This technical presentation debunks the myths and theories around design limitations of miniaturized devices. Perceived biases exist during design and CAD modelling that place limits on geometry, size, and feature size regarding high-volume medical and drug delivery miniaturized device designs such as:

• High speed automated assemblies of 5-10 micron-positional accuracy
• Biomimicry surface finishes that defines how and where fluid is attracted or repelled
• 50:1 and higher aspect ratios
• 002” (50 µm) wall thicknesses of both injection-molded and 3d printed parts
• An injection molded part down to a fraction of a plastic pellet in size
• 5-micron radii on needle, anchor, cannula, or sheath
• 002” (50 µm) injection molded holes in a filter-like pattern

The outputs to high volume, miniaturized device designs are:

1. Significant company value and intellectual property
2. Platform products
3. Individual, industry, and inter-company innovative product honors of both scientific and commercial prominence

With these rewards come risks and challenges that are rarely extrapolated by previous learnings of conventional or macro methods of manufacturing. This technical presentation explores high volume proven processes of scaling multi-cavity tooling to multiple component assemblies, reducing to practice the basic principles of miniaturized device success backed up with empirical and scientifically analyzed data. An understanding of component and automated assembly stack-up tolerances for each component is a baseline of success but not enough. Each component must be scrutinized and “process mapped on steroids” to prevent late and very costly development and clinical trial failures.