Our themes & topics
Through carefully selected themes & topics, the MedTechONE knowledge base brings together key knowledge & resources (often scattered and hard for beginners to find) into a structured and clearly navigable platform.
Technical development
How to design & build a medical device?
This theme encompasses the process of designing, engineering, and developing the medical device itself. It involves activities such as conceptualization, 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
How to evaluate the performance, safety, & efficacy of a medical device?
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.
Market access & integration
How to introduce a medical device into healthcare markets & integrate it into clinical practice?
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.
Business strategy & funding
How to commercialise a medical device?
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 complaince & legal aspects
How to navigate complex regulatory requirements & legal frameworks?
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.
