Ajay Rane: How the IoT Can Keep U.S. Healthcare Manufacturers Competitive in the EU

October 28, 2020

Ajay RaneAjay Rane, Vice President of Business Development, Sigfox

 

 

 

 

 

In 2017, the European Union revised its Medical Device Regulation (MDR) to require medical device manufacturers to show proof of their devices working as intended, and healthcare providers to show proof that they’re recording inventory of their devices. The objective of these amendments, effective May 2021, is to establish a higher standard of quality and safety for the medical devices being used within the region.

While an EU-issued mandate, the regulation doesn’t only apply to European stakeholders; any organization that operates or is interested in operating in the EU must also comply with the MDR. As the biggest suppliers of the EU medical device market, it’s particularly critical for American manufacturers to meet the requirements of this amendment if they want to continue business there.

Benefit to Medical Device Manufacturers: Continuous Device Performance Surveillance

Per the revised MDR, manufacturers must have a system established for executing ongoing surveillance of their products’ efficacy to prove to regulators that their devices work as intended over time. Such a system is necessary because manufacturers are required to report within 48 hours of becoming aware of any device malfunction that could pose potential public health issues.

IoT-enabled sensors attached to devices can recognize and alert operators to subtle changes in system behavior that may disrupt product function, which allows manufacturers to identify issues, notify healthcare providers and avoid serious harm caused by equipment failure. Being able to provide this level of proactivity through their devices can help manufacturers maintain ongoing compliance with EU regulations, in addition to ensuring their products are safe and effective for users.

Benefit to Healthcare Providers: Easier Inventorying Process

The updated MDR also requires all medical devices to have a unique device identification (UDI) code registered in the EUDAMED database so that each device is traceable to its point of origin. After a device has entered the market, data on its whereabouts and functionality need to be reported on an ongoing basis to provide clarity into how many devices are in use across the market. It’s important for healthcare providers to have a record of where devices are currently being used because, if a manufacturer notifies them that a product is malfunctioning, the providers can immediately locate where the device is and make the arrangements for replacing or fixing it.

If devices have IoT sensors attached to them and are connected to IoT-specific networks (e.g., a 0G network), inventory management within a healthcare organization’s system and uploading UDIs to the EUDAMED database can be carried out with greater ease, since geographic and conditions data from each device can be automatically transmitted.

IoT-specific networks like 0G can also be used in conjunction with local connectivity solutions like Wi-Fi to ensure insights on medical device whereabouts are consistently reliable as they travel with patients. Regardless of whether devices are being used in patients’ homes or in hospitals, these networks can work together to deliver the insights providers need to maintain central inventory tracking systems.

By equipping devices with IoT-enabled sensors, manufacturers can help healthcare providers and themselves keep track of their equipment in real-time, even when those devices are spread across multiple locations, and ensure every device is working as promised. By offering consumers products optimized with IoT capabilities, U.S. manufacturers will be able to operate in this critical market, in addition to making their offerings even more attractive to healthcare providers in any region.

 

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Experts Views and Opinions

Caroline Petersen writes, "Forging an emotional connection and bonding with potential customers is critical to converting prospects into lifelong clients, but doing so can be challenging in complex fields like medical devices, where products involve intricate scientific engineering and precise functionality. This is where the power of visual storytelling comes in." Learn more.
For this American Heart Month, Dr. Trotter is equipping Scribes with essential life-saving knowledge, providing CPR training and enabling them to make a meaningful impact during life or death situations. Read on.
Last year was one of the worst years ever for cyber attacks on healthcare organizations. According to John Riggi, national advisor for cybersecurity and risk for the American Hospital Association, the number of people affected by attacks broke records, with US federal data indicating that around 106 million people were impacted by a healthcare data breach, more than double when compared to 2022.
Moby Cutter™ is one of the safest surgical wire cutters on the market today! Their medical design team has over 35 years of experience performing surgical procedures in Hospitals, Emergency Rooms and Urgent Care Systems. It has been cleared for commercialization per FDA guidelines and sold as a prescription only (Rx) medical device. Dr. Stanley shares the advantages of the Moby Cutter.
Health systems continue to face ongoing pressures to reduce costs while maintaining quality patient care. With the average operating margin for hospitals at 0.84%, health systems are searching for ways to more effectively manage operating and capital budgets. However, gaps in data often hinder health systems by hiding cost burdens throughout the organization. These hidden costs limit health systems to finding one-time-savings without lasting relief from industry-wide pressures.

By using this website you agree to accept Medical Device News Magazine Privacy Policy