Douglas Hamilton, Covestro
Diabetes is on the rise. The International Diabetes Federation (IDF) estimates there are roughly 415 million people affected by this chronic condition. By 2045, this is expected to rise to 629 million. For many, living with diabetes requires injecting insulin on a regular basis – a painful yet necessary ritual. In addition, it’s believed that there are some people who do not adequately treat their condition due to a fear of needles. Increasingly, medical device companies are looking for alternative methods of delivering medicine to those who need it.
One area of promise is needle-free injection technology, a drug delivery system that directly transfers medicine into patients without piercing the skin with a conventional needle. With biologics and other drugs that require self-injection entering the marketplace, needle-free injection technology offers many advantages over needle injections, including more efficient and less painful drug administration for patients. It is hoped that providing a more comfortable, efficient injection experience will help increase medication compliance.
Bringing this type of advancement to market requires pharmaceutical developments. But that’s just half of the equation. Life-enhancing medical technology like this also requires materials that can meet the rigorous challenges these applications demand.
New healthcare technologies = new material challenges
For decades, medical devices and equipment creators have depended on polycarbonate resins formulated specifically to meet the unique requirements of the healthcare industry. Polycarbonates have been proven for decades in a number of life-enhancing applications, including blood separation, cardiovascular, surgical instruments, and syringes and catheters, among others. As needle-free injection technology advances, polycarbonate is proving itself in this burgeoning application, due to its light weight, toughness, design flexibility and processability for injection molding.
A helpful reference for needle-free injectors is the International Organization for Standardization (ISO) standards listed in ISO 21649:2006. This International Standard provides safety, performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use.
The most recent example of a medical-grade polycarbonate in action for such an application is a needle-free injection insulin delivery device from QS Medical Technology Co. (QS). New research studies indicate needle-free injection is a viable therapy for diabetes and effective blood glucose control. In fact, compared to a conventional insulin pen, needle-free injectors are predicted to result in faster absorption and greater glucose-lowering effects in the period after administration. With more than 114 million Chinese patients with diabetes, this application is an important one for the Beijing-based company.
Polycarbonate forms the insulin-delivery interface and ampoules containing the medicine. For this application, the material needed to meet QS’ requirements of precise size, high strength and toughness for the plastic drug-delivery components and ampoule bottles. These properties are necessary to ensure that the drug-suction component can consistently and safely puncture through the plug of an insulin reservoir. The material also needed to fulfill the medical OEM’s design requirements, so that the drug-transfer needle and the protective cover of the drug suction component could be manufactured in one shot via injection molding.
QS kept several other important material considerations in mind, which should be considered for all needle-free injection device material selection:
- Lipid resistance (drugs in lipid emulsions can degrade polycarbonate materials, so it is important that selected materials can withstand lipids).
- Resistant to radiation sterilization (to ensure high productivity and efficiency during the device manufacturing process).
- Because these devices are in direct contact with the human body, it’s important that they are biocompatible and comply with multiple requirements of ISO 10993-1.
- Accuracy in molding size, and ability to maintain stability under different application environment.
- A consistent and reliable global supply of the material.
It’s important to note that a device manufacturer still must evaluate medical-grade polycarbonate for suitability to ensure the final product meets relevant biocompatibility requirements, performs or functions as intended, is suitable for its intended use and complies with all applicable FDA and other regulatory requirements.
As medicines continue to evolve, needle-free injection technology is expected to increasingly help facilitate more efficient and less invasive drug delivery. Materials manufacturers will do their part, continuing to work collaboratively with OEMs to tailor their materials and bring next-gen needle-free injection technologies to market.
Doug Hamilton is the global healthcare segment leader at Covestro. He has over 30 years’ global leadership experience in engineering thermoplastics, life sciences and specialty chemicals.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.