It is not the Medical Device Original Equipment Manufacturer’s (OEM) fault, nor specifically the Design Engineer, Procurement Management or the Production Supervisor; the innovators that bring their ideas to a true medical device development/manufacturing company should find a real partner in their effort to bring a concept to reality.
The truth lies within planning, or perhaps we should state, the lack of that sometimes nebulous concept…and it is a big concept in successful medical device manufacturing.
The rub is this…when the manufacturing company operates under a smaller banner of product development strategy, planning (which should include: prototyping, R&D, process design, quality management, material selection and all the other steps in the production-process which actually do require extensive planning) often go unaddressed until it’s too-late to halt the “product development cost-train” which is often speeding along way too fast to slow it’s pace or shut-down quickly.
It is known that many Medtech contract manufacturers submit estimates (based often upon rudimentary drawings) along with caveats which may well turn into a high frequency of “change orders” helping to justify higher production costs.
That is not “best practices”. Nor is it the way to build solid relationships for the future.
This is also about the very real ability and fervent desire to communicate with each other. Contract manufacturers within the medical device community need to be up-front and on top of their current understanding of their own capability-set and what is available outside their own purview which can assist in streamlining the process.
The ideas need to be shared. Production steps need to be meticulously outlined and discussed. Consensus needs to be reached.
Every rock (or boulder in some cases) needs to be toppled over and looked at with well-focused eyes. Only then can the higher cost of development be tamed.
Experience counts in this arena. Knowing what has worked in the past, but more importantly what has not, is generally a significant key to unlocking lower developmental costs.
The well-shared but often-times overlooked steps behind real “Design for Manufacturability” studies must be a significant link in the production-process before anything is started.
These studies (from an enlightened contract manufacturer) will show how actual cost-savings are uncovered, as well as, ways to bring the part, component or assembly to market in the most time-effective manner.
Helping to bring a new product to market on time can be a huge cost-saving measure, as well.
It can mean the difference between bringing your best possible version forward, ready to help save lives, or a failed attempt still on the table…awaiting approval for more cost-overruns.
