The Business Case for Technical Training in Medical Device Development

How upstream competence reduces design rework, shortens design cycles, and accelerates product submission approval. A free white paper by Dr. John Salvato, Design Quality Services. No signup needed to read it. Download the PDF​

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    Economics of design rework

    Rework consumes an estimated 40 to 50% of development dollars, and 70 to 85% of it traces back to requirements and specification errors. Errors introduced early are expensive to find late but inexpensive to prevent.

    Submission multiplier

    Roughly two-thirds of first-cycle FDA submissions are stopped by Additional Information requests. The 510(k) review goal is 90 days, but clearance typically takes 140 to 175 calendar days.

    Financial return

    A 20-person technical team returns about $210,000 per year in reduced rework alone, an estimated four-month payback. Including faster regulatory approval, the annual return approaches $1.4 million against a training investment near $75,000.