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Meet Carolyn McCuan of CTM Medical Consulting in Orange County

Today we’d like to introduce you to Carolyn McCuan.

Carolyn, can you briefly walk us through your story – how you started and how you got to where you are today.
I grew up on welfare living in a rough neighborhood in East Side San Jose, shared a roof with 13 other family members and did not have much for most of my childhood life. My parents worked a lot so I was often left home with my younger brother to raise ourselves. I learned at a young age that in order to get to where I wanted to be in life, I had to work hard for it. It wasn’t going to be given to me, I had to earn it. Hard work is in my blood.

After grinding through many years of school, I obtained my Master’s Degree in Molecular Biology from USC and my Bachelor’s Degree in Biological Sciences from UC Irvine. I started working in research labs as a scientist and after several years, realized that it wasn’t my passion. I had too much drive and personality to feel stuck in a lab. I then moved to into a Regulatory Affairs medical writing role at Medtronic and this was my first experience in the medical devices industry. I LOVED IT. I loved how fast-paced the industry was, how quickly we were able to navigate through innovation while also focusing on patient benefits and safety. I knew this was my industry.

I then joined Edwards Lifesciences, a heart valve manufacturing company and became a Clinical Affairs Manager, then later became a Director of Medical Writing at a small consulting firm. I loved the work we did because we were making a huge impact to the innovation of patient health, also while focused on assessing clinical safety and performance of these medical devices. We were saving lives every day.

Yet, the corporate life began taking a toll on me. Working 16-hour days and virtually every weekend. I was burned out, tired, and unhappy. This was not the life I had imagined for myself. I got married and became pregnant with our first child and knew that I needed a change. I am not afraid of hard work. I have grit, but I also deserve to be happy.

With a decade of experience under my belt, I decided to take a leap of faith and start my own company: CTM Medical Consulting. It’s a consulting firm that works with medical device, in vitro diagnostic, and pharmaceutical companies to help them through the clinical and regulatory hurdles of product approval. It was scary and daunting at first, but I knew that I had to try because my happiness was on the line. I had to do this for myself and for my family. Within a year, my company had grown from a solo operation to a busy consulting firm with multiple employees.

As the founder and CEO, I work extremely hard. Don’t get me wrong, I do still have very long days, but it’s different now. The passion and drive that I have is based on a new purpose: I do it for myself, my clients, and my employees. We work hard because we want to provide quality work and to build sustainable relationships. Even though we work remotely, we are like a family.

Every day, I remind myself of how far I’ve come. I recently found God and he has opened up my eyes to a whole new, beautiful world full of love and opportunities. Every morning I meditate and pray about how grateful I am to have this amazing opportunity to lead a company, help my clients, and provide incomes for other families, especially during these times when the economy is suffering immensely. As a working mom, it is insanely HARD to juggle running a business and taking care of a family at the same time. But by doing so, I am able to provide for my family and mentor others who seek a similar path. As women, we don’t have to choose between having a career or family, you CAN have both and be successful at it.

I can’t think of a more rewarding job than this and am so thankful to be where I am now. Inspiring others is what keeps me going day in and day out.

We’re always bombarded by how great it is to pursue your passion, etc – but we’ve spoken with enough people to know that it’s not always easy. Overall, would you say things have been easy for you?
Absolutely not! My family had major doubts about me leaving a stable career to start my own company. I also experienced a lot of criticism for starting this venture while pregnant and raising a baby. Regardless of the negativity that was thrown my way, I listened to my heart and pushed forward. My husband was 100% supportive of my decisions and helped me every step of the way. I don’t regret it one bit!

Please tell us about the company.
My company, CTM Medical Consulting is a small consulting firm that specializes in regulatory and medical writing submissions for different types of medical device companies. It’s a small niche industry and in a nutshell, we help medical device/pharmaceutical manufacturers with researching and writing the reports needed to assess patient safety as required by regulatory agencies such as FDA and other global regulatory agencies. This is a requirement for the manufacturers to get their devices/products approved. It is also a requirement to periodically condcut these re-evaluations to keep these products on the market to ensure continued safety of these devices. We contribute to patient health and medical innovation by ensuring that the products remain safe and effective.

My role in the company as Founder, CEO & Principal Consultant varies greatly. I wear many hats: I work with our clients to ensure we have effective solutions, manage our team, manage and review our projects, and also jump in to do some of the medical writing myself.

What I am most proud of is that I am very hands-on. I can ensure we are providing the best quality work, ensure that our clients are happy, and also provide the best mentorship available to our team. I am proud of how far we’ve come and I’m proud of the work that we produce. We remain small because it allows us to maintain great quality.

I believe what sets me apart from others is that I am able to always see the big picture and put myself in someone else’s shoes. It’s very easy in our line of work to get pigeon-holed in meticulous details, but I am always one to take a step back and visualize the most efficient, logical path on how to obtain success in our work. Having also worked in the medical device and pharmaceutical industry as a manufacturer, I understand our client’s point of view and experience.

In addition, I am very personable, which helps me connect with our team on a personal level even though we work remotely. As a hardworking mother (I have a toddler and am expecting our second in a couple months!), I am able to multi-task well. It doesn’t deter me from what I have to do each and every day, whether it is at home or at work. If we set our minds to something and with God behind us, we really can achieve anything our hearts desire.

So, what’s next? Any big plans?
Ah, that is a fantastic question. With a two-year old running our house and another baby on the way, my plans for the future are to SURVIVE! Definitely a big change! I know the sleepless nights are coming, business will keep going, and I just have to brace myself for this rollercoaster ride. All jokes aside, I hope and plan to continue running our business well, all while raising our children the best we can. Inspiring others, especially women, is a huge passion of mine. I plan to continue being a part of this motivational movement.

Contact Info:


Image Credit:

Alex Disuvero, Nike

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