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
Working in a Regulated Market
One of the biggest problems facing medical device companies is accounting for the cost of getting FDA approval. Once we complete our initial consultation and determine your likely regulatory paths we will calculate the costs, both in capital and product deployment time, that you will most likely incur. Depending on your classification, submitting a 510(k) application can be very costly and involves numerous factors. We can outline differing approaches to your marketing and business strategy that can minimize your costs while still meeting FDA expectations by shifting your classification which will subsequently decrease your requirements as a medical device. Being able to account for the delay in product deployment because of the approval time will also allow you to plan accordingly and not be side-lined waiting on the FDA
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.