Analytical Solutions for the Combination Medical Device Development Process

Billions of patients worldwide benefit from a diverse range of medical devices. The global medical device market in 2011 was approximately $300 billion and is predicted to grow by 4% per year to reach over $400 billion by 2018. Specifically, the European medical device market is estimated to make up 30% of global sales (i.e. $100 billion) and is second only to the US which makes up 40% of the market. A medical device is an implant, implement, instrument, apparatus, in vitro reagent or other similar article that can diagnose, prevent, monitor, treat and alleviate disease. The Food and Drug Administration (FDA) has classified 1700 different types of medical devices into three regulatory groups (Class I, II and III).

The basis of the classification system is the risk the device poses to the patient. Class I and Class III devices are lowest and highest risk, respectively. Medical devices are extremely diverse and range from simple tongue depressors, disposable gloves and thermometers, to more complex implants, prostheses and diagnostic ultrasound products. The focus of this paper will be drug delivery medical devices, which safely transport pharmaceutical therapeutic chemicals to target areas in the body.

Drug delivery devices include stents (e.g. cypher and dual therapy stents), hypodermic needles, infusion pumps, inhalers (e.g. vaporisers and nebulisers), intrauterine devices and prefilled syringes to mention only a few examples. Often drug delivery devices are considered ‘combination products’, which are comprised of a drug and device. Prefilled syringes containing drugs will be used as a case study in this paper, to help illustrate analytical approaches to testing drug delivery medical devices throughout the product development process.

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