Safety syringe: Toward market readiness

Debbie Ulansky

Recently I came across an interesting article (Click Here) about product champions.

It pointed out that more than enthusiasm and foresight is required, if inventors want to get their idea from the drawing board via the lab to market.

Commercialization of ideas and prototypes takes plenty of hard work, foresight and adequate funds. A bit of luck does not hurt either.

We share some of our experiences on this journey through what experts call  the “valley of death”

Background – Safe Injection

We all know that it takes plenty of time to develop a prototype and turn it into a marketable product.

The more technology is involved, the more fine-tuning is generally needed. In the process from the lab to marketplace one also discovers new things that need to be considered before we can sell the product.

Prior to 2013 it was thought that we would only need working prototypes of the single use retractable safety syringe. Our syringe prototypes were produced using prototype style molds.

The prototype syringes allowed us then to demonstrate that the concept of our novel pneumatic retraction mechanism functioned.

But as we discuss below, things did not all work out as planned.  A quite common experience when trying to get a prototype ready for market.

From prototype to market ready or as the experts call going through the “valley of death”

In the context of product innovation, the bridging of the valley of death is a challenge. The UK Parliament has tried to address this problematic journey:

House of Commons, Science and Technology Committee (2013). Bridging the valley of death: improving the commercialisation of research. Eighth Report of Session 2012–13.

The report points out that in nearly all cases, products need substantial additional development before they are even close to commercialization. Unfortunately, access to further funding is sometimes lacking. As well, additionally required engineering know-how may not be available either. In turn, the innovation experiences a stillbirth and fails to make it to market.

The UK’s House of Commons, Science and Technology Committee reports that with a bit more time, engineering ingenuity and money, the majority of products can be made ready for commercialization.

Nevertheless, the report also emphasizes that this often takes several years before moving from lab to commercialization can be accomplished. Unfortunately, most innovations fail to leave behind this what experts call the valley of death.

In LOMMI’s case, things were such that by 2015 we learned during talks with interested parties that they wanted a product ready for market rather than our initial prototype. Their risk management and business models are such that without a market ready product such as our original prototype, there was no deal possible.

Getting smart syringe with sharps injury and reuse prevention ready

Based on these developments in 2015, management and the board decided to move ahead on the final journey to commercialization.

The process that engineers are trained to do, is to make one modification at a time. With each simple modification the syringe is then put through a battery of tests to check if these modifications work properly.

Once testing revealed all worked according to plan, they went ahead and modified another part of our safety-engineered syringe.

As with most products, if they change the design of one part, the safety-engineered syringe with reuse prevention needs to be fully tested again.

Sometimes things do not work out 100% as hoped, so a re-modification is required. Of course, this process takes both, time and patience.

Feature: Reducing medication waste due to syringe dead space

When medication is injected, a small amount of it is retained in the syringe after the plunger is fully depressed.

In syringes with minimal dead space, the leftover amount averages to 0.3% of the volume of the medication doses. This is one tenth of what a syringe with plenty of dead space leaves behind.

While this is a small amount, a study reveals that this can add up to as much as $2,300 per year for a patient. .

Oramasionwu CU, Cole AL, Dixon MS, Blalock SJ, Zarkin GA, Dunlap LJ, Zule WA. Estimated Cost of Injectable Medication Waste Attributable to Syringe Dead Space. JAMA Intern Med. 2016;176(7):1025–1027. doi:10.1001/jamainternmed.2016.2301

Because of these costs, medical device companies use low waste space as a selling feature. Therefore it is imperative that our syringe waste space be competitive with the lowest waste space syringes on the market. Management and the board decision was to continue to develop our smart syringe to reduce our medication waste space.

After modifications and retests, our smart syringe with sharps injury and reuse prevention resulted in waste space that is virtually non-existent, except the medication that remains in the needle.

PS. In their research the authors (Oramasionwu et al, 2016) found that the median value of the wasted medication per dose was $5 for high-dead-space medications and about 50 cents for low-dead-space medications.

Per year, this does work up to about a $1,600 median for high-dead-space medication syringes they tested versus about $125 for low-dead-space medication. Reducing this waste helps both, patients as well as society paying less tanks to lower waste in medication.

Herbert Towning sketching out plans for the Smart syringe with sharps injury and reuse prevention.

Herbert Towning sketching out plans for the Smart syringe with sharps injury and reuse prevention.

Feature: Reducing plunger push button force

As our Chairman has pointed out in our video – “… we know how to manage pain” as far as injection pain is concerned using safety-engineered syringes.

We have now designed our syringe to retract with less plunger push button force than current retractable needle syringes on the market.

We have achieved a  lower plunger push button force for our safety engineered syringes.

The syringe function Tensile Tester indicated a reduction in the needle retraction activation features.

Research indicates that low activation pressure represents an increased ergonomic benefit of an injection syringe.. This makes it easier for a health professional to extend less plunger push button pressure and allows the needle to be safely retracted from within the patient.

Production: Increasing efficiency

In order for FDA 510(k) clearance and CE Marking Class ll applications, we need to  manufacture our test syringes using production style molds. The parts are molded, syringes assembled and sealed in our LOM labelled packaging, all in an ISO certified clean room. The syringes are then sterilized.

This is important because this manufacturing process will be used to produce the  3,000 syringes for independent laboratory testing and marketing purposes.

These tests provide data required to submit a report as part of the FDA 510(k) clearance and CE Marking Class ll applications.

Where we stand

Above shows  where we came from and what steps we have taken to cross what the experts call the “valley of death” in innovation as quickly as possible.

Also during the market ready design stage, we are consulting with high volume production mold designers and manufacturers. We are also meeting with  automation equipment designers and manufacturers.  We are currently receiving quotations to build one set of molds and a fully automated assembly line to produce and package 50 million 3 mL syringes annually.

Our partners must follow various ISO procedures that requires detailed records of the design process,

  • verification testing
  • risk analysis
  • all matters related to ISO standards and
  • all matters related to FDA 510(k) clearance and CE Marking Class ll

We are moving ahead to commercialize our safety-engineered syringe as fast as possible.

Nevertheless, management and the board have kept three important factors in mind:

1. All procedures must be correctly preformed in order to produce a market ready syringe with sharps injury and reuse  prevention.

2. Allow time and funds for the numerous steps and modifications required to make our syringe market ready.

3. There has been time issues that we had to cope with that are outside our sphere of control. Examples are such as delays in transportation and logistics as well as custom delays.

Developing a new technology is a complex and time consuming process. The good news is We Are Near Completion.  Please know an update will be  provided upon completion of our test syringes.

Have your say – join the Conversation

  • What are your experiences in innovation in the medical or any other field (things run smooth most of the time?)?
  • What are your experiences with pain when getting an injection?

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LomMedical CEO Herbert Towning talking with Urs E. GattikerLOM Medical Syringe board of directors