Summary of article from Edge Industry Review, by Gilad David Maayan:
Releasing a medical IoT device involves a detailed process to ensure its effectiveness, compliance, and market viability. The first step is conducting market research to assess demand, compare with competitors, and evaluate market size and acceptance, guiding stakeholders on investment decisions. Regulatory planning is crucial, requiring familiarity with laws like the EU MDR and FDA regulations to define the device’s use and ensure compliance.
Design controls must be documented throughout development, adhering to standards such as ISO 13485 to maintain product quality. Establishing a tailored Quality Management System (QMS) addresses design, risk, and supply chain management, ensuring compliance with relevant standards. Clinical evaluation demonstrates the device’s safety and efficacy through trials or literature review, summarizing risks and benefits.
Postmarket surveillance is essential for ongoing monitoring of the device’s performance, ensuring long-term safety and effectiveness, and complying with stringent regulations. Edge computing enhances medical IoT devices by enabling local data processing, which speeds up analysis and response times, reduces reliance on internet connectivity, and ensures functionality in remote areas. Key considerations include hardware capabilities, data security, interoperability, and processing speed, all vital for timely healthcare decisions.
The Internet of Medical Things (IoMT) is transforming healthcare by providing personalized, detailed treatment outside hospitals. Despite the complexity of development and regulatory approval, these devices offer significant potential for improved patient outcomes and profitability.