We've certainly come a long way. This statement means something different to all of us, but we can all agree that almost every area in life and society has been swept by technological advancements. From finance to agritech and healthcare, we are constantly finding better ways to do things. The same is true for the medical device industry, but there's still a long way to go. In this article, I will discuss a key area: quality management systems (QMS). Like anything related to quality, we need to consider the cost of quality (CoQ) and the financial implications of successfully (or unsuccessfully) maintaining a QMS.
Introduction to medical device QMS
If you are involved in one or more stages of the life-cycle of a medical device, such as design and development, production, storage and distribution, installation, servicing and final decommissioning, and disposal , compliance with a QMS is inevitable and in most cases, required by law. The requirements may vary based on the market that you find yourself in but the principle is the same: ensuring and maintaining quality and effectiveness in your organization. The most popular QMS standard for medical devices is ISO 13485.
What is an eQMS, anyway?
An eQMS is simply an electronic QMS. This is not the same as using a Google Drive, for example, although Google Drive is an electronic tool. eQMS solutions are integrated cloud-based platforms that provide automated workflows for your processes. In addition, eQMS's allow you to centralize and control all your documentation. And the most important aspect is compliance. eQMS solutions are designed and developed in compliance with the applicable standards and regulations. So choose wisely. An interesting article about choosing a suitable eQMS can be accessed here.
Now the question is, why switch from what you already have? You've spent a lot of time and effort to set up your QMS so it probably sounds unreasonable to throw it away and start with something new. Before we go on, let's talk about the cost of quality (CoQ). Generally speaking, CoQ is measured by summing the cost of poor quality (CoPQ) and the cost of good quality (CoGQ) . To truly get a sense of the cost-benefit of an eQMS, let's better define CoPQ and CoGQ. CoPQ is captured by the following elements:
Internal failures - costs associated with defects found before the product or service reaches the customer;
External failures - costs associated with defects found after the customer receives the product or service
CoGQ is captured by the following elements:
Prevention costs - costs incurred from activities intended to keep failures to a minimum;
Appraisal costs - costs incurred to maintain acceptable product quality levels.
Now that you have the picture, it is clear that implementing and maintaining your QMS should minimize your CoQ. If the opposite is true, then perhaps your QMS is not living to its true potential. This is typically the case when a QMS has processes that rely on repetitive and administrative tasks such as manual document control and manual process monitoring.
Here are 2 simple examples to further make my point:
A company with several hundred users could spend 120 hours on document management processes.
Organizations spend at least an hour per month per employee on average with processes (and their associated documentation) related to training. Approximately 30% of this time can be recovered with eQMS.
The fundamental difference between an eQMS and a "normal" or traditional QMS is the former automates processes and workflows. This saves you a tremendous amount of time and money, as shown in the figure below. DotCompliance has proposed a very insightful breakdown of a return of investment calculation when implementing their eQMS solution for a mid-sized pharmaceutical organization (full article can be accessed here).
While you may want to explore different eQMS solutions, the sooner you make the shift the better. A good example of the necessity to move to an electronic system is that international regulations are also making this shift. The European Medical Device Regulation is in the process of implementing a centralized product registration database. Sooner or later, the way forward will be electronic systems. As we go into the new year, this strategic decision could not only save you money but also give you a competitive and reputational advantage. The ball is in your court.
 ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes