Jon Speer’s picture

By: Jon Speer

Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International Organization for Standardization (ISO), standard 13485 outlines the guidelines for medical device quality management systems. ISO 13485:2016 has been adopted by regulatory agencies around the world as a universally harmonized standard.

However, the International Organization for Standardization itself is not a governing regulatory agency; unlike government agencies, ISO does not publish reports to the public of violations during audit findings. This fact makes it nearly impossible for device makers in this market to research and learn from others’ mistakes.

With more than 20 years of experience working in the medical device industry, I’ve seen my fair share of mistakes made during ISO 13485 implementation, with six mistakes in particular that commonly trip up device makers. You can learn from these missteps of others and avoid making them yourself:

Paul Foster’s picture

By: Paul Foster

When Deloitte wanted to get people excited about employee training, the company decided to adopt a gamification strategy for its online training portal. Using elements like achievement badges, missions, and leaderboards, they achieved a 37-percent increase in participation.

And when Ford Canada gamified its sales and service training, platform usage jumped a massive 417 percent, with big gains in engagement among younger employees.

Saying gamification makes work a game is an oversimplification. In reality, it’s all about leveraging proven psychological principles around our motivation to compete, encouraging habits and behavior that improve business performance.

These principles can also be used in manufacturing to increase engagement in audits, which are critical to quality but often suffer from low participation. Key gamification tools and techniques to consider include mobile apps, competitions, and recognition programs.

Eric Weisbrod’s picture

By: Eric Weisbrod

In manufacturing, standardization in production and process control leads to increased profitability and cuts down on many siloed problems that can plague even the most quality-focused organization. But when you have multiple, disparate plants around the country or the globe, standardization can seem unattainable, as each site operates more like an island with its own way of doing things.

I previously worked with one company that had numerous plants throughout the United States and Europe. Over time, each site had developed unique practices. One specific issue that came up was whether to use the metric system for quality data collection. Unfortunately, the company did not standardize. So, when it was time to run cross-plant reports, the results were in different units, presenting a challenge to comparative analysis.

In contrast, I worked with a separate organization that was very adamant about using a standardized approach and implementing the same quality management system at every site. Standardization made it easy to deploy the system to approximately 80 plants in merely 18 months. In addition to streamlining deployment, standardization enabled the company to perform enterprisewide reporting for better decision-making.

William A. Levinson’s picture

By: William A. Levinson

The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance, but it is only that—a first step. It covers only by implication many of the risks and opportunities that IATF 16949 covers explicitly, such as six of the Toyota Production System’s (TPS) Seven Wastes as well as crippling supply-chain interruptions, inadequate metrology systems, and more.

IATF 16949 is actually ISO 9001:2015 plus additional requirements, which makes it easy for ISO 9001 users to implement relevant clauses of IATF 16949. ISO 9001 users don’t need to implement all the additional clauses—if they did, they might as well register to IATF 16949—but many of IATF 16949’s key clauses are as relevant to nonautomotive applications as they are to automotive ones. This article will cover what look like the most important ones, although others also might be helpful.

Jennifer Lopez’s picture

By: Jennifer Lopez

Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and Drug Administration (FDA) announced its intention to adopt the internationally recognized quality management standard ISO 13485:2016 for medical devices. According to the FDA, the revisions are intended to modernize and reduce compliance and record-keeping burdens on device manufacturers by harmonizing current domestic and international requirements.

For FDA-regulated manufacturers, the required actions to close the gap between the FDA’s existing Quality System Regulation (QSR) 21 CFR part 820 and ISO 13485:2016 should not increase manufacturers’ regulatory administration significantly. However, it is important that manufacturers are aware of and prepared for these changes, and they understand what the changes will mean for their businesses. They can do this by seeking industry insight on best practices.

ISO’s picture

By: ISO

Innovation isn’t just about having a few bright ideas. It’s about creating value and helping organizations continuously adapt and evolve. ISO is developing a new series of International Standards on innovation management, the third of which has just been published.

Innovation is an increasingly important contributor to the success of an organization, enhancing its ability to adapt in a changing world. Novel and innovative ideas give rise to better ways of working, as well as new solutions for generating revenue and improving sustainability. It is closely linked to an organization’s resilience, in that it helps stakeholders understand and respond to challenging contexts, and seize the opportunities that might bring and leverage the creativity of both its own people and those it deals with.

Ultimately, big ideas and new inventions are often the result of a long series of little thoughts and changes, all captured and directed in the most effective way. One of the most efficient ways of doing just that is through implementing an innovation management system.

Stephanie McArdle’s default image

By: Stephanie McArdle

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted medical device manufacturers to send the FDA an accounting of device injuries and malfunctions on a periodic basis (e.g., quarterly or annually) in lieu of fulfilling their standard public reporting obligations. The ASR program actually ended in 2017, but evidence shows that device exemptions were still accepted by the FDA.

Grant Ramaley’s picture

By: Grant Ramaley

Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region. 

This could be more problematic for dental products, which are inherently lower risk. Rubber dams and dental operating lights will have to comply before MRIs and pacemakers. 

To ensure that medical device manufacturers of class 1 devices understand that they must comply immediately on May 27, 2020, when the new regulation goes into effect, the European Commission states this plainly in its “Fact Sheet to Medical Device Manufacturers.”

Multiple Authors
By: Chad Kymal, Gregory F. Gruska

During the early 1980s, GM, Ford, and Chrysler established the Automotive Industry Action Group (AIAG), a not-for-profit organization with the mission “To improve its members’ competitiveness through a cooperative effort of North American vehicle manufacturers and their suppliers.” In the late 1980s, U.S. automotive suppliers, through the auspices of the American Society for Quality (ASQ), approached the VPs of purchasing for GM, Ford, and Chrysler and explained the burden of multiple standards that were being imposed on the supply base. Not only where there multiple OEM standards, there were hundreds of tier one standards as well.

Jyoti Madhusoodanan’s picture

By: Jyoti Madhusoodanan

A frog the size of a fingernail. A poncho-clad farmer leading his mule. A tree, some intertwining leaves, a silhouetted figure holding a pot. Such logos are stamped on labels of coffee, cocoa, mangoes, jeans, and myriad other products, certifying that the object for sale is in some way “sustainable”—made, in other words, in a way that meets humanity’s needs without jeopardizing the ability of future generations to meet their own.

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