March 18, 2024

Pat Shafer
Managing Director, Health Solutions | FTI Consulting

Most of us have felt the impact of culture in the workplace. It’s often difficult to describe culture, and even more difficult to measure it. But the impact is there. We may be motivated by our company’s mission, by the knowledge that what we are doing will impact patients, their caregivers, their families, and beyond. Or, we may be demotivated by the prevailing pressure to bring the safest product possible to market.

It’s not that both scenarios cannot exist concurrently. Most of us work for organizations that serve both patients and shareholders. But we have heard through many testimonials that leadership teams who keep patient focus and mission at the forefront find that in doing so, their financial objectives are better served.

The Medical Device Innovation Consortium’s Case for Quality has been focusing on the impact of culture and leadership’s role in enabling a culture of quality. The working group’s initial output was a Leadership Engagement Playbook which offers ten best practices for companies moving from a culture of compliance to a culture of quality. The working group is now focused on better understanding the drivers of culture so that leaders, indeed all employees, can nurture a culture that supports quality products, empathy for patients, as well as a productive and motivated work environment.

The working group identified multiple work streams in an effort to better understand how culture is formed and the forces that form it.

Has automating workflow and introducing artificial intelligence had a motivating or demotivating influence? This work stream will address the impact that technology has had on the work environment and strives to assist organizations in enhancing their quality culture through digitalization.

This sub-group is working to better understand how leaders can respond to internal and external events, both positive and negative, in ways that motivate employees and lead to better products. They’re also exploring ways to guide leaders in identifying factors that prevent successful promotion of a culture of quality.

What happens in a merger or in a liquidity crisis? How can leaders address operational and financial constraints while at the same time keeping the workforce focused on the mission? This team has been working intently to identify disruptors and assess the impact they have on culture.

Measuring Culture
Measuring culture has always been a challenge. This group is focused on providing guidance on how development measures can be used to improve a culture of quality. They are studying approaches such as applying predictive analytics or surrogate metrics in place of cumbersome, backward-looking surveys.

Skills and Competencies
This team is working to equip an organization’s workforce to have the knowledge, abilities, and attitudes to produce high-quality products or services that effectively support patient safety.

The mission of this group is to help organizations better understand how to effectively communicate the importance of quality. They aim to explore how a culture of quality can be reflected in the behaviors and statements of the entire organization.

Team members in this group are establishing tools and guidance to help companies address the issues and opportunities identified by the other teams. The objective is to provide the leaders and employees of medical device manufacturers with the ability to achieve a culture of quality that supports the entire ecosystem, from manufacturers and their employees to providers and patients who benefit from quality medical devices.

The Case for Quality Collaborative Community offers a unique opportunity for medical device stakeholders to work together to enhance device quality and patient safety.  Learn more about MDIC’s Case for Quality Initiative