Medical Device Assembly Process

As Modern Grinding grows and starts to develop manufacturing processes for a variety of products, we are getting into more and more multi-step medical device assembly processes. Our capabilities now include wire forming, wire grinding, coiling, microcoiling, welding, electropolishing and metal stamping.

Multi-Filar machine part of medical device assembly
Multi-Filar machine part of medical device assembly

One major product that we manufacture and assemble is guidewires. Many guidewires include a ground core wire (also referred to as mandrel), a coil (or microcoil) and a safety ribbon. These multiple parts typically are formed and welded together. While it would seem like this is a simple medical device assembly process, during the prototype phase it can be very time consuming to nail down the correct process. For one, your machines open up at different times. If you are trying figure out the correct process to form your ground core wires, you might need to try several different core wire designs. Once you have manufactured your core wires, you might realize that you need a different design once you get to the forming stage. This is fine if your grinding machine is always, open but ours rarely is, so you need to wait until machines open up to start over.

We recently started to pick and choose components of the six sigma process program to create a more robust project management process for medical device assembly. In the past, we did this type of project management in our heads, but as our production capabilities became more complex we realized the need for this type of system. Along with the principles of six sigma, we relied on the lean software principles of starting with a minimal design for project management and working with the main customers to create a product that everyone could use.

The main goals for me were to make sure that when we get a medical device assembly job, we get buy in from all of the departments we will be working with and we get confirmation from each department that they can accomplish the job within a given time frame. In the past, managers would take responsibility for department that they didn’t run and when a project started to get hard, the buck would get passed.

Here are a few tips from our medical device assembly project management experience:

  • Have a manager responsible for each step in the process
  • Think about alternative process routes while developing your process
  • Put your process on paper, from step 1 to shipment

Does anyone use simple project management tools for medical device assembly? We would love to hear about your trials and successes.