Safety-engineered syringe: Plunger push button force matters

Ralph Woloschuk

In short: This is a progress report. I took a trip to China. Here I share  some insights regarding production and testing of our smart-syringe.

Design and Production

In the July AGM Report to Shareholders it was noted that we were in progress of finalizing the engineering drawings for production style molds.

As well, we informed that with these molds we will produce the initial batch of 3,000 3mL retractable needle safety syringes. These would then be used for regulatory and marketing purposes with a completion date in August 2017. We also reported that the L.O.M. team was working with various partners to ensure the design, manufacturing and regulatory processes.

We did progress and here is our report how our auto-disable syringe is coming along.

Trip to China

Our  partners along with L.O.M. met at Shanghai Kindly Enterprise Development Group Co. Ltd (KDL).

The team had time to discuss and learn from each other. During these exchanges we made an important strategic decision. We wanted to make further improvements to the

  • design, and
  • components

In turn, we were willing to accept a slight delay  in producing the 3,000 production quality syringes as required for marketing and regulatory purposes. However, as a result we were able to further improve the product and thereby make it even more attractive to the market.

For this reason alone as described above, getting the team together on site in China was extremely useful. It is just different to talk-face-to-face then do it via the phone.  And yes, this even applies if you are wearing face masks and contamination suits to avoid bringing dust and other materials into the production / testing facility.

There are different levels of clean rooms and this is the level required for medical device manufacturing.

These are the garments everyone in the factory “clean room” must wear to prevent products being contaminated by street wear, hair, skin cells, etc. (see picture below).

There is a washing station to sterilize the hands prior to entering the factory. You then go through a series of rooms:

  1. first to install booties, then
  2. the suits, thereafter
  3. the washing, and finally,
  4. you may enter the factory.

Of course, the air circulating in the factor is being filtered as well of all components that might contaminate the facility (see also picture below).

The "Clean Room" in one of KDL's syringe factories.

The “Clean Room” in one of KDL’s syringe factories.

What was accomplished?

We are pleased to report on the progress to date.

Toolbox Medical Innovations (Toolbox) was contracted to finalise the engineering drawings for the production style molds. They completed the drawings in July 2017

KDL, our Original Equipment Manufacturer (OEM) in China, completed the production style molds. They also produced a sample run of syringe parts in August 2017.

All this was completed as per schedule.

Symbient Product Development had previously built the propellant gas cell fill and seal system. This required a critical component which was shipped to KDL.

From September 18th – 22nd L.O.M.’s Chief Technical Officer (CTO) and a design engineer from Symbient Product Development both attended at KDL to inspect the Needle Guides that house the propellant gas cell.

We are happy to report that the needle guide met the specifications. In turn, our Symbient engineer filled and sealed a trial number of cells.

From September 25th – 28th two engineers from Toolbox were on site at KDL’s together with LO.M.’s CTO to inspect the KDL produced parts. They assembled sample syringes and tested their performance.

These parts met Toolbox specifications. Their look and feel was comparable to the finest retractable syringes currently on the market.

10% lower plunger push button force for our safety engineered syringes

The syringe function was tested in the KDL laboratory. One piece of equipment, the Tensile Tester, indicated a reduction in the needle retraction activation features.

Why does this matter?

3mL retractable needle safety syringes are on the very low end. Research indicates that such low pressure represents a highly ergonomic way of injection a needle. This makes it easier for a health professional to administer a syringe by having to extend less pressure.

Moreover, the patient will appreciate if we can further reduce this pressure by achieving a 10% lower plunger push button force. As well, this requires lesser thumb strength to administer the syringe.

Finally, the reduced thumb push button force is so gentle that it gives the caregiver even more comfort, to activate the needle retraction directly from within the patient. That adds safety for all parties involved.

The tensile tester checks the plunger push button force of LomMedical's safety engineered syringes.

The tensile tester checks the plunger push button force of LomMedical’s safety engineered syringes.

This is the device called tensile tester that we used to measure each resistant feature and the total activation resistance.

It accurately measures force either pushing or pulling. It is connected to a computer and printer so the forces are recorded and drawn on a graph.

Conclusion

The production mold design improvements by Toolbox and the KDL molds permit the production of parts or components for our syringe with closer tolerances. This resulted in a slight delay regarding our timetable.

However, since it further improves our auto-disable syringes we made a strategic decision. We accepted the slight delay even though we did not stay within our timetable. This was done to further improve our safety-engineered syringes.

The final design related to function is done. Now we are working to further minimize waste space for our auto-disable syringe product. In practice, this means we want to limit the medication remaining in the auto-disable syringe after injection.

Furthermore, we want to make sure that our safety-engineered syringe will pass all the required tests that third-party laboratories will conduct with our product.

Have your say – join the conversation

  • What was the best experience you have had getting an injection?
  • This was my report from this trip, if I forgot something that might interest you, please ask.

Leave a Comment

Ralph Woloschuk - LomMedical - visiting the KDL stand in Duesseldorf.