Designers of medical devices have many more issues to consider than developers of other types of safety equipment. Medical devices are complex. In addition to various types of users (possibly including the patient), medical devices have complex communication requirements, including safeguarding confidential patient data. Medical devices must achieve their therapeutic goals while minimizing risks to patients and those who interact with the devices.
More in-depth safety considerations are required since these devices monitor or treat the health of patients; therefore, any issues can directly impact a person’s safety.
For example, device graphics that care providers need are complex, so governments have built regulatory infrastructures (such as the U.S. Food and Drug Administration) to review and approve devices before they are marketed and used for their intended purposes.
