‘Compliance by inspection’ is no longer the only standard medical devices must meet. As the medical device industry enters its mature stage, manufacturers have understood that regulatory compliance and quality are altogether two different things. The growing complexity of medical services, innovative medical equipment, and an increase in competition has placed a greater focus on the quality of medical devices.
Shift from speed to quality
Traditionally the medical device industry gave utmost importance to ‘speed to market,’ i.e. how quickly can a company come up with a new product launch. Rather, there used to be a rat race on who would be the first one to roll out the most innovative products. However, according to the latest medical device market intelligence, this trend seems to be changing. It is found that manufacturers can increase their profits by nearly 15% on an annual basis by assuring better quality devices through adherence to cross-industry best practices. And this is not just about the profit figures – high-quality medical devices play a vital role in the faster delivery of medical services, helping patients recover sooner, thereby improving the overall market value of the manufacturers.
How do you define ‘quality’ in the medical devices industry?
Anything which will have a positive or negative impact on the manufacturer’s goodwill and competitiveness in the market comes under the definition of quality. It can be something as simple as the durability of the device, to a difficult situation where product recalls must be undertaken.
Quality, therefore, is a sum of factors like robust materials, superior design, ease of use, and great end results. Losing out on any one or more of these aspects is sure to damage the reputation of medical device manufacturers.
Infiniti’s take on the case for quality medical devices
There is immense pressure on medical device manufacturers to improve the quality of their products without raising prices. The situation gets rather tricky with cut-throat competition and the emergence of constant media scrutiny. Even a minor quality event has the potential to wipe off at least 10% of a company’s market share. Moreover, the effect of a defective device on a patient’s health is sure to damage the manufacturer’s reputation beyond repair.
Our medical device market intelligence shows that the medical industry value chain has failed to keep pace with the growing demand for eliminating quality issues. To achieve the goal of delivering top-class medical services, it is essential that medical device manufacturers implement quality best practices at the earliest. There is a pressing need to hire quality engineers, adopt statistical tools like Quality Function Deployment (QFD), and most important of all have a full-fledged quality management system in place.