The IPD team has over 50 years of combined experience bringing complex medical devices from concept to market. Our risk-based development process ensures that key technical and scientific challenges are addressed early and that the resulting device meets the clinical need and can secure regulatory clearance in worldwide markets. Our consultants dig deep into the science and clinical need, leveraging our development, QA, and management teams to bring devices to market. As part of our development process, we generate all aspects of your Design History File and Device Master Record for Class I, II, III, and IV devices.
IPD has extensive experience developing a wide range of medical and health related software from low-level embedded systems to mobile wellness applications. Particular areas of expertise include user-interface development, image processing software development, embedded systems for safety critical functions, and machine learning/AI software applications for medical devices.
Our software development processes are compliant with IEC 62304 and the FDA requirements for software development and validation and have been tested through dozens of successful FDA, Health Canada, and CE marking submissions.
Our electronics team understands the complex requirements for electro-medical devices. All of our projects begin by considering key regulatory requirements around EMC (60601-1-2), electrical safety (60601-1), battery safety, and performance standards. Key areas in which we excel include portable battery powered systems, wireless systems development (Bluetooth, Wifi, LoRa), battery and power management, signal acquisition and instrumentation, and complex motor and actuator control for microfluidics, patient movement, and critical care systems.
Our mechanical design experience ranges from tiny implantable and wearable devices to large installed capital equipment. We are experts in design for manufacturing, including injection molding, machining, casting, and additive manufacturing. We thrive on complex technical challenges managing competing requirements for function, size, sterility, and biocompatibility.
Industrial Design and Human Factors/Usability
We understand that industrial design is not only making a product look good, but ensuring it functions safely and effectively in its intended use environment. Our industrial design and human factors and usability process is based on ISO 62366 and the FDA guidance on usability and begins with an initial formative evaluation followed by conceptual design, down selection, and ultimate usability validation.