Q: What is the greatest design challenge when it comes to developing mobile medical device technology?
Mobile medical device technology is a great opportunity for many medtech companies today with the proliferation of small scale, cost effective components. But, creating a device that works isn’t the problem. The challenge lies in making the technology available to users by sorting through the many complex paths of global regulatory rules and regulations.
Many product developers assume that medical device regulation is the hard part. However, in many countries the radio technology licensing path is more highly regulated than the medical functions of the device. This and other often unaccounted for regulations create delays and unforeseen costs to get mobile medical devices to market.
The development of a regulatory strategy with the incorporation of regulatory resources into the product requirements discussion and design process will ensure fewer surprises and allow for more efficient testing and regulatory submissions. Early consideration of regulations and compliance reduces time to market and costs associated with redesign.