Leaving it all on the Field

•    How long have you been at Integra? What does your role at Integra entail? 
I joined Integra as part of the ACell integration in 2021. Since then, my role has expanded. My team supports the Wound Reconstruction and Care franchise and regulatory compliance at the Collagen Manufacturing Center (CMC), Añasco, Columbia, and Memphis sites. This includes reviewing advertising and promotional materials, participating on new product introduction (NPI) core teams, assessing changes to our designs and/or manufacturing processes, authoring submissions to regulatory authorities, and acting as a liaison between Integra, the FDA, and our EU notified bodies.

•    What drew you to pursue a career in regulatory affairs? 
Regulatory affairs interested me because regulatory professionals are involved in every aspect of the medical device lifecycle, including design, manufacturing, quality, post-market, clinical studies, marketing, and more. While I didn’t have any industry experience at the time, I fell in love with regulatory and have stayed with it for the last nine years.

•    What would you want the broader Integra team to know about the regulatory affairs organization? 
One thing I’d like the broader Integra team to know about RA is that we do much more than just submissions to the FDA. That may be the most visible thing we do, but we also provide technical and strategic insights that can potentially bring products to market faster or ensure our products can stay on the market. RA requires a lot of critical thinking and a solutions-oriented approach to ensure we are compliant while also supporting our critical business objectives as much as possible.

•    Can you tell us more about your educational background and career journey at Integra? 
I have a bachelor of science in biomedical engineering and a Ph.D. in bioengineering from Rose-Hulman Institute of Technology (Go Fightin’ Engineers!) and Notre Dame (Go Irish!), respectively. In graduate school, my research focused on orthopedic tissue engineering and so my first role in industry was in the Orthopedic Trauma division at a medical device company. However, when an opportunity arose at the legacy ACell company to get back into the “tissue” space, I jumped at it, and then we were acquired by Integra just a few months later. I truly enjoy working at Integra and navigating through the complex regulatory space and addressing challenges since I know how meaningful our products are to patients. 

•    What's the best piece of professional advice you've ever received? 
I think the most important piece of advice is that you are your own best advocate. Instead of hoping that some amazing opportunity or promotion will fall in your lap, it’s critical to be proactive. Make the most of opportunities, communicate with your manager about your professional goals and suggest ways to learn new skills such as attending conferences. One of my favorite quotes is “Ask and it will be given to you; seek and you will find; knock and the door will be opened to you;” the opportunities exist, oftentimes you just have to be willing to ask/seek/knock.

•    What would you like people to know about you on a personal level? What are your favorite things to do in your free time? 
I’m located in Indiana, and I have three kids (ages 9 and twin 7-year-olds), so I don’t know what free time is! Most of my non-working hours are watching and/or coaching my kids play whatever sport is in season, which is always a blast. I love all sports. I played football in college at Rose-Hulman. I also love IndyCar racing. My family has gone to the Indy 500 every year for decades and it’s always a big highlight of my year. I have strived to apply the lessons I learned from athletics, such as teamwork, perseverance, and sacrifice, into both my personal and professional pursuits.

•    Can you talk about in your own words what enterprise mindset means to you? And any examples of how you have embodied this?
To me, an enterprise mindset is operating as ‘One Integra’ which requires cross-functional, cross-site, and cross-divisional collaboration. This is one area where RA has strived to take a leadership role since our roles inherently require us to work with multiple teams and sites. One example is that we collaboratively created a single RA assessment process that is used across all sites. Another example is I’ve worked in collaboration with marketing, legal, CSS RA, medical affairs, and others to create enhanced tools, procedures, and training to ensure that there is consistency across franchises and divisions in our advertising compliance practices. 

•    What are your top goals/priorities this year? 
I have three top priorities this year. First, is to support the collagen recovery projects at CMC/ Añasco to help make our manufacturing processes more efficient and sustainable to address any supply challenges. Second, is to support the Compliance Master Plan (CMP), particularly the non-conformances (NC) and corrective and preventive action (CAPA) workstreams. Third, is supporting general sustaining efforts and design history file (DHF) improvement projects, particularly for MediHoney®.

•    What is your advice to employees who are joining Integra on how they can be successful?
In Tissue Technologies RA, we established three pillars that we look for in new employees and hold ourselves accountable to – to confidently adapt to an ever-changing environment, utilize open communication to foster a collaborative and inclusive culture, and to take initiative to continuously improve our processes. While we created those for RA, I think embracing change, being collaborative, and taking initiative are universally applicable actions that lead to success in any role.

•    What is a moment or accomplishment in your career here at Integra that stands out? 
One accomplishment that stands out is the regulatory clearance and launch of MicroMatrix® Flex. The 510(k) for that project had to overcome a lot of obstacles, but in the end, we were able to successfully obtain clearance and launch a new, innovative product into the market. 

•    In your own words, describe what our purpose, mission, vision means to you? 
To me, they provide the “why” and “how” Integra operates. The way I summarize it in my head is that we “lead to serve.” When we lead by living our values this serves both our colleagues at Integra by promoting a positive culture, and it also serves our patients by promoting innovation and advancing outcomes.