The Impact of Regulatory Requirements on Bringing Medical Devices to Market
When we talk about bringing a new medical device to market, many steps are involved in the process. One of the very first and most important steps in this process is to put together a full-service team of experts. A strong team is built with people of unique skill sets; their varied expertise ranging from quality to regulatory, clinical, laboratory and manufacturing will help build a solid foundation on which your product is built. The regulatory experts work and learn about the regulatory environment in which medical device customers operate. They understand the regulatory complexities medical device manufacturers face and can help support the go-to-market process.
If you’re looking to market your medical device, there are many tasks to complete. Depending on your device, its indications or the presence of drug or biologic components, submissions to the U.S. FDA, EU Notified Bodies or Competent Authorities, and other regulatory bodies are not out of the question. Many medical devices are brought to market with global teams. New products may be designed in one country, manufactured in another country, while being supported operationally around the world.
As a product designer, know there is a difference between using a component as a layer between other components and using a component as a stick to skin solution. If you’re using a component as a layer between other components of your medical device, little more than a product composition report on the component part may be needed for your internal records or submissions. However, if you’re using a component to adhere a device to skin, more may be expected by the FDA or other regulatory agency reviewer. When adhering a device to skin special attention should be given to the final, finished device composition and biocompatibility, inclusive of all component(s).
The process of bringing a medical device to market can be a challenging journey, but also an exciting one. Expanding your team with external experts, particularly in the regulatory field, to help you through the obstacles can help alleviate the pressure.
For more information, download the whitepaper, Device Innovation and Regulatory Bodies
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