About Us
Boots-on-the-ground Experience
- Broad experience developing medical devices, spanning from concept phase through market release
- Project Leadership of a class III PMA medical device system
- Classic project management (scope, schedule, budget) of complex medical device projects
- Regulatory and Clinical strategy development, including experience leading pre-sub meetings with the FDA and Health Canada, as well as experience creating an MDD Technical File and working with notified bodies
- R&D and design transfer of optical biopsy devices, intravenous catheters, spine surgery devices, in vitro diagnostic machines (CLIA)
Philosophies
Being comfortable with ambiguity is critical to successfully navigating the twists and turns of medical device development. From technical feasibility to working with regulatory bodies to obtain clearances, the right perspective can make or break a project.
By using empathy and embedding ourselves into the use-cases, our team flips challenges into opportunities after better understanding and defining the problem. We prepare for serendipity while de-risking the project.
Nick Romcevich - CEO/Founder
Educated in “design thinking” at Stanford, Nick is an innovator with a unique business background. Working for medical device start-ups and launching a cold brew coffee company, Nick has honed his executive, managerial and strategic thinking skills.
Nick has led several projects to market in the medical device industry by driving cross-functional teams of engineers, industrial designers, regulatory specialists, clinical representatives, vendors and subcontractors. Additionally, Nick has a good sense of the business case for projects, due to his experience starting and running a small business.
Nick also believes in self-improvement, taking on challenges and experiencing as much as life has to offer. That is why he has completed three academic degrees, finished two IRONMAN® Triathlons and traveled to all seven continents.