Medical Software & Medical Device Development

Fellowship Learning Experience

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In this rotation focused on medical software and medical devices, the Fellow will dive into the intricacies of designing, developing, and implementing software applications and devices within the healthcare industry. They will explore the lifecycle of medical software and devices, including regulatory compliance, usability, and safety considerations. The rotation will include the following components:

1. Regulatory Compliance: The Fellow will gain an understanding of the regulatory frameworks and standards governing medical software and devices. They will explore regulations such as FDA guidelines for software as a medical device (SaMD), medical device classification, quality management systems, and compliance with applicable laws and regulations. The Fellow will learn the importance of adhering to these regulatory requirements throughout the software and device development process.

2. Usability and User Experience: This aspect will focus on the usability and user experience principles specific to medical software and devices. The Fellow will learn how to design intuitive user interfaces, considering factors such as workflow integration, information architecture, and user-centered design. They will gain insights into conducting usability testing, gathering user feedback, and iterating designs to optimize the usability and user experience of medical software and devices.

3. Software Development Lifecycle: The Fellow will delve into the software development lifecycle (SDLC) for medical software applications. They will learn about requirements gathering, software design, coding, testing, and maintenance. The Fellow will explore agile development methodologies, version control, and documentation practices relevant to medical software development. They will gain hands-on experience with programming languages, development tools, and software testing techniques specific to medical software applications.

4. Medical Device Development: In this aspect, the Fellow will explore the development process of medical devices. They will learn about design controls, risk management, and verification and validation activities specific to medical device development. The Fellow will understand the importance of usability engineering, human factors, and risk assessment in ensuring the safety and effectiveness of medical devices. They will gain insights into prototype development, manufacturing considerations, and post-market surveillance.

5. Cybersecurity and Data Privacy: The Fellow will examine the critical aspects of cybersecurity and data privacy in medical software and devices. They will learn about the potential vulnerabilities and threats associated with digital healthcare technologies, such as data breaches, unauthorized access, and patient privacy concerns. The Fellow will explore cybersecurity best practices, encryption techniques, and privacy regulations to ensure the security and protection of sensitive healthcare data.

6. This rotation aims to provide the Fellow with a comprehensive understanding of the complexities involved in developing, deploying, and maintaining medical software and devices. Through a combination of theoretical knowledge and practical application, the Fellow will develop the skills and expertise necessary to contribute to the advancement of safe, innovative, and effective digital health solutions in pharmacy practice.