Date

6-19-2024

Department

Graduate School of Business

Degree

Doctor of Business Administration (DBA)

Chair

Jonathan Wilson

Keywords

medical device, regualtory strategy, strategic planning, FDA, market access

Disciplines

Business

Abstract

In the evolving medical device industry, understanding how to achieve effective regulatory strategies is crucial. This study explored the foundations of regulatory strategy success in the United States, using qualitative insights from regulatory affairs professionals and industry investors. It identified operational, leadership, product design, and external factors essential for developing and implementing successful regulatory strategies. Key findings highlighted the importance of financial planning, agile regualtory process management, strategic knowledge integration, and proactive engagement with regulatory authorities. The study also pointed to the role of business ecosystems in supporting regulatory outcomes, suggesting a strategic planning approach that aligns product design with quality and business goals. This research contributed to the academic and practical discussion on regulatory strategy in the medical device sector, providing insights for stakeholders from entrepreneurs to investors. It shed light on the complexity of regulatory pathways in the United States and its influence on market access, encouraging further research on the impact of technological advancements and global regulatory changes on strategy effectiveness.

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Business Commons

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