Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
For FDA, 2018 was a busy year; the agency began a number of new initiatives, released a plethora of new draft guidance, and took major steps toward greater collaboration among themselves, industry, and other agencies. In the coming year, expect these efforts to keep going and important new initiatives to take flight. In preparing for these regulatory actions, there are four main trends to watch out for.
Mobile medical applications are part of the future in medical devices. More apps are coming online now than ever before; an estimated 200 health-related mobile apps make it to market each day. Their growing presence in healthcare has significant impact, from reductions in healthcare costs, to advancing smarter diagnostics (through leveraging big data analytics and AI), to greater access to care—especially in remote locations.
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Usability is important for manufacturers to consider when coming up with life science products. Ultimately, users and patients interact with your product, and those interactions inherently carry levels of varying risk.
As the end of 2018 approaches, FDA is busy getting the last of this year’s regulatory activities wrapped up. Here are a few highlights of what they were up to in November.
In November 2018, FDA released its Medical Device Enforcement and Quality Report. In the report, the agency reveals how its initiatives on inspecting medical device manufacturers have grown in recent years. In the last decade alone, device inspections have increased by 46 percent.
Life science organizations sometimes struggle in managing complaints; the postmarket environment and the surveillance necessary to monitor your product effectively can be difficult to stay on top of. However, there are a number of tools and strategies your organization can apply to get out of complaint management difficulties.
In November 2018, CNBC released a report on how some patients have been hacking their insulin pumps to augment how they manage their diabetes:
Software validation is a common pain point for life science organizations. Ensuring the tools your teams use in your product development processes meet regulatory requirements and are performing in a safe and effective manner is a challenge many deal with. As life science industries move further away from paper-based product development to electronic systems, software validation only becomes more important. To address these issues, there are a few tips and tricks your organization can implement now that save time and effort down the road.
Our lives are rapidly evolving, thanks in part to the technological revolution of our current age. As our way of life changes, so too does the healthcare required to support it. This is forcing a massive disruption in the medical device industry. The user needs of the past are giving way to new ones, and planning for the changes now helps your organization prepare for the future of medical devices.