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The Case for Quality

Complying with FDA regulations does not guarantee a quality system or product.

Luann M. Pendy usually is the consummate guest in her customers’ corporate castles. During her visits, the Medtronic Inc. quality executive abides by the rules of basic business etiquette: She’s prompt, polite and above all, professional.

Pendy also is diplomatic, a trait that has served her well during those rare occasions when she disagrees with or must (tactfully) correct her hosts. Such anomalies generally are few and far between, though Pendy did have to show some decorum several months ago at a customer’s manufacturing plant.

“I was visiting a certain facility and I was introduced as the head of compliance,” recalled Pendy, Medtronic’s vice president of global quality. “I told the person who introduced me that I’m not the head of compliance, I’m the head of quality. He looked at me and asked, ‘what is the difference?’ “

A clear distinction in definition, for starters. The two words have radically different meanings: Merriam-Webster dictionary defines compliance as “conforming to requirements,” while it describes quality as a “degree of excellence” or “superiority in kind.”

That basic disparity—while easily comprehendible—is considerably less discernable in the medical device industry, where manufacturers are focused on “procedural compliance” rather than underlying product quality. Most companies understand that compliance with U.S. Food and Drug Administration (FDA) regulations does not guarantee high quality devices and they agree that properly-achieved compliance (e.g., through mature, embedded processes) can deliver a baseline level of quality. But the industry, as a whole, still remains inexpediently focused on regulatory compliance at the expense of a quality culture.

“There has been an emphasis in this industry on compliance, not quality,” noted Steven Silverman, director, Office of Compliance, at the FDA’s Center for Devices and Radiological Health (CDRH). “I am the head of the office of compliance, not the office of quality. The name of my office is indicative of the cultural perspective that exists. We at the FDA view compliance as a baseline. As an agency, we strive for high-quality products, not products that simply are compliant.”

Silverman, Pendy and a half-dozen other industry experts participated in a panel discussion at AdvaMed 2012 The Medtech Conference (Oct. 1-3) that examined the gaps in compliance programs, rising product recalls and the steps both the FDA and the device industry can take to improve quality outcomes. Panelists agreed the FDA must better define quality and identify best practices that result in excellent quality, while companies must ensure their employees truly understand the importance of good quality products. As one panelist noted, “Compliance is an excuse to do things. Quality is the reason to do things. Compliance is the cheapest ticket in the house, not the best seat. We all want a better seat—in order to do that, you can’t just be compliant. You have to get your organization to understand the difference between compliance and quality. One is the foundation for the other.”

Orthopedic Design & Technology convened its own panel of experts recently to discuss the relationship between regulatory compliance and product quality. They included:

Don Beals, director of quality at Aztalan Engineering Inc., a Lake Mills, Wis.-based manufacturer of precision machined parts;
Patrick Beauchemin, P.Eng., Ph.D., president of VISIONx Inc., a software and systems maker for machine vision, visual inspection, image analysis, general defect detection, and metrology. The Canadian firm manufactures a device called the VisionGauge Digital Optical Comparator, a drop-in replacement for traditional optical comparators;
David A. Cabral, president of Five Star Manufacturing Inc., a New Bedford, Mass.-based contract manufacturer of high-tolerance, high-precision orthopedic devices; and
William MacFarland, director, Division of Enforcement B, Office of Compliance, CDRH, FDA.

What are the driving forces behind the push for quality regulations in the medical device industry?

Don Beals: I think the largest driving force is the public. The public expects that when they receive medical treatment or take a medication that they are safe in doing so. Whenever a mishap occurs, it is often national news, with the public demanding that corrective action be taken.

Patrick Beauchemin:
We are on the periphery. We work with a lot of the big OEMs as well as with a lot of their suppliers. Documentation requirements used to be a lot less than they are today. Today, simply saying, ‘yeah, we checked those parts’ doesn’t cut it. The need for complete documentation, for the device history, makes a lot of sense.

David A. Cabral:
I believe that due to some improprieties by a handful of medical manufacturers, the FDA is clamping down on the industry as a whole. “Patient first” must come before dollars. As with any product, reliability and value will bring profits. We hear the stories about medical device manufacturers that may not be doing their due diligence. When the FDA becomes aware of those kinds of things it becomes a problem. And what happens is they tighten up their regulations more and it affects all of us. When you look at the medical industry, it’s almost that patient safety comes before dollars. Regular businesses are always focused on profits; and although that is why we’re all in business, when you’re in the medical arena (similar to aerospace, i.e., safety of planes and spaceships), there must be a focus on the patient. It’s about product reliability and positive patient outcomes.

William MacFarland:
FDA has recently been looking at the state of device quality through the Case for Quality Initiative. One of the issues we were seeing as we looked at our current approach to device quality is a high rate of quality problems related to design control, corrective/preventive actions. The case for quality initiative is a joint effort between the ORA [Office of Regulatory Affairs] and CDRH. It comprises three efforts—the first is making data on device quality available to the public, the second is providing more engagement with stakeholders on device quality, and a third part of the effort is seeing what we can do mutually—the industry and FDA—to focus not only on compliance but on device quality as well. Quality is about meeting user needs and intended uses, which is of mutual interest to device firms and FDA.

At a recent industry conference, an FDA representative said the agency strives for high-quality products rather than products that simply are compliant. What is the difference? Do most medical device companies know the difference between the two?

Cabral: I understand “High quality” to describe a product that is designed to exceed expectations for its intended use, versus a product that meets minimum safety criteria, albeit, “Compliant.” I believe the quality companies know the difference. If I look at compliant—I envision a certain threshold that a product must meet that complies with a determined safety criteria. High quality represents a product that exceeds that “compliant” criteria. As an example, assume compliant to be ISO 9001 certified. As a contract manufacturer, my customer requires ISO 9001; whereas for my company, I see ISO 13485 as a much higher level—looking at myself as a company and being ISO 13485 versus that baseline makes me a better choice. It looks better to my customer and could increase my business. Look at the auto industry. There are cars that are great cars and there are basic mid-level transportation. Then you have other cars that exceed the expectations of handling, braking, etc.

I look at it the same way with medical instruments. There are certain devices that do more and simplify the procedure for the physician. I don’t know what the FDA would define as high quality vs. compliant but I believe whatever it is; whether it’s in the design or materials, functionality, etc., it doesn’t just meet the baseline, it’s had the attention in the design phase to exceed the normal levels of compliance.
Beals: A high-quality product would be one that is manufactured such that a slight difference in the production process will not seriously affect the outcome. This is where the significance of Six Sigma is derived, in that if the product is manufactured very precisely, then the product’s performance can be accurately predicted and not vary batch to batch.

Has the FDA ever defined “quality” as it pertains to medical devices? Has the industry defined the term? Are they the same?

Beauchemin: We see a great focus on compliance. One of our customers’ first objectives is to be compliant—they can’t ship products unless they are compliant. If they are compliant, then that means that many of their quality objectives have been met.

Cabral: We define “quality” as meeting the design criteria, but “quality” to the FDA represents a product that will not fail the patient. It’s a product that performs to its intended use, without risk to patient safety. They don’t necessarily define quality. They [FDA] require manufacturers to design products that have been tested, approved and comply to design standards. If something happens to a product, surely the quality, design criteria used is no longer acceptable. That was one of the recent changes to the 510(k) process as well. If a product was run through clinicals successfully and becomes a viable product, another manufacturer can piggy back on that design and obtain 510(k) for, essentially, the same product as yours. The problem is that if you have problems with yours; and your trending shows failure, patient safety, etc., the FDA could go back and stop your product; while in the meantime, I’m flooding the market with a similar product under a different name. Would my product failure rate be similar? We’re talking about lives. It’s not just a broken toy. There’s a baseline safety level that passes and a level that fails.

Beals: Whether quality is defined as fitness for use or the ability to satisfy given requirements or any other variation of these does not matter, in my opinion, as long as the manufacturer is providing what the customer asked for. The customer is everything. Companies that listen to their customers, and strive to ensure a consistent product will realize high quality, regardless of the definition someone chooses to use.

What steps can the device industry take to improve quality outcomes? What steps should the FDA take to drive quality in the manufacturing space?

MacFarland: We’ve heard that some firms have a system for ensuring compliance and a separate system for ensuring quality. From what I’m hearing from firms, this relates to the urgency of the compliance issues that are coming up as compared to a longer-term view of the issues of quality that are coming up. There seems to be a perception that FDA and industry have different concepts of quality and compliance and this is something we are looking into at FDA. This leads to the question when a firm has complete commitment to device quality, why wouldn’t compliance follow? That’s come to be known as the perception gap, and it’s something we’re tackling. One of the three initiatives in the Case for Quality is called the focus on quality and the perception gap is something we are focusing on. It’s early yet and we want to promote lasting change, that means giving a lot of internal and external input on our collective views on quality and compliance. We’re still at that stage of getting input but the direction we are intending to go is the identification of policy, procedures or perhaps tools that would promote a focus on quality, not just compliance.

Beauchemin: Improving inspection equipment, using more accurate equipment, automating the documentation process. That has to help quality in the medium and long term. Documentation can be burdensome, but with better documentation comes a lot of good things—you have lot of information which leads to better process understanding and control. By collecting such documentation you are simultaneously being forced to look into a number of other things. If you’re not keeping the data you’re not looking into the issues as in-depth. Documentation forces you to go more in-depth and if you go more in depth you learn something, you can spot more subtle problems.

Cabral: I believe the industry does a great job at designing, testing, validating and monitoring products throughout the life cycle. But, products made outside of our borders do not always get the stringent monitoring and can enter the country (we’ve seen this with lead paints, counterfeit products, etc.), being identified after a failure, or fatality happens. I think the FDA has taken the steps, we just need them to be able to control that which is entering the marketplace from elsewhere. For all this discussion, both the industry and the instruments are very safe. When you look at some of the issues that we have; in comparison to the number of people we service on a daily basis in hospitals and elsewhere, we are a benchmark.

Devicemakers’ facilities increasingly are being spread across the globe, making it more challenging for them to ensure uniform compliance with quality system regulations. How can devicemakers with global facilities become compliant with quality system regulations?

Beals: When manufacturing is spread across the globe one must monitor the supply chain very closely. This means audits at the manufacturing facility, close inspection of product and product documentation received to ensure compliance. Distance can make high-quality versus simple compliance harder to ensure. Supplier quality engineers become weary world travelers to conduct the audits, follow up on corrective action, and monitor outcomes.

Beauchemin: We are familiar with some OEMs with large facilities scattered around the world—in North America, Europe and China. From what we are being told, in most cases, parts being produced in China are for the Chinese market. It’s different if, for example, a U.S. company based in the United States produces parts for the United States and parts in China for the Chinese market, than if a U.S. company produces parts in the United States for the Chinese market and parts in China for the U.S. market. I think it would actually strengthen a company’s expertise by having global requirements. I know for a fact that large OEMs that open plants in China send American workers over there for a few years to work and that this helps with the exchange and cross-breeding of knowledge.

Cabral: They must follow the same guidelines that they have in their U.S. facilities. We all know it is not easy, but all of us have qualified and capable quality management associates. It’s part of that global expansion. Although a challenge, patient safety cannot be compromised. A quality requirement is that we must have an approved supplier list to approve suppliers. Through questionnaires, site visits, etc., we can determine which suppliers are meeting the acceptance criteria that we have; whether per a print specification, or a test result. As a small company, purchasing product overseas requires a certain level of infrastructure that would be robust enough to ensure compliance. Large companies have staff and departments that travel the world to different suppliers and audit them to ensure they are compliant to the criteria set. That’s their job. They make sure those parts meet specifications through incoming inspection. It’s all about the documentation you have to make sure the part complies—materials, processes, validations, etc.

Is it realistic to expect OEMs to be responsible for guaranteeing the quality of the products they make when various components of the manufacturing process is now outsourced? Can OEMs adequately monitor each part of the quality equation?

Beauchemin: Historically that’s how it’s always been done. We’re also seeing a trend—requirements put on suppliers by the FDA are getting more and more stringent, approaching OEM requirements. We are approaching the point where the FDA is demanding from suppliers to OEMs what they used to demand from the OEMs themselves. That appears to be the trend. Before, suppliers to OEMs didn’t have to worry about compliance so directly. Now, we often hear of the FDA going to audit suppliers, putting more stringent requirements on suppliers.

Cabral: Yes it should be expected. I am responsible to approve my suppliers and I am responsible for inspecting what I receive from them. If it does not meet my print specifications, then I must make it correct. The monitoring of suppliers can be complex, but it’s a requirement to the approval cycle. My customers audit my facility, inspect my products shipped and hold my company accountable for having all documentation available. It comes down to taking the manufacture of medical devices seriously.
“Would I want this product used/implanted in my spouse, child or family member?”It comes down to choosing the supplier, auditing them, making sure they have what they say they have. You’re either auditing them relative to documentation, or you’re auditing them for incoming inspection. You really have to show that you’ve done your due diligence on your supplier—that they do what they say they will do. We are responsible—it doesn’t matter who we are. My customers are responsible for making sure that I comply and I’m responsible for making sure my suppliers comply. They give me a certificate of compliance that says they have complied. It comes back to the beginning of the questionnaire—are we working with people who are trusted partners? Are we in here with people who know and understand what they are doing? One of the questions we ask of our associates. “Would you use the product you are making on your spouse, child, parent, or yourselves?” If you have the mentality that a medical device is the same as a screwdriver you’d purchase at a hardware store, then you probably shouldn’t be in this business.

Global manufacturers wrestle daily with optimizing and leveraging the cost advantages of global supply networks while ensuring product quality to protect their products and patients. How can medical device firms predict quality and analyze incidents from internal supply chains and external suppliers to improve product quality?

Cabral: Via inspection data collected and trended. This should be part of the monitoring of the approved vendor list and which supplier gets on and which supplier goes off of it.

MacFarland: The current top five issues for orthopedic suppliers appear to be components not meeting specifications, issues with metal alloy material specifications, incorrect labeling, compromised packaging, and the fifth is incorrect assembly by the supplier. When I see orthopedic firms having good control over their suppliers, they are integrating their supplier qualification systems early on with design controls including risk analysis. And they’re not just stopping at selecting good suppliers but ensuring that the manufacturer ensures appropriate controls over the supplier, given the risk of the components, the material or the assembly. The orthopedic firms with excellent supplier controls are monitoring these controls based on their risk and history of the supplier. You talk about the geographic location having impact here and I would agree. It would be difficult to get an auditor halfway around the world on a routine basis. Even so, when orthopedic firms can’t get an auditor on site they are still involved with the supplier and routinely review supplier performance information. And where they feel they don’t have sufficient levels of supplier control they will proportionately increase the incoming acceptance of activity. But it can’t be emphasized enough that communication is key. There needs to be two-way sharing of information, especially on specification changes. Excellent communication between the manufacturer and suppliers can be key to avoiding downstream quality problems. The bottom line on supplier control—orthopedic firms with successful purchasing systems treat the manufacturer/supplier arrangement as a relationship where both parties benefit from a good quality product.

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