Developing a successful combination product requires more than selecting a delivery system; it requires the right device strategy, timing, and cross-functional alignment from the start.
In this Spotlight Interview, Ventura Solutions CEO Chuck Ventura sits down with combination product expert David Karvani to discuss key considerations pharma companies must address when integrating a device into their development programs.
From early device engagement to platform selection, quality system readiness, and organizational alignment, this conversation explores the broader strategies required to successfully develop and commercialize combination products.
Key Topics Covered:
- Device Strategy & Timing – When to bring in the device team and why early alignment matters
- Device Development Roadmap – Feasibility, clinical development, and commercial readiness phases
- Delivery System Selection – Evaluating platform vs. bespoke devices and key technical considerations
- Quality System Readiness – Aligning with design controls and 21 CFR Part 4 requirements
- Human Factors & Usability – Importance of early planning and validation timing
- Risks & Common Pitfalls – Delays, technical issues, and downstream rework
- Organizational Alignment – Breaking down silos between pharma and device teams
Whether you’re developing your first combination product or scaling an existing pipeline, understanding how to integrate device strategy effectively can significantly impact timelines, risk, and overall program success.
Explore Our Combination Product Solutions
Ventura Solutions provides end-to-end support for combination product and medical device development, helping organizations navigate regulatory requirements, manage risk, and accelerate commercialization.
Whether you need consulting, engineering support, staffing, or training, our team works with you to develop and sustain your combination products.
👉 Click here to learn more about our integrated combination product services.
Developing a successful combination product requires more than selecting a delivery system; it requires the right device strategy, timing, and cross-functional alignment from the start. In this Spotlight Interview, Ventura Solutions CEO Chuck Ventura sits down with combination product expert David Karvani to discuss key considerations pharma companies must address when integrating a device into their development programs. From early device engagement to platform selection, quality system readiness, and organizational alignment, this conversation explores the broader strategies required to successfully develop and commercialize combination products.
