FDA Regulatory Coaching
Our comprehensive analysis begins with a consultation meeting to review your application’s benefits, your target market, business and marketing strategy and language, and your development process. We will then look to current, pending, proposed, and rumored regulations to determine if and/or when your product will fall under FDA jurisdiction. We will provide detailed definitions and background to help you to better understand why your product falls within a specific category and class. Most importantly we will inform you of your obligations as a medical device including registration and reporting requirements as well as what the 510(k) process entails. Since many medical devices can fall under differing regulations, we will also inform you of changes you can make, both short and long term, to limit your regulatory burden. All of these tools can be the propelling force that allows you to separate your product from the competition
Because we are a start-up ourselves, we understand the need for early legal help during the initial stages of a company's formation. As an extension of corporate legal and regulatory departments we often provide advice and assistance on matters outside of FDA regulation and more tailored to common legal issues facing start-up healthcare companies. Because an in-house counsel is sometimes an expensive initial expenditure we can provide outsourced advice on a range of issues both healthcare focused and business focused. On the healthcare front we offer HIPAA and privacy law analysis, anti-kickback and Stark law interpretation, BAA agreements, and Medicare and Medicaid reimbursement overviews. On the business side our additional offerings include contract creation, review, and interpretation, partnership and client negotiations, and corporate governance review. We also provide employment contract review and stock options and vesting plan creation as well. Having a legal counsel in the early stages of development can help ensure compliance with the relevant laws and save you time and money in the future.
Helping with Additional Product Strategies
Our background includes more than 20 years of combined health information technology, digital health, and mobile health experience. Our advisors have education and practical experience in a number of fields including marketing, finance, economics, and law. We leverage our knowledge to provide additional product strategies on top of our regulatory coaching. We can help you and your company with domestic and international market research, customer acquisition and retention, appropriate pricing strategies, product development and functionality, branding, and go-to-market strategies. We also have cultivated an extensive network of strategic partners to better help our clients with any issue that may lie outside of our areas of expertise. We provide only the highest quality advice and pride ourselves on offering the best solutions while incorporating any end-goals that you and your company might have. Using us will definitely help you learn, prepare, and succeed in this thriving market.