New medications, devices and other medical advancements often begin with a scientist focusing on a specific target, such as a molecule or a mechanism that plays a critical role in a particular disease.
The scientist then builds a team with expertise in that molecule or mechanism. For a medicine, this may mean assembling a team of chemists, pharmacologists and biologists to screen thousands of chemical or genetically engineered compounds to test how they may affect the targeted molecule. For a device, this may mean the inventor works with a team of physicians, engineers, designers and material scientists to conceptualize and design a device to alter or treat the disease mechanism.
Questions are also raised at the early stage of conception, such as:Does the innovation pose any initial safety threats to the patient and, if so, how can those threats be minimized?
Is the new medication or device likely to be more effective than existing therapies?
How can it be effectively delivered (injection, inhaler, pill, etc.) or implanted?
Can it be mass produced with the highest quality?
These questions guide the design phase of a new medical product. From there, the innovative medicine or device must be created and tested before the manufacturer seeks approval from the U.S. Food and Drug Administration (FDA).