept to reality requires a seamless blend of engineering, science, and regulatory insight. Our integrated team ensures your device or product is developed efficiently, reliably, and with patient safety in mind. We focus on practical, manufacturable solutions while anticipating challenges early in the development cycle.

  • Choose
  • eXECUTE
  • SCALE
  • SUSTAIN

Needs Assessment & Device Selection

  • Comprehensive landscape and needs assessments to inform strategic decisions
  • Device feasibility and characterization testing
  • Vendor evaluation and platform performance analysis

Design Controls & Risk Management

  • Full support for FDA 21 CFR 820.30 and ISO 13485 design controls
  • Risk Management File (RMF) gap assessments and ISO 14971 remediation
  • Design verification planning and execution in our 2,000 sq. ft. design lab

Design Transfer & Manufacturing Integration

  • Phase-appropriate design transfer (clinical vs commercial scale)
  • Process development, qualification, and ongoing verification
  • Integration with downstream manufacturing and CMO/CDMO coordination

Commercialization & Lifecycle Management

  • Post-market surveillance, change control, and design change management
  • Support for design controls and risk management activities
  • Lifecycle strategies to maintain performance and regulatory compliance
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Test Engineering

Our test engineers have diverse experience in drug delivery systems, medical devices, aerospace, and related industries, providing them with a deep understanding of the unique testing challenges associated with each product type.

Design Lab - Makerspace

Stage-Appropriate Testing

  • Exploratory testing to inform early design and development decisions
  • Design Verification (DV) support: protocol development, execution, data analysis, and reporting
  • Empirical assessment supporting analytical model development to guide design and risk mitigation
  • Design of Experiments (DOE), statistical analysis, and data visualization
  • Sample size determination and optimization, accelerated aging studies

Test Method Development & Custom Fixtures

  • Custom test method development and validation
  • Design and implementation of specialized test fixtures and data acquisition
  • Environmental chambers, vacuum chambers and, other specialized equipment setups for realistic testing conditions

Lab & Vendor Management

  • Operator training and technical transfer to ensure reproducibility
  • GxP/CGxP-compliant testing, sample preparation, and method validation
  • Wide network of vendors supporting all aspects of medical device and drug delivery device testing such as biocompatibility and emission (EMI) testing

Data Analysis & Compliance

  • Quality Management System (QMS) compliant testing and documentation (ISO 13485, FDA 21 CFR 820)
  • Root cause analysis and support for regulatory submissions
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Human Factors Engineering

Our team brings deep insight into what regulators expect and how to design compliant, patient-focused human factors programs.

  • Human Factors Startegy & Regulatory Guidance

    Global strategy development, gap assessments, and submission readiness for FDA, BLA, and international submissions. We align your program with regulatory expectations while keeping patients at the center of your design.

  • Human Factors Studies

    Formative and validation studies, actual use studies, and threshold analyses. We ensure the right methodology, participants, and metrics to generate results that matter for both patients and regulators.

  • Instructional System Design

    Instructions For Use (IFUs), training materials, and instructional videos developed with patient usability in mind. We test materials with real users before launch to reduce use errors and improve outcomes.

  • Risk Management

    Use Failure Modes and Effects Analysis (FMEA), task analysis, and use-related risk assessment to identify critical errors before they impact patients. We integrate findings into your overall risk management strategy to support safe, effective products.

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Sterilization Engineering

Our sterilization engineering team has developed portable, flexible solutions that deliver real-time data monitoring without sacrificing reliability. From complex formulations to challenging packaging requirements, our technology adapts to your specific needs.

Sterilization Validation

Kymanox sterilization and validation experts assist clients with cleaning, disinfection, and sterilization validations, sterility assurance, Sterile Barrier System (SBS) and Container Closure Integrity (CCI) testing, residuals testing, and bioburden reduction.

Development and Optimization of Sterilization Processes

We design and optimize sterilization process for all FDA established Category A methods (e.g., dry heat, ethylene oxide, steam, irradiation) as well as several FDA established Category B methods as well as novel sterilization methods.

Sterilization Strategy

Kymanox can conduct sterilization processes analyses including virtual dose mapping and dose visualization for complex complex irradiation programs. Additional dose uniformity calculations for all radiation sterilization processes, gas diffusion and heat transfer analyses, optimized exposure determinations for bioburden methodologies, and most resistant site determination.

Complete Sterilization Lifecycle

Sterilization Engineering provides design inputs early in the device design cycle for a successful development program with no surprises.

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Quality Assurance

A robust Quality Assurance (QA) program is the backbone of manufacturing in the life sciences. Our QA professionals guide you from operational readiness and documentation to internal audits and Corrective and Prevention Action (CAPA) management, ensuring every process is inspection-ready and every product meets quality standards.

Support Includes

  • Design traceability and documentation readiness 
  • Collaboration on regulatory compliance 
  • QMS support 
  • Data integrity in testing and documentation 
  • Support for design and test documentation for regulatory submissions 
  • Risk management and compliance 
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