For a new medical device company, we defined and executed both Regulatory and Marketing Strategies. We clarified US and European regulatory requirements and timelines and established the company’s Quality Management System, including numerous processes and procedures to ensure adherence to current Good Manufacturing Practices. We led Market Research efforts to ensure the device met target clinicians’ usability expectations and confirmed Medicare reimbursement amounts so target customers could understand potential profitability for their practices. Working with the CEO and internal engineers, we determined a viable product pipeline, set reasonable financial metrics and created pro-forma volume and revenue models. We developed marketing and sales materials for print, web and social media, established partnerships with independent sales reps and promoted the device at international conventions and trade shows.
