QualiMed is a Design, Development and Manufacturing firm specializing in medical device implants with a primary focus on implantable mechanical devices, catheter based technologies, drug device combination products, and biodegradable and bioabsorable technologies. The company has vast expertise in taking products from any point in the development process from Ideation through manufacturing.
QualiMed has created a 12 Step process to take products from various stages of Ideation through to manufacturing. The approach lets the QualiMed team assess new ideas, market conditions, competitive landscapes, and current technology including IP in an effort to determine the viability of various technologies and partners it would like to engage to bring products to the manufacturing or continuous improvement phase of the products life cycle.
The process based pathway methodology allows QualiMed and its partners to evaluate opportunities from the ideation of a potential product through to commercialization with a focus on consistent risk mitigation throughout the development lifecycle regardless of the stage of development or commercialization. This unique methods based approach to evaluate and manage a potential opportunity at any point in the products lifecycle of development uniquely positions the QualiMed to assist its customer partners to achieve their desired success.
The companies methodology is designed to achieve success through the early recognition of critical to quality parameters in the products development lifecycle that can cause increased risk to the pathway leading to the commercialization of the technology and continuous product improvements there after.
QualiMeds Research and Development Department has assisted customers with taking their ideas from thoughts to clinical implants through what we call conceptual development. Through a method based fact gathering approach that captures critical market based, literature based, and clinician based data the company focuses on early stage concept risk mitigation through the adequate identification of the user needs requirements. By leveraging our multi disciplinarian approach, our in-house scientist, external data analysis and assessment, and direct clinical expertise we are able to reduce risk through out the entire development lifecycle through to market launch and continuous quality and process improvements.
During the ideation phase QualiMed utilizes rapid prototyping (RP) to enhance and validate the user and device interface at any point during the development or manufacturing lifecycle of the product commencing at the conceptual phase through to continuous improvements during manufacturing.
During the initial design phase or throughout the product lifecycle QualiMed utilizes an extensive literature review process to consistently and accurately assess existing product outcomes and modalities to insure proper user needs identification based on key critical to quality parameters outlined based on complication rates and success rates established in the historical literature..
During the feasibility phase the company along with its partners assess the real market opportunity for the technologies success based on a number of critical elements the company has established to insure that QualiMed and its partners achieve their respective levels of success.
Phase 4 - Design Input Specification
QualiMed uses the Design Input Specification phase of its development methodology as a risk mitigation tool to assess the required design inputs to achieve the appropriate design outputs based on key user needs specifications that are then validated by the literature review, feasibility assessment, and expert user input to insure the greatest opportunity for meeting the requirements of the initial Idea.
Phase 5 - Regulatory Assessment
During the regulatory assessment QualiMed utilizes its extensive staff of regulatory personnel to evaluate the global regulatory needs to launch the devices commercially and to minimize the regulatory risk through the early adoption of this process
Bench testing is an essential element to insure that the user need specifications are met in the design input and output specifications. The bench testing accurately assesses weather the design meets the user needs requirements
QualiMed uses the animal trial phase of the development process to further validate the user needs specifications are met through the design inputs and validated in the design outputs. QualiMed has the capabilities to manage the animal trial process from the protocol writing to testing of the technology through various partner facilities throughout the world.