While a systems engineering approach will not, in and of itself, resolve all challenges currently faced by the medical device industry, it is the cornerstone and framework for allowing organizations to begin addressing these challenges by adopting a more holistic, efficient and systematic approach to product realization.
This installment covers what’s missing and what pain does it cause. Without systems engineers, what is the impact to project teams and organizations?
Over the past few years, systems engineers and the role of systems engineering have all but disappeared from the medical device industry landscape. The impact on many organizations has been significant – slipped schedules, cost overruns, difficulty in component integration, limited focus on effective system risk management, numerous verification cycles due to late defect detection, and system designs that are evolutionary rather than planned.