Better medtech UDI management could be an app away

Boston-based 121nexus said it can solve UDI supply chain master data problems through image recognition technology. Experts say the best apps on the market are “peace of mind” apps. 121nexus aims to deliver that feeling with its scanner. The company launched a free scan app that can verify and “open up” GS1 and unique device

Medtech stories we missed this week: Oct. 6, 2017

From Intellijoint’s CE Mark to Patrona Medical and Kopis’ new partnership, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intellijoint CE Mark for flagship hip navigation Intellijoint surgical announced in an Oct. 4 press release that it has received CE Mark for its Intellijoint HIP System in

How medical device risk management is connected with design controls

Medical device design controls play an important role when it comes to risk management, but the relationship isn’t always immediately clear. Intended use is especially important, says Jon Speer, founder of Greenlight.guru (Indianapolis), which markets a cloud-based quality management software. “If you don’t have a clear order or boundaries for conducting your risk management activities,

Webinar: Reducing risk through material science

    Medical device material failures are common and costly. Fortunately, the risk of these failures can be greatly reduced through better understanding of materials science earlier in the product development cycle, preventing both delays and post market issues. During this webinar, strategies will be discussed of how to avoid material failures through better understanding

Medical device requirements management: Here’s what it is

Rebecca Haag and Gary Seim, Minnetronix The total number of requirements for a project is generally correlated with the complexity of the system under development (i.e. how many functions and qualities it needs to have). For even moderately complex projects, this can become overwhelming. It can be difficult to keep track of where specific requirements

Star Wars medtech lesson: Rogue documents led to Empire’s downfall

Warning: This story is filled with terrible Star Wars references. Management would like to apologize in advance. In our defense, David Butcher at MasterControl started it —the story comes from his original post.  When Rogue One: A Star Wars Story arrives in theaters this week, we will learn how the Rebel Alliance brought down the Death Star

Changing your medical device: 6 things you need to know

Medical device regulatory consultant Michael Drues has never liked the phrase “change management.” The words seem boring to him. “Not only does it not have to be boring, it is incredibly important—and can be exciting and dare I say fun,” says Drues, who is president of Vascular Sciences (Grafton, MA). Whether it involves a medical

Four lessons learned: Managing 21CFR Part 11 Compliance for medical devices

By Marlee Rosen, Research Analyst, Rosen Associates A new wave of medical device manufacturers are looking at ways to leverage the mobile health space. The idea is to combine medical devices with the computing power of smartphones to increase the functionality of these devices and extend their value. Of course, those innovations come with design

Robot in the cath lab takes surgeons out of radiation’s way

A recently devised robotic system aimed at cath-lab interventions reduces the radiation exposure of surgeons by 95% while still allowing precise sub-millimeter measurement and 1 mm advancement accuracy. Physicians who have used the equipment say that by optimizing stent selection and positioning, the CorPath Vascular Robotic System lets them position the right stent in the

A better way to diagnose PTSD and TBI: Draper approach could help ensure vets receive proper care

As many as 20% of veterans who served in Iraq and Afghanistan suffer from Post-Traumatic Stress Disorder (PTSD). Many others go undetected and do not receive care for the condition, often leading to substance abuse, less than honorable discharges and suicide, which claims approximately 22 veterans each day. Clinicians today diagnose PTSD based on discussions

UL experts aim to “raise the baseline” in cybersecurity

Industry is facing increasing risk of both unintentional and malignant cyber threats, and an increasing sense of responsibility to protect against those factors. Cyber threats continue to be a high priority for medical technology companies, but there are continued questions on how and where to introduce security measures. Now, UL says the process should be