Surgical equipment, catheters and delivery systems, stents, medical pumps, and parts for various implantable devices are all commonly manufactured using machining and laser processing. However, these methods have to be upgraded to meet the demands of medical device manufacturers.

The cornerstone methods of five-axis machining and Swiss turning are evolving beyond their original purposes to include multitasking capabilities, so the machining center can completely machine components in a single handling. Lasers can be used to micromachine many materials to the necessary and intricate and precise geometries of implantable devices. Ultrashort-pulse lasers are becoming an attractive option because they minimize damage and allow precise processing of more complex medical device components. Hybrid systems are even combining Swiss turning and laser cutting/welding, or additive and subtractive processes in one work area.
 
Like all manufacturing, machining and laser processing operations are trending toward “Industry 4.0”—a streamlined, intelligent, connected network of machines, devices, and systems. In time, connected processes may well replace conventional machines or be synchronized with legacy systems to ensure large data streams are available. These additions can track machine performance, and optimize logistics and supply chains.
 
To gather insight on the trends and challenges impacting machining and laser processing equipment and services for medical device and component manufacturing, I spoke with three industry experts from Weiss-Aug Co. Inc.:
 

• Greg Costa, JK Tool division
• Armand Pagano, senior engineer, advanced product development, Weiss-Aug Co.
• Scott Vormbrock, product development engineer, Weiss-Aug Surgical

 
The full extent of their input was not included in the recent feature article “Machining Moves to Modernize with Industry 4.0,” so the entirety of our conversation is included in the Q&A below.
 
Sam Brusco: What machining/laser processing services do you offer, and (generally speaking) what sorts of medical components might they be used to manufacture?
 
Armand Pagano: All conventional machining technologies are performed in our facilities, which include 3-, 4-, and 5-axis milling, wire electrical discharge machining (EDM), servo stamping, 3D printing, laser cutting, laser welding, and laser etching. Additionally, we have the ability to perform high precision machining in our East Hanover, N.J. location to include hard milling, EDM, and contour grinding. Each of these operations can be completed to tolerances within a two-micron range.
 
Typically, these machining operations are not used to create medical components directly, except for certain prototype operations. They are normally used in the indirect manufacturing of medical components, in that all the die and mold tooling employs these operations.
 
Brusco: What are the latest technologies you have invested in for your machining/laser processing business? Why was it deemed as important?
 
Greg Costa: Our JK tool division is investing in 8-axis Swiss turning centers, as well as 4-axis horizontal machining centers. These will allow us to create more complex components, reduce set-up costs, and produce high volume machined components which are required for our medical customers.
 
Pagano: We have expanded our capabilities most recently for the manufacture of non-ruled geometry—i.e., complex surfaces needed for most medical component manufacture. It is necessary because it’s the tooling and not the end component being machined. This typically warrants an accuracy threshold an order of magnitude more accurate. Couple this with the complex geometry, and only the very best equipment is capable of achieving the accuracy and dealing with exotic materials for finish and hardness.
 
We have also added specialized metrology, as you cannot make what you cannot measure. Complex surfaces are not best measured with CMM and or a contour profilometer. A quicker way is with modern scanning technology to understand the whole surface accuracy. No special programming is required and you get a 3D view instead of just a peek at a given location.
 
Scott Vormbrock: Our latest addition is a femtosecond laser micromachining center. It will improve and expand our machining capabilities as we can now add ceramics and glasses to our already diverse range of product materials.”
 
Brusco: Which specific “Industry 4.0” innovations have most significantly impacted your operations and how?
 
Pagano: We have been employing additive manufacturing for a few years, with the most recent acquisition being a unit capable of producing items used in production for part fixturing or in the automation used to manufacture our products.
 
Vormbrock: Using modular tooling for stamping and molding, the production and prototyping capabilities and deliveries have improved significantly. 3D printing has sped up fixturing, which has equated to faster lead times on prototyping. CAD/CAM software also cannot be understated.
 
Brusco: What skill sets are required for machine/laser operators in order to be successful in a modern manufacturing environment?
 
Costa: The most important skill to be successful in today’s machining environment is a clear vision of the part to be manufactured, a methodical approach to the sequence in which to machine, and a thorough knowledge of the options you have to manufacture parts. There are multiple ways to create a component—the trick is to find the easiest, most repeatable, and efficient way to do so.
 
Pagano: An analytical mindset is desired. In short, it is the engineering background or interest that is most important. It’s not enough to know how to set up and program a machine, it is also important to understand how to improve the interaction. This means being able to create your own macros and implement them in a post to any machine desired using the given CAM software. This means being able to look at the workflow and know enough to continuously improve the output.
 
Brusco: What “best practices” should medical device OEM customers consider for a successful manufacturing partnership?
 
Costa: We do our best to keep up with the latest and best equipment and proper procedures for our medical machining practices. These include the highest-grade equipment and best cutting tool technologies utilizing top grade carbide cutters with super coatings to improve tool life. We also implement continuous software upgrades to optimize tool paths and continuous training to keep pace with new material cutting technologies.
 
Strong and open communication lines, state of the art inspection technologies, and meticulous record keeping are also crucial.
 
Brusco: If your operations include hybrid machining, please describe them. What benefits can be found in using hybrid machining to manufacture parts?
 
Pagano: Some mold tool components are best served using a hybrid approach. One example is additive manufacturing a complex conformal cooling part, then finishing with machining to size. Another example might be starting with additive and refining with conventional machining for prototype parts.
 
Vormbrock: Hybrid machining generally leads to less handling which results in faster manufacturing time and a reduced risk of error.
 
Brusco: Is there anything else you’d like to say regarding machining/laser processing for medical device manufacturing, or are there any particular topics within the machining/laser processing sector I have not asked you about that you feel MPO readers should know?
 
Pagano: The whole process must be tied together to achieve the desired result. The results are only as good as the weakest element—CAD/CAM software, work holding, tool holding, fixtures, metrology—these must all work in concert, or time or effort will be wasted.
 
Vormbrock: Quality should always be your number one priority when working on medical devices. Always remain committed to the industry and strive to stay ahead of the curve.