Leading in the Combination Product Space: Insights for Improving Internal Development and Management

STUDY OVERVIEW

KEY TOPICS

• Combination product development timeline
• Development phases and decision points
• Partner management
• Demo device management
• Feedback for continuous improvement
• IP protection

KEY METRICS

• How long does your entire combination product development process typically last, beginning with demonstrated feasibility and ending with launch into the market?
• What development phases do you use in developing new combination products from inception through launch - and approximately how long does each phase typically last?
• As a pharma/biotech drug maker, how do you manage the development of delivery devices in conjunction with development of your own drug substance and drug product?
• Who in your organization is responsible for managing the supply chain process for each kind of supplier?
• Which groups tend to be responsible for the initial development of demo devices for your combination product – and who tends to be responsible for ensuring up-to-date versions are rolled out to the field?
• How valuable are each of the listed sources for obtaining feedback for drug delivery device improvements?

SAMPLE KEY FINDINGS

• Companies spend an average of 5 years between demonstrated feasibility and launch: According to respondents, the combination product development cycle - starting with demonstrated feasibility and ending with market entry - can take between 2-10 years, depending on the product. The average development life cycle time is nearly 5 years.

METHODOLOGY

Best Practices, LLC engaged 17 executives with deep expertise in the development and launch of combination products at 14 leading pharmaceutical, biotechnology and other healthcare companies through a benchmarking survey.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.