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Effective Vendor Management For Medical Device Industry

Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency - in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.

There are a lot of contract manufacturers that are shifting their focus to medical technology due to the stability of the marketplace as compared with the automotive or aerospace industry. While many of them have good intentions, they often don’t understand the complexities of medtech manufacturing.

However, for Medical Device Manufacturers, their suppliers are their partners. Although they are ultimately responsible for complying with regulations and standards, their vendors should provide support by being compliant themselves.

The manufacturer of the finished device - not the supplier - is responsible for compliance. However, the regulations also specify that device manufacturers should select only suppliers with the capability to provide quality products. It is said that, “Quality cannot be inspected or tested into Products and Services. It must be built into device.”

Medical Device Manufacturers should identify suppliers that have a successful track record in the device industry. They should be competent to satisfy quality and regulatory needs.

Purchasing Controls: It is necessary to establish and maintain quality requirements for suppliers, vendors, and contractors.

Medical Device manufacturers should evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements.

The major issues that impact a device manufacturer’s Compliance efforts are:

1 Vague Quality Requirements: Not having quality requirements for suppliers is one of the major problems. Working closely and collaboratively with suppliers in creating and documenting the criteria is very essential. This result in making suppliers part of quality process which in turn results in better quality for your materials/components. It will also help manufacturing to produce high quality products at reasonable cost.

2 Participation in Validation: It is god to prefer suppliers that implement meaningful validation program. This along with strict change control is very essential. It is also necessary to ensure that suppliers are notifying us of any changes that take place in material and/or processes.

For, effective Vendor Management, some of the important considerations are:

  • Getting the right references from the suppliers.

  • Installing good software system to have a robust audit program.

  • Use of latest technology to incorporate purchasing controls in the Quality Management Systems (QMS)

  • Ensuring that the suppliers and their suppliers/subcontractors are in harmony and the suppliers have control over their outsourcing process.

Medtech Companies Need Collaboration With External Partners For Innovation And Growth

As per a recent global study by “PwC Health Research Institute”, Medtech executives are beginning to appreciate that innovation must occur outside of traditional research and development units, they cocreate - that is, they involve customers or external partners from idea generation to execution - on onethird or less of their products and services. Most Medtech companies identify “open innovation” - external and internal people generating and commercializing ideas together - as one of the top two approaches that will generate the most growth. Nearly 81% of executives have plans to collaborate with strategic partners during the next three years, but more than half said a major challenge is finding the right partners. How they collaborate with these partners will be key.

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