The rapid shift to value-based healthcare (VBHC) is reshaping markets for medical and diagnostic devices in several important ways. This article examines some of the major factors that influence how different stakeholders define value. It then describes a model for mapping stakeholder value that can help drive profitable device development programs in increasingly value-driven markets.
Learn how a hybrid medical chart review (MCR) combined cross-sectional study (CSS) can be an advantageous study design for real-world evidence (RWE) generation and how gaining a better understanding of the implementation of these designs can allow for better future planning, as well as to guide the development of the next generation of real-world studies.
Biosimilars are generally expected to offer a competitive price advantage to appeal to healthcare organizations and payers, which makes them an attractive business opportunity. This article provides an introduction into key regulatory and development concerns for sponsors, including a discussion of the factors that affect biosimilar uptake for the United States and Europe and recommendations to address these issues.
Device sponsors and developers need to generate compelling evidence not only of clinical safety and efficacy of their products, but also of their positive effects on community health and overall healthcare costs. Understand the challenges value-based care will present, along with success strategies for transforming them into opportunities for innovation and increased market share.
Now, more than ever, sponsors must understand the role real-world evidence (RWE) can play in developing a product’s value story across the development continuum. This webinar discusses how RWE is playing a larger role across the entire product life cycle, with a focus on late-phase regulatory discussions and payer decision making.