Quality Is The Heartbeat Of Your Company
Quality. It’s difficult to assign a single definition to a word that carries many connotations. Instead, let’s look at quality as an experience. There is a vibration to it. It’s palpable. Quality, in its highest and lowest states, is felt from the moment we experience it.
Within an organization, quality is a decision, a driver that guides people to harness processes to improve themselves and the organization they represent. Quality is the result of a mindset — a standard — by which each part operates. Quality should not be mistaken for processes. While it’s true defined frameworks and procedures are paramount for quality control, quality is more than operations.
As the CEO of a quality management system software company that’s specifically designed for the medical device industry, it should be easy to see why I’m committed to improving the quality of our software and the people who bring the software to life. The ultimate end users aren’t only the quality engineers that use our system, but also the patients who are recipients of medical devices developed through our quality system software. In the medical device industry, high-quality products can quite literally make the difference between life and death. Quality cannot be a byproduct of our labor; our labor must be focused on our demand for high quality.
Quality Teams Build Quality Products
Quality teams build quality products — that’s why the hiring processes for the best companies in the world are grueling. Every company is looking for specific character traits that are indicative of a quality candidate, but in-demand candidates evaluate companies for signs of quality just the same.
As Richard Winters, the main protagonist in Band of Brothers and a real-life war hero, said about the men of the 506th Parachute Infantry Regiment, “You know why they volunteered? Because they knew that the man in the foxhole next to them would be the best. Not some draftee who’s going to get them killed.”
Developing software isn’t the same as parachuting into occupied Normandy, but the commitment to quality, especially in an industry such as ours, should be just the same. Establishing a high bar of quality within your business builds a bond between co-workers. Knowing that the person sitting at the desk next to you is just as committed as you are to delivering a quality product is inspiring. Making this commitment to quality known during the recruitment process shows candidates from the moment they walk in the door that your organization, and those who work there, are committed to the highest standard of quality.
Quality Products Create Quality Outcomes
A high-quality product doesn’t manifest from following a list of regulatory requirements, but rather a quality-focused mindset. Take Apple, for example. The latest iteration of the Apple Watch, the Series 4, has an electrocardiogram feature that can identify atrial fibrillation, an irregular heart rhythm that can increase the risk of stroke, heart failure and other heart conditions. This feature classifies the Apple Watch as a medical device, similar to a pacemaker or insulin pump, and Apple must abide by a rigorous set of standards to maintain compliance.
Long before Apple was a medical device manufacturer, the company functioned as if it was already bound to the regulations of a medical device manufacturer. Apple enacted quality metrics, training, traceability and controls before it was required by any regulatory agency. The team responsible for the Apple Watch voluntarily made their jobs more challenging than what was required at the time.
Why? Because they were committed to developing a quality product that would deliver quality outcomes to its end users.
First-time medical device companies are under scrutiny to ensure they have the right processes in place to properly bring a medical device to market. Apple showed regulators that it was focused on quality from the outset. Quality teams are willing to go the extra mile to develop high-quality products.
I often hear executives say something to the tune of “we aren’t curing cancer” as a way to help maintain perspective. While that may be true depending on the nature of their job, the companies using our software quite literally are developing products intended to cure cancer and treat serious illnesses while they can still be fought. Because of this, we want to enable our users to develop medical devices made with the highest level of quality. We operate from the mindset that our friends and family will be using these devices. The way in which we help our clients achieve this outcome is through an unrelenting investment in quality.
Building a culture of quality can be challenging, but the rewards are endless. The hundreds of hours spent reviewing resumes, hundreds of thousands of dollars invested in professional development and the high level of intensity in developing the best product in the world are essential to the lifeblood of our company. Whether you’re manufacturing cars, baking decadent pastries or developing software that improves the quality of life, making quality a part of your company’s DNA will yield returns well worth the investment.
