On May 8, 2017, the US FDA’s Center for Radiological Health announced that it will be establishing a new digital health unit under the Office of the Center Director.  This is just the latest step the Agency is taking to try to keep pace with the quickly evolving and rapidly growing digital medical device industry.  Whether it is software as a medical device (SaMD), wireless mobile technology, cloud computing, or wearable gadgets, the growth of the digital universe and its impact on medical device technology seems boundless.

The medical device market is predicted to maintain a strong, positive growth through 2023, per Visiongain, a business intelligence provider.  Industry surveys conducted by Emergo indicate that, of 3000 industry players, 68% stated that regulatory challenges, such as new ISO, IVD, and Medical Device Regulation in the EU and the flux of the regulatory climate in the US continue to be the greatest challenges to positive growth.

New guidelines for combination devices, FDA’s decision to consider anecdotal evidence, and patient influence all drive FDA’s finessing of regulations to both promote innovation and ensure safety of devices on the market.   The most recent Warning Letters issued to medical device companies continue to demonstrate that, while technology is developing into digital platforms and 3D printing, the same quality system principles apply, and, failure to comply will be a costly mistake.  Read more about the changing medical device industry, new challenges and expectation, and how to get and stay ahead of the game in Lachman’s whitepaper, “Don’t Wait! Keeping Up with Medical Device Compliance”.

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