• Saideep Nakka
• Prof.(Dr.) Arpit Jain

Cross-functional collaboration in medical device development is emerging as a pivotal strategy for driving innovation and ensuring regulatory compliance in a complex healthcare environment. This paper explores how integrating diverse expertise—spanning engineering, clinical practice, regulatory affairs, and quality management—within a systems engineering framework enhances the development process. By leveraging structured methodologies, teams can identify interdependencies among subsystems early, mitigate risks, and streamline design iterations. The systems engineering approach emphasizes a holistic view of product development, ensuring that each component aligns with overall system performance and patient safety objectives. Furthermore, cross-functional collaboration fosters a culture of continuous improvement, where feedback loops between departments facilitate rapid problem resolution and process optimization. The research highlights key success factors such as clear communication channels, shared goals, and leadership support that drive effective teamwork. It also examines challenges, including conflicting priorities and communication barriers, and proposes strategies to overcome these obstacles. By integrating systems engineering principles with collaborative practices, organizations can better navigate the regulatory landscape and address technical complexities inherent in medical device development. This comprehensive approach not only accelerates time-to-market but also improves product quality and reliability. Ultimately, the paper demonstrates that embracing a collaborative systems engineering framework is essential for fostering innovation, ensuring compliance, and achieving competitive advantage in the rapidly evolving medical device industry.

Cross-functional collaboration, medical device development, systems engineering, regulatory compliance, innovation, quality management, interdisciplinary teamwork

"Cross-Functional Collaboration in Medical Device Development: A Systems Engineering Approach", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 2, page no.h860-h869, February-2025, Available :http://www.jetir.org/papers/JETIR2502793.pdf

"Cross-Functional Collaboration in Medical Device Development: A Systems Engineering Approach", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 2, page no. pph860-h869, February-2025, Available at : http://www.jetir.org/papers/JETIR2502793.pdf