Bringing an in vitro diagnostic (IVD) to market requires strong clinical, regulatory, and reimbursement strategy. Misalignment in any area can delay market access, limit adoption, or diminish long term value. As the IVD industry becomes more diversified, competitive, and global, proactive coordination across disciplines is a prerequisite for competitive market entry. By aligning regulatory strategy, clinical evidence generation, and reimbursement planning early in the development process, IVD developers can build both the data and strategies for global commercial success.

Authored by David Kowalski, Michelle Bulliard, Eric Kong and Nicole Fitzpatrick, this insight brief includes expert IVD insights and case studies that illustrate how proactive planning and an integrated approach to evidence generation can expedite timelines and lower costs.