Solving Cybersecurity Issues in Medical Devices Is a Group Effort

Hackers are finding their way into many different digital networks and medical devices are on the radar. Connected devices including drug-infusion pumps, pacemakers and other medical devices have the potential for vulnerabilities, which could be dangerous or fatal for the patients using them. The U.S. Food and Drug Administration (FDA) wants medical device manufacturers to perform risk assessments and expose vulnerabilities and solutions, without concern for compliance or penalties. Patient safety is the bottom line.

The FDA is encouraging greater collaboration among manufacturers of medical devices and the public with the goal of improving the security of their devices. As discussed in “FDA says cooperation is essential on cybersecurity,” posted by Joe Carlson on, Seth Carmody, an FDA cybersecurity project manager, wants manufacturers to prepare against the hackers and other adversaries to protect the infrastructure for critical health devices. At the AdvaMed 2016 conference, Carmody suggested an exemption to the Digital Millennium Copyright Act may enable the public and competitors to test and identify potential security vulnerabilities in these devices. The FDA is also encouraging manufacturers to perform a full risk assessment of devices and release information about identified vulnerabilities and solutions.

There has been no known case of a hacker causing harm to a patient by manipulating the dosing process or draining a device battery. However, hospital networks have been subject to random attacks and, in theory, medical devices can be similarly hacked. This concern is enough to spur the FDA to call for a group effort, working together to strengthen cybersecurity measures.

Improve Products, Strengthen Patient Safety With ERP

Medical device manufacturers can turn to modern enterprise resource planning (ERP) to manage product development and manufacturing processes, including the quality assurance and control testing needed to evaluate devices and identify weaknesses. ERP also offers an efficient way to track raw materials and finished products, strengthening traceability and your ability to be prepared in event a recall is needed.

Armed with real-time data and powerful business intelligence features, medical manufacturers can focus on their devices with even greater precision, using these insights to make them stronger, more efficient and safer for the patients who use them. Contact AKA Enterprise Solutions for guidance with choosing and deploying the ERP solution that best aligns with unique business processes and supports efforts to improve products and protect patient safety.

By AKA Enterprise Solutions, a Microsoft Dynamics CRM and ERP Partner for Life Sciences

By | 2018-07-06T20:56:38+00:00 November 4th, 2016|Compliance, Data, Finance & Operations (ERP/AX/GP)|0 Comments
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Contributor: AKA Enterprise Solutions

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