Medical Devices is an extremely broad category encompassing everything from simple Band Aids to large and complex magnetic resonance imaging systems, from disposables like gloves, gowns, and catheters to durables like medical beds, wheel chairs, and dialysis machines. The participants in the sector are equally fragmented with thousands of small firms competing with and supplying large multi-billion-dollar healthcare companies like Johnson & Johnson, GE, Siemens and Medtronic to small start-ups and niche players.
The complexity of the industry has increase rapidly as new hybrid devices have become common. Devices such as drug-eluting stents and other implantable devices that incorporate a pharmaceutical component have entered the market in the past decade. New drug delivery mechanisms often also cross-over categories between the device sector and the pharma sector. Information technology has also contributed to that increasing complexity, as monitoring and imaging systems incorporate telecommunications and data processing capabilities.
Like other areas of medical product manufacturing like pharmaceuticals and diagnostics, the $200 billion medical device industry is highly regulated globally. Devices must be approved for use in humans by the appropriate regulatory agencies and pass muster from both clinical trial and manufacturing practice. In addition, reimbursement levels for devices used in both the critical care and home/consumer-use settings continues to be a challenge for the industry as manufacturers must now more than ever prove the efficacy and cost benefits of their devices in clinical outcomes and not just novelty.