Mark Crawford12.01.14
There is unrelenting pressure—internally and externally from customers and the U.S. Food and Drug Administration (FDA)—on orthopedic manufacturers and subcontractors to improve process quality and validation.
When implemented and run correctly, quality systems benefit both the manufacturer and the client, because the production process is streamlined, approvals come faster, and the products get to market more quickly. An increasing number of companies are focused on continuous improvement and risk management. It doesn’t even have to be a technological improvement—administrative improvements, such as the automation of device master records, can make a big difference in overall quality and operational performance.
Because most orthopedic products are used in hospital settings, more companies are moving toward sterile packaging versus non-sterile packaging to reduce infection rates in hospitals, boost sales in Europe and meet or exceed regulatory expectations for cleaning.
For orthopedics, a key focus of quality assurance is on the inspection and validation testing of the products prior to distribution. OEMs direct a lot of attention toward inspection tolerances and visual and mechanical inspection criteria, as well sterility, package integrity and distribution simulations.
As a result, contract manufacturers are being challenged by orthopedic OEMs to add quality system capability. For example, manufacturers that are interested in CE marking their devices are requiring their suppliers to have ISO 13485 certification from a company that is a notified body in the European Union, which often requires upgrades to their quality systems.
“Customers are requiring more validation from their contract manufacturers for cleaning, passivation, heat treating, etc.,” said Mark F. Schenk, a quality assurance (QA) and regulatory affairs medical device consultant in West Lawn, Pa. “Even for processes such as CNC milling, customers are asking for installation qualification and operational qualification and some form process capability. They are also asking for PFMEA (process failure mode and effects analysis).”
Safety, Speed & Accuracy
OEMs want safety, speed and accuracy. They expect their vendors to have quality systems that cover all stages of design and development of new medical devices. This includes material selection, lot traceability, surface finish control, machine tool preventive maintenance and product handling, which often present unique challenges for orthopedic products—especially implantables.
“Material selection and control can be particularly detailed, as an increasing number of customers want specific material chemistries that may only apply to their products,” said Brian Stewart, director of quality and continuous improvement for Oberg Industries, a Freeport, Pa.-based manufacturer of precision components and tooling for the medical industry. ”It is critical for us to source these custom alloys properly, ensure they are certified properly and keep them segregated from similar alloys.”
Quality improvement is a continuous, ongoing process. At Millstone Medical Outsourcing, a Fall River, Mass.-based provider of medical packaging solutions for the medical device industry, the company’s full-time quality assurance team evaluates quality systems on a daily basis.
“Our ‘roving’ QA team regularly performs in-process quality assurance reviews to verify processes at the time of execution,” said Victoria Hughes, vice president of quality systems for Millstone. “The inspectors and quality operators verify procedures and material usage within work cells while product is in process—this is in addition to each verification check following completion of every process step of our batch records.”
In this age of technology, brimming with high expectations of sophisticated software management systems solving quality issues, it’s nice to know that simply some extra training, or acting on employee ideas, can have major impacts on quality and cost reduction. Oberg Industries, for example, has a very active suggestion program, where employees receive monetary rewards if their improvement ideas are adopted. There are numerous examples of front-line employees suggesting process changes that have resulted in improved quality and cost.
“Some of our biggest quality improvements have come in the area of training, including the use of lean manufacturing, which affects all the products we manufacture,” said Stewart. “We have raised the bar on both compliance and skills training and are generating positive results, especially in geometric dimensioning and tolerancing.”
Improving quality reduces variation from product to product, which results in many opportunities to save money. For example, inventories that once were in place to buffer against variation can be reduced, thereby reducing lead times and carrying costs.
“This flexibility allows us to be more responsive to the sometimes-highly-variable demands customers may have,” added Stewart. “It also helps us win more business. Quality improvement can create this virtuous cycle again and again—not to mention the bottom-line savings of reduced scrap and rework reduction.”
Oberg is using an optical capability maturity model process that especially is helpful for measuring complicated geometries for parts the company makes for the aerospace industry. The Wenzel CORE DS machine uses optical sensors to measure even highly reflective and polished surfaces. The 5-axis system has three linear and two rotational axes. The zero-contact point measurement uses a double-eyed sensor. Even with a tilt angle of 85 degrees to the surface, measurement points can be captured with accuracy and repeatability (features with diameters as small as 35 micrometers can be measured precisely). Oberg expects to use this inspection process for its medical device products in the future.
Quality processes at Millstone include custom ultrasonic cleaning of fixtures for maximized throughput and efficiency, in-depth trending analysis on a monthly basis and real-time particulate monitoring in clean environments.
“Our most common quality-related requests from clients are quality reports and process reviews,” said Hughes. “We provide our customers with key performance indicators and customer quarterly reviews on a monthly or quarterly basis. These provide information on vendor non-conformances, complaints, audit and response status and procedure reviews, etc., which allow customers to accurately assess their vendors, including Millstone.”
With unique device identification (UDI) label requirements for Class 3 devices and more requirements coming in the future for other classes of devices labeling, more companies are interested in automating their labeling.
“Services that offer systems and online tools for controlling labels are very useful for managing this,” said Schenk. “Specification developers have to ensure that their labels meet the requirements of UDI, especially the barcodes, and contract manufacturers must have the ability to print the labels.”
The Challenges of Regulation
OEMs and suppliers must meet the standards of both the FDA and ISO 13485. FDA regulations continue to evolve—for example, recent changes to the 510(k) process with the use of the “refuse to accept” (RTA) checklist, as well as UDI require system adjustments. (Editor’s note: The FDA’s RTA policy includes an early review against specific acceptance criteria and to inform the device company within 15 calendar days after receipt of a 510(k) notice submission if the submission is administratively complete, and if not, to identify missing required elements of the submission.) Another example is the FDA requirement that all steam sterilization validations be performed using ANSI/AAMI ST79. Although this hasn’t led to any major quality system changes, it does mandate a single sterilization process, which streamlines approval.
OEMs expect their vendors and contract manufacturers to fully understand regulatory requirements and have effective quality systems in place for final inspection.
“Specification developers must demonstrate that the product meets specifications, even though they aren’t necessarily inspecting the devices,” said Schenk. ”Customers are asking for more inspection details and reports, including first articles, in process, final inspection, and process capability.
Programs that assist in creating comprehensive inspection plans are very beneficial here, such as Minitab. Minitab is a popular tool that makes it easy to carry out design of experiments, analysis of variance and capability analysis.”
Companies that must undergo an FDA audit especially want as much objective evidence and data from their vendors’ quality system as possible to make the audit go smoothly, particularly failure modes and effects analyses, documentation/validation records and inspection reports. This all works best when the contract manufacturer is part of the design process early on and can contribute valuable insights regarding quality design and ease of validation prior to production.
“Contract manufacturers often use specification developers to put systems in place that result in gathering critical quality information up front, at the beginning of project development,” Schenk told Orthopedic Design & Technology.
“An increasing number of customers today are asking us to speak with data,” added Stewart. “Our quality assurance group is well-positioned to partner with our customer-facing functions to respond to this need to understand manufacturability and quality control. We do this through proactive capability analysis to show our confidence in our processes. By staying on top of the latest inspection technologies, we also demonstrate to our customers that we can accurately inspect even their most demanding product features.”
For orthopedic manufacturers, getting product to market is tedious and time-consuming. To alleviate both the time and costliness of this process, Millstone has developed pre-validated and universal packaging solutions. Pre-validated packaging solutions reduce the cost and time of executing package integrity and distribution validations, which gets products to market faster and more efficiently. By partnering with Barger, the medical division of packaging designer and manufacturer Placon Corporation, Millstone has developed a special packaging that fits roughly 80 percent of spinal and extremities implants and can be sterilized by gamma irradiation and ethylene oxide. Packaging consists of a double-sterile barrier thermoform tray with two polyurethane liners for protection, inner and outer lids made from Tyvek and a shelf carton.
“The universal packaging is a flexible design that cuts down on validation costs as well as the validation timeline to release sterile products to market,” said Hughes. “Millstone’s pre-validation testing can reduce the validation timeline up to 12 weeks for one-year aging and up to seven weeks for five-year aging.”
In addition, having all of the necessary federal and state licenses/certifications provides Millstone the ability to launch OEM products quickly and efficiently. “The licensing process is very tedious and federal regulations and state mandates can be overwhelming, challenging and costly,” said Hughes. “We eliminate this for our customers by obtaining all of the licensing and requirements needed for distribution of their products.”
A Legal Perspective on QMS
James W. Kolka is a Marietta, Ga.-based attorney and international legal consultant who provides American and European Union companies and law firms with legal expertise, especially regarding product liability/product safety audits and risk assessment/hazards analysis. He often serves as a legal expert or expert witness in litigation involving ISO 9001, ISO 13485, ISO 14001, CE marking in the United States and the European Union and the FDA’s quality system regulations.
In a recent lawsuit, a supplier’s employee had not followed the company’s quality management systems (QMS) procedures for unloading a tank car of ethanol and failing to clean the hoses after a previous tank car of acetone had been unloaded. This mistake resulted in tainted ethanol being mixed with other chemicals that were used to manufacture diabetic test strips that failed to work. “After unraveling what had occurred, the medical device manufacturing company alleged that it had experienced a $1.5 million loss,” said Kolka. “The forensic accounting firm verified the loss.”
In another lawsuit, a Texas medical device company was sued by a United Kingdom-based machinery manufacturer that alleged a breach of contract and asked for damages. The U.K. manufacturer claimed that it had completed manufacturing a medical machine to the Texas medical device company’s specifications. In turn, the device company countersued, claiming that it had not contracted for the machine manufactured.
“In depositions we conducted in the U.K., the officers of the machine manufacturer were asked why they had not followed the contracting procedure in their ISO 9001:2000 QMS,” said Kolka. “Basically the deposition revealed that they had failed to follow their own QMS contracting procedure, instead creating a new contract that was not mutually agreed upon by both parties. Both of these examples illustrate how knowledge of a QMS can be used in a lawsuit. These are simple examples—most QMS lawsuits are more complex.”
One of the best ways to stay out of trouble with the FDA is to respond quickly to warning letters and remedy any deficiencies as soon as possible. Second or third warning letters show a deliberate lack of regard for fixing the problem and patient safety. If the observations made in warning letters help prove an injury to a patient, they are powerful support for the plaintiff’s position in a lawsuit.
Kolka points out that the FDA’s quality system regulation has been beneficial in winning product liability lawsuits. In addition, FDA warning letters and penalties have provided an effective entry to product liability lawsuits.
“FDA warning letters are very specific in identifying areas where a manufacturer failed to follow requirements of 21 CFR Part 21 Quality Regulations,” he said.
A good way to better understand the expectations of FDA inspectors is to read the various materials the FDA has prepared on its Quality System Inspection Technique (QSIT) and attend various QSIT workshops.
“Every regulatory manager and quality manager should review all FDA Center for Devices and Radiological Health guidance publications and examine the language and expectations,” advised Kolka. “Often they will find a ‘shall’ emphasis instead of a permissive emphasis. The duty of every competent regulatory manager and quality manager is to use the QSIT questions as well as the related regulations to see how their QMS is complying. The QSIT and QSIT workshops are very beneficial for showing how QSIT might be relevant to a lawsuit.”
QSIT incorporates seven subsystems and provides guidance to its inspectors on auditing each of the subsystems. The seven subsystems are management, design controls and material controls, records and documents, change controls, equipment and facility controls, production and process controls, and corrective and preventive action.
“The FDA’s QSIT and QSIT workshops should be a source of study for all medical device manufacturers,” said Kolka. “Likewise, this material should be studied by corporate counsel, defense counsel, and trial attorneys. It not only underscores FDA’s focus, it provides a focus that is useful to attorneys involved in product liability litigation. Whatever is of importance to FDA is important to an attorney, these are areas where most mistakes are made and opportunities are presented.”
Kolka recently joined a group of international colleagues that is working with medical device companies in the United States and the European Union that want to reduce as much as possible the risks of product liability litigation in the U.S. market.
“We combine legal expertise in risk management, human factors, document control, insurance, loss control, preventive law, product liability audits that can be applied to FDA’s Quality System Regulation, E.U. medical devices directives and ISO 13485 and ISO 9001 quality management systems,” said Kolka. “We use a QMS as a platform for product liability avoidance, including document management and ‘word control’ training and the creation of a product management system. We are preparing new approaches to work with companies to address these concerns.”
Mark Crawford is a full-time freelance business, marketing and communications writer based in Madison, Wis. He can be reached at mark.crawford@charter.net.
When implemented and run correctly, quality systems benefit both the manufacturer and the client, because the production process is streamlined, approvals come faster, and the products get to market more quickly. An increasing number of companies are focused on continuous improvement and risk management. It doesn’t even have to be a technological improvement—administrative improvements, such as the automation of device master records, can make a big difference in overall quality and operational performance.
Because most orthopedic products are used in hospital settings, more companies are moving toward sterile packaging versus non-sterile packaging to reduce infection rates in hospitals, boost sales in Europe and meet or exceed regulatory expectations for cleaning.
For orthopedics, a key focus of quality assurance is on the inspection and validation testing of the products prior to distribution. OEMs direct a lot of attention toward inspection tolerances and visual and mechanical inspection criteria, as well sterility, package integrity and distribution simulations.
As a result, contract manufacturers are being challenged by orthopedic OEMs to add quality system capability. For example, manufacturers that are interested in CE marking their devices are requiring their suppliers to have ISO 13485 certification from a company that is a notified body in the European Union, which often requires upgrades to their quality systems.
“Customers are requiring more validation from their contract manufacturers for cleaning, passivation, heat treating, etc.,” said Mark F. Schenk, a quality assurance (QA) and regulatory affairs medical device consultant in West Lawn, Pa. “Even for processes such as CNC milling, customers are asking for installation qualification and operational qualification and some form process capability. They are also asking for PFMEA (process failure mode and effects analysis).”
Safety, Speed & Accuracy
OEMs want safety, speed and accuracy. They expect their vendors to have quality systems that cover all stages of design and development of new medical devices. This includes material selection, lot traceability, surface finish control, machine tool preventive maintenance and product handling, which often present unique challenges for orthopedic products—especially implantables.
“Material selection and control can be particularly detailed, as an increasing number of customers want specific material chemistries that may only apply to their products,” said Brian Stewart, director of quality and continuous improvement for Oberg Industries, a Freeport, Pa.-based manufacturer of precision components and tooling for the medical industry. ”It is critical for us to source these custom alloys properly, ensure they are certified properly and keep them segregated from similar alloys.”
Quality improvement is a continuous, ongoing process. At Millstone Medical Outsourcing, a Fall River, Mass.-based provider of medical packaging solutions for the medical device industry, the company’s full-time quality assurance team evaluates quality systems on a daily basis.
“Our ‘roving’ QA team regularly performs in-process quality assurance reviews to verify processes at the time of execution,” said Victoria Hughes, vice president of quality systems for Millstone. “The inspectors and quality operators verify procedures and material usage within work cells while product is in process—this is in addition to each verification check following completion of every process step of our batch records.”
In this age of technology, brimming with high expectations of sophisticated software management systems solving quality issues, it’s nice to know that simply some extra training, or acting on employee ideas, can have major impacts on quality and cost reduction. Oberg Industries, for example, has a very active suggestion program, where employees receive monetary rewards if their improvement ideas are adopted. There are numerous examples of front-line employees suggesting process changes that have resulted in improved quality and cost.
“Some of our biggest quality improvements have come in the area of training, including the use of lean manufacturing, which affects all the products we manufacture,” said Stewart. “We have raised the bar on both compliance and skills training and are generating positive results, especially in geometric dimensioning and tolerancing.”
Improving quality reduces variation from product to product, which results in many opportunities to save money. For example, inventories that once were in place to buffer against variation can be reduced, thereby reducing lead times and carrying costs.
“This flexibility allows us to be more responsive to the sometimes-highly-variable demands customers may have,” added Stewart. “It also helps us win more business. Quality improvement can create this virtuous cycle again and again—not to mention the bottom-line savings of reduced scrap and rework reduction.”
Oberg is using an optical capability maturity model process that especially is helpful for measuring complicated geometries for parts the company makes for the aerospace industry. The Wenzel CORE DS machine uses optical sensors to measure even highly reflective and polished surfaces. The 5-axis system has three linear and two rotational axes. The zero-contact point measurement uses a double-eyed sensor. Even with a tilt angle of 85 degrees to the surface, measurement points can be captured with accuracy and repeatability (features with diameters as small as 35 micrometers can be measured precisely). Oberg expects to use this inspection process for its medical device products in the future.
Quality processes at Millstone include custom ultrasonic cleaning of fixtures for maximized throughput and efficiency, in-depth trending analysis on a monthly basis and real-time particulate monitoring in clean environments.
“Our most common quality-related requests from clients are quality reports and process reviews,” said Hughes. “We provide our customers with key performance indicators and customer quarterly reviews on a monthly or quarterly basis. These provide information on vendor non-conformances, complaints, audit and response status and procedure reviews, etc., which allow customers to accurately assess their vendors, including Millstone.”
With unique device identification (UDI) label requirements for Class 3 devices and more requirements coming in the future for other classes of devices labeling, more companies are interested in automating their labeling.
“Services that offer systems and online tools for controlling labels are very useful for managing this,” said Schenk. “Specification developers have to ensure that their labels meet the requirements of UDI, especially the barcodes, and contract manufacturers must have the ability to print the labels.”
The Challenges of Regulation
OEMs and suppliers must meet the standards of both the FDA and ISO 13485. FDA regulations continue to evolve—for example, recent changes to the 510(k) process with the use of the “refuse to accept” (RTA) checklist, as well as UDI require system adjustments. (Editor’s note: The FDA’s RTA policy includes an early review against specific acceptance criteria and to inform the device company within 15 calendar days after receipt of a 510(k) notice submission if the submission is administratively complete, and if not, to identify missing required elements of the submission.) Another example is the FDA requirement that all steam sterilization validations be performed using ANSI/AAMI ST79. Although this hasn’t led to any major quality system changes, it does mandate a single sterilization process, which streamlines approval.
OEMs expect their vendors and contract manufacturers to fully understand regulatory requirements and have effective quality systems in place for final inspection.
“Specification developers must demonstrate that the product meets specifications, even though they aren’t necessarily inspecting the devices,” said Schenk. ”Customers are asking for more inspection details and reports, including first articles, in process, final inspection, and process capability.
Programs that assist in creating comprehensive inspection plans are very beneficial here, such as Minitab. Minitab is a popular tool that makes it easy to carry out design of experiments, analysis of variance and capability analysis.”
Companies that must undergo an FDA audit especially want as much objective evidence and data from their vendors’ quality system as possible to make the audit go smoothly, particularly failure modes and effects analyses, documentation/validation records and inspection reports. This all works best when the contract manufacturer is part of the design process early on and can contribute valuable insights regarding quality design and ease of validation prior to production.
“Contract manufacturers often use specification developers to put systems in place that result in gathering critical quality information up front, at the beginning of project development,” Schenk told Orthopedic Design & Technology.
“An increasing number of customers today are asking us to speak with data,” added Stewart. “Our quality assurance group is well-positioned to partner with our customer-facing functions to respond to this need to understand manufacturability and quality control. We do this through proactive capability analysis to show our confidence in our processes. By staying on top of the latest inspection technologies, we also demonstrate to our customers that we can accurately inspect even their most demanding product features.”
For orthopedic manufacturers, getting product to market is tedious and time-consuming. To alleviate both the time and costliness of this process, Millstone has developed pre-validated and universal packaging solutions. Pre-validated packaging solutions reduce the cost and time of executing package integrity and distribution validations, which gets products to market faster and more efficiently. By partnering with Barger, the medical division of packaging designer and manufacturer Placon Corporation, Millstone has developed a special packaging that fits roughly 80 percent of spinal and extremities implants and can be sterilized by gamma irradiation and ethylene oxide. Packaging consists of a double-sterile barrier thermoform tray with two polyurethane liners for protection, inner and outer lids made from Tyvek and a shelf carton.
“The universal packaging is a flexible design that cuts down on validation costs as well as the validation timeline to release sterile products to market,” said Hughes. “Millstone’s pre-validation testing can reduce the validation timeline up to 12 weeks for one-year aging and up to seven weeks for five-year aging.”
In addition, having all of the necessary federal and state licenses/certifications provides Millstone the ability to launch OEM products quickly and efficiently. “The licensing process is very tedious and federal regulations and state mandates can be overwhelming, challenging and costly,” said Hughes. “We eliminate this for our customers by obtaining all of the licensing and requirements needed for distribution of their products.”
A Legal Perspective on QMS
James W. Kolka is a Marietta, Ga.-based attorney and international legal consultant who provides American and European Union companies and law firms with legal expertise, especially regarding product liability/product safety audits and risk assessment/hazards analysis. He often serves as a legal expert or expert witness in litigation involving ISO 9001, ISO 13485, ISO 14001, CE marking in the United States and the European Union and the FDA’s quality system regulations.
In a recent lawsuit, a supplier’s employee had not followed the company’s quality management systems (QMS) procedures for unloading a tank car of ethanol and failing to clean the hoses after a previous tank car of acetone had been unloaded. This mistake resulted in tainted ethanol being mixed with other chemicals that were used to manufacture diabetic test strips that failed to work. “After unraveling what had occurred, the medical device manufacturing company alleged that it had experienced a $1.5 million loss,” said Kolka. “The forensic accounting firm verified the loss.”
In another lawsuit, a Texas medical device company was sued by a United Kingdom-based machinery manufacturer that alleged a breach of contract and asked for damages. The U.K. manufacturer claimed that it had completed manufacturing a medical machine to the Texas medical device company’s specifications. In turn, the device company countersued, claiming that it had not contracted for the machine manufactured.
“In depositions we conducted in the U.K., the officers of the machine manufacturer were asked why they had not followed the contracting procedure in their ISO 9001:2000 QMS,” said Kolka. “Basically the deposition revealed that they had failed to follow their own QMS contracting procedure, instead creating a new contract that was not mutually agreed upon by both parties. Both of these examples illustrate how knowledge of a QMS can be used in a lawsuit. These are simple examples—most QMS lawsuits are more complex.”
One of the best ways to stay out of trouble with the FDA is to respond quickly to warning letters and remedy any deficiencies as soon as possible. Second or third warning letters show a deliberate lack of regard for fixing the problem and patient safety. If the observations made in warning letters help prove an injury to a patient, they are powerful support for the plaintiff’s position in a lawsuit.
Kolka points out that the FDA’s quality system regulation has been beneficial in winning product liability lawsuits. In addition, FDA warning letters and penalties have provided an effective entry to product liability lawsuits.
“FDA warning letters are very specific in identifying areas where a manufacturer failed to follow requirements of 21 CFR Part 21 Quality Regulations,” he said.
A good way to better understand the expectations of FDA inspectors is to read the various materials the FDA has prepared on its Quality System Inspection Technique (QSIT) and attend various QSIT workshops.
“Every regulatory manager and quality manager should review all FDA Center for Devices and Radiological Health guidance publications and examine the language and expectations,” advised Kolka. “Often they will find a ‘shall’ emphasis instead of a permissive emphasis. The duty of every competent regulatory manager and quality manager is to use the QSIT questions as well as the related regulations to see how their QMS is complying. The QSIT and QSIT workshops are very beneficial for showing how QSIT might be relevant to a lawsuit.”
QSIT incorporates seven subsystems and provides guidance to its inspectors on auditing each of the subsystems. The seven subsystems are management, design controls and material controls, records and documents, change controls, equipment and facility controls, production and process controls, and corrective and preventive action.
“The FDA’s QSIT and QSIT workshops should be a source of study for all medical device manufacturers,” said Kolka. “Likewise, this material should be studied by corporate counsel, defense counsel, and trial attorneys. It not only underscores FDA’s focus, it provides a focus that is useful to attorneys involved in product liability litigation. Whatever is of importance to FDA is important to an attorney, these are areas where most mistakes are made and opportunities are presented.”
Kolka recently joined a group of international colleagues that is working with medical device companies in the United States and the European Union that want to reduce as much as possible the risks of product liability litigation in the U.S. market.
“We combine legal expertise in risk management, human factors, document control, insurance, loss control, preventive law, product liability audits that can be applied to FDA’s Quality System Regulation, E.U. medical devices directives and ISO 13485 and ISO 9001 quality management systems,” said Kolka. “We use a QMS as a platform for product liability avoidance, including document management and ‘word control’ training and the creation of a product management system. We are preparing new approaches to work with companies to address these concerns.”
Mark Crawford is a full-time freelance business, marketing and communications writer based in Madison, Wis. He can be reached at mark.crawford@charter.net.