Smooth Involuntary Cardiac Involuntary Voluntary Skeletal Voluntary Attached to skeleton.
The Recall ImPact - WordPress.com · The Recall ImPact Medical Device Manufacturing An involuntary...
1
The Recall ImPact Medical Device Manufacturing An involuntary recall which is mandated by a regulative agency involuntary recall A voluntary recall, which occurs when the company manufacturing the device finds a critical problem with the product Voluntary recall types of Recalls Medical device recalls are extremely costly. Reducing costs for a Life Sciences company in a highly complex regulated environment requires efficient production and quality processes that creates safe, quality products. according to the 2014 FDA report the number of recalls has almost doubled in the past decade Since 2014, packaging and labeling issues have accounted for of medical device recalls 53% Faulty medical device connections have accounted for of medical industry recalls since 2014 10% Medical device recalls can be caused by a number of factors ranging from issues with design, change controls, process controls, materials, components, labeling or packaging. Why are medical devices recalled? Major recall costs have been as high as in the medical device industy $600 million A closer look at the recall challenges for medical device manufacturers The Increasing complexity of medical devices Medical device manufacturers are quickly incorporating new technologies into their designs to enable wearable devices and interconnectivity through IoT. This push for innovation can result in technical and compatibility issues and glitches. The push for frequent advances can affect the efficiency of devices as well as their relevance and product life cycles. Another issue can arise as a result of the complex worldwide network of suppliers and sub-suppliers who individually manufacture different aspects of these products. Vetting vendors takes a tremendous amount of time and is often difficult. A preventative approach requires an initial investment; however, the ROI is significantly justifiable when it can prevent a recall. The Global supply chain Speed to commercialization Medical device manufacturers are under increasing pressure from both shareholders and consumers to bring innovative, advanced devices to market in a timely manner. As the rate of advancement accelerates manufacturers face additional pressure to enter the market quickly to avoid obsolescence as newer, more advanced devices proceed them into the market. Unfortunately, this rush to get products into the marketplace can result in quality shortcuts. Regulation & Compliance Medical device manufacturers are under growing pressure to comply with increasingly stringent regulations. Manufacturers must remain vigilant to ensure they comply with evolving regulations locally and abroad. This infographic has been created from the information provided by EngiSystems. The information herein is for broad informational purposes only and while Generis strives to ensure the information is up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability of the information for any purpose. Any reliance you place on such information is strictly at your own risk. In no event will Generis or EngiSystems be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this infographic.This document may not be duplicated or altered without the express permission of Generis and EngiSystems. It’s Time for a New Perspective & New Approach! Download Your Free Report Explore the chain of events that have and will alter the Medical Device Industry indefinitely
Transcript of The Recall ImPact - WordPress.com · The Recall ImPact Medical Device Manufacturing An involuntary...
The Recall ImPact
Medical Device Manufacturing
An involuntary recallwhich is mandated by a
regulative agency
involuntaryrecall
A voluntary recall, whichoccurs when the companymanufacturing the device
finds a critical problem withthe product
Voluntaryrecall
types of Recalls
Medical device recalls are extremely costly. Reducing costs for a Life Sciences company in ahighly complex regulated environment requires efficient production and quality processes that
creates safe, quality products.
according to the 2014 FDA report the number ofrecalls has almost doubled in the past decade
Since 2014, packagingand labeling issues have
accounted for
of medical device recalls53%
Faulty medical deviceconnections have
accounted for
of medical industryrecalls since 2014
10%
Medical device recalls can be caused by a number of factors rangingfrom issues with design, change controls, process controls, materials,components, labeling or packaging.
Why are medical devices recalled?
Major recall costs havebeen as high as
in the medical deviceindusty
$600 million
A closer look at the recall challenges formedical device manufacturers
The Increasing complexityof medical devices
Medical device manufacturers arequickly incorporating new technologiesinto their designs to enable wearabledevices and interconnectivity throughIoT. This push for innovation can resultin technical and compatibility issuesand glitches. The push for frequentadvances can affect the efficiency ofdevices as well as their relevance andproduct life cycles.
Another issue can arise as a result ofthe complex worldwide network ofsuppliers and sub-suppliers whoindividually manufacture differentaspects of these products. Vettingvendors takes a tremendous amount oftime and is often difficult. A preventativeapproach requires an initial investment;however, the ROI is significantlyjustifiable when it can prevent a recall.
The Global supply chain
Speed to commercializationMedical device manufacturers areunder increasing pressure from bothshareholders and consumers to bringinnovative, advanced devices to marketin a timely manner. As the rate ofadvancement acceleratesmanufacturers face additional pressureto enter the market quickly to avoidobsolescence as newer, moreadvanced devices proceed them intothe market. Unfortunately, this rush toget products into the marketplace canresult in quality shortcuts.
Regulation & ComplianceMedical device manufacturersare under growing pressureto comply with increasinglystringent regulations.Manufacturers must remainvigilant to ensure they complywith evolving regulationslocally and abroad.
This infographic has been created from the information provided by EngiSystems. The information herein is for broad informational purposes only and whileGeneris strives to ensure the information is up to date and correct, we make no representations or warranties of any kind, express or implied, about the
completeness, accuracy, reliability, suitability or availability of the information for any purpose. Any reliance you place on such information is strictly at your ownrisk. In no event will Generis or EngiSystems be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss
or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this infographic.This document may not be duplicated oraltered without the express permission of Generis and EngiSystems.
It’s Time for a New Perspective & New Approach!
Download Your Free Report
Explore the chain of events that have and will alter the Medical DeviceIndustry indefinitely
