Avoid the Consequences of an Experiment Gone Wrong
Linking the experimental process to the design controls defined by FDA can help ensure an effective and efficient new product development effort, as well as a competitive market advantage.
Testing
Design Verification vs. Design Validation: Right Questions or Right Answers?
When it comes to verification and validation, medical device companies need to ensure that what they're doing actually makes sense.
Risk of Wire Breakage Prompts Penumbra Recall
FDA said 155 devices on the U.S. market are included in a recall of Penumbra's 3D Revascularization device because the delivery wire could break or separate during use. Amanda Pedersen Penumbra initiated a voluntary recall of its Penumbra 3D Revascularization device because of a risk that the...
Did Magellan Try to Hide its Quality Control Problems?
Meridian Bioscience's diagnostics unit knew about its faulty blood lead test results for almost three years before FDA caught wind of the problem, the agency noted in its inspection report. Amanda Pedersen At best, Magellan Diagnostics ignored customer concerns about its faulty blood lead test...
Some Surgical Nav Systems are Error-Prone, FDA Warns
*/ FDA issued a safety warning regarding possible navigational accuracy errors linked to frameless stereotaxic navigation systems, although the agency said the overall benefits of using these systems continue to outweigh the risks. Amanda Pedersen Certain types of stereotaxic navigation systems...
What Caused Magellan’s Lead Test Problem? FDA is Stumped
FDA has not been able to identify the root cause of Magellan's inaccurate lead test results, and the recall has been expanded to include two additional testing systems. Amanda Pedersen FDA is conducting studies with the CDC to identify the cause of Magellan's faulty blood-based lead tests. Magellan...
Harmful Chemicals in Spine Implants Prompt Zimmer Recall
Zimmer Biomet recalled two implantable spinal fusion stimulators after a routine cytotoxicity test indicated high levels of chemicals that could be toxic to tissues or organs. Amanda Pedersen Zimmer Biomet is recalling its SpF PLUS-Mini and SpF XL llb implantable spinal fusion stimulators due to...
The Zen of Anytime Audit Readiness
You know an FDA audit can happen at any time, but would you really be prepared if it happened today?
New Expectations for Biocompatibility Testing: Are You Ready?
Are you aware of the regulatory changes and testing advances involving biocompatibility? Image of an in vitro irritation test courtesy Nelson Laboratories. Biocompatibility testing requirements for medical devices are changing. "A lot of things are happening, on all fronts," Thor Rollins,...
Do You Subject Your Packaging to Human Factors Studies?
Medical device designers should consider including packaging in their human factors studies. Human factors studies are now commonplace during medical device development, thanks to FDA’s guidance “ Applying Human Factors and Usability Engineering to Medical Devices .” But what about during packaging development?
Is Zimmer Out of the Woods With Manufacturing Problems?
Zimmer Biomet's production delays are not yet in the rearview mirror, and investors seem to be running out of patience with the company's recent "one step forward, two steps back" routine. Amanda Pedersen Zimmer Biomet CEO David Dvorak told investors during the company's first-quarter earnings call...
Will Abbott Have to Pay for St. Jude’s Mistakes?
Abbott is in hot water with FDA over St. Jude Medical's past mistakes, including what was either a lie of omission - or worse. Amanda Pedersen At best, St. Jude Medical management pussyfooted around the truth back in 2014 during the handling of an ICD battery problem that eventually resulted in a...
FDA Takes Abbott to Task for ‘Hazardous Situation’
FDA is taking Abbott Laboratories to task for essentially downplaying manufacturing flaws and cybersecurity concerns related to devices acquired through its $25 billion purchase of St. Jude Medical. Amanda Pedersen It seems Abbott Laboratories acquired more than it might have bargained for when it...
Medtronic Has a Potentially Deadly Shunt Problem
Medtronic has pulled all unused units of the StrataMR valves and shunts from the market after logging an increase in product complaints, including one reported patient death. Qmed Staff Report Dublin-based Medtronic plc said this week that an increase in product complaints prompted a Feb. 22 recall...
Will Your EpiPen Work in an Emergency?
Mylan said its manufacturing partner for EpiPen devices has expanded a recall of the product in the United States and other markets. Amanda Pedersen Mylan's manufacturing partner for the EpiPen and EpiPen Jr products has recalled 13 lots of the devices due to the potential that they contain a...
Alignment of Risk Management Processes for Medical Device Products and Projects
Learn how to use risk management tools and techniques to streamline medical device and diagnostic product development.