Monogram Orthopaedics Inc. announced the completion of the Development Phase and the start of the Verification Phase for the Company's next-generation autonomous surgical robotic system, a key milestone in Monogram's commercialization journey. The development cycle for medical devices involves several phases to ensure their effective and safe production, including Conceptualization, Feasibility Studies, Design and Development, Verification, Validation, Regulatory Approval and Clinical Evaluation, and Manufacturing and Commercialization. During the Verification phase, Monogram will rigorously test and validate its autonomous surgical robotics and related software to ensure the required design specifications, functionality, standards, and quality under different conditions and scenarios are met before surgeons use the product in the operating room on patients.

The team will perform extensive tests and evaluations to ensure the product performs as intended. Any identified issues will be addressed and rectified before moving forward. After completing the Verification phase, the Company expects to enter the Validation phase to validate that the technology meets end-users' and customers' needs and expectations.

The Validation phase will assess the product's overall usability and appropriateness in real-world scenarios, including surgeons running simulated surgeries on cadavers and evaluating iatrogenic injury and general product performance (for example accuracy and repeatability).