SYRINGE FORCES REPRESENT A SERIOUS RISK
MANAGEMENT ISSUE FOR MEDICAL DEVICE R&D
A Research & Development team at a leading device company worked tirelessly to bring a promising diabetes patch pump to market for many years. After several years of product development with many millions invested in device engineering, they discovered that lubrication of the container was causing their device to fail. The failure was related to inconsistent dose accuracy and high plunger forces. The inconsistent plunger forces in turn required a larger battery causing a weight and size issue for the infusion pump. With huge investments in terms of time and money sunk into the project, it finally came down to the device lubrication that brought the launch to a grinding halt.
The TriboFilm Research team tested its TriboGlide-DS® lubrication technology against their standard and demonstrated the advantages of the immobilized lubrication system. Not only did the device perform well within specifications for dosage accuracy but the absolute value of plunger forces were reduced by over 50% with corresponding savings in power consumption. Solving the device lubrication problem resulted in a more accurate pump, which was lighter and cheaper and used a smaller battery!
SYRINGE FORCE DATA
Force-Displacement curves for silicone oil, TriboLink-Si® and TriboGlide-DS® lubrication systems measured using Zwick Z0.5 Universal Testing Machine. Break-Loose Force (FB) is defined as the maximum force required to break the static friction of the plunger. Glide Force (FG) is defined as the force required to maintain plunger movement once static friction has been overcome. All samples are 1 mL long glass syringes filled with a 0.05% Polysorbate 80 solution in sterile filtered water. All samples were stored for 12 weeks at 40°C and agitated for 24 hours just prior to characterization. As you can see, Free Silicone (the blue line) has much higher forces than TriboLink-Si® (the red line) and TriboGlide-DS® (the green line).
Average Break-Loose Force (FB) and average Glide Force (FG) for silicone oil, TriboLink-Si® and TriboGlide-DS® lubricated syringes. All samples are 1 mL long glass syringes filled with a 0.05% Polysorbate 80 solution in sterile filtered water. Sets of samples were aged for 2, 4, and 12 weeks at 40°C, and all were agitated for 24 hours just prior to characterization. Error bars represent the standard deviation of the values for 10 identically prepared samples averaged to obtain each point.
This is a crucial test because agitation and extended storage may have a significant impact on test results.
APPLICATION IDEAS FOR TRIBOFILM’S TECHNOLOGIES:
Clients reach out to us because they have an urgent need to either reduce forces or reduce particles in their devices. We have helped diabetes device makers, nicotine pump device makers, ophthalmic applications, and several others applications we did not anticipate. Do you have ideas for other applications? We would love to hear from you!
CAN A LUBRICANT REDUCE THE ENVIRONMENTAL
IMPACT AND THE WEIGHT OF YOUR MEDICAL DEVICE?
One of the hidden benefits of lowering forces through TriboFilm’s two flagship technologies is you may need a smaller battery to power your device.
The fewer batteries necessary, the greener the pump or device. This also translates to a smaller and lighter device, and for diabetic pumps and other wearables, this is a huge marketing advantage.
One of our clients in the diabetic wearable market put it this way:
“I never imagined that a lubricant would be a competitive advantage for us. Using TriboFilm’s technology, we have reduced the number of batteries in our device by a factor of three and thus reduced the overall weight of the device!”