Designing safe, effective, and differentiated combination products

Early definition:

establishing your device strategy

Identifying unmet needs

Understanding the patient journey

Developing roadmaps for device and beyond

Advanced Development:

optimizing the technologies that drive innovation

Developing new core technologies

Leveraging existing technologies into new applications

New product development:

under design controls through transfer to commercial manufacturing

Optimizing design for manufacturing

Quick and efficient commercial scale up and life cycle management

Related Articles

User needs and the patient journey – Utilizing global ethnographic research to better understand users and inform more appropriate device development

Transformative Innovation in Drug Delivery via the Patient Journey

How Needs Characterization Can Fuel Patient Engagement

Successfully Developing Combination Products – Key factors to consider when developing your device strategy

Combination Product Success Drivers

Human factors engineering – Supporting key regulatory factors while designing for optimal user experiences

The Value of a Sound Human Factors Plan

How to Characterize and Prioritize User Needs for Effective CombinationProducts and Delivery Systems Innovation

Advanced R&D – Characterizing, innovating, and implementing novel injection platforms that can be scaled to multiple applications

Pushing Combination Product Risk Upstream to Accelerate Time to Market


Learn more about our work in Pharmaceutical Delivery Devices.