{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fda80783d-0308-4a4c-9a60-e8fc912661ad","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies","description":"Regulatory compliance is critically important. However, some think product liability is just as important, if not more. \n\nToday\u2019s guest is Mike Drues of Vascular Sciences and we discuss how companies shouldn\u2019t fear the FDA and its regulations. Instead, they should have a healthy respect for the FDA. Who should they fear? Product liability attorneys because they can cause much more damage to a company than the FDA.\n\nSome of the highlights of the show include:\n \n\u25cf\tYou may not be limited to what the FDA requires. For product liability, passing FDA\u2019s regulations isn\u2019t enough or include everything that should\u2019ve been done. \n\u25cf\tWhen designing a product, consider product liability. Would you recommend the product to a friend or family member? Would you use it yourself? \n\u25cf\tProduct risks to consider include labeling. Does the device function normally and is it safe and effective when used according to its label? \n\u25cf\tManufacturers are liable when a customer doesn\u2019t follow instructions or intended uses for the device, if they knew/should have known it could be used off label. \n\u25cf\tDocumentation is important from a regulatory/quality perspective. But for product liability, it can be the kiss of death. Be careful about what you document. \n\u25cf\tCompanies should report adverse events with a device to the FDA in a timely manner. Or, they should face regulatory and product liability consequences.\n\u25cf\tDo you want to be proactive or reactive? Prevent issues, rather than have to correct them. Adopt a true quality culture.\n\u25cf\tEngage regulatory guidance into the product development process early on. It\u2019s easier, faster, and cheaper to make changes sooner than later.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/f74d810f-d459-47a9-9e8c-20f0e171fd5b/fae9ff17-451a-420f-a6c7-06b5bf44f5a4.jpg"}