Medical device quality assurance: why is it needed?

It’s important to remember that medical professionals would be very limited in treating patients without the use of medical devices. The industry is highly regulated to ensure that any device released onto the market is safe for use; one way of guaranteeing this is through medical device quality control.

Why is medical device quality assurance required?

This question is based around the possible added challenges that quality may create throughout the design process. It could be suggested for example that quality control slows down medical device design.

But as quality is highly regulated, especially in the pharmaceutical market, it can be hard to imagine what the consequences would be if less importance was placed on it. There are two primary examples of the ramifications of lax quality: Thalidomide and the 2011 breast implant incident.

Thalidomide was a drug prescribed to pregnant women in the late 50s and 60s to prevent morning sickness. Interestingly, this was not the intended purpose of the drug. But after an obstetrician began recommending it to his pregnant patients, it became a worldwide trend.

However, the use of Thalidomide resulted in many children being born with phocomelia, a condition where the limbs are attached close to the trunk. It is still common for drugs to be recommended for off-label purposes, but this incident indicates the dangers of doing so.

The breast implant scandal in 2011 occurred due to the discovery that over 30,000 women received breast implants filled with industrial silicone instead of medical-grade fillers. Women who received these faced the risk of implant rupture. A silicone breast implant rupturing can have severe consequences such as chemical toxicity and cancer. Despite claims that intact implants were safe to leave in, many doctors advised that women get them removed as a precaution.

Not only can lax quality have an impact on patient lives but it can also have a financial impact for medical device companies. A study published by McKinsey characterises the cost of quality as:

• Direct cost of ensuring good quality such as costs involved in preventing quality issues from arising
• Direct cost of poor quality relating to the cost needed to remediate failure
• Indirect quality costs which refers to market-cap losses for example

The study states that: “The medical device industry’s direct cost of quality of approximately 6.8 to 9.4 percent of industry sales equals $26 billion to $36 billion annually, based on the industry’s current annual sales of about $380 billion. The direct cost of ensuring good quality represents about one-third of this total cost, with the remainder resulting from the direct cost of poor quality.”

The importance of medical device quality assurance

The Thalidomide and breast implant scandal, and the impacts they had on the lives of many caused major changes in the industry. These cases and the study published by McKinsey highlight the importance of strict regulations and the negative repercussions of not following medical device quality assurance policies.

As Team’s Managing Consultant QA/RA, Mark is responsible for ensuring that our internal operating systems reflect current best practice. He focuses on project management and development of medical devices, from early stage technical assessment of potential technologies/devices through to industrialisation.