Product & Device Development to Commercialization

Our team of experts adapts to your current development phase and supports within the areas of product development regulated by international standards and health authorities.

We work on products from early clinical development through commercialization, launch, and post-market lifecycle management.

  • Needs and Landscape Assessment
  • Feasibility Testing
  • Device Selection
  • Device Development
  • Risk Management
  • Design Verification Testing
  • Design Transfer of Combination Products
  • Capabilities

    We can support your device or combination product anywhere in the product life cycle, from evaluating your current needs and selecting a device all the way through commercialization and lifecycle management. We have expertise with many different types of combination products as well as various medical and diagnostics equipment.
    01

    Needs and Landscape Assessment

    Our subject matter experts provide comprehensive landscape assessments across the medical device and combination product spaces. We analyze the current and emerging competitive landscape, regulatory environment, clinical practices, and reimbursement scenarios. Our customized assessments identify market opportunities, differentiation strategies, and value drivers to inform your strategic decisions from R&D through commercialization.
    02

    Device Selection and Feasibility

    Our team provides a de-risked approach to the selection of device, including characterization of the device performance and primary container compatibility, human factors assessments of user preferences and use errors, vendor evaluations, and assessments of device platform performance to help our clients select the right device to fit their needs.
    03

    Design Controls

    At Kymanox, our team of subject matter experts provides full design control support to medical device and combination product manufacturers. We guide clients through all design control elements mandated by FDA 21 CFR 820.30 and ISO 13485, including including the planning phase, design inputs, design outputs, design verification and validation, leading to design transfer, and design history files.
    04

    Risk Management

    Kymanox can support your device risk management activities to ensure the actions are properly planned, executed, and controls implemented with proper documentation to support your regulatory submissions. We can also conduct a Risk Management File (RMF) gap assessment to identify missing or incomplete information and support remediation of identified gaps in accordance with ISO 14971 standards.
    05

    Design Verification

    We have full service capabilities and work cross functionally to support strategy, Test Method (TM) development, and execution of design verification planning and testing at our 2,000 sq. ft. design lab. Kymanox has extensive experience with test method development for Break Loose Glide Force (BLGF), liquid leakage at luer connection and past plunger stopper, deliverable volume, burst resistance, Container Closure Integrity (CCI), and more.
    06

    Design Transfer

    We can develop and implement a strategy for design transfer of the combination product. This includes planning, process development, process qualification, and ongoing verification of the process. This provides robust processes that are capable of reliably producing the combination product and support the documentation required per 820.30 section H. Kymanox can also help with Contract (Development and) Manufacturing Organizations (C(D)MO) activities including C(D)MO selection, management, and coordination.
    07

    Commercialization and Lifecycle Management

    We manage post-market lifecycle management activities, including post-market approval surveillance and monitoring, change control management, design change management, and project remediation support including design controls and risk management activities.

    Voice of the Customer

    "They make it make sense"
    VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS
    "It’s obvious that they always want to put their best foot forward."
    ELLA STAMLER
    HEAD OF QUALITY ORGANIZATION AT NOVEN PHARMACEUTICALS, INC.

    Frequently Asked Questions (FAQs)

    How do you handle technology transfer when an onsite visit is not possible?
    Traditionally, tech transfer has required a site visit, but occasionally this is not possible. This makes the tech transfer process more challenging, as it increases the risks on both the technology and business sides, but Kymanox has procedures in place to handle these situations.  We request video walkthroughs of facilities and filming of critical processes and additional aspects such as important tips from operators at the sending site. Documentation review and a deeper understanding of the process at a very early stage become even more important.  Additional meetings with the subject matter experts (SMEs) are typically needed to cover additional questions and ensure a smooth tech transfer process. 
    What is a Detailed Product and Process Description (DPPD) and why do I need it?
    Although the DPPD is not a mandatory document that is required by the FDA, it is an essential document for a successful tech transfer process. Our subject matter experts (SMEs) will work with you to document all process and product history. Everything is summarized in a detailed report, and this document covers everything from product specifications, process details, in-process checks, and critical equipment, to material and critical equipment vendors, tests done on materials and processes, and raw materials specifications. Many companies prefer to keep their DPPD up to date, as it is also a proven tool that supports training of new employees. 
    At what phase of the development process should I engage Kymanox and why?
    Kymanox is ready and able to support you at any point during the development process, however, earlier is better! Changes to product design become exponentially more expensive and challenging as development progressesKymanox can provide expert review of your proposed development and regulatory strategy and make sure your project is set up for success. Whether your product is in early concept feasibility, preparing for a clinical trial, gearing up for commercialization, or anywhere between, Kymanox can provide scalable and phase-appropriate support solutions. 
    I recently selected a contract manufacturer for my product. Why involve Kymanox now?
    Kymanox is uniquely positioned to represent our client’s interests and ensure your contract manufacturer is held accountable to maintain project budget and timelines. Access to the entire Kymanox network of subject matter experts (SMEs) provides our customers and their Contract Development and Manufacturing Organizations (CDMOs) with technical, quality, and regulatory strategy guidance to ensure the successful approval and launch of your product. Technical development programs commonly encounter unforeseen technical and supply chain issues, and many of these problems can be outside the scope of your development agreement with the CDMO. Kymanox can quickly deploy the appropriate experts to investigate the problem and provide efficient solutions to keep your project on schedule.