Systems thinking is a disciplined way of thinking beyond the traditional boundaries of a product, and considers the complete flow of information or activities across a cooperating set of systems and human interventions to complete an intended job. For healthcare, this includes the span of activities for people, devices, information systems, and processes needed to meet various clinical and home healthcare scenarios.
Swift, frequent prototyping and testing, combined with tightly-integrated design and engineering, can help guide your project from opportunity identification, through market release.
There are many manufacturing pitfalls associated with physical architecture, vendor selection, and details like specifying the correct coating on a part – that come with the territory. Address these five themes to avoid problems and achieve your manufacturing goals.
The term “Big Data” is a few years old, but its implications for medical devices is at an inflection point.
This installment covers what’s missing and what pain does it cause. Without systems engineers, what is the impact to project teams and organizations?
When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.
It’s not just about architecture; what are the critical systems engineering roles and responsibilities?
Creating a simple-to-use product is vital to creating a great user experience in any industry, but in the medical industry, simplification can, quite simply, save lives.
The results of usability testing and expert reviews can be inconsistent across evaluators. How can we make these more reliable?
Should you design your perfect product or begin with your minimum viable product?