The U.S. market for medical devices is huge – currently more than $100 billion per year. However, the old model for early stage development is broken. The traditional new product pipeline for the big multinational device companies, has been cash burning, VC backed startups. This source for innovation has largely dried up due to uncertainly in global capital markets. FocusStart is seeking to reinvent the early stage development process and business model. The model focuses on 3 key processes: evaluation, capital-efficient accelerated development and early exit. Capital-efficient and accelerated development is possible by leveraging existing infrastructures, processes, quality systems, networks and resources of outside partners (versus having to recreate those). Lastly, the ultimate goal after development is to seek an exit of the developed product. This is accomplished via strategic sale, licensing or formal spinout as operating company. FocusStart is currently developing several innovative technologies. FocusStart’s culture is one of valuing collaboration and teamwork, with the clear goal to drive innovation at the technology as well as at the business level. FocusStart’s innovative business model has been recognized by Life Science Alley (2014 New Company of the Year Award), but also by many industry experts, financial institutions, and multinational device companies.