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.
Showing 18 comments
  • Dave Percifield
    Reply

    Nice to see that improvements have / are being made but one has to ask if these are absolutely necessary for version 1.0 to pass FDA approval and be a leading syringe on the market or if they could wait for version 2.0. Obviously a trade off between delay in production and going to market versus possibly gaining more of market share.

    If version 1.0 is sufficient to meet FDA requirements why can’t additional improvements be made between when version 1.0 is submitted for testing and FDA approval and version 2.0? Does making additional changes require going through the entire testing/FDA approval process again?

    I noticed that no update on the schedule was provided. When do you expect the syringes for testing to be made available to the testing groups?

    What needs to be done prior to approaching interested parties for determining the degree of interest and most likely method to maximize shareholder return in the most time efficient manner?

    • Ralph Woloschuk
      Ralph Woloschuk
      Reply

      Dear Dave

      Thanks so much for this important comment. I will try to answer as good as I can in this public forum.

      There are 3 very important factors to assure added value to the L.O.M shareholder regarding the L.O.M. safety syringe.
      1. It is Safe,
      2. Ease of use and
      3. Cost to produce is as low as is feasible.

      While the L.O.M. team was together in China, a conscious decision was made to make some improvements to the L.O.M. Safety Syringe.

      This would make the syringe further attractive to prospective clients.

      We tried to this in the most time and cost effective manner.

      It was a strategic decision. We felt it was worth to accept the slight delay before submitting our product for FDA 510(k) clearance and CE marking process. This would permit us to improve the product substantially in short time and at low cost.

      Once the changes have been completed the L.O.M. Safety Syringes will then go ahead and manufacture the batch of 3,000 syringes.

      Two certified testing facilities will undertake the required tests before we can get regulatory clearance.

      I hope this clarifies the issue.

      Ralph

  • Harold Rands
    Reply

    Have the 3000 syringes now been produced and sent for testing ? ( now Oct 25 )

    • Ralph Woloschuk
      Ralph Woloschuk
      Reply

      Dear Harold

      Thanks for your question you asked above.
      I can definitely say (see also my longer answer above), the syringes have not bee produced so far.
      But we will get there as soon as possible with as little delay as possible.

      Thanks and have a great day.
      Ralph

  • Pam Butler
    Reply

    Sounds like lots of good progress on ensuring the product is the best it can possibly be !

    • Ralph Woloschuk
      Ralph Woloschuk
      Reply

      Dear Ms Butler
      Thanks so much for taking the time to stop by and leave a comment.
      Yes, I agree we have made progress and are pleased about that.
      Nevertehelss, a few important milestones must still be reached. But we are working on it.
      Ralph

  • John Maatman
    Reply

    If there happens to be a glitch and manufacturing tolerances are not met in ANY of the components used in the retractable syringe, is there any way for the contents of the gas cell to migrate around seals and enter the patient?
    Hopefully you understand if this happened ONCE that would be the end of the gas charged pneumatic syringe. I can only hope the syringe is designed in such a way that the charge within the gas cell could never enter the patient and cause a heart failure.

    I do not think recommending retraction while the needle is still inserted into the patient is a good idea?

    • Ralph Woloschuk
      Ralph Woloschuk
      Reply

      Dear John,

      Thanks so much for your comment which I try to answer to below.

      You write:

      If there happens to be a glitch and manufacturing tolerances are not met in ANY of the components used in the retractable syringe, is there any way for the contents of the gas cell to migrate around seals and enter the patient?

      Safety is a priority not only for L.O.M. but also for the companies who will distribute, the practitioners who dispense and ultimately the patient who will receives the benefit.

      For this very reason L.O.M. has chosen engineering experts in medical device development to develop the safest syringe possible. Ensuring that propellant gas does not flow through the needle was a priority in the design and proven in our own laboratory tests.

      This test will also be conducted by two independent laboratories in Europe. The laboratories will provide their written report that will be included in the FDA 510(k) clearance in the USA and CE marking in Europe.

      This independent test process is there for the purpose of safety. Of course, our syringe must not allow propellant gas to pass through the needle before it receives clearance. We are confident that our syringe will conform to this and to all safety regulations.

      You also write:

      I do not think recommending retraction while the needle is still inserted into the patient is a good idea?

      The manufacturers of the current retractable syringes state their syringe needles can be retracted directly from within the patient. Therefore, our instructions are not unusual.

      The caregivers may be reluctant to activate the retraction from within the patient. They will, if the activation occurs with a gentle force upon the plunger push button. The L.O.M. Syringe has a very low push button activation force. We believe, practitioners will be comfortable retracting the needle directly from patients.

      There are over one million needle stick injuries occurring annually in the USA alone. Needle stick injuries only occur when the sharp tip of a needle is exposed by removing it from the patient before activating the safety device such as retraction, flip cover or shield. We believe the caregivers will activate our retraction safety feature directly from within the patient, thereby drastically reducing needle stick injuries.

      World Health Organization (WHO) would like to see, “smart” safety syringes that the needle can be retracted without harming the patient and protecting the caregiver from an accidental needle stick injury. This is what we have managed to develop.

      Thank you for taking the time to let us know your thoughts.

      Ralph

  • Craig LaPointe
    Reply

    Nice feedback Ralph on what has transpired over the last few months. I know most shareholders like myself and others are getting impatient but this update gives proper reasoning on the FDA certification moving forward. Thanks for your efforts that you and the rest of the team are doing. Could you give us a best guess scenario on when we might see the FDA approval completion and what time frame would see our manufactured samples getting to the labs.

    best regards.
    Craig LaPointe

    • Ralph Woloschuk
      Ralph Woloschuk
      Reply

      Dear Craig

      I replied to Tim:

      We now have everything in place to bring our 3 mL syringe into production and make applications for US FDA 510(k) clearance and CE marking certifications.
      The latest changes have resulted in only a “slight“ delay.

      The above does reflect our standpoint on this issue.

      You also write:

      Could you give us a best guess scenario on when we might see the FDA approval completion and what time frame would see our manufactured samples getting to the labs.

      We cannot predict the future as far as timing is concerned. Our technology is unique but what the future holds we cannot accurately predict. I hope this is useful to you.

      Herzlichst
      Urs

  • John Maatman
    Reply

    I don’t believe any of the current safety syringe manufacturers use gas pressure to power the retraction process?

    With spring retraction there is little danger to a patient should the device fail. I can understand why retraction while the needle is still in the patient may be desirable, but unless it is impossible for the contents of the gas cell to ever enter a patient, it should not be recommended or suggested.

    If retraction was performed immediately after the needle was manually removed from the patient, safety should still increase dramatically? If simple instructions cannot be followed maybe medical devices are not the root of the problem?

    • Ralph Woloschuk
      Ralph Woloschuk
      Reply

      Dear John

      Thanks for your opinion.

      As we reported in the previous two shareholder meetings, L.O.M has made steady and reliable progress. During the past four years we have taken the 3mL syringe from a crude design to the next generation of “smart” syringes.

      We have also designed and produced a working 1 mL syringe, a working blood collection prototype and designed a second blood collection device. Our technology can be applied to all larger sizes of syringes.

      We have patents or patent applications on all our products.

      Our technology works as our coming tests will further confirm.

      Cordially
      Urs

  • Tim
    Reply

    I agree with Dave Percifield. What is the new schedule? Delays could enable a competitor to get to market quicker.

    • Ralph Woloschuk
      Ralph Woloschuk
      Reply

      Dear Tim

      The L.O.M. team has worked as quickly and diligently as possible to make design changes that are necessary to produce the finest possible syringe and move forward towards certifications.

      We now have everything in place to bring our 3 mL syringe into production and make applications for US FDA 510(k) clearance and CE marking certifications.

      The latest changes have resulted in only a “slight“ delay.

      Greetings
      Ralph

  • Brian
    Reply

    All of this is nice but nobody is giving a time frame on share holders seeing a return or how we are going to see a return. I’ve been a share holder since inception and have listened to the same thing over and over again. “We are very close”? If history is to repeat itself, “close” could mean another 10 yrs?

    • Ralph Woloschuk
      Ralph Woloschuk
      Reply

      Dear Brian

      If we could accurately predict the future regarding timing we would happily give you a date. Our new technology, which makes L.O.M. unique and very valuable, also causes us to be unable to accurately predict the future regarding timing.

      Going forward, we will continue to give you updates on our progress so you and all shareholders are informed.

      Ralph

      • Tim
        Reply

        Ralph, are you a politician?
        Almost everyone has asked about timing and you continually sidestep the question. Not impressed.

        • Ralph Woloschuk
          Ralph Woloschuk
          Reply

          Dear Tim

          I appreciate your concern. But I do appeal to your business know-how and experience.

          I cannot speculate about things I do not have under control. Neither is it prudent that I speculate on matters regarding a regulator. These things are not and should not be in my sphere of influence.

          Of course, once we have important news regarding these matters, you will be informed here.

          Until then, I apologise but this is all the information I can disclose to you.
          All the best.

          Ralph.

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