Trust is among the most fragile of human emotions. Once lost, it can be nearly impossible to rebuild. But broken trust doesn’t just impact relationships; it’s also a key influence on consumer behaviors and purchasing decisions—especially when patient lives are on the line. If a pharmaceutical or medical device company suffers a serious hit to its reputation, such as an FDA warning letter or a product recall, consumers are dramatically less likely to engage with that brand as a whole in the future.

In a recent survey my company conducted of more than 2,000 Americans, we found that more than half of consumers are unlikely to use a product after a recall, even if the issue has been adequately addressed.

Even a warning letter can have serious consequences. A staggering 80% of consumers are at least somewhat unlikely to use a particular healthcare product if they learn about the FDA’s concerns. Fifty-two percent would be very unlikely or absolutely refuse to use the product again.

To avoid consumer backlash, pharmaceutical and medical device companies need to stay one step ahead of any safety or quality issues that may lead to FDA involvement. They can do so by investing in proactive, data-driven quality and product development best practices that promote transparency and enable swift action should a problem arise.

As both consumers and the FDA heighten their scrutiny of life sciences companies, a clear and well-structured quality and product development process will be essential for navigating this rapidly changing environment.

Highly informed consumers have a lot to say about quality and trust.

As out-of-pocket healthcare prices continue to rise and information becomes more readily available through a variety of channels, consumers are no longer hesitating to take charge of their health decisions.

In a 2022 survey conducted by my company, three-quarters of respondents actively follow news and updates about the healthcare products they use, including prescription drugs, medical devices and over-the-counter products.

And they’re not subtle about their opinions when they hear about something going wrong. Regardless of the actual reason for a recall, consumers are likely to jump to the worst possible conclusions.

Thirty-eight percent said that a recall means the product is of poor quality, while the same number believe that the product can no longer be trusted.

It doesn’t even have to be an official recall to sour perceptions: When the FDA placed a temporary pause on one company’s Covid-19 vaccine, 47% of survey respondents took that to mean that the company is a “lower quality brand” than its competitor.

This may not seem fair to insiders who are familiar with the nuances of how the FDA controls quality and patient safety, but the reality is that consumers are prone to swift and harsh judgments.

Lofty consumer expectations even extend to quality documentation and best practices.

It’s not impossible to shore up trust in a brand, however. Consumers have an appetite for transparency and honesty and are actively seeking better ways to understand the life cycle of the products they rely upon.

For example, 84% want the FDA to publicize quality data about a manufacturer’s entire operation to assuage their concerns about design and production. The same number would feel comfortable placing their trust in a public-facing quality culture score.

Unfortunately, it might not be easy to develop such scores to help meet consumer expectations. Many members of the life sciences community are still using paper-bound quality management systems or scattershot spreadsheets that make it extremely difficult to understand the big picture within the organization. For 56% of respondents, a fully digital approach to life sciences quality management would make it easier to decide on companies and products to trust.

As consumers continue to put pressure on life sciences companies, these ad hoc systems will no longer be adequate for clearly showcasing the quality, safety and reliability of new and existing product lines to consumers or to regulators.

How can you improve healthcare product quality to maintain consumer trust and confidence?

Patients aren’t the only ones who are interested in enhancing the quality management landscape. In March 2022, the FDA itself asked for additional industry comments on the proposed Quality Metrics Reporting Program, which would include provisions to monitor quality across the entirety of a pharmaceutical manufacturer.

Should the FDA establish this program, companies will need to upgrade their quality approach to meet more standardized and potentially public-facing criteria.

Instead of relying on three-ring binders filled with handwritten papers, companies should explore digital tools that offer more robust tracking and management features while enhancing visibility across the organization—and powering a smarter approach to disparate collaboration between product and quality teams.

To safeguard quality, companies should begin with a thorough assessment of their existing quality management capabilities, technology and future goals. With the aid of senior leadership and an internal quality champion, life sciences companies can help build enthusiasm for supporting workflow changes. Quality management leaders should also work closely with stakeholders to optimize and refine quality documentation procedures to maximize the value of new tools. And organizations should then periodically review these changes to ensure compliance and make any tweaks necessary to improve the effectiveness of new processes.

As consumers become increasingly choosy about how they engage with life sciences partners, companies will need to take a proactive stance on demonstrating safety and quality. Adopting a digital-driven approach to quality management can reduce the likelihood of a warning or recall and safeguard companies against negative opinions from a vocal general public.