Consistency is the main goal of quality systems in a medical device company. Quality systems ensure what we produce today is the same as what we produce tomorrow. Consistency doesn’t seem like it would change the world the way a breakthrough idea for early diagnosis of diabetes or cancer might.
In the IVD world, however, lofty goals are met by building solid foundations. A robust, usable quality system is one of the key foundations on which IVD success is built.
Just Enough Process
Ideally, companies should have just enough process to support ongoing design and decision-making at each stage of growth. Integrating quality systems with other business needs is the best way to measure how much process is enough.
The best quality systems are those that tie systems to the growth stage where they will deliver the highest value. This staging creates both good financial value and better development outcomes.
Aligning quality systems with other business needs requires asking a number of questions, such as:
- How will quality system choices impact clinical trials or regulatory strategy?
- Are our quality systems designed to facilitate entry into the EU or other non-US markets?
- Have we chosen our product requirements in a way that ties them to our market goals?
- What is the best time to introduce each piece of the quality system?