Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Innovation requires the space for failure and continuous improvement.
FDA, CDC and other agencies are trying to foster the development of diagnostics, therapeutics and vaccines that help address the outbreak.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
The goal is to establish a baseline of cybersecurity hygiene and assurance for devices that are part of the national critical infrastructure software supply chain.
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
Aging is not for the faint of heart.
The company is dedicating more funds to research, development and innovative projects.
Successful integration requires a rethinking around the role of data science in product design and lifecycle management.