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On behalf of the Advisory Committee on Administrative Burden Testing (ACTAL), Dialogic - in collaboration with the Minase agency - conducted a sector scan examining the obstacles arising from laws and regulations in the development and market introduction of new products and potentially related services in Medical Technology.
Innovations in medical technology make a significant contribution to the quality of healthcare. According to entrepreneurs, however, government procedures and assessments are unnecessarily obstructive. The sector scan aimed to identify all relevant obstacles and solutions, ensuring that entrepreneurs developing medical technology are not hindered by administrative burdens. Administrative burdens refer to all costs incurred by an entrepreneur when complying with laws and regulations (including supervisory costs).
It appears that the procedures from initial development to market introduction of a product are very complex and lack transparency. These obstacles result in entrepreneurs focusing on incremental improvements to existing medical devices, known as me-too innovations.