Quality is critically important in healthcare -- because patients’ lives are at stake. In the highly-competitive and highly-regulated medical device industry, quality is a “must have.” For companies seeking unique competitive advantage as a leader in quality, their partners must share the same relentless commitment to operational excellence in every aspect of the device lifecycle.
Strategic outsourcing should include a high-level of collaboration, deep customer intimacy, a strong on-site presence for your business and responsive support at every point of your device’s lifecycle.
As you consider integrating outsourcing partners into your operation, be sure they meet these key requirements:
The ability to meet demanding regulatory and compliance standards is essential to maintain leadership in quality and the partner’s track record is vital. When considering outsourcing partners, be sure to evaluate their success in maintaining compliance in all aspects of the device lifecycle, from component sourcing to manufacturing through distribution.
While some quality standards are global, many regions have specific regulatory requirements. If you compete in different regions- or have plans to expand- make sure your outsourcing partners possess that market-specific experience.
Like a medical device, your supply chain is comprised of countless moving parts. Integrate an outsourcing partner and the scope of your supply chain processes grows exponentially. Make sure your outsourcing partner has the experience to seamlessly integrate into complex supply chains and manufacturing processes.
When lives are at stake, 99% quality is just not enough. When evaluating potential outsourcing partners, make sure they share your patient safety focus. A partner committed to manufacturing excellence and engineering expertise can create a zero-defects production process that will help you deliver reliable, high-performance devices with 100% quality.
Raising device quality and controlling costs should not be mutually exclusive in your outsourcing partner’s vocabulary. For instance, expertise in operational excellence and materials science expertise can help companies with options to improve quality, which, in turn, can positively impact the financial dimension of the business, including: