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Systems Engineering for Complex Portable Medical Device Development

As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount. Taking a systems-engineering (SE) approach to development provides a holistic, organized, and deliberate method for identifying as well as reducing both patient and business risks early in the process. Furthermore, it facilitates efficient progression throughout the entire product development life cycle.
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White Papers

Conveying Medical Guidance in Clinical Trials – A Survey

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With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project. When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
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