Terry Daglow, director of mechanical engineering, Velentium, explains the purpose and function on contract manufacturing in medical technology that expands the scope of assumptions about its role.
Over years of working at Medtronic, Intermedics, Advanced Neuromodulation Systems (ANS) and others, I have enjoyed the amazing rollercoaster ride of medical device invention and development. I have heard countless colleagues debate the title ‘Contract Manufacturer,’ but not the intent or the meaning behind the term. Our conversations almost always slip into the fine details of everything from idea creation to clinical success, or sometimes clinical failure. It goes without saying that none of us denies the value of both success and failure, nor the role played by Contract Manufacturers (CMs) in enabling the existence of medical device innovation and development.
Contract manufacturing seems simple enough: CMs will assemble your product and ship it to your customers. In reality, the process is far more complex and robust. Depending on the range of their capabilities, contract manufacturers could handle the entire development cycle, from design and development to full-scale production and marketing, and everything in between.
More than 30 years into my medical device career, each day still brings a new lesson about what CMs contribute to this life-saving industry. Some CMs make a single component, without which a more complex device could not function. At the other end of the spectrum are CMs that work with an idea coming out of a research lab and help the IP holders turn that idea into a commercial product.
Before joining Velentium, a full-service medical device life cycle developer, I never thought much about why CMs were part of every medical device innovation; they just were. My colleagues at Medtronic, Intermedics and ANS all knew from whom to buy materials, components, and assemblies, and we also understood those same vendors were there to answer countless questions and help solve our many challenges. Sitting in my office today, I now see and hear the other side of that relationship. I witness daily conversations and the absolute genius of the engineers solving some of the most technical and clinical challenges facing the medical device industry – making devices smaller, more energy efficient, with faster communication, faster re-charging, easier to use, lower cost to build, less invasive, quick-turn proof of concepts, stream-line design history files, “first-time” approval for FDA submissions and the list goes on.
How is this possible? Because almost every technical director here has also worked directly for medical device manufacturers (MDMs). We have participated in countless successes and enough failures to understand what it takes to achieve clients’ goals and how to manage creative resilience, recall our inner institutional memory and guide those around us. This is true not only for Velentium, but for many CMs I have had the honor of working with throughout my career. In our field, each day is an opportunity to connect with global customers who challenge us to exceed their expectations and push the boundaries of life-saving technology by participating in one, several or all phases of med-tech product development.
When it comes to commercializing medical devices, build-to-order vendors are rarely the right choice. A build-to-order shop is exactly what it sounds like: they take the customer’s order and fulfil it exactly, no questions asked. If no mistakes have been made, and if the customer has “thought of everything” prior to designing and placing the order, all will go well. But in my decades of experience working on both sides of the MDM-CM relationship, that is rarely the case. Successfully commercializing a medical device is a lengthy, complex, and expensive endeavor. Having more brains on the project, and more breadth of experience, is crucial. That means working with CMs who ask questions.
Contract manufacturing can and should look more like partnering. Robust CMs encompass aspects of an incubator, accelerator, innovation center and collaboration center, guiding the transformation of innovative concepts from product ideation to product realization. CMs offer real-world design and manufacturing solutions that will bring each idea, invention, and product to market. Together, CMs and MDMs are part of a greater community, on a mission to improve the quality of life around us. We are a creators and inventors partnering to turn transformative visions of medical innovation into reality.