By Sean Fenske, Editor-in-Chief
When it comes to medical device manufacturing, companies want suppliers who offer cutting edge capabilities, but don’t often want to be the guinea pig for it. As such, working with a company that has familiarized itself with the technology through experience in other ways or from other industries can be valuable. These partners can offer unique solutions to challenges other firms may not be using.
At the same time, it’s equally important to work with a manufacturing partner that keeps abreast of the latest innovations within mature fabrication methods, such as machining. While the processes seem to have been unchanged for some time, subtle upgrades and advancements to machines and techniques can provide unexpected solutions to problems.
To gain insight on some of the advancements happening with orthopedic device manufacturing, Jag Palanisamy, Director of Advanced Manufacturing Engineering at Tecomet, responded to a number of questions around this topic. He offers his thoughts on what technologies are new and interesting for manufacturers and provides clarity on what processes orthopedic device OEMs may want to be asking their suppliers about.
Sean Fenske: When it comes to machining for orthopedic devices and implants, how important is it for Tecomet to remain open to new technologies?
Jag Palanisamy: While Tecomet is a leading medical device contract manufacturer, we are always exploring new technologies and innovations to enhance projects for our customers. We want to be sure and provide the very best solutions. In addition, since we service multiple industries, we gain insights from what’s happening in other markets and determine how to transfer to medical device manufacturing projects.
For example, a recent customer presented a CNC machining project to Tecomet and we were reviewing potential options to create a solution. In doing so, we began to explore lights-out machining. With this project, Tecomet gained the insights of the benefits for robotic and automated solutions.
With Tecomet’s 16 global locations, this technology allows our team members to be exposed to multiple capabilities and technologies. The ability to collaborate and communicate throughout the organization and share ideas and techniques provides Tecomet an opportunity to keep up-to-date manufacturing technologies and ultimately stay ahead of customer demands.
Fenske: Can you further explain “lights-out” machining? What are the benefits it offers?
Palanisamy: Really, we’re looking at is semi-lights out, meaning there is a portion of the process that requires operator intervention. For example, the operator may need to load or unload parts from the machine before completing other tasks. Overall, this setup period may take three or four hours and then the machine runs automatically for an additional 10 to 12 hours unmanned to complete the job.
Tecomet has talented employees who are managing multiple jobs, this technology allows the employee flexibility and manage additional projects to perform their daily tasks. That’s a tremendous benefit with the concerns of the current labor shortage.
Fenske: Glad you brought up the labor shortage as it seems to have been impacting the machining space in particular for quite some time. How is automation helping with this problem?
Palanisamy: If you ask manufacturers, most will cite the struggle to find talent and labor as the number one concern they have. It is a serious issue, and we are routinely working to address this challenge with our existing staff members. Automated machining definitely is a technology that provide our company additional flexibility to manage our customer’s product requirements.
As I mentioned, when you can have a semi-automated machining centers in place, the results are achieving higher efficiency and quality, with fewer operators required to manage the human aspect, that’s a fantastic solution. The ROI is readily apparent as it addresses both shortcomings with staff as well as providing a high level of precision, which is so often required by our medical device customers.
Further, automation enables us to look at the processes involved with a machining project. Not just the machining itself, but also what happens during the post processing steps. This is often where both efficiency and/or quality is potentially lost. With automation, we have gained the ability to group the machining and post-processing steps into one machine. A great example here, machining a part and then perform deburring operation before an operator is needed to become involved.
Fenske: Are there any new developments in the area of materials (metal and/or plastics) being used for machined orthopedic devices?
Palanisamy: Overall, I don’t see much here. We still have high demands for cobalt chrome and stainless-steel components. However, titanium is gaining traction due to new post-processing techniques that we’re still testing.
Also, PEEK is still in play and will continue to be used for some time. I don’t see that changing anytime soon.
Fenske: Additive manufacturing has created quite a stir within manufacturing across several industries. Can you speak to how it’s being implemented within orthopedic device fabrication?
Palanisamy: Additive manufacturing is gaining momentum slowly, but it does provide one significant benefit. When it comes to the porous structure that is so critical to bone ingrowth, additive manufacturing is the best process to produce that pattern.
Fenske: When it comes to machining, are you doing anything that is outside what might be considered the norm in medical device manufacturing?
Palanisamy: Fortunately, medical device machining is a well-developed and understood process. This allows our organization to recruit machinists who have machining experiences from other industries who are both talented and proficient with CNC machining processes and procedures. We view this as an opportunity to learn from other industries by listening to machinists who come from outside of medical device manufacturing and learn from the best practices that they have learned from their previous experiences.
I received some great advice years ago, to lease machines rather than buying capital equipment. This allows manufacturers to provide cutting edge machining centers for use with growing customer demands. I’m a big proponent of using the latest and greatest technologies, by leasing equipment, Tecomet can possibly provide new technologies in a responsive time frame.
Another thing worth mentioning is the machine tool providers have become very advanced in the last 20 years. They’ve made substantial investments in R&D to enhance their offerings. For example, you may be seeking equipment for milling, but they can provide a solution that can mill, turn, drill, etc. with one system. We collaborate with them, which results in a win-win situation, because they get a new system to offer while we gain access to equipment that specifically suits our needs.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
Palanisamy: The documentation required to bring new machining centers online is a differentiator in this industry. Some companies are afraid to bring in new equipment because the approval time required for its use. As a medical device manufacturing supplier, we must have the documentation to support any change to ensure the new equipment can be used. Obtaining customer acceptance can be a challenge due to their quality requirements, however we have learned throughout this process and attempt to share how previous outcomes have benefitted both Tecomet and ultimately the customer.
Click here to find out more about Tecomet >>>>>
When it comes to medical device manufacturing, companies want suppliers who offer cutting edge capabilities, but don’t often want to be the guinea pig for it. As such, working with a company that has familiarized itself with the technology through experience in other ways or from other industries can be valuable. These partners can offer unique solutions to challenges other firms may not be using.
At the same time, it’s equally important to work with a manufacturing partner that keeps abreast of the latest innovations within mature fabrication methods, such as machining. While the processes seem to have been unchanged for some time, subtle upgrades and advancements to machines and techniques can provide unexpected solutions to problems.
To gain insight on some of the advancements happening with orthopedic device manufacturing, Jag Palanisamy, Director of Advanced Manufacturing Engineering at Tecomet, responded to a number of questions around this topic. He offers his thoughts on what technologies are new and interesting for manufacturers and provides clarity on what processes orthopedic device OEMs may want to be asking their suppliers about.
Sean Fenske: When it comes to machining for orthopedic devices and implants, how important is it for Tecomet to remain open to new technologies?
Jag Palanisamy: While Tecomet is a leading medical device contract manufacturer, we are always exploring new technologies and innovations to enhance projects for our customers. We want to be sure and provide the very best solutions. In addition, since we service multiple industries, we gain insights from what’s happening in other markets and determine how to transfer to medical device manufacturing projects.
For example, a recent customer presented a CNC machining project to Tecomet and we were reviewing potential options to create a solution. In doing so, we began to explore lights-out machining. With this project, Tecomet gained the insights of the benefits for robotic and automated solutions.
With Tecomet’s 16 global locations, this technology allows our team members to be exposed to multiple capabilities and technologies. The ability to collaborate and communicate throughout the organization and share ideas and techniques provides Tecomet an opportunity to keep up-to-date manufacturing technologies and ultimately stay ahead of customer demands.
Fenske: Can you further explain “lights-out” machining? What are the benefits it offers?
Palanisamy: Really, we’re looking at is semi-lights out, meaning there is a portion of the process that requires operator intervention. For example, the operator may need to load or unload parts from the machine before completing other tasks. Overall, this setup period may take three or four hours and then the machine runs automatically for an additional 10 to 12 hours unmanned to complete the job.
Tecomet has talented employees who are managing multiple jobs, this technology allows the employee flexibility and manage additional projects to perform their daily tasks. That’s a tremendous benefit with the concerns of the current labor shortage.
Fenske: Glad you brought up the labor shortage as it seems to have been impacting the machining space in particular for quite some time. How is automation helping with this problem?
Palanisamy: If you ask manufacturers, most will cite the struggle to find talent and labor as the number one concern they have. It is a serious issue, and we are routinely working to address this challenge with our existing staff members. Automated machining definitely is a technology that provide our company additional flexibility to manage our customer’s product requirements.
As I mentioned, when you can have a semi-automated machining centers in place, the results are achieving higher efficiency and quality, with fewer operators required to manage the human aspect, that’s a fantastic solution. The ROI is readily apparent as it addresses both shortcomings with staff as well as providing a high level of precision, which is so often required by our medical device customers.
Further, automation enables us to look at the processes involved with a machining project. Not just the machining itself, but also what happens during the post processing steps. This is often where both efficiency and/or quality is potentially lost. With automation, we have gained the ability to group the machining and post-processing steps into one machine. A great example here, machining a part and then perform deburring operation before an operator is needed to become involved.
Fenske: Are there any new developments in the area of materials (metal and/or plastics) being used for machined orthopedic devices?
Palanisamy: Overall, I don’t see much here. We still have high demands for cobalt chrome and stainless-steel components. However, titanium is gaining traction due to new post-processing techniques that we’re still testing.
Also, PEEK is still in play and will continue to be used for some time. I don’t see that changing anytime soon.
Fenske: Additive manufacturing has created quite a stir within manufacturing across several industries. Can you speak to how it’s being implemented within orthopedic device fabrication?
Palanisamy: Additive manufacturing is gaining momentum slowly, but it does provide one significant benefit. When it comes to the porous structure that is so critical to bone ingrowth, additive manufacturing is the best process to produce that pattern.
Fenske: When it comes to machining, are you doing anything that is outside what might be considered the norm in medical device manufacturing?
Palanisamy: Fortunately, medical device machining is a well-developed and understood process. This allows our organization to recruit machinists who have machining experiences from other industries who are both talented and proficient with CNC machining processes and procedures. We view this as an opportunity to learn from other industries by listening to machinists who come from outside of medical device manufacturing and learn from the best practices that they have learned from their previous experiences.
I received some great advice years ago, to lease machines rather than buying capital equipment. This allows manufacturers to provide cutting edge machining centers for use with growing customer demands. I’m a big proponent of using the latest and greatest technologies, by leasing equipment, Tecomet can possibly provide new technologies in a responsive time frame.
Another thing worth mentioning is the machine tool providers have become very advanced in the last 20 years. They’ve made substantial investments in R&D to enhance their offerings. For example, you may be seeking equipment for milling, but they can provide a solution that can mill, turn, drill, etc. with one system. We collaborate with them, which results in a win-win situation, because they get a new system to offer while we gain access to equipment that specifically suits our needs.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
Palanisamy: The documentation required to bring new machining centers online is a differentiator in this industry. Some companies are afraid to bring in new equipment because the approval time required for its use. As a medical device manufacturing supplier, we must have the documentation to support any change to ensure the new equipment can be used. Obtaining customer acceptance can be a challenge due to their quality requirements, however we have learned throughout this process and attempt to share how previous outcomes have benefitted both Tecomet and ultimately the customer.
Click here to find out more about Tecomet >>>>>