Practical Playbook For The Manual Assembly Of Combination Products

By Justin Lacombe, Ph.D., Chief Scientific Officer, Experic

Manual assembly remains a critical yet often overlooked element in the development of combination drug‑device products. While automation ultimately delivers speed and consistency, the early clinical phases demand flexibility, rapid iteration, and cost‑effective production — making expert‑managed manual processes indispensable. This piece explores how thoughtful process design, early stakeholder collaboration, and meticulous quality controls help teams build reliable products long before automation becomes practical. Readers will gain insight into how operators, designers, CDMOs, and innovators can work together to simplify fills, reduce errors, and optimize complex workflows.

The article breaks down essential considerations—from process qualification and in‑process measurement to the strategic decision of when to segment production steps. It also highlights methods for minimizing human error, improving traceability through reconciliation, and conducting meaningful risk analysis under ISO 14971. A practical checklist helps teams evaluate CDMO partners who can deliver the right blend of regulatory rigor, technical capability, and collaborative culture.

For organizations navigating early‑phase combination product development, this overview offers actionable guidance to strengthen quality, enhance operational control, and accelerate progress toward clinical and commercial goals. Access the full blog to explore the complete playbook.