Tele: 561.316.3330
Breaking Medical Device News

Monday, September 27, 2021
HomeOpedAjay Rane: How the IoT Can Keep U.S. Healthcare Manufacturers Competitive in the EU

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 is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Tyber Medical Reaches Agreement to Acquire CatapultMD

Once the acquisition is complete, Tyber Medical will own and operate a combined 100,000-square feet of manufacturing space between its Pennsylvania headquarters and Florida-based facilities.

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

Matthew Cranfill New ExtriCARE USA Director Of Clinical Services

"Matt's impressive experience and skillset easily made him our top pick," said Peter Mason, President of ExtriCARE USA.

FDA Authorizes Software that Can Help Identify Prostate Cancer

The software is called Paige Prostate and is compatible for use with slide images that have been digitized using a scanner.

Shannon Lantzy MedCrypt New VP of Consulting

"I met Shannon at a healthcare-related event several years ago and was immediately impressed with her passion and drive to move healthcare into a digital future," said Mike Kijewski, CEO of MedCrypt.

Mark Foster Joins Xenocor BOD

Foster is a versatile and visionary C-Suite executive who brings 20 years of general management and leadership experience from both venture-backed growth-stage organizations and world-class medical device companies

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

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