Every technology and product sold in the US and any of the major markets around the world requires regulatory clearance by the respective government agency. The regulatory requirements are constantly changing and becoming more complex. With decades of experience working both on the sponsor side and for the FDA (at different time periods), we understand how to navigate this environment. We also understand the implications of the regulatory requirements on product design, marketing plans, reimbursement, competitiveness and market acceptance.
Understanding the intricacies of such issues and developing appropriate plans can spell the difference between success and failure for projects and investments. Selecting less than optimal strategy can be prohibitively expensive, extend time-to-market and slow down sales for otherwise, promising products.
Boston MedTech Advisors can assist medical technology companies, inventors and investors in addressing these critical issues by: