How do you succeed in business without really trying? It’s a myth. According to Tracey Wielinski, the key to success in business is finding the perfect balance between work and life. As Insulet Corporation’s Vice President of Global Regulatory/Clinical Affairs and Quality Assurance, she has a lot of valuable experience dealing with the medical device production industry, as well as the regulatory agencies associated with it. The Daily Free Press spoke to Wielinski about her experiences in her field and the role gender plays in her career.
The Daily Free Press: At Insulet, you serve as Vice President of Global Regulatory/Clinical Affairs and Quality Assurance. What does that entail?
Tracey Wielinski: I work for a medical device company, and my job has three parts: ensuring that we have the appropriate legal documentation so that we can market out product, making sure that we’ve designed and developed the products so that they are safe and effective, so that we can obtain marketing approval and then when we’re manufacturing the product, making sure that it has been made according to all of our standards and the global standards.
FreeP: What is the role of agencies like the U.S. Food and Drug Administration in your field, and how do you work with them?
TW: The role of the FDA, in my industry, is to ensure that products are safe and effective for use by the general population. That’s basically how they spend their time, making sure that industry companies like ours are following the rules that need to be followed. Then, how do I work with them? It’s different in different settings. We work with them face-to-face with meetings. We work with them in collaborating to ensure that the requirements that are expected of our products are being met. And then also, we have industry meetings in which we, together with other members of the industry, collaborate on standards and guidelines that the FDA would like to see in place. It’s multiple-pronged, and it’s certainly meant to be a collaborative effort.
FreeP: Consumer technology is changing at a very rapid pace, and we are seeing more and more healthcare-related apps available for consumers. How does this impact the regulatory process and the pace of adoption in the healthcare industry?
TW: This is something that’s really quite new in our industry. Both the industry and the FDA are trying to understand all of the implications. The industry, of course, is always trying to find innovative ways to get the product to the market, and the agency is always trying to ensure that products are safe and effective. So that’s where the collaboration comes in — in trying to understand how far industry can push an idea forward and still work within the FDA’s framework. We spend a lot of time talking with the agency and understanding where their comfort point is, and then looking at it from our company’s perspective and how best to put those products on the market while meeting everybody’s needs.
FreeP: You ran your own consulting company before joining Insulet. What made you want to return to an industry position at a company like Insulet?
TW: I actually did it solely for personal reasons. My daughter was starting high school when I joined Insulet, and having your own consulting company means you travel an awful lot. I wanted to be closer to her in Boston, so that I wouldn’t have to travel as much. Interestingly enough, I probably travel more for my current job. It didn’t quite work out the way that I thought it would with the traveling, but the idea was that I’d be home more.
FreeP: What do you do in your free time?
TW: Believe it or not, as much as I travel for work, I love to travel. That really is one of the bonuses of my job. I also love to cook, I’m a pretty good baker and I used to ride dressage, which is an equestrian discipline. And of course, my family. It’s really fun to have a daughter who is almost 17 and to get to do all the good stuff with her. Then the other thing that I do is this mentoring. I work with this group in Boston called Conexión. So that’s pretty much how I spend my time.
FreeP: As a female in business, what are some things that you have to be aware of?
TW: You know, it’s still not quite a level playing field. It seems as though you have to either work harder or smarter than some of the men in the field. I think for women, it’s really important that we network more and better and make sure that we have as much knowledge at our fingertips as we possibly can. It’s unfortunately still a bit of a male’s world, so the nice thing about regulatory and what I do is that there are a lot of women in the field. And there are even a lot of women in executive positions. So it’s a great field to be in as a woman, and it’s a really great launching pad for if you want to go run your own company or be the CEO of another company. It gives you a lot of great experiences.
FreeP: What advice would you give to young women who aspire to work in the business field?
TW: I’d say to work really hard and make sure that you’re making good decisions about what you want to be. When I was in college, my degree wasn’t really what I ended up doing. So I think it’s really important to not limit yourself. Just because your degree says biology or journalism, it doesn’t really mean that you can’t go off and do something totally different. Just always have confidence in yourself, and don’t ever let somebody tell you no.
FreeP: What kind of challenges do you face as an entrepreneur?
TW: I think just balancing everything. As you get to be older in your life, you’ve got a family and you’ve got a career and you want to have some personal time. Trying to balance all of that and trying to not feel guilty that you’re leaving one piece with, maybe, less attention than another piece is hard. What I tell all of my mentees is to not ever feel guilty about all the decisions you’re making because it’s only one point in time and all of those experiences are going to help you build onto something else. Everything is happening for a reason, and you just need to keep going and not feel bad about the decisions you’re making.
