Understanding the Relationship Between Medical Device Training and Digital Health

Medical device training is becoming more advanced than ever, thanks to the Food and Drug Administration’s (FDA’s) increased focus on digital health.

The FDA’s Digital Health Innovation Action Plan provides an in-depth look into what the FDA is prioritizing when it comes to digital health, what they have accomplished, and what their current action plan looks like.

Digital health is one of the most innovative and far-reaching sectors of the medical industry because of the technological advancements it can offer to both stakeholders and individuals who rely on medical devices.

As of today, medical device manufacturers and other key stakeholders are prioritizing digital health in order to create tangible improvements, including:

• More efficient products
• Better access
• Lower costs
• Personalizing care

How Is the FDA Approaching Digital Health and Medical Device Training?

Digital health is an expansive area that interconnects various medical services, devices, and other endpoints. However, this interconnectivity comes with a price when dealing with sensitive data, patient privacy, and other high-risk areas.

The push for digital health has made it easier than ever for patients to connect with healthcare providers, researchers, device manufacturers, and other relevant third parties.

In response to this, the FDA has been focusing heavily on providing clarity for the following topics:

• Cybersecurity. The more advanced medical devices become, the more the need for cybersecurity becomes apparent. The FDA is looking into the relationship between advanced digital health platforms, medical devices, and user safety when it comes to mitigating cybersecurity risks.
• General Wellness. Defining general wellness products in the wake of the rise of the wellness industry.
• Software as a Medical Device (SaMD). The rise of “as a service” platforms in tech has extended to the medical industry as well, with many companies creating subscription-based platforms for health software applications they offer.
• Medical Device Interoperability. Data security is essential today. Companies must ensure that all data exchanged is done in a safe, secure, and effective manner.
• Telemedicine. Expanding access to healthcare in remote areas is an important initiative that many companies are focusing on as part of their mHealth initiatives.
• Health IT. The National Coordinator for Health IT defines Health IT as “hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information.” This complex category of IT is heavily regulated and is something that companies must prioritize if they want to avoid costly fines and penalties.
• Wireless Medical Devices. With more advanced networks and compatibility than ever, most medical devices use wireless technologies to function. However, this connectivity requires these devices to be compliant with Federal Communications Commission (FCC) regulations and other RF spectrum regulations.

Keep Your Medical Device Training Current

With technology changing rapidly, your organization and its key employees need to stay up to date on the latest medical device requirements. The most efficient way to do that is to learn about current regulations, best practices, and other relevant information through medical device training with the Center for Professional Innovation and Education.

We offer a wide variety of medical device training courses that can help you improve your employee’s knowledge of medical device regulations. 

Here are a few upcoming medical device training courses we recommend:

• Effective Document Management for Pharma, Biotech & Medical Device
• Design Control for Medical Device Professionals
• Design Validation, Verification, and Risk Analysis for Medical Device Professionals
• Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
• Medical Device Process Validation Training for Professionals

Please contact the CfPIE team today at 1-610-648-7550 or [email protected] if you have any questions at all about the courses we offer.