Trends in Medical Device Recalls

By Apoorva Joshi, Bing Zhen Zhu and Lauren Xu,
Northeastern University

A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads.

FDA Issues Warning About Unauthorized Diabetes Management Devices

By MedTech Intelligence Staff

The use of such devices could result in patient injury or even death.

MEDdesign

510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria

By Jay Mansour,
EAS Consulting Group, LLC

This new pathway is a considerable change for the medical device industry.

Featured Quote

Robots simply don’t have the empathy, creativity and adaptability of our healthcare system’s hard-working nurses. But the robot nurse can lend a hand and allow human nurses to focus on the important work of caring for patients.

— Arjun Arya, Applied Nursing Research

Soapbox

Corporate Culture as a Competitive Advantage

By Eric Soederberg, Sunrise Labs

Integrity is what matters most, and it just makes good business sense.

Soapbox

Product Myths Put Patient Safety at Risk

By Scott Hensley, ivWatch

There is hope for transparency in a post-Theranos world. To restore trust as promising medical technology is developed, both up-and-coming as well as established medical technology companies must have the ability to back up lofty claims with deep-rooted science.

Benefits of SPI Injection Mold Classifications When Getting Quotes

While each injection mold builder has a fundamental basis for building tools the way they do. Setting a general standard on the RFQ is helpful to comparing “apples-to-apples”. Best practice for getting pricing from many sources is following genral guidelines. The Plastics Industry Assocation developed mold classifications to help OEMs achieve uniformity for their injection mold quotes.

Click to read these mold classifications.

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• Medical Recall