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.

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