Medical Devices and Biomedical Engineering

Analysis of medical devices requires expertise in a wide variety of fields including mechanical systems, electo-mechanical systems, biomechanics and medicine. Principia’s consultants have expertise in these fields to provide the tools that are necessary for the examination of medical devices.

Medical devices range from simple syringes and scalpels to computer controlled anesthesia machines. Medical devices include both implantable and non-implantable products. We have experience with many implantable medical devices such as:

• Orthopaedic – prosthetic joints such as hips and knees, and fracture fixation
• Cardiovascular – catheters and stents
• Cosmetic – breast implants

Our experience with many non-implantable medical devices includes pneumatic tourniquet machines, lasers and peristaltic pumps.

Example: Breast Implant Rupture

	In this example a woman claimed that a vehicle door opened into her chest and ruptured both of her silicone breast implants, requiring a revision with new implants. The picture on the left shows a silicone breast implant of the type involved in this project.
	Principia was able to calculate the force on the woman’s implants from the door impact and compare it to known rupture forces of silicone breast implants. The analysis results shown at the left indicate that the force from the door was less than the force needed to rupture the implants.

Example: Evaluation of a Patient Controlled Analgesic (PCA) Infusion Pump

Principia’s consultants were asked to examine the performance characteristics of a pain management system consisting of a patient specific ambulatory pump. This pump provided pain medication sub-cutaneously at a specified rate or a bolus while allowing the patient to be ambulatory. We designed a protocol to test the performance and reliability of these pumps.