As a well-known opinion, regulatory compliance of medical device is harder to achieve or even fundamentally incompatible with the nature of artificial intelligence if expecting it to a build-and-freeze model. Such a bureaucratic nightmare can often cost two years and seven figures of money, not so affordable normally to any of new start-ups.
In Scandicode Oy (Ltd.), a solution for the challenge has been tried by applying its limited resource and growing on this pathway cost-efficiently via MVP (Minimum Viable Product) model shown as above picture from Business Model Toolbox. Due to the scarcities of time, money, and other options, lean start-up has to be an alternative approach to utilise and succeed almost as a must in daily execution. For regulatory compliance of medical device, relevant work is very close now to finalize MVP for its sales in EU legally – to be the simplest / cheapest product of elderly cognitive assessment as a digital tool – before the end of this year available soon to Finnish healthcare sector!
Learnt a lot from its clinical evaluation and CE mark process, Scandicode Oy (Ltd.) is continuing R&D further for an AI-enabled solution to fight or repair age-related problems as its new innovation. Business breakthrough beyond current assessment as an interface is aimed to healthcare or eldercare sectors, as well as the seniors’ wellness, creating win-win value together to solve their challenges as the key in Scandicode Oy (Ltd.) business. With company’s excellent execution ability, AI is thus determined and developed to markets and end-users undoubtedly safe, effective, and fit for intended use.