The medical device sector continues to grow internationally, with many developing nations focusing on expanding the reach of their healthcare services to remote, under served areas.
Nowhere, however, is the use of medical devices more prolific than in the United States; with the US accounting for 38% of the worlds medical device usage. Despite the mass adoption of medical devices in the United States, bringing a product to market and ensuring its success remains a huge challenge for a number of manufacturers. Some of the factors influencing the commercialization of medical innovations include:
Product Development & Design
Medical device manufacturers find themselves subject to more stringent guidelines in terms of what products can be brought to market; designers and engineers do not only need to ensure that the product demonstrates the value and functionality of its intended use, but also need to take into consideration the design for manufacturability; balancing production costs with supply chain logistics and ease of production.
Manufacturers in this space strive to produce a reliable and safe medical device while balancing the demands of government regulations and containing production costs. Implementing quality controls and creating a proactive quality culture are essential to mitigating risks and avoiding complex issues at a later stage.
Navigating the Regulatory landscape
Navigating the regulatory landscape can often be the most arduous, and necessary, of the steps to get your device on the American market. Manufacturers often face lengthy submission and approval processes, submission associated fees, Medical devices brought to market in the US are subject to regulatory approval by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA dictates that the following steps must be taken prior to bringing a device to market.
- Step One: Classify Your Device
- Step Two: Choose the Correct Premarket Submission
- Step Three: Prepare the Appropriate Information for your Premarket Submission to the FDA
- Step Four: Send your Premarket Submission to the FDA and Interact with FDA Staff during Review
- Step Five: Complete the Establishment Registration and Device Listing
Explore strategies to overcome these challenges at the American Medical Device Summit 2015