Medical Device Recalls: Creating a Balance

Medical Device Recalls: Creating a Balance

Right now, there are some 6.6 billion people in the world, and over the next 30 years, it will soar to over 9 billion. At the same time, the global population is aging, and mostly so in the U.S. and Europe. As the population ages, health care needs will likely increase, leading to an increase in medical device consumption, an industry currently valued at $290 billion dollars. (Kalorama Information, A division of The U.S. represents the largest medical device market with $130 billion dollars in revenues.

It’s pretty easy to see the growth in the industry over the last several years. Medical devices are everywhere and are a critical aspect in today’s healthcare. As much as they are necessary, medical devices can have quality failures that result in potential health risks. The challenge for medical device companies is a careful balance in developing innovating and potentially life-saving medical devices while ensuring that quality issues such as manufacturing defects, don’t create a medical disaster. As more and more medical device companies flood this market, competition is strong, and so is the desire to come to market with devices that can help our sick and elderly. It is just this challenge that medical device makers need to consider: How can we be innovative, quick to market, and still maintain the highest level of quality?

There are several participants that are deeply affected if a medical device fails

The largest of these is clearly the patients.  Even doctors are somewhat reluctant to try new, innovative devices, as they fear quality failure. There have been so many recalls, some with drastic impacts. It makes you wonder, what will it take to get the industry to take better quality measures?

Take the perspective of stakeholders of medical device companies. A recall would likely result in revenue losses. Who would invest in a company that carries such risk? A company that invests in quality and risk measurements with a focus on preventative tells its stakeholders: we can be trusted.

Perhaps the financial consequences of quality failures in the medical device industry aren’t a high enough penalty. Should there be stiffer penalties? Should they only apply to repeat offenders? Or perhaps should there be a waiting period before introducing a product would help manufacturers better prepare their product for release. Or, maybe medical device manufacturers can take steps towards a risk, compliance and quality management system that reduces the possibility of quality defects reaching the end user and drives the firms’ commitment to providing reliable products to the market.

The only way to overcome defects is to identify factors that systematically increase or decrease the likelihood of device failures and make appropriate adjustments. Having an automated risk, compliance and quality management system is well worth the time, effort and investment to ensure that there is a balance between speed to market and product quality.

Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 25 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.