By: Andrés J. Calderón, Ph.D.
In the development of medical and scientific equipment, Biomedical Engineers combine engineering principles to design, invent, and create medical or scientific equipment, devices, computer systems, and software to aid medical professionals. These devices include vascular and orthopedic implants, machines to diagnose medical problems, dental chairs, surgical instruments, etc. Biomedical Engineers provide safety efficacy for such equipment or instruments and are experts in understanding how these machines work and operate. Therefore, Biomedical Engineers have expertise and knowledge in understanding medical products and devices. For example, Biomedical Engineers can analyze and design software to run medical equipment, as well as design rehabilitation exercise equipment. Biomedical Engineers have the knowledge to assure devices are safe for their intended use, as well as for the patient those devices serve.
As engineers, Biomedical Engineers design devices with specific safety parameters and are familiar with the FDA Medical Device Regulations. Medical Devices are regulated by the FDA and there are different classifications for medical devices. These devices can range from tongue depressors to MRI machines, implants, infusion pumps, etc. Biomedical Engineers understand the Premarket approval (PMA) of the FDA, which is the scientific and regulatory review process the FDA uses to evaluate the safety and effectiveness of Class III devices. Class III devices are those that support or sustain human life. There are other devices that may not require PMAs, such as a Premarket Notification called 510(k). Biomedical engineers can aid in understanding if the medical device should be under the scrutiny of a PMA or 510(k), and the different safety standards that each medical device should have. Navigating through patents and evaluating under what category of the approval process a device was required or warranted to comply for FDA approval is also a topic that a Biomedical Engineer can assist with.
At Consulting Engineers & Scientists, we can provide assistance in litigation cases where medical devices were used and/or are alleged to be the cause of an injury. We have worked on numerous cases involving pharmacology mixing devices, infusion pumps, cardiovascular implants, orthopedic implants, medical equipment, transport chairs, and safety software implementations, among others. Our expertise includes a knowledge in engineering ranging from metallurgy, mechanical engineering, and electrical engineering that are coordinated with biomedical engineering, which provides an ability in aiding an investigation in the majority of medical device cases. Please contact us with any questions regarding cases involving medical devices or medical products at 610-296-2250 or at firstname.lastname@example.org. You may also contact Dr. Calderón directly at 610-889-0762 or email@example.com.