A medical device is a range of products that are used in the treatment, diagnosis or prevention of a disease or a physical condition. New and exciting medical device ideas are always being developed making Medical Device Consulting a growing and exciting career. In Canada, in order to sell a medical device manufacturers and companies must obtain two types of licenses which are issued by Health Canada; the device license known as the Medical Device License (MDL) and for some devices, an establishment license known as the Medical Device Establishment License (MDEL) is required.
A new and upcoming medical device that we have become aware of is known as the Chrono Therapeutics’ Wearable Device, a device used to help people quit smoking. Smokers could wear this device and it would provide “timed transdermal nicotine delivery and logs users’ cravings” (Hartford). This device was created using medical technology from Chrono Therapeutics and is trying to modernize the traditional approaches taken to break the smoking habit, such as the skin patch.
How does it Work?
This medical device is a wearable technology that will administer nicotine. A behavioral support system is also involved through a mobile app that is believed to excite consumers and investors interest in the product. The user will prepare the device in the evening before they fall asleep. A cartridge is inserted into the medical device which contains enough nicotine to last throughout the entire following day. The user must then enter in the time he/she will wake up.
The device is then affixed to the body before falling asleep and will begin to administer nicotine approximately 90 minutes before waking up to help avoid the first cigarette craving of the day, which is usually the hardest one to resist. Manufacturers believe that “if we can cut off that first craving, they can start the day fresh” (Hartford). Once users begin their day they can press a “crave button” and the device will then administer the drug to help defeat the craving. The app which will sync to the device will also deliver motivational coaching and will track craving patterns which can then help users change behaviors depending on what contributes to their smoking urges.
When will it be available?
The Chrono device will begin large clinical trials in 2016 and 2017. From then, this medical device must be approved and cleared by regulators. As reported by Chrono Therapeutics, if all goes according to plan this device will be marketed over the counter, along with the nicotine patches and gum currently being sold.
Product manufacturers entering the Canadian and American market must pay close attention to the different regulations in regards to Medical Device in order to successful in this growing industry along with maintaining strong customer loyalty. Focal Point Research Inc has been involved with working as Medical Device Consultants for over 20 years; therefore we offer an immense knowledge and unique advantage in licensing and regulating these medical gadgets.