Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use.
EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, director of sales with Loftware, an enterprise labeling and artwork management provider, to discuss common pain points in label development and maintenance as well as best practices to help companies to stay compliant with the ever-changing and diverse range of medical device regulatory requirements around the globe.
MedTech Intelligence (MTI): When should companies start developing their labeling for new devices?
Johnson: The labeling aspect should be part of the planning from day one, because you do need to consider the placement of the label on either the actual device or on the packaging that the device will be stored or shipped within. And sometimes that can be very small or limited real estate. So, you might need to be creative in terms of how to capture and display the amount of data that is required from a regulatory standpoint.
MTI: Who should be brought into that conversation?
Johnson: Usually the regulatory team. Quite often in medical device manufacturing, the branding and marketing team also has insight into what type of information needs to be on those different labels. There’s going to be common information, such as the product part number or description of the product, quite often a graphic related to what the product looks like and then symbols and barcode information. All of that can be fairly standard across different product lines and, usually, someone from either regulatory affairs or branding and marketing would have a good insight into what you need to have for formatting.
MTI: When it comes to the labels that are going physically on to the device, what are the best materials to use to make sure that the label is going to weather well, age well and stay where it’s supposed to be?
Johnson: If it’s a single-use product that is going to be disposed of, that label or the substrate that holds the label to the product may not need to be extremely durable or resistant to different temperature ranges or sterilization. However, a device that is reusable or in a surgical suite and is constantly being cleaned in between procedures needs an adhesive that is extremely resistant to different types of chemical compounds and sterilization processes. There are also devices that need to be kept in a cold environment, so that is a different type of adhesive or label if you’re talking about freezing temperatures.
This goes back to considering your labeling from day one. All those aspects of the product and how the product is going to be used need to be considered from the first day of development, and the label needs to be tested in these different use scenarios.
MTI: How did the new EU MDR regulations affect device labeling?
Johnson: There were some very big changes. For example, the change to the manufacturer address. Before, if the company was based in the U.S. but had a manufacturing facility in Europe, as a brand owner they could use the address of the U.S. facility. One of the major changes with EU MDR was that the address needs to reflect where that device was physically manufactured. There are also different ISO symbols required, so there were a number of different symbols and CE marks that needed to be updated.
It is a longer process than many people expected, because many manufacturers manage their label content or their labels as a one-to-one match with the product. So if you have 10,000 products, you need to modify 10,000 labels. So it has been a big undertaking.
MTI: Is one-to-one labeling a best practice, or is there a better way to handle the labeling?
Johnson: There are absolutely better ways to do this, and that’s what many organizations took a look at following the EU MDR. Their legacy solutions process was this one-to-one ratio, so they had to go in and make these modifications on each label. Many companies took the new regulations as an opportunity to evaluate more modern solutions and software to be able to manage what we refer to as dynamic labeling.
With dynamic labeling, you have a template that can support multiple different products and that template is based on the size of the label itself. For example, if you are manufacturing part A on Monday and part B on Tuesday, and they go into a similar-sized package, you can use a single template to support full integration to your system of record, whether that’s your ERP or MES solution, for the required product information and symbols. Also, it allows for sharing of the symbols and different cautionary statements in order to make the management of your overall labeling and template library much easier.
MTI: When it comes to tracking regulatory changes and responding to them, what should companies have in place to make sure that once those changes happen, they can address any required labeling changes?
Johnson: That is something that has proven to be fairly challenging, because regulations vary by region and country to country. Oftentimes organizations will manage that with their regulatory affairs or government affairs teams internally using something as simple as a robust spreadsheet or a SharePoint site where they can share that information between different departments as required, and keep it up to date.
The term medical device covers everything from a Band-Aid and surgical gloves all the way to implantable devices, so understanding your product portfolio is imperative, and tracking those regulatory requirements based on the classifications of the products you manufacturer can be cumbersome.
With dynamic labeling, you can implement business logic or business rules. If you’re manufacturing a product for Europe, for example, you know those labels need to have specific statements translated into multiple languages as well as specific ISO symbols. Once a regulation is defined, putting those parameters—or logic—into your labeling software helps to ensure that the regulations are being met and that the data elements are appearing on the labels as they are printed in production.
So it’s two-fold process. One is tracking the regulations as they are happening, and the other is keeping the system up-to-date to support them.
MTI: What happens in the scenario where a company gets FDA clearance for a new indication, in terms of labeling changes to the device?
Johnson: The labeling update process usually takes a little while—it can take months for some devices—so there is leeway allowed as that new product is being released for additional or new use cases. The company would have the ability, if the product is in stock and labeled with the original label, to apply a secondary label if it’s being shipped out for that new indication while they’re making the label updates to the core template for future production runs.
MTI: What are some of the most common pain points for companies in terms of regulatory problems related to labeling?
Johnson: The regulations are constantly changing. That seems to be the biggest one. Another challenge is that there is always pressure to reduce costs and to be more efficient and, of course, the labels need to be perfect, meaning they need to be exactly what was approved by the different regulatory agencies.
This is where dynamic labeling also can be helpful, because you are able to make those changes and have them affect multiple templates at the same time. This supports that reduction of effort and reduction of cost because you are making mass changes and then verifying those mass changes rather than going into every label individually, making the change and then doing the verification.
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Tony Blank is president of Infinity Biomedical Group. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Immediately prior to forming Barton & Blank, Blank spent 12 years at Boston Scientific Corp. in both corporate and business regulatory leadership roles. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has likewise been an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups—including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He is very involved in developing and delivering meaningful educational programs in the field of regulatory affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Blank has worked with cardiopulmonary, surgical, ophthalmic, vascular access and critical care medical devices.
Pat Baird works at Philips as the head of global software standards. Baird likes to think of his job as “policy engineering”— understanding the unmet needs (and frustrations) of regulators and developers, and working to develop standards, whitepapers and training to meet those needs. Past roles have included software developer, engineering manager, project manager, lead engineer, and most recently he was the director of risk management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented more than 50 papers regarding product development. Baird has an MBA and a Masters in healthcare quality and patient safety from Northwestern University.
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created more than 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for the world’s largest medical device manufacturers, Goode turned her attention to sharing that wealth of accumulated knowledge. Look for her in 2018 in a technical training and mentoring role as the head of Altrec, LLC.
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Susan Alpert, M.D. is president of SFA Consulting, LLC. She previously served as senior vice president, chief regulatory officer at Medtronic and was responsible for all of the company’s global regulatory efforts. Prior to joining Medtronic, Alpert served as vice president of regulatory sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the director of the Office of Device Evaluation.
Alpert is a microbiologist and a pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. She serves on the board of advisors for the Medical Technology Leadership Forum and the board of the Women Business Leaders, or organization of women leaders in the health care sector. She also serves on the Executive Committee of the Clinical Trials Transformation Initiative, one of the public/private partnerships working with FDA to streamline the development of medical products.
Dr. Christopher Joseph Devine is the president of Devine Guidance International, a consulting firm specializing in providing solutions for regulatory compliance, quality, supplier management, and supply-chain issues facing the device industry. Devine has 32 years of experience in quality assurance, regulatory compliance and program management. He is a senior member of the American Society for Quality (ASQ), a member of the Regulatory Affairs Professionals Society (RAPS), and a member of the Project Management Institute, and resides on several technical advisory boards. Devine received his doctorate from Northcentral University, with his doctoral dissertation titled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Devine holds a graduate degree in organizational management (MAOM) and an undergraduate degree in business management (BSBM).
Mark Leimbeck is the principal of UL Solutions Risk Management Practice. He has served as a subject matter expert and advisor in a number of functional areas, including risk management, quality management, project management, software application development, and engineering. During his career, Leimbeck has led and supported the implementation of various corporate improvement and development programs including quality system and regulatory compliance programs, new product development, IT systems and enterprise resource planning (ERP) implementation, and quality/lean Six Sigma process improvement projects. Leimbeck continues in a subject matter and advisory role, and participates in international, national and industry-based standards and guidance development committees. He holds a B.S. E.E.T. from Southern Illinois University and an M.B.A from the University of Chicago.
Stephen Wilcox, Ph.D., FIDSA is a principal and the founder of Design Science (Philadelphia), a 30+ person firm that specializes in optimizing the usability of products, particularly medical devices for clients including many major multinational corporations. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He also served for several years as Chair of the IDSA Human Factors Professional Interest Section.
Wilcox also serves on the Advisory Boards of the Industrial Design Department of Philadelphia University and the School of Design of Carnegie Mellon University, on the Human Factors Engineering Committee of AAMI, and on the ISO/IEC committee (“Working Group 4”) that wrote the standard, IEC/ISO 62366. He holds a BS in psychology and anthropology from Tulane University, a Ph.D. in experimental psychology from Penn State, and a Certificate in Business Administration from the Wharton School of the University of Pennsylvania. He has won a number of design awards, has guest edited the journal Innovation several times and has served as a judge for a number of product design award competitions.
Wilcox has given hundreds of invited addresses to various organizations, has published more than 70 articles in professional journals, and is the current Editor in Chief of the Human Factors and Ergonomics Society journal, Ergonomics in Design. His book, Designing Usability into Medical Products (CRC/Taylor & Francis), co-authored with Michael Wiklund, was published in 2005.
Alberto Velez is a consultant for Chimera Consulting North America, LLC. Velez is a recognized expert in organization development for combination products with more than 12 years of experience in applying CGMP concepts to more than 35 combination products in new product development, manufacturing and quality systems. He is a frequent speaker on combination products topics at industry meetings and has more than 30 years of varied experience in medical device and combination product quality assurance, FDA readiness, product development and organizational effectiveness in the pharmaceutical and medical device industries. Velez has applied the CGMP’s/QSR’s to several different divisions in the Johnson & Johnson family of companies as well as other smaller medical device companies. He has also led R&D teams to develop and launch new technologies in endoscopic surgery and enteral feeding. His educational background is in chemical engineering, industrial engineering and quality engineering.
John Pracyk, is a rare Neurological Surgeon with an uncommon blend of business and medical expertise. This sophisticated futurist is recognized as a national thought leader in the design, development, and management of collaborative care delivery based on his history of healthcare program build-outs and medical administration successes. An accomplished writer and platform speaker, he is a frequently requested keynote speaker at prestigious organizations such as the Congress of Neurological Surgeons, The Barrow Neurological Institute, and Stryker Performance Solutions.
Having completed a healthcare-focused MBA from the nation’s preeminent physician-only degree program, with a Master’s thesis on competitive strategy and service-line development, Dr. Pracyk is a proactive innovator who inspires teams to surpass organizational goals, exceed patient care metrics, and enable transformational change. Healthgrades acknowledged him with their honor roll distinction.
His career to date has been characterized by three key elements: First, his ability to foster multidisciplinary consensus and collaborative care; second, his grasp of competitive strategy as a program architect; and third, his ethics-driven approach to medicine. While recognizing that revenue generation drives business, Dr. Pracyk balances business necessities with patient care and market realities. In 2016, Johnson & Johnson Medical Devices appointed him Franchise (Worldwide) Medical Director for Spine.
Patrick Caines is director, quality & post-market surveillance at Baxter Healthcare where he is responsible for the company’s global post-market surveillance and associated quality systems. Caines has 20 years’ experience in quality systems and compliance for both medical devices and clinical diagnostics and served as director, corporate post-market surveillance at General Electric Healthcare and Boston Scientific, and director of worldwide customer quality at Johnson and Johnson. Caines began his career as a hospital-based clinical laboratory scientist and held faculty appointments at the University of Windsor and Wayne State University. He holds a Ph.D. in clinical biochemistry from the University of Windsor, Ontario, Canada as well as an MBA from St. John Fisher College, Rochester, New York.
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