Hello,
General consequences of insufficient design controls:
• Design not meeting the needs or wants of the intended market/customer
• Faulty product in the market requiring replacements
• Product having a negative ROI
• Product success = company reputation; potentially harm the company’s identity
• Product providing misunderstanding/analysis of medical information
• Design injuring or killing the patient
• Product being having field corrective actions, recalls, lawsuits
An example I found online is where an insufficient design input led to the FDA issuing an industry-wise recall of glucose meters. Glucose meters allowed users to choose between units of measure (UOM: mmol/L or mg/mL) during setup of the glucose meter. This design input allowed the meter to be marketed to both US and Europe, decreasing production cost of having multiple configurations of the same product. This design input also accommodated users who traveled frequently. The difference between the two units of measure is by a factor of 18, which if mistaken could lead to patients incorrectly interpreting the shown blood glucose readings and taking incorrect insulin dosages. Insufficient design controls for blood glucose meters could result in patients suffering from hyperglycemia, hypoglycemia, diabetic coma, or death. This use error resulted in the FDA requiring all manufacturers to remove the capability of changing the UOM.