Medical devices are unlike most mass-produced products, such as auto parts, razors, pens or spray pumps. Blood filters, catheters, diagnostic probes, syringes, ventilator tubes and other disposable items need to meet strict criteria set by the Food and Drug Administration. Many products must undergo an intense premarket approval and validation process to ensure that they will not harm patients.

Medical device manufacturers have the same quality concerns as manufacturers in other industries, but they also face a much greater risk of lawsuits. "The potential liability associated with product failure is enormous," says Howard Speiden, senior applications engineering specialist at systems integrator ATS Automation. "And a product recall generated by a failure in the field is extremely costly."