Dawn A. Lissy , President & Founder, Empirical05.01.19
It seems the only time I catch up on the latest clothing fashions is when I seek inspiration online for columns I write pertaining to trends. Each time I do, I’m reminded why I read magazines like MPO and ODT instead of something in the checkout line.
In my research on manufacturing trends, I went to some dark places courtesy of search parameters that weren’t nearly precise enough. Now I can’t unlearn that women my age are not only wearing neon and tie-dye, but other women write articles to help them do this on purpose.
I thought we were a village?
So rather than text my girlfriends photos of outfits none of us would be caught dead in, I decided to check in with two colleagues for their take on what’s trending in the world of medical device manufacturing in the United States and abroad.
Dan Gerbec is founder and president of Zigg Design, a Utah-based product development and manufacturing house. Like so many of us, he’s keeping a close eye on additive manufacturing. It’s the primary trend he’s tracking for a variety of reasons. He’s pondering how to add it to his suite of services as a manufacturing outsource provider, but the self-described “fatigue and fracture guy” said he tends to consider things from the perspective of how things might fail because of his background.
“I think there are some challenges there,” Gerbec said. “I don’t think they’re insurmountable, but they are significant.”
His chief concern is about the integrity of metals formed through an additive process.
“If we’re machining [implants] out of rods, the microstructure of these materials is very well controlled, the composition is very well controlled. We get very predictable behavior out of them,” he said. “With additive manufacturing, I’m not convinced we have good control of microstructures, particularly with titanium alloys. Most implantable titanium alloys are particularly sensitive to microstructure in terms of their fatigue behavior.
“When we make these material changes, which is basically what an additive manufactured component would be, we have to be very careful to understand what we have changed and what effect it has on the probability of failure.”
But again, this isn’t a deal-breaker. Gerbec said it’s similar to the evolution of materials for the aerospace industry through the 1950s and 1960s.
“They learned some hard lessons on how to process this material,” he said. “If we want to have structural integrity of those implants, we have to understand what they’re making them out of.”
A lesson he’s awaiting: how ever-advancing technology can be integrated into existing manufacturing shops at a realistic price point. Also, adopters of additive manufacturing need to focus on ensuring the biocompatibility, cleanliness, and structural integrity of the materials they’re using in the increasingly popular realm of custom implants, he said.
“I think if we don’t do it right, we run the risk of more regulation,” Gerbec said. “Few regulations were developed out of foresight, but rather, as a result of failures in the field. We have an opportunity to make sure we’re doing this correctly. If we run along too quickly and make some errors and harm some patients, then I think the FDA will have no choice but to come in and regulate it a little more.”
The industry needs to be proactive in self-policing and aware of potential pitfalls, he said. Like Mark Zuckerberg’s engagement on Capitol Hill with lawmakers discussing the regulation of social media platforms, Gerbec said members of the medical device industry must be part of the larger regulatory conversation concerning 3D printing.
“If we bring in the right expertise, we have the opportunity to do this in a safe and effective manner,” he said. “I believe we’re going to get there. It’s just a matter of how many times we stumble along the way.”
But he remains optimistic about the impact of additive manufacturing and its long-term benefits.
“I’m certainly excited about it, but I’m the sort of guy that wants to pull back on the reins,” Gerbec said. “I don’t want us to change the direction, I just want us to slow down a bit.”
For an international view on what’s trending in medical device manufacturing, I turned to Denis Leissing, CEO of Mediliant, a Swiss contract manufacturing company for medical devices. He said a series of issues are driving up the costs in manufacturing and the industry as a whole.
“Manufacturing processes are more digitalized and connected,” he said. “Coupled with stronger regulation on process controls, this will affect costs.”
Robotics are becoming increasingly common in the ever-evolving technical landscape of manufacturing, he added.
“Robots are becoming much more accessible in terms of price. [Robots are] less expensive and easier to integrate,” he said. “I think the idea behind that is to focus the people where you have the best use of their skills. For sure, robotics will somewhat help counterbalance some costs.”
For the industry as a whole, the increasing demand of data and managing larger volumes of it is also affecting manufacturing. New requirements for better process controls are part of what’s driving the demand for information, but that also means more data to process related to manufacturing.
“It’s somewhat unique for proper IT infrastructure to be able to scale in time to deal with the amount of data,” he said. “There’s always more and more data to track and manage.”
Leissing said new regulations will require more clinical evidence of device performance, leading to more costs during the design phase and post-market. All of these factors increasing expenses for medical device developers mean fewer products in the queue for market, he said.
And just like in the United States, additive manufacturing is becoming increasingly common even as it continues to be complex and expensive to integrate.
“If you want to use 3D printing, you need to understand and validate the process and it’s pretty cumbersome,” Leissing said. “There is kind of a hype behind it. It’s been used already for years in the medical device industry. There are some very specific applications for which it’s working pretty well. It does not replace all the other products, and I don’t think it will do so very rapidly.”
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
In my research on manufacturing trends, I went to some dark places courtesy of search parameters that weren’t nearly precise enough. Now I can’t unlearn that women my age are not only wearing neon and tie-dye, but other women write articles to help them do this on purpose.
I thought we were a village?
So rather than text my girlfriends photos of outfits none of us would be caught dead in, I decided to check in with two colleagues for their take on what’s trending in the world of medical device manufacturing in the United States and abroad.
Dan Gerbec is founder and president of Zigg Design, a Utah-based product development and manufacturing house. Like so many of us, he’s keeping a close eye on additive manufacturing. It’s the primary trend he’s tracking for a variety of reasons. He’s pondering how to add it to his suite of services as a manufacturing outsource provider, but the self-described “fatigue and fracture guy” said he tends to consider things from the perspective of how things might fail because of his background.
“I think there are some challenges there,” Gerbec said. “I don’t think they’re insurmountable, but they are significant.”
His chief concern is about the integrity of metals formed through an additive process.
“If we’re machining [implants] out of rods, the microstructure of these materials is very well controlled, the composition is very well controlled. We get very predictable behavior out of them,” he said. “With additive manufacturing, I’m not convinced we have good control of microstructures, particularly with titanium alloys. Most implantable titanium alloys are particularly sensitive to microstructure in terms of their fatigue behavior.
“When we make these material changes, which is basically what an additive manufactured component would be, we have to be very careful to understand what we have changed and what effect it has on the probability of failure.”
But again, this isn’t a deal-breaker. Gerbec said it’s similar to the evolution of materials for the aerospace industry through the 1950s and 1960s.
“They learned some hard lessons on how to process this material,” he said. “If we want to have structural integrity of those implants, we have to understand what they’re making them out of.”
A lesson he’s awaiting: how ever-advancing technology can be integrated into existing manufacturing shops at a realistic price point. Also, adopters of additive manufacturing need to focus on ensuring the biocompatibility, cleanliness, and structural integrity of the materials they’re using in the increasingly popular realm of custom implants, he said.
“I think if we don’t do it right, we run the risk of more regulation,” Gerbec said. “Few regulations were developed out of foresight, but rather, as a result of failures in the field. We have an opportunity to make sure we’re doing this correctly. If we run along too quickly and make some errors and harm some patients, then I think the FDA will have no choice but to come in and regulate it a little more.”
The industry needs to be proactive in self-policing and aware of potential pitfalls, he said. Like Mark Zuckerberg’s engagement on Capitol Hill with lawmakers discussing the regulation of social media platforms, Gerbec said members of the medical device industry must be part of the larger regulatory conversation concerning 3D printing.
“If we bring in the right expertise, we have the opportunity to do this in a safe and effective manner,” he said. “I believe we’re going to get there. It’s just a matter of how many times we stumble along the way.”
But he remains optimistic about the impact of additive manufacturing and its long-term benefits.
“I’m certainly excited about it, but I’m the sort of guy that wants to pull back on the reins,” Gerbec said. “I don’t want us to change the direction, I just want us to slow down a bit.”
For an international view on what’s trending in medical device manufacturing, I turned to Denis Leissing, CEO of Mediliant, a Swiss contract manufacturing company for medical devices. He said a series of issues are driving up the costs in manufacturing and the industry as a whole.
“Manufacturing processes are more digitalized and connected,” he said. “Coupled with stronger regulation on process controls, this will affect costs.”
Robotics are becoming increasingly common in the ever-evolving technical landscape of manufacturing, he added.
“Robots are becoming much more accessible in terms of price. [Robots are] less expensive and easier to integrate,” he said. “I think the idea behind that is to focus the people where you have the best use of their skills. For sure, robotics will somewhat help counterbalance some costs.”
For the industry as a whole, the increasing demand of data and managing larger volumes of it is also affecting manufacturing. New requirements for better process controls are part of what’s driving the demand for information, but that also means more data to process related to manufacturing.
“It’s somewhat unique for proper IT infrastructure to be able to scale in time to deal with the amount of data,” he said. “There’s always more and more data to track and manage.”
Leissing said new regulations will require more clinical evidence of device performance, leading to more costs during the design phase and post-market. All of these factors increasing expenses for medical device developers mean fewer products in the queue for market, he said.
And just like in the United States, additive manufacturing is becoming increasingly common even as it continues to be complex and expensive to integrate.
“If you want to use 3D printing, you need to understand and validate the process and it’s pretty cumbersome,” Leissing said. “There is kind of a hype behind it. It’s been used already for years in the medical device industry. There are some very specific applications for which it’s working pretty well. It does not replace all the other products, and I don’t think it will do so very rapidly.”
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
