Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
In this new survey, medtech manufacturers are invited to share their perspective on business initiatives, manufacturing execution systems and latest challenges.
Medical devices and medical software are becoming increasingly connected to hospital networks, other medical devices or the Internet. As a result, manufacturers and developers are required to consider cybersecurity from the very early stages of development. This in turn necessitates comprehensive risk management along the entire lifecycle of a device.
To change the landscape of cyber threats in healthcare, companies must prioritize designing security into devices.
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
Adding wireless connectivity to medical devices brings convenience to patients, and can facilitate more effective healthcare delivery and lower healthcare costs. Its success depends on the ability of manufacturers to produce reliable, connected products that do not fail prematurely in the field.
Recent transportation challenges have affected the medtech industry’s ability to deliver healthcare products.
Digital twins have the capability to enable safer medical devices and improve overall patient outcomes.
In this segment of Ask the Experts, James Thompson of Siemens responds to questions about how digital infrastructure is leading the way in medical device advancements and innovation.
Medical device manufacturers can accelerate their digital transformation priorities through lean practices to better manage supply chain risk, complexity and disruptions.
