Contact us to discover Intercax's solutions, schedule a time with our Syndeia experts, enroll in our Syndeia training program, or request a quote.
From Concepts to Reality
Biomedical system and equipment manufacturers face several unique challenges that distinguish the industry from others such as electronics, agriculture, or aerospace. Regulatory compliance and certification are among the most significant hurdles, as biomedical devices directly impact human health and safety. Stringent regulatory frameworks require extensive testing, clinical trials, and documentation to ensure safety, efficacy, and reliability. Unlike electronics or aerospace, where failures may lead to financial losses or operational downtime, malfunctions in biomedical systems can lead to severe patient harm or fatalities, making compliance a non-negotiable priority.
Healthcare is a complex system of systems, with the human body made up of multiple interacting subsystems influenced by environmental factors, lifestyle choices, and epidemiological conditions. When health issues arise, the medical care domain, often seen as the healthcare system, comes into play. Each of these subsystems is managed by specialists using specialized tools. Syndeia can play a vital role by connecting these diverse systems, enabling seamless data flow, enhancing traceability, and improving decision-making. By integrating medical device development, patient care, and facility operations, it ensures a more comprehensive understanding of health outcomes and optimizes healthcare delivery.
The biomedical industry, in contrast to the defense and aerospace industries, is composed of many relatively small companies which have relatively more responsibility for the entire engineering lifecycle. Companies here are often new adopters of model-based Systems Engineering and of the use of elsewhere-common digital engineering tools such as those for requirements management and for product life management. Intercax offers these companies its expertise in the promotion of MBSE and its advice on the selection of compelling digital engineering tools that support integration throughout the engineering lifecycle. Further, Syndeia can be used by these innovating engineering teams to prepare the many reports and technical data packages to help the company through the many audits and design reviews.
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Contact us to discover Intercax's solutions, schedule a time with our Syndeia experts, enroll in our Syndeia training program, or request a quote.
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Modern engineering uses computer models and systems engineering (SE) is following this pattern. The basis of Model-Based Systems Engineering (MBSE) is that the system can be captured in a single unified computer model, a single source of truth from which all required SE views and artifacts can be generated. Good MBSE practices can reduce errors and ambiguity, shorten development times, and improve collaboration between disciplines.
