Orthopedic Design & Technology reviews MedAccred

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Orthopedic Design & Technology reviews MedAccred

05 January 2016

Vital Links

Industry consolidation and product complexity are raising the stakes in medtech supplier selection.

In some ways, coming up with the idea for a medical device and its design is the easy part. But that’s only the beginning of the product development process. There are lots of other steps involved: validation, verification, quality control, regulatory process, production, inspection, sterilization, and packaging. Making the whole system work smoothly (and profitably) depends largely on the quality of your supply chain partners.

If you are the OEM, you depend on the entire supply chain to make the product the way you want it made. If you are a vendor in the supply chain, not only must you meet your OEM’s/customer’s demands, your own downstream suppliers must comply with your requirements. It’s an intricate relationship. If a supplier fails, or underachieves, it has a ripple effect throughout the entire supply chain and ultimately hurts the customer. It also is easier to keep a supplier than find a new one—which is why vetting vendors and carrying out thorough due diligence is one of the most important actions an OEM or supply chain partner can do to ensure manufacturing success.

Evaluating suppliers is becoming a more challenging process. An increasing number of products are becoming more complex to design and manufacture, which can challenge the capabilities of suppliers. Companies also want to be as productive and cost-efficient as possible and provide the highest possible quality for their customers. Moreover, the U.S. Food and Drug Administration (FDA) is focusing more on supplier management during quality system inspection technique audits.

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