Compliance with 60601-1 is not just about electrical safety; it is also about addressing mechanical, structural and environmental factors, and following a process to address usability, risk management and software development.
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
Whether you are thinking about Annual Planning or Year End Closing, we are in a time of reflection and resolve to improve. Over the years I have learned to choose a limited number of improvement efforts, apply management resources, then measure with them regularly for progress and impact. The costs of not focusing sufficiently in a few key areas can ruin a great idea.
What is Fourslide forming, what are some advantages it offers to medical device component manufacturers, and why is it ideal for certain types of manufacturing? A discussion with experts from Acme Monaco .
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.