As sponsors look for outside expertise to help them gain a competitive edge in today’s medical device industry, it is critical they not only select the right outsourcing partner but also set that relationship up for success... Defining the expectations and deliverables in a measurable, accountable, and tactical way allows for a quantifiable determination of whether each party is meeting its commitments. In an article posted on Med Device Online, KMC Systems' Mike Kallelis, head of business development for the medical engineering and contract manufacturing firm, weighs in on how having a clear understanding can also improve efficiency, facilitate problem resolution, and eliminate confusion, which benefits the company, the customer, the end user and, ultimately, patient care.
Embracing risk is an element of a true partnership.
Kallelis states "During the CMO selection process, most sponsors consider the usual list of attributes, such as experience, compliance, organizational structure, and supply chain management. Yet, something important that should be considered is risk. Risk is inherent in new platforms, especially those with a lot of invention in the architecture. It is unrealistic to expect your CMO to never incur a problem while manufacturing a complex scientific instrument, and those problems may have nothing to do with the assembly and test process. If both parties are seeking a true partnership, working together is essential."
Integrating two different supply chains is another factor for a successful CMO partnership. Medical device supply chains are prequalified, and simply changing to another supply chain is not as easy one may think. So how do you do it?
Mike Kallelis explains "Consideration must be given to the vendor qualification process to ensure the new supplier meets certain standards. Those standards may be vastly different for a CMO that is striving for flexibility in its supplier base versus a large OEM that may have a legacy qualification process. To align the two supply chain organizations, it is helpful to come together during the later stages of the new product development phase and map the desired process going forward. Doing so may reveal that one party has certain leverages." Kallelis explains that ultimately "Rationalizing processes will result in an understanding of who is buying from whom and aligns the two supply chain teams’ expectations."
Engaging And Aligning Quality Systems
Similarly, the approach for integrating and mapping two supply chains is helpful when aligning two quality systems. Early on, work together to compare and contrast each system. Answer critical questions, such as:
- What is a nonconformance? How do you document them?
- When do you issue supplier corrective action requests, corrective and preventive actions, field notices, and customer notices?
- How is change documented, and are all changes reported to the customer or just significant changes? If just significant changes, how are they defined?
- How often is a quality audit expected, and what will its scope be?
- How is an out-of-the-box failure defined?
To learn more ways to build a successful partnership with your CMO, Click here to read the full article on Med Device Online.
Ultimately, how a customer is feeling and how the CMO is performing, is the true measure of a CMO’s services and its commitment to your overall success.
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