Approximately 400,000 hospitalized patients each year experience some type of preventable harm related to medical devices. The cause could be medical equipment flaws, design mishandling or user error malfunctions – all of which can be prevented with a robust usability engineering plan.
With more public attention than ever being paid to the fast-moving, competitive, lucrative and sometimes life-changing world of medical device development, it sounds obvious to say that no company wants to experience a product recall.
Despite a common misconception, Agile is compatible with all industries – even those with strict regulatory standards.
MediSync has leveraged Jama to achieve substantial time and cost savings through better collaboration and improved security.
After extensive industry research and interviews with customers in the medical device space, Jama saw an opportunity to provide a more straightforward, intuitive approach based on industry best practices and ISO standards.
Systems thinking is an approach to solving complex problems by breaking their complexity down into manageable units so the system can be evaluated holistically and by each constituent part. In our experience working with some of the market’s foremost medical innovators, we’ve seen that teams who embrace systems thinking are better-positioned to modernize and improve their product development processes.
To recap the busy year, we compiled a list of some of the most notable moments from companies that are pushing the boundaries of what’s possible.
Medical device companies must balance increasingly complex development processes; the need to release high-quality, regulatory-compliant, market-driven products; intense pressure to nail delivery timelines; and the imperative of patient safety.
With the growing amount of connected medical devices, the number of potential targets for hackers and other cyber criminals to exploit continues to rise.
Whether you’re an established medical device company or a new player, every stakeholder faces numerous challenges to keep up with the pace of the market while delivering compliant products that ensure patient safety.