The ability to pivot operations to quickly respond to design changes and scale-up production is key to success for the industry.
Within the medical device manufacturing sector, changes to part specifications and quantities are frequent and often unpredictable. As a result, clients require a machining partner who can nimbly and quickly adapt to design and production changes as they occur and be capable to scale up to ‘lights out’ manufacturing when needed.
“Medical device manufacturing customers may prefer large machining operations,” said Tony Doan, CEO of Halcyon Manufacturing, an ITAR registered and AS-9100/IS-9001-certified machining shop based in San Jose, California. “But size alone does not equate to capacity. Smaller shops can have an advantage when a client needs a machining partner to also be nimble and flexible. For our clients, the ability to adapt and problem solve is incredibly important as complex manufacturing requirements frequently evolve and change.”
“Medical device machining involves a lot of low volume, high mix work,” adds Doan. “The reality is not every machine shop wants to take on small orders or highly complex jobs. A client needs a machining partner who really embraces this kind of work in addition to the high-volume orders.”
When evaluating the capacity of a precision machine shop, the capability to respond to changes in specifications and production quickly becomes a key factor.
Building capacity through cross-training
Staff cross-training is one way a machine shop can improve their ability to respond to unexpected and time-sensitive machining needs. While today’s machine shops are filled with a mix of high-tech precision CNC equipment, each requires trained staff to manage, maintain, and operate.
“A lot of medical device machine shops will assign an operator to a specific CNC machine,” said Doan. “This can create a situation where a particular operator has to be available and not working on other orders, to operate a given machine.”
Having the ability to move people from machine to machine, as well as from line to line and from shift to shift, without interruption enables a machine shop to respond to changes in demand more quickly.
At Halcyon, where they machine bar grade 6061 aluminium, brass, copper, titanium, stainless steel, and plastics, they have cross-trained their entire staff to work across all their equipment to maximise their capability for scale up.
“We have not only cross-trained our team, but we all work multiple shifts, and we have the same controls throughout our shop,” said Doan. “It makes it easy for our people to be able to move around as needed. So, when a client needs something over a weekend, we don’t have to completely rethink how we’re going to schedule. We can easily plug in people for surge hours or to increase our manpower as needed.”
The company made the decision to further enhance their cross-training through their selection of machining equipment. Unlike shops that purchase a variety of types and brands of CNC equipment over time, Halcyon intentionally purchases the same model of high-end 5-axis CNC machine from Doosan Machine Tools with FANUC controls as they expand. This further reduces the learning curve for their staff.
Lights out manufacturing capability
Nimbleness and adaptability are also needed to be able to scale production up quickly. Some machine shops such as Halcyon operate on a 24/7 basis enabling customers to connect with them outside of traditional office hours.
“‘Lights out’ manufacturing takes scaling up production to the next level,” says Doan. “CNC operators can set up the equipment to run on its own without supervision overnight. This ‘lights out’ capability means smaller shops can maximise their capacity without adding more staff.”
It starts with culture
The mindset that a machining partner brings to precision medical device machining is also critically important.
“It starts with the culture of the shop and the problem-solving mindset they bring to a project – particularly for complex, precision parts,” explains Doan. “You also need a machining partner to be proactive. By engaging early in the process, a medical device machine shop can anticipate and resolve machining issues before any parts are produced.”
In a recent example, Halcyon had a customer bring them what appeared to be a simple part but could not find a machine shop that wanted to take the job. The part had a 6” threaded shaft with a hex head. There was an 832 thread across the outside diameter (OD) of the shaft.
“Most lathes aren’t able to cut those threads across six inches,” said Doan. “We had to get creative since we could not use round stock, which is generally used when cutting OD threads.”
The team determined how to form the threads while accounting for the “growth” that occurs when threads are formed on plate steel to meet the tight requirements. For it to run on a CNC machine, they also had to create a modified thread using a cut die to create a formed thread.
“We took the challenge on and were able to meet the client’s deadlines with parts that met spec when no one else could do it,” said Doan. “It takes more than the equipment and know-how; it also means really having an appetite to take on these kinds of complex challenges.”
Nimbleness and adaptability in precision machining represents a key consideration for medical device clients as they seek partners to provide solutions to their complex design problems and production scale-up needs. Through cross-training, lights-out manufacturing and a problem-solving proactive mindset, smaller machine shops are well-equipped to meet the demand.