Dawn Luehrs, Director of Quality, Cretex Medical

Originally from Minnesota, Dawn Luehrs received her Bachelor of Science (BS) Degree in Physics from the University of Wisconsin–River Falls. She began her career as a Manufacturing and Project Engineer with a disc drive manufacturer in the Twin Cities, specializing in stamping and materials science. After moving to the Medical Device field, she became a Quality Engineer and then Operations Manager for a company making pulse oximeters. Later she managed contract manufacturers, OEM suppliers, and integration quality for Boston Scientific. Over her 6 years with Cretex Medical | QTS, Dawn has been Director of Quality Systems and Sterilization, and more recently her role has expanded to include supply chain sourcing and procurement.

Outside of work, Dawn enjoys camping, hiking, and running. She recently completed her fifth triathlon.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

Many members of my family have benefited from medical device technologies, such as defibrillators and orthopedic implants. In the computer industry where I began, there were very tight tolerances and precise requirements. I knew there would be similar challenges in the medical devices field, so I felt I could make the transition.

Over the course of my career the number of technical advancements and diseases we can treat has just exploded. It has been both fun and rewarding to be part of helping so many patients live longer and live better.

As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?

The pace of advancements continues to accelerate as the medtech companies push boundaries, and each other, to find new solutions. Artificial intelligence, of course, will impact how we manufacture products, how physicians treat patients, and how we all share knowledge.

The contract manufacturing space will continue to support OEMs as they create new advancements and as the CMOs focus on supply chain management and device manufacturing. The industry is full of big companies with resources and experience as well as small firms with new ideas. Investment by larger players in start-up companies will help drive innovations. Those relationships will help integrate advancements into the medtech ecosystem.

From your experience, what are some of the key challenges that medtech engineers are likely to face in the coming years? How can professionals in the industry prepare for and navigate these challenges effectively?

We have already begun to see the ongoing cost impact of global trade conflict. Onshoring and nearshoring come with risks, but I believe that this pressure may generate innovations as companies look to manage costs.

To keep abreast of technical advancements and rapidly evolving regulatory requirements, it’s vital for medtech engineers to build connections with people from across the industry. That means taking the time to sit down with your colleagues regularly and share learnings.

In your opinion, what areas or applications within medtech have the greatest potential for growth and innovation? Why do you consider them promising?

I’m excited by the latest research and developments in cancer and Afib treatment. There have been several improvements in pharmaceuticals, radiation treatments like brachytherapy seeds and radioembolization beads, as well as mechanical treatments such as ablation. The new advancements have fewer side effects, and when combined with traditional treatments, have provided increased quality of life and lifespan. We’ve even seen stage 4 patients recover to NED (no evidence of disease) status. For other patients who had a 5-year outlook, new treatment advancements have doubled to a 10-year outlook or more.

As technology continues to advance rapidly, how do you think medtech engineers can stay ahead of the curve and ensure they are equipped with the necessary skills and knowledge?

Be curious. You can’t just wait for the knowledge to come to you. Read, investigate, attend seminars or shows, and continue to take classes and professional development. Engage with your peers, schools and industry groups. Participate in the development of regulations and standards if you can.

Most of all, embrace change. Be a champion for new technologies and be the first to demonstrate how they can alter how we do business for the better.

From a broader perspective, how do you see the role of medtech engineering in shaping the future of healthcare? What impact do you anticipate it will have on patient care and outcomes?

When we work on cutting-edge technology, it may be that 9 of 10 of those devices never make it through medical trials, regulatory reviews, or testing. However, each failure provides us with valuable information we can use for the next success story. We continue to gain greater insights into the complex systems of the body. As our understanding deepens, the innovations we develop will continue to drive improved outcomes, fewer side effects, and longer lives.

Considering the increasing importance of interdisciplinary collaboration, how do you think medtech engineers can effectively collaborate with professionals from other fields, such as medicine and computer science, to drive innovation in the industry?

Keep finding new ways to learn. Take on roles that let you make connections and develop skills outside of general engineering. Maybe take a practicum course or join a club or interest group on a new topic (prosthetics, mental health, heart health, etc.). Join professional organizations and take professional courses. Seize opportunities to see early studies and get certified to be part of cases, or visit the environments where devices are used.

Do not limit yourself just to medical device engineering. There are so many fields that connect with ours. Learn about supply chains, operations, regulatory, quality, research and more. Connect with medical practitioners and deepen your understanding of how our devices are actually used in the field.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

A homogeneous team tends to have homogenous output. Teams that bring together different experiences, backgrounds, opinions, and social statuses are better at looking at things in new ways. Innovation comes from combining curiosity and experience, critical thinking with creativity. You need different skill sets and perspectives. Operational Excellence programs create environments where solutions are encouraged to come from the production floor and bubble up. Companies should give everyone the time, space and support to have ideas and see them through because it creates the best output while helping ensure that everyone is engaged, whatever their background.

On my teams I’m intentional about engaging everyone differently. Due to different cultures or experiences, some people may be less comfortable contributing in a group discussion or challenging conventional wisdom. So, I make sure that I give teammates questions ahead of time and follow up with people as much as I can. I’ve worked with teams from across the globe and I know that different cultures significantly shape group dynamics. You need to figure out what kind of support your team needs so you can drive idea sharing and innovation. If you’re just listening to the loudest voices in the room, you’ll miss something. Sometimes the quietest person in the corner has the brightest idea.