7 Critical Factors For Predictable Quality In Medical Device Manufacturing

By Matt Knutson, Vice President of Manufacturing Operations, Donatelle

In their mission to create innovative products that enhance and save lives, medical device manufacturers today are challenged with several opposing priorities, including:

• As products must be safe, reliable and accurate, regulatory approval requires adhering to stringent standards and implementing proven processes to adhere to stringent standards.
• Stakeholders are pushing for lower costs and better value.
• A crowded market adds more cost pressure and requires speed.

From a business standpoint, noncompliance can result in costly approval and product launch delays, customer returns, potential field corrective actions or recalls, reputational damage, and worse.

Predictable quality is essential – and requires a very high level of diverse engineering expertise, electronic integration of quality and business systems, and proven experience in the medical device sector. Predictable quality does not happen by accident or luck. It comes from a culture, knowledge, experience, and track record of performance to produce products and provide services that meet requirements.

Here are seven critical elements for achieving predictable quality.