MAE Group is the capstone between the inventor and investor. We offer a full bespoke suite of commercialization services to early-stage companies. Our teams will efficiently get you through the commercial process, maximize the inventor’s exit strategy, and de-risk the investor’s funding exposure. We bring medical device and in vitro diagnostic device technology to global markets, allowing the inventor to focus on science and technology and the investor on portfolio management and ROI.
Starting up a business is complex. Here are some real statistics that are not for the faint of heart.
- The average cost to bring a medical device to US market through the 510(k) pathway is $31 million, the PMA pathway is $94 million.
- 60%-75% early-stage medtech companies fail with 75%-80% attributed to the lack of knowledge in the commercialization process to market
In other words it’s not the technology, it’s the managerial experience.
MAE Group is here to assist you. Our focused, professional team provides comprehensive commercialization expertise to navigate your project from early development through final approval. MAE Group provides all the proficiency you’ll need.
Perhaps you’re still getting your operations off the ground. Our team is here for you. No other service provider has the expertise and strategic alliances that allow you to realize the full potential of your product, business and successful product launch in your target market.
Trust MAE Group to handle key functions of your organization. We want you to realize your company’s full potential. If your company isn’t yet fully staffed or you lack critical infrastructure to advance, MAE Group’s team becomes part of your team. Our focused, professional team provide comprehensive expertise and partnership.
MAE Group specializes in global regulatory affairs, quality systems, and project management. We offer unparalleled industry expertise. Team members have all of the needed experience and expertise to bring products to global markets. MAE Group offers target services and expertise that translate into an efficient and economical fast-track to global markets.
MAE Group’s thoughtful approach and expertise has enhanced our product development efforts and has given us confidence in our ability to deliver high quality products. The team’s responsiveness and ability to accommodate new challenges and questions is impressive.Sona Shah, CEO & CO-Founder Neopenda