5 Questions with Stephen Tyrpak, Associate VP of Medical Device Operations & Associate Partner at PQE Group

“5 Questions With…” is a recurring BioBuzz series where we reach out to interesting people to share a little about themselves, their work, and maybe something completely unrelated. This week we welcome Stephen Tyrpak, Associate VP of Medical Device Operations; US and Canada at PQE Group.

Stephen Tyrpak is a healthcare executive and commercialization expert with over 14 years experience working with medical devices, pharmaceuticals and combination products. He has worked with companies from 5 to 5,000+ employees and has focused many of his efforts in supporting startup companies. He works for the PQE Group, a global consulting firm with 25 years of success, with more than 2,000 employees located in 32 offices around the globe.

He has spent years learning and helping companies develop strategies not only to achieve market notification in the US but also post-market reimbursement, out of U.S regulatory approval and breakthrough device designation. He has also aided nine startup companies in raising over $90 million in commercial seed funding and over $10 million in state and federal grants. He is recognized as a commercialization expert and an invited speaker and panel expert in the areas of regulatory, reimbursement, startup business strategy and young professional business training. He is a peer reviewed published author, keynote speaker and sits on the board of directors for the University at Buffalo’s Industrial Advisory Board as well as the Mental Health Advocates of Western New York (WNY). He was one of WNY’s 30 under 30 in 2021.

1) Please introduce yourself to our audience by looking back at your education, training, and career path.

My education background is in Biochemistry and I started my career working in pharmaceuticals. I enjoyed pharmaceuticals (and still do) but once I started working in medical devices, I knew that was my passion. There are certain areas of pharmaceuticals I still focus on because I enjoy them and they are areas I have spent many years learning and mastering – areas such as Manual Visual Inspection, and clinical trial design. I also enjoy representing clients from around the globe as their US Agent.

The first half of my career was mainly working with large pharma and medical device companies; eventually I started focusing on startups and universities. I really like supporting new entrepreneurs because they are typically the most passionate and have often given up full time jobs and risked everything to bring an idea to market. Their passion drives me to want to find the most efficient, fastest, and, frequently, cheapest path to market.

My work with startups has included supporting regulatory, quality, reimbursement, business strategy and fundraising initiatives. I have been able to raise more than $90 million dollars in the last few years for these startups, and I am hoping that number will grow in the comings months. I joined PQE group last year and have been able to support clients all over the world and work with an amazing team of professionals that allow me the continue to learn and grow in this industry.

2) Can you share more about your specific role at PQE Group? What are your main goals in this role, and what’s your favorite part about your job?

At PQE Group my primary function is to support clients here in the US and around the world with their FDA needs. I focus on understanding the client’s needs and building a strategic plan and team to support them. I manage resources from around the globe and also work on projects when my expertise is needed.

Most recently, I have been given the opportunity to grow my position to include building a business unit around startups and universities. This is a passion of mine and I am excited by the opportunity to provide the global reach of PQE to startups and universities at a more customizable business model that fits their ever-changing needs and budget. I have also been encouraged to present seminars and webinars to help educate these companies and universities on how to translate Academic Progress into Industry Success. This was only made possible because our CEO, Gilda D’Incerti, has recognized my skills and experience can help me successfully achieve these activities and my interest and passion in them can only help to support these startups and universities with their success as well.

3) Can you tell us more about why companies should consider partnering with PQE Group and what type of services you offer to your clients?

Having worked in America for all of my career, I can truly say PQE is one of a kind. We work with Medical Devices, Pharmaceuticals, Biologics and Medical Cannabis and support the areas of Regulatory Affairs, Quality and Compliance, Audit Readiness, Lab Excellence, Data Integrity, CSV, Cybersecurity, CQ and more. Our team now numbers more than 2,000 employees in 32 offices located around the world, and we have experience in most regulated markets. We focus on a “Glocal” approach. Glocal references our local support with a global mindset that leads to global success. I am fortunate enough to be able to work with colleagues in EU, Israel, Japan and other countries to work with clients who need support in some or all of those markets.

4) Consulting is becoming a popular career path, particularly for scientists and medical professionals. What, in your opinion, are the top skills needed to be successful in a life science-focused consulting role?

Growing up, I never thought I would want to be a consultant. I have been doing it for over 7 years now and I do not think I could ever go back to a “normal” job. Consulting is for people who thrive on challenging situations and problem-solving. It is for people who have accepted that they will never stop learning. It is our job, as a consultant, to always stay on top of changing regulations and trends and we have to learn how to use our experience to work more efficiently. It is important to stop “reinventing the wheel” and to learn how to use previous projects to help with future ones. To be a successful consultant, in my opinion, you have to humble yourself to the fact that you can never know everything — some projects will push you out of your comfort zone. Those projects though are the ones I enjoy the most because I learn the most from them.

5) Now for the fun question – what is the best piece of advice that you’ve ever been given?

I have been fortunate enough to have amazing mentors that have helped get me to where I am today. Probably the most influential advisor would have to be my former boss, Brian. He believed in me more than I believed in myself most days. He was able to show me my potential and when everyone else in my life was saying that decisions I was making were crazy and would never get me anywhere, he reminded me that none of that mattered. I had a vision for where I wanted to be and he never let anything get in the way of that. I hope everyone has a Brian in their life who can push them to see their potential.