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In the highly competitive and complex healthcare marketplace, effective timely launch of new combination products can provide strategic advantage to organizations in better meeting patient needs and driving overall growth.
However, complexities of the product development cycle and stringent regulatory requirements have made it challenging for organizations to successfully develop and launch new combination products. Consequently, organizations need to adopt an effective approach toward external engagement and internal development and management to address these key challenges.
Best Practices, LLC undertook this benchmarking research to help pharmaceutical, biotechnology and other healthcare companies improve the way they develop, manage and commercialize new combination products. In particular, this report will inform product and leadership teams about key external engagement approaches, development phases and decision points, timing, staffing and investment, partner management, and IP protection needed to successfully develop and launch combination product assets.
Kindly note that “external engagement” in this report refers to the activities and collaborations undertaken to help shape future combination-product standards and regulations. Examples include peer-to-peer interactions with other firms, attendance at industry events, and active membership on standing ISO committees for combination products.