This theme encompasses the process of designing, engineering, and developing the medical device itself. It involves activities such as conceptualisation, prototyping, testing, refining, and manufacturing. Technical development focuses on ensuring that the device meets design specifications, performs effectively and safely, and is compatible with intended applications.

Product evaluation involves assessing the performance, safety, and efficacy of the medical device through rigorous testing and evaluation processes. This theme includes preclinical testing, clinical trials, usability studies, and other forms of evaluation to gather data on the device's performance, potential risks, and benefits. Product evaluation aims to provide evidence to support regulatory approval and market acceptance of the device.

This theme is more specifically concerned with how the device enters the market and becomes integrated into healthcare systems. It involves activities such as understanding reimbursement mechanisms, engaging with healthcare stakeholders (such as clinicians, administrators, and payers), developing distribution channels, implementing marketing strategies, providing training and support to users, and monitoring market dynamics.

This theme focuses on the overall strategic approach to developing and commercialising a medical device. It involves developing a business plan, defining market opportunities, identifying target customers, determining pricing strategies, securing funding (such as venture capital or grants), and establishing partnerships or collaborations.

Regulatory compliance and legal aspects refer to navigating the complex regulatory requirements and legal frameworks governing the development, manufacturing, and marketing of medical devices. This theme includes understanding and adhering to regulations set forth by regulatory authorities (such as the FDA in the United States or the EMA in Europe), obtaining necessary approvals or clearances, managing intellectual property rights, addressing liability issues, and ensuring compliance with relevant laws and standards.