As the quality manager for our ISO-17025 laboratory it is become native for me to evaluate machine purchases through a global and perhaps a more cynical vista. With medical device packaging machinery, you need to consider a multitude of factors. How easily will I be able to validate the equipment, will it create a liquid workflow and provide solid user ergonomics? Perhaps the most often overlooked and vitally important metric in procurement discovery is “cost of ownership”. Cost of ownership analysis can be more complicated than just asking for the cost of replacement parts.
Medical device manufacturers need to understand how much intellectual resources will be needed from their quality group in order to qualify the equipment. We need to understand lifespan cycles for this equipment so we can better amortize its value over the equipment’s expected life. If the machinery does not perform and causes a secondary problem such as a packaging recall, what is the cost to mitigate such an event?
I am famous for developing deeply robust RFP’s (request for proposal). My RFP’s can only be described as epic works, probing wide and deep, well beyond a simple price request. I have no problem spelling out my requirements ad Absurdum so as not to be disappointed with my product or service. At the very least it’s vital that you create a single page purchased specification document that outlines your core requirements if nothing else to better navigate you to the correct product or service. Front loading this process will be time well spent. With all the complicated components orbiting medical device packaging validation, why ad frustration with poorly spec’ed packaging machinery. I think our company really went the extra mile by itemizing reasons to choose our company on our Why Buy page on our website.
My parents were from Missouri, the “show me” state. Happily, much of their sober skepticism landed on me, and I constantly find myself in a “prove it” state of mind. Imagine for moment that in our personal lives if we were to evaluate the world through the lens of cost ownership, how would we proceed? Would we smoke? Would we over eat? Would we speed? If we think in terms of “costs” and if we will be honest with ourselves and look deep, we may reach a level of edification that could save our lives and our companies. Forgive me for distilling down this blog with a well-worn cliché, but indeed “an ounce of prevention is worth a pound of cure”