Top 5 Medical Device Industry Trends in 2018, Free MasterControl Inc. White Paper #hcsmeufr #esante
Free White Paper to Top 5 Medical Device Industry Trends in 2018 Digital device technology continues to move at a fast pace, which means device manufacturers should keep a close watch on emerging trends and be ready to adapt to new ideas and methodologies.
• Trend #1: Software in Medical Devices Will Become More Common — and Complex
"The benefits of innovative technology to both providers and patients are exponential. However, given the complexity of technology in devices, manufacturers will need to revamp some of their approaches to design and development. This includes devoting even more time and effort at the onset of device planning — particularly design control, risk management and cybersecurity." ...
• Trend #2: Atypical Medical Device Technology Will Become More Typical
- Communication needs to be inclusive and on record
- Having a device doesn’t always mean it gets used right away.. "health care providers need to adopt their clinical processes to work with medical devices. Developers of medical devices and products should consider pacing themselves with new device technologies as some devices may require providers to customize their workflows around using them. Some providers may be hesitant to do this until there is a wider need for a device.
• Trend #3: Medical Device Industry Will Experience More Challenges with “Proving” Compliance
Device manufacturers will face challenges in demonstrating compliance as the medical device industry continues to experience ongoing changes and updates to regulations, guidelines and reciprocating conditions...
According to the FDA, a mobile app that serves as an accessory to support, supplement or augment an existing medical device, or to transform a mobile platform for some form of medical use is now considered an FDA- regulated mobile medical app. The FDA will use the same risk-based approach to ensure the safety and effectiveness of mobile apps that it uses for other medical devices. ...
The International Medical Device Regulators Forum (IMDRF) is currently implementing a medical device single audit program (MDSAP).
• Trend #4: Regulatory Authorities Will Continue to Emphasize Human Factors Engineering
Human factors engineering (HFE) is a regulatory requirement intended to reduce medical device use errors and develop more user-friendly and intuitive devices. Human factors is part of robust design controls for medical devices. The push toward reducing or eliminating user errors includes ANSI/AAMI/IEC 62366, which focuses on the safety aspects of usability engineering....
Certain human factors issues can only be validated in the actual use environment because simulated use testing might not be sufficient....
• Trend #5: De Novo Pathway Will Become Easier and Faster
The number of successful de novo classifications is on the rise. This is due in part to the FDA streamlining the application process by no longer requiring a 510(k) and a not substantially equivalent (NSE) determination.
The “De Novo Classification Process (Evaluation of Automatic Class III Designation” guidance states “If a person believes their device is appropriate for classification into Class I or Class II and determines, based on currently available information, there is no legally marketed predicate device, they may submit a De Novo request without a preceding 510(k) and NSE.”
The de novo pathway is risk-based, so a strong risk mitigation strategy is key.
Medical devices become more complex, so the registration will be more difficult: It impacts design, processes development communication and information.
It should as our lifes depend on it. Time of "just" coding "a" new healthapp is over:"a mobile app that serves as an accessory to support, supplement or augment an existing medical device, or to transform a mobile platform for some form of medical use is now considered an FDA- regulated mobile medical app. The FDA will use the same risk-based approach to ensure the safety and effectiveness of mobile apps that it uses for other medical devices. "..