Inside Toyota's 'Cult': Car-Maker's Quality VP Tells Device-Makers How They Can Adopt 4-Pronged Quality Strategy
• By Shawn M. Schmitt
Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.
Discovering product problems tickles Kristen Tabar pink.
"We love to find problems. Love it. We celebrate finding problems. We recognize and reward people for … raising a problem up," she said.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
