Ranica Arrowsmith, Associate Editor05.14.14
When manufacturing medical devices that will be used by patients, on patients or in patients, quality is not only paramount, it is personal. It’s 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. In November last year, Medical Product Outsourcing’s sister magazine Orthopedic Design & Technology examined the personal connection quality personnel have with patients, as they ensure the devices they produce will serve and heal patients in the best way possible. This month, MPO looks at the other end of the manufacturer-to-patient spectrum: training of the manufacturer.
Training quality personnel is an essential component to the quality chain in medical device manufacturing. Helping quality assurance (QA) employees understand the implications of their job to the end-user, whether it’s the clinician or the patient, is vital to the success of a device. Recently, S4 Netquest, a Columbus, Ohio-based custom training solutions company primarily focused in the medical spaces, conducted a survey that suggested medical professionals, specifically physicians, nurses and technicians felt underprepared for their jobs. In a field in which lives are on the line, this is not an insignificant issue. According to the survey, immediately after training, 47.6 percent of respondents reported lacking confidence about starting their jobs. Nearly 5 percent of respondents indicated that the poor level of training made them want to switch jobs. As a group, individuals aged 18-24 felt more unprepared going into their current jobs than any other age group.
That, of course, concerns medical professionals such as physicians. But S4 also conducts training for medical device companies to rectify the issues highlighted by that survey.
“We’re finding within the medical industry, across personnel, whether it’s with leadership, the sales force, QA personnel or production associates, that they’re using older traditional methods where a subject matter expert (SME) lectures in front of a class,” Jim Guilkey, president and co-founder of S4, told MPO. “SMEs have a thorough knowledge of content, but little or no expertise related to adult learning theory or instructional design methodologies The result, and this is more critical within the medical industry, is a very low-level of learning. It’s rote memorization, which leads to maybe some understanding, but it doesn’t do a lot past that simply because of the way the training is designed.”
The definition for an SME given by the U.S. Federal Office of Personnel Management (OPM) is “a person with bona fide expert knowledge about what it takes to do a particular job. First-level supervisors are normally good SMEs. Superior incumbents in the same or very similar positions and other individuals also can be used as SMEs if they have current and thorough knowledge of the job’s requirements.” Other possible SMEs can include former supervisors or incumbents with recent experience; as long as they have bona fide expert knowledge about a particular job, they can serve as an SME. According to the OPM, a larger number of SMEs not only ensures you are capturing all of the key requirements of the job, but it also provides multiple points-of-view regarding the criticality of the tasks and competencies.
Patricia E. Benner, R.N., Ph.D., FAAN, is a well-known name in the area of training in the medical space. Professor emerita of the department of social and behavioral sciences at the University of California, San Francisco, she introduced her theory of “novice to expert” in the American Journal of Nursing in 1982. She proposed that one could gain knowledge and skills (“knowing how”) without ever learning the theory (“knowing that”), which obstructs the passage of a professional from novice to expert level or proficiency. Her spectrum of knowledge starts with “novice,” which then moves to “advanced beginner,” to “competent,” to “proficient,” and finally to “expert.”
For quality training in the medical device industry, the problem with SMEs is that they often are training to the novice level without an eye on the future development of the personnel. SMEs have proficiency in the actual subject matter of QA, but they are not experts in training and teaching.
“When SMEs are not only delivering the training but also designing it, it tends to be at the novice end of the spectrum level where they’re teaching people the process but not really giving them enough scenario-based learning or problem-based learning,” Guilkey said. “These learning techniques accelerate the path from novice to competency and eventually expertise. We find that that’s really lacking throughout the industry.”
But let’s not discredit SMEs entirely. They are an important part of the training process, certainly.
“SMEs are absolutely critical to the learning process. They know a lot about the particulars of QA or whatever the subject might be,” Guilkey continued. “But they are basically ‘tellers.’ They relate the steps of the process. Although they are good at delivering training, they are not equipped to actually design effective learning programs.”
The Anatomy of Quality
A key component of any quality program is compliance. The U.S. Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Part 820 deals with quality for medical devices. The regulations cover definitions of what quality means, to requirements, to corrective and preventative action (CAPA) protocols, to directions on handling, storage, and other aspects of medical device movement, to record-keeping and servicing protocols. Part 820.3, which covers definitions of terms associated with QA, defines quality as “the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance”—and this is only one of 29 basic terms a QA employee needs to know in order to perform her job. And those 29 terms make up only one of dozens of sections under Part 820.
QA personnel need to understand all the terms that relate to FDA regulations. For instance, a “complaint” means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. Take note that the definition includes verbal communication, so a QA professional must understand that even a statement that is not in writing is included under this definition for legal purposes. A “component” refers to any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. Personnel need to understand fine distinctions, like the difference between validation and process validation. Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled, while process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Personnel need to understand the difference between a device history record and a device master record: the first is a compilation of records containing the production history of a finished device; the second is a compilation of records containing the procedures and specifications for a finished device. This may seem like an ignorable distinction, but in the event of an audit, it is essential that each record contains correct and pertinent information. What is at stake? Both the quality of the product and the very life of a company. For if “nonconformity” is identified (the nonfulfillment of a specified requirement), a company could receive a warning letter or even, in extreme cases, find itself the subject of a federal criminal investigation.
The threat that hangs over medical device companies should they fail to meet quality requirements is not an empty one. In 2012, dental device company Accurate Set was completely shut down by the FDA over violating regulations governing quality service protocol at its manufacturing facility in Newark, N.J. Under the terms of the consent decree, signed by Judge Susan D. Wigenton of the U.S. District Court for the District of New Jersey on Feb. 7, 2012, Accurate Set agreed to (read: was ordered to) discontinue its operations until the FDA clears or approves its products, which include a variety of restorative dental products such as dental
impression and repair materials. To date, the agency still has not approved the company to resume operations.
Accurate Set previously has received two warning letters in 2003 and 2010. The FDA’s most recent inspection of the company, between December 2010 and January 2011, revealed “significant violations of the FDA’s quality system (QS) regulation, including violations related to the firm’s corrective action and consumer complaint procedures, purchasing controls, and quality audits.” The QS regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices. Investigators also found that medical devices made by the company, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA pre-market review.
“This consent decree demonstrates the FDA’s commitment to protecting the public health from the dangers of unapproved and improperly manufactured medical devices,” Dara A. Corrigan said at the time (she is now director of FDA’s Europe office), stressing how ultimately, medical device quality comes down to public safety.
In a piece advising medical device startups on what to expect from the FDA, NYTechConnect.com contributor Jerry Korten wrote, “The FDA inspector will doggedly go step by step through your documentation process, your customer interaction documents, your corrective actions and, by golly, they can usually find something you are doing that isn’t optimal. And your company will ultimately benefit by incorporating their feedback.” Korten also warned that inspections occur when a company is “least able to devote time to such a distraction,” but that it is imperative to be ready—or risk the fate of Accurate Set.
Korten continued, “You do need to show that you have done all you know to do in order to be compliant with your quality system. You may have deficiencies, but if you are following your procedures well and you have documented that behavior consistently, you only need to correct the procedures, not your behavior, and the FDA appreciates this. Allow them to help you find these corrections before any error can cause problems for you in the future.”
For startups, one of the main concerns, of course, is funding. And training costs money. According to Nancy Singer, J.D., LL.M, founder and president of pharmaceutical and medtech consultancy company Compliance-Alliance LLC, when companies are tight for funds, training programs often are the first programs they cut.
“They may also cut quality resources and training budgets when they perceive that they will not be inspected by the FDA,” Singer told MPO. “Companies need to view quality as a revenue driver.”
Training Processes
“Most companies do annual refresher training on the quality system regulation,” Singer said. “To develop the training, they look at the root causes for customers’ complaints, the results from internal audits, and FDA 483 observations and warning letters. The training is generally provided by an internal quality manager or an outside consultant who is able to present best practices in the field. When I am brought into a company, I teach quality by challenging people to look at their performance from a perspective of an outside observer. Each judgment is subject to second-guessing throughout the life of the device. I help people understand that their commitment to quality is tested every day.”
Singer refers to a dichotomy that Guilkey refers to: the internal trainer versus the external expert. As Singer suggests, an external trainer inherently provides a perspective free of biases or blind spots an internal trainer might display.
“Let’s say a QA employee who is very good at their job becomes a supervisor and eventually a trainer of the QA group,” Guilkey said. “That is a natural progression through many of these positions within the medical industry, so what you’re asking somebody to do is basically stand up in front of a class—an SME—and train the next group of new associates. The issue with that is that although those folks have an in depth knowledge of that particular process, they don’t know adult learning theory or instructional design principles. Therefore the training is usually not very engaging, and doesn’t result in a very high level of learning. When you look at what a QA person has to have, it’s a very diverse set of both technical and analytical skills. A technical skill might be the process, e.g., I put a component in this machine, I heat it up, I read the dial—those types of processes. But then there are a lot of judgment, decision-making and communication skills that need to go along with that. When you look at what these types of individuals do on the job, judgment—that ability to really know whether or not this device can pass the particular standards—takes a different type of training.”
Companies such as S4 don’t just offer the benefit of an outside perspective. They offer expertise in learning theory, cost savings in the form of more efficient training that reduces error later, and reduced training times. In fact in a recent medical training project, S4 reports that it reduced the company’s training times by 50 percent. Some of the tools S4 uses in its training are gaming and discovery learning, cognitive engagement to reinforce learning, animation for visualization, and 3-D animation. Such specialized learning tools serve to engage employees and create more proficient QA personnel with a real shot at reaching the “expert” level instead of trudging along at the novice level. This in turn increases the likelihood of the employee remaining at the company long term, which is beneficial to the quality systems in place. The more proficient employees that remain at the company, the better it is for the company.
But external trainers do not have to be the gold standard for quality personnel training. Randolph, N.J.-based Glenbrook Technologies Inc., a manufacturer of X-ray inspections systems—one of which is used by the FDA itself—has its own specialized training program for QA personnel.
“The training program [at Glenbrook] actually has various components to it,” Glenbrook’s Executive Vice President and Chief Financial Officer Claire Zweig told MPO. “Each system that goes out the door has a quality control checklist. The system itself has to be inspected by three people—three different sets of eyes—because each person is looking at something new to them. One of the three people is either the president or CEO.”
Even though Glenbrook focuses its training internally, the company makes sure it incorporates a sense of externality to it by ensuring at least three different people inspect the checklist. The company also convenes every Monday morning where any quality issue can be raised and shared between all different departments, not just quality control.
“Quality is an obligation that we take very seriously, obviously because our reputation is on the line,” Zweig continued. “We’ve been a manufacturer of X-ray inspection systems for 32 years. I don’t think you last for 32 years if you don’t have quality as part of your programming. When we’re working with medical devices, many times that can be the difference between life and death. We’re helping our customers develop new products as well, so we understand the obligation that they have in manufacturing a quality product.”
Glenbrook is concerned with the quality of its X-ray systems, but the company’s X-ray systems in turn are used by medical device manufacturers to inspect devices for quality. Glenbrook’s QA personnel are tasked with understanding how their X-ray systems work and what benefits they provide to manufacturers that use them to inspect their own devices for quality. CEO Glenn Zweig explained how Glenbrook’s X-ray systems fit into the quality expectations from the FDA by using cardiovascular devices as an example. In 2010, the FDA recommended that manufacturers indicate via labeling the radiopacity of cardiovascular devices. The reason is that once such a device is implanted, it is important for clinicians to know how easy it will be to view the device via X-ray post implantation. QA personnel at Glenbrook need to understand not only how to manage the quality of their X-ray inspection systems, but also how to manage the various specialized quality needs of their clients who are using the machines in their own quality systems to inspect for aspects of a device such as radiopacity. Therefore, Glenbrook also provides services to medical device manufacturers who wish to create a quality control program.
“What’s interesting is that as medical device manufacturers are developing new products, they’re contacting us,” Claire Zweig said. “So we get involved in a lot of products on the development end. I think there is an awareness that X-ray can help in their process, but we can also work with medical device manufacturers in helping them create a quality control program. Sometimes they don’t know that’s what they need and that X-ray can help them in the process. That’s what we hope to help them with.”
“When I say our claim to fame is measurable business results, we’re not talking about whether trainees can pass a test or not, because SMEs can get personnel to pass a simple multiple choice knowledge test,” said Guilkey, driving home the importance of training for independent thinking, not just subject area knowledge. “A test of really good training is the actual application of that knowledge. QA folks can have a tremendous effect on their organization—anything from shutting down a production line to actually passing a medical device that enters a patient. So training must get these folks to that higher level for the sake of safety and quality.”
Training quality personnel is an essential component to the quality chain in medical device manufacturing. Helping quality assurance (QA) employees understand the implications of their job to the end-user, whether it’s the clinician or the patient, is vital to the success of a device. Recently, S4 Netquest, a Columbus, Ohio-based custom training solutions company primarily focused in the medical spaces, conducted a survey that suggested medical professionals, specifically physicians, nurses and technicians felt underprepared for their jobs. In a field in which lives are on the line, this is not an insignificant issue. According to the survey, immediately after training, 47.6 percent of respondents reported lacking confidence about starting their jobs. Nearly 5 percent of respondents indicated that the poor level of training made them want to switch jobs. As a group, individuals aged 18-24 felt more unprepared going into their current jobs than any other age group.
That, of course, concerns medical professionals such as physicians. But S4 also conducts training for medical device companies to rectify the issues highlighted by that survey.
“We’re finding within the medical industry, across personnel, whether it’s with leadership, the sales force, QA personnel or production associates, that they’re using older traditional methods where a subject matter expert (SME) lectures in front of a class,” Jim Guilkey, president and co-founder of S4, told MPO. “SMEs have a thorough knowledge of content, but little or no expertise related to adult learning theory or instructional design methodologies The result, and this is more critical within the medical industry, is a very low-level of learning. It’s rote memorization, which leads to maybe some understanding, but it doesn’t do a lot past that simply because of the way the training is designed.”
The definition for an SME given by the U.S. Federal Office of Personnel Management (OPM) is “a person with bona fide expert knowledge about what it takes to do a particular job. First-level supervisors are normally good SMEs. Superior incumbents in the same or very similar positions and other individuals also can be used as SMEs if they have current and thorough knowledge of the job’s requirements.” Other possible SMEs can include former supervisors or incumbents with recent experience; as long as they have bona fide expert knowledge about a particular job, they can serve as an SME. According to the OPM, a larger number of SMEs not only ensures you are capturing all of the key requirements of the job, but it also provides multiple points-of-view regarding the criticality of the tasks and competencies.
Patricia E. Benner, R.N., Ph.D., FAAN, is a well-known name in the area of training in the medical space. Professor emerita of the department of social and behavioral sciences at the University of California, San Francisco, she introduced her theory of “novice to expert” in the American Journal of Nursing in 1982. She proposed that one could gain knowledge and skills (“knowing how”) without ever learning the theory (“knowing that”), which obstructs the passage of a professional from novice to expert level or proficiency. Her spectrum of knowledge starts with “novice,” which then moves to “advanced beginner,” to “competent,” to “proficient,” and finally to “expert.”
For quality training in the medical device industry, the problem with SMEs is that they often are training to the novice level without an eye on the future development of the personnel. SMEs have proficiency in the actual subject matter of QA, but they are not experts in training and teaching.
“When SMEs are not only delivering the training but also designing it, it tends to be at the novice end of the spectrum level where they’re teaching people the process but not really giving them enough scenario-based learning or problem-based learning,” Guilkey said. “These learning techniques accelerate the path from novice to competency and eventually expertise. We find that that’s really lacking throughout the industry.”
But let’s not discredit SMEs entirely. They are an important part of the training process, certainly.
“SMEs are absolutely critical to the learning process. They know a lot about the particulars of QA or whatever the subject might be,” Guilkey continued. “But they are basically ‘tellers.’ They relate the steps of the process. Although they are good at delivering training, they are not equipped to actually design effective learning programs.”
The Anatomy of Quality
A key component of any quality program is compliance. The U.S. Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Part 820 deals with quality for medical devices. The regulations cover definitions of what quality means, to requirements, to corrective and preventative action (CAPA) protocols, to directions on handling, storage, and other aspects of medical device movement, to record-keeping and servicing protocols. Part 820.3, which covers definitions of terms associated with QA, defines quality as “the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance”—and this is only one of 29 basic terms a QA employee needs to know in order to perform her job. And those 29 terms make up only one of dozens of sections under Part 820.
QA personnel need to understand all the terms that relate to FDA regulations. For instance, a “complaint” means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. Take note that the definition includes verbal communication, so a QA professional must understand that even a statement that is not in writing is included under this definition for legal purposes. A “component” refers to any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. Personnel need to understand fine distinctions, like the difference between validation and process validation. Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled, while process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Personnel need to understand the difference between a device history record and a device master record: the first is a compilation of records containing the production history of a finished device; the second is a compilation of records containing the procedures and specifications for a finished device. This may seem like an ignorable distinction, but in the event of an audit, it is essential that each record contains correct and pertinent information. What is at stake? Both the quality of the product and the very life of a company. For if “nonconformity” is identified (the nonfulfillment of a specified requirement), a company could receive a warning letter or even, in extreme cases, find itself the subject of a federal criminal investigation.
The threat that hangs over medical device companies should they fail to meet quality requirements is not an empty one. In 2012, dental device company Accurate Set was completely shut down by the FDA over violating regulations governing quality service protocol at its manufacturing facility in Newark, N.J. Under the terms of the consent decree, signed by Judge Susan D. Wigenton of the U.S. District Court for the District of New Jersey on Feb. 7, 2012, Accurate Set agreed to (read: was ordered to) discontinue its operations until the FDA clears or approves its products, which include a variety of restorative dental products such as dental
impression and repair materials. To date, the agency still has not approved the company to resume operations.
Accurate Set previously has received two warning letters in 2003 and 2010. The FDA’s most recent inspection of the company, between December 2010 and January 2011, revealed “significant violations of the FDA’s quality system (QS) regulation, including violations related to the firm’s corrective action and consumer complaint procedures, purchasing controls, and quality audits.” The QS regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices. Investigators also found that medical devices made by the company, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA pre-market review.
“This consent decree demonstrates the FDA’s commitment to protecting the public health from the dangers of unapproved and improperly manufactured medical devices,” Dara A. Corrigan said at the time (she is now director of FDA’s Europe office), stressing how ultimately, medical device quality comes down to public safety.
In a piece advising medical device startups on what to expect from the FDA, NYTechConnect.com contributor Jerry Korten wrote, “The FDA inspector will doggedly go step by step through your documentation process, your customer interaction documents, your corrective actions and, by golly, they can usually find something you are doing that isn’t optimal. And your company will ultimately benefit by incorporating their feedback.” Korten also warned that inspections occur when a company is “least able to devote time to such a distraction,” but that it is imperative to be ready—or risk the fate of Accurate Set.
Korten continued, “You do need to show that you have done all you know to do in order to be compliant with your quality system. You may have deficiencies, but if you are following your procedures well and you have documented that behavior consistently, you only need to correct the procedures, not your behavior, and the FDA appreciates this. Allow them to help you find these corrections before any error can cause problems for you in the future.”
For startups, one of the main concerns, of course, is funding. And training costs money. According to Nancy Singer, J.D., LL.M, founder and president of pharmaceutical and medtech consultancy company Compliance-Alliance LLC, when companies are tight for funds, training programs often are the first programs they cut.
“They may also cut quality resources and training budgets when they perceive that they will not be inspected by the FDA,” Singer told MPO. “Companies need to view quality as a revenue driver.”
Training Processes
“Most companies do annual refresher training on the quality system regulation,” Singer said. “To develop the training, they look at the root causes for customers’ complaints, the results from internal audits, and FDA 483 observations and warning letters. The training is generally provided by an internal quality manager or an outside consultant who is able to present best practices in the field. When I am brought into a company, I teach quality by challenging people to look at their performance from a perspective of an outside observer. Each judgment is subject to second-guessing throughout the life of the device. I help people understand that their commitment to quality is tested every day.”
Singer refers to a dichotomy that Guilkey refers to: the internal trainer versus the external expert. As Singer suggests, an external trainer inherently provides a perspective free of biases or blind spots an internal trainer might display.
“Let’s say a QA employee who is very good at their job becomes a supervisor and eventually a trainer of the QA group,” Guilkey said. “That is a natural progression through many of these positions within the medical industry, so what you’re asking somebody to do is basically stand up in front of a class—an SME—and train the next group of new associates. The issue with that is that although those folks have an in depth knowledge of that particular process, they don’t know adult learning theory or instructional design principles. Therefore the training is usually not very engaging, and doesn’t result in a very high level of learning. When you look at what a QA person has to have, it’s a very diverse set of both technical and analytical skills. A technical skill might be the process, e.g., I put a component in this machine, I heat it up, I read the dial—those types of processes. But then there are a lot of judgment, decision-making and communication skills that need to go along with that. When you look at what these types of individuals do on the job, judgment—that ability to really know whether or not this device can pass the particular standards—takes a different type of training.”
Companies such as S4 don’t just offer the benefit of an outside perspective. They offer expertise in learning theory, cost savings in the form of more efficient training that reduces error later, and reduced training times. In fact in a recent medical training project, S4 reports that it reduced the company’s training times by 50 percent. Some of the tools S4 uses in its training are gaming and discovery learning, cognitive engagement to reinforce learning, animation for visualization, and 3-D animation. Such specialized learning tools serve to engage employees and create more proficient QA personnel with a real shot at reaching the “expert” level instead of trudging along at the novice level. This in turn increases the likelihood of the employee remaining at the company long term, which is beneficial to the quality systems in place. The more proficient employees that remain at the company, the better it is for the company.
But external trainers do not have to be the gold standard for quality personnel training. Randolph, N.J.-based Glenbrook Technologies Inc., a manufacturer of X-ray inspections systems—one of which is used by the FDA itself—has its own specialized training program for QA personnel.
“The training program [at Glenbrook] actually has various components to it,” Glenbrook’s Executive Vice President and Chief Financial Officer Claire Zweig told MPO. “Each system that goes out the door has a quality control checklist. The system itself has to be inspected by three people—three different sets of eyes—because each person is looking at something new to them. One of the three people is either the president or CEO.”
Even though Glenbrook focuses its training internally, the company makes sure it incorporates a sense of externality to it by ensuring at least three different people inspect the checklist. The company also convenes every Monday morning where any quality issue can be raised and shared between all different departments, not just quality control.
“Quality is an obligation that we take very seriously, obviously because our reputation is on the line,” Zweig continued. “We’ve been a manufacturer of X-ray inspection systems for 32 years. I don’t think you last for 32 years if you don’t have quality as part of your programming. When we’re working with medical devices, many times that can be the difference between life and death. We’re helping our customers develop new products as well, so we understand the obligation that they have in manufacturing a quality product.”
Glenbrook is concerned with the quality of its X-ray systems, but the company’s X-ray systems in turn are used by medical device manufacturers to inspect devices for quality. Glenbrook’s QA personnel are tasked with understanding how their X-ray systems work and what benefits they provide to manufacturers that use them to inspect their own devices for quality. CEO Glenn Zweig explained how Glenbrook’s X-ray systems fit into the quality expectations from the FDA by using cardiovascular devices as an example. In 2010, the FDA recommended that manufacturers indicate via labeling the radiopacity of cardiovascular devices. The reason is that once such a device is implanted, it is important for clinicians to know how easy it will be to view the device via X-ray post implantation. QA personnel at Glenbrook need to understand not only how to manage the quality of their X-ray inspection systems, but also how to manage the various specialized quality needs of their clients who are using the machines in their own quality systems to inspect for aspects of a device such as radiopacity. Therefore, Glenbrook also provides services to medical device manufacturers who wish to create a quality control program.
“What’s interesting is that as medical device manufacturers are developing new products, they’re contacting us,” Claire Zweig said. “So we get involved in a lot of products on the development end. I think there is an awareness that X-ray can help in their process, but we can also work with medical device manufacturers in helping them create a quality control program. Sometimes they don’t know that’s what they need and that X-ray can help them in the process. That’s what we hope to help them with.”
“When I say our claim to fame is measurable business results, we’re not talking about whether trainees can pass a test or not, because SMEs can get personnel to pass a simple multiple choice knowledge test,” said Guilkey, driving home the importance of training for independent thinking, not just subject area knowledge. “A test of really good training is the actual application of that knowledge. QA folks can have a tremendous effect on their organization—anything from shutting down a production line to actually passing a medical device that enters a patient. So training must get these folks to that higher level for the sake of safety and quality.”