Q: Needle-free devices seem to have lost some traction in the market, why might this be the case?
Kaufman: At this time, innovations in drug delivery devices with needles continue to move forward in addressing the growing need to
administer biologics. Auto injectors and pen injectors have been proven to be effective, safe and reliable devices. With this
established track record, needle-based devices will continue to strengthen their position in the self-administration market.
Novara: There are two factors that may have contributed to this. Firstly, needle-free technology can be more complex, and there are
various safety and operational challenges. Secondly, needles are now available that are very fine, as well as being shorter
and less painful than previous generations of needles. Self-injection devices also continue to become more advanced.
Potter: The needle-free devices that have been commercialised are all liquid jet injectors. These devices work by firing a tiny jet
of liquid through the skin. The concept was first patented many decades ago and niche products have been on the market for
years. The products are either disposable devices or reusable actuators with a singleuse drug component.
The reusable devices have been used in the past in the developing world and in the military for vaccine studies, but lost
favour when the potential for cross-contamination between patients was identified. Single–use jet injectors are expensive
and have never been widely used. I believe this is because the benefit of needle-free technology does not outweigh the increase
in costs over alternative technologies. Liquid jet injectors will continue to be used for a number of niche products, but
they will struggle to dramatically increase their market share. However, other technologies in development, some of which
are needle-free, are likely to get good market traction as they are commercialised.
Sadowski: It's not a matter of needle-free having lost traction; it's a matter of the matching the technology to the needs of the patient
population. I have no doubt that we will see greater applications of needle-free technology as additional biologic drugs are
developed for populations best served by that approach, such as paediatric patients.
Q: What recent groundbreaking innovations have you seen in the area of selfadministration devices?
Kaufman: Groundbreaking is a powerful statement. I have seen a number of significant innovations in the area of auto injectors over
the past seven years, particularly when it comes to the look and the size of devices. Auto injectors are more discreet and
are now available in sizes that are not much bigger than a marker pen, which allows patients to travel and use the devices
whenever and wherever they wish without feeling embarrassed. Industrial designers have also worked closely with human factors
engineering groups to make several devices (launching soon) that are completely customized to suit the needs of a specific
patient group. For example, if rheumatoid arthritis patients have difficulty removing a cap, industrial designers can overcome
this by engineering a new solution for cap removal. These may not be groundbreaking, but to me they represent a significant
shift in the way devices are being made—working more with patients at the earliest stages and making drug delivery devices
that are simple and intuitive.
Novara: The innovations I am very impressed with are the patch injectors/patch pumps. This new technology is allowing companies to
deliver therapies, which historically have been infused in a hospital setting, in the privacy and convenience of the patient's
home. For example, technology is in development that can allow patients to have continuous infusion at home with a ready-to-use
Potter: I believe that the two most groundbreaking innovations in the area of self-injection devices are microneedle patches and
solid dose injectors.
Patches are being commercialised that incorporate tiny needles to aid the delivery of drugs and vaccines across the skin.
The microneedles are either solid and coated in a film of drug; hollow to allow liquid formulations to be pushed through them
and into the skin; or solid and made from the drug. The key is to ensure that the microneedles penetrate the skin so that
the drug or antigen can be accurately delivered. Several companies are commercialising microneedle patch technologies and
these will be suitable for the delivery of a range of peptides, proteins and vaccines.
Solid dosages are currently injected using a needle and trocar. This is a painful procedure and is not suitable for self-injection.
Our solid dose injector technology differs in that a tiny rod of drug is produced with a point on one end so that it can be
pushed into the skin without the need for a needle. When placed in the skin, the rod dissolves and releases the drug or vaccine
into the tissue. Storing the drug in a solid dosage form offers stability benefits and may avoid the need for refrigeration.
Solid dosages have been shown to dissolve quickly in clinical trials, providing bioequivalence compared with a subcutaneous
needle and syringe injection. However, the formulations can also be designed to provide controlled release, if desired, by
incorporating polymers in the formulation. The device is simple to use and could be used for self-injection. Most applications
will comprise a small, lowcost, disposable cassette that will be pre-filled with the drug or vaccine dosage, and a handheld,
springpowered, reusable actuator. The cost per injection will be low and the technology will be suitable for a wide range
of peptides, proteins and vaccines.