There is a pressure on medical device product development teams to come to terms with new types of users, environments, distribution and sales models as opposed to more traditional scenarios of device use and sale, says ide’s Richard Sokolov.
When developing highly complex medical devices, the mountain of “interesting” ideas that result from traditional brainstorming all too often buckles under technical scrutiny. A more efficient and effective way to generate and refine ideas that are technically viable is needed.
Data reporting can be a very tedious process for medical device manufacturers. The functionality of the device needs to be spot-on for it to be considered viable in the medical community. Because there is little to no room for error in this process, medical devices must help decrease error prone manufacturing activities, and in many cases also help companies meet the desired Six Sigma goal for process control.
Solutions from the field of micro system engineering help to make faster, more flexible and smarter medical devices. The ambitious goal of the developers is to sustainably enhance the quality of patients’ lives through more mobility, faster test results on location, checking vital signs and blood values or through innovative therapy systems for the chronically ill.
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.
In the face of new potentials and new demands in the health care space, as well as the digitization of daily life, the health care industry is feeling significant pressure to reinvent itself and keep up. The digital transformation of health care is imminent.
How can regulatory engineers help integrate regulatory requirements into the design and development process?
Quality should be considered at all stages of production, starting at the earliest stages of product design, says Dr. Vinny Sastri, President of Winovia LLC. Quality System Regulations Series Reports Sponsored by
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.
