Accessibility Links

Why quality is paramount in medical device manufacturing

Written by: Bethan Williams
Date: 26 May 2016

It used to be that the top priority of medical device manufacturers was speed to market. It was a race to launch new products before competitors. Over the last decade or so, this has slowly changed. The key factor for producers now is quality. Manufacturers are much more risk-averse and would prefer to delay a launch than introduce a product with design flaws, however minor.

This prompts a few questions. What is the definition of “quality” in a medical device, and which professionals are leading the way in delivering improved standards? What are the factors that have led to quality taking centre-stage?

The cost of poor quality in medical device manufacturing

Let’s look at the context in which this change has taken place. According to a recent McKinsey report, sales of medical devices have been growing at an annual rate of 9% over the past decade, and within this time the range and complexity of devices has also mushroomed. Devices now include automation and wireless technology; functions are more precise and components are increasingly intricate.

At the same time, globalization is putting increased competitive pressure on medical device companies to reduce costs and improve standards. This global marketplace is scrutinized by vigilant media outlets, ready to broadcast news of a defective product in one region to the rest of the world at lightning speed.

Quality issues can stem from any link in a hugely complex international supply chain, or within the detailed design, testing, and manufacturing process. A slip somewhere along the line can result in severe consequences not only for patients, but also shareholders: over the last ten years, on average one company per year has seen its share price drop 10% after a single major quality event.

What does “quality” mean?

It is meaningless to say that quality has overtaken speed to market as a top priority for producers of medical devices unless you know what “quality” is. Does it refer to ease of use, durability of materials, excellence of design, a combination of these, or another factor entirely?

Quality may be defined differently according to context. For example, for a device that can be replaced easily and with minimal risk, durability may be less important than ease of use. Devices fitted internally and expected to last for decades may have different key criteria.

The bottom line is that quality is something that impacts on a company’s competitiveness and performance within the market. Product recalls, court claims, and whistle-blowers can severely impair market reputation, even if doubts about quality prove to be groundless.

The guardians of qualit

In this environment, the role of the quality engineer has never been more important. Dedicated engineers play a pivotal role in Quality Assurance of devices or QMS development, as well as CRM software development and integration.

Good quality engineers are much in demand, because of the increased focus on quality and the tightening of regulations in many regions of the world. They have an important role in understanding risk prior to product launch, compliance with ISO 13485 and post-market surveillance. They also need to ensure ISO 14971 is complied with, envisaging any potential risks from using products otherwise than recommended.

Quality engineers are dedicated and passionate about their work, taking the role of protecting patient safety very seriously. This is one factor as to why companies often find recruitment challenging; engineers can only be tempted by new opportunities with companies drawing a fascinatingly diverse range of products or clear career development, not currently available.

Knowledge combined with proactivity

Personal traits are arguably as important as knowledge for quality engineers. Abstract knowledge of regulations, processes and systems is vital, but unless the individual is motivated and proactive in ensuring production systems reflect that knowledge, quality will suffer.

Quality engineers come from a range of engineering backgrounds, with life sciences experience a considerable plus point. Quality engineers should be data-driven, independent-minded, and assertive enough to challenge their colleagues to achieve the highest standards.

To talk more about the evolving medical device manufacturing landscape and potential career paths, speak to the EPM team today.