tag:blogger.com,1999:blog-8550428.post4092208405983467345..comments2024-03-27T01:34:23.434-04:00Comments on Pharma Marketing Blog: Device DTC: Imagine How Far It Will Go!Vladhttp://www.blogger.com/profile/04114063498108633047noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-8550428.post-61908939650953017152007-06-04T14:43:00.000-04:002007-06-04T14:43:00.000-04:00DTC is gaining momemtum, Device start ups are usin...DTC is gaining momemtum, Device start ups are using DTC for clinical trial recruitment and to marketing of medical devices after recieving marketing approval. Medtronic displays its ad in major newpapers and even on TV. As a regulatroy and clinical affairs expert, I feel that medical device companies can be aggressive with their marketing activities, nothing wrong with that, but also have to be more cautious with thier claims made on TV commercials and advertisments. I feel the FDA (agency) monitors marketing activities very carefully and I know companies have recieved citations and warning letters for mis branding medical products. Readers should keep in mind that FDA is there for helping medical device companies to make sure their product is safe and effective to use in patients with clinical need.<BR/>In the above case Stryker's intention was to demonstrate functional improvement after a knee replacement surgery. There has to be a balance between the clinical outcomes, clinical claims, branding, labelling and advertising.<BR/> <BR/>Raj Nihalani, MD, RAC(US)<BR/>www.trialmed.comAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-37199268323919440642007-04-06T12:03:00.000-04:002007-04-06T12:03:00.000-04:00Zimmer has had Gender Knee going for 5 months. I w...Zimmer has had Gender Knee going for 5 months. I would rather the govt. worry about supplements before squashing the rights of hardworking medical device companies. With no FDA oversight of DTC for Med Device its left to the states and FTC.Anonymousnoreply@blogger.com