Managing Costs And Scale-Up Risks For Medical Devices

By Dave Seaward, founder and engineering director, 3P Innovation

Bridging the gap between low-volume clinical supply and high-volume commercial manufacturing is a major hurdle. How can you ensure the process used for early trials reliably scales? The answer lies in using scalable process prototyping techniques early on.

Instrumented manual assembly fixtures and semi-automatic systems, often using pucks, allow you to produce initial clinical samples using processes that directly replicate the intended commercial methods, albeit at lower speeds.

This approach provides cost-effective clinical supply while simultaneously validating the manufacturing process and eliminating scale-up risks. You gain crucial process understanding and robustness data (like Six Sigma capability) early, enabling smooth transitions and avoiding costly surprises during commercialization.

Download the full article for strategies on achieving seamless manufacturing scale-up.