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Two-Step Injectors – Benefits That Drive Auto-Injector Simplification

Auto-injectors (commonly referred to as AIs) need to be simplified. Costs have to be reduced but at the same time, very strict regulatory standards need to be respected. As a result, several new technologies are being developed as we speak to be used in auto-injectors for syringes. An example of this is Flexi-Q-CAI, which was created by Elcam Medical.

The most important thing with modern AIs is simplicity. This is why two-step injectors were created. They only need 2 steps. The first one is to remove the cover. The second one is to press the device on the skin. This activates it. Patients end up with fully automatic injections through a process that completely removes the need to use a button for activation. We are talking about a very easy-to-use device that prevents the appearance of needlestick injuries while improving patient compliance. Skin reactions are reduced because injections can only start after the full penetration of the needle. For extra safety added, there is an extra observation window that shows the full volume of the syringe and details about the injection progress.

By taking the Flexi-Q products as an example, we can see they are fully compatible with intramuscular and subcutaneous injections. They offer a completely flexible delivery volume ranging from 0.1 ml to 2.25 ml. There is also a proprietary damping mechanism capable of preventing the glass syringe impact while making it very easy for the injection springs to be used even for drugs with a high viscosity level. Even fast injections are possible, which is a huge advantage for when there is a need to use emergency drugs.

The Two-Step Injectors

Fully disposable AIs can be used for 2 separate purposes:

  • The Flexi-Q EAI – perfect for acute situations and emergency injections.
  • The Flexi-Q CAI – Perfect for chronic conditions and pre-planned injections.

These AIs feature a similar design. However, the EAI does go through tougher regulatory processes. This is because they are to be used in acute situations or during emergencies. The FDA simply has stricter rules meant to guarantee high reliability.

The two models go through the exact same preconditioning and verification tests. But, statistical analysis is so much stricter with EAI, just like the acceptance criteria. We can say the exact same thing when looking at the used manufacturing process. Quality control is much more serious. Basically, the EAI model goes way past FDA requirements.

For the AI device to gain approval, interchangeability is needed. The FDA requires a strong threshold analysis to prove that a submitted drug can perform at the required level. When looking at the user, the entire Flexi-Q family is not the only two-step injector on the market right now.

At the end of the day, we are talking about completely simplifying how auto-injectors are used and created. Two-step injectors are very fast and can prove to be very beneficial in several parts of the medical system. This is why so many new models are being developed right now. Some are even used in the training of resident doctors and nurses.

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