Are you in the midst of raising funds for a device that you are trying to bring to market? It can be challenging, and even more so due to the regulatory impact. Jon Speer of Greenlight Guru and Mike Drues of Vascular Sciences share tips to consider when raising funds for your medical device. Put yourself in your investor’s shoes, and be capital efficient - focus on the right things at the right time. Some of the highlights of the show include: ● Putting together a regulatory strategy executive summary and pre-submission; pre-submission costs time and money to prepare, but is cheap insurance to minimize setbacks. ● Demonstrate that you know what you are doing and have the knowledge to run with the punches. ● Level of scrutiny, criticism FDA applies regarding medical devices has changed. ● Types of investors and what they all want: Make money and minimize risk. ● Different regulatory events serve as key milestones for companies to raise funds. ● Fast majority of submissions are rejected by FDA the first time through. ● Some companies are reckless and haven’t performed proven engineering or design controls; sync clinical data requirements with human factor requirements. ● If a company has limited resources, it has to choose what to put money into (prototype, quality management system, etc.) to grow the company.