As part of Integer’s Executive Leadership Team, Margaret is responsible for leading quality assurance, regulatory and clinical affairs and playing a primary role in driving a culture of quality at Integer.
Under Margaret’s leadership, Integer is focused on maintaining a quality system that puts the patients served by Integer’s products first in all decisions and actions. She reports directly to the CEO, leading an organization that collaborates cross-functionally to develop and execute a strategy in accordance with the latest FDA, applicable ISO, and other international requirements.
Margaret has been with Integer since 2004, serving in a variety of quality and regulatory roles. Her in-depth expertise extends to international quality and regulatory laws and standards in North and South America, Asia, Australia, and across Europe. Prior to her appointment to lead Integer’s overall quality efforts, she was VP of Quality and Regulatory for the Cardio & Vascular product category. Before joining Integer, Margaret was a Quality & Regulatory Leader for the European Region at Sola International (now Carl Zeiss).
What first drew you to MedTech? When did you first know you wanted to be in the industry?
I was fortunate in that when I finished graduate school there was a large factory within a few miles of my home that was part of a multinational medical device manufacturing company. I obtained a junior position in the Technical Services group, whose objective was to improve the manufacturing yield of the polymer lenses through experimentation with the chemistry. The work was varied, interesting and challenging, and I received excellent training. I was lucky in those first years to be involved in many continuous improvement and automation projects and process improvements. My move into Quality seemed a natural one, where I could help ensure improvements were properly embedded into procedures and systems, ultimately ensuring compliance while meeting business and customer needs. It was in this capacity that I learned the importance of the products the MedTech industry brings to the marketplace and the corresponding significance of effective and efficient Quality systems to the business and the end patient.
What projects, past and present, have made you love what you do?
One real highlight of my career at Integer has been changing out a problematic subcontracted coating and moving customers to an excellent in-house alternative. I got enormous satisfaction not only in providing a solution but in managing the submission to get it approved in an expedited way — turning an issue into a win-win for our company and our customers. I thrive on employing good project management and pragmatic user-friendly quality systems to support product innovation and time to market.
What projects are you most looking forward to?
I am looking forward to how the industry and the notified bodies handle the next generation of products, which will increasingly incorporate smart technology, miniaturization and customization of the device to the individual patient. How will the design process for these much more flexible products be verified, validated, and controlled in such a way that supports continued acceleration of innovation and the potential to improve patients’ lives? I expect we will see yet another change to the regulatory system, even more fundamental than we saw with MDR (Medical Device Regulation) implementation.
What are some of the barriers women face in today’s MedTech industry?
I believe that unconscious bias is one of the largest barriers women face in the MedTech industry today. Education across all levels of organizations is the first step in removing the gender bias. We need to think more creatively to retain women in the industry. At Integer, I’m proud to be part of the steering committee for our Athena Alliance Employee Resource Group (ERG), which focuses on gender diversity and inclusion, to help remove these barriers. Our focused workstreams are structured to bring awareness to gender diversity, inclusion, and its benefits. This in turn helps develop female talent by addressing gender gaps while supporting and connecting women within Integer and the communities where we live and work globally.
Describe your biggest leadership challenge. How did you conquer or resolve it, and what was the outcome?
In the early stages of being a senior leader, I think handling different perspectives was my biggest challenge. In Quality, we can often be the bearer of bad news that, if not handled properly, can cause conflict. I learned the best approach to diffusing a potential conflict was through a calm discussion at a time when there wasn’t a live issue. This way, conflicting ideas can be channeled into a productive discussion that results in shared understanding and, for me, results in better cross-functional collaboration from that point forward.
Talk about your leadership skills. What is the most important lesson you have learned that has guided you in your career?
Success depends on achieving results as quickly as possible, and a leader must hold their team accountable to do that. You must do whatever you can to allow your team to be successful, but you can’t do it for them. If you clearly communicate your expectations and vision, your team will want to make it happen and will work together with you to find ways to execute and deliver.
In your opinion, what more can be done to promote greater participation of young women in the MedTech industry today?
It starts early on in school. Girls should be expected to take the same courses in science, technology, engineering, and mathematics (STEM) subjects as boys. With that foundation, there should be enough familiarity with STEM that more girls would develop an interest in pursuing a career in the industry, especially if they are also exposed to stories of women who have succeeded in the industry. In the early part of my career, I volunteered to take part in a national program to help students make connections between what they learn in school and how it can be applied in the real world. The programs begin at the primary school level, teaching students how they can impact the world around them as individuals, workers and consumers and continue through to the second level, right up to age 18, preparing students for their future careers. At Integer, we have a very successful program where young women can see firsthand women who have succeeded in the industry.
Why is it important for companies to be more inclusive and have more women in charge?
There are different dynamics between male-majority groups and more diverse groups. With more diverse and inclusive groups, I believe there is less likelihood of the dominance of an individual overpowering the quality of an argument. Less groupthink and more wide-ranging discussion lead to more options being considered and better decisions, which is ultimately better for business.