DEVELOPMENT PHASES

Needs Identification: This phase begins with identifying a market need or an opportunity to improve an existing device. User demand, clinical problems to be addressed, and gaps in current technology are analyzed.

Product Conceptualization: Once the need is identified, a preliminary concept of the medical device is developed. This includes defining its main functions, features, and how it will address the identified problems.

Feasibility Study: Technical, economic, and regulatory feasibility studies are conducted. This includes preliminary cost analysis, possible materials, technologies to be used, and identifying potential regulatory barriers.

Detailed Design: In this phase, the initial concept is transformed into a detailed design. Technical drawings, 3D models, and precise specifications for each component of the device are developed. This design must meet the functional and safety requirements established during the R&D phase.

Prototype Development: Prototypes of the device are built to test its functionality and identify potential design issues. This can include physical prototypes and virtual models.

Design Verification and Validation: The design undergoes rigorous testing to verify that it meets the technical and functional specifications. Validation ensures that the device meets user expectations and regulatory requirements.

Laboratory Testing: Prototypes and initial versions of the device undergo exhaustive testing in a controlled environment to evaluate their performance, durability, and safety. This includes mechanical, electrical, and biocompatibility testing, among others.

Preclinical Trials: If necessary, preclinical trials are conducted on animal models to evaluate the device's safety and efficacy before proceeding to human trials.

Clinical Trials: For high-risk medical devices, clinical trials are conducted on humans under strictly controlled protocols. These trials are designed to evaluate the safety, efficacy, and performance of the device in real clinical use conditions.

Technical Documentation: During this phase, the necessary technical documentation is prepared for submission to regulatory authorities. This documentation includes test results, risk analysis, design and manufacturing descriptions, and any other information required by the authorities.

Certification Application: Applications are submitted to obtain the necessary certifications, such as FDA approval in the United States or CE marking in Europe. The process may include review by notified bodies, manufacturing plant audits, and evaluation of the quality management system.

Regulatory Approval: Once approval is obtained, manufacturing and commercialization of the device can proceed in the markets where it has been certified.

Preparation for Production: Manufacturing processes are established and optimized. This includes material selection, production line setup, and implementation of quality controls.

Manufacturing: Large-scale production of the medical device begins. Strict quality controls are followed to ensure that each manufactured unit meets approved specifications and standards.

Market Launch: The device is prepared for market launch. This includes marketing strategies, training for sales personnel, and the development of educational materials for users.

Post-Market Monitoring: After launch, the device's performance in the market is monitored. Data on its use, possible incidents are collected, and follow-up is conducted to improve or update the product if necessary.