The principal objective of a QMS for a medical device company is patient safety. Patient safety is well understood and communicated throughout the medical device industry, leading to an almost single-minded passion for preventing defects. However, if we lose sight of the urgency to deliver a medically-effective and cost-effective device, we can allow the concern for safety to go beyond what is necessary and turn into a bureaucracy. It is crucial to be able to balance without compromising any of these four goals. Remember, a valuable QMS should be optimized and risk-driven to deliver a safe and effective product rapidly and cost-effectively.
While we continuously emphasize the benefits of simplicity, we conversely underscore the importance of not “cutting corners.” If a design or process has been optimized and simplified, what remains is essential and necessary. Each remaining step has value toward our four goals. In the same way, we strongly encourage fixing problems immediately at the root cause. While fixing problems seems intuitive, the process meets resistance when the root cause is in a long-lead item (e.g., an ASIC). There’s immense pressure in such cases to find workarounds and “bandages.” While there may be situations in which these are acceptable, they must be done with great caution and consideration. We have observed many instances in which the long-term impact of the workarounds negatively affects one or more of the four goals.
Taking this 4-goal approach allows us to appropriately size our QMS for a variety of products and stages within the development lifecycle. While the QMS principles remain consistent, the methods and relevant components may change. One size does not fit all, but the safety, efficacy, speed, and cost-effectiveness are a common denominator throughout.
Overt efficiency can also be enjoyable, not only for us but also for our clients. We recognize that productivity can accelerate the device toward meeting the patient’s needs sooner. We’ll go so far as making this bold claim: a QMS can be fun. Many people perceive QMSes negatively due to unfortunate past experiences (“training,” “paperwork,” “administration,” etc.) Recognizing the value of positive culture, we actively seek to overcome those negative perceptions. We understand the importance of QMS checks and balances, while simultaneously celebrating the successes produced by efficient processes, enhanced quality, and accelerated projects. After the foundation of a lean and effective QMS has been laid down, the satisfaction comes the first time – and every time – we realize that a significant delay was avoided due to the processes we prescribed.
A valuable QMS will be used as a tool rather than as an afterthought, the latter being recognizable when a QMS is seen as primarily a documentation process. (Note: if true in your company, it’s time to hit the brakes!) Alternatively, and more nobly, many consider a QMS to be just a safety system. What if a QMS wasn’t just a safety system like a seat belt, but actually helped us drive better? Then it becomes a valuable QMS.
Every medical device company has to create a QMS, expending energy and resources to do so. Why not make it productive instead of a deterrent? A well-thought-out QMS can be a tool used to roll out products faster, speed up design and development, and give the engineering team more freedom in which to do their work. The principles are mandatory, so why not create a process which is competent, efficient, and enjoyable at the same time? Seize the opportunity: don’t make it a hindrance, but a boon!
We’ve said it throughout this blog series: a valuable QMS should be optimized and risk-driven to deliver a safe and effective product rapidly and cost-effectively (our 4 goals). Or, in a simple mnemonic, a valuable QMS makes a product RISE (Rapidly and Inexpensively be Safe and Effective).
