Roman Zastawny is a Medtech Advisor at ventureLAB with a lifelong passion for understanding how things work, which evolved into a successful career in diagnostic medical device development. His early curiosity led him to earn a Ph.D. in molecular biology and cancer research, where he gained significant experience in the medical device sector. Notable achievements during his career include winning a best-in-class award for product design and contributing to innovations that enhance patient care.
After years in product development, Roman recognized a deeper calling: to support others in navigating the challenging terrain of medical device innovation in Canada. This realization prompted his transition into consulting, focusing on assisting start-ups in bringing novel medical devices to market. As a MedTech Advisor, he works closely with these emerging companies, guiding them through the complex processes of research, design, development, regulatory compliance, and commercialization. His considerable industry knowledge, combined with hands-on experience, equips him to provide vital insights that help start-ups avoid frequent pitfalls and expedite their journeys to success.
One of Roman’s critical roles involves highlighting common mistakes start-ups make in medical device development. He identifies three prevalent errors: the neglect of early user feedback, underestimating regulatory compliance, and lacking a robust risk management process. Many companies overlook the importance of gathering input from end-users and healthcare professionals early on, resulting in products that may not address clinical needs effectively. By prioritizing user feedback, start-ups can refine their designs for better usability and clinical effectiveness.
Additionally, regulatory compliance is often underestimated, which can lead to costly delays and the need for rework. It’s essential for companies to incorporate regulatory considerations into their product development process from the beginning to streamline approval timelines. Lastly, a lack of rigorous risk management can result in products with safety concerns, undermining their success in the market. By implementing comprehensive risk assessment and mitigation strategies, start-ups can enhance the safety and reliability of their devices, ensuring quicker market acceptance and reducing the risk of damaging recalls.
Today, Roman aspires to be a catalyst for innovation in the medical device sector. He aims to serve not only as an inventor but also as a mentor and strategist for budding entrepreneurs. His journey from a curious child to a successful consultant exemplifies the impact of passion for innovation in healthcare. By leveraging his expertise alongside the resources of ventureLAB, Roman seeks to empower the next generation of medical device entrepreneurs, encouraging them to develop solutions that significantly improve patient care globally.
For those interested in learning more about medical device product development or how ventureLAB can support their commercialization efforts, Roman invites them to connect through email at [email protected] or via LinkedIn. Through collaboration and mentorship, he hopes to inspire innovation in the medical device industry and contribute to advancements in healthcare solutions.
This website uses cookies to save your preferences, and track popular pages. Cookies ensure we do not require visitors to register, login, or share any identity information.