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Monitoring with Process Signature Analysis

Facing ever-increasing regulation and scrutiny by FDA, medical device manufacturers need cost-effective ways to monitor their manufacturing processes and to test their products. The industry has made significant advances in recent years in the area of monitoring and improving process control. By automating processes that were once manual, many companies have seen their quality improve. And by monitoring the process, they’ve been able to ensure that control is maintained.
 

However, when it comes to product testing, the change has not been quite so forward-thinking. Today’s de facto quality test standard, batch destructive testing, is expensive, reduces yields, and, ultimately, fails to certify that every part conforms to standard.
 

There is a way to eliminate destructive testing, bring more accuracy to the manufacturing process, and reduce costs: process signature verification. For signature verification, every aspect of the manufacturing process that could impact product quality is captured as it happens. One accurate approach involves monitoring and recording key attributes in real time throughout the duration of the process, producing what is called a process signature. The shape of the characteristic curve contains detailed information about the quality of the manufacturing process for each individual part. By recording and analyzing these process signatures, it is possible to identify key features in the signatures that are correlated with final product quality. These features can then be tracked and tested against limits to determine pass or fail on a part-by-part basis.
 

Rather than subjective post manufacturing quality control approaches, such as visual testing, or statistically based tests, like destructive testing practices or auditing, comprehensive process signature verification provides actionable insight into manufacturing processes as well as a wealth of data that can prove compliance with internal directives and FDA regulations. This approach ensures product quality in real time on a part-by-part basis. Automotive and industrial manufacturers have used the process for several years but it is also beneficial to the medical device industry.
 

The Status Quo: Destructive Batch Testing
 

Medical devices are typically manufactured in batches or lots, with quality checks through an end-of-line test that determines whether the products meet the quality standards dictated by both internal policy and regulatory standards. Using destructive testing, a representative sample of parts from each production batch is tested both from a function and performance perspective and for reliability and durability.
 

In most scenarios, the sample parts are destroyed during this testing process. Based on the results of these sample tests, the failure rate of the balance of the batch is then estimated. Should the estimated failure rate fall above acceptable parameters, the entire batch is removed from production, quarantined, and most often, scrapped entirely, regardless of the fact that there are probably a considerable number of the units that were up to standard. The good units get scrapped along with the bad because there is no way to determine which are which, let alone identify exactly what caused some units to fail.
 

Sampling versus Comprehensive Quality Testing Methodologies
 

Although the sampling method is the de facto standard, it is a costly approach. At a minimum, manufacturers diminish their yield by the sample size or, worse yet, the entire batch.
 

The significant labor and capital costs associated with the performance of the test contribute to its expense. The effectiveness and cost-effectiveness of this approach relies heavily on how well the process is controlled through regular and effective maintenance, and strict adherence to procedures and protocols. In short, the less controlled the process, the larger the required sample size, and the higher the cost of the testing. As a result, maintaining a well-controlled process is critical to controlling costs.
 

Because batch destructive testing relies on a representative sample rather than on information from each unit produced, it provides little or no direct evidence of product quality for the parts that are actually shipped to customers. Instead, it is assumed that because parts are manufactured in the same batch, and ostensibly pass under the same conditions, the rest of the parts in the batch are also good. This supposition jeopardizes customer safety because the manufacturer cannot assert that it indeed inspected and determined the quality of the device that was used by the patient.
 

Another inherent problem with sample testing is the lack of actionable data available based on results. It’s an end-of-line methodology that takes place after the entire batch is through manufacturing and whatever variables changed during processing are already completed. If a sample fails at this point, the manufacturer has two options: institute an expensive part-by-part manual inspection, which still won’t catch some defects that are impossible to determine by inspection alone, or reject the entire lot so that the 5–10% that are of poor quality do not get shipped to the customer.
 

Should manufacturers opt for the former, the test process may be lengthy and take days or even weeks to complete. If defects are detected, the long delay between manufacture of the product and the conclusion of the testing can mean that several other batches, and perhaps thousands of devices, have been manufactured with the same potentially defective process parameters and will also need to be quarantined. The costs associated—in dollar terms and in terms of a company’s reputation with prospects, customers, and FDA—are in some cases incalculable.
 

Process Signature Technology
 

An in-process strategy is based on the principle that all manufacturing defects are the result of deviations in one or more process inputs, including variations in component characteristics, process station parameters, or environmental factors. It is important that all potential variables during critical manufacturing processes are monitored, from a compliance standpoint and also for traceability and risk mitigation. What was the humidity in the plant at the time? Which operator oversaw a particular process on the line? What was the temperature in the plant at the time of manufacture? By monitoring and measuring all of these inputs, it is easy to assess when a variable has changed and act quickly to rectify it. It can be quickly determined whether the problem is with the process, training, or component quality. This kind of insight is tremendously valuable when faced with proving compliance to FDA.
 

Figure 1. A press-fit process signature (force versus distance). A-1 is the alignment work, Dy is the differential force, Y(x1) the maximum force required to align the part, X1 is the maximum distance traveled by the part, Dx is the differential force to measure the press retract travel.

What constitutes best practices for in-process testing? Process signature technology is the capture of the unique process signatures created by each manufacturing process as the process is carried out. Figure 1 shows an example of a process signature and highlights the sorts of data points that can provide manufacturers with actionable insight. The area represented by A1 indicates a higher than normal value, meaning that a great deal of work is needed to align the parts for the pressing process. Two possible outcomes could result in poor part quality, such as a mismatch between the subcomponents being fitted or a misalignment of the parts press. Based on this information, the manufacturer can audit part geometry to identify whether parts are mismatched or audit the tooling station to determine whether misalignment is the problem.
 

By capturing and, in turn, analyzing these signatures for critical manufacturing processes, manufacturers can quickly identify any deviation from the ideal and, because they’re capturing all inputs, then manage the problem.
 

Market Drivers for Process Signature Analysis
 

This is a global marketplace and when it comes to medical device manufacturing, there has been significant adoption of offshoring and outsourcing to contract manufacturers in Asia and elsewhere. To compete with the savings offered by these lower-cost options, U.S. companies looking to keep research and development close to home must streamline and find ways to reduce costs, while never sacrificing quality. In-process testing is a viable solution.
 

As a participant in the global marketplace, U.S. medical device manufacturers are in a highly competitive environment where cost is a significant factor in purchasing decisions. Process signature technology lowers costs for manufacturers because it increases yield, improves process efficiency, and facilitates continuous improvement to manufacturing, all in real time. This enables manufacturers to make better products for less money, savings that can then be passed on to the customer in the form of lower prices.
 

Perhaps the biggest driver for process signature technology adoption is compliance, both to internal standards and to FDA regulations. FDA’s introduction of title 21 CFR part 820 quality system regulation (QSR) instituted multifaceted manufacturing and process-measurement regulations.
 

The mandate of the QSR is to ensure that variations in the device manufacturing process are understood and minimized to produce low-risk, high-quality products. The stringency of FDA’s regulatory framework requires that systems be put in place to protect the consumer, even at the expense of a manufacturer’s bottom line. Process signature analysis supports compliance with these regulations.
 

In its recommended quality framework for pharmaceutical manufacturing, called process analytical technology, FDA outlines process signature capture and analysis as a sound methodology for quality control. “For certain applications, sensor-based measurements can provide a useful process signature that may be related to the underlying process steps or transformations. Based on the level of process understanding, these signatures may also be useful for process monitoring, control, and end point determination when these patterns or signatures relate to product and process quality.” The same principles apply for medical device manufacturing and the same benefits can be achieved.
 

Before a manufacturer is permitted to market a new medical device, it must produce a premarket approval (PMA) submission to FDA. A successful PMA or 510(k) submission must be accompanied by sufficient data for FDA to judge the safety and effectiveness of the new device. Such a task is more easily accomplished when there is a comprehensive dataset demonstrating that the critical processes are well understood, and the causal relationships between the process controls and product attributes have been established. Again, in-process testing and process signatures support these efforts.
 

If, despite a manufacturer’s best efforts, a defective product makes it into circulation, manufacturers using signature process methodology can quickly find and fix the problem, prove how it has been corrected, and get the production lines running again. Recalls are limited only to those products that are defective and the manufacturer has a comprehensive and detailed history record for its products that provide actionable proof as to which units were implicated. Intensive analysis can then be done to find out which variable caused the defect and why. Meanwhile, FDA can be assured that the product is well understood and a solution is in progress, limiting if not eliminating downtime on the line.
 

Environmental initiatives such as lean manufacturing also support the adoption of signature process methodology. By eliminating destructive testing, manufacturers also eliminate the scrap produced by the destroyed units. Rather than these destroyed samples or, worse yet, the whole batch, ending up in landfill, problems are eliminated at the root. Further, manufactured products adhere to requirements and can be shipped to the customer with the manufacturer confident of the product’s integrity.
 

Of course, the most important reason is the very real improvement in consumer safety that comes when 100% of all devices are individually checked for quality. When using process signature analysis, medical device manufacturers can provide solid assurances to their customers that each unit meets internal standards and FDA regulations. This ability provides a far greater level of assurance than relying on testing just a representative sample. Given the huge focus on quality in the marketplace, consumers are demanding more stringent and reliable quality processes, and there’s no situation in which quality is more important than when human life is at stake.
 

Making the Transition to Process Signature Analysis
 

Table I. Comparison of end-of-line destructive testing and real-time release, made possible through process signature technology.

When medical device manufacturers want to make even slight changes to their manufacturing processes, they are required to submit the change to FDA for approval. When adopting a new technology approach, it can be met with initial skepticism, especially when faced with the seemingly pie-in-the-sky prospect of driving down costs by deploying a new quality control system. Thankfully, this technology is proven to be effective and cost-effective, as shown in Table I.
 

When building the case for adoption of signature analysis, it is important to emphasize to regulatory agencies a number of key points. It’s obvious that product quality improves when test coverage increases from a representative sample to 100% of all parts. A manufacturer’s case is be even stronger if it seeks to institute quality control of each critical manufacturing process rather than just several points on the line, such as during welding or crimping. Without such a holistic approach, 100% product quality cannot be confirmed.
 

Furthermore, using in-process testing, data acquired during manufacturing can be correlated to the precise step where a defect was created, providing valuable feedback for optimizing and maintaining the manufacturing processes. This ensures that the quality of the manufactured product is controlled and maintained on a continuous basis. Finally, by consolidating and storing all of the in-process test data and process signatures associated with each part, it becomes a vital component of the device history record. These are compelling arguments for adoption.
 

Conclusion
 

The current approach to quality in medical device manufacturing is inadequate, expensive, and, worst of all, does not ensure patient safety. Because industry is so heavily regulated, and rightly so, making the transition to a holistic process might be met with skepticism. But a significant number of leading medical device manufacturers have adopted in-process testing as an alternative and this should pave the way with the regulatory bodies for widespread adoption of the technology.
 

A clear understanding of the cost, environmental, business process, and consumer safety benefits can help a medical device firm adopt process signature analysis. The method is a comprehensive approach to in-process testing, one that captures and analyzes the process signatures of all critical manufacturing processes, that arms the manufacturer with a wealth of information. The process signature method not only supports regulatory compliance, but provides visibility into processes and enables complete product life cycle traceability. Root causes are readily determined and plans can be quickly put in place to rectify any problems that arise.
 

It’s not enough, however, to merely capture these data. An important step in streamlining manufacturing processes is stringent analysis of the collected data. This analysis provides manufacturers with insight into how to avoid future problems and identify issues that are impacting product quality. Such challenges could range from poor component quality to training issues, from temperature to humidity, to when and where the process was completed. Problems can be avoided in the future, which again saves both the manufacturer and its customer money.
 

Ron Pawulski is director of sales, medical for Sciemetric Instruments (Ottawa, ON, Canada).

FDA Recognizes HE75

The guidance document was released early in 2010. The nearly 500-page document—intended for manufacturers, clinical engineers, biomedical equipment technicians, regulators, and students—covers a variety of topics, such as visual displays, software-use interface, packaging design, usability testing, and user documentation.

FDA's recognition of the guidance gives the association and the document more prominence. It also cements the agency''s growing interest in human factors as a risk prevention tool.

Increasing emphasis on human factors is a crucial part of medical device manufacturing, as OEMs turn more and more to consumers as a target audience. I don't think I'm being too controversial to say that human factors could be the most important determining edge in comparing similar medical devices.

Heather Thompson

Miniature Solar Cell Could Reduce the Toxicity of Chemotherapy Treatment

When one thinks of photovoltaic devices--otherwise known as solar cells--the first thoughts that come to mind are clean energy and solar panels on the roofs of buildings. But now, ScienceDaily reports that a team of scientists under assistant professor Tao Xu at the University of Texas (El Paso) has developed a miniature photovoltaic device that could eventually be used to release chemotherapy drugs directly to tumors, minimizing the drugs' toxicity to surrounding tissue.

Current chemotherapy drugs are administered to patients via an IV drip. The problem with this method is that the drugs have to travel through the bloodstream to reach their target, contacting many organs on the way and affecting patients systemically. Xu's device is designed to deliver the drugs only where they are needed. This goal is accomplished by means of light: The device converts light into electric current, which causes chemotherapy drugs to be released. For this purpose, infrared or laser light could be used because scientists believe that they can penetrate tissues over 10 cm deep.

To test the device, an in vitro model was built. Positively or negatively charged model drugs were used to coat opposite sides of the miniature solar cell. When a light beam was applied, one side of the device became positively charged, repelling the positively charged molecules the investigators had placed there and causing them to be released. The same thing happened with the negatively charged side and negative model molecules.

"In the first step, we were able to prove the concept," Xu comments, adding that the amount of drug released can also be controlled by varying the intensity of light. While the first phase of this study used an in vitro model, the next step will be to apply the technology to small animal models.

November 2010 Contributors

Richard DeRisio is vice president, global regulatory affairs for Abbott Medical Optics Inc. (AMO; Santa Ana, CA). He develops innovative regulatory strategies for obtaining and sustaining worldwide product approvals for AMO’s medical products and ensures that advertising and promotional practices comply with regulatory requirements. At previous companies, including Kinetic Concepts Inc., Johnson & Johnson, and Pfizer, he had clinical, regulatory, and quality responsibility for a variety of products including mechanical heart valves, defibrillators, electrophysiology catheters, wound-healing systems, robotic-surgery devices, and sterilization equipment.He has been a member of MD+DI’s Editorial Advisory Board since 1993. Contact him at [email protected].
  James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry and a contributing editor to MD+DI. He has been writing for the magazine since its beginning in 1979. He is also cofounder and president of Ferdic Inc., a company that published Dickinson’s FDA Webview.   William R. Doyle is president and CEO of Vystar Corp. (Duluth, GA). Prior to joining Vystar, he was vice president of marketing for women’s health for Matria Healthcare Inc. (now Alere), where he spearheaded the initial branding efforts and held responsibility for sales development, training, public relations, and marketing. He has worked in healthcare for more than 25 years in areas that include manufacturing, sales, marketing, and advertising with such companies as Isolyser Company Inc., McGaw Inc., and Lederle Laboratories (now Wyeth). Reach him at [email protected].   Ron Pawulski is director of medical sales for Sciemetric Instruments (Ottawa, ON, Canada). He manages technical and sales functions for the division and has hands-on experience in creating quality systems that use process signatures to meet the unique challenges of medical customers. Contact him at [email protected].   Joe Rotino is vice president of QA/RA and acting vice president of engineering for Pro-Dex Inc. (Irvine, CA). He has more than 20 years of quality assurance and regulatory experience in the medical device industry at companies that include Sybron Dental Specialties, Baxter Healthcare, and Kendall McGaw. Contact him at [email protected].

Breathing a Sigh of Disease Detection

A University of Florida professor is taking breath sampling a step further with an add-on device that touts more sensitivity and thus more accuracy in detecting chemicals, cells, and microorganisms in exhaled breath. Paul Davenport, PhD, developed the device to work in conjunction with existing breath testers, which should improve the function of the tests while also reducing costs. The device uses high frequency oscillation to apply vibratory air pressure waves to increase the concentration of substances in a breath sample. The waves are superimposed on airflow to create airway turbulence and increase gas molecule diffusion towards the mouth. Cells that line the airway, along with bacterial components, are pushed out when the patient exhales to create more concentrated substances in the sample. The technology is patent pending and available for licensing. Contact John Byatt in UFL's Office of Technology Licensing for more details.

 Maria Fontanazza

$89 billion in branded prescription sales at risk for generic competition by 2014: PharmaLive Special Reports

Experts predict that the European generics market will grow at twice the rate of the branded pharmaceutical sector in that region during the next five years. The world’s second-largest pharma market, Japan, generates worldwide pharmaceutical sales of about $64.5 billion. However, only 6.6% of the nation’s prescription drug sales are accounted for by generics. In addition, a reported 40% of pharma products available in Japan are off-patent and thus subject to generic competition.
 
The worldwide market for advanced drug-delivery systems reached $134.3 billion in 2008 and is projected to increase to $196.4 billion by 2014. Drug-delivery firms continue to be popular partnership and M&A targets for pharma, biotech, and device companies. Despite recent advances, there continues to be significant unmet needs for drug-delivery technologies that improve safety and efficacy, increase patient compliance, provide greater ease of use, expand product indications, and reduce cost. Drug-delivery companies can add value to the industry and investors by meeting these needs as well as developing business models that include multiple technology platforms and product opportunities.
 
PharmaLive’s most recent Special Report, Top 50 Specialty Companies 2010, examines the generic, niche, and drug-delivery sectors, leading companies, as well as market drivers and technological advances.
 
“The dynamics of the specialty pharma market are dramatically changing as big pharma gains entrance, and competition as well as demand continually increase,” says Andrew Humphreys, editor in chief of UBM Canon Data Products Group. “Segments with strong growth potential include specialty generics, branded generics, biosimilars, and devices with advanced electronic functionality.”
 
More information is available in PharmaLive’s newest Special Report, Top 50 Specialty Companies 2010, including expert analysis of the current conditions and future outlook for the generics sector, the impact of generics on brand sales, new drug-delivery technologies, as well as potential investment, partnership, and acquisition opportunities in these sectors. This report can be found at www.PharmaLive.com/specialreports <http://www.pharmalive.com/specialreports> .
 
About Canon Data Products Group
Canon Data Products Group, a division of Canon Communications LLC, publishes PharmaLive Special Reports and Appliance Market Research Reports, which provide financial, company, and product statistical data and qualitative analysis for the global pharmaceutical, biotechnology, medical device, and appliance industries; maintains eKnowledgeBase and MDRWeb, comprehensive market intelligence tools serving the pharmaceutical, biotechnology, and medical-device sectors; and manages company-wide Site Licenses for PharmaLive.com, Med Ad News, and R&D Directions.

Please direct all media inquiries to:
Sandra Baker
215-944-9836
[email protected]

Greener Pastures at Greenleaf

In her new capacity, Rosecrans will serve as a senior regulatory advisor to “provide strategic consulting services and work with Greenleaf clients to bring innovative devices to patients,” according to the firm. A fourth 510(k) figure, former CDRH Office of Device Evaluation director Donna-Bea Tillman, earlier resigned to go into private service as a health information technology specialist at Microsoft's Health Solutions Group. —Jim Dickinson

MX: Meeting the New Compliance Challenges

These and other barriers put a financial strain on many device manufacturers’ ability to succeed.

 
Eric Marks

The insights are derived from extensive research, surveys, and perception studies conducted by the American Society for Quality (ASQ), ARC Advisory Group, and Zacks Equity Research (ZER) into the critical obstacles facing device manufacturers today. From this research, it is possible to pinpoint the practices and processes that device manufacturers are using to overcome the compliance and engineering obstacles that impede product innovation. Foremost among these practices is a concept called “product life cycle management,” or PLM.

Engineering and Compliance Challenges
 

ZER reports that the global medical devices industry is fairly large, with projected annual worldwide sales in 2010 of more than $220 billion. The U.S. accounts for approximately 41% of this market. In terms of industry growth, the market will be worth $256 billion by 2011.

Medical device manufacturers have a positive outlook about economic growth in 2010 in terms of increased revenues. Fifty-seven percent of ASQ survey respondents believe their companies will experience more economic growth than in 2009. Twenty-seven percent believe they will experience about the same growth as in 2009, and only 11% believe there will be less growth than last year. Five percent are unsure what the future outlook holds. However, that growth will come with engineering and compliance challenges.

ASQ recently conducted a 2010 survey that polled 2000 medical device manufacturers for the biggest industry trends and challenges they face today. Medical device manufacturers believe the most challenging obstacles for 2010 and 2011 will be the impact of healthcare reform, the proposed medical device tax, and the dire need to manage cost reduction while maintaining quality. According to the survey, 64.7% of the respondents said healthcare legislation would have a negative impact on the industry in the year ahead due to the increased FDA mandates concerning compliance.

In today’s newly regulated economic climate, therefore, medical device manufacturers are looking for solutions that address these challenges—with added emphasis on reducing costs. For example, companies that embrace solutions for managing the life cycles of their medical manufacturing processes are better poised for growth in a weak economy. ZER states that life cycle management for sustaining the life of products will show the most growth of all in the medical devices market.

Dick Slansky, the principal author of ARC’s Product Lifecycle Management Worldwide Outlook study, states: "The medical device manufacturing sector is refocusing the strategic direction of their companies toward innovation and new product development to gain critical market share and grow top line revenues. While innovation, new product concepts, and design are necessary to a company in order to maintain its competitive edge, getting the right product, at the right time, to the right market sectors will often determine a company’s profitability."

Growing Demand for Productivity
 

Omnify Software, a company specializing in PLM, says many of the medical device companies it works with use product life cycle management to streamline project management, increase quality control, and improve training. Omnify reports it has seen an increase in inquiries about using PLM to help mitigate such problems and, specifically, to manage training and quality programs that impact FDA compliance. ASQ supports Omnify’s findings, reporting that 54% of survey respondents believe that they could benefit from more training and a better understanding of requirements like 21 CFR Part 11 compliance.

A recent medical device study by ARC Advisory Group explains that there are several reasons for the growing use of PLM. Among them are the demand for increased efficiency and productivity, a continuing need for collaboration across a global manufacturing life cycle, and the rapidly growing need for product reinvention and innovation. The study exposed the growing use of a comprehensive, PLM solution that ARC expects will contribute to growth of the worldwide PLM market.

Various PLM solutions target the medical device industry. The ideal solution should reach across departmental barriers and allow information sharing and process automation across the enterprise. The development and manufacturing of a medical device is an increasingly difficult endeavor as competition grows stronger and regulatory constraints broaden. Device companies must look for ways to increase efficiency in their processes in order to remain competitive and in compliance with the various regulatory bodies governing world markets. Medical device manufacturers often use PLM functionality to fill in gaps, such as taking a closed-loop corrective action and automating data capture and routing related to product issues and defects. In addition to the much-needed documentation for FDA-required audit trails, a PLM system can greatly simplify the capture and routing process.

Faster Time-to-Market
 

Typically, a PLM system that embraces an open platform and leveraging Web services can help achieve an open infrastructure for easier data sharing and customization. Web services enhance a PLM system’s existing open platform for third-party integration. They also enable easy customization of user interfaces and reports. The ability to tailor interfaces creates a familiar environment for users, assuring a simple transition from legacy practices. Custom reporting offers high-level views of key development data to identify trends and issues early in the development cycle.

Most PLM systems offer medical device manufacturers project-management capabilities. Capturing all product and program data in a PLM system creates executive views, which are used to more easily recognize common problems. Ultimately, this leads to better resource allocation and streamlined processes that impact deadline-sensitive development activities. Managers can look at a dashboard that displays project-management metrics such as status, completion percentage, and completed milestones to determine project status at a glance.

Software programs such as PLM that tie together the information-sharing requirements of the various departments within a device company have been shown to reduce development costs by as much as 25%, reduce time-to-market by a staggering 40%, and foster innovation. Medical device manufacturers that use such software to gain a competitive advantage over slower manufacturers will get a jump on the future.

Eric Marks is a medical device industry practice leader for PricewaterhouseCoopers. He is the author of four books, including SOA: Planning and Implementation Guide for Business and Technology (Wiley, 2006) and Business Darwinism—Evolve or Dissolve (Wiley, 2003). Marks may be reached at 1-617-800-5576.
 

Binding Antibacterial Coatings to Devices Could Help Reduce Biofilm Formation

In response to the reimbursement crackdown on hospital-acquired infections (HAIs) and the rise of the Superbug, an urgent need has arisen for antimicrobial or antibacterial agents that help to battle bacteria and biofilm formation. Among the latest contributions to this field is a binding technique to facilitate better attachment of antibacterial coatings to device surfaces.

Noting that antibacterial materials often do not adhere well to device surfaces, a research team from the University of South Australia has begun investigating binding techniques that yield a stronger bond between the antibacterial coating and the implant's surface.  At the core of the various techniques is the application of an ultrathin plasma polymer coating that acts as a binding scaffold. The researchers then bind materials to the scaffold designed to prevent bacterial attachment, to prohibit cell multiplication once attached to the device, or to interfere with the attachment mechanism of the bacterial cell.

"We believe that no solution will be universal, so we want to establish an array of approaches," says Hans Griesser of the University of South Australia. "The new diterpene compounds that we are testing are structurally quite different from established antibacterial compounds, and they are effective against methicillin-resistant Staphylococcus aureus. That is what got us excited about them."

The researchers presented their findings this week at the AVS International Symposium & Exhibition.

CI Medical's New Radiopaque Ink Helps Surgeons Track Implantable Devices

CI Medical's radiopaque ink can be used to mark a range of temporary and permanent implantable devices.

CI Medical Inc. (Norton, MA) has developed a specialized radiopaque ink printing technology for use on medical devices that enables surgeons to track or read those devices after they have been implanted in a patient's body. Under development for several years, the technology is now being used on both temporary and permanent implantable devices.

Coupled with fluoroscopy, radiopaque ink gives surgeons visibility of marked medical device components implanted beneath the skin or deep within the body. Surgeons require this capability for such purposes as proper device positioning and subsequent device identification. Implantable devices already utilizing the company's radiopaque ink include pacemakers and chemotherapy ports. Tubes, fabrics, and polypropylene sheets employed in stentless or spinal procedures are are also using this technology.

For more than five years, CI Medical has been partnering with medical device OEMs to customize medical devices requiring radiopaque ink markings. As a result, the ink has been successfully developed for use on a variety of substrate materials, including silicone, according to the manufacturer.