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.

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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.