Ranica Arrowsmith, Associate Editor09.16.14
When I got Dawn Lissy on the phone to interview her for this story, we were talking for about 10 minutes before I heard the familiar, yet invasive “beep…beep…beep” sound of a truck backing up. She politely asked me to hold on for a second. After returning, she jumped right back into our conversation on orthopedic device testing without skipping a beat, after apologizing and telling me she was moving and had to deal with some logistical issues. I wouldn’t have had any idea she was talking to me amid the chaos of moving to a new house had she not had to step away for a moment. I was soon to learn that this kind of focus and go-getter attitude is exactly what makes Lissy tick.
Back in the 1990s, Lissy was frustrated. A biomedical engineer by training, she was a partner on the Trauma Tumor Team at AcroMed (since bought by DePuy and then Johnson & Johnson), and she was constantly fighting a battle to find competent orthopedic device testing companies. She found herself complaining about the testing industry missing a certain service niche. No one testing provider was able to provide her with all the services and competencies she needed at once.
Her husband Chris asked her a simple question: Why not do it yourself?
So she did.
At AcroMed, she was one of two people responsible for one of the small business units, which essentially gave her a crash course (in her words) on how to run a business. In 1998, Lissy wrote a business plan, secured a Small Business Administration loan, bought her first test frame, and founded Empirical Testing Corp. After almost 16 years, the company she founded has grown to become Empirical Technologies, and is the umbrella above three separate companies: Empirical Testing Corp., Empirical Consulting LLC and Empirical Machine LLC. After expanding the company’s services, Chris, who previously served as vice president (and business partner), took on the role of CEO, which made best sense strategically; Dawn became president and founder.
When Empirical Testing was founded, most of the testing the company did was for spinal implants, Lissy told Orthopedic Design & Technology. “At the time, that market was booming, had been booming, and still is in its own right booming compared to other orthopedic market segments,” she said. “We evolved as the market has evolved. We have always done other types of medical device testing, but we weren’t very active in promoting that fact. That changed about five years ago.”
Empirical now offers biomechanical testing services for large and small joint implant testing in a large swath of markets such as trauma, sports medicine, external fixation, dental, cranio-maxillofacial and more, as long as the devices fall under metals or polymers. And the key, Lissy said, to Empirical’s unique testing approach, is to get in on the ground floor with its clients.
“We try to get involved with a project in its design phase, before they manufacture. We want to make sure we have the right number of parts, we’re testing the right components, we have the right size, and we have the right everything, because its very expensive if you don’t.”
When Lissy opened the doors to Empirical, she set out to create the company she had wanted to work with when she was with an OEM (original equipment manufacturer) but couldn’t find. As part of achieving that end, Empirical has several representatives active in ASTM International (known until 2001 as the American Society for Testing and Materials), a West Conshohocken, Pa.-based standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems and services.
“We’re also taking a proactive approach to partner with the FDA (U.S. Food and Drug Administration) whenever possible,” Lissy said. “For instance, when artificial discs were coming to market, they were a class III device and were going to require both characterization and wear testing. But there wasn’t a respective ASTM or ISO (International Organization for Standardization) standard that outlined wear testing. So Chris and I went to the FDA and just asked them what it would be looking for. We then took that testing criteria, worked directly with our vendor and built a machine to do that testing.”
As far as differentiating its contract testing services, Empirical Testing even features a blog on its company website. An entry from January last year describes Lissy’s experience with the FDA’s Entrepreneurs-in-Residence.
“As a biomedical engineer and a person who’s started a small business, I understand there’s always a simpler, more efficient, safer way to get from point A to point B,” Lissy said at the time. “Like so many entrepreneurs, I have experience streamlining processes and focusing on the fundamentals.”
During the Entrepreneurs-in-Residence program, she and the other participants looked at three different pathways to innovation. Lissy was part of a “tactical team” that examined streamlining clinical trials.
“I was one of eight industry folks working with 22 FDA folks; and one of only two people in the entire program that represented orthopedics,” Lissy recalled. She took the insights from the program back to her 30-plus employees at Empirical to make sure they, like her, stayed plugged in to the FDA as to how to best help their clients meet the agency’s expectations.
The FDA’s Center for Devices and Radiological Health created a document based on the ongoing efforts of the program, titled “2014-1025 Strategic Priorities.” It outlines objectives such as 90 percent customer satisfaction by Dec. 31 next year, and the full review of 100 percent of device types subject to premarket approval that have been on the market to determine whether premarket data requirements should be re-assessed. “Patients are at the heart of what we do,” the report reads in its introduction page. “It’s no coincidence that our vision starts with patients: ‘Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world.’ We want our actions to improve the health, and enhance the quality of life of patients. If a device is safe and effective, we want patients to have access to it as quickly as possible.”1
Testing is, no doubt, an integral part of that overall vision.
OEMs and Regulators: What Do They Want?
“Clients’ demands typically fall into two categories: technical expertise and timing,” Kevin Knight, president of Fort Wayne, Ind.-based Knight Mechanical Testing LLC, told ODT. “On the project planning side, they rely on our expertise to develop the test plan to satisfy regulatory requirements and address any risk unique to their device that may be mitigated with mechanical testing. Obviously, in the testing phase, our customers count on us to provide accurate, timely data as well as monitor the results in the event they are not meeting established acceptance criteria. The last thing our customers want is to run unnecessary tests that may last weeks or months on a design that has proven to be inadequate in the first few days of testing. In this situation, our customers often rely on our guidance to improve their device using the analytical tools at our disposal including FEA (finite element analysis), SEM (scanning electron microscope), and 3-D optical microscopy. Finally, even after the testing is complete on a successful design, we are often engaged in addressing any additional information requested by the regulatory agency. Many times this is the most critical phase of the project, as the customer is subject to strict deadlines to address these issues.”
Empirical Testing, too, has added FEA to its list of offerings. The process was first developed in 1943 by R. Courant. FEA consists of a computer model of a material or design that is stressed and analyzed for specific results. It is used in new product design and existing product refinement. A company is able to verify a proposed design will be able to perform to the client’s specifications prior to manufacturing or construction. In case of structural failure, FEA may be used to help determine the design modifications to meet the new condition.2
“When you test for a class II device, you need to determine what represents the worst case for the entire family of devices and then test that size,” Lissy explained. “That allows you to obtain 510(k) clearance for the whole group of devices.
“Imagine when you had simple plates, pedicle screws and rods,” she continued. “Determining worst case scenario was as simple as determining the smallest diameter. As technologies and geometries have evolved and become more complex, you can’t just look at a device family and say ‘this is obviously the worst case and here’s why.’ You have to do comprehensive testing, which is expensive because you have to make multiple components of different sizes and test all of them. Or, you can use FEA to determine worst case.”
FEA now increasingly is being recognized as a useful tool for eliminating costly and needless tests. Parker Hannifin Corp., a motion-control technology company based in Cleveland, Ohio, that makes the new exoskeleton device Indego, uses FEA to “meet FDA expectations.” According to the company website, FEA is increasingly being used for the design of complex medical devices, especially those made from plastic or rubber. It is a sophisticated computer modeling program that shows a visual simulation of how materials for a proposed product might perform during the proposed use, using on-screen virtual environments. Material performance over a range of conditions is tested to see if the product will perform as expected, or if the design needs to be adjusted. FEA can be repeated as many times as needed to fine-tune the design and make the final product as strong, functional and reliable as possible. The process is completed before any prototyping, mold design or production is undertaken, reducing the possibility of errors or redesign issues occurring later. Proper use of FEA greatly can improve both the speed and the quality of product design, reducing overall cost.
Highpower Validation Testing & Lab Services Inc., a Rochester, N.Y.-based sterilization testing and cleaning services provider, has seen a clash between European and U.S. regulatory demands and allowances. President Gary Socola explained that while European regulators allow the use of radionuclide and bioburden testing during cleaning validation studies, “the U.S. FDA is unfamiliar with these methods and this can stall a 510(k) submission or result in a non-equivalency decision.
“Many of our European customers test using hemoglobin and this marker is accepted by the FDA,” Socola continued. “Highpower is currently validating our cleaning process with hemoglobin and we will be adding this marker to our cleaning study program very soon. The atmosphere within the FDA’s Office of Device Evaluation is certainly more difficult now than it has been in the past. We are seeing an increase in more device cleaning validations but more importantly, we see an increase in request for combination device cleaning and sterilization test data. The FDA wants to see not only repetitive sterilization processing of a device but also the device cleaning steps being performed in conjunction with the sterilization data to support functionality and usage claims. This can create a substantial amount of data if your device has a long usability life in the field.”
Emily F. Mitzel, laboratory manager for Nelson Laboratories Inc., a Salt Lake City, Utah-based microbiology testing services provider, added one more piece to the puzzle of demands from various stakeholders: what needs and wants does the hospital, in which these devices will be used, have?
“Devices are becoming more complex, thus necessitating increased testing,” she said. “We need to ensure that the healthcare facility can reprocess these devices easily and efficiently.”
Device Trends Affect Testing Trends
With an eye to the future, ODT asked our experts what trends they are observing in orthopedic device innovation, and how it is affecting their testing business.
ODT: Have there been any trends lately as to what kinds of orthopedic devices and components you are called upon to test? How have these trends affected your approaches to testing?
Bill Greene, CEO and vice president of business development for Level 3 Inspection, a Stuart, Fla.-based testing services company that provides white-light scanning and computer-aided inspection (CAI) for precision-manufactured products and tooling: “All of our clients really like the CAI results we’ve provided them, but the repercussions that occur when they learn something new from considering 10,000-times more inspection information with our comprehensive inspection, they are not always able to just improve the process and make better parts, which they should. This is mainly due to regulatory agencies’ negative reaction to more information, which is not the best way to work with the industry. So the trend continues to be leveraging these advantages on new products even though we can help improve performance of legacy products equally or more.
“In addition to full 3-D geometry comprehensiveness, and 2-5 micron accuracies, we are focused on delivering throughput speed in our CAI processes with our automated smart inspection station achieving single-digit minutes inspection time. This fully automated system is not only faster than any other method of dimensional inspection, but it produces much easier to understand results that better support engineering decisions on manufacturing process resolution and optimization. Plus it eliminates human input and the chance for human error.”
Maciej Jakucki is associate director of engineering operations for Accutek Testing Laboratory, a Fairfield, Ohio-based testing services company: “There has been a significant increase in wear testing of joint replacement devices such as hips, knees, and shoulders. We have seen more side-by-side testing required to evaluate performance, rather than reliance on published literature. This stems from observed physiological patient issues and the onset of new products in the market. The testing can be difficult to perform, especially from a physiological simulation standpoint, and proper evaluation is limited to a handful of laboratories. In response, Accutek has increased traditional implant wear testing capacity, as well as our pin on disc wear testing capabilities over the last two years. We look forward to continuing to be on the cutting edge of testing groundbreaking new products.
“New specifications are developed and released throughout the year to address emerging technologies. Participation in committees such as ASTM allows us to share our expertise and be at the forefront of developing new methodologies. While these test standards are helpful in evaluating traditional devices, new devices often require a combination of existing specifications and custom methods to address unique device features. In these instances, Accutek’s team consults with clients up front to determine proper methodology and agree upon protocol requirements prior to beginning the project. Our involvement in ASTM committees and our vast experience in the medical device industry often provide insight to clients developing these novel devices.
“In terms of different approaches, wear testing is in the vanguard of advancement in the medical device industry. Hips and knees have been exposed to years of evaluation, yet there is still much room for improvement. Other joints such as shoulders are going to require advanced technology to evaluate and accurately represent the physiological motions.” Knight: “Broadly stated, yes there are definitely trends to the devices we are called upon to test. Without getting into specific trends with respect to each part of the body—spine, extremities, large joint—I think it is fair to say that the overall trends in device design are driven by one of two factors—patient safety and cost. The industry is always trying to design implants that require smaller incisions and fewer steps, which leads to less trauma and a lower risk of infection to the patient. Often, the intellectual property pertaining to a device might actually lie in the surgical technique and instrumentation, and so we have seen quite a bit of innovate solutions in that realm as well. Additive manufacturing holds the promise of rapid production of patient specific implants, allowing the surgeon to remove less healthy bone and improve fit. However, patient-specific implants present a testing challenge because there is no defined product line from which you can select the smallest or weakest size for testing. Because the final form is unknown, and since the timeline between design, manufacturing and implantation may be as short as a few days, mechanical testing cannot be used to validate a patient specific implant after it is created. Instead, mechanical testing must be used to generate guidelines and design parameters that are inputs into the rapid development process itself.”
Socola: “There have always been complex orthopedic devices and there will always be new complex orthopedic devices Many devices are now so complex that they have to be designed to be taken apart for cleaning and sterilization. We are seeing this a lot in reconstructive spine and trauma sets from orthopedic companies. But what’s challenging as a validation lab is finding a way of placing a biological indicator challenge in the worst case location of a complex device whether it be a scope, shaver or drill—or any device with a complex mobility).”
Lissy: “We’ve seen a lot of changes in external fixation devices—a lot of combinations of materials/technologies to make them more user- and patient-friendly. Patient compliance is a vital part of success, so making devices easier to use will bring better success.
“For spinal implants, OEMs are trying to find ways to eliminate the need to go from pain management and physical therapy straight to spine fusion, which is very invasive. There is a focus on minimally invasive surgical devices such as interspinous plate systems. Test methods weren’t developed for this kind of evolution of these kinds of emerging technologies. They were developed for the baseline of the more invasive device. So we’ve had to adapt test blocks, fixtures and test configurations to meet the challenges of testing as technology evolves.
“In large joints we’re seeing things like adding vitamin E to polymers to fight infection. Engineers are trying to take technologies that have existed and the application of existing technologies and improve upon them so there’s better success in patients.”
References
Back in the 1990s, Lissy was frustrated. A biomedical engineer by training, she was a partner on the Trauma Tumor Team at AcroMed (since bought by DePuy and then Johnson & Johnson), and she was constantly fighting a battle to find competent orthopedic device testing companies. She found herself complaining about the testing industry missing a certain service niche. No one testing provider was able to provide her with all the services and competencies she needed at once.
Her husband Chris asked her a simple question: Why not do it yourself?
So she did.
At AcroMed, she was one of two people responsible for one of the small business units, which essentially gave her a crash course (in her words) on how to run a business. In 1998, Lissy wrote a business plan, secured a Small Business Administration loan, bought her first test frame, and founded Empirical Testing Corp. After almost 16 years, the company she founded has grown to become Empirical Technologies, and is the umbrella above three separate companies: Empirical Testing Corp., Empirical Consulting LLC and Empirical Machine LLC. After expanding the company’s services, Chris, who previously served as vice president (and business partner), took on the role of CEO, which made best sense strategically; Dawn became president and founder.
When Empirical Testing was founded, most of the testing the company did was for spinal implants, Lissy told Orthopedic Design & Technology. “At the time, that market was booming, had been booming, and still is in its own right booming compared to other orthopedic market segments,” she said. “We evolved as the market has evolved. We have always done other types of medical device testing, but we weren’t very active in promoting that fact. That changed about five years ago.”
Empirical now offers biomechanical testing services for large and small joint implant testing in a large swath of markets such as trauma, sports medicine, external fixation, dental, cranio-maxillofacial and more, as long as the devices fall under metals or polymers. And the key, Lissy said, to Empirical’s unique testing approach, is to get in on the ground floor with its clients.
“We try to get involved with a project in its design phase, before they manufacture. We want to make sure we have the right number of parts, we’re testing the right components, we have the right size, and we have the right everything, because its very expensive if you don’t.”
When Lissy opened the doors to Empirical, she set out to create the company she had wanted to work with when she was with an OEM (original equipment manufacturer) but couldn’t find. As part of achieving that end, Empirical has several representatives active in ASTM International (known until 2001 as the American Society for Testing and Materials), a West Conshohocken, Pa.-based standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems and services.
“We’re also taking a proactive approach to partner with the FDA (U.S. Food and Drug Administration) whenever possible,” Lissy said. “For instance, when artificial discs were coming to market, they were a class III device and were going to require both characterization and wear testing. But there wasn’t a respective ASTM or ISO (International Organization for Standardization) standard that outlined wear testing. So Chris and I went to the FDA and just asked them what it would be looking for. We then took that testing criteria, worked directly with our vendor and built a machine to do that testing.”
As far as differentiating its contract testing services, Empirical Testing even features a blog on its company website. An entry from January last year describes Lissy’s experience with the FDA’s Entrepreneurs-in-Residence.
“As a biomedical engineer and a person who’s started a small business, I understand there’s always a simpler, more efficient, safer way to get from point A to point B,” Lissy said at the time. “Like so many entrepreneurs, I have experience streamlining processes and focusing on the fundamentals.”
During the Entrepreneurs-in-Residence program, she and the other participants looked at three different pathways to innovation. Lissy was part of a “tactical team” that examined streamlining clinical trials.
“I was one of eight industry folks working with 22 FDA folks; and one of only two people in the entire program that represented orthopedics,” Lissy recalled. She took the insights from the program back to her 30-plus employees at Empirical to make sure they, like her, stayed plugged in to the FDA as to how to best help their clients meet the agency’s expectations.
The FDA’s Center for Devices and Radiological Health created a document based on the ongoing efforts of the program, titled “2014-1025 Strategic Priorities.” It outlines objectives such as 90 percent customer satisfaction by Dec. 31 next year, and the full review of 100 percent of device types subject to premarket approval that have been on the market to determine whether premarket data requirements should be re-assessed. “Patients are at the heart of what we do,” the report reads in its introduction page. “It’s no coincidence that our vision starts with patients: ‘Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world.’ We want our actions to improve the health, and enhance the quality of life of patients. If a device is safe and effective, we want patients to have access to it as quickly as possible.”1
Testing is, no doubt, an integral part of that overall vision.
OEMs and Regulators: What Do They Want?
“Clients’ demands typically fall into two categories: technical expertise and timing,” Kevin Knight, president of Fort Wayne, Ind.-based Knight Mechanical Testing LLC, told ODT. “On the project planning side, they rely on our expertise to develop the test plan to satisfy regulatory requirements and address any risk unique to their device that may be mitigated with mechanical testing. Obviously, in the testing phase, our customers count on us to provide accurate, timely data as well as monitor the results in the event they are not meeting established acceptance criteria. The last thing our customers want is to run unnecessary tests that may last weeks or months on a design that has proven to be inadequate in the first few days of testing. In this situation, our customers often rely on our guidance to improve their device using the analytical tools at our disposal including FEA (finite element analysis), SEM (scanning electron microscope), and 3-D optical microscopy. Finally, even after the testing is complete on a successful design, we are often engaged in addressing any additional information requested by the regulatory agency. Many times this is the most critical phase of the project, as the customer is subject to strict deadlines to address these issues.”
Empirical Testing, too, has added FEA to its list of offerings. The process was first developed in 1943 by R. Courant. FEA consists of a computer model of a material or design that is stressed and analyzed for specific results. It is used in new product design and existing product refinement. A company is able to verify a proposed design will be able to perform to the client’s specifications prior to manufacturing or construction. In case of structural failure, FEA may be used to help determine the design modifications to meet the new condition.2
“When you test for a class II device, you need to determine what represents the worst case for the entire family of devices and then test that size,” Lissy explained. “That allows you to obtain 510(k) clearance for the whole group of devices.
“Imagine when you had simple plates, pedicle screws and rods,” she continued. “Determining worst case scenario was as simple as determining the smallest diameter. As technologies and geometries have evolved and become more complex, you can’t just look at a device family and say ‘this is obviously the worst case and here’s why.’ You have to do comprehensive testing, which is expensive because you have to make multiple components of different sizes and test all of them. Or, you can use FEA to determine worst case.”
FEA now increasingly is being recognized as a useful tool for eliminating costly and needless tests. Parker Hannifin Corp., a motion-control technology company based in Cleveland, Ohio, that makes the new exoskeleton device Indego, uses FEA to “meet FDA expectations.” According to the company website, FEA is increasingly being used for the design of complex medical devices, especially those made from plastic or rubber. It is a sophisticated computer modeling program that shows a visual simulation of how materials for a proposed product might perform during the proposed use, using on-screen virtual environments. Material performance over a range of conditions is tested to see if the product will perform as expected, or if the design needs to be adjusted. FEA can be repeated as many times as needed to fine-tune the design and make the final product as strong, functional and reliable as possible. The process is completed before any prototyping, mold design or production is undertaken, reducing the possibility of errors or redesign issues occurring later. Proper use of FEA greatly can improve both the speed and the quality of product design, reducing overall cost.
Highpower Validation Testing & Lab Services Inc., a Rochester, N.Y.-based sterilization testing and cleaning services provider, has seen a clash between European and U.S. regulatory demands and allowances. President Gary Socola explained that while European regulators allow the use of radionuclide and bioburden testing during cleaning validation studies, “the U.S. FDA is unfamiliar with these methods and this can stall a 510(k) submission or result in a non-equivalency decision.
“Many of our European customers test using hemoglobin and this marker is accepted by the FDA,” Socola continued. “Highpower is currently validating our cleaning process with hemoglobin and we will be adding this marker to our cleaning study program very soon. The atmosphere within the FDA’s Office of Device Evaluation is certainly more difficult now than it has been in the past. We are seeing an increase in more device cleaning validations but more importantly, we see an increase in request for combination device cleaning and sterilization test data. The FDA wants to see not only repetitive sterilization processing of a device but also the device cleaning steps being performed in conjunction with the sterilization data to support functionality and usage claims. This can create a substantial amount of data if your device has a long usability life in the field.”
Emily F. Mitzel, laboratory manager for Nelson Laboratories Inc., a Salt Lake City, Utah-based microbiology testing services provider, added one more piece to the puzzle of demands from various stakeholders: what needs and wants does the hospital, in which these devices will be used, have?
“Devices are becoming more complex, thus necessitating increased testing,” she said. “We need to ensure that the healthcare facility can reprocess these devices easily and efficiently.”
Device Trends Affect Testing Trends
With an eye to the future, ODT asked our experts what trends they are observing in orthopedic device innovation, and how it is affecting their testing business.
ODT: Have there been any trends lately as to what kinds of orthopedic devices and components you are called upon to test? How have these trends affected your approaches to testing?
Bill Greene, CEO and vice president of business development for Level 3 Inspection, a Stuart, Fla.-based testing services company that provides white-light scanning and computer-aided inspection (CAI) for precision-manufactured products and tooling: “All of our clients really like the CAI results we’ve provided them, but the repercussions that occur when they learn something new from considering 10,000-times more inspection information with our comprehensive inspection, they are not always able to just improve the process and make better parts, which they should. This is mainly due to regulatory agencies’ negative reaction to more information, which is not the best way to work with the industry. So the trend continues to be leveraging these advantages on new products even though we can help improve performance of legacy products equally or more.
“In addition to full 3-D geometry comprehensiveness, and 2-5 micron accuracies, we are focused on delivering throughput speed in our CAI processes with our automated smart inspection station achieving single-digit minutes inspection time. This fully automated system is not only faster than any other method of dimensional inspection, but it produces much easier to understand results that better support engineering decisions on manufacturing process resolution and optimization. Plus it eliminates human input and the chance for human error.”
Maciej Jakucki is associate director of engineering operations for Accutek Testing Laboratory, a Fairfield, Ohio-based testing services company: “There has been a significant increase in wear testing of joint replacement devices such as hips, knees, and shoulders. We have seen more side-by-side testing required to evaluate performance, rather than reliance on published literature. This stems from observed physiological patient issues and the onset of new products in the market. The testing can be difficult to perform, especially from a physiological simulation standpoint, and proper evaluation is limited to a handful of laboratories. In response, Accutek has increased traditional implant wear testing capacity, as well as our pin on disc wear testing capabilities over the last two years. We look forward to continuing to be on the cutting edge of testing groundbreaking new products.
“New specifications are developed and released throughout the year to address emerging technologies. Participation in committees such as ASTM allows us to share our expertise and be at the forefront of developing new methodologies. While these test standards are helpful in evaluating traditional devices, new devices often require a combination of existing specifications and custom methods to address unique device features. In these instances, Accutek’s team consults with clients up front to determine proper methodology and agree upon protocol requirements prior to beginning the project. Our involvement in ASTM committees and our vast experience in the medical device industry often provide insight to clients developing these novel devices.
“In terms of different approaches, wear testing is in the vanguard of advancement in the medical device industry. Hips and knees have been exposed to years of evaluation, yet there is still much room for improvement. Other joints such as shoulders are going to require advanced technology to evaluate and accurately represent the physiological motions.” Knight: “Broadly stated, yes there are definitely trends to the devices we are called upon to test. Without getting into specific trends with respect to each part of the body—spine, extremities, large joint—I think it is fair to say that the overall trends in device design are driven by one of two factors—patient safety and cost. The industry is always trying to design implants that require smaller incisions and fewer steps, which leads to less trauma and a lower risk of infection to the patient. Often, the intellectual property pertaining to a device might actually lie in the surgical technique and instrumentation, and so we have seen quite a bit of innovate solutions in that realm as well. Additive manufacturing holds the promise of rapid production of patient specific implants, allowing the surgeon to remove less healthy bone and improve fit. However, patient-specific implants present a testing challenge because there is no defined product line from which you can select the smallest or weakest size for testing. Because the final form is unknown, and since the timeline between design, manufacturing and implantation may be as short as a few days, mechanical testing cannot be used to validate a patient specific implant after it is created. Instead, mechanical testing must be used to generate guidelines and design parameters that are inputs into the rapid development process itself.”
Socola: “There have always been complex orthopedic devices and there will always be new complex orthopedic devices Many devices are now so complex that they have to be designed to be taken apart for cleaning and sterilization. We are seeing this a lot in reconstructive spine and trauma sets from orthopedic companies. But what’s challenging as a validation lab is finding a way of placing a biological indicator challenge in the worst case location of a complex device whether it be a scope, shaver or drill—or any device with a complex mobility).”
Lissy: “We’ve seen a lot of changes in external fixation devices—a lot of combinations of materials/technologies to make them more user- and patient-friendly. Patient compliance is a vital part of success, so making devices easier to use will bring better success.
“For spinal implants, OEMs are trying to find ways to eliminate the need to go from pain management and physical therapy straight to spine fusion, which is very invasive. There is a focus on minimally invasive surgical devices such as interspinous plate systems. Test methods weren’t developed for this kind of evolution of these kinds of emerging technologies. They were developed for the baseline of the more invasive device. So we’ve had to adapt test blocks, fixtures and test configurations to meet the challenges of testing as technology evolves.
“In large joints we’re seeing things like adding vitamin E to polymers to fight infection. Engineers are trying to take technologies that have existed and the application of existing technologies and improve upon them so there’s better success in patients.”
References