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.
Have you considered using design thinking for risk management?
Developing design inputs for your life science product requires understanding the needs of your stakeholders. You can build this understanding by leveraging design thinking tools such as stakeholder mapping. But who are the stakeholders you need to keep in mind in the design of your product?
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Can looking at your life science organization’s business model really spur advances? The answer’s a bit complicated, but it is possible to work with your business model in coming up with new products and services. However, you need the right tools for the job. The business model canvas, a strategic management template, is one of those tools, offering three key benefits for your life science organization’s early-stage innovation and development.
Once you go through the work to generate the design data of your medical device and establish the case for its safety and effectiveness, all that data needs to be compiled into submission deliverables for regulatory bodies. Making sure those deliverables are thorough and meet the reviewers’ requirements for submissions can be a long process. FDA has implemented some tools to help with this process over the years, but these have been limited. In September 2018, however, they announced the launch of a new program that would expand the reach of these tools and support from the agency: the Quality in 510(k) “Quik” Review Program Pilot.
August has been a busy month for FDA. Here are just a few FDA updates worth keeping an eye on as we move toward the end of summer.
It can sometimes seem, in life science product development, that everything needs to be validated. From the design of your product to the computer systems you utilize in your design controls and risk management activities, regulatory bodies ask for validation. And processes have no exception from validation requirements.
More often than not, when your development teams are working through risk management activities for your life science products, their primary focus is on the design. Yet multiple risk elements such as design errors, use errors, hazards, harms, and failure modes need to be identified and controlled to ensure safety and effectiveness. This work is absolutely critical in getting your product to market.
Our Cockpit platform is powerful guided compliance software, and at its heart is a deep focus on systems engineering. Many of Cockpit’s features, while aligned to regulations and standards for design controls and risk management, also allow our customers to develop and manage the complex designs of a product’s systems throughout its lifecycle. The systems engineering tools built into Cockpit have been repurposed for a manner of other projects beyond life science product development.
Developing a use specification for your medical device is important—not just for your human factors/usability engineering exercises, but for compliance as well. Because the use specification summarizes characteristics related to the context of device use, it helps narrow the scope of your product and can help you align its intended use to its device type within FDA regulations.