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The critical role of quality assurance in medical device manufacturing

5 minutes

It's no secret that the medical device industry is booming, with a projected compound annual...

It's no secret that the medical device industry is booming, with a projected compound annual growth rate of 5.5% between 2022 and 2030. With growth comes innovation, including combination products, automation, and wireless technology, which have all delivered life-enhancing benefits to patients.

As quality assurance professionals, you have a critical role to play in ensuring that medical devices are safe, effective, and compliant with regulatory requirements. There are greater than 70,000 adverse events - those resulting in hospitalisation, disability, or death - reported to the FDA every month, which is concerning for all stakeholders involved in the medical device value chain.

But quality assurance only really hits the headlines after issues have arisen, real investment into the field often happens after regulatory concerns are voiced. Firms can benefit from early investment in a strong quality department, though—and there are several benefits you’d be taking advantage of in building out a quality team early.


Lower costs and risks

Ensuring good quality assurance in the medical device industry can result in significant cost savings and risk reduction. McKinsey estimates the total cost of quality for the medical device industry at $17 to $26 billion per year, or 12-18% of industry revenue.

However, companies that consistently deliver high-quality medical devices can achieve a 3% increase in revenue and a 15% increase in earnings before interest and taxes. This translates to a roughly 14% growth in EBIT for an average company. By adopting best practices that significantly reduce quality issues and costs, companies can move towards top-quartile performance and increase their profits by 3-4% of revenue.

McKinsey also reported that non-routine quality events such as major observations, recalls, warning letters, and consent decrees, along with associated warranties and lawsuits, cost the industry between $2.5 and $5 billion per year on average. This includes $1.5 to $3 billion per year on non-routine costs, plus $1 to $2 billion in lost sales of new and existing products. Adopting best practices can cut these costs in half.

It's also important to note that the risk of a major quality event causing serious, long-term value destruction on the overall business is high and rising. In the past decade, an average of one company per year has seen a 10% drop in share price after a single, major quality event such as a product recall.

It is essential that you adopt these quality best practices to significantly reduce quality issues and costs, so you can ensure you’re moving towards top-quartile performance and growth opportunities.


Offer better products

When we talk about medical devices, we are talking about products that are directly related to patient health and safety. It is, therefore, imperative that these devices meet stringent quality standards. By developing new and innovative products, companies can set themselves apart from their competitors.

However, innovation cannot come at the expense of quality. By implementing robust quality assurance systems, you stand the best chance of ensuring products you produce are safe and effective.

It has been reported that companies with a strong focus on quality assurance are more likely to develop innovative products. This is because they have the necessary processes in place to ensure the safety and efficacy of their devices. By investing in quality assurance, companies can drive innovation while maintaining high standards for patient safety.

The importance of quality assurance in the medical device industry cannot be overstated. By championing quality assurance, you ensure your firm stays at the forefront of medical device innovation, meets the highest quality standards, and stands a good chance of making a real impact on patient outcomes while achieving business success.


Improve patient outcomes

The medical device industry exists to improve patient outcomes. Any malfunction or error in a medical device can have devastating consequences, with the potential to cause harm or even death to patients. In fact, in the past decade alone, medical device quality issues have led to a staggering 83,000 patient deaths.

As alarming as these statistics may be, we can take steps to prevent such tragedies from happening in the future. By maintaining rigorous quality assurance standards, we can reduce the risk of product failures and ensure that patients receive safe, reliable medical devices.

Ensuring good quality assurance isn’t just a moral obligation; it’s also good business sense. If you prioritise quality assurance you can avoid costly recalls, minimise legal liabilities, and preserve reputations. On the other hand, if you neglect quality assurance you may be faced with damage to your bottom line and find yourself unable to compete in the market.


The importance of quality is set to rise

Historically, the market has favoured companies that can launch new products quickly, but that trend is changing for a few reasons. Firstly, the increasing complexity of medical devices and user environments is increasing the likelihood of significant quality issues. As a result, companies are realising that they need to place a greater emphasis on quality assurance to ensure that their products are safe and reliable.

Secondly, quality issues are receiving more regulatory, legal, and media attention than ever before, just typing “FDA recall” into a search engine brings up thousands of media articles. This means that when problems do occur, they have the potential to have a huge impact.

In fact, the average drop in a company's share price following a quality incident has increased significantly over the last decade. Patients and healthcare providers are becoming increasingly interested in the companies behind the products they are marketed, and they are more likely to choose products from companies that have a reputation for high-quality products. Therefore, if you prioritise good quality practices, you could end up having a more successful product launch.


Quality assurance is critical to the success of the medical device industry. At SEC Life Sciences, we understand the importance of hiring top talent who can navigate the quality assurance space. Our extensive network of highly skilled QA professionals, paired with our deep understanding of the life science sector, enables us to match your organisation with the best candidates for your unique needs.

If you're looking to strengthen your quality assurance team, then contact us today to discuss your hiring needs. 

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