Multispectral SWIR Camera Focuses on Biomedical Applications

A multispectral camera that performs SWIR analysis at 700 to 1700 nm can be used in such biomedical applications as endoscopy.

Shortwave infrared (SWIR) cameras have already revolutionized night vision goggles. The technology dramatically increases visibility and clarity over standard options. While the last movie you saw showing night vision systems probably evokes images of a grey green haze surrounding soldiers or buildings, objects viewed using SWIR technology are perfectly discernable. That's why Ocean Thin Films (Golden, CO) thinks the technology is perfectly suitable for medical device applications.

In an effort to exploit shortwave infrared technology, the company has introduced PixelCam, a snapshot, multispectral camera that performs SWIR analysis at 700 to 1700 nm. "Multispectral imaging is interesting and useful because it produces an image using only a small section of the spectrum, usually in the 10- to 100-nm range," explains Steve Smith, product manager at Ocean Thin Films. "The technology includes the nonvisible--UV and infrared--regions instead of strictly the visible range of 400 to 177 nm that your eyes are sensitive to."

To create the camera, the company paired its PixelTec precision micropatterned optical coating technology with SWIR-area sensor cameras manufactured by Sensors Unlimited (Princeton, NJ). Based on SWIR technology, the camera simultaneously acquires four or more standard and custom spectral bands using a single camera, enabling users to extract spectral information that is not noticeable using panchromatic SWIR devices. "The PixelCam represents a combination of technologies that facilitates a series of advanced applications," Smith says.

A snapshot multispectral imager captures all of the spectral information simultaneously," Smith comments. "Compare that to current multispectral instruments that mostly work by capturing a single spectral image at a time and then utilizes processing to extract interesting or meaningful information from those images."

The PixelCam multispectral camera uses a custom filter array integrated into a solid-state indium gallium arsenide imager with a resolution of 640×512. These high-transmission dichroic filter arrays are aligned directly over corresponding pixels in the imaging array, enabling the camera to achieve optimal spectral and spatial resolution. The camera platform also provides simultaneous 12-bit Camera Link digital and RS170 analog outputs and an external trigger. The form factor, frame rates, operating temperature, and power requirements are unchanged by the passive spectral filters. Thus, they can be integrated into handheld and mobile devices.

The camera, according to Smith, can be used in such biomedical imaging applications as noninvasive surgery. "For example, the speed of snapshot multispectral imaging might be useful in endoscopy, where you could look to find spectral signatures to differentiate healthy tissues from problematic cells." Multispectral imaging equipment, he adds, could be used in hospitals within 12 to 18 months. "We believe there will be a large market in the medical device world for this technology."

Managing Heat in Medical Device Applications

With the proliferation of miniaturized and implantable devices and rapid advances in microprocessor computing power, the medical device designer and developer must pay increasing attention to heat-management concerns. John Bilski, senior thermal engineer at Thermacore Inc. (Lancaster, PA), highlights how to select the right thermal-management solution for the right medical device.

MPMN: How are evolving medical device technologies forcing medical device designers and developers to address and solve thermal-management issues?

Bilski: As medical devices continue to become smaller and more compact, designers are often challenged with meeting their project's size, performance, operating temperature, noise, and budget requirements. Heat-management technologies can often move, spread, and dissipate heat efficiently. While this helps improve system reliability, speed, precision, and service life, it can also help designers reduce their devices' packaging size, weight, energy consumption, noise, and fouling or bioburden concerns.

A passive heat-pipe cold-plate assembly is one technique offered by Thermacore for managing heat in medical device application

MPMN: What steps should medical device manufacturers take to select a thermal-management technology for a given medical device application?

Bilski: The manufacturer should begin by laying out all of the known thermal design requirements, including the number and location of heat sources, the total power of the heat sources, the available volume, system limitations, maximum allowable heat source temperatures, the maximum ambient temperature, and the available airflow if the device is air cooled. The manufacturer must then determine the thermal technology to be used to solve the heat problem, such as an all-metal heat sink, a heat-pipe assembly, a vapor chamber assembly, liquid cooling, Thermacore's k-Core annealed pyrolytic graphite (APG), or enclosure heat exchangers.

Of course, the optimal thermal-management tool depends on the application and the application-specific requirements. Ultimately, the solution depends on the heat loads, temperature requirements, form factors, available airflow, noise considerations, and other factors. In the medical device industry, solutions can range from a simple piece of aluminum to an air-liquid heat exchanger for cooling enclosures.

For basic applications or applications in which the thermal-solution technology is obvious or understood, the next step is analysis. Basic application analysis can be accomplished using a simple hand or spreadsheet calculation. For more-complex designs, a thermal model of the system can be created. For example, Thermacore might use one or more of the seven different CFD programs available to it to develop thermal models for helping manufacturers to determine which technology best meets a project's requirements. The ultimate objective is to balance the device's thermal/mechanical performance, reliability, speed, precision, service life, size, weight, energy consumption, noise, bioburden concerns, and system cost.

MPMN: What thermal-management concerns should be considered when balancing among airflow, fin size, and fan noise in a medical device application?

Bilski: The concerns will vary with each application. For lower-power devices, it may be possible to dissipate heat to the walls of the metal enclosure using heat pipes, allowing the medical device designer to bypass concerns associated with airflow, fins, or fans. Natural convection methods may also be an option, but they often have a large footprint and add weight to the overall medical device design. In addition, integrating one of many heat-spreading technologies can enable the medical device manufacturer to optimize the size of the heat sinks and modulate the fin pitch to best suit the allowable airflow. For example, more fin area does not necessarily mean better performance. If the fin spacing is too tight for the available airflow, performance can actually decrease.

MPMN: What materials should the medical device designer or developer consider for ensuring effective heat management?

Bilski: Because of its favorable thermal properties and relatively low cost, aluminum is a common choice for managing heat through metal conduction. It has good thermal conductivity, can be anodized for hardness, can be dyed various colors, and is relatively lightweight. While plastic offers lower mass and cost than aluminum, it also has poor thermal conductivity. Copper is another good thermal conductor, but it is usually more expensive and heavier than aluminum. Another thermal-management material is Thermacore's APG. It is 20% lighter than aluminum and three to four times more conductive than copper. Although it is more expensive than other materials, APG is often suitable for medical device applications in which size and mass are critical, such as handheld devices and thermal cyclers.

Lab-on-a-Chip Using Lasers and Electric Fields Has Diagnostic Device Potential

Purdue University researchers have demonstrated a new technology that combines a laser and electric fields to create tiny centrifuge-like whirlpools for separating particles and microbes by size--a potential lab-on-a-chip system. Above, the technique is used to collect Shewanella oneidensis bacteria. (Image courtesy of Purdue University)

Researchers at Purdue University (West Lafayette, IN) have engineered a new lab-on-a-chip device that could potentially be used in future medical diagnostic applications. Dubbed rapid electrokinetic patterning (REP), the system uses a laser and electric fields to produce centrifuge-like whirlpools for separating particles and microbes by size. "The new results demonstrate that REP can be used to sort biological particles but also that the technique is a powerful tool for development of a high-performance on-chip bioassay system," remarks Steven T. Wereley, a professor of mechanical engineering at Purdue.

Employing a highly focused infrared laser, the technology heats fluid in a microchannel containing particles or bacteria. An electric field is then applied, combining with the laser's heating action to circulate the fluid in a 'microfluidic vortex,' creating a centrifuge that isolates specific types of particles based on size. Particles of different sizes can be isolated by changing the electrical frequency, and the vortex moves wherever the laser is pointed, enabling the researchers to position specific types of particles for detection and analysis.

"By properly choosing the electrical frequency we can separate blood components, such as platelets," Wereley says. "Say you want to collect Shewanella bacteria, so you use a certain electrical frequency and collect them. Then the next day you want to collect platelets from blood. That's going to be a different frequency. We foresee the ability to dynamically select what you will collect, which you could not do with conventional tools." REP could be suitable for medical diagnostic applications because it requires only tiny samples, unlike conventional tools.

Labeling Mistakes and How to Avoid Them

By following best practices for labeling companies can also take greater advantage of the flexibility offered by electronic labeling.  Image courtesy of PRESSURE UA

More than a decade ago, FDA held meetings to explore why medical device user instructions were generally found to be ineffective. When the agency issued “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” in June 2011 with its strong encouragement to validate user instructions, FDA essentially set the expectation that the purpose of effective labeling is to control risk in medical device use. Label design should be considered as much a part of risk mitigation the device would be. 
 
Although FDA has long considered labeling as part of the device user interface, testing its effectiveness was not really an expectation. However, many manufacturers continue to claim the problem rests with users who either do not bother to read the instructions or fail to follow instructions after they’ve read them. FDA is clearly unsympathetic to that argument and has placed more responsibility on manufacturers to ensure clarity and comprehension in their labeling. FDA’s message is that labeling has to do more than just read well. It has to measurably support safe and accurate user performance. 
 
Labeling Problems, Deficiencies, and FDA
Simulated use validation studies have revealed important labeling deficiencies, as follows:
 
  • Instructions are not based on good user profiles or task and use-error analysis. 
  • Instructions are not written at a level of detail to guide user performance. 
  • The first step is either missing or buried in an introductory paragraph likely to be overlooked by the user. 
  • Instructions are open to interpretation. Two people read and follow the same step and perform it differently. 
  • Warning and caution statements are misplaced relative to the corresponding step.
  • Illustrations are either not included or are incorrectly displayed.
  • Instructions are not available where and when the user needs them. 
 
FDA initially expressed its concern about labeling in 2001. At that time, the agency's research made it clear that labeling was viewed as little more than a late-stage writing project that often occurred prior to submission with no consideration given to human factors or performance analysis.l Manufacturers often did not even consider performance testing for labeling that would verify whether the home or professional user clearly understood how to use a device.  
 
The publication of HE75, “Human Factors Engineering, Design of Medical Devices” by AAMI was a landmark standard developed by applying best practice guidance to medical device human factors engineering. Included in its section on user documentation was a strong recommendation for observational testing of materials and training guides to verify if the user, particularly the lay person, understood and could correctly follow this information. Another notable result of HE75 was an emphasis that directed manufacturers to refrain from citing the common phrase “user error” as the explanation for device usage issues. AAMI recognized that applying good human factors methods including improved labeling and would help ensure better user performance. FDA has since recognized HE75 as a best practice.
 
The View from a FDA Specialist
Molly Story, PhD, human factors and accessible medical technology specialist with FDA, does not hesitate when asked about the most common labeling error the agency encounters: failure to test labeling with real users. “Too often companies write labeling for themselves and they presume that the user has the same base of understanding as they do,” Story says. “They don’t necessarily understand the assumptions they’re making until they put labeling and the device in the hands of someone unfamiliar with its proper use.” Story says the assumptions tend to omit “critical information that can lead to user error.” 
 
Information provided to FDA from market research can also be a fundamental problem with labeling. Market research often only collects users’ opinions or asks them how much they “agree” with carefully-worded positive statements about the device.
 
“Too often companies provide marketing information that does not provide the evidence we need that the device is safe and effective,” Story says, pointing out that marketing research does not explain the details of user interaction to FDA’s satisfaction. She noted that such research fails to adequately prove that users understand and appropriately respond to the labeling despite what they tell researchers. “What users say they do is not the same as what users think or actually do,” Story says. ”User opinions do not provide evidence of safety and effectiveness.” 
 
Story says the AAMI Medical Devices and Systems in Home Care Applications Committee is preparing a Technical Information Report (TIR) that should be very useful to the industry. The committee’s TIR is expected to be a guideline on more effective validation of labeling than is currently available. The FDA specialist strongly recommends that device manufacturers validate labeling and training before they validate the device. “If training and labeling have to be changed (after device validation), then you have to go back and revalidate the device,” Story says. “It’s much more efficient to validate in the proper sequence.”
 
Some manufacturers have discovered that sometimes their best efforts at device innovation have gone for naught. In these cases, FDA found that labeling was unclear about device function and proper use. The result is user confusion that often surfaces with the introduction of a component that requires certain requisite skills and knowledge that users may not possess. In one situation, the manufacturer of a blood glucose meter had to withdraw an advanced component that it believed would have been a market differentiator because users did not understand some basic concepts (e.g. how to dose insulin based on meals versus blood glucose test results). Although the team knew there was a knowledge problem, the expectation was that labeling would take care of this. Human factors testing uncovered a profound lack of understanding of what the manufacturer considered to be basic concepts. The gap was beyond the scope of basic use instructions. As a result, the much anticipated component had to be dropped for the device to clear FDA. This situation caused significant delays in the device’s launch and may have been avoided had the early stage testing focused more on users’ demonstrated skills and knowledge instead of other aspects of the user interface. 
 
Initiating Best Practices
Examples like this  show an all-too-frequent disconnect between written instructions and user perception. The time to bridge this obvious communication gap is not during device validation but at the beginning with an instructional design process. 
 
Companies are best served by initiating the human factors process early in the design stage and sharing that process with those who will be responsible for labeling. The process should begin by resolving two very pertinent questions for example: 
 
  • Are the users lay people, who have not had professional medical training; are they healthcare professionals, or are both groups users? 
  • Where and under what conditions will the user interact with the device? “Where” could mean a hospital or a rescue vehicle. Conditions may involve everyday use or an emergency.
Companies should start by determining the users’ performance needs for instructional information to support safe and accurate device use. The perceptual, cognitive, and manual action model in FDA’s human factors draft guidance is immensely useful in capturing this information. It should be asked whether a written or paper-based guide is sufficient or if additional training is required, as is often the case for users of home dialysis for example. Answers can be found through the user and task analysis. The process is the best way to eliminate erroneous assumptions through examination and analysis of the real environment of the everyday user. User and task analysis can facilitate decision-making about the type of training that labeling may require.
 
Training decisions should also be based on the complexity of the task that the user is required to perform. Numerous steps, a large number of tasks, and long-term memory retention are obvious signs that written guides alone will be insufficient. The more complex the interaction, the more likely training will be required.
 
 Testing user performance should begin with small and informal assessments during the early stages of the process when information is refined. The process actually mirrors the same testing used for the device. Limiting labeling comprehension testing to employees without including user performance testing is unacceptable for the most obvious of reasons: human factors have been excluded. Labeling instruction to be most effective and understandable has to take general user limitations and characteristics into account. Only after this analysis has been completed should there be validation testing that will eventually be submitted to FDA.  
 
Electronic medical device labeling offers flexibility that is nearly impossible with paper-based labeling, but it also needs to be held to many of the same best practices. Electronic labeling, sometimes called electronic performance support systems (EPSS), can offer users detailed, just-in-time instructions. Too often, electronic ‘help’ features simply give the user access to content when what they are really searching for is ‘how do I apply this content to what I’m doing now?’ A well-designed EPSS can provide the type of information  users want and, very importantly, adjust the level of detail (task versus step versus sub-step) that the user requires.
 
Lessons from a Successful Labeling Experience
While focused on creating labeling for its new t:slim Insulin Delivery System, Tandem Diabetes Care Inc., a San Diego-based provider of technologies for managing diabetes, found that “In the majority of our studies, at least 70 percent of our users did not refer to the labeling,” says Linda Parks, Tandem’s national director of clinical education. “People don’t really go back and read the instructions unless they have a question or problem.”
 
Parks described the initial labeling, which had no input from Tandem’s human factors staff, as “very technical text” that could be confusing to users. “That’s when we made a labeling transition by talking less about the device and more about how the users interact with it,” Parks says.
 
Tandem used human factors engineering to conduct a usability study and a day of training that included labeling comprehension. The next day, the users were given a group of 10 tasks to perform and labeling had to be understood for all of them. “The labeling passed with flying colors,” Parks says. She credits the company’s good human factors methods as the drivers behind its successful labeling effort. In November 2011, the device became the first insulin pump with a touch screen approved by FDA.
 
Conclusion
Good labeling and training can never be a substitute for a device that is well-designed. This is a difficult goal but it has to be considered given  the standards set by HE75 and the draft guidance from FDA. Companies need to understand who their users are. Cautions and warnings on labels are insufficient without consideration of the vital data that only testing and eventual validation can provide. It behooves manufacturers to recognize that users are much too varied to be categorized by marketing demographics. Human factors engineering, user profiles that are specific, task analysis, and performance testing apply to labeling as much as they do the device. 
 
 
Patricia A. Patterson is President of Agilis Consulting Group, LLC and an FDA assigned expert consultant. She is a contributor to HE75: 2010, Human Factors Design for Medical Devices, and a member of the AAMI/HA Medical Devices and Systems in Home Care Applications Committee. For further information, e-mail ppatterson@agilisconsulting.com, visit www.agilisconsulting.com, or call (480) 614-0486. 2
 

Designing Fluid Path Products for Incremental Innovation

 With ongoing technological advances in materials and manufacturing processes, it should come as no surprise that innovation is a megatrend currently extending across various industries. However, because of the impending Affordable Care Act, the medical device tax, efforts to create a unique device identification system, and other building cost pressures, there is the fear that medical device innovation could be stifled. But the changes in policy don’t have to mean expensive, risky changes to product development. As medical device manufacturers look ahead, they can apply the methods such as incremental innovation and design for manufacturing to yield value in existing and new product lines. 

This article explores the latest trends in fluid path components such as silicone tubing, and assesses material formulation, manufacturing processes, and testing methods. Understanding these trends can help designers produce meaningful advances without requiring significant investments in potentially risky processes.

Advances in Material Formulation

Global regulations are driving some advances in medical device materials. Developed to safeguard human health and the environment from risks associated with hazardous chemicals, the European Union’s Registration, Evaluation, Authorization, and Restriction of Chemicals (REACh) has restricted the use of di (2-ethylhexyl) phthalate (DEHP) in medical devices. DEHP is a plasticizer that can be used in fluid path components, including IV tubes and bags to make the base material pliable. Other restricted materials include bisphenol-A (BPA), used in the high performance plastics common in medical device component manufacturing. In some segments of the medical device market manufacturers are looking to replace PVC altogether as they anticipate future trends and regulations. The fear of having to requalify and revalidate products due to material changes up and down the value chain is forcing companies to take a much longer range approach to supplier and material selection.

Rather than creating new material alternatives from scratch, which can be difficult to get approved by FDA, many medical device manufacturers are looking to existing materials, such as silicone or thermoplastic elastomers (TPEs). These materials can be custom compounded to meet fluid path application needs. There are no restrictive regulations and silicone offers a clean alternative to substances of concern that are regulated for fluid path components. Custom compounding, while not a novel concept, can provide unique designs without including materials of concern, such as DEHP and BPA.

 
Molding processes can be improved through automation techniques.

Custom compounding can be used to formulate application-specific performance silicone or TPEs, with tighter control and just the right performance properties including tear strength, compression set, elongation, modulus, and durability. Keep in mind, it is virtually impossible to optimize all properties. Custom compounding focuses on developing the right balance of performance for a specific application. By reducing the tolerance range on key physical properties, manufacturers are able to target certain properties to meet their needs, rather than unnecessarily striving to develop the holy grail of polymeric materials. For example, additives can be used to develop gamma resistant (GR) silicone compounds to create medical valves that prevent sealing or rehealing when exposed to high levels of gamma sterilization, and maintain an effective fluid path throughout their life cycle. Additives can also be used to develop antimicrobial silicone compounds that can ensure patient safety. In addition, TPEs can be used as a viable PVC replacement material for fluid path delivery applications.

Manufacturing Methods for Performance

The ongoing pressure to cost-effectively improve product performance and quality is what drives advances in manufacturing processes. The current trend towards complex component minimization is increasing the need for advances on the production line. Automation innovations can provide two of the most important elements in medical device manufacturing—consistency and precision. 

Advanced automated manufacturing processes now allow fluid path OEMs and component suppliers to reduce variation from production run to production run, ensuring consistency over the life of the product. For molded components, the use of automation can be found throughout the process and lights-out manufacturing (completely automated) has become a reality for many molded components. 

Further advances in automated part handling have led to incremental innovations such as two-shot molding and micromolding. In silicone to thermoplastic two-shot molding, thermal management is vital to successful production. The cold thermoplastic tool needs to be isolated from the hot silicone tool, and all the carefully calculated shrink rates depend on constant control of temperatures in the mold area. Consistent part transfer times between molds, or automatically rotating molds, are necessary to maintain this thermal balance.

Micromolding capabilities allow manufacturers to produce small components for minimally invasive surgical procedures with increased precision and decreased variability. It is necessary for manufacturers to look for precisely controlled, automated part handling options because the components are often too minute to be handled manually. Air movement from HVAC or air filtration systems, or even a static electrical charge, can significantly disrupt part transfer from molding to packaging. 

Advances in extrusion technology have led to microbore tubing.

These advances do not apply to molded components only. Automation is a critical part of the extrusion process as well. Closed loop feedback systems that measure critical parameters during production can be used to automatically adjust the process resulting in lower dimensional variation in finished parts. Improved automation and precision also enables an expanded range of small diameter or microbore tubing that supports the trend towards minimally invasive surgery.

UV curing is another recent advance for which innovations in material engineering and manufacturing come together to improve fluid path components. Specialized additives and inhibitors within the compound enable faster cure using less energy for products coming off the line. With such materials, UV curing is almost instantaneous, allowing for dramatic increases in extrusion rates. For example, in two-shot molding (e.g., a silicone and thermoplastic) manufacturers were historically required to use an engineered thermoplastic to withstand the high temperatures used to cure the silicone. Innovations in UV curable silicones enable manufacturers to potentially use lower cost thermoplastic materials. 

In addition, automation helps maintain the purity of cleanroom operations. Common in fluid path component extrusion and molding, cleanrooms must be kept sterile and contaminant-free to ensure patient safety. Finally, automation is being used to improve product quality through automatically inspecting and testing components. Imperfect products are rejected before they reach the customer, and more importantly, the patient.

Measurement is Key

Incremental innovations in manufacturing are yielding new processes, like minimization. However, it is not enough to simply develop an innovative method to make a part. Manufacturers must be able to verify the process and ensure overall quality. Improvements in metrology, and data collection and analyses are a critical part of incremental innovation.

Vision systems used to detect defects before they are passed along to the patient are typical in-process measurement tools. Many engineering groups are replacing optical comparators with advanced vision systems that include programmable automated measurement capabilities—further evidence that vision inspection systems are a critical part of the design and measurement process of molding parts. These types of visual inspection systems are more complex as components become smaller and more advanced. In extrusion processes, x-ray systems provide improved measurement of critical dimensions during the production process.

Crunching the Numbers

All the high-tech inspection and measurement tools in the world are hardly worth the investment if the data are not utilized properly. Understanding how to analyze and treat data to detect trends and optimize processes is key. Although Six Sigma-related processes exist to analyze data and identify variations, advanced modeling software is being developed for extruded components. Eventually the software could be used to predict performance of the full system based on varying properties in the components, particularly where solid components come into contact with fluids. Imagine a system model for use in peristaltic pump applications that can virtually assess and adjust key variables contributing to consistent flow rate. This type of technology is still in its infancy. However, continued progress, such as in advanced modeling systems, will help manufacturers all along the supply chain to better understand how different aspects of a medical device work together to improve performance.

Conclusion

Refining rather than revolutionizing seems to be the trend today as progress meets economic realities. Incremental innovation is bringing big value to the overall medical device component manufacturing process from advances in material formulation to manufacturing processes, including new ways to consider data collection and analysis. 

Through custom compounding, high-performance materials such as silicones are being formulated to not only meet fluid path component performance needs, but to replace materials of concern. Manufacturing processes are also becoming more advanced, increasing speed, consistency, and precision of parts that are becoming smaller and more complex. Finally, keeping pace with parallel advances throughout the supply chain, innovative test methods and validation processes are ensuring product quality and enabling future innovations in component and device design. 

Fluid path OEMs and component manufacturers are faced with the unique opportunity to work together and spur incremental innovation from material formulation to the product line to design and manufacture the most advanced devices that provide best patient care possible.

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Robert D. Schwenker is a business manager for Saint-Gobain Performance Plastics, based in Austin, TX. He has worked in the healthcare market group for 10 years in new product development and business management. Schwenker has a chemical engineering degree from Cornell University and an MBA from the University of Texas.

Aaron Updegrove is marketing manager in the healthcare markets segment of with Saint-Gobain Performance Plastics, based in Portage, WI. He has more than 18 years of experience in sales and marketing for companies that produce engineered materials and components. Updegrove holds a mechanical engineering degree from Marquette University. 

 

Using Audits to Improve Supplier Performance

Using Audits to Improve Supplier Performance

With the agency’s increased vigilance over device manufacturers, how can companies better position themselves to achieve and sustain compliance? One key tool is the establishment of an effective purchasing control procedure that places significant emphasis on supplier controls and a value-added supplier audit program. A value-added supplier audit program can help organizations mitigate business and regulatory risk while reducing the cost of poor quality (COPQ). 

21 CFR, Part 820 – Subpart E Purchasing Controls says that each manufacturer must establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. Two sections are critical to understanding purchase controls, outlined here. 

Evaluation of Suppliers, Contractors, and Consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements that must be met by suppliers, contractors, and consultants. According to this section, each manufacturer must perform the following tasks: 

  • Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. Evaluations should be documented. 
  • Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results. 
  • Establish and maintain records of acceptable suppliers, contractors, and consultants. 

Purchasing Data. Manufacturers must establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with 820.40. 

One of the terms employed by FDA throughout the QSR is “establish.” According to FDA, establish means to define, document (in writing or electronically), and implement. In support of establishing an effective value-added supplier audit program for improving supplier performance, attention to detail is important. Documenting the entire process in writing an implementation should be considered a mission-critical task. 

Warning Letter Excerpt — 2/9/2012

 “Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm does not have any purchasing controls procedures to ensure that all purchased or otherwise received powered muscle stimulator devices conform to specified requirements. Your firm has not evaluated your supplier and vendor of the powered muscle stimulator device, your label manufacturer, or your overseas import broker on their ability to meet specified requirements, including quality requirements.”

Additionally, the trend in the agency’s issuance of warning letters for failure to comply with 820.50 can easily by reversed if device manufacturers establish adequate procedures and controls for purchasing and supplier management. Warning letters, such as one issued on February 9, 2012 (see the sidebar “Warning Letter Excerpt — 2/9/2012), highlight the need for device manufacturers to establish effective procedures and actually employ them for assuring the quality of products purchased. 

Value-Added Supplier Audit Program 

There are many reasons for organizations to establish a value-added supplier audit program. Now granted, sustaining regulatory compliance is a salient requirement; however, there are other factors organizations need to consider when establishing an approach to value-added supplier audits, some examples of which are as follows: 

  • Preservation of brand equity
  • Ensuring values and strategy are clearly understood by the supplier
  • Establishment of consistent practices amongst suppliers
  • Achieving supplier return on investment (ROI) goals
  • Providing supplier oversight, so efficiency and continuous improvement targets can be achieved. 

When intelligently designed, a value-added supplier audit program can provide real value for a device manufacturer. Establishing a value-added program begins with the understanding that the program fundamentals expand beyond the physical performance of supplier audits. Suppliers that have a certified quality management system (QMS), in accordance with ISO 9001:2008 or ISO 13485:2003, have the basic system elements in place. Certification allows device manufacturers to focus on process-specific audits, which inherently provide more value. However, Trautman cautions manufacturers against relying solely on ISO certification by third parties as evidence that suppliers have the capability to provide quality products or services. Key elements needing to be considered for inclusion into a value-added supplier audit program are as follows: 

  • A well-written supplier quality agreement delineating responsibilities and expectations; 
  • A supplier questionnaire that focuses on business and technology; 
  • Supplier scorecards that are performance centric; 
  • Supplier onsite assessment checklist; 
  • Supplier statistical data program in support of reduced incoming inspection; and 
  • Creation of supplier categories premised on risk (business and regulatory). 

Device Industry Trends in Auditing 

The device industry continues to employ three categories of supplier assessments: supplier selection and qualification audits, supplier surveillance audits to ensure conformance to requirements is being sustained, and for-cause audits, when supplier nonconformances negatively influence finished device performance. Because of the expense associated with performing supplier audits, device manufacturers are in a constant cost-containment battle. The trade-off becomes containing costs associated with supplier oversight while reducing costs associated with COPQ. It has never been economically viable to perform on-site audits on all of a device manufacturer’s suppliers, nor is it value added. 

Another trend influencing the medical device industry is suppliers wanting to be paid for entertaining audits. Device manufacturers invest a significant amount of time and money selecting, approving, and incorporating purchased components into finished medical devices. Considering the expense of validation and the regulatory ramifications associated with the changing of critical component suppliers, it is seldom economically viable to replace suppliers charging for audits. A supplier charging for an audit is an expense that must be considered in advance. 

Focused versus QMS Audits 

Focused and QMS audits provide value depending upon the application. If a supplier has a certified QMS, then the elements of an effective quality system are already in place. However, if a potential supplier does not have a certified QMS, performing an initial audit of the supplier’s quality system is considered prudent and categorized as value-added. Considering the costs associated with device validation, it is too risky to proceed with a business relationship without first kicking the tires. However, if the supplier has a certified QMS, a focused audit is probably the correct path to travel. A focused audit can be employed to assess technical capabilities, capacity, and supply chain. 

Audit Need and Frequency 

Audit need versus frequency is one of the significant influencers driving the need for a value-added supplier audit program. It makes zero sense for device manufacturers to attempt an audit 100% of their supplier base. Conversely, not auditing suppliers or establishing a program for supplier oversight will in all likelihood result in an increase in the COPQ, and potentially invite regulatory action from FDA. A value-added supplier audit program should be governed by audit need, premised on supplier risk. For example, critical suppliers, such as a sterilization facility, should warrant an annual assessment. For the supplier of a poly/Tyvek pouch (sterile barrier), once every three years may be appropriate. The key is for the device manufacturer to adequately define need and frequency. Regardless of the approach, FDA will want to see evidence of program effectiveness. 

Evaluating Risk 

Performing supplier audits can be expensive. Costs such as employing trained auditors, having to manage an extensive list of suppliers, time associated with pre and post-audit activities, and the cost of travel can quickly become problematic even for the most cost-conscience organizations. That is why it is extremely important to include the assessment of risk as part of the program. Creating risk categories, performing risk analysis, focusing on risk reduction, and when appropriate, identifying levels of risk assessment are important features associated with a value-added supplier audit program. 

Third-Party Audits 

Third-party audits, the use of consultants as an extension of a device manufacturer’s value-added supplier audit program, can be a blessing or a curse. Outsourcing supplier audits can result in an immediate and often substantial savings to device manufacturers. However, there is also significant trust involved when outsourcing supplier audits. Auditor competency will influence the overall effectiveness of third-party audits. Auditors lacking experience to assess compliance against applicable regulations, standards, and industry guidelines or lacking technology-specific competency, regardless of credentials, affect the performance of optimum audits resulting in missed opportunities for driving supplier corrections and improvements. 

Conclusion 

Considering the current regulatory climate and the need for organizations to focus on factors reducing the COPQ, implementing an effective value-added supplier audit program becomes a fundamental requirement for device manufacturers. It will never be practical to institute a program requiring a 100% performance of on-site supplier audits, nor will it be acceptable not performing some level of supplier assessments. The solution is to develop and implement an appropriate tool set that supports a value-added approach. Audit type, frequency, and the employment of third-party auditors will influence the cost of any audit program. However, the goal of the program should be to reduce the COPQ. An effective value-added supplier audit program will significantly reduce the COPQ ensuring: (a) suppliers maintain a QMS; (b) suppliers sustain compliance to applicable regulatory requirements; and (c) suppliers manufacture and/or supply a quality product or service. 

Important Links

Warning letters. Retrieved March 10, 2012. 

Medical device warning letter statistics 2011.  

SQA Services Website Protecting the global supply chain through an effective audit program.  

Managing risk in supplier audits

SGS Website Supplier Audit

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Bob Mehta is principal consultant of GMP ISO Expert Services, a Los Angeles/Orange County-based consulting firm specializing in global supplier quality management, supporting quality systems for FDA and ISO regulated companies and helping with remediation of quality systems as a result of FDA’s warning letters to make the system compliant to regulatory requirements. Mehta has more than 22 years of experience in the fields of quality, regulatory compliance, regulatory and notified body inspections, supply management, and risk management. Mehta holds MSQA, MBA, B.S. (Chem), and ASQ - CSSBB, CQE, CRE, CSQE, CBA, CQA, CPA certifications. He serves on the committee of the Industry Board of Advisor for Medical Device Industry Education Consortium (MDIEC). He is heavily involved in remediating and implementing the risk-based quality systems and supplier audit program for Fortune 500 clients in a variety of industries, including medical device, pharmaceutical, biotech and neutraceutical. 

Don't Miss Friday's Deadline to Submit for the Medical Design Excellence Awards

This Friday, January 11, 2013, is the last call for entries in the 2013 Medical Design Excellence Awards (MDEAs), the industry's premier awards program honoring the highest caliber medical devices on the market. The MDEAs celebrate the achievements of medical product manufacturers, their suppliers, and the many people behind the scenes—from entineers and scientists to designers and clinicians—whose innovations are changing the face of medtech. 

Have you:

  • Participated in the design, engineering, manufacture, or distribution of an outstanding finished medical device or medical packaging?
     
  • Developed a high caliber medical product that is saving lives or is responsible for the diagnosis, cure, mitigation, treatment, and/or prevention of disease?
     
  • Created a groundbreaking medical innovation that is changing the face of medtech?

If so, don't miss your chance to earn the recognition your product and company deserve. Submit your product for the 15th annual MDEAs today.

Don't miss your chance to win gold, silver, or bronze in 10 medical product categories.  

Entry Information

1. Eligibility Requirements

2. Download the Entry Form

3. Entry Materials Checklist

Enter Before Final Deadline—January 11!

Multilayer and Multilumen Extrusion From Vesta

A provider of contract extrusion services to medical device manufacturers specializes in the extrusion of multilayer and multilumen tubing featuring difficult profiles and challenging tolerances. In addition to offering tight-tolerance thermoplastic extrusion capabilities, the company can produce silicone extrusions suitable for applications ranging from long-term-implantable lead tubing and wound drains to peristaltic-pump tubes and catheter bodies. Equipped with more than 30 extruders across its manufacturing operations, the ISO 13485–certified manufacturer maintains dedicated R&D facilities and offers automated inspection and quick-turnaround capabilities.

Franklin, WI

Gateway Laser Services Provides Diamond-Like-Carbon Laser Micromachining Services

A company provides medical device manufacturers with laser micromachining service, using a high-resolution laser process capable of machining extremely small features with high levels of precision and accuracy. The company employs excimer and YAG laser technologies to perform laser ablation with single-micron precision. Capabilities include ultraviolet machining, a cold process that leaves a clean edge without heat-affected zones and thus does not diminish the integrity of the material. Laser micromachining promises high levels of consistency and repeatability and very tight tolerances. The service provider can machine most metals and alloys, ceramics, nitinol, silicon, and such plastic materials as polyimides, polyurethanes, PEEK, nylon, PET, silicones, polypropylene, PEBA, PMMA, ABS, and others in thin-film form. Applications include implants, biomedical filters, tubes, orifices for gas flow, medical electronics, and catheters.

Maryland Heights, MO

Plastics One Inc. Offers Electronic Components Manufacturing

A registered and ISO 9001:2008–certified full-service contract manufacturer specializes in the design, molding, and assembly of components and electronics for medical devices. Each product the company creates is designed with tight tolerances; even very small components, including parts that are assembled under a microscope, have tolerances equivalent to those of parts of standard and above-standard size. The manufacturer additionally produces and assembles devices for patient diagnostics and monitoring applications, nerve integrity monitoring, hearing enhancement, and sleep and respiratory studies.

Roanoke, VA