"You get what you pay for" – an idiom that has been around just about forever. It suggests that the quality of a product improves or increases with the amount of money one pays for that product. But for medical devices, quality products need to equate to more than a just a price tag.
Quality medical devices need to equate to a commitment – a commitment from top executive management that the products a company produces, not only meet “customer” requirements, but are safe and effective for their intended use. This commitment is to be communicated to all individuals at all levels of the organization who need to "buy–in" to it - and since this commitment is driven from the top down, employee resistance or "push back" should be reduced into the "slim to none" category!
Because they know their job functions best, employees need to become actively involved in the development of processes and procedures specific to their area of responsibility. These processes and procedures will evolve into the company’s "bible" or Quality System that guides and directs the operation.
"Customers" can be "internal" (engineering may be a customer of marketing, manufacturing may be a customer of sales) as well as external (regulatory agencies are customers of the Quality & Regulatory department, the end user or patient is a customer of sales or product support). A quality medical device is produced when customer requirements and specifications are translated into attainable and realistic design inputs. These inputs will develop into a finished medical device which, prior to being released to market, must go through extensive verification/validation testing to ensure the medical device functions according to specifications and is indeed safe and effective.
Consistency is paramount. Adhering to those employee developed processes and procedures such as purchasing items used in manufacturing only from pre-determined, experienced and competent suppliers are instrumental in maintaining the quality of a medical device.
Lastly, the commitment to quality cannot ever become stagnant. Customer requirements, customer feedback, processes and procedures used in product design and manufacturing as well as the infrastructure of the business itself must be continuously monitored, assessed, measured and improved upon if the medical device organization is to remain competitive, profitable and compliant with regulatory agencies.
Notice that throughout this blog cost was never mentioned? Sometimes you get a lot more than what you pay for!