Ranica Arrowsmith11.18.13
Last year, Orthopedic Design & Technology examined the difference between compliance and quality. Compliance to regulatory requirements for quality gets a medical device through the door; that is to say, compliance is what is required by the U.S. Food and Drug Administration (FDA) for a device to be safe, reliable, and efficient, and approved or cleared for commercialization in the United States. The agency has extensive instruction published on how a medical device company should run its quality management systems (QSM). The stated goal of Code of Federal Regulations Title 21 (CFR21) is to make sure that “finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug and Cosmetic Act.”
Quality, on the other hand, is what makes a medical device successful and, even better, profitable in the marketplace. Quality makes for a superior product rather than merely a product that meets minimal requirements. But now more than ever, the challenge for medtech companies is to find a way to make medical products high quality while at the same time being less expensive both to manufacture and to buy. These two factors together make for a challenging product development process.
“Quality is, of course, meeting the requirements and specifications of the employees, suppliers, customers and products,” Dana King, quality assurance manager at Roanoke, Va.-based Plastics One Inc., told ODT. “A lot of times it’s also meeting the perception of the customer. But the way I see quality is as a horizon. We’ll never fully acquire it, but will always be striving towards it. Compliance is more black and white. You have guidelines, and by meeting those guidelines, you can continue. It’s a day-to-day consideration. In the medical device world, quality and compliance are dependent, but in another realm, I think you can of course have a good quality system and a good quality product and not necessarily be compliant. Quality is just a constant state of not being satisfied with where you are but always trying to go forward.”
But the story gets harder. This year marked the start of the 2.3 percent medical device tax, part of the Patient Protection and Affordable Care Act. And while it certainly was a burden on medical device companies across the board—Zimmer Holdings Inc., Medtronic Inc. and Stryker Corporation are some of the big names that instituted layoffs this year and last in anticipation of the impact of the tax—smaller companies and startups felt the burn more than anyone else. Making medical devices that are expected to be compliant, of high quality and cheap to boot is a tall order for OEMs in the current economic and regulatory climate.
Offshoring production is a traditional method of forcing manufacturing costs down, but the tradeoff is having to negotiate cross-cultural grids while still ensuring compliance and, more to the point, quality products. Leave aside regulatory, language and distance barriers that make manufacturing slightly more challenging; ultimately what is lost translation when medical device manufacturing is offshored is, when it comes down to it, the empathy factor. The more removed a product is, both physically and philosophically, from its target market, the less incentive there is for the product to achieve quality not for compliance or competition’s sake, but for the sake of saving lives.
“I’ve been in the healthcare technology field for a long time and almost every one you meet who does this for a living does this in part because they know they're making patients’ lives better,” Tim Kulbago, president and CEO of Cleveland, Ohio-based imaging contract research organization ImageIQ Inc., told ODT. “Yes, you want a paycheck and you want a career, but you also come to work every day and make a difference in the quality of patients’ lives. When you keep the manufacturing of these devices in the United States there is that connection. It could be my neighbor who needs this hip replacement or needs the new joint. It’s real and it’s here.”
A Personal Story, a Personal Touch.
Orthozon Technologies LLC founder, owner, Chief Technology Officer and CEO Joshua Aferzon would agree. If there’s anyone in the medical technology industry who could attest to the importance of a personal connection to the quality of medical devices, it’s Aferzon. The young executive got his start in the medtech industry at the age of 16. Aferzon had been tinkering with the 3-D software made by Solidworks, and his father, a neurosurgeon currently practicing in Connecticut, put him to task to design a medical device they had an idea for. Within a couple of months, with the help of a 3-D printed prototype and his father, Aferzon had his first patent.
Fast forward to Aferzon’s senior year at the University of Connecticut. The young biomedical engineering student, who was on track for medical school, received word that Carlsbad, Calif.-based spine technology company Alphatec Spine Inc. had licensed the patent he registered while in high school. Today, that patent is used in Alphatec’s anterior lumbar interbody fusion device, designed for spinal column stability through the deployment of four internal fixation blades. News of that patent license inspired Aferzon.
“I did it once, I can do it again,” Aferzon thought to himself, and put himself to work just before graduation to design a retractor device for spine surgery. What resulted was the Lumiere minimally invasive retractor system, which was released this year and has won design awards.
He chose to focus his first efforts on a retractor system because when he first saw the design he thought “it had a very elegant appearance.”
“I thought there was a lot that could be done with the design,” Aferzon continued. “Once I started playing around and adding more features such as fiber optic lighting, an expanded field of view and rotatable blades, I started to see the potential of this wonderfully multifunctional product. Once I saw it all come together I thought this was a product I wanted to start with. It’s simple, fast, efficient, and it would make a good statement about the company, starting it off on the right foot.”
And what’s key to this device is that, according to Orthozon, it reduces surgery costs by an average of 40 percent to 60 percent per procedure. How did Aferzon and his team manage to design a device of such high quality that it already has won design awards, yet keep costs so low?
“We use a very cheap manufacturing process,” Aferzon explained. “By doing so we’re able to lower costs for both ourselves and the hospitals who purchase our products. One of the main focuses in the medtech industry today is cost reduction, a concept which we integrate into all of our decision-making. That’s why we’re keeping our margins very tight."
Being a very small company—a core team of only four—Orthozon outsources its quality management. One of the teams the company works with, which handles regulatory compliance, is based in New York, N.Y., a 45 minute train ride from the Stamford, Conn.-based offices of Orthozon. That personal connection is vital to maintaining good faith that the quality of its devices is in good hands.
“It’s easy for them to hop on a train, have a one-on-one meeting, have them look at our facility, our equipment and the way we’re processing the devices,” Aferzon explained. “That proximity allows us to have good compliance and quality management.”
The young company’s experience with the FDA has been pleasant so far, and Aferzon told ODT he had found the paths to market relatively easy to navigate—at least for spine devices. The way he sees it, regulation’s job is to make sure devices are safe and effective. Beyond that, it’s the device maker’s responsibility to ensure their product is high quality.
“As long as compliance doesn’t overstep its boundaries and starts nitpicking at exactly what features can be added to the design and what can’t; as long as the FDA does not overregulate and stifle our freedom to innovate, providing quality equipment and implants will continue to be possible,” Aferzon said.
It’s Our House: Keeping Quality at Home
To provide insight into the benefits of keeping manufacturing domestic for the purpose of tight quality management, consider one component manufacturer's approach.
Jesse Flores, vice president of quality assurance at Bal Seal Engineering, Inc., a Foothill Ranch, Calif.-based component manufacturer, detailed what goes into quality consideration at a company such as his.
“We consider compliance with ISO 9001 standards to be a baseline, entry-level criteria that our customers expect,” Flores said. “We’re consistently looking for ways to enhance our quality system, and thus we are striving more for overall quality assurance (QA), rather than rely on quality control (QC) methods for product compliance.”
The International Organization for Standardization (commonly known as ISO), might in its very existence be an argument for offshoring quality—namely, that there are systems in place to make it easier. And if offshoring cuts costs, why not? There are standards such as those laid out by the ISO—including the International Medical Device Regulators Forum—that are intended to make it easier for companies to operate offshore and to operate in various locations around the world with one set of standards in hand to ensure quality across the board. ISO 9001 sets out the requirements of a quality management system, and any company that wants to be viable in the medtech landscape earns this ISO certification.
However, Flores goes on to explain exactly what quality assurance at Bal Seal entails.
“The purpose of QA is to determine the capability and consistency of our manufacturing processes and to help make applicable processes capable. “Inspection” then becomes only a formality to confirm product compliance (predictable and reliable). The QA approach makes manufacturing responsible for product quality and changes the general role of the quality department to assessing the effectiveness of various processes. It also means collecting, analyzing and acting on other data. For instance, what percentage of orders get rejected in each area and why? Which operations generate the most scrap, and for which reasons? How many orders get returned from customers? What type of complaints do we get from customers? What do our internal audits reveal about our quality system? How effective are our corrective actions. With a QA process, we have metrics and quality trends in place—a QA dashboard that enables us to identify where and when our improvement activities should take place.”
Now imagine every single one of those working parts being managed from thousands of miles away instead of just over a state line (as with Orthozon). Imagine needing a translator to communicate these needs. Imagine a cultural divide so great, a cultural mediator is needed. These and more are necessary considerations when any company decides to collaborate with CMOs (contract manufacturing organizations) or other partners across international boundaries. In recent years, most every major medtech industry conference has featured a speaker or a panel to discuss what companies need when they enter any type of operations in foreign markets, particularly the BRIC (Brazil, Russia, India and China) nations. The experts always stress the importance of understanding the local culture and hiring trustworthy legal counsel. The risk of misunderstanding, being cheated, or ending up with an inferior product must be weighed against the benefit of offshoring, and often, the answer is it is worth the effort to keep operations domestic.
“It’s easier when you’re speaking the same language, coming from the same culture, and using the same terms,” ImageIQ’s Kulbago said. “Culturally it’s easier to have a conversation with somebody who is manufacturing your part one time zone away than it is half a world away. Communication just becomes more of a challenge.”
A market research report on BRICS (the S is for South Africa) released by Espicom Business Intelligence in September noted that “high-quality, high-tech products are sought after” in India, but also that “new regulations were to have been published as the Drugs, Cosmetics and Medical Device bill in the winter 2012 parliamentary session, but implementation has been further delayed.” It is regulatory rubbernecking such as this that adds a further layer of complication to maintaining consistent quality (and compliance—it’s difficult to achieve compliance in nations where the regulatory bodies are inconsistent) when offshoring production.
Plastics One’s King agreed that consistency is key to quality:“Having what I would call a consistent system is important. Regulators must have well defined, very clear quality management system requirements for industry to maintain consistency. When it comes to offshoring, maintaining quality consistency and control are the biggest challenges. There are challenges in the understanding and interpretation of standards and regulations. We do have some suppliers we purchase from in other countries. When we do that and we know that there are some known inconsistencies, we increase our inspections when they come in house. We also monitor them closer throughout our processes. Keeping manufacturing or suppliers in the United States—it’s the same manufacturing language and understanding, the same direction.”
It almost goes without saying that managing quality systems and maintaining consistency and tight control is a different ball game for smaller companies than for the Medtronics and Johnson & Johnsons of the world. For instance, Medtronic has the finances and manpower to put forth a hefty quality program. Alongside its regulatory compliance, product performance, CAPA (corrective and preventative action), and customer satisfaction programs, the company also has a separate supplier quality management program and global complaint program. A smaller company such as Orthozon couldn’t dream, at this stage of its development, of having the wherewithal to deal with global suppliers and CMOs.
Large companies such as Medtronic couldn’t handle its quality program any other way than having strict systems in place and making sure they are followed across the board, a well oiled machine. On the other hand, domestic service providers such as ImageIQ also can provide personalized quality services very quickly without its clients needing to jump through cultural, translation and regulatory hoops to do so.
Recently, the quality team at ImageIQ provided a new validations process to a client.
“We use what I would call standard practices plus,” Kulbago explained. “We use a lot of standard process validation methods and standard techniques you’d find in any kind of best practice environment, but sometimes we need to go a little further because some things we do are so cutting edge that we want to push it just that much further.”
Kulbago went on to say how his quality team recently received a challenge from a client. ImageIQ had been making some ultrasound measurements for the client company. After consulting with the FDA, the client asked ImageIQ to perform phantom measurements in its validation process in addition to the traditional measurements. Creating phantom measurements requires the construction of an actual “phantom”—a faux version of whatever it is the end product will be measuring. In this case, it was a section of the human body.
“We built a phantom—an analog to the body part that we’re ultrasounding—and we imaged that mock-up,” Kulbago said. “We make sure the measurements we get on the ultrasound machine are comparable to the measurements we’re getting in the controlled environment, and that way we’ve got a much higher degree of confidence that what we’re measuring in the clinical trial is accurate.”
It is this type of customized quality control measures that reminds U.S. OEMs of the value of keeping quality at home.
“At the end of the day, the United States is the biggest market in the world,” said Plastic One’s King. “This is where things are happening. The advantage of keeping manufacturing here is a pride in your work, a sense of purposefulness in the work you do because it makes a difference in peoples’ lives—people that you know.”
Last Word: The Future of Orthopedic Quality Management
“From an industry standpoint, orthopedic device makers can take measures to ensure that their component manufacturers are plugged into the design process from the very beginning, and that product quality criteria, production validation expectations, quality system expectations (such as control plans, failure mode effects analysis, etc.) and other logistical details are communicated as soon as they become available,” said Bal Seal’s Flores. “Just doing these things can greatly reduce the risk of encountering quality issues, and can eliminate the need to deal with engineering roadblocks while under pressure to make trial deadlines or launch dates. Of course, OEMs can also invest time and effort in the vetting of suppliers, ensuring that quality systems are clearly described and documented, and that the proper certifications are in place to meet manufacturing and regulatory requirements.”
And finally, ImageIQ’s Kulbago sees a very particular trend coming out of the FDA: The demand for more quantifiable, demonstrable results in clinical testing and research.
“The FDA and other regulatory bodies are really being clear to orthopedic companies about the need for more objective data,” said Kulbago. “At ImageIQ we’ve been getting a lot of feedback from our clients that the FDA is pushing them towards more quantifiable data. Be objective, be quantifiable, don’t give subjective feeling that it ‘looks better.’ Demonstrate how much better. The FDA is very astute, they understand that sometimes you can’t answer all the questions. That’s the nature of being on the leading edge. But we like the direction we’re seeing relative to quality. Our job is to deliver objective data, so we like that the FDA is asking for more objective and quantifiable data. That’s a promising thing for the industry as a whole.”
Quality, on the other hand, is what makes a medical device successful and, even better, profitable in the marketplace. Quality makes for a superior product rather than merely a product that meets minimal requirements. But now more than ever, the challenge for medtech companies is to find a way to make medical products high quality while at the same time being less expensive both to manufacture and to buy. These two factors together make for a challenging product development process.
“Quality is, of course, meeting the requirements and specifications of the employees, suppliers, customers and products,” Dana King, quality assurance manager at Roanoke, Va.-based Plastics One Inc., told ODT. “A lot of times it’s also meeting the perception of the customer. But the way I see quality is as a horizon. We’ll never fully acquire it, but will always be striving towards it. Compliance is more black and white. You have guidelines, and by meeting those guidelines, you can continue. It’s a day-to-day consideration. In the medical device world, quality and compliance are dependent, but in another realm, I think you can of course have a good quality system and a good quality product and not necessarily be compliant. Quality is just a constant state of not being satisfied with where you are but always trying to go forward.”
But the story gets harder. This year marked the start of the 2.3 percent medical device tax, part of the Patient Protection and Affordable Care Act. And while it certainly was a burden on medical device companies across the board—Zimmer Holdings Inc., Medtronic Inc. and Stryker Corporation are some of the big names that instituted layoffs this year and last in anticipation of the impact of the tax—smaller companies and startups felt the burn more than anyone else. Making medical devices that are expected to be compliant, of high quality and cheap to boot is a tall order for OEMs in the current economic and regulatory climate.
Offshoring production is a traditional method of forcing manufacturing costs down, but the tradeoff is having to negotiate cross-cultural grids while still ensuring compliance and, more to the point, quality products. Leave aside regulatory, language and distance barriers that make manufacturing slightly more challenging; ultimately what is lost translation when medical device manufacturing is offshored is, when it comes down to it, the empathy factor. The more removed a product is, both physically and philosophically, from its target market, the less incentive there is for the product to achieve quality not for compliance or competition’s sake, but for the sake of saving lives.
“I’ve been in the healthcare technology field for a long time and almost every one you meet who does this for a living does this in part because they know they're making patients’ lives better,” Tim Kulbago, president and CEO of Cleveland, Ohio-based imaging contract research organization ImageIQ Inc., told ODT. “Yes, you want a paycheck and you want a career, but you also come to work every day and make a difference in the quality of patients’ lives. When you keep the manufacturing of these devices in the United States there is that connection. It could be my neighbor who needs this hip replacement or needs the new joint. It’s real and it’s here.”
A Personal Story, a Personal Touch.
Orthozon Technologies LLC founder, owner, Chief Technology Officer and CEO Joshua Aferzon would agree. If there’s anyone in the medical technology industry who could attest to the importance of a personal connection to the quality of medical devices, it’s Aferzon. The young executive got his start in the medtech industry at the age of 16. Aferzon had been tinkering with the 3-D software made by Solidworks, and his father, a neurosurgeon currently practicing in Connecticut, put him to task to design a medical device they had an idea for. Within a couple of months, with the help of a 3-D printed prototype and his father, Aferzon had his first patent.
Fast forward to Aferzon’s senior year at the University of Connecticut. The young biomedical engineering student, who was on track for medical school, received word that Carlsbad, Calif.-based spine technology company Alphatec Spine Inc. had licensed the patent he registered while in high school. Today, that patent is used in Alphatec’s anterior lumbar interbody fusion device, designed for spinal column stability through the deployment of four internal fixation blades. News of that patent license inspired Aferzon.
“I did it once, I can do it again,” Aferzon thought to himself, and put himself to work just before graduation to design a retractor device for spine surgery. What resulted was the Lumiere minimally invasive retractor system, which was released this year and has won design awards.
He chose to focus his first efforts on a retractor system because when he first saw the design he thought “it had a very elegant appearance.”
“I thought there was a lot that could be done with the design,” Aferzon continued. “Once I started playing around and adding more features such as fiber optic lighting, an expanded field of view and rotatable blades, I started to see the potential of this wonderfully multifunctional product. Once I saw it all come together I thought this was a product I wanted to start with. It’s simple, fast, efficient, and it would make a good statement about the company, starting it off on the right foot.”
And what’s key to this device is that, according to Orthozon, it reduces surgery costs by an average of 40 percent to 60 percent per procedure. How did Aferzon and his team manage to design a device of such high quality that it already has won design awards, yet keep costs so low?
“We use a very cheap manufacturing process,” Aferzon explained. “By doing so we’re able to lower costs for both ourselves and the hospitals who purchase our products. One of the main focuses in the medtech industry today is cost reduction, a concept which we integrate into all of our decision-making. That’s why we’re keeping our margins very tight."
Being a very small company—a core team of only four—Orthozon outsources its quality management. One of the teams the company works with, which handles regulatory compliance, is based in New York, N.Y., a 45 minute train ride from the Stamford, Conn.-based offices of Orthozon. That personal connection is vital to maintaining good faith that the quality of its devices is in good hands.
“It’s easy for them to hop on a train, have a one-on-one meeting, have them look at our facility, our equipment and the way we’re processing the devices,” Aferzon explained. “That proximity allows us to have good compliance and quality management.”
The young company’s experience with the FDA has been pleasant so far, and Aferzon told ODT he had found the paths to market relatively easy to navigate—at least for spine devices. The way he sees it, regulation’s job is to make sure devices are safe and effective. Beyond that, it’s the device maker’s responsibility to ensure their product is high quality.
“As long as compliance doesn’t overstep its boundaries and starts nitpicking at exactly what features can be added to the design and what can’t; as long as the FDA does not overregulate and stifle our freedom to innovate, providing quality equipment and implants will continue to be possible,” Aferzon said.
It’s Our House: Keeping Quality at Home
To provide insight into the benefits of keeping manufacturing domestic for the purpose of tight quality management, consider one component manufacturer's approach.
Jesse Flores, vice president of quality assurance at Bal Seal Engineering, Inc., a Foothill Ranch, Calif.-based component manufacturer, detailed what goes into quality consideration at a company such as his.
“We consider compliance with ISO 9001 standards to be a baseline, entry-level criteria that our customers expect,” Flores said. “We’re consistently looking for ways to enhance our quality system, and thus we are striving more for overall quality assurance (QA), rather than rely on quality control (QC) methods for product compliance.”
The International Organization for Standardization (commonly known as ISO), might in its very existence be an argument for offshoring quality—namely, that there are systems in place to make it easier. And if offshoring cuts costs, why not? There are standards such as those laid out by the ISO—including the International Medical Device Regulators Forum—that are intended to make it easier for companies to operate offshore and to operate in various locations around the world with one set of standards in hand to ensure quality across the board. ISO 9001 sets out the requirements of a quality management system, and any company that wants to be viable in the medtech landscape earns this ISO certification.
However, Flores goes on to explain exactly what quality assurance at Bal Seal entails.
“The purpose of QA is to determine the capability and consistency of our manufacturing processes and to help make applicable processes capable. “Inspection” then becomes only a formality to confirm product compliance (predictable and reliable). The QA approach makes manufacturing responsible for product quality and changes the general role of the quality department to assessing the effectiveness of various processes. It also means collecting, analyzing and acting on other data. For instance, what percentage of orders get rejected in each area and why? Which operations generate the most scrap, and for which reasons? How many orders get returned from customers? What type of complaints do we get from customers? What do our internal audits reveal about our quality system? How effective are our corrective actions. With a QA process, we have metrics and quality trends in place—a QA dashboard that enables us to identify where and when our improvement activities should take place.”
Now imagine every single one of those working parts being managed from thousands of miles away instead of just over a state line (as with Orthozon). Imagine needing a translator to communicate these needs. Imagine a cultural divide so great, a cultural mediator is needed. These and more are necessary considerations when any company decides to collaborate with CMOs (contract manufacturing organizations) or other partners across international boundaries. In recent years, most every major medtech industry conference has featured a speaker or a panel to discuss what companies need when they enter any type of operations in foreign markets, particularly the BRIC (Brazil, Russia, India and China) nations. The experts always stress the importance of understanding the local culture and hiring trustworthy legal counsel. The risk of misunderstanding, being cheated, or ending up with an inferior product must be weighed against the benefit of offshoring, and often, the answer is it is worth the effort to keep operations domestic.
“It’s easier when you’re speaking the same language, coming from the same culture, and using the same terms,” ImageIQ’s Kulbago said. “Culturally it’s easier to have a conversation with somebody who is manufacturing your part one time zone away than it is half a world away. Communication just becomes more of a challenge.”
A market research report on BRICS (the S is for South Africa) released by Espicom Business Intelligence in September noted that “high-quality, high-tech products are sought after” in India, but also that “new regulations were to have been published as the Drugs, Cosmetics and Medical Device bill in the winter 2012 parliamentary session, but implementation has been further delayed.” It is regulatory rubbernecking such as this that adds a further layer of complication to maintaining consistent quality (and compliance—it’s difficult to achieve compliance in nations where the regulatory bodies are inconsistent) when offshoring production.
Plastics One’s King agreed that consistency is key to quality:“Having what I would call a consistent system is important. Regulators must have well defined, very clear quality management system requirements for industry to maintain consistency. When it comes to offshoring, maintaining quality consistency and control are the biggest challenges. There are challenges in the understanding and interpretation of standards and regulations. We do have some suppliers we purchase from in other countries. When we do that and we know that there are some known inconsistencies, we increase our inspections when they come in house. We also monitor them closer throughout our processes. Keeping manufacturing or suppliers in the United States—it’s the same manufacturing language and understanding, the same direction.”
It almost goes without saying that managing quality systems and maintaining consistency and tight control is a different ball game for smaller companies than for the Medtronics and Johnson & Johnsons of the world. For instance, Medtronic has the finances and manpower to put forth a hefty quality program. Alongside its regulatory compliance, product performance, CAPA (corrective and preventative action), and customer satisfaction programs, the company also has a separate supplier quality management program and global complaint program. A smaller company such as Orthozon couldn’t dream, at this stage of its development, of having the wherewithal to deal with global suppliers and CMOs.
Large companies such as Medtronic couldn’t handle its quality program any other way than having strict systems in place and making sure they are followed across the board, a well oiled machine. On the other hand, domestic service providers such as ImageIQ also can provide personalized quality services very quickly without its clients needing to jump through cultural, translation and regulatory hoops to do so.
Recently, the quality team at ImageIQ provided a new validations process to a client.
“We use what I would call standard practices plus,” Kulbago explained. “We use a lot of standard process validation methods and standard techniques you’d find in any kind of best practice environment, but sometimes we need to go a little further because some things we do are so cutting edge that we want to push it just that much further.”
Kulbago went on to say how his quality team recently received a challenge from a client. ImageIQ had been making some ultrasound measurements for the client company. After consulting with the FDA, the client asked ImageIQ to perform phantom measurements in its validation process in addition to the traditional measurements. Creating phantom measurements requires the construction of an actual “phantom”—a faux version of whatever it is the end product will be measuring. In this case, it was a section of the human body.
“We built a phantom—an analog to the body part that we’re ultrasounding—and we imaged that mock-up,” Kulbago said. “We make sure the measurements we get on the ultrasound machine are comparable to the measurements we’re getting in the controlled environment, and that way we’ve got a much higher degree of confidence that what we’re measuring in the clinical trial is accurate.”
It is this type of customized quality control measures that reminds U.S. OEMs of the value of keeping quality at home.
“At the end of the day, the United States is the biggest market in the world,” said Plastic One’s King. “This is where things are happening. The advantage of keeping manufacturing here is a pride in your work, a sense of purposefulness in the work you do because it makes a difference in peoples’ lives—people that you know.”
Last Word: The Future of Orthopedic Quality Management
“From an industry standpoint, orthopedic device makers can take measures to ensure that their component manufacturers are plugged into the design process from the very beginning, and that product quality criteria, production validation expectations, quality system expectations (such as control plans, failure mode effects analysis, etc.) and other logistical details are communicated as soon as they become available,” said Bal Seal’s Flores. “Just doing these things can greatly reduce the risk of encountering quality issues, and can eliminate the need to deal with engineering roadblocks while under pressure to make trial deadlines or launch dates. Of course, OEMs can also invest time and effort in the vetting of suppliers, ensuring that quality systems are clearly described and documented, and that the proper certifications are in place to meet manufacturing and regulatory requirements.”
And finally, ImageIQ’s Kulbago sees a very particular trend coming out of the FDA: The demand for more quantifiable, demonstrable results in clinical testing and research.
“The FDA and other regulatory bodies are really being clear to orthopedic companies about the need for more objective data,” said Kulbago. “At ImageIQ we’ve been getting a lot of feedback from our clients that the FDA is pushing them towards more quantifiable data. Be objective, be quantifiable, don’t give subjective feeling that it ‘looks better.’ Demonstrate how much better. The FDA is very astute, they understand that sometimes you can’t answer all the questions. That’s the nature of being on the leading edge. But we like the direction we’re seeing relative to quality. Our job is to deliver objective data, so we like that the FDA is asking for more objective and quantifiable data. That’s a promising thing for the industry as a whole.”