Regulatory is a big deal for medical device companies. Whether it’s a startup or established business, a strong understanding of regulations and regulatory strategy is vital for product success in the marketplace. Today’s guest is Isabella Schmitt, regulatory affairs consultant at Proxima Clinical Research where she specializes in quality and regulatory business advice. Isabella shares how medical device companies can establish a solid foundation for fundraising and product success through a heightened regulatory focus. Some of the highlights of the show include: - Lack of Focus: When a medical device company starts with technology rather than solving a problem, it makes accelerators, investors, and others nervous. - Minimum Viable Product (MVP): What are you targeting and when to stop developing product? Break the habit of perpetually perfecting something. - Don’t forget your mission. Obtain feedback and be receptive to it. Different opinions, along with expertise and knowledge, help you make a judgement call. - Design Controls: Be clear on what needs to be done and justify changes made. - Regulatory Approval: Determine minor and major milestones that need to be achieved before reaching the finish line to increase company and product value. - 1/10/100 Rule: How much will an issue cost, if caught early on or later in the validation and verification process of designing a medical device? - What can you do to prevent and identify unexpected twists and turns, sooner than later? MVP, iteration, feedback, and tests. - Platform Technology and Pipeline of Tests: Marketability justifies classification of a medical device, appropriate regulatory pathway, and reimbursement strategy.