For a longtime, the biggest issues in manufacturing a medical device were the safety of the patient, improvement in their condition and quality of life, and whether or not the device functioned properly.


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A number of physical factors affected this, including material and the latest technology, but overall the goal and the obstacles to surpass in reaching it remained the same. Now there’s a major issue that’s complicated medical matters more so.

Connectivity and the Internet’s role in medical devices and healthcare systems may help providers and patients be more proactive in addressing health concerns, whether they be minor or severe.

However, technology, connectivity, and the rapid pace at which these factors are changing the medical device and health care industry, may be compromising security and safety.

Now the FDA is stepping in to offer new guidance for medical device manufacturers as they designing and developing safer connected products and systems.

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Guidance To Improve Safety And Mitigate Risk
The FDA is taking action over concerns that medical devices, which exchange data and information on a patients health, are made to function safely, accurately, and securely.

With the recent release of new draft guidance, the FDA is hoping to address issues with healthcare industry cybersecurity, device interoperability, and additional risks that are present when technicians, system integrators, and other third parties must be involved in making devices and systems operable.

The agency is also seeking to help manufacturers avoid errors and inconsistencies that could result in inaccurate measurements, disfunction, mislabeling and misinformation that might result in patient harm or even death.

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Catching Up With The Technology We Create
With the pace of technology and the potential it has for saving and bettering lives, it appears that we still have some catching up to do when it comes to safe and reliable integration of advanced medical devices.

Will the new FDA guidance help make things easier for manufacturers and improve safety and security for patients and health care providers?

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