Dawn A. Lissy, President & Founder, Empirical02.13.19
As the mom of a young teen, I get a daily, real-time view of the of the challenges of a human doing his best to grow up. There are a lot of false starts, half-baked ideas, and epic fails, but there’s also tremendous potential and frequent victories.
As the owner of a family of companies supporting the path to market for a range of medical devices, I see a lot of that same awkwardness in emerging markets and new technologies. Our industry is built on and powered by innovation, so it’s constantly growing and changing—not unlike my 13-year-old son.
One segment of our industry I’m following closely is additive manufacturing. Since its introduction in the 1980s, the process has grown into a $7 billion industry as of 2018. Its application in the medical device industry is also growing. Since the first medical device with metallic parts from a 3D printer gained clearance in 2010, more than 85 new products have followed.
In 2016, I wrote that there were no 3D print shops specializing in medical devices and the potential pitfalls of that gap. (Read “3D Printing: Third Industrial Revolution or Productivity Stalemate?” in the October 2016 issue of MPO.) The demand and interest in this process is growing. But like a gawky teenager, this segment of our industry is still developing and facing its share of challenges.
At Empirical, we’ve considered diving into the waters of 3D printing to add to our options to support clients on their paths to market. But much like I refused to buy the first iPhone, I’m reluctant to invest time, money, and people until I have a better understanding of where the industry is headed and how it fits into my established wheelhouse of mechanical testing and regulatory support.
At a recent ASTM conference in Washington, D.C., which focused on additive manufacturing, the question I received repeatedly was: Will the U.S. Food and Drug Administration (FDA) require new ASTM/ISO standards for testing products made by a 3D printer? From a mechanical performance standpoint, additive manufacturing does not cause any changes. I know from experience the FDA’s concern is solely that the mechanical performance of a finished device meets the current bar of substantial equivalence. I don’t see any significant changes pending in mechanical characterization regulatory requirements for devices crafted through 3D printing, except for the scrutiny in ensuring the manufacturing process is validated and well documented.
But that’s one of the very few aspects of the industry not changing right now. Tom Barrett is the president of Oerlikon AM Medical. The company, formerly owned by Arcam and GE Additive, was an early adopter of the technology and my go-to source for how 3D printing is affecting our industry and why we should all be paying attention to its growth curve. Barrett has been working in the orthopedic industry for more than 25 years with both large original equipment manufacturers and contract manufacturers. He has been working with evidence-based medicine and laser-additive technologies for the past three years as a contract manufacturer.
He said it’s not just the technology that’s evolving and becoming simpler—support services for additive manufacturing are also on the rise.
“It’s maturing, but I wouldn’t say it’s mature,” Barrett said of 3D printing in the medical device space. “It’s still evolving. But I do think the technology is becoming more robust, and I think the processes and technology are becoming more consistent. It’s driving more toward the industrialization of the technology.”
So there are more resources to help grow your business in that direction. But given how quickly technology is advancing, Barrett said businesses like his are grappling with big, expensive decisions.
“It’s complex,” he said. “Settling in and picking one [type of technology] is going to be a challenge in the future. It takes a while to get there. You drop a piece of equipment on the floor, it’s a year before you are ready for production, with your process validations, procedures, and qualification and validation of a product. If you pick a technology that doesn’t go mainstream, that’s going be a big swing and a miss.”
In addition to the rapidly changing capabilities of the machines, another consideration: Do you develop a business around the potential growth of the process, or around the potential needs of your existing client base?
“Is it, ‘If you build it, they will come’?” Barrett asked. “It almost becomes, do you partner with your customers to understand what they need and make sure you’re aligned? Do you need to become closer with the client to make sure we’re investing in the right equipment and technology to meet their needs?”
The commitment goes beyond just the purchase of machinery.
“It’s a big investment,” he said. “It’s equipment. It’s new software. It’s people— people dedicated to learning the technology. It’s money and lots of time. This isn’t a CNC machine you just drop on the floor and you’re in business. There’s a lot more to additive manufacturing than just printing of the part.”
At this point, the technology advances and commercialization are outpacing the growth of actual bodies to operate those systems, Barrett said.
“There are still a very limited amount of skilled resources that might know additive design, additive manufacturing. I think that’s going to challenge the industry in regards to how do we train more people,” he said, adding when his son recently graduated with a bachelor’s degree in engineering, additive manufacturing wasn’t part of his studies. “Our ability to leverage that new technology might be limited by human resources.”
But all these issues are essentially growing pains of an industry that’s here to stay.
“Personally, I think we’re beyond the fad phase,” Barrett said. “The cost has come down…I still think there are technology improvements we’re going to see, efficiency improvements we’re going to see. We’re going to continue to evolve as an industry and become more effective and more commercially robust as that technology advances.”
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.
As the owner of a family of companies supporting the path to market for a range of medical devices, I see a lot of that same awkwardness in emerging markets and new technologies. Our industry is built on and powered by innovation, so it’s constantly growing and changing—not unlike my 13-year-old son.
One segment of our industry I’m following closely is additive manufacturing. Since its introduction in the 1980s, the process has grown into a $7 billion industry as of 2018. Its application in the medical device industry is also growing. Since the first medical device with metallic parts from a 3D printer gained clearance in 2010, more than 85 new products have followed.
In 2016, I wrote that there were no 3D print shops specializing in medical devices and the potential pitfalls of that gap. (Read “3D Printing: Third Industrial Revolution or Productivity Stalemate?” in the October 2016 issue of MPO.) The demand and interest in this process is growing. But like a gawky teenager, this segment of our industry is still developing and facing its share of challenges.
At Empirical, we’ve considered diving into the waters of 3D printing to add to our options to support clients on their paths to market. But much like I refused to buy the first iPhone, I’m reluctant to invest time, money, and people until I have a better understanding of where the industry is headed and how it fits into my established wheelhouse of mechanical testing and regulatory support.
At a recent ASTM conference in Washington, D.C., which focused on additive manufacturing, the question I received repeatedly was: Will the U.S. Food and Drug Administration (FDA) require new ASTM/ISO standards for testing products made by a 3D printer? From a mechanical performance standpoint, additive manufacturing does not cause any changes. I know from experience the FDA’s concern is solely that the mechanical performance of a finished device meets the current bar of substantial equivalence. I don’t see any significant changes pending in mechanical characterization regulatory requirements for devices crafted through 3D printing, except for the scrutiny in ensuring the manufacturing process is validated and well documented.
But that’s one of the very few aspects of the industry not changing right now. Tom Barrett is the president of Oerlikon AM Medical. The company, formerly owned by Arcam and GE Additive, was an early adopter of the technology and my go-to source for how 3D printing is affecting our industry and why we should all be paying attention to its growth curve. Barrett has been working in the orthopedic industry for more than 25 years with both large original equipment manufacturers and contract manufacturers. He has been working with evidence-based medicine and laser-additive technologies for the past three years as a contract manufacturer.
He said it’s not just the technology that’s evolving and becoming simpler—support services for additive manufacturing are also on the rise.
“It’s maturing, but I wouldn’t say it’s mature,” Barrett said of 3D printing in the medical device space. “It’s still evolving. But I do think the technology is becoming more robust, and I think the processes and technology are becoming more consistent. It’s driving more toward the industrialization of the technology.”
So there are more resources to help grow your business in that direction. But given how quickly technology is advancing, Barrett said businesses like his are grappling with big, expensive decisions.
“It’s complex,” he said. “Settling in and picking one [type of technology] is going to be a challenge in the future. It takes a while to get there. You drop a piece of equipment on the floor, it’s a year before you are ready for production, with your process validations, procedures, and qualification and validation of a product. If you pick a technology that doesn’t go mainstream, that’s going be a big swing and a miss.”
In addition to the rapidly changing capabilities of the machines, another consideration: Do you develop a business around the potential growth of the process, or around the potential needs of your existing client base?
“Is it, ‘If you build it, they will come’?” Barrett asked. “It almost becomes, do you partner with your customers to understand what they need and make sure you’re aligned? Do you need to become closer with the client to make sure we’re investing in the right equipment and technology to meet their needs?”
The commitment goes beyond just the purchase of machinery.
“It’s a big investment,” he said. “It’s equipment. It’s new software. It’s people— people dedicated to learning the technology. It’s money and lots of time. This isn’t a CNC machine you just drop on the floor and you’re in business. There’s a lot more to additive manufacturing than just printing of the part.”
At this point, the technology advances and commercialization are outpacing the growth of actual bodies to operate those systems, Barrett said.
“There are still a very limited amount of skilled resources that might know additive design, additive manufacturing. I think that’s going to challenge the industry in regards to how do we train more people,” he said, adding when his son recently graduated with a bachelor’s degree in engineering, additive manufacturing wasn’t part of his studies. “Our ability to leverage that new technology might be limited by human resources.”
But all these issues are essentially growing pains of an industry that’s here to stay.
“Personally, I think we’re beyond the fad phase,” Barrett said. “The cost has come down…I still think there are technology improvements we’re going to see, efficiency improvements we’re going to see. We’re going to continue to evolve as an industry and become more effective and more commercially robust as that technology advances.”
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.
