PESTEL Analysis of the Medical Devises Industry in Australia

PESTEL Analysis of the Medical Devices Industry in Australia

Political

The medical devices industry in Australia has become the focus of political leaders in recent months. For instance, the Australian Senate launched an investigation into regulation of the medical device regulation in response to growing concerns about Poly Implant Prostheses breast implants. According to Murphy (2012), "The inquiry, which is being conducted by the Senate's Community Affairs Committee, follows a senate committee inquiry into Australia's medical device regulation that was completed late last year and that generated 18 recommendations on how to improve the regulations" (p. 1). Increased regulatory oversight, though, is complicated by the very nature of the medical devices industry. According to Breton and Stinson, "The medical device world is a shapeless blob" (2010, p. 27). This point is also made by Egan (2001) who emphasizes that while there have been a number of major pieces of legislation regulating medical devices passed in recent years, "Many small companies had taken no action as they do not regard their products as medical devices" (p. 194).

Economic

The nebulosity of the medical devices industry makes its economic impact difficult to calculate (Breton & Stinson 2010). As an example, these industry analysts write: "How much does a device cost? We have never been able to average prices of all devices, since both $0.99 Foley catheters and the $27,000 spinal implants will completely skew all analysis" (p. 27). "Various quotes one can find on the internet place the device market in the billions of dollars. Just the manufacturing of devices was approximately $90 billion in 2006, and that does not take into account all the money spent on research and development, clinical trials, marketing, and distribution of samples of select products to physicians" (2010, p. 27). Currently, the global medical devices market is estimated at $80 billion, with the U.S. accounting for about 50 per of that total (Breton & Stinson 2010).

Sociological

Babies born today have a fifty-fifty chance of living to see their hundredth birthday, a process that will inevitably be facilitated by innovations in medical devices (Breton & Stinson 2010). Therefore, there will be an increasing demand for these devices fueled in large part by such innovations and these issues are discussed briefly below.

Technological

Although the industry may be a "blob," it is reasonable to conclude that future innovations in the medical devices industry will include exoskeletons that allow paraplegics to walk, the blind to see, and the mute to talk in ways that are only the realm of scientific fiction today. Computer-driven applications and improvements in the mechanical devices will ultimately combine to provide humans with a cyborg-like quality, and it may be that people will live to be 200 years or more by the 22nd century thanks to medical devices. For instance, a joint industry statement emphasizes that, "New medical devices are designed to give better and earlier diagnosis, more effective and successful treatment and completely new treatments" (Joint Industry Statement 2007, p. 2).

Legal