How to Build a Culture of Quality in Medical Device Organizations
Fostering a quality culture goes deeper than just following a set of rules. In the med tech industry, you need a total shift in your mindset and function. This change begins at the top and moves through every level of an organization.
At the 2024 Med Tech True Quality Summit series, four panelists gathered to discuss what goes into a medical device quality management system. Together, the four offered inside advice on fostering a quality culture and how this culture can improve efficiency, reduce risk, and enhance market competitiveness.
This is your chance to learn from their extensive experience in the field.
Meet the Med Tech Quality Management Experts
Meet the four med tech experts who presented in the webinar, “Achieving Quality Culture in Medical Device Organizations”:
- Joanne Lebrun: Joanne, the vice president at MDC, brings over 20 years of experience. She specializes in quality systems, clinical trials, in-vitro diagnostics, and regulatory submissions.
- Edwin Lindsay: He is the principal consultant and managing director at Compliance Solutions. This firm advises on quality regulations for medical devices across the EU, UK, and US.
- Jean-Yves Pairet: He serves as the director of quality assurance at CLEIO. With over 14 years in quality control and medical device development, his expertise is invaluable.
- Duane Mancini: As the Founder and CEO of Project Medtech, Duane assists startups with financial strategies and CFO duties. His work includes budget management and investments.
At a glance —
- Fostering a quality culture goes deeper than just following a set of rules.
- A quality culture reflects a company’s views and practices on quality. This is essential in the medical device industry, where quality can affect lives.
- To establish a quality culture, start with your core values.
- Check out 6 strategies for growth without sacrificing quality culture
- Creating a quality-focused culture takes experience, perseverance, and time.
The Role of Leadership in Shaping a Quality Culture
A quality culture reflects a company’s views and practices on quality. This is essential in the medical device industry, where quality can affect lives.
The State of the Med Tech report showed top organizations focus more on quality culture. So, what role does leadership play here?
Joanne Lebrun believes leadership is key in quality culture, especially in clinical quality management. Leaders must live and breathe this culture for it to be ingrained in the company’s identity.
Duane Mancini echoes this sentiment. He states that you shouldn’t have to explicitly tell anyone about your culture for them to identify it. That’s how integrated it should be in your organization.
Defining and Communicating Company Values in Med Tech?
When was the last time you sat at a restaurant and praised the food for compliance? Probably never. Most people define food by its quality. Quality culture should go beyond being compliant and should explain who you are. It should be the center of everything you do.
To establish a quality culture, start with your core values. These should make your company both dependable and trustworthy in the highly regulated med tech environment.
Edwin Lindsay says values shouldn’t just tick boxes for compliance. They must reflect the values the company believes in.
The regulatory department and leaders are responsible for guiding everyone in understanding and embracing these values and standards. This approach ensures that the team does not just follow them but believes in them.
Jean-Yves Pairet emphasized the importance of a quality culture that focuses on people. This quality management system includes tools and support employees need to actively practice a quality culture.
6 Strategies for Growth without Sacrificing Quality Culture
Our med tech experts share six strategies to help businesses, especially startups, grow and evolve without losing their commitment to quality:
- Align with Your Goals: Always keep your end goal in mind. Shift your quality culture to support these goals.
- Foster Open Dialogue: Regularly start conversations about your quality management system, expectations, and successes.
- Empower Your Team: Encourage employees to make decisions and take on responsibilities.
- Hire Wisely: Hire people who value and contribute to your company’s quality culture.
- Practice Empathy: Always show empathy and understanding toward those within the organization.
- Give Constructive Feedback: Provide feedback on your quality management system to build a stronger structure.
Watch the Webinar On Demand
Hosted by Greenlight Guru, watch the session here.
Build a Quality Management System for the Medical Device Industry
Clear communication about expectations and autonomy in decision-making are key for a successful quality management system. This approach empowers companies across clinical trials, med tech, and diagnostics. Leadership plays an important role here, not just telling others what to do but showing what a quality culture looks like.
Are you ready to roll up your sleeves and work alongside your team to build a strong medical device quality management system?
Creating a quality-focused culture takes experience, perseverance, and time.
Contact MDC for help with compliance with your quality systems.
