Lessons Learned from the Medical Device Industry: Part V Learning and Education

ast blog we talked about the sequence of the Operation and Troubleshooting section of your devices Label, and how to leverage existing information.

Finally, we come to our last category, Additional information.  Such as the details that are provided, so users have the ability to learn and educate themselves on the supporting information. Such as, clinical trial studies associated with the device and competitive devices, any educational self-care on health and wellness, list of adverse events and warranty, especially during travel.

While the extensiveness of using the regulatory device user labeling for wellness products may seem like an overkill, the benefits of a well-built product that users know how to function becomes both an investment into adoption and lays the foundation for wellness devices that can expand into medical devices.  Though regulatory hurdles are costly, the value of having the Government validate the product does have value as a gold stamp of approval, and opens up the potential for new clients.  After all, the difference between a wellness application and a regulated mobile medical device is a fine line; tracking clinical data for monitoring wellness and tracking clinical data to diagnose the progression of a disease in real-time, may use the same clinical data such as the A1c levels.  A study by Freedman's team showed rising disability levels among those nearing retirement age (ages 55 to 64) and flat trends for those ages 65 to 84, which means making decisions in real-time can help reduce diseases from advancing to more severe stages.  ClearRoadmap™ Pathways provides step-by-step through regulatory and reimbursement processes, so you can build your wellness app to expand into the larger market of clients that need your help.

  • -- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™