Insights for FDA Regulated and HIPAA Compliant Organizations

25 Years of experience in marketing, sales and customer service provides priceless insights into what is needed for today's bio-kitting & fulfillment customers.


Manufacturers of Class I and II Medical Devices and Diagnostics have increased their focus on core competencies and is the main driver of outsourcing in all its forms.  

The trend is nurtured by corporate leaders' desire to concentrate on those elements of the value chain that they master best and delegate everything else to specialized third-party service providers. 

Establishing supply chain stability is particularly critical for medical device enterprises, whether their supply networks are established or nascent. 

Every medical device manufacturer needs a stabilizing and standardizing manufacturing processes across the supply chain and it's essential for companies to meet customer product quality and order fulfillment expectations. Medical Device and Diagnostic manufacturers need flexible capacity to handle spikes or surges in demand.

There are established classifications for approximately 1,700 different generic types of devices grouped into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. 

The three classes and the requirements which apply to them are Class I General Controls; Class II General Controls with Special Controls and Class III General Controls and Premarket Approval.

The top challenges facing large, mid-size and emerging medical device manufacturers are reducing the costs and risks of compliance. And according to Jeff Russell, director of the Global Medical Device Practice at Camstar, here's how these challenges shake out, depending on the type of enterprise:

For large manufactures, supply chain stability efforts are a response to the increase in manufacturing velocity and scope, which minimizes supply chain disruptions and improves customer satisfaction at all levels.

Mid-size manufactures are reducing costs to offset margin pressures as a means to compete with larger enterprises (despite sparer resources) and to funnel operational savings into research and development.  Because of their relatively smaller scale, mid-sized manufacturers must reduce the costs and risks of compliance because they cannot compete if product quality, reliability, or brand reputation becomes an issue.

Mid-sized manufacturers want to establish agile supply chains as a means of maneuvering with or out-maneuvering larger competitors. They, too, must configure their supply chains to meet rising customer demand.

For newer ventures, reducing costs to offset margin pressures is more a cost-avoidance benefit. This happens when they minimize or reduce the need for more headcount as they ramp up to commercial volumes.

Emerging companies these days want to focus on core competencies and farm out everything that others can do more efficiently. This is nothing new, but what started out as the outsourcing of isolated processes such as IT or payroll accounting has now evolved to encompass entire front-end activity: fulfillment, packaging, including final article assembly, distribution, and warehousing.

The day of market expansion services has dawned. Outsourcing originally grew out of companies' desire to concentrate on their core competencies and, in so doing, to cut costs.  Companies' increased focus on core competencies is another main driver of outsourcing in all its forms, and specifically in market expansion services. 

The trend is nurtured by corporate leaders' desire to concentrate on those elements of the value chain that they master best and delegate everything else to specialized third-party service providers like TAGmedica.

With the rapid growth of the medical technology, the concept of supply chain management continues to change to meet the unique challenges presented when moving sensitive medical device products. There are a number of variable conditions that must be accounted for to ensure on-time delivery and protection of product condition and integrity from origin to destination.

TAGmedica offers a risk-based approach in developing a sound and comprehensive supply chain management program that will ensure that product quality, integrity and identity is protected and preserved throughout the supply chain.

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