My name is Roman Zastawny and I am a Medtech Advisor at ventureLAB. From an early age, I was always intrigued by how things worked. Whether I was taking apart household electronics or sketching ideas for new inventions, my passion for understanding and creating was evident. This curiosity ultimately led me to a career in diagnostic medical device development, where I combined my natural curiosity and technical expertise to make a meaningful impact on healthcare.
After earning my Ph.D. in molecular biology and cancer research, I established myself in the medical device industry. I had a keen focus on designing and building unique products that were not only innovative but also practical and easy to use, with one product winning a best-in class award. Working at the executive level with talented product development teams throughout my career, I was able to contribute to ground-breaking advancements in patient care, improving both clinical outcomes and user experience.
However, beyond my own success in product development, I realized my true passion lay in helping others navigate the complex landscape of medical device innovation here in Canada. This realization led me to transition into consulting, where I now dedicate my time and expertise to assisting Canadian start-up companies in bringing novel medical devices to market.
As a consultant and ventureLAB MedTech Advisor, I work closely with emerging companies, guiding them through the intricate processes of research, design, development, regulatory landscape, and commercialization. My deep understanding of the industry, combined with my hands-on experience in medical device development, allows me to offer invaluable insights that help start-ups avoid common pitfalls and accelerate their path to success. I am committed to fostering innovation, ensuring that new medical technologies meet the highest standards of safety, efficacy, and usability.
One of the key aspects of my work is helping start-ups avoid critical mistakes in medical device development. Mistakes made earlier on can have dire consequences as products get closer to commercialization. Here are the top three most common mistakes I see being made by start-up companies. First, many companies neglect early user feedback, resulting in products that do not fully meet clinical or patient needs. By engaging end-users and healthcare professionals from the outset, start-ups can refine their designs for better usability and effectiveness.
Second, regulatory compliance is often underestimated, leading to costly delays and rework. Companies need to integrate regulatory considerations into their product development process from the beginning thereby streamlining approval timelines. Third, a lack of robust risk management process in the product development lifecycle can result in products with safety concerns that hinder market success. By implementing comprehensive risk assessment and mitigation strategies, start-ups can develop safer and more reliable medical devices that gain faster market acceptance and avoid possible product recalls which could severely impact a company’s reputation.
Today, I strive to be a driving force in the medical device sector, not only as an inventor but as a mentor and strategist. I hope my journey - from an inquisitive child fascinated by mechanics to a respected executive and consultant—serves as an inspiration for those looking to turn their passion for innovation into tangible contributions to healthcare. By leveraging my expertise and that of ventureLAB I hope we can empower the next generation of medical device entrepreneurs to develop life-changing solutions that enhance patient care worldwide.
If you interested in knowing more about the ins and outs about medical device product development or how ventureLAB can help you commercialize your product idea, email me at rzastawny@venturelab.ca or connect with me on LinkedIn.
